JP2000166902A - Lancet injection instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To prevent plural times of impalement of a lancet for blood drawing by launching a lancet. SOLUTION: This lancet injection instrument 10 is constituted by loading the lancet having an impalement element 44 into a lancet holder 36 and using two spring means 16 and 18 in such a manner that the impalement element of the lancet is impaled into an objective section by advancing the lancet holder and thereafter the impalement element of the lancet is removed and retreated from the objective section by retreating the lancet holder. In such a case, the lancet launching device further has a brake member 50 which imparts resistance to the advancing lancet holder while permitting the advance to the lancet holder and the initial impalement of the impalement element into the objective section when the lancet holder advances for the purpose of the impalement.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a lancet launching device having a piercing element (for example, a needle), which is used when collecting a small amount of blood, a so-called lancing device. More specifically, the present invention provides that the lancet is advanced by a spring means built into the launching device so that the target portion (for example, a fingertip)
The present invention relates to a launch device having a mechanism for retracting after penetrating the skin.

[0002]

2. Description of the Related Art In recent years, the performance of a blood analyzer and a test paper for the same (transferred blood has been transferred onto the test paper and analyzed and measured by the blood analyzer) has been rapidly advanced, and the performance of the analyzer has been rapidly improved. The required blood volume is also low, and it is often sufficient to collect a volume of, for example, 2 μl to 5 μl. In addition, in addition to the blood sugar level, a variety of items relating to hemoglobin, cholesterol, and certain viruses (for example, AIDS virus) can be measured in addition to the blood sugar level that has been used for a long time.

[0003] Further, not only the performance of the analysis and measurement, but also the miniaturization and the reduction of the price of the analysis and measurement device are progressing, and the use of the miniaturized blood analysis and measurement device is increasing not only in hospitals and clinics but also at home. continuing. Therefore, the chance of collecting a very small amount of blood is increasing.

[0004] When such a small amount of blood is collected, a user usually loads a lancet into a firing device and fires the lancet toward a target site where blood is to be collected, for example, a fingertip. The lancet in the firing device is automatically retracted into the firing device after the piercing element pierces the skin by a retracting mechanism built into the firing device.

Typically, after the lancet has been fired from the firing device, the tip of the piercing element (eg, the needle point) protrudes from the firing device and penetrates the skin, retracts and the tip is withdrawn from the skin. The time is said to be between 0.003 and 0.010 seconds. Such a lancet movement will automatically remain retracted after piercing the skin, and then again advance, pierce, retreat again, or again advance, pierce and retract again. That is, it was considered that the target site was not repeatedly pierced (that is, the target site was pierced only once).

[0006] Such a movement of the lancet cannot be recognized by the naked eye, but if a high-speed video camera having a resolution of 0.001 second is used, this movement is changed every 0.001 second. The inventor of the present application has found that it can be accurately decomposed and recognized.

The inventor of the present application has observed the behavior of the lancet when firing and retreating using such a high-speed video camera. According to it, when using a launching device of the type using two spring means for forward and backward movement, the lancet will first penetrate the skin once,
It was found that the robot automatically retreated, had a second advance, penetrated the skin again, had a retreat, and had a third advance. Some commercially available firing devices employ a cooperative mechanism of spring means and cam means, which does not have the problem of re-piercing, but is expensive due to the complexity of the mechanism. There is a disadvantage that it is.

[0008] Without being bound by any theory and not limiting the invention described below,
Considering the lancet behavior described above, from the perspective of the launch device mechanism, one possibility can be analyzed as follows:

[0009] The firing device has two spring means (A and B). Immediately before the launch of the lancet, one of the spring means A is restrained while accumulating energy in a state of being sufficiently compressed from the original shape, and the restrained state is released and the spring means A is moved toward the original shape. The lancet fires forward and vigorously as it tries to stretch. While the spring means A extends toward its original shape and further toward its stretched state, so that the lancet advances,
Immediately before the launch of the lancet, the other spring means B is compressed from its original stretched state and stores energy.

When the piercing element of the lancet penetrates the skin, the end face of the lancet body strikes the end face of the end cap of the ejector and is then bounced back by the end cap, reversing the direction of movement of the lancet, ie , Lancet retreats. At this time, the spring means A
Stops growing and shrinks back to its original shape,
The compressed spring means B tends to expand. That is, the spring means A tries to return from the original shape to the original shape by the energy of the spring means B in addition to the energy of the repulsion by the cover element, and the spring means B is compressed. It tries to extend from the state where it was done toward the original shape.

In the case of a launching device as described above, the energy of the repulsion by the cover element and the energy of the spring means B trying to extend is very large,
As a result, the spring means A is in a state of being compressed again after passing through the original shape (a degree of compression smaller than the first degree of compression due to energy loss due to penetrating the skin and colliding with the cover element). And accumulate energy again.

In this way, the spring means A accumulates energy again, and after the retraction of the lancet stops,
Again, the spring means A attempts to re-extend towards its original shape, the momentum causing the lancet to compress the spring means B and again strike the end cap end face. At this time, the piercing element will pierce the skin again. Then, as before, the lancet retreats,
The spring means B expands, the spring means A contracts, and in some cases, the spring means A is
A second piercing may occur.

As described above, when the lancet is fired by the conventional firing device, the lancet loaded in the ejector repeats forward, piercing and retreating motions by repeating compression and extension of the two spring means. Is thought to gradually attenuate and stop.

In the lancet firing device which relies on the two spring means (forward spring means A and backward spring means B) to advance and retract the lancet as described above, the lancet is repeatedly advanced and retracted. The linear motion as may not be repeated along substantially the same axis, and a second piercing as described above may pierce the skin at a different location than the first piercing . In this case, the lancet will perform substantially two punctures for one blood draw, which will cause unnecessary pain and skin damage to the user. Such different axis movements, as described above,
When a lancet was fired using a blood sampling device of this type on the surface of clay instead of the skin, two piercing marks could be confirmed. If the piercing traces are close together, there may be a substantially larger piercing trace.

Consider the case of measuring the blood glucose level of a diabetic patient. In the case of an insulin-dependent patient, 5 to 7 times a day
Since the blood sampling may be performed twice, using a lancet firing device that penetrates the skin two or three times in one blood sampling in this way causes a large amount of damage to the piercing site, which is more than necessary. The pain of the device and the double pain of slow healing of the wound are given to the user of the device.

[0016]

SUMMARY OF THE INVENTION It is therefore an object of the present invention to prevent a lancet from penetrating a plurality of times when a lancet is fired and blood is collected using a firing device having a forward (or firing) spring means and a backward spring means. That is, it is an object of the present invention to solve the problem that the first advance of the lancet does not substantially hinder the piercing and effectively suppresses the second and subsequent re-advancement (re-launch). It is.

[0017]

SUMMARY OF THE INVENTION An object of the present invention is to load a lancet having a piercing element into a lancet holder and advance the lancet holder to pierce the piercing element of the lancet with a target portion. A lancet firing device configured using two spring means to retract a lancet element from a target site by retracting a holder, wherein the lancet holder is moved forward for piercing. When the lancet holder is retracted, it provides resistance to the advancing lancet holder and allows the lancet holder to retract, while permitting a substantially pierceable initial piercing with respect to both advancement of the lancet holder and blood collection at the target site of the piercing element. And a brake member for providing resistance to the lancet holder to be changed. It is solved by a lancet firing device to have been found.

[0018] The device of the present invention is characterized in that a brake member is present around the lancet holder, which mitigates the momentum of the lancet moving during the initial advancement of the lancet and especially the subsequent retraction, and in some cases the lancet Will also mitigate momentum during the second advancement of
The second and subsequent times are intended to prevent piercing.

In one embodiment of the present invention, the lancet holder has a columnar shape, and the brake member has a cylindrical shape.
It is composed of a main body member and a resistance member extending so as to taper forward from the main body member, and can be located around the lancet holder, wherein a cross section of the main body member of the brake member is larger than a cross section of the resistance member, and At least a part of the cross section is smaller than the main body member and larger than the resistance member, and the lancet holder is arranged inside the brake member so that the lancet holder and the brake member can approach each other along the axial direction from that state. The relative movement causes at least a portion of the lancet holder to come into contact with the resistance member, and further continuing the movement allows the constricted resistance member to elastically spread. In this aspect, any part of the lancet holder comes into contact with the brake member.

In another aspect of the invention, the lancet holder is columnar and has a first portion in front and a second portion in back.
The second part is configured to contact the brake member. That is, in this aspect, the lancet holder is columnar, and is composed of a first portion in the front and a second portion in the rear, and the brake member is cylindrical, and is tapered forward from the body member. The lancet holder is composed of a resistance member that extends so as to be constricted and can be positioned around the lancet holder.
The cross section of the main body member of the brake member is larger than the cross section of the resistance member, the cross section of the first portion of the lancet holder is smaller than the cross section of the brake member, and the cross section of the second portion of the lancet holder is smaller than the main body member, and The lancet holder is disposed inside the brake member, and the second portion is positioned inside the body member. From this state, the lancet holder and the brake member approach each other along the axial direction. , The second portion comes into contact with the resistance member, and when the movement is further continued, the constricted resistance member is elastically spread.

In these embodiments of the invention, the terms lancet holder "pillar-shaped" and brake member "tubular" mean that the brake member is located around the lancet holder, if necessary, separated by a space. The relationship is not limited to the general meaning of the term as long as the relative positional relationship between the two, that is, the relationship in which the lancet holder can be inserted into the brake member, is made possible. That is, in this specification, one member A is replaced with the other member B
The member A is columnar in the sense that it can be inserted into the internal space, and the member B having such a space is referred to as a columnar shape.

Thus, the term “columnar” may be, but does not necessarily mean, solid, and may be at least partially cylindrical, and in some cases substantially substantially entirely. It may be hollow. Also, it is not always necessary that the cross section perpendicular to the axial direction defines a single surface (for example, in the case of a cylinder, the cross section is a single circular surface), and an assembly in which the cross section is composed of a plurality of surfaces (For example, in the case of a columnar aggregate in which three quadrants are separated by three spaces (however, three quadrants are integrally connected at any point in the axial direction), the cross section should be (A set of three quadrants that are separated from each other).

As for the “cylindrical shape”, the cross section perpendicular to the axial direction is a single closed curve or straight line or a combination thereof (for example, in the case of a cylinder, the cross section is a single closed circle). It is not always necessary to define (in this case, it corresponds to the original cylindrical shape), and the cross section may be one in which a part of a closed line is missing or an aggregate of such. For example, the cross section perpendicular to the axial direction may be one in which a part of a circle is missing (for example, an arc having a center at 270 to 330 °). In addition, for example, an aggregate in which three curved side surfaces of a quadrant cylinder are separated from each other in the circumferential direction with a space therebetween is also included in one embodiment of the cylindrical shape. In this case, the cross section has three quadrants (that is, the central angle). (A 90 ° arc) are circumferentially separated from each other by three.

In the present invention, a section is a section perpendicular to the lancet firing direction (hereinafter simply referred to as “section”).
Also called). The size of the cross section is used to mean that when the columnar object can pass through the inside of the cylindrical object, the cross section of the columnar object is smaller than the cross section of the cylindrical object, and conversely, when it cannot pass through the cylindrical object, it is large. The term “elastically spread” is used to mean that the material deforms when a force is applied, but substantially returns to its original shape when the force is removed.

In the device of the present invention, the brake member is made of an elastic material, for example, a thermoplastic elastomer or rubber, and it is particularly preferable that the brake member is formed by integral molding. It is particularly preferred that the resistance member is in the form of a tab or wing extending forward from the body member.

In another aspect of the device of the present invention, the brake member has a groove parallel to the firing direction of the lancet, and the lancet holder has a protrusion fitted into the groove,
This allows the forward movement of the lancet holder to be linear along a substantially constant axis.

The present invention further provides a brake member having a body member and a resistance member for providing resistance to advancement of the lancet holder. The characteristics of this brake member will be readily understood by referring to the description of the lancet launching device of the present invention described above and below.

[0028]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The preferred lancet launching device of the present invention will now be described in more detail with reference to the accompanying drawings. In this specification, the direction in which the lancet is fired is referred to as forward, and the opposite direction is referred to as rear, and the front and rear directions are defined for convenience.

FIG. 1 is a schematic perspective view of a lancet launching device 10 of the present invention, with the upper half of a housing 12 cut away so that the inside can be seen.
FIG. 1 schematically shows a perspective view of a lancet firing device 10 of the present invention in a state where a front half of a housing 12 is cut away so that the inside can be seen. In the illustrated embodiment, the lancet 14 is loaded in the launch device 10, and a state immediately before the lancet 14 is launched is shown.

The device 10 comprises a forward spring means A
And spring 18 as retraction spring means B. A rod 20 is disposed at the center of the housing 12, and the housing 12 is divided into a first chamber 24 in the front and a second chamber 26 in the rear by a partition (partition) 22, and the rod 20 spans both of these chambers. Are located.

The spring means 16 and 18 are arranged around the rod 20 on both sides of the partition 22 so that they do not penetrate beyond the partition into the opposite chamber. In the illustrated embodiment,
The spring means 16 is restrained from its original shape (i.e., the shape without any restraint) in a sufficiently compressed state (the lancet is ready to be fired), and the spring means 18 is stretched to its original shape or more. It is constrained by the shape.

Such a restrained state is achieved by the locking means 30 provided at the front end of the engaging member 28 integrally connected to the front end of the rod 20 around which the spring means is disposed. , By contacting a stop 32 provided in the housing. Further, the rod 20 further has a connection rod 34 integrally connected at a front end, and the connection rod 34 has a lancet holder 36 holding the lancet 14 at the other front end.

In the embodiment shown, an end cap 38 is located at the front end of the housing 12 and is engaged, for example, by a snap fit. From the state shown,
When the firing button 40 is pressed downward, the contact state between the locking means 30 and the stop 32 is released, and the energy stored in the compressed state causes the spring means 16 to extend to return to the original shape. , Thereby rod 2
0, connection rod 34, lancet holder 36
And the lancet 14 integrally moves forward (to the left in the illustrated embodiment). At this time, the spring means 18
Are gradually compressed, and thus gradually store energy. In general, the energy stored in the spring means 16 is considerably large, so that even if the spring means 18 is gradually compressed, the spring means 16 tends to extend beyond the original shape and further extend than the original shape. .

As described above, the lancet 14 causes the end cap 38
And the end 42 of the lancet 14 strikes the end face 48 of the end cap 38. At this time, the piercing element 44 protruding from the end surface 42 of the lancet 14 protrudes from the opening 46 of the end cap 38, and pierces the piercing target site (not shown), for example, the skin of the fingertip. Pierce.

Thereafter, the lancet 14 is rebounded by the end face 44 of the end cap and the spring means 18
Tends to expand from the compressed state in the opposite direction, and the spring means 16 tends to contract toward its original shape. By these actions, the piercing element 44 escapes from the target site and retracts into the end cap 38, and the lancet 1
4. The lancet holder 36 and the rod 20, etc., are retracted integrally.

The lancet is fired by such a mechanism, and the lancet is retracted by penetrating the target portion.
Lancet firing devices that use two spring means are well known and will not be described in further detail. The basic mechanism of such a device is described in, for example,
No. 141929, and as a specific launching device, for example, trade name: PENLET-
II, which is commercially available from LifeScan, can refer to these for details of the launch mechanism of the lancet launch device.

The lancet launching device 10 of the present invention comprises:
Around the lancet holder 36, a brake member 50 for braking the movement of the lancet holder 36 is provided on the housing 1.
It is characterized in that it is arranged in 2. As is apparent from the figure, the brake member 50 is located around the lancet holder 36, so that the brake member 50 is cylindrical and the lancet holder 36 is columnar.

The lancet holder 36 is preferably substantially line-symmetric or point-symmetric in cross section perpendicular to the lancet's firing direction (also referred to simply as “cross section” as described above). The center (in the case of line symmetry, the center between the points where the axis of symmetry intersects the perimeter of the cross-section) is the longitudinal axis of the lancet (usually the axis substantially coinciding with the piercing element, hereinafter simply referred to as the "axis "). The cross-sectional shape of the lancet holder 36 may be a circle, an ellipse, a rectangle, a polygon, or the like, and a shape in which these are partially combined (for example, as can be seen from FIG.
(A shape combining a circular arc portion and a straight line portion). The cross section of the lancet holder 36 may be uniform in the axial direction or may vary.

The lancet holder 36 includes a first portion 60 having a gap at a front end thereof and a second portion 62 behind the first portion 60. The gap has an end portion at which the piercing element 44 of the lancet 14 projects. The end opposite to 42 can be fitted. Cross section 6 of second part
2 has a shape larger than and including the cross section of the first portion 60, that is, a shape in which the cross section of the second portion is surrounded by the cross section of the first portion when comparing the cross sections. In the illustrated embodiment, the lancet holder 36
Has a second portion rearwardly larger in cross section than the first portion, but the cross section of at least a part of the lancet holder 36 is smaller than the main body member 62 and larger than the resistance member 54, and the cross section of the remaining portion is It is smaller than both the member 52 and the resistance member 54. Such a portion may be present at any location on the lancet holder 36, and in another aspect, rather than a portion, the lancet holder 36
Is smaller than the main body member 62 and the resistance member 54
It may be larger.

The brake member 50 includes a cylindrical main body member 52.
And a resistance member 54 extending forward (in the firing direction) therefrom.
Having. The cross-sectional shape of the main body member 52 is such that the second portion 6 surrounds the second portion 62 of the lancet holder 36.
2 has a shape that can pass through the inside of the main body member 52 substantially without resistance (or friction). That is, the cross section of the second portion 62 is smaller than the cross section of the main body member 52. For this purpose, it is preferable that a space is present at least partially between the second portion 62 and the main body member 52.

Specifically, the cross section of the second portion 62 is similar to the cross section of the main body member 52, and the main body member 52 may have a cross section slightly larger than the cross section of the lancet holder. For example, if the cross section of the second portion 62 is circular, the cross section of the body member 52 may be a circle slightly larger than the diameter of the circle (thus, if they are concentrically arranged, the second A space is formed around the portion 62 between the main body member 52).

In another embodiment, when the cross section of the second portion 62 is a polygon, the cross section of the main body member 52 may be a circle slightly larger than the circumscribed circle of the polygon. In order to reduce the substantial resistance as much as possible, it may be preferable that the cross-sectional shape of the second portion 62 and the cross-sectional shape of the main body member 52 are not similar. This is because when the positional relationship between the two members is deviated from concentricity, there is a possibility that both the members come into surface contact and the resistance may be increased. The main body member 52
Does not need to be an original cylindrical shape around the entire axis at all parts along the axial direction. For example, as can be seen from FIG. 2, a part along the axial direction lacks a part of the circumference. Is also good. In yet another aspect, the brake member may lack a portion of the circumference along the entire axial direction (e.g.,
(See FIG. 5).

When the lancet is fired and moves forward, the resistance member 54 causes the first portion 60 of the lancet holder 36 to move forward.
Has a function of giving resistance to the movement by contacting the second portion 62 without substantially contacting the second portion 62. Therefore, the cross section of the resistance member 54 is
Is substantially larger than the cross section of the first portion 60, but at least a part of the cross section along the axial direction of the resistance member 54 is the second portion.
It must be substantially smaller than the cross section of portion 62.

As described above, in the present specification, a small or large cross section does not mean a magnitude based on a cross sectional area, but one member A (for example, the first portion 60) is connected to the other member B ( For example, if it can pass through the inside of the resistance member 54), preferably without substantial resistance,
The cross section of the member A is referred to as smaller than the cross section of the member B. If the cross section cannot pass, the cross section of the member B is referred to as smaller than the cross section of the member A. In the opposite case, it is called large. Therefore, the cross section of the second portion 62 is smaller than the cross section of the main body member 52.

In the firing device of the present invention, the resistance member 54 of the brake member 50 is connected to the second portion 6 as described above.
A section smaller than the section 2 is defined. This small cross-section does not remain fixedly small, but when the lancet is fired, the lancet holder 36 advances and passes through the first portion 60 while the second portion 62
When contacting and providing resistance thereto,
, A forward force is exerted by being pushed by the lancet holder 36. This force pushes out the resistance member 54 having a small cross section, and enlarges the cross section. In the illustrated embodiment, the second portion 62 is located behind the lancet holder 36, but the second portion may be partially present anywhere on the lancet holder 36, or the entire lancet holder 36 It may have a cross section like two parts (in this case the resistance provided by the brake member is increased).

The energy of the spring means 16 for firing the lancet is very large, so that the force acting on the resistance member 54 is such that the cross section of the resistance member is
Is substantially the same as the cross section of FIG. As a result, the second portion 62
Can advance while being resisted by the resistance member 54, and finally, the end face 42 of the lancet 14 collides with the end face of the end cap 38, and the piercing element 44
It protrudes from the opening 46 of the end cap 38 and pierces the target site. At this time, at least a portion of the second portion 62 remains in contact with the resistance member 54, that is, the second portion 62 exists below the resistance member 54.

After the collision, the lancet 14 is rebounded by the end face of the end cap 38, the second portion 62 is retracted, and the piercing element 44 comes out of the target portion. Since the portion 62 remains in contact with the resistance member 54, the retreating momentum of the second portion 62 is further reduced, and then the lancet holder 36
Is further retracted, and the contact between the second portion 62 and the resistance member 54 is released. When the contact is released, the shape of the resistance member 54 returns to the original constricted shape having a small cross section.

When the second portion 62 is thus retracted, the compression of the spring means 16 does not proceed as much as when the brake member 50 is not present. That is, the spring means 16
Does not store much energy, so that even if the compressed spring means 16 re-extends and the lancet holder 36 advances, the second portion 62 retains the resistance provided by the resistive member 54 which has returned to its original shape. for,
The lancet 14 cannot advance beyond the front end of the resistance member 54 so that the piercing element 44 of the lancet 14 does not protrude from the end cap 38, preventing multiple piercings as described with respect to the prior art.

The change in the cross section of the resistance member 54 as described above (change in the cross section from a small constricted state to an expanded state and a return to the original constricted shape) is elastic. That is, the resistance member 5
When a force acts on the resistance member 4, the resistance member 54 changes from the original constricted shape to an expanded cross-sectional shape, and when the force acting on the resistance member 54 disappears, the resistance member 54 substantially reduces from the expanded shape to the original constricted shape. Return to section.

In the launch device of the present invention, the lancet 1
4 must be fired to cause the piercing element 44 to protrude from the opening 46, so that the resistance member 54 should not provide enough resistance to stop the fired lancet,
The cross-section must be configured to resiliently change so as to provide enough resistance to reduce the forward momentum of the fired lancet. That is, the resistance member 54 is a
Extended forward and tapered (or narrowed)
It has a tapered shape as its original shape, which can elastically expand when a force is applied to expand it. The configuration of such a resistance member can be controlled by the material used for the brake member 50, the shape of the resistance member 54, and the like.

The resistance member 54 may have any configuration as long as it comes into contact with the second portion 62 to absorb the kinetic energy of the lancet that advances first and prevent the second penetration. It may be. For example, the resistance member 54 may be in the form of an opposed pair of wings, as shown, depending on the cross-sectional shape of the second portion 62 of the lancet holder, either along the axial direction of the resistance member 54. Contact the second portion.

In the illustrated embodiment, the second portion 62 includes
Although it has a cross section larger than the resistance element 54 over the entire circumference, since the resistance element only partially exists at two places, the portion that does not actually contact the resistance element 54 is: It may have a small cross section. That is, the second portion 62 having a large cross section need not provide a large cross section over the entire circumferential direction,
It is sufficient that at least only the circumferential portion in contact with the resistance member 54 has a large cross section.

The brake member 50 may be made of an elastic material such as a plastic material, preferably a thermoplastic elastomer (for example, polyester elastomer, polystyrene elastomer, polyolefin (for example, polypropylene / polyethylene) elastomer), silicone rubber,
It is formed from natural or synthetic rubber, urethane or the like. When a material having a lower elasticity or a material having a higher coefficient of friction is used, it is preferable that the taper angle of the resistance element with respect to the axial direction is made smaller (that is, closer to the horizontal direction). This formation is preferably performed integrally by injection molding.

The structure of such a brake member is as follows.
In order to prevent the second penetration, it is necessary that the first penetration is not hindered, while giving a suitable resistance to the lancet holder advancing as described above. That is, regarding the performance of the brake member, the resistance applied when the lancet holder moves forward is smaller than the energy stored in the forward spring means, and the resistance applied when the lancet holder retracts after piercing is applied to the reverse spring. It is preferable that the resistance is larger than the stored energy, and the resistance member functioning in this manner may be designed by a combination of materials and dimensions.

The specific configuration of the resistance member and, therefore, the structure of the brake member is as follows in a conventional lancet firing device.
Introduce the concept that multiple penetrations have been performed, that such penetrations can be confirmed by using a high-speed video camera, and that the brake member provides a moderate resistance to the advancing lancet holder. Based on the disclosure of the present specification which discloses that a plurality of piercings can be prevented by those skilled in the art, those skilled in the art can easily correspond.

For example, as shown in FIG.
Reference numeral 0 denotes a substantially cylindrical main body member 52 and a resistance member 54 extending from the main body member 52 so as to be narrowed forward. The resistance member is formed in a cylindrical shape by separating a plurality of slits opened at the front end thereof. By providing them at a distance, they can be composed of a plurality of elements.

The resistance member may have an original cylindrical shape.
In the above-mentioned cylindrical meaning, it is not necessary to extend forward from the entire circumference of the main body member, and the function can be fulfilled only by extending forward from at least a part of the periphery of the main body member. For example, in the embodiment shown in FIG. 2, a substantially rectangular one extending from both sides that are part of the circumference of the main body member 52 is provided.
Only the pair of elements (only the front side is visible) functions as the cylindrical resistance member 54, and the element 70 extending forward from the other part of the periphery of the main body member does not function as the resistance member (of course, If desired (i.e., if it is necessary to provide a higher resistance), it may be formed to function with a resistive element). Although the main body member 52 may be originally cylindrical, it is not necessary that the main body member 52 has a closed cross section over its entire length in the axial direction, and the upper portion may be open as shown in FIG. Embodiments are also included in a cylindrical shape.

In the embodiment shown in FIG. 2, the resistance member is in the form of at least one pair of rectangular objects such as wings, tabs, teeth, etc., which protrude forward from the main body member, and is preferably such an embodiment. . Alternatively, it may be in the form of a comb or whisker protruding from the entire circumference of the main body member 52 or a part thereof so as to narrow forward.

Usually, the material itself has elasticity and is in the form of a rectangular object (in other words, the resistance member 54
Is provided only on a part thereof along the outer periphery of the main body member 52), so that the resistance member can be configured to be rich in appropriate flexibility and perform a predetermined function.

FIG. 3 is an enlarged perspective view of the illustrated brake member 50. In the illustrated embodiment, the brake member 5
Reference numeral 0 denotes a main body member 52 and a resistance member 54. In the brake member, the regions of these members cannot be clearly separated, but the boundaries of these members are indicated by broken lines 80 for convenience. As noted above, the body member 52 is substantially cylindrical in the sense of the present description, but its cross-section is not closed along the entire axial direction 82 and is open at a portion 84 (ie, an open line). , Having both ends), and the upper part 86 is open, but is a closed line (both ends are connected) along the other part 88, and has an original cylindrical shape.

The opposing pair of resistive elements 54 are in the form of wings or tabs extending from the body portion 52 so as to taper forward. In the embodiment shown, there is only one pair of resistive elements 54 and the other elements 90 extending from the body member 52 are formed so as not to be substantially constricted. These elements 90 may be constricted as well as the resistance element 54 as necessary. However, if the function as the resistance element is not required, part or all of the element 90 can be omitted. In the embodiment shown, the resistive element 54 is part of the original tubular form and the element 90
Also acts as a resistance element, the resistance element (54+
90) is substantially the original cylindrical shape.

As described above, in the present specification, the term “cylindrical” does not necessarily have to be a cylinder whose side face is completely closed. It is used in the meaning included in. When the resistance element 54 is formed in a rectangular shape such as a tab or a wing, slits 92 having open front ends exist on both sides. By changing the position of the slit, the length of the resistance element 54 in the circumferential direction 94 can be changed to change the resistance applied to the lancet holder. The resistance element 5 can also be changed by changing the material used and the angle of the taper.
4 can change the magnitude of the resistance.

As shown in FIG. 3, when no force is applied to the brake member 50 from the outside and the resistance element 54 is narrowed forward, any one of the resistance elements 54 along the axial direction The cross section at that position (preferably near the axial midpoint) is the second of the lancet holder.
It is smaller than the cross section of the portion 62. For example, the distance between the tips of the opposing resistive elements is the second part 6 of the lancet holder.
2 is formed so as to be smaller than the maximum distance between two points on the outer periphery of the cross section (the diameter if the cross section is circular). In general, the axial position where the cross section of the resistance element 54 and the cross section of the second portion 62 are the same, that is, the position where the second portion 62 contacts the resistance element 54, The resistance provided by element 54 to second portion 62 is reduced.

When the launching device is not in use, the second part 62 of the lancet holder is located behind the resistance member 54 and is not in contact with the resistance element 54, so that the resistance element 54 Since no force is applied, the resistance element 54 does not creep and does not lose the performance of the brake member.

In a particularly preferred embodiment of the present invention, a groove for guiding the forward / backward movement of the lancet holder 36 is provided on the inner wall of the brake member 50, and the lancet holder has a projection corresponding to the groove. Is provided. For example, in the embodiment shown in FIG. 3, a groove 100 parallel to the firing direction of the lancet is provided as a guide across the inner walls of the resistance member 54 and the main body member 52.

The lancet holder 36 is provided with a protrusion having a shape protruding so as to be located in the groove. The protrusion may be in a long form (e.g., 5 mm to 8 mm long). In another aspect, the protrusion may be two point-like projections arranged parallel to the firing direction of the lancet, and in some cases, one projection.
It is preferable to provide at least one combination of the groove and the protruding portion, but it is particularly preferable to provide one pair so as to face each other as shown in FIG. The grooves and protrusions ensure that the lancet holder cooperates stably and linearly along the lancet firing direction axis while the lancet holder advances and retracts. This also helps to minimize pain and wounds during piercing. still,
It is also possible to provide the groove on the lancet holder and the projection on the brake member.

The brake member 50 as described above can be manufactured by integral molding, and is preferably an integral molded product. When assembling the lancet launching device, the integrated lancet holder 36, connection rod 34 and the rod 20 with the spring means 16
And 18 (for forward and backward), and with the brake member 50 covered on the lancet holder 36,
The assembly of the lancet launching device of the present invention is simple, since these need only be set in the hanging 12 on one side.

FIG. 4 is a schematic sectional view showing a change in the state of the brake member in the lancet firing device of the present invention. Immediately after launch of the lancet (Fig. 4 (a))
The state from the time of collision with the end cap 38 (FIG. 4E) is shown:

FIG. 4A: Immediately after firing, the lancet holder 36 advances inside the brake member 50, and the second portion 6
2 does not come into contact with the main body portion 52 (since the space between the main body portion and the second portion is small, it looks as if they are in contact with each other in the figure, but there is some gap between them); Further, the first portion 60 includes the main body portion 52 and the resistance member 54.
Not in contact with

FIG. 4B: When the lancet holder 36 further advances, the first portion advances beyond the tip of the resistance member. Even in this state, the second portion 62 is
(Because the distance between the main body and the second part is small,
In the figure, it looks as if they are touching, but there are some gaps between them).
It is not in contact with the resistance member 54 (since the distance between the resistance member and the first portion is small, it looks as if they are in contact in the figure, but there is some gap between them). If the lancet 14 can strike the end face of the end cap 38, the first portion 60 may contact the resistance member 54, and the resistance member 54 only provides resistance to the advancing lancet holder.

FIG. 4 (c): This is essentially the same as FIG. 4 (b), except that the lancet holder is further advanced. FIG. 4D: The resistance member 54 which has been tapered has started to spread. The lancet holder moves forward against the resistance while receiving the resistance by the resistance member 54.

FIG. 4 (e): The lancet 14 has collided with the end face of the end cap 38. The second portion 62 comes into surface contact with the resistance member 54 and receives a large resistance from the resistance member 54, and as a result, the momentum of the lancet holder retreating is greatly reduced.
Meanwhile, the manner in which the lancet retreats reversely changes from FIG. 4 (e) to FIG. 4 (a).

FIG. 5 shows another embodiment of a brake member 50 ′.
Is shown similarly to FIG. In the illustrated embodiment, the cross section perpendicular to the axial direction of the brake member 50 'is a line (for example, an arc-shaped curve) open along the entire axial direction, so that the brake member 50' Has an opening 104 along the upper side. Such an embodiment has the advantage that the lancet holder can be inserted through the opening 104 from a direction perpendicular to the axial direction when assembling the firing device, depending on the material used for the brake member 50 '. Except for having an opening 104, the illustrated brake member 50 'is substantially the same as the brake member 50 of FIG.

[0074]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A lancet launching device 10 as shown in FIGS. 1 to 3 was designed, a one-piece mold was prepared for each required part, and a resin member was obtained by injection molding.

In the examples, the following materials were used for each part: Housing 12 (ABS resin) End cap 38 (Polycarbonate resin) Lancet holder 36 + Connection rod 34+
Rod 20 + engagement member (polycarbonate resin) Brake member (polyester elastomer resin) Launch button (polyacetal resin)

The distance (inner method) between the narrowed end of the resistance member 54 of the brake member 50 is 7.7 mm, and the diameter of the largest portion of the cross section of the second portion 62 of the lancet holder is 7.8 mm.
Since it was 7 mm, the diameter difference was 1 mm, and the axial length of the resistance member 54 was 5.8 mm. Further, the thickness of the resistance element 54 was 0.8 mm. The following spring means were used: for forward use-6.2 mm in outer diameter × 21.5 mm in length;
Sus3 with 45mm and spring constant of 0.021kgf / mm
04 spring for retreating-outer diameter 6.45 mm x length 22.7 mm, wire diameter 0.26 mm, spring constant 0.0016 kgf / mm
us304 spring

After assembling each part into the housing 12,
The left and right housings were welded using an ultrasonic processing machine to obtain a completed lancet device 10 of the present invention. The brake member has a groove for guiding the protrusion 102 provided on the lancet holder 36.

Example 1 As a first check, the following test was performed to determine whether the advancement of the lancet holder 36 due to the attachment of the brake member 50 was adversely affected.

A firing device having no braking performance is similarly manufactured by cutting off the resistance element 54 of the brake member 50,
A commercially available lancet was loaded into this, and a test was performed to determine how many sheets to pierce when the lancet was fired on the stacked commercial copy sheets, and 11 sheets were pierced. (About 0.97 mm / 11 sheets thick).

Next, a commercially available lancet was loaded into the lancet firing device of the present invention having a brake member, and a commercially available copy sheet was pierced.
I pierced one sheet. The lancet was renewed each time, and this test was performed five times. In this test, the piercing traces remaining on the copy paper were observed with a loupe, and the number of piercing traces recognized was defined as the number of piercings.

From this test, it was confirmed that in the lancet firing device of the present invention, the brake member did not hinder the advancement of the lancet holder (and thus the lancet) at all.

Example 2 Next, a commercially available lancet was attached to the lancet launching device of the present invention, and the lancet was launched toward a flat clay, and the state of piercing marks remaining on the clay was observed with a loupe. This test is 5
The procedure was repeated five times, but the number of piercing traces was one for all five times, and the cross section of the piercing trace was similar to the cross section of the piercing element of the needle. From this, it was determined that the performance of guiding the lancet holder (lancet) of the brake component in the present invention was extremely high.

For comparison, a lancet was mounted on a commercially available firing device having no mechanism for guiding a spring-driven lancet holder, and the lancet was fired on the same flat clay. Piercing marks were observed. This means that in the use of a spring-driven blood collection device that does not have a guide function and a brake function, there is twice penetration in one blood collection operation, and two wounds due to the penetration can be made. Was determined to be.

Example 3 Next, a high-speed video camera having a resolution of 1/1000 second was prepared, one side of the front part of the end cap was cut off, and the lancet mounted on the firing device and fired was pierced. , And the behavior after piercing can be taken. At the end of the end cap, a 0.8 mm thick silicone rubber film was set to simulate human skin

A commercially available lancet was attached to the launching device of the present invention, launched, and the situation was photographed and recorded by high-speed video.

This test was performed three times, and thereafter, the behavior of the lancet was observed using the recorded video tape. The lancet was advanced to the most advanced position (the inner front end of the end cap) in all three times, He pierced the rubber and was retreating. Thereafter, it was confirmed that the brake member applied the brake and stopped during the re-advancement. When the lancet was stopped, the distal end of the piercing element was stopped short of the inner wall of the front end of the end cap, and therefore, the second piercing of the silicone rubber had not been achieved. In addition, the lancet holder and lancet advance and rear end are smooth,
A state in which the firing direction axis fluctuated up and down was not observed at all.

For comparison, a high-speed video was also observed for a spring-driven launching device in which the lancet holder did not have a guide mechanism, but the lancet retreated after the first piercing, then retreated. It was observed that he retreated, and then re-advanced. The number of times of piercing was determined based on whether or not the tip of the piercing element of the lancet was exposed from the end face of the end cap. It was confirmed that the film was exposed three times. In addition, the piercing element rocked up and down during the forward and backward movement of the lancet holder and the lancet. These things are
When piercing is performed two or three times, it means that wounds due to piercing can be formed at two or three places.

These findings can be said to support the findings found in the piercing test on clay. In this test, the lancet pierces, retreats, re-advance, re-retreat, re-advance, re-retreat,
After that, it took 7.2 hours on average to completely stop.
/ 1000 seconds.

In the embodiment, the repulsive force of the forward spring means 16 is 353 g (at a compression of 15 mm), and the repulsive force of the backward spring means 18 is 31.
7 g (at a compression of 15 mm), the difference between the diameter of the second part 62 of the lancet holder and the distance between the tip of the resistance member of the brake member is 1.0 mm, and the second part of the lancet holder has the resistance member Was 47.2 g (average of 5 measurements) (measured by a tensile tester).

From this data, it can be seen that even if the launching device of the present invention has a brake member, it does not substantially hinder advancement of the lancet holder and effectively suppresses re-advancement of the lancet holder. .

Through Examples 1 to 3, the lancet firing device having the brake member of the present invention can secure only one puncture in one blood sampling operation, and can ensure a substantially linear lancet firing. Can be said to have been confirmed. This promises the user much less pain and a small wound as compared to conventional lancet launching devices, and users who have to take one to seven blood samples from the skin every day Very useful for.

[0092]

As is apparent from the above description, in one blood sampling operation using the lancet firing device,
It is possible to ensure a single puncture and furthermore to ensure minimal pain and minimal wound damage by guiding the lancet holder (lancet) substantially straight.

[Brief description of the drawings]

FIG. 1 is a schematic perspective view of a lancet launching device of the present invention with the upper half of the housing cut away so that the interior can be seen.

FIG. 2 is a schematic perspective view of the lancet launching device of the present invention with the front half of the housing cut away so that the interior can be seen.

FIG. 3 is an enlarged schematic perspective view of a brake member used in the lancet firing device of the present invention.

FIG. 4 is a step-by-step schematic cross-sectional view showing a state in which a lancet is fired by the lancet firing device of the present invention and penetrated.

FIG. 5 is an enlarged schematic perspective view showing another embodiment of the brake member used in the lancet firing device of the present invention.

[Explanation of symbols]

10 ... Lancet launch device, 12 ... Housing, 1
4 ... Lancet, 16, 18 ... Spring means, 20 ...
Rod, 22 partition, 24 first chamber, 26 second chamber, 28 engaging member, 30 locking means, 32 stop, 34 connection rod, 36
... Lancet holder, 38 ... End cap, 40 ...
Launch button, 42: lancet end face, 44: piercing element,
46 opening, 48 end cap end face, 50 brake member, 52 body member, 54 resistance member, 80 virtual boundary, 82 axial direction, 86 upward opening, 92 slit, 100 groove, 102 ... projecting part, 104 ... opening.

Claims (9)

[Claims] 1. A lancet having a piercing element is loaded into a lancet holder, and the lancet holder is advanced to cause the piercing element of the lancet to penetrate a target site, and then the lancet holder is retracted to thereby cause the lancet holder to retract. A lancet firing device configured using two spring means to pull out a piercing element from a target site and retract the lancet holder, wherein when the lancet holder is advanced to pierce, the lancet holder is moved forward and out of the lancet holder. Provides resistance to the advancing lancet holder and resistance to the retracting lancet holder after the piercing, while permitting a substantially safe initial piercing of both the blood collection at the target site of the piercing element A lancet-launched debye further comprising a brake member . 2. The lancet holder has a columnar shape, and the brake member has a cylindrical shape, and is composed of a main body member and a resistance member extending so as to taper forward from the main body member. The cross section of the body member of the brake member is larger than the cross section of the resistance member, and the cross section of at least a part of the lancet holder is smaller than the main body member and larger than the resistance member, and the lancet holder is disposed inside the brake member. do it,
When the lancet holder and the brake member are relatively moved from the state so as to approach each other along the axial direction,
The device of claim 1, wherein at least a portion of the lancet holder contacts the resistive member and the constricted resistive member resiliently spreads as it continues to move. 3. The lancet holder is columnar,
The brake member is formed of a first member on the front side and a second portion on the rear side, and the brake member is formed of a cylindrical member, and is formed of a body member and a resistance member extending so as to taper forward from the body member. The cross section of the second part is larger than the cross section of the first part, the cross section of the main body member is larger than the cross section of the resistance member, the cross section of the first part is smaller than the cross section of the brake member, and The cross section of the two parts is smaller than the main body member and larger than the resistance member, and the lancet holder is arranged inside the brake member,
When the second portion is located inside the main body member, and the lancet holder and the brake member are relatively moved along the axial direction toward each other along the axial direction from the state, the second portion is obtained.
2. The constricted resistance member elastically spreads as the portion contacts the resistance member and continues to move.
Or the device of 2. 4. The device according to claim 1, wherein the brake member is made of an elastic material. 5. The device according to claim 1, wherein the elastic material is a thermoplastic elastomer or rubber. 6. The device according to claim 1, wherein the resistance member is in the form of a tab or wing extending forward from the body member. 7. The device according to claim 1, wherein the brake member has a groove parallel to the firing direction of the lancet, and the lancet holder has a protrusion fitted into the groove. 8. A lancet having a piercing element is loaded into a lancet holder, and the lancet holder is advanced to pierce the piercing element of the lancet with a target site, and then the lancet holder is retracted to thereby cause the lancet holder to retract. A brake member used in a lancet firing device configured by using two spring means so as to pull out a piercing element from a target site and to retract the lancet element, wherein the lancet is moved when the lancet holder is advanced to pierce. A brake member that allows advancing of the holder and piercing of a target portion of the piercing element, but also provides resistance to the advancing lancet holder. 9. A brake member according to claim 8, which is used for the lancet firing device according to claim 1.