JPWO2009041110A1 - Lancet assembly and lancing device - Google Patents

Abstract

A puncture device is provided that includes an indicator mechanism having an outer plate member and an inner plate member. In such a puncture device, the outer plate member and the inner plate are accommodated adjacent to each other in the injector housing. In a state where the lancet assembly is not loaded, the outer plate member and the inner plate member are located at the installation position of the window portion provided in the housing, and the outer plate member is visible from the window portion. When the lancet holder is inserted into the injector, the outer plate member moves backward due to the lancet holder. As a result, when the lancet holder is inserted until puncturing is possible, the outer plate member moves to a position shifted backward from the installation position of the window portion, and the inner plate member is moved from the window portion. Become visible.

Description

  The present invention relates to a puncture device used for puncturing a predetermined part of a body with a sharp puncture member (for example, a needle) for the purpose of collecting body fluid such as blood. The present invention also relates to a lancet assembly (consisting of a lancet and a lancet holder that accommodates the lancet assembly) that is a component of such a puncture device, and an injector used in combination with such a lancet assembly.

  In order to measure the blood glucose level of a diabetic patient, it is necessary to collect the blood of the diabetic patient. Various puncture devices are used to collect a small amount of blood. Such a device is generally composed of a lancet and an injector provided with a puncture member for puncturing a predetermined part of the body. The injector has a function of firing the lancet toward a predetermined location. In use, after the lancet is loaded into the injector, the lancet is fired toward the predetermined location by utilizing the action of the spring compressed in the injector to puncture the predetermined location.

In such a puncture device, starting from the operation of loading the lancet into the injector, the puncture operation and the operation of taking out the used lancet from the injector must be performed, and the following nine steps are generally present:
(1) Remove the injector cap from the injector;
(2) Insert the lancet into the injector;
(3) removing the lancet cap from the fitted lancet to expose the tip of the puncture member;
(4) Cover the injector cap removed in (1) above;
(5) Cocking the injector so that the lancet is loaded (ie, ready for puncture);
(6) Attach the front end opening of the injector to the puncture site and press the trigger button to fire the lancet;
(7) Remove the injector cap;
(8) Isolate the tip of the puncture member from the surrounding environment by fitting a protective cap on the tip of the exposed puncture member; and (9) Remove the lancet from the injector and dispose of it as a used lancet .

  Carrying out these nine steps in sequence is actually a cumbersome task and preferably requires fewer steps.

  When collecting blood using a puncture device, special care must be taken when handling a used lancet. In the lancet after puncturing, the puncture member (particularly, the distal end portion of the puncture member) to which the blood of the blood sample has adhered is usually exposed from the front end of the lancet body. Therefore, if the tip of this puncture member is accidentally touched by a person other than a blood sample, such as a nurse or a medical worker such as a doctor who performs blood sampling, the tip may damage the body. As a result, there is a risk that the blood of the blood sampled from the wound will enter the medical worker's body and become infected.

  The puncture devices currently in use are not necessarily fully studied in terms of handling used lancets. For example, it has been proposed to put a protective cap on the tip of the puncture member exposed as described above (see Patent Document 1). However, in such a puncture device, the act of putting the protective cap itself is dangerous. That is, when covering the protective cap, it is necessary to handle the lancet in a state where the tip of the puncture member is exposed, and the above-mentioned danger has not been eliminated in that respect.

  In view of such circumstances, the present applicant has proposed a puncture device as shown in Patent Document 2. Such a puncture device and a lancet assembly of its components will be briefly described with reference to the drawings. The lancet assembly is composed of a lancet 150 '(see FIGS. 32A to 32C) and a lancet holder 102' (see FIGS. 33A and 33B) for receiving it. As shown in FIGS. 32A to 32C, the lancet 150 ′ includes a lancet body 151 ′, a lancet cap 152 ′, and a puncture member 153 ′, and the metal puncture member 153 ′ is a resin lancet body 151 ′. And the lancet cap 152 ′, the tip of the puncture member 153 ′ is covered by the lancet cap 152 ′, and the lancet cap 152 ′ and the lancet body 151 ′ bridge the bridge member 154 ′. Are joined together. As shown in FIGS. 33A and 33B, the lancet holder 102 'has an opening end 103' and a puncture opening 105 'on a surface 104' facing the opening end 103 '. In the lancet assembly before use, the lancet body 151 'is fixed to the lancet holder 102'. More specifically, the lancet holder 102 ′ is provided with guides 107 ′ for guiding the lancet body along the puncturing direction on the inner walls facing each other (see FIG. 33B). A guided portion 157 ′ is provided to be fitted in the guide 107 ′ (see FIG. 32A), and a convex portion 158 ′ provided in the guided portion 157 ′ and a convex portion 108 ′ provided in the guide ( , And the lancet body is fixed in the lancet holder. In particular, as shown in the dotted line in FIG. 34, the lancet body 151 'is fixed in the lancet holder 102' so that the two protrusions A (158a ', 158b') sandwich the one protrusion B108 '. When only the lancet cap 152 ′ is pressed in the puncture direction from the opening end 103 ′ toward the puncture opening 105 ′ with the lancet body 151 ′ fixed to the lancet holder 102 ′ as described above, the bridge member 154 ′ is As a result, the lancet cap 152 ′ is separated from the lancet body 151 ′, and the lancet body 151 ′ in which the tip of the puncture member 153 ′ is exposed is obtained. When the separated lancet cap 152 ′ is subsequently pressed in the puncturing direction, the lancet cap 152 ′ moves to a position deviating from the puncture track of the puncture member 153 ′ within the lancet holder 102 ′ (see FIGS. 34 and 35). In particular, such a lancet assembly is loaded into the injector 200 ′ (see FIGS. 36A and 36B) so that the lancet cap 152 ′ is separated from the lancet body 151 ′ and the separated lancet cap 152 ′ is removed from the puncture track. It comes to be located.

  Injector 200 'is a device that can be used in combination with a lancet assembly to fire a lancet body with the tip of the puncture member exposed. As shown in FIG. 37, the injector 200 ′ can be engaged with the rear end portion of the lancet body, the plunger 204 ′ for firing the lancet body in the puncturing direction, and the lancet cap removal member 206 ′ that can be engaged with the lancet cap. It has. Therefore, when the lancet holder 102 'is inserted from the front end opening 202' of the injector 200 'and the lancet assembly is loaded into the injector 200', the lancet cap removal member 206 'is engaged with the lancet cap as shown in FIG. Will do. Since the lancet body 151 ′ is fixed in the lancet holder 102 ′, when the lancet holder 102 ′ is further inserted while the engagement between the lancet cap 152 ′ and the lancet cap removal member 260 ′ is maintained. The lancet cap 152 ′ and the lancet body 151 ′ are moved away from each other. As a result, the bridge member 154 ′ connecting the lancet cap 152 ′ and the lancet body 151 ′ is broken. When the bridge member 154 ′ is broken, the lancet cap 152 ′ is separated from the lancet body 151 ′, so that the tip of the puncture member 153 ′ is exposed. When the lancet holder 102 'is subsequently inserted, the separated lancet cap 152' is moved to a position deviating from the puncture trajectory in the lancet holder 102 'while being pushed by the lancet cap removal member 206'. . The insertion of the lancet holder 102 ′ causes the plunger 204 ′ to retreat and the plunger spring 205 a ′ to be compressed to accumulate the force necessary for puncturing. However, the lancet cap 152 ′ is attached to the lancet body 151. After separation from ', the injector 200' is configured to prevent further retraction of the plunger 204 '(specifically, the rear end of the plunger 204' is connected to the inner wall of the injector (the drum member)). The plunger 204 ′ is prevented from retreating by contacting the inner wall). If such further retraction of the plunger 204 ′ is prevented, further insertion of the lancet body 151 ′ engaged with the plunger 204 ′ will be prevented, and then the lancet holder 102 ′ When the lancet holder 102 'is further moved in the insertion direction, a force that moves in the insertion direction is applied to the lancet holder 102', while a force against the lancet body 151 'is applied. As a result, a force that relatively moves the lancet holder 102 ′ and the lancet body 151 ′ acts, and the fixed state of the lancet body 151 ′ to the lancet holder 102 ′ is released. More specifically, when a force that relatively moves the lancet holder 102 ′ and the lancet body 151 ′ acts, as shown in FIG. 39, the convex portion B108 ′ in the guide of the lancet holder 102 ′ becomes the lancet body 151. The convex portion A (specifically, 158b ') of the guided portion of' is overtaken (in other words, the convex portion A (158b ') of the guided portion is projected to the convex portion B ( 108 ′), the contact state between the convex part of the lancet body and the convex part of the lancet holder is released. By releasing the contact state, the fixed state of the lancet body 151 ′ to the lancet holder 102 ′ is released, so that the lancet body 151 ′ is ready to be fired in the puncture direction along the guide.

  When the loading of the lancet assembly into the injector is completed, the puncture device is ready for puncture (in this state, as shown in FIGS. 40A and 40B, the rear end 230a ′ of the trigger lever 230 ′ and the plunger 204 ′ and the flange portion 204b ′ are in contact with each other, and the plunger spring 205a ′ is compressed). At the time of puncturing, the puncture opening 105 'is applied to a predetermined site (for example, fingertip) to be punctured, and then the distal portion (230b' in FIG. 40A) of the trigger lever 230 'is pushed toward the inside of the injector 200'. By pushing the trigger lever 230 ′, the contact state (locking state) between the rear end portion 230a ′ of the trigger lever 230 ′ and the flange portion 204b ′ of the plunger 204 ′ is released, and as a result, the trigger lever 230 ′ is compressed. The spring 205a ′ extends instantaneously at a stroke, and the lancet body 151 ′ is fired toward the front puncture direction. The puncture member 153 'will quickly retract after firing forward. Eventually, by sliding the ejector 270 ′ forward, the used lancet assembly 100 ′ including the used puncture member in the lancet holder 102 ′ is removed from the injector 200 ′ (FIG. 41A and FIG. 41). (See FIG. 41B). Specifically, the lancet holder 102 is removed from the injector 200 ′ by sliding the ejector 270 ′ with a finger or the like and pressing the edge of the opening end 103 of the lancet holder 102 ′ with the foremost part of the ejector. The removed used lancet assembly will be discarded.

  Here, when using the puncture device, it is preferable that the user can visually grasp the operation stage and settings. In particular, if the user can reliably grasp and operate the puncture enabled state, smooth use can be assisted, and erroneous operations can be prevented. Therefore, it is desirable that the puncture device has an appropriate indicator mechanism.

  In addition, when the puncture member is launched, if the linearity of the puncture trajectory of the puncture member is significantly impaired, the pain felt by the blood sample during puncture will increase, so the puncture trajectory of the puncture member may be as straight as possible. desired.

Furthermore, in order to provide a puncture device that is easier to operate and hygienic, the following items are also desired.
(1) The user can perform a puncture operation (particularly, a puncture member firing operation) more smoothly.
(2) The puncture device that has been used once is not used for puncture again. Particularly in hospitals, from the viewpoint of preventing blood infection, it is required that a single puncture device is not reused when collecting blood from a plurality of patients, and a puncture device that takes measures for that purpose is desired.
(3) The used lancet assembly can be smoothly discharged from the injector after puncturing.
US Pat. No. 5,385,571 International Patent Publication (WO) No. 2007/037207

  The present invention has been made in view of the above circumstances. That is, an object of the present invention is to provide a puncture device that allows a user to visually grasp the operation stage and setting conditions, and to provide a lancet assembly in which the puncture trajectory of the puncture member is as straight as possible. It is. It is also an object of the present invention to provide a hygienic device that is simpler to operate.

In the present invention, a puncture device comprising a lancet assembly and an injector,
The lancet assembly is a device composed of a lancet and a lancet holder that accommodates the lancet. The lancet has a lancet body, a lancet cap, and a puncture member, and the metal puncture member is a resin lancet body and lancet cap. The lancet cap is covered by the lancet cap, and the lancet cap and the lancet body are integrally connected via the bridge member.
An injector is a device that can be used in combination with a lancet assembly to fire a puncture member. “A plan that can engage with the rear end of a lancet body and fire a lancet body having a puncture member in the puncture direction. Jar "," lancet cap removal member that can contact the lancet cap "," trigger lever that triggers the puncture member when it is pressed during firing ", and" to remove the lancet assembly from the injector after puncture " Having an ejector,
A puncture device that allows a lancet assembly to be loaded into an injector by inserting the lancet holder into the injector from the front end opening of the injector,
Comprising an indicator mechanism comprising two plate members, an outer plate member and an inner plate member;
In the injector housing, the outer plate member and the inner plate member are accommodated adjacent to each other such that the outer plate member is located more outwardly with respect to the inner plate,
The outer plate member and the inner plate member can move back and forth along the puncture direction;
In the unloaded puncture device in which the lancet assembly is not inserted into the injector, the outer plate member and the inner plate member are located at the installation position of the window provided in the housing so that the outer plate member can be seen from the window. And
When the lancet assembly is loaded into the injector, the outer plate member is pressed rearward due to the lancet holder inserted into the injector, and the outer plate member moves rearward from the installation position of the window portion. As a result, when the lancet holder is inserted into the injector until the puncture member can be fired, the outer plate member moves to a position shifted backward from the installation position of the window portion. Accordingly, there is provided a puncture device characterized in that the inner plate member becomes visible from the window portion because the outer plate member is not blocked. The feature of this invention is that the puncture device includes an indicator mechanism. Specifically, when the lancet holder is inserted into the injector when the lancet assembly is loaded, the plate member moves accordingly, and a window portion (hereinafter referred to as “indicator window portion” provided in the injector housing). The plate member that can be seen from this also changes. In particular, in an unloaded or unused puncture device, the outer plate member can be seen from the indicator window, while the lancet holder is inserted into the injector until the puncture member can be fired. Thus, the inner plate member can be seen. In the specification, the “position position of the window portion” substantially means an area that can be seen from the window portion when the window portion is viewed from the outside, and more specifically, the injector. It means a region / position on a straight line extending from the vicinity of the center of the window portion in the transverse direction of the injector (refer to FIG. 13, in particular, “straight line extending in the transverse direction of the injector” refers to FIG. 13. Corresponds to the dotted line as shown in

  The outer plate member is preferably provided on the ejector (more specifically, “ejector wing part” or “ejector pressing member” described later), and the inner plate member is preferably provided on the plunger.

In a preferred embodiment, the inner plate member has a size larger than that of the outer plate member. In this case, in the unloaded puncture device in which the lancet assembly is not loaded in the injector, the rear half of the inner plate member is located at the installation position of the indicator window,
When the lancet assembly is loaded into the injector, the rear end of the lancet body engages with the front end of the plunger, and the plunger is retracted as the lancet holder is inserted into the injector. When the lancet holder is inserted into the injector until the inner plate member is moved backward and the puncture member can be fired, the front half of the inner plate member is the indicator window. The front half of the inner plate member can be seen from the indicator window. In such an aspect, in the unloaded or unused puncture device, the outer plate member was visible from the indicator window, while the lancet holder is inserted into the injector until the puncture member can be fired. The front half of the inner plate member can be seen from the indicator window. Next, when the plunger moves forward at the time of firing the puncture member, the inner plate member whose front half is located at the installation position of the indicator window portion is shifted forward and moved. Therefore, in the used puncture member after firing the puncture member, since the plunger returns to the original position, the rear half of the inner plate member is located at the installation position of the indicator window, and the inner plate member The rear half of can be seen from the indicator window. That is, the front half of the inner plate member can be seen from the indicator window when the puncture member can be fired, while the rear half of the inner plate member can be seen in the used state after puncturing.

  Here, in this specification, “the rear half” of the inner plate member means “a part of the inner plate member” that is located at the installation position of the indicator window in the puncture device that is not loaded or in use. Is substantially pointing to. On the other hand, the “front half” of the inner plate member substantially refers to “a part of the inner plate member” located at the installation position of the indicator window portion in the puncture device in a puncturable state. In a preferred embodiment, the “rear half” of the inner plate member is a portion located on the right side when the inner plate member is viewed from the side of the injector, whereas the “front half” of the inner plate member. Is a portion located on the left side when viewed from the side of the injector (see, for example, FIG. 14). The “front half” and the “rear half” are not necessarily equally divided from each other, and one of them may be larger than the other.

  The outer plate member and the inner plate member preferably have different colors. When changing from “unloaded or unused” to “a state in which the puncture member can be fired”, the plate member visible from the indicator window changes from “outer plate member” to “inner plate member”. When the outer plate member and the inner plate member have different colors, the “change in the plate member that can be seen from the indicator window” becomes clear. That is, the user can easily grasp the change in the indicator window. In the present specification, “different color” substantially means a color difference that can be visually discerned by a user of the puncture device or a blood sample.

  Furthermore, "When the inner plate member is larger than the outer plate member and the piercing member can be fired, the front half of the inner plate member can be seen from the indicator window, but it is used after puncturing. In the state in which the rear half of the inner plate member is visible in the state, in addition to the outer plate member and the inner plate member having different colors, the front half and the rear half of the inner plate member are It is preferable that they have different colors. Thereby, the change in the indicator window portion when changing from “a state in which the puncture member can be fired” to “a used state after puncture” is made clearer.

The present invention also provides a lancet assembly in which the puncture track of the puncture member is as straight as possible. Such a lancet assembly consists of a lancet and a lancet holder that houses it,
The lancet has a lancet body, a lancet cap, and a puncture member, and the metal puncture member is present in the resin lancet body and the lancet cap, and the tip of the puncture member is caused by the lancet cap. Covered, the lancet cap and the lancet body are joined together via the bridge member,
When the lancet body is fixed to the lancet holder and the lancet cap is pressed in the puncture direction, the bridge member is broken and the lancet cap is separated from the lancet body, and the lancet body with the tip of the puncture member exposed is obtained. And
The separated lancet cap is a lancet assembly that moves to a position deviating from the puncture trajectory of the puncture member when subsequently pressed in the puncture direction,
A convex portion is provided on the side surface of the lancet cap, and the puncture member comes into contact with the convex portion when the lancet body where the tip of the puncture member is exposed is fired during puncturing. Such a lancet assembly is characterized in that the puncture member comes into contact with the “convex portion provided on the side surface of the lancet cap” during puncture, and thereby the puncture trajectory of the puncture member is corrected to be linear. Preferably, when the puncture member fired in the puncture direction returns in a direction opposite to the puncture direction, the puncture member and the convex portion come into contact with each other.

  In a preferred embodiment, the “convex portion provided on the side surface of the lancet cap” is formed in an elongated shape along the puncture direction, and the rear portion of the convex portion becomes gradually higher in the puncture direction. It has a slope shape. This makes it easier to obtain a linear puncture trajectory of the puncture member. The slope-shaped inclination angle with respect to the side surface of the lancet cap is particularly preferably 9 ° to 11 °.

Furthermore, the present invention also provides an injector having a puncture depth adjusting mechanism. Such an injector is an injector capable of firing a puncture member when used in combination with a lancet assembly,
The lancet assembly is a device composed of a lancet and a lancet holder that accommodates the lancet. The lancet has a lancet body, a lancet cap, and a puncture member, and the metal puncture member is a resin lancet body and lancet cap. The lancet cap is covered by the lancet cap, and the lancet cap and the lancet body are integrally connected via the bridge member.
The injectors are “plungers that can engage the rear end of the lancet body and fire the lancet body with the puncture member in the puncture direction”, “lancet cap removal member that can abut against the lancet cap”, “when launching the puncture member It has a trigger lever that causes firing of the puncture member when pressed, and an “ejector for removing the lancet assembly from the injector after puncturing”
A protrusion provided at the rear end of the plunger and protruding outward from the plunger in the transverse direction thereof;
Puncture depth comprising a cylindrical member having a step portion formed such that the height of the end portion differs stepwise, and a drum member engaged with the cylindrical member so as to be able to rotate integrally with the cylindrical member Comprising an adjustment mechanism,
When the plunger moves forward at the time of puncture, the protruding portion at the rear end of the plunger collides with the step portion of the cylindrical member, so that the plunger cannot move further forward.
By rotating the drum member and rotating the cylindrical member about its axis, the step part where the protrusion part collides can be changed to a step part of a different height, so that the plunger moves forward during puncture. You can change the distance you can move,
On the outer peripheral surface of the drum member, a groove portion is formed along the annular direction (or the circumferential direction). On the other hand, a convex portion (or protrusion) that fits into the groove portion is formed on the housing of the injector (preferably the inner wall or inner wall surface of the housing) When the drum member rotates, the convex portion is guided along the groove portion, and the drum member rotates by the contact between the convex portion and the end portion of the groove portion. Is limited. In such an injector, the range in which the drum can be rotated is limited to a certain range by the groove portion of the drum member and the convex portion of the housing of the injector, and the depth adjustment of the puncture member is performed within the limited drum rotation range. It is characterized by.

In a preferred embodiment, a notch (or opening) is formed at the rear end of the injector housing, while a scale is displayed in the annular direction (circumferential direction) on the outer peripheral surface of the drum member.
The drum member is fitted inside the rear end of the injector housing so that the notch and the scale overlap each other, and the scale value exposed from the notch is determined by the rotation of the drum. It is going to change with it.

In a preferred aspect, the user can perform the puncturing operation more smoothly. In the puncture device having this preferred aspect, an intermediate portion of a trigger lever provided in the injector is pivotally provided on the inner wall of the housing of the injector,
A force is applied to the front side of the trigger lever toward the outer side of the injector housing, while a force is applied to the rear side of the trigger lever toward the inner side of the injector housing. A spring member is provided between the injector housing and the side wall surface. Therefore, when puncturing, when the front side portion of the trigger lever is pressed toward the inside of the housing against the force in the housing outer direction, the trigger lever rotates around the intermediate portion. As a result, the rear side portion of the trigger lever moves toward the outside of the injector housing, causing the puncture member to fire.

  In a preferred embodiment, the puncture member is not used for another puncture after it has been used. In this aspect, the flange member is provided on the outer peripheral surface of the drum member, while the narrowed portion or the convex portion is provided on the inner wall of the housing of the injector. As a result, when a rear force is applied to the drum member, the flange member and the narrowed portion or the convex portion come into contact with each other, so that the drum member cannot move rearward relative to the housing. That is, since the drum member cannot be moved rearward after puncturing, the plunger cannot be retracted, and it is impossible to obtain a puncturable state after puncturing.

  In a preferred embodiment, the used lancet assembly can be discharged more smoothly from the injector. In this aspect, the ejector is movable between the “ejector pressing member that enables the lancet holder and the lancet body to be pressed forward” and the “ejector slide member that enables the ejector to slide forward”. It is composed by combining. In particular, the ejector is provided with a spring member capable of applying a forward force to the ejector pressing member. In this aspect, the lancet holder further includes a locking projection on the outer wall surface adjacent to the opening end thereof, and the injector is a holder locking member provided on the inner wall of the housing on the front side of the injector. A holder lock member having a stopper portion (that is, “stopper portion A” and / or “stopper portion B”, which will be described later) protruding on the surface (ie, “surface S”, which will be described later) projecting in the direction toward the inside of the injector. Furthermore, it is preferable to comprise. In this case, when the ejector slide portion is slid forward and the loaded lancet assembly is discharged from the injector, the spring member is compressed due to the contact between the stopper portion and the locking projection, and then By releasing the contact, the discharge of the lancet assembly is assisted by the restoring force of the compressed spring member.

  In the puncture device according to the present invention, when the lancet holder is inserted into the injector until the outer plate member can be seen from the indicator window in a non-loaded state or an unused state until the puncture member can be fired, The inner plate member can be seen from the indicator window. Further, when the inner plate member is formed to be larger than the outer plate member, the front half of the inner plate member can be seen from the indicator window when the piercing member can be fired. In the used state, the rear half of the inner plate member can be seen. Therefore, the user can visually grasp the operation stage from the change in the status of the indicator window, so that smooth use is assisted and erroneous operation can be prevented.

  In the lancet assembly according to the present invention, at the time of puncturing, the puncture member comes into contact with the “convex portion provided on the side surface of the lancet cap”, and thereby the puncture trajectory of the puncture member is corrected to be linear. Therefore, it is possible to reduce the pain felt by the person to be punctured (for example, a blood sample) during puncturing.

  In the injector according to the present invention, the depth adjustment of the puncture member is performed within the limited range of drum rotation. In particular, the “number of scales exposed from the notch” changes with the rotation of the drum, so the user can indirectly grasp the puncture depth from this number, and smooth use is assisted. At the same time, the setting of the puncture depth can be performed without making a mistake.

  In the “puncture device having a function that allows the user to perform a puncture operation more smoothly” according to the present invention, the pressing force and the pressing distance when pressing the trigger lever at the time of puncturing are appropriate (especially pressing in) The user can easily perform the puncture operation because less force is required at the time).

  Moreover, the following can be said with respect to the effects of the “puncture device having a repuncture prevention function that cannot be used for puncture again after being used” according to the present invention. Without such a function, the plunger can be moved backward by pulling the drum member backward after firing the puncture member once, and the puncture possible state can be obtained again (for example, in FIG. 19). A puncturable state can be obtained again by picking the outer drum with a finger and pulling it in the direction c shown. However, since it can be punctured again with a used puncture member, there is a concern about sanitary problems. In this respect, a puncture device having a repuncture prevention function does not have such a concern, and thus is more hygienic.

  Furthermore, in the “puncture device that can discharge a used lancet assembly more smoothly from an injector” according to the present invention, the discharging operation of the used lancet assembly is assisted, so that the discharging operation can be performed smoothly. In particular, the used lancet assembly can be ejected from the injector with a certain amount of momentum so that the puncture device can be in any orientation (eg, even if the front end opening of the injector faces upward). The used lancet assembly can be reliably discharged from the injector.

FIG. 1A is a schematic perspective view of a lancet holder. FIG. 1B is a schematic perspective view showing the lancet holder in the form of half cut along the longitudinal direction (for convenience, the slit 118 extends long along the longitudinal direction of the holder). The lancet holder is half cut out). FIG. 1C shows a longitudinal section of the lancet holder (a section taken along line Z1-Z1 and a section taken along line Z2-Z2). FIG. 2A is a schematic perspective view of a lancet. FIG. 2B is a side view of the lancet. FIG. 2C is a schematic perspective view showing the lancet half cut along the longitudinal direction thereof. FIG. 2D is a schematic perspective view of the lancet, showing the lancet from the side opposite to that seen from FIG. 2A. In particular, FIG. 2D shows a convex portion provided on the side surface of the lancet cap. FIG. 3 is a schematic perspective view of the lancet assembly, in which the lancet holder is shown in a half-cut form along its longitudinal direction. FIG. 4 is a schematic perspective view showing a state immediately before the lancet is inserted into the lancet holder. FIG. 5A is a schematic perspective view of the lancet assembly, showing the state before the lancet cap is separated (ie, the state of the unused lancet assembly). FIG. 5B is a schematic perspective view of the lancet assembly, showing a state in which the lancet cap is separated. FIG. 5C is a schematic perspective view of the lancet assembly, showing a state in which the separated lancet cap is moved to a position deviating from the puncture trajectory of the puncture member. FIG. 5D is a schematic perspective view of the lancet assembly, showing a state in which the lancet body with the distal end portion of the puncture member exposed is fired. FIG. 5E is a schematic perspective view of the lancet assembly, showing a state after puncturing. FIG. 6A is a schematic perspective view showing a state immediately before the lancet assembly is loaded into the injector. FIG. 6B is a schematic perspective view showing a state in which the lancet assembly is completely loaded in the injector. FIG. 7A is a schematic perspective view showing the appearance of the injector. FIG. 7B is a schematic perspective view showing the internal structure of the injector. FIG. 7C is a schematic perspective view showing the internal structure of the injector, and shows a partially transparent view of FIG. 7B. FIG. 8A is a schematic perspective view of the plunger. FIG. 8B is a schematic perspective view of the lancet cap removing member. FIG. 8C is a schematic perspective view of the trigger lever. FIG. 8D is a schematic perspective view of the ejector, and particularly shows an outer plate member provided on the ejector. FIG. 8E is a schematic perspective view of the holder lock member. FIG. 8F is a schematic perspective view of the flange portion of the plunger, and particularly shows the inner plate member provided on the flange portion. FIG. 9A is a schematic perspective view showing a half member forming the housing of the injector. FIG. 9B is a schematic perspective view showing a half-divided member that forms the housing of the injector. FIG. 10 is a schematic perspective view showing an aspect in which the lancet holder presses the ejector. FIG. 11 is a diagram schematically illustrating the function of the indicator mechanism. FIG. 11A shows the positional relationship between the outer plate member and the inner plate member in an unloaded state or an unused state, and FIG. 11B shows the outer plate member and the inner plate member in a puncture enabled state. The positional relationship is shown. FIG. 12 is a diagram schematically showing the function of the indicator mechanism. FIG. 12A shows the positional relationship between the outer plate member and the inner plate member in an unloaded state or an unused state, and FIG. 12B shows the outer plate member and the inner plate member in a puncture enabled state. FIG. 12C shows the positional relationship between the outer plate member and the inner plate member in the used state after the puncture member is fired. FIG. 13 is a diagram schematically showing the installation position of the window. FIG. 14 shows an embodiment of the puncture device in an unloaded state or an unused state. In particular, a mode immediately before the unused lancet assembly is inserted into the injector is shown. FIG. 15A and FIG. 15B are schematic perspective views of the ejector, and particularly show an aspect of the outer plate member provided in the ejector. FIG. 5B shows a form in which the ejector shown in FIG. 15A is half cut in the longitudinal direction. FIG. 16 is a schematic perspective view showing a state before the lancet assembly is inserted into the injector. FIG. 17 is a schematic perspective view showing an aspect when the lancet assembly starts to be inserted into the injector. FIG. 18 is a schematic perspective view showing an aspect at the time when the loading of the lancet assembly to the injector is completed. FIG. 19 is a schematic perspective view showing an embodiment of a puncture device after puncturing. FIG. 20 is a schematic perspective view showing a state in which the used lancet assembly is discharged from the injector after puncturing. FIG. 21 is a schematic perspective view showing a state in which the used lancet assembly is discharged from the injector. FIG. 22 is a developed view schematically showing members used in the puncture depth adjusting mechanism. FIG. 23 is a schematic perspective view of a cylindrical member used in the puncture depth adjusting mechanism. FIG. 24 is a schematic perspective view of a drum member used in the puncture depth adjusting mechanism. FIG. 25 is a schematic perspective view showing the arrangement of the cylindrical member and the plunger used in the puncture depth adjusting mechanism. FIG. 26 is a schematic perspective view of the outer drum. FIG. 26A is a perspective view of the outer drum viewed from the side where the groove 355 is provided, and FIG. 26B is a perspective view of the outer drum viewed from the side where the groove 355 is not provided. is there. FIG. 27A is a graph (puncture depth 0.8 mm) showing “transverse direction variation (X axis)” and “puncture direction variation (Y axis)” of the puncture trajectory of the puncture member. FIG. 27B is a graph (puncture depth: 1.05 mm) showing “transverse direction variation (X axis)” and “puncture direction variation (Y axis)” of the puncture trajectory of the puncture member. FIG. 28A is a schematic perspective view (perspective view) showing a state before the lancet assembly is inserted into the injector. FIG. 28B is a schematic perspective view (perspective view) showing a state in which the lancet assembly is inserted into the injector. FIG. 29 is a schematic perspective view showing a preferred embodiment of the trigger lever in the puncture device of the present invention. FIG. 30 is a schematic perspective view showing a preferred embodiment of a puncture device having a repuncture prevention function. FIG. 30A shows a mode in which re-puncture prevention is achieved by contact between the flange member 370 and the constricted portion 253, and FIG. 30B shows a state in which re-puncture is prevented by contact between the flange member 370 and the convex portion 253. The aspect which aims at puncture prevention is shown. FIG. 31A is a schematic perspective view showing a preferred embodiment of the puncture device of the present invention, and shows a state after puncture. In addition, a spring member 454 compressed due to the contact between the locking projection 116 and the stopper B284 during the discharging operation is also shown. FIG. 31B is a schematic perspective view showing a preferable aspect of the puncture device of the present invention, and shows an aspect immediately after the contact state between the locking projection 116 and the stopper B284 is released during the discharging operation. ing. FIG. 31C is a schematic perspective view showing a preferred embodiment of the puncture device of the present invention. In the discharge operation, the spring member 454 is temporarily compressed when the engagement state between the rear end portion of the lancet body and the front end portion of the plunger is released. FIG. 31D is a schematic perspective view showing a preferred embodiment of the puncture device of the present invention, and shows a state after puncture. Note that a spring member compressed due to the contact between the locking projection 116 and the stopper A282 during the discharging operation is also shown. FIG. 31E is a schematic perspective view showing a preferred embodiment of the puncture device of the present invention. An embodiment is shown in which the used lancet assembly is completely discharged from the injector. FIG. 32A is a schematic perspective view of a lancet. FIG. 32B is a schematic perspective view of the lancet, and is a perspective view seen from a side different from FIG. 32A. FIG. 32C is a schematic perspective view showing the lancet half cut along the longitudinal direction thereof. FIG. 33A is a schematic perspective view of a lancet holder. FIG. 33B is a schematic perspective view showing the lancet holder in the form of half cut along the longitudinal direction thereof. FIG. 34 is a schematic perspective view of the lancet assembly, showing a state before the lancet cap is separated. In addition, the area | region enclosed with the dotted line shows the schematic diagram (view seen from the P direction) showing the contact state of the convex part A (158a ', 158b') and the convex part B (108 '). FIG. 35 is a schematic perspective view of the lancet assembly, showing a state where the separated lancet cap has moved to a position deviating from the puncture trajectory of the puncture member. FIG. 36A is a schematic perspective view showing a state immediately before the lancet assembly is loaded into the injector. FIG. 36B is a schematic perspective view showing a state in which the lancet assembly is completely loaded in the injector. FIG. 37 is a schematic perspective view showing the internal structure of the injector. FIG. 38 is a schematic perspective view showing a state in which the lancet assembly is being inserted into the injector, and shows a state where the lancet cap and the lancet cap removal member are engaged. FIG. 39 is a schematic perspective view showing the mode of the lancet in the lancet holder as seen from the P direction (upper side) shown in FIG. 34 or 35 (the upper half of the lancet holder in FIG. 34 or 35 is cut away). Show). FIG. 39 (a) shows a mode in which the lancet body is fixed to the lancet holder, and FIG. 39 (b) shows a mode in which the fixed state between the lancet body and the lancet holder is released. FIG. 40A is a schematic perspective view showing an aspect at the time when the loading of the lancet assembly to the injector is completed. FIG. 40B is a schematic perspective view showing an aspect at the time when the loading of the lancet assembly to the injector is completed. FIG. 41A is a schematic perspective view showing a state in which the lancet assembly is completely discharged from the injector. FIG. 41B is a schematic perspective view showing a state in which the lancet assembly is completely discharged from the injector.

Explanation of symbols

DESCRIPTION OF SYMBOLS 100 ... Lancet assembly, 102 ... Lancet holder, 103 ... Open end of lancet holder, 104 ... Surface opposite to open end, 105 ... Puncture opening, 106 ... Inner wall of lancet holder, 107 ... Guide or guide channel, 109 ... Lancet A continuous protrusion provided on the outer surface of the holder, 113 ... a notch, 113a ... an area between the two notches, 116 ... a locking protrusion provided on the outer surface of the lancet holder, 118 · Slit portion, 120 ··· fixed groove, 121a ··· front fixed convex portion (fixed convex portion A), 121a ₁ · · · front side surface of the front side fixed convex portion, 121a ₂ · · · front side The rear side surface of the fixed convex part, 121b ... the fixed convex part on the rear side, 150 ... lancet, 151 ... lancet body, 152 ... lancet key 152a ... Indicator part of lancet cap, 153 ... Puncture member, 153a ... Tip part of puncture member, 154 ... Bridge member, 155 ... First wing part, 155a ... Plate-like part of lancet cap, 156 ... rearward protruding portion of lancet cap, 156a ... tip of rearward protruding portion of lancet cap, 157a ... upper guided projection, 157b ... lower guided projection, 158 ... fixed projection, 159 ... 2nd wing part (used lancet drop prevention wing), 159a ... abutment part at the tip of the 2nd wing part, 165 ... engagement part at the rear end part of the lancet body, 165a ... lancet body Rear end of 170, slope member provided in lancet holder, 171 ... lancet cap Slope portion 180, stopper surface in the lancet holder, 200 ... injector, 201 (201a, 201b) ... injector housing, 202 ... front end opening of injector, 204 ... plunger, 204a ... tip of plunger 204b: Flange portion provided on the plunger, 204d ... Rear end (rear end) of the plunger, 204f ... Groove portion of the plunger, 205a ... Spring for injection provided on the plunger, 205b ... Plunger return spring, 205c ... ejector spring provided, 206 ... lancet cap removing part, 206a, a pair of elongated portions of 206 b ... lancet cap removing _part, 206a 1, 206 b 1 _... tip of the lancet cap removing part, 206c ... Base portion of the lancet cap removing member, 206d ... Arch-shaped groove portion of the lancet cap removing member, 206d ₁ ... Arch-shaped groove portion located on the paper surface side, 209 ... Partition in the injector housing, 210 ... Inner wall of the housing, 212... Housing side wall surface, 218... Projection provided at the rear end of the injector housing, 220. Periphery of the opening provided at the front side of the injector housing, 230... Trigger lever, 230 a. Trigger lever rear stepped portion, 230c... Trigger lever locking portion (front stepped portion), 230d ... leaf spring-like portion of the trigger lever, 230e ... spring provided on the trigger lever, 230f ... trigger Intermediate part with lever pivoted, 230g ... trigger lever , 230h... Rear portion of the trigger lever, 230i... Rear extension portion of the trigger lever, 250... Notch portion at the rear end of the injector housing, 253. Narrowed portion or convex portion provided on the housing 255, side wall surface of the housing of the injector, 270 ... ejector, 270a ... ejector slide member, 270a ₁ ... opening provided in the slide member, 270a ₂ ... slide member that puts a finger on ejection 270a ₃ ... rear inner wall surface provided inside the protrusion of the slide member, 270b ... part of the slide member, 274 ... ejector pressing member (wing part of the ejector), 274a ... ejector pressing leg of the member, the legs of 274a ₁ ··· ejector pressing member 275 ... The inside of the tip of the ejector pressing member, 275b ... The outside of the tip of the ejector pressing member, 280 ... Holder lock member, 280a ... Spring used for holder lock member, 280b ... Front end of holder lock member, 282 ... Stopper part A, 284 ... Stopper part B, 286 ... Release part A, 288 ... Release part B, 290 ... Trigger lock member, 290d ... Spring used for trigger lock member, 300 ... Puncture depth adjusting mechanism, 310 (310a, 310b) ... Protrusion provided on plunger , 320... Cylindrical member provided with a step at the end, 325 (325a, 325b, 325c, 325d, 32 5e, 325f) ... step portion of cylindrical member, 360 ... lid member, 340 ... inner drum member, 340a ... annular groove on inner peripheral surface of inner drum member, 345 ... drum member, 348... Concavity and convexity provided on the outer peripheral surface of the inner drum, 350... Outer drum member, 355... Groove provided on the outer drum member, 355 a. Plate spring member in contact with the uneven portion of the inner drum, 370... Flange member provided on the outer peripheral surface of the drum member, 375... Second flange member provided on the outer peripheral surface of the drum member, 377. Annular groove formed on the outer peripheral surface, 400 ... Puncture device, 440 ... Indicator window, 450 ... Outer plate member, 452 ... Spring provided on the ejector, 4 4 ... Spring member provided on the ejector, 460 ... Inner plate member, 100 '... Lancet assembly, 102' ... Lancet holder, 103 '... Open end of the lancet holder, 104' ... Face facing the open end, 105 '... Puncture opening, 106' ... Inner wall of lancet holder, 107 '... Guide or guide channel, 108' ... Convex part B in guide channel, 108a '... Front surface of convex part B, 109' ... Outer surface of lancet holder 111 '... hemispherical protrusion provided on the outer surface of the lancet holder, 150' ... lancet, 151 '... lancet body, 152' ... lancet cap, 153 '... puncture member, 153a' ... puncture member 154 '... bridge member, 155' ... first wing part, 156 '... provided on the first wing part Engaging portion, 157 '... guided portion, 158' (158a ', 158b') ... convex portion A, 159 '(159a') provided on the guided portion, second wing portion, 165 '... lancet body 170 '... slope member provided in the lancet holder, 170a' ... slope surface, 171 '... sloped portion provided in the first wing part, 180' ... in the lancet holder Stopper surface, 200 '... injector, 201' ... injector housing, 202 '... front end opening of injector, 204' ... plunger, 204a '... tip end of plunger, 204b' ... flange provided on plunger , 204c ′: rear part of the plunger, 204d ′: rear end (rear end) of the plunger, 205a ′: injection spray provided on the plunger 205b '... a return spring provided on the plunger, 205c' ... an ejector spring, 206 '... a lancet cap removing member, 206a', 206b '... a pair of long portions of the lancet cap removing member, 206a ₁ ' , 206b ₁ ′… the tip of the lancet cap removal member, 230 ′ —the trigger lever, 230 a′—the rear step portion of the trigger lever, 230 b′—the front portion of the trigger lever, 230 c′—the locking portion of the trigger lever (front step Part), 270 '... ejector, 300' ... puncture depth adjusting mechanism, 350 '... outer drum.

  A puncture device of the present invention and a lancet assembly and an injector constituting the same will be described in detail with reference to the accompanying drawings. Although the mode shown in FIGS. 1A to 26 and the mode shown in FIGS. 29 to 31E are slightly different, FIGS. 29 to 31E only show a more preferable mode. Are also included in the scope of the present invention.

  First, the basic configuration and basic functions of the lancet assembly, injector and puncture device according to the present invention will be described, and then the features of the present invention will be described.

  In the present specification, “front” substantially means a puncture direction in a direction in which a puncture member (or a lancet body in which a distal end portion of the puncture member is exposed) is fired during puncture, and “rear” means This means the direction opposite to the forward direction. In other words, the “puncture direction” in which the lancet moves during puncturing (that is, the direction in which the puncture member moves when puncturing the puncture site) is the “front” direction, and the opposite direction is the “rear” direction. The “puncture direction” corresponds to a direction from the opening end of the lancet holder toward the puncture opening. These directions and the “transverse direction” used in this specification are shown in the drawings. The “transverse direction” substantially means a direction orthogonal to the puncture direction.

  In this specification, “depart from (or deviate from) the puncture trajectory” means that the lancet body (more specifically, “the lancet body with the tip of the puncture member exposed”) is forward (ie, “puncture direction”). This means that the lancet cap does not impede such firing and puncturing when the puncture member is fired and punctures a predetermined location. In general, the lancet body does not come into contact with the separated lancet cap. However, in the case where the above-mentioned or later-described straight advancement convex portion is provided on the side of the lancet cap, The tip portion temporarily comes into contact with the straightness promoting convex portion.

  Further, “spring” and “spring” as used herein, unless otherwise stated, both refer to substantially similar elements.

  The lancet assembly according to the present invention is used in a state where the lancet 150 shown in FIG. 2A is fixed in the lancet holder 102 shown in FIG. 1A. FIG. 3 shows a schematic diagram of the lancet assembly 100. In FIG. 3, the lancet holder 102 is shown in a half cut along the longitudinal direction so that the structure of the lancet assembly 100 can be easily understood.

As shown in FIG. 1A, the lancet holder 102 has, for example, a rectangular tube shape as a whole. The size of the lancet holder 102 is small. For example, the lengths (L, H ₁ , H ₂ , W ₁ , W ₂ ) shown in FIG. 1A are L = 23.4 to 31.4 mm and H ₁ = 6.9. ˜10.4 mm, H ₂ = 8.6 to 12.4 mm, W ₁ = 4.2 to 7.9 mm, and W ₂ = 4.7 to 8.5 mm. However, the shape of the lancet holder 102 is not necessarily limited to the rectangular tube shape, and may be, for example, a cylindrical shape. In the drawing, a continuous protrusion 109 is provided on the outer surface of the lancet holder 102, which is mainly for preventing play that may occur when the lancet assembly 100 is inserted into the injector 200 ( However, such a continuous protrusion 109 not only has a function of preventing backlash, but also has a function of increasing the strength of the lancet holder 102 itself. Further, as shown in FIG. In the case where one continuous protrusion 109 is provided, for example, when the continuous protrusion 109 is arranged downward, the continuous protrusion 109 can also function as a foot portion. In particular, when a long groove portion (preferably a groove portion having a shape complementary to the continuous protrusion 109) along the puncture direction is provided on the inner wall of the injector, the lancet holder 102 is placed in such a state that the continuous protrusion 109 fits into the long groove portion. It can be inserted inside the injector. In this case, if the continuous protrusion 109 is not fitted into the long groove portion, the insertion of the lancet holder becomes impossible or unnatural (for example, an unnecessary resistance is generated during the insertion). There is an effect of making it possible to insert the lancet holder 102 into the injector without making a mistake in the direction of the rotation direction around the direction axis. The lancet holder 102 may be formed of any kind of resin material as long as it is a resin material used for a general lancet. The lancet holder 102 has an open end 103 and a puncture opening 105 on a surface 104 facing it. The puncture opening 105 is a portion applied to a predetermined site (for example, a fingertip) to be punctured. The lancet assembly 100 according to the present invention is configured by inserting the lancet 150 into the lancet holder 102 from the opening end 103 and fixing the lancet 150 in the lancet holder 102. In particular, a notch 113 provided in a slit shape in the longitudinal direction of the holder is formed at the end of the lancet holder 102 of the lancet assembly 102 according to the present invention on the open end side 103 (that is, the holder wall portion of the open end). ing. As shown in the figure, it is preferable that the two notches 113 are formed in parallel and the holder wall 113a between the two notches 113 is further partially cut off. Further, a locking projection 116 is formed on the outer wall surface adjacent to the opening end 103 of the lancet holder 102. In the vicinity of the front center of the side surface of the lancet holder, a slit portion 118 extending along the longitudinal direction of the holder is provided. FIG. 4 schematically shows an aspect when the lancet assembly 100 is configured. As shown in the figure, the lancet 150 is inserted into the lancet holder 102 from the opening end 103 with the lancet cap 152 at the tip.

  Next, the use of the lancet assembly 100 will be described. When the lancet assembly 100 is used, a lancet cap removing member (a member provided in the injector 200 for firing the puncture member through the opening end 103 of the lancet holder 102, which is denoted by reference numerals in FIG. 7B or FIG. 8B). Member 206) is inserted into the lancet holder 102. When the lancet assembly 100 is loaded into the injector, as shown in FIG. 6A, the lancet holder 102 is placed in the direction in which the puncture opening 105 faces frontward and the opening end 103 faces rearward, and the front end opening 202 of the injector 200 is placed. Therefore, the lancet cap removing member 206 can enter the lancet holder 102 from the opening end 103 of the lancet holder 102 (see, for example, FIG. 28B). Further, for example, as can be understood from FIGS. 5A to 5E showing the change over time of the lancet assembly 100, the puncture direction in which the puncture member 153 (or lancet body 151) moves during puncture is the puncture opening from the opening end 103. This may correspond to the direction toward 105. 5A shows a state of the unused lancet assembly 100 before puncturing, FIG. 5B shows a state where the lancet cap 152 is separated from the lancet body 151, and FIG. 5C shows a state where the separated lancet cap 152 is the puncture member 153. FIG. 5D shows a state in which the lancet body 151 with the distal end portion of the puncture member 153 exposed is launched, and FIG. 5E shows an aspect of the lancet assembly 100 after puncture. Is shown.

  As described above, puncture opening 105 provided in lancet holder 102 is a portion that is applied to a puncture site (for example, a fingertip) during puncture. If blood of a blood sample is attached to the holder outer wall surface 104 (see FIG. 1A) at the time of puncture, the body (eg, hand or finger) may touch the blood when the lancet holder is discarded, and there is a risk of getting an infection. However, in the present invention, the size of the puncture opening contributes to such a risk reduction. For example, the diameter of the puncture opening 105 is preferably 0.5 to 4.0 mm, more preferably 1.0 to 3.5 mm, for example 3.0 mm. In this specification, “diameter” refers to the case where the shape of the puncture opening is circular. However, the shape of puncture opening 105 is not particularly limited, and may be a shape other than a circle. When the shape of the puncture opening 105 is other than a circle, the puncture opening 105 preferably has an equivalent diameter corresponding to the “diameter” described above. Here, “equivalent diameter” means that the shape of the puncture opening is made circular without changing the area of the puncture opening (more specifically, “the cross-sectional area of the puncture opening in the direction perpendicular to the puncture direction”). It means the assumed diameter. It should be noted that the above-mentioned “diameter” is based on the assumption that a puncture opening is assumed in the absence of such a notch when the puncture opening 105 has a notch as shown in FIG. 1A. I want to be.

  In order to understand the internal structure of the lancet holder 102, the lancet holder 102 is shown in FIG. 1B, and a longitudinal sectional view of the lancet holder 102 is shown in FIG. 1C. The lancet holder 102 has two protrusions in the fixing groove 120 on the facing inner wall 106 (more specifically, the inner wall facing the opening end 103 and the puncture opening 105 in a direction orthogonal to the direction facing each other). It has parts 121a and 121b. On the other hand, the lancet body 151 of the lancet 150 has a fixed protrusion 158 that fits into the fixing groove 120 (see FIG. 2A for the “fixed protrusion 158”). The lancet body 151 is brought into contact with the fixed projections 121a and 121b and the fixed projection 158 so that the two fixed projections 121a and 121b of the lancet holder 102 sandwich the fixed projection 158 of the lancet body 151. It will be fixed to the lancet holder 102. Refer to the schematic diagram in the dotted line in FIG. 1C (note that the schematic diagram in the dotted line is a diagram seen from the U direction in FIG. 3 (a diagram seen from above the lancet assembly shown in the figure), and the fixed convex portion 121a. , 121b and the fixed protrusion 158 are in contact with each other). The lancet holder 102 has a guide 107, preferably two guide channels 107, for guiding the lancet body 151 of the lancet 150 along the puncturing direction on the inner walls 106 facing each other. On the other hand, as shown in FIG. 2A, the lancet body 151 has a pair of guided projections 157a and a pair of guided projections 157b (a pair of guided projections in FIG. 2A) that can be fitted into the guide channel 107. Only one of the parts is mainly shown). Accordingly, the pair of guided projections 157a and the pair of guided projections 157b of the lancet body 151 are provided so as to fit into the respective guide channels 107 of the lancet holder 102, so that the lancet body 151 is inserted in the puncture direction. Can be moved to. As described above, the lancet assembly 100 according to the present invention includes a protrusion for fixing the lancet body 151 to the lancet holder 102 (ie, the protrusion 158) and a protrusion for guiding the lancet body (ie, 157a and 157b). ) Are provided separately.

  Lancet 150 is shown in perspective view in FIG. 2A. FIG. 2B is a view of the lancets 150 viewed from different sides. The size of the lancet 150 is also small like the lancet holder 102 and has a size that can be accommodated in the lancet holder 102. As illustrated, the lancet 150 includes a lancet body 151, a lancet cap 152, and a puncture member 153 (see FIG. 2C for the puncture member 153). The puncture member 153 is, for example, a metal needle. As shown in FIG. 2C, the puncture member 153 is present in the lancet body 151 and the lancet cap 152 made of resin, and the tip portion 153a of the puncture member 153 is covered by the lancet cap 152. . For this reason, the puncture member 153 is not shown in FIG. 2A. As shown in FIG. 2A, the lancet cap 152 and the lancet body 151 are integrally coupled via a bridge member 154. The lancet 150 can be manufactured by so-called insert molding in which a puncture portion 153 is inserted into a mold to mold a resin (for example, polyethylene, polypropylene, etc.), and the bridge member 154 is manufactured together with the insert molding. can do. Therefore, the bridge member 154 can be formed of the same resin material as the lancet cap 152 and the lancet body 151. The bridge member 154 is preferably in a form that is easily broken (hence, the bridge member can also be referred to as a “weakened portion” or an “easy breakable portion”). For example, as shown in FIG. 2A, the bridge member 154 may be a small-diameter rod-like member, and is preferably provided in a form that bridges the lancet cap 152 and the lancet body 151. As shown in FIG. 2A, it is particularly preferable that two bridge members 154 are provided symmetrically about the central axis (or puncture member 153) of the lancet 150. Note that the bridge member 154 may be provided with a notch (for example, a V-shaped notch) so that the bridge member 154 is more easily broken. In some cases, the bridge member 154 may be cut in advance, or may not have the bridge member 154. By pressing the lancet cap 152 as described later, the lancet cap 152 and the lancet body 151 As a result, the lancet cap 152 is separated from the puncture member 153, and the lancet body 151 with the distal end portion of the puncture member 153 exposed is obtained.

  The lancet cap 152 has a pair of first wing portions 155. As shown in FIG. 2A, in the pair of first wing portions 155, the plate-like portion 155a is symmetrical about the central axis of the lancet 150 (that is, the central axis in the longitudinal direction of the lancet 150 or the puncture member 153). It is preferable that the side portion of the plate-like portion 155a protrudes rearward. In particular, as illustrated, the portion 156 protruding rearward is preferably substantially parallel to the central axis of the lancet. Since the lancet cap 152 has a structure with which the lancet cap removal member 206 can contact, the lancet cap removal member 206 enters the lancet holder 102 when the lancet assembly 100 is loaded into the injector 200 (see FIG. 28B). The lancet cap removal member 206 and the lancet cap 152 (more specifically, the portion 156) come into contact with each other.

As described above, the lancet body 151 has a pair of guided projections 157 a and a pair of guided projections 157 b configured to fit into the guide channel 107 of the lancet holder 102. As shown in FIGS. 2B (a) and 2 (b), the pair of guided projections (157a, 157b) protrudes outward symmetrically about the central axis of the lancet. Further, as shown in FIG. 2A, for example, the pair of guided protrusions 157a and 157b extend in a direction orthogonal to the direction in which the pair of protruding portions 156 of the first wing portion 155 face each other. It is preferable. As shown in FIGS. 2A and 2B (c) and (d), the pair of guided projections 157a and the pair of guided projections 157b are provided to face each other across the central axis of the lancet. It is preferable. The lancet body 151 is brought into contact with the lancet holder 102 by the fixed projections 121a, 121b and the fixed projection 158 coming into contact with each other so that the fixed projections 121a, 121b sandwich the fixed projection 158 of the lancet body 151. When the force acting between the lancet holder 102 and the lancet body 151 exceeds a predetermined threshold value, the fixed convex part (that is, the fixed convex part A) 121a on the front side of the lancet holder 102 is covered with the cover of the lancet body 151. The fixed projection 158 will be overcome (that is, if the view is changed, the fixed projection 158 will get over the fixed projection 121a), and the fixed projection 158 and the fixed projections 121a and 121b are brought into contact with each other. The state is released. Thereby, a state is obtained in which the lancet body 151 can move in the puncture direction and the opposite direction (in this case, the pair of guided projections 157a and the pair of guided projections 157b are respectively provided along the guide channel 107). Will move). Therefore, when the lancet assembly 100 is loaded into the injector 200, if the lancet holder 102 is further moved in the insertion direction while further insertion of the lancet body 151 is prevented, the lancet holder 102 and the lancet body 151 are relatively moved. A force to move away is generated, and the fixed protrusion 121a on the front side of the lancet holder 102 gets over the fixed protrusion 158 of the lancet body 151 (that is, if the view is changed, the fixed protrusion 158 is fixed to the fixed protrusion 121a). To get over). In the case where the securing protrusion 158 is tried rides over the securing boss 121a, as shown in FIGS. 1B and 1C, the rear side 121a ₂ of the securing boss 121a is formed smoothly diagonally to facilitate overcoming together, climbs over once, as the lancet 150 does not fall off from the lancet holder 102, the front side 121a ₁ of such securing boss 121a is a plane straight extending into the holder transversely (more specifically, in the puncturing direction (In other words, the rear side surface of the fixed convex portion 121a is formed in a curved shape, while the front surface of the fixed convex portion 121a is formed in a direction perpendicular to the holder 121a ₁ ). The side is formed in a straight line). If the front side 121a ₁ of the thus securing boss 121a is formed into a flat, even used lancet body 151 is moved rearward in the lancet holder 102 inside, it is the securing protrusion 158, such plane 121a ₁ so that the used lancet body 151 does not fall out of the lancet holder 102.

  2A and 2B (c) and (d), the lancet body 151 is symmetrical about the central axis of the lancet 150 (that is, the central axis in the longitudinal direction of the lancet 150 or the puncture member 153). Thus, a pair of second wing portions 159 that gradually spread outward toward the rear are provided. The pair of second wing portions 159 functions so that the distal end portion 153a of the puncture member 153 is not exposed from the puncture opening portion 105 after the puncture (that is, the puncture member 153 is inserted into the puncture member 153 from the puncture opening portion 105 of the lancet holder 102). It is possible to prevent the tip 153a from being easily touched as much as possible). Specifically, in the used lancet assembly 100 removed from the injector 200 after puncturing, the pair of second wing portions 159 is provided so that the tip end portion 153a of the puncture member 153 is not exposed from the puncture opening portion 105. It can abut against or collide with a stopper surface (indicated by reference numeral 180 in FIG. 1B) provided inside the lancet holder 102, and the movement of the puncture member 153 in the puncture direction is restricted (particularly the mode of FIG. 5E). See Here, the pair of second wing portions 159 has contact portions 159a at the tips so that the second wing portions 159 and the stopper surface 180 can contact with each other reliably.

Note that the lancet cap removal member 206 has an arcuate groove portion that can accommodate the second wing portion 159 (a portion continuously depressed in an arc shape as indicated by reference numeral 206d in FIG. 8B or a portion that is continuously cut out). ), When the lancet cap removing member 206 enters the lancet holder 102 by the operation of loading the lancet assembly 100 into the injector 200, the pair of second wing portions 159 are not substantially deformed and the arcuate groove portions are formed. 206d. That is, in a state where the preparation for launching the puncture member 153 is completed, the second wing portion 159 is held without being substantially deformed due to the arc-shaped groove portion 206d of the lancet cap removing member 206, and preferably without any deformation. It is held (that is, the deformation state is not held due to the creep phenomenon). Thus, since the second wing portion 159 is held without being deformed, when the lancet cap removing member 206 is pulled out from the lancet holder 102 after puncturing, the pair of second wing portions 159 maintains the original shape as they are. As a result, it is possible to reliably contact or collide with the stopper surface 180 provided inside the lancet holder 102. Note that the arcuate groove 206d shown in FIG. 8 (b), the actual arcuate groove located to the paper奧側the (arcuate groove indicated by 206d ₁ in FIG. 8 (b)) and the second wing portion Functions to accommodate 159. The fact that the arcuate groove 206d that actually accommodates the second wing 159 is an arcuate groove that is located on the back side of the drawing indicates that, for example, referring to FIGS. 28A and 28B, the second wing 159 is in the lancet holder 102. It can be understood from the fact that it is located on the back side of the page.

  FIG. 3 shows a state in which the lancet 150 is fixed in the lancet holder 102 (for ease of understanding, the lancet holder 102 is shown in a half-cut form along its longitudinal direction. ). As shown in the figure, the lancet cap 152 is located on the puncture opening 105 side of the lancet holder 102, while the lancet body 151 is located on the opening end 103 side of the lancet holder 102. As described above, the fixed protrusions 121a and 121b and the fixed protrusion 158 are connected to each other so that the two fixed protrusions 121a and 121b of the lancet holder 102 sandwich the fixed protrusion 158 of the lancet body 151. By contact, the lancet 150 is fixed in the lancet holder 102 (see the dotted line in FIG. 1C). That is, the lancet body 151 is fixed to the lancet holder 102, while the lancet cap 152 itself is not fixed to the lancet holder 102. Accordingly, when only the lancet cap 152 is pressed in the puncturing direction, a force that moves the lancet cap 152 and the lancet body 151 relatively apart acts, so that the bridge member 154 is broken. As a result, the lancet cap 152 The lancet body 151 is separated from the lancet body 151, and the tip of the puncture member 153 is exposed (see FIG. 5B).

  When the separated lancet cap 152 is subsequently pressed in the puncturing direction, it moves forward. Here, in the vicinity of the puncture opening 105 in the lancet holder 102, a slope member 170 for guiding the separated lancet cap 152 to a position deviating from the puncture trajectory is provided. A sloped portion 171 having a corresponding shape is provided (more specifically, the slope member 170 and the sloped portion 171 have flat surfaces that can complementarily contact each other). The slope member 170 is clearly shown not only in FIG. 3 but also in FIGS. 5A to 5C, and the sloped portion 171 is clearly shown in FIGS. 2A and 5A. Since the slope member 170 and the sloped portion 171 are provided as described above, when the separated lancet cap 152 continues to move forward, the sloped portion 171 of the lancet cap 152 is connected to the slope member in the lancet holder 102. The lancet cap is slid in a state of being in contact with 170 (in other words, the sloped portion 171 slides on the slope member 170), and as a result, deviates from the puncture trajectory. 152 can move. 5D and 5E show a state where the separated lancet cap 152 has moved to a position deviating from the puncture trajectory.

  More specifically, the movement of the lancet cap 152 will be described. The slope member 170 in the lancet holder 102 has a slope surface 170a (shown in FIG. 3) that forms an angle with respect to the puncture direction, while the sloped portion 171 of the lancet cap 152 is complementary to the slope surface 170a. A surface that can be brought into contact with each other. Therefore, when the lancet cap 152 is pressed in the puncturing direction, the lancet cap 152 slides forward with the surfaces in contact with each other, and as a result, moves obliquely forward. . For example, FIGS. 5A and 5C show a state before and after the lancet cap 152 is moved. When the lancet cap 152 is moved from the position shown in FIG. 5A to the position shown in FIG. 5C, the lancet cap 152 is punctured. You can see that it moves to a position that deviates from the orbit. 5A shows the movement trajectory of the lancet cap 152 viewed from the U direction (upper side). It can be understood from this moving track that the lancet cap 152 finally moves to a position deviated from the puncturing track of the puncture member 153. Note that the angle formed by the slope surface 170a with the puncturing direction (that is, the angle α of the moving trajectory shown in FIG. 5A) is preferably 30 ° to 60 °, and more preferably 40 ° to 50 °.

  As described above, as a result of the lancet cap 152 moving obliquely forward to a position deviating from the puncture trajectory, the puncture member 153 (specifically, the lancet body 151 with the puncture member 153 exposed) is attached to the lancet cap 152 during puncture. It is fired forward without being disturbed. 5D schematically shows the state of the lancet assembly 100 at the time of puncturing (that is, when the puncturing member is fired), and the tip 153a of the puncturing member is not obstructed by the lancet cap 152 and the puncture opening. The state exposed from the part 105 is shown.

When the lancet assembly 100 is loaded into the injector 200 during use, the assembly 100 is inserted rearward from the front end opening 202 of the injector 200 as shown in FIG. 6A. For this loading, the lancet holder 102 is inserted into the front end opening 202 of the injector 200 while the lancet holder 102 is pinched with the fingertip of one hand and the injector 200 is held with the other hand. Then, the loading is completed at a point in time when it becomes impossible to insert with a force that a normal person can apply. A state in which the loading is completed is shown in FIG. 6B. In such a loading operation, the plunger in the injector 200 is retracted and the force necessary for firing the puncture member 153 is gradually stored in the plunger, but in parallel with the retraction of the plunger. And
(1) The bridge member 154 is destroyed and the lancet cap 152 is separated from the lancet body 151,
(2) The separated lancet cap 152 moves so as to deviate from the puncture trajectory.
It will be.

  7A to 7C show an injector 200 according to the present invention. FIG. 7A is an external view of the injector 200, and FIGS. 7B and 7C are views showing the inside of the injector 200. As shown in FIGS. 7B and 7C, the injector 200 includes a plunger 204 and a lancet cap removing member 206, and in addition, a trigger lever 230, an ejector 270 (the ejector 270 has an outer plate member 450 as will be described later). ), A holder lock member spring 280a, a trigger lock member 290, a trigger lock member spring 290d, and a flange portion 204b of the plunger 204 (as will be described later, the flange portion 204b has an inner plate). Member 460), injection spring 205a, return spring 205b, puncture depth adjusting mechanism 300, and the like. The plunger 204, the lancet cap removal member 206, the trigger lever 230, the ejector 270, the holder lock member 280, and the flange portion 204b of the plunger 204 are each schematically shown in FIGS. 8 (a) to 8 (f). It shows with.

  The housing 201 of the injector 200 is preferably composed of two divided members, for example, a member 201a shown in FIG. 9A and a member 201b shown in FIG.

  The plunger 204 is arranged along the longitudinal axis of the injector 200 and has a function of firing the lancet body 151 in the puncture direction. As shown in FIG. 7C or FIG. 8A, the distal end portion 204a of the plunger 204 can be engaged with the rear end portion of the lancet body 151 (the engagement portion of the rear end portion of the lancet body). Is indicated by reference numeral 165 in FIG. 2A). When the lancet assembly 100 is loaded into the injector 200, the lancet body 151 is inserted into the injector 200, whereby the tip end portion 204a of the plunger 204 and the rear end portion 165 of the lancet body 151 are engaged, and then rearwardly. When the lancet body 151 is further inserted, the plunger 204 is pushed backward. As a result, the spring 205 a provided on the plunger 204 is compressed, and the force necessary for firing the puncture member 153 is stored in the plunger 204.

The lancet cap removal member 206 can abut the lancet cap 152 and functions to remove the lancet cap 152 when the lancet assembly 100 is loaded into the injector 200. As shown in FIG. 8 (b), the lancet cap removing member 206 has a form in which two long members 206a and 206b protrude forward (therefore, the lancet cap removing member 206 is projected. The distal ends 206a ₁ and 206b _{1 of} the long members 206a and 206b abut the distal ends 156a of the rearward protruding portions 156 of the pair of first wing portions 155 of the lancet cap 152. It is configured. The tip portions 206a ₁ and 206b ₁ of the lancet cap removal member 206 are positioned on the front end opening 202 side of the injector 200 so that the lancet cap 152 and the lancet cap removal member 206 come into contact with each other when the lancet assembly 100 is loaded. The lancet cap removing member 206 is provided in the injector 200 so that the base portion 206c of the cap removing member 206 is positioned on the rear end side of the injector 200 (see FIGS. 7B and 8B). The tip portions 206a ₁ and 206b ₁ of the lancet cap removal member 206 and the tip 156a of the rearward projecting portion 156 of the lancet cap 152 may have complementary shapes so that they can contact more reliably. Good.

  The injector 200 has an ejector 270 used for removing the lancet holder 102 from the injector 200 after puncturing. The ejector 270 as shown in FIG. 8D is provided in the injector 200 so that only a part 270 b of the slide portion 270 a is exposed from the injector housing 201, and the lancet holder 102 is loaded into the injector 200. In this state, the front end portion 275 of the pressing member 274 of the ejector 270 (more specifically, the pair of wing portions of the member) is the edge of the opening end 103 of the lancet holder 102 and the rear end region 165a of the lancet body 151. (Refer to FIG. 10). Accordingly, when the portion 270b is pressed forward and slid, the pressing member 274 of the ejector 270 acts to push out the lancet holder 102 and the lancet body 151, and the used lancet assembly 100 is removed from the injector 200. Become. The portion 270b of the slide portion is formed so as to gradually increase in height toward the puncture direction (particularly preferably the surface touched by the thumb) so that it can be easily slid forward with a finger (especially the thumb). Is preferably curved) (see, for example, FIGS. 7A, 8D, and 10).

  In addition, after puncturing, the lancet holder 102 removed from the injector 200 by the ejector 270 houses the separated lancet cap 152 and the lancet body 151 from which the tip of the puncture member 153 is exposed. Since the pair of second wing portions 159 of the lancet body 151 are in contact with or collide with the stopper surface 180 provided inside the lancet holder 102, the puncture member 153 is exposed from the puncture opening 105. There is nothing. Therefore, the used lancet assembly 100 can be safely processed.

  Hereinafter, the features of the present invention will be described in detail. The puncture device according to the present invention has an “indicator function”. Members and parts that contribute to the indicator function are mainly “a window portion provided in an injector housing (= indicator window portion)” and “an outer plate member and an inner plate member” provided in the injector housing. is there. The indicator window 440 is preferably provided near the center of the side surface of the injector housing, as shown in FIGS. 7A, 9A and 9B, for example (the shape of the window is particularly limited). However, it is preferably rectangular, square or circular). The outer plate member 450 and the inner plate member 460 are shown in FIGS. 8D and 8F, respectively. In the illustrated embodiment, although the outer plate member and the inner plate member are each paired with two plate members, the following description is based on the premise that one plate member is provided for convenience. Give an explanation. As illustrated, the outer plate 450 is preferably provided on the ejector 270, and the inner plate member 460 is preferably provided on the flange portion 204b of the plunger. The outer plate member 450 and the inner plate member 460 are accommodated adjacent to each other in the housing of the injector as shown in FIGS. 11A, 12A, and 14, for example (“injector housing”). Hereinafter also referred to as “injector housing”). The term “adjacent” as used in the present specification means a mode in which the outer plate member and the inner plate member are adjacent to each other substantially in parallel (more specifically, the main surface of the outer plate member). And the main surface of the inner plate member are adjacent to each other in a parallel relationship). The outer plate member and the inner plate member are arranged adjacent to each other in a substantially parallel positional relationship with a space therebetween, for example, about 0.5 mm to 3 mm, preferably about 0.5 mm to 1 mm. Here, the outer plate member 450 is accommodated in the housing so as to be located outside the inner plate member 460. In other words, the inner plate member 460 is accommodated in the housing so as to be located inside the outer plate member 450 (see, for example, FIG. 14). The outer plate member 450 and the inner plate member 460 can move back and forth along the puncture direction when an external force is applied.

The outer plate member 450 provided in the ejector is provided with respect to the ejector pressing member (more specifically, “a pair of wing portions of the ejector that enables the lancet holder and the lancet body to move forward”). Preferably it is. Thus, the outer plate member 450 is provided in a movable state so as to slide back and forth. This will be specifically described as follows. As shown in FIGS. 15A and 15B, the outer plate member 450 is an ejector pressing member 274 having a wing shape (the “ejector pressing member” is also referred to as a “wing portion” because of its shape. The ejector pressing member 274 can be moved back and forth along the puncture direction, and accordingly, the outer plate member 450 can be moved back and forth along the puncture direction. . As shown in FIGS. 15A and 15B, the ejector pressing member 274 is combined with the ejector slide member 270a so as to be movable back and forth. Here, a spring member 452 as shown is attached between the ejector pressing member 274 and the rear end portion of the ejector slide member 270a, and a force acts on the ejector pressing member 274 forward in the puncture direction. (Note that the forward movement of the ejector pressing member 274 is limited to a certain position in combination with the engagement with the ejector slide member 270a). Therefore, in an initial state in which no force is applied to the ejector pressing member 274 (that is, an “unloaded state” or “unused state” described later), the outer plate member 450 provided on the ejector pressing member 274 has a certain amount. When the force is applied rearward to the ejector pressing member 274, the ejector pressing member 274 moves rearward in a form that resists the force of the spring member 452, while being maintained in the position. 450 will move backwards. On the other hand, when the force applied to the ejector pressing member 274 is released, the ejector pressing member 274 moves forward, and the outer plate member 450 returns to the original initial position. In addition, if the dimension of the outer side plate member 450 is demonstrated with reference to FIG.15 (b), the height H becomes like this. Preferably it is 7.5-9.8 mm, More preferably, it is 7.5-7.9 mm, The width W is preferably 3.9 to 5.1 mm, more preferably 3.9 to 4.1 mm, and the thickness T _h (average thickness T _h (not shown)) is preferably 0.65. It is -0.95mm, More preferably, it is 0.65-0.75mm. The outer plate member 450 may be formed of any kind of resin material as long as it is a resin material used in a general lancet. As shown in FIGS. 15A and 15B, the wing of the ejector is used. It may be formed by integral molding with the portion 274.

The inner plate member 460 is preferably provided with respect to the middle portion of the plunger 204. More specifically, it is preferably provided in a flange portion 204b attached to an intermediate portion of the plunger 204 (see, for example, FIG. 8 (f) and FIG. 14). Accordingly, in an initial state where no force is applied to the plunger (that is, an “unloaded state” or “unused state” described later), the inner plate member 460 is maintained at a certain position, and the lancet assembly. When the plunger is retracted when the injector is loaded, the inner plate member 460 is moved rearward accordingly, while when the plunger is moved forward when the puncture member is fired, The inner plate member will also move forward. In addition, if the dimension of the inner side plate member 460 is demonstrated with reference to FIG.8 (f), the height H becomes like this. Preferably it is 6.4-8.3 mm, More preferably, it is 6.4-6.6 mm. The width W is preferably 10.4 to 13.3 mm, more preferably 10.4 to 10.6 mm, and the thickness T _h (average thickness T _h ) is preferably 0.6 to 2.7 mm, More preferably, it is 0.6-2.1 mm. As described above or as illustrated, the width dimension W of the inner plate member is preferably larger than the width dimension W of the outer plate member (the reason will be described later). The inner plate member 460 may be formed of any type of resin material as long as it is a resin material used for a general lancet, and as shown in FIG. 8 (f), it is integrated with the flange portion 204b of the plunger. You may form by shaping | molding.

When the lancet assembly is not inserted into the injector or in an unused state, the outer plate member 450 and the inner plate member 460 are located at the installation position of the indicator window provided in the injector housing (FIG. 11). (See (a)). Refer to FIG. 13 for the “position of the indicator window”. In the unloaded state or the unused state, as shown in FIG. 11A, the outer plate member 450 is positioned outside the inner plate member 460, so that the outer plate member 450 is exposed from the indicator window 440. When the indicator window 440 is viewed from the outside, the outer plate member 450 can be seen. The dimensions of the indicator window 440 will be described with reference to FIG. 7A. The height H is preferably 4.95 to 6.30 mm, more preferably 4.95 to 5.05 mm, and the width W is , Preferably 2.95 to 3.80 mm, more preferably 2.95 to 3.05 mm, and the thickness T _h (ie, substantially the thickness of the housing wall (not shown in FIG. 7A)). The thickness is preferably 1.45 to 1.55 mm. That is, the height and width dimensions of the indicator window are generally smaller than the height and width dimensions of the outer plate member and the inner plate member, and the outer plate member (and the inner plate member are unloaded). ) Is positioned in place, the outer plate member is exposed from the indicator window so as to occupy the entire area of the indicator window.

  Here, when the lancet assembly is loaded into the injector, when the lancet holder is inserted into the injector, the end of the lancet holder 102 on the opening end side 103 becomes the wing portion 274 of the ejector (that is, the “ejector described above or later”). The wing member 274 is pressed rearward with the insertion of the lancet holder (see FIG. 10). When the wing part 274 is pressed backward, the outer plate member provided in the wing part 274 moves rearward from the installation position of the indicator window part. Then, when the lancet holder is inserted into the injector until the puncture member can be fired (hereinafter also referred to as “a puncture possible state”), the outer plate member 450 moves backward from the installation position of the indicator window 440. It moves to the position which shifted | deviated (refer FIG.11 (b)). That is, the outer plate member 450 moves from the indicator window 440 to a position where it is not exposed. As a result, when the puncture device is ready for puncturing, the inner plate member 460 is exposed from the indicator window 440 due to the fact that the outer plate member 450 is not blocked. 460 becomes visible.

  When the lancet assembly is loaded into the injector, the plunger moves backward, so that the inner plate member provided on the plunger also moves backward, but the inner plate member 460 does not move. However, it has such a large size that a part of it can still be located at the installation position of the indicator window 440. Therefore, even if the inner plate member moves backward, a part of the inner plate member, more specifically, “the front half of the inner plate member” is located at the installation position of the indicator window, When the outer plate is not blocked, the inner plate is exposed from the indicator window. In other words, in the unloaded state or unused state, the rear half of the inner plate member is located at the installation position of the indicator window, whereas in the puncture enabled state, the front half of the inner plate member is It will be located at the installation position of the indicator window. FIGS. 12A and 12B schematically show how the position of the inner plate member is changed. FIG. 12 (a) schematically shows the positional relationship between the two plate members and the window portion when the lancet assembly is not inserted into the injector or in an unused state, and FIG. FIG. 3 schematically shows the positional relationship between the two plate members and the window portion in a puncture enabled state. Referring to FIGS. 12 (a) and 12 (b), the inner plate member 460 is removed due to the fact that the outer plate member 450 is not blocked during the transition from the unloaded state or the unused state to the puncturable state. Is visible from the indicator window 440, and the inner plate member 460 whose rear half is located in the indicator window 450 is shifted rearward so that its front half is located in the indicator window. You can understand. When the lancet assembly is loaded into the injector, the flange portion 204b of the plunger moves from the front step portion of the trigger lever (a locking portion when not in use or not loaded) 230c to the rear step portion of the trigger lever (in a punctureable state). The engaging plate is moved rearward to 230a (see FIGS. 28A and 28B), and the inner plate member is also moved rearward by an amount corresponding to the moving distance of the flange portion 204b. Therefore, assuming such a moving distance, even if the state changes from an unloaded state or an unused state to a puncture enabled state, a part of the inner plate member (particularly the front half) can be positioned at the installation position of the indicator window. In addition, it is preferable to determine the dimensions of the inner plate.

  Thus, when the lancet holder is inserted into the injector until the puncture device is ready, the puncture device according to the present invention can be seen from the indicator window in the unloaded state or the unused state. The inner plate member can be seen from the window, and the user of the puncture device can visually and reliably grasp whether or not the lancet assembly is correctly loaded in the injector from the change in the status of the indicator window.

  As shown in FIGS. 15A and 15B, each wing of the “pair of wing portions 274 provided with the outer plate member” extends upward from the ejector main body portion 270a and then forwards. It is preferable to bend at a right angle so as to extend in the direction. Moreover, it is preferable that the front-end | tip part 275 of each wing bends inward so that the edge of the opening end 103 of the lancet holder 102 can press the front-end | tip part of each wing. In particular, as shown in FIG. 10, it is preferable that the edge of the opening end 103 of the lancet holder is configured to abut on the “outer portion 275b of the front end portion of each wing”. Thus, the outer portion 275b preferably has a concave shape as shown in FIGS. 15 (a) and 15 (b). Since such contact occurs, when the lancet holder is inserted, the lancet holder 102 can surely press the pair of wing portions 274, and the outer plate member moves backward in the injector.

  Further, the side of the wing 274 is long so that the sliding movement of the wing 274 to the rear (or front) is stable, that is, the movement of the outer plate member to the rear (or front) is stable. Protrusions 276 are provided (see FIG. 15A), and guide channels 446 (for example, 2 provided on the inner wall of the injector housing) can be fitted into the inner walls of the injector housing. Preferably, a parallel rail of books is provided (see FIGS. 9A and 9B). In this case, when the wing part 274 moves rearward (or forward), the long convex part of the wing part is guided along the guide channel 446, and therefore, backward (or forward) of the wing part 274. The sliding movement of the outer plate member is stabilized, and the movement of the outer plate member to the rear (or the front) is stabilized.

  Furthermore, the spring member 452 (see FIG. 15A and FIG. 28B) provided between the wing portion 274 and the rear end portion of the ejector body portion 270a desirably has an appropriate spring force (ie, puncture). Moderate force to press the wing member 274 in the direction). This will be specifically described as follows. When the lancet assembly 100 is loaded into the injector 200, the rear end portion 165a of the lancet body 151 engages with the front end portion 204a of the plunger 204, but when it is inserted to some extent (specifically, the lancet holder 102 and the lancet 150 are inserted to a state just before the fixed state is released), the rear end portion 165a of the lancet body 151 is “an inner portion 275a of the front end portion” 275 of the wing portion 274 of the ejector 270 ( (See FIG. 15). When the lancet holder is further inserted to release the fixed state between the lancet body 151 and the lancet holder 102, the wing member 274 is pushed backward. Here, when the wing member 274 is pushed backward at the stage where the lancet body 151 and the lancet holder 102 are not yet released, the outer plate member 450 moves backward. Thus, the inner plate member 460 is partially visible from the indicator window 440. In other words, when the fixed state between the lancet body 151 and the lancet holder 102 is not released (= “the stage where the puncture is not possible”), the outer plate member 274 is pushed backward. 450 slightly shifts to the rear, and the state of the indicator window changes even though the puncture is not possible. Therefore, in order to avoid such inconvenience, even if a lancet holder is further inserted when the fixed state is released and a backward force is applied to the wing member 274, a force against the wing member 274 acts on the wing member 274. It is desirable to secure it with the spring force of the spring member 452. Generally speaking, if the spring force of the spring member 452 is weak, the outer plate member 450 may be displaced rearward even though the fixed state is not released, but the spring force of the spring member 452 is reduced. If it is strong to some extent, the inconvenience that “the outer plate member 450 shifts backward although the fixed state has not been released” does not occur. Is preferably provided in the spring member 452.

  Next, the function of the indicator mechanism from the puncturable state to the used state after puncturing will be described. In the puncture enabled state, as described above, the outer plate member is displaced backward from the installation position of the indicator window portion and is held at a position where it is not exposed from the indicator window portion, while the inner plate member has a front half thereof. Located at the installation position of the indicator window, it is exposed from the indicator window. Here, when the front portion of the trigger lever is pushed inward at the time of puncturing, the locked state of the rear step portion 230a of the trigger lever with respect to the flange is released. As a result, due to the force that the compressed plunger spring 205a extends toward its original shape, the plunger moves forward so that it returns to its original position, and the puncture member (ie, “lancet body”) More specifically, “a lancet body with the tip of the puncture member exposed”) is fired forward. Here, when the plunger moves forward at the time of firing the puncture member, the inner plate member whose front half is located at the installation position of the indicator window portion moves and moves forward, and the puncture member In the used puncture member after firing, the rear half of the inner plate member is located at the installation position of the indicator window. That is, in the used state, the rear half of the inner plate member can be seen from the indicator window. In addition, since the outer plate member is in a state in which the lancet holder is still inserted, the outer plate member is pressed rearward and is maintained in a state shifted from the indicator window portion, and the inner plate member is blocked by the outer plate member. There is no. In other words, the lancet holder inserted to the insertable state is held in a predetermined position by the “holder lock mechanism” provided in the puncture device, so that the ejector wing member moves forward. Is prevented, and the outer plate member is maintained in a state shifted from the indicator window. Here, the “holder lock function” will be briefly described. This function is a function of holding the lancet assembly without dropping from the injector even when the lancet assembly receives a force in the direction opposite to the insertion direction when the lancet assembly is inserted into the injector. The members and portions that contribute to the holder lock function are mainly the “holder lock member 280” of the injector and the “lock projection 116” provided on the lancet holder. As shown in FIGS. 7B and 7C, the holder lock member 280 is provided on the inner wall of the housing adjacent to the front end opening 202 of the injector 200. Further, as shown in FIG. 1A, the locking projection 116 is provided on the outer wall of the holder adjacent to the opening end 103 of the lancet holder 102. The holder lock member 280 itself is shown as a single body in FIG. As can be seen from FIG. 8 (e), the holder lock member 280 has a stopper portion A282 and a stopper portion B284 on the surface S thereof. As shown in FIGS. 7C and 14, the front end 280b of the holder lock member 280 is pivoted with respect to the inner wall of the housing of the injector (that is, is rotatably attached). Here, as shown in FIG. 14, since the spring 280a is provided between the holder lock member 280 and the housing side wall surface 212 of the injector, the holder lock member 280 has an internal direction of the injector (in FIG. 8 (e)). A force is acting in the direction indicated by the arrow F). When the lancet assembly 100 is inserted into the injector 200 having such a holder lock member 280, the locking projection 116 of the lancet holder 102 slides on the holder lock member 280. If the insertion is continued as it is, the locking projection 116 gets over the stopper portion A282. Since the holder lock member 280 is exerted with an inward force by the spring 280a, when the stopper portion A gets over, the locking projection 116 makes the holder lock member 280 circularly move around its front end. The holder lock member 280 is returned to the original position again once it is moved over. Similarly, when the insertion is continued as it is, the locking projection 116 gets over the stopper B284, and a puncture possible state is obtained. In this state, the locking projection 116 and the stopper B284 can be brought into contact with each other. In other words, the P surface (see FIG. 1A) of the locking projection 116 and the T surface (see FIG. 8 (e)) of the stopper portion B284 can contact each other, so that the lancet holder does not fall out of the injector. Held in position.

  FIGS. 12 (b) and 12 (c) schematically show how the position of the inner plate member is changed from the puncturable state to the used state. FIG. 12B schematically shows the positional relationship between the two plate members and the window portion in the puncturable state, as described above. FIG. 12C schematically shows the positional relationship between the two plate members and the window in the used state after puncturing. Referring to FIGS. 12 (b) and 12 (c), the inner plate member 460 whose front half is located in the indicator window 440 is located on the rear side when the state is changed from the puncturable state to the used state. It will be understood that the half is shifted forward so that half is located in the indicator window 440.

  As described above, in the puncture device according to the present invention, when the puncture is possible, the front half of the inner plate member can be seen from the indicator window, while the puncture member (more specifically, “the lancet with the tip of the puncture member exposed” is shown. In the used state after firing the "body"), the rear half of the inner plate member will be visible from the indicator window, and the puncture device user will be able to see the "used" It can be surely visually grasped from the change of the situation of the indicator window.

  In a preferred embodiment of the “indicator mechanism”, the outer plate member and the inner plate member have different colors so that the user or blood sample can visually grasp changes in the indicator window more easily. Yes. Thereby, the user or the blood sampled person can grasp | ascertain the puncture possible state more easily. In other words, the plate member seen from the indicator window portion changes from the “outer plate member” to the “inner plate member” during the transition from the “unloaded state or unused state” to the “puncture enabled state”. When the member and the inner plate member have different colors, the “change in the plate member that can be seen from the indicator window portion” becomes visually clear. In such an indicator mechanism, when the plate member is molded, the outer plate member and the inner plate member may have different colors as a whole (for example, by changing the colorant used during molding, The inner plate member can be a different color). Alternatively, by attaching a color sticker to the surface exposed from the indicator window (hereinafter also referred to as “exposed surface”) or by painting with a colored paint, the outer plate member The exposed surface and the exposed surface of the inner plate member may have different colors. In some cases, either the outer plate member or the inner plate member uses the color of the resin material used for molding the plate member as it is, and a color sticker is attached only to the other side or painted with a colored paint. (That is, in this case, either one of the outer plate member and the inner plate member may not be attached with a color sticker or painted with a colored paint).

  When the outer plate member and the inner plate member have different colors, the outer plate member (or the exposed surface of the outer plate member) is preferably also referred to as the injector housing color (hereinafter “housing body color”). Have the same color. Here, as the body color of the housing, white, gray (gray), light blue, and the like can be cited. In this case, the outer plate member has white, gray (gray) or light blue. Is preferable. On the other hand, the inner plate member (or the exposed surface of the inner plate member) preferably has a color different from that of the outer plate member, for example, red or yellow. As an example, the combination of the color of the outer plate member and the color of the inner plate member is “outer plate member: white, inner plate member: red”, “outer plate member: white, inner plate member: yellow. ”,“ Outer plate member: gray (gray color), inner plate member: red ”,“ outer plate member: gray (gray color), inner plate member: yellow ”, and the like.

  Further, in addition to the outer plate member and the inner plate member having different colors, it is more preferable that the front half and the rear half of the inner plate member have different colors. Accordingly, the user or the blood sampler can more easily grasp whether or not the puncture device in which the lancet assembly is already inserted into the injector has been used. In other words, the plate member visible from the indicator window portion changes from “the front half of the inner plate member” to “the rear half of the inner plate member” during the transition from the “puncture enabled state” to the “used state”. However, if “the front half of the inner plate member” and “the rear half of the inner plate member” have different colors, the “change in the inner plate member visible from the indicator window” becomes clear. . In such an indicator mechanism, when the inner plate member is molded, the front half and the rear half may have different colors (for example, by changing the colorant used during molding, the front half and the rear half). Half can be different colors). For simplicity, different color stickers may be attached to the front half and the rear half, or the front half and the rear half may be painted with different colored paints. In particular, a color sticker may be applied to only one of the front half and the rear half, or may be painted with a colored paint, and the other may use the color of the resin material as it is (that is, “front” Only the side half is subjected to coloring treatment, and the rear half is not particularly required to be colored ”or“ only the rear half is subjected to coloring treatment, and the front half is not particularly required to be colored. ").

  In addition to the outer plate member and the inner plate member having different colors, if the front half and the rear half of the inner plate member have different colors, the outer plate is merely an example. The member (or the exposed surface of the outer plate member) preferably has the same color as the housing body color. Here, examples of the housing body color include white, gray (gray), and light blue. In this case, the outer plate member has white, gray (gray), or light blue. It can be said that it is preferable. On the other hand, it is preferable that the front half of the inner plate member (or the exposed surface of the inner plate member) has yellow or green, and the rear half thereof has green or yellow. As an example only, the combination of the color of the outer plate member, the color of the front half of the inner plate member, and the color of the latter half of the outer plate member is “outer plate member: white, inner plate member” Front half: yellow, rear half of inner plate member: green, “outer plate member: white, front half of inner plate member: green, rear half of inner plate member: yellow”, “outer plate member : Gray (gray), front half of inner plate member: yellow, rear half of inner plate member: green, “outer plate member: gray (gray), front half of inner plate member: green, inner For example, the rear half of the plate member: yellow ”. Furthermore, “outer plate member: white, front half of inner plate member: red, rear half of inner plate member: yellow”, “outer plate member: blue, front half of inner plate member: red, inner plate Various combinations of colors such as “the rear half of the member: yellow” or “the outer plate member: green, the front half of the inner plate member: red, the rear half of the inner plate member: yellow” can be given.

  The outer plate member and the rear half of the inner plate member have the same color (referred to as “A color”), and the front half of the inner plate member is different from the A color (“B color”). It is also possible to have an embodiment having In such a case, in the “unloaded state or unused state” and the “used state after puncturing”, the A color is visible from the indicator window, while in the “puncture enabled state”, the B color is visible from the indicator window. It will be. That is, in this aspect, whether or not the puncture device is in a puncturable state can be determined by only two colors, A color and B color, and a simpler indicator function can be achieved. For example, a housing body color (for example, white or gray (gray)) may be adopted as “A color”, and red, yellow, or green may be adopted as “B color”. More specifically, “outer plate member: white, front half of inner plate member: yellow, rear half of inner plate member: white”, “outer plate member: white, front half of inner plate member: Green, rear half of inner plate member: white, “outer plate member: white, front half of inner plate member: red, rear half of inner plate member: white”, “outer plate member: gray (gray color) ), The front half of the inner plate member: yellow, the rear half of the inner plate member: gray (gray), the “outer plate member: gray (grey), the front half of the inner plate member: green, the inner plate Rear half of member: Gray (gray) ”,“ Outer plate member: Gray (gray), Front half of inner plate member: Red, behind inner plate member Side half: are possible color combinations, such as gray (gray) ".

  Next, in the following, with reference to FIGS. 16 to 21, the change in the indicator window starts from the loading operation of the lancet assembly 100 to the completion of loading, puncturing, and removal of the lancet assembly 100 after puncturing. Is explained in a comprehensive manner.

  First, as shown in FIG. 16, when the lancet assembly 100 is not inserted into the injector 200 or not used, the outer plate member 450 and the outer plate member 450 and the installation position of the indicator window 440 provided in the injector housing are disposed. An inner plate member 460 is located. In this case, since the outer plate member 450 blocks the inner plate member 460, the outer plate member 450 can be seen from the indicator window 440. FIG. 17 shows a state in which the lancet holder 100 starts to be inserted into the injector 200. When the lancet holder 102 is inserted into the injector 200, the rear end portion of the lancet body and the front end portion of the plunger are engaged, and the plunger is retracted, so that the inner plate member 460 is moved backward and moved. Will do. FIG. 18 shows a state in which the lancet holder 102 is inserted into the injector 200 until the puncture is possible. When the lancet holder 102 is inserted until the puncture is possible, the end on the opening end side of the lancet holder 102 comes into contact with the tip of the wing portion 274 of the ejector and presses the wing member. The provided outer plate member 450 moves rearward from the installation position of the indicator window 440. Further, when the lancet holder 102 is inserted until the puncture is possible, the inner plate member 460 moves backward until the front half of the inner plate member 460 is located at the installation position of the indicator window 440 as the plunger moves backward. And will move. That is, when the lancet holder 102 is inserted into the injector 200 until the puncture is possible, the outer plate member 450 is shifted rearward from the installation position of the indicator window 440 and the rear half is positioned in the indicator window 440. Since the inner plate member 460 that has been moved is shifted rearward so that the front half of the inner plate member 460 is located at the indicator window 440, the inner plate member can be seen from the indicator window 440. Whether or not the lancet assembly is correctly loaded into the injector can be visually grasped from such a change in the indicator window 440. In FIG. 19, the aspect of the puncture device 400 of the used state after puncture is shown. When the puncture member is fired, the plunger moves forward, so that the inner plate member 460 whose front half is located at the installation position of the indicator window portion is shifted forward and moved. In the used puncture member after firing, the rear half of the inner plate member 460 is located at the installation position of the indicator window 440. Therefore, in the used state, the rear half of the inner plate member can be seen from the indicator window. Thereby, the user of the puncture device can visually grasp whether or not the lancet assembly has been used from such a change in the state of the indicator window 440. FIG. 20 shows a state in the middle of discharging the lancet holder 102 (that is, the used lancet assembly) after puncturing. As the lancet assembly 100 is discharged, the ejector 270 is slid forward. Accordingly, the outer plate member 450 is moved forward. FIG. 21 shows the embodiment after the lancet holder 102 (ie, the used lancet assembly 100) has been discharged. Since this aspect is the same as the initial unused state or the unloaded state, the outer plate member 450 and the inner plate member 460 return to their original positions and wait. That is, the outer plate member 450 and the inner plate member 460 are located at the installation position of the indicator window 440, and the outer plate member 450 can be seen from the indicator window 440.

  This is the end of the description of the “indicator mechanism”, but in a preferred embodiment, the indicator function is not provided only on one side of the injector, but on opposite sides of the injector as illustrated in the present application. Is provided. In this case, two indicator windows are provided so as to face each other at the housing wall, and as shown in FIGS. 8D and 8F, an “outer plate member” and an “inner plate member” are provided. Are formed in pairs so that two of them are opposed to each other. The above description of the indicator mechanism is similarly applied to any of the "mode provided only on one side surface of the injector" and the "mode provided on opposite sides of the injector". Please note that.

  Next, the “mechanism for promoting linearity of the puncture trajectory of the puncture member (hereinafter also referred to as“ straight forward acceleration mechanism ”)” of the lancet assembly according to the present invention will be described. Members / parts that contribute to the mechanism are mainly convex portions (hereinafter also referred to as “straight forward acceleration convex portions”) provided on the side portions of the lancet cap. Such a straightness promoting convex portion 600 is best shown in FIG. 2D, for example.

  As shown in FIG. 2D, the straight advancement convex portion 600 is provided on the side surface of the cap member (more specifically, “the side surface side that comes into contact with the slope member of the lancet holder when the lancet cap is separated”). Yes. When the “lancet body with the tip of the puncture member exposed” is fired or moved at the time of puncture, the puncture member comes into contact (for example, temporarily comes into contact) with the straightness promoting convex portion 600. In addition, it will be understood that the puncture member is in contact with the rectilinearity promoting member with reference to the modes shown in FIGS. 5A to 5E.

  Preferably, when the puncture member fired in the puncture direction returns in the direction opposite to the puncture direction, the puncture member contacts the straightness promoting convex portion. That is, it is preferable that the puncture member exposed from the puncture opening of the lancet holder at the time of puncture comes into contact with the straightness promoting convex portion in the process of returning to the puncture opening after puncturing a predetermined portion such as the body (more specifically, In this case, it is preferable that the puncture member contacts the straight-advancing convex portion while the puncture member is moving in the direction opposite to the puncture direction. Moreover, it is preferable that the front-end | tip part of a puncture member contacts a rectilinear advance promotion convex part. When the puncture member comes into contact with the straightness promoting convex portion, the straightness of the puncture member during puncture increases. In other words, the puncture trajectory of the puncture member is corrected so as to be as straight as possible by the straight advancement promoting convex portion. As a result, an effect of reducing pain felt by a person to be punctured (for example, a blood sampled person) at the time of puncture is obtained (note that the puncture site is punctured, although not limited by a specific theory / idea). It is thought that the pain to be felt can be reduced due to the reduction of the “penetration” phenomenon by the member).

  Preferably, as shown in FIG. 2D, the rectilinear advancement convex portion 600 is formed in an elongated shape along the puncture direction, and the rear portion 610 of the rectilinear advancement convex portion is gradually higher toward the puncture direction. It is preferable to have a slope shape. In this case, referring to the lower diagram in FIG. 2D, the height H (the height in the normal direction with respect to the side surface of the cap) or the maximum height H is preferably 0.45 to 0.70 mm, More preferably, it is 0.45-0.55 mm, and the length L along the puncture direction is preferably 4.7-6.1 mm, more preferably 4.7-4.9 mm. Further, the width W (length in the direction orthogonal to the length L) of the straight advancement promoting convex portion is preferably 0.7 to 1.1 mm, more preferably 0.7 to 0.9 mm. 2D, the slope angle β of the slope-shaped portion with respect to the side surface of the lancet cap is preferably 9 ° to 11 °.

  There is no particular limitation on the installation position of the straightness promoting convex portion on the side surface of the lancet cap as long as the puncture member can be in contact with the lancet cap, but in general, as shown in FIG. Near the center. Further, as long as the straight advanceability of the puncture member is not greatly affected, the straight advancement-protruding convex portion may be partially lacked except for the slope-shaped portion on the rear side. Further, the method of forming the straight advancement convex portion is not particularly limited, and may be formed integrally when forming the lancet cap or the lancet, or may be formed by providing a separate member on the side surface of the lancet cap. Also good.

  Next, the “puncture depth adjusting mechanism” according to the present invention will be described. The puncture depth adjusting mechanism 300 is provided on the rear side of the injector (see FIG. 7B). The members that contribute to the puncture depth adjustment mechanism are mainly “the protrusion 310 provided at the rear end of the plunger and projecting outward from the plunger in the transverse direction thereof”, “the height of the end is stepped. These are “cylindrical member 320 having step portions formed differently” and “drum members 340 and 350 engaging with the cylindrical member so as to rotate integrally with the cylindrical member”. FIG. 22 is a development view of members used in the puncture depth adjusting mechanism 300.

  The protrusion 310 is provided at the rear end of the plunger 204 and protrudes outward from the plunger 204 in the transverse direction. Such an embodiment is best shown in FIGS. 8 (a) and 25. FIG. The protruding portion 310 may be provided by attaching a separate protruding cap to the rear end of the plunger 204.

  The cylindrical member 320 is best shown in FIG. As shown in FIG. 23, the cylindrical member 320 has step portions 325 (325a, 325b, 325c, 325d, 325e, 325f) formed so that the heights of the end portions thereof are stepwise different. Yes. As can be seen from FIG. 23, the cylindrical member 320 has a ring shape in which a step is provided at the end.

  The drum member 345 is preferably composed of an inner drum 340 and an outer drum 350 as shown in FIG. In this case, the inner drum 340 and the outer drum 350 are engaged so as to be able to rotate integrally. In the injector, since the outer drum 350 is provided so as to protrude rearward from the injector housing, the outer drum 350 can be rotated with a finger or the like (see, for example, FIG. 7A).

  In such a puncture depth adjusting mechanism, when the plunger 204 moves forward during puncture, the protrusion 310 of the plunger moves as shown by an arrow b as shown in FIG. The final collision with the step portion 325 prevents the plunger 204 from moving further forward. As a result, the cylindrical member 320 is rotated about its axis, and the step portion 325 where the projecting portion 310 collides is changed to a step portion having a different height (for example, change from the step portion 325a to 325b). Thus, the distance that the plunger 204 can move forward during puncturing can be changed. That is, the puncture depth can be adjusted. Note that the step 325 of the cylindrical member 320 is preferably formed point-symmetrically about its axis so that the pair of protrusions 310a and 310b can collide with the step 325 having the same height (FIG. 23). reference). The cylindrical member 320 is provided so as to fit into the inner wall of the inner drum 340 (more preferably, “annular groove 340a provided on the inner wall”) (see FIG. 22). The cylindrical member 320 can be indirectly rotated by rotating using the.

  Here, in the injector mechanism according to the present invention, as shown in FIG. 24, a groove portion 355 along the annular direction is formed on the outer peripheral surface of the outer drum 350, while on the other hand, as shown in FIG. A convex portion 218 that fits into the groove portion is formed on the inner wall. When the outer drum 350 rotates, the convex portion 218 is guided along the groove portion 355, and the end portion of the convex portion 218 and the groove portion 355 (for example, a portion 355a as shown in FIG. 24) is mutually connected. , The rotation of the outer drum 350 is restricted. Therefore, the drum member does not rotate more than necessary, and the drum member can be rotated within a certain range. This means that the puncture depth can be adjusted appropriately within the range in which the outer drum can rotate.

  In a preferred embodiment, a notch 250 is formed at the rear end of the injector housing as shown in FIGS. 9A and 9B, while a scale is provided on the outer peripheral surface A of the outer drum 350 as shown in FIG. Are marked along the annular direction (or circumferential direction). In this case, the drum member is fitted inside the rear end of the injector housing so that the notch 250 and the scale of the drum member (more specifically, the outer drum 350) overlap each other. The numerical value of the scale exposed from the notch 250 changes with the rotation of the drum member (see, for example, FIG. 7A). The notch 250 may be in the form of an opening formed in the housing side of the injector. The scale value corresponds to the puncture depth. For example, when the scale value is assigned as “1, 2, 3, 4, 5, 6”, the puncture corresponds to each value. The depth changes in six steps. For example, when the scale value is set to “1”, that is, when the outer drum 350 is rotated so that the scale value “1” is exposed from the notch 250, the cylindrical member 320 has the most The cylindrical member 320 is rotated so that the high step portion (step portion 325f) and the protruding portion 310 collide with each other, and the puncture depth becomes the smallest. On the other hand, for example, when the scale value is set to “6”, that is, when the outer drum 350 is rotated so that the scale value “6” is exposed from the notch 250, the cylindrical member is used at the time of puncturing. The cylindrical member 320 is rotated such that the lowest step portion (step portion 325a) of 320 collides with the protruding portion 310, and the puncture depth becomes the deepest. Thus, by changing the scale value from “1” to “6” in stages, the puncture depth can be changed in six stages. The difference in height between adjacent step portions is preferably 0.2 to 0.3 mm, more preferably about 0.25 mm. Therefore, by changing the scale value by one step (for example, the scale value is “2”). From 3 to 3), the puncture depth will preferably change at a rate of 0.2-0.3 mm, more preferably about 0.25 mm. In a particularly preferable aspect, the scale is written in an annular direction at a location adjacent to the groove 355 of the outer drum (see FIG. 26A), and the same scale is also provided on the side where the groove 355 is not provided. It is preferable that it is written in the annular direction (see FIG. 26B). Thereby, the numerical value of the same scale can be exposed from the two notch portions 250 formed at the opposing positions of the side portions of the housing, and the setting of the puncture depth can be grasped from the two side surfaces of the injector. (Ie, the puncture depth scale can be seen on two sides of the injector).

  In a more preferred embodiment, for example, as shown in FIG. 16, FIG. 24 or FIG. 30, the outer peripheral surface of the outer drum body has an uneven shape 348 (in this case, the cross section of the protrusion is approximately half as shown A leaf spring member 357 is provided in the injector housing so as to be in contact with the uneven shape 348 (for example, refer to FIG. 16). Thereby, the drum member can be rotated stepwise (stepwise) corresponding to the numerical value of the scale. That is, the outer drum can be rotated so that the scale value of the outer drum 350 is exposed from the notch 250 in a stepwise manner.

  Such setting of the puncture depth adjustment may be performed at any time point from the unloaded state to the puncturable state. In other words, the puncture depth may be adjusted / set prior to loading the unused lancet assembly, or the puncture depth may be adjusted / set after the puncture possible state is obtained.

  Next, “a puncture device having a function of allowing a user to perform a puncture operation more smoothly”, which is one preferred embodiment of the present invention, will be described. With this function, the pressing force and the pressing distance when the trigger lever is pressed during puncturing become appropriate, so that the user can easily perform the puncturing operation. Members / portions related to such functions are mainly “trigger lever” and “spring member provided between the trigger lever and the injector housing”.

  In FIG. 29, the specific mode of the “trigger lever” related to the above function is indicated by reference numeral 230. As shown in the figure, the trigger lever 230 is provided inside the housing on the front side of the injector. When the puncture member is fired, when a part of the exposed portion from the opening on the side of the housing is pressed (specifically, “the upper surface of the front portion 230g of the trigger lever 230 is pushed into the injector”), The puncture member is fired.

  The trigger lever 230 has an intermediate portion 230f pivoted with respect to the inner wall of the housing of the injector (that is, attached to be rotatable about the intermediate portion 230f). The rear side of the trigger lever 230 is such that a force A acts on the front side portion 230g of the trigger lever 230 toward the outer side of the housing, while a force B acts on the rear side portion 230h of the trigger lever 230 toward the inner side of the housing. A spring member 230e is provided between the side portion 230h and the housing side wall surface 255 of the injector. In FIG. 29, “force A in the housing outer direction acting on the front portion 230g of the trigger lever 230” and “housing inner direction B acting on the rear portion 230h of the trigger lever 230” are indicated by arrows.

  FIG. 29 shows an aspect of the trigger lever in the puncture enabled state. In such an aspect, in such a puncture enabled state, the rear end portion of the trigger lever is in contact with the flange of the plunger (more specifically, the contact between the rear end stepped portion 230a and the flange portion 204b of the plunger 204). On the other hand, the front end portion of the trigger lever is in contact with the “periphery portion 220 of the opening provided on the front side portion of the injector housing”. When puncturing, the front portion 230g of the trigger lever 230 is pushed toward the inside of the injector. By such pushing, the rear side portion 230h of the trigger lever 230 moves toward the housing outer side, so that the contact state (locking state) between the rear end stepped portion 230a of the trigger lever 230 and the flange portion 204b of the plunger 204 is achieved. Canceled. As a result, the compressed spring 205a extends instantaneously, and the puncture member is fired toward the front puncture direction.

  Such a trigger lever 230 has a more appropriate pressing force and pushing distance when pressing the trigger lever than the embodiment of the trigger lever 230 shown in FIG. 18, for example. This is because, in the trigger lever 230 as shown in FIG. 18, force is applied to the trigger lever by utilizing the bending of the portion 230 i extending to the rear side, whereas the trigger lever 230 shown in FIG. This is because a force is applied to the trigger lever by the spring member 230e instead of such bending. That is, by appropriately adjusting the spring force and length of the spring member 230e, the “pressing force and pressing distance when the trigger lever is pressed during puncturing” becomes appropriate. Thereby, in particular, the user can perform puncture by lightly pressing the trigger lever without applying an unnecessarily large force.

  The trigger lever itself is preferably made of resin. While providing a convex part in the middle part of the trigger lever and providing a concave part in the inner wall of the housing of the injector and fitting them together, the middle part of the trigger lever can be pivoted with respect to the inner wall of the housing of the injector. Even if a concave portion is provided in the middle portion of the trigger lever and a convex portion is provided on the inner wall of the housing of the injector, the trigger lever can be similarly pivoted. The spring member 230e is preferably made of metal, for example, a metal coil spring. As shown in FIG. 29, a recess is provided on the upper surface of the rear portion 230h of the trigger lever, and a recess is also provided on the housing side wall surface 255 of the injector, and the spring member 230e can be provided in a form sandwiched between the two recesses. .

  Next, another preferred embodiment of the present invention, “a puncture device having a repuncture prevention function that cannot be used for puncture again after being used” will be described. This function is a function in which the used puncture member once fired and used for puncture is not used for puncture again. More specifically, the “puncture device in which the puncture member has been fired once but the lancet assembly is still loaded in the injector” is not allowed to puncture again (the puncture member is ready to fire). It is a function that was made. In other words, it can be said that “the puncture member cannot be punctured twice when the puncture member is loaded in the injector”. As a result, it is impossible to “use a puncture device once used for a patient to another patient”, so that blood infection can be prevented in blood collection applications in hospitals. The members / parts that contribute to the repuncture prevention function are mainly “the flange member provided on the outer peripheral surface of the drum member” and “the constricted part or the convex part provided on the inner wall of the injector housing”.

  FIG. 30A and FIG. 30B show a specific mode of “the flange member provided on the outer peripheral surface of the drum member” by reference numeral 370. As illustrated, the flange member 370 is provided in an annular direction (or circumferential direction) on the outer peripheral surface of the drum member, and has a form protruding outward from the drum member. Preferably, the flange member 370 is provided immediately behind the uneven portion 348 provided on the outer peripheral surface of the drum. Preferably, the flange member 370 is made of an elastic material such as a rubber material. The flange member 370 may be provided on the outer peripheral surface by means such as adhesion, but in some cases, it may be integrally formed when the drum member is formed (in this case, the “flange member” is also referred to as a “flange portion”). Is possible).

  A specific embodiment of “a constricted portion or a convex portion provided on the inner wall of the housing of the injector” is denoted by reference numeral 253 in FIG. 30 (a) or FIG. 30 (b). 30A shows “the narrowed portion 253 provided on the inner wall of the injector housing”, and FIG. 30B shows “the convex portion 253 provided on the inner wall of the injector housing”. In either aspect, there is no change in the effect of preventing re-puncture, and it is appropriately selected according to the individual design of the puncture device. The narrowed portion 253 shown in FIG. 30A is provided in the annular direction (circumferential direction) on the inner wall of the injector housing, and has a form protruding inward from the inner wall of the housing. Moreover, the convex part 253 shown in FIG.30 (b) has the form protruded from the inner wall face of the housing of an injector to the inner side of the cross direction. As shown, the constriction or protrusion 253 is preferably provided in the rear portion of the injector housing. For example, the narrowed portion 253 may be provided adjacent to the rear end opening of the injector housing, and the convex portion 253 may be provided inside the housing in front of the rear end opening of the housing. The narrowed portion or the convex portion 253 may be integrally formed from the housing material when molding the housing, but may be separately provided by using an annular ring member or the like.

  As shown in FIGS. 30A and 30B, the flange member 370 needs to be positioned on the front side relative to the narrowed portion or the convex portion 253. Further, the flange member 370 and the constricted portion or the convex portion 253 need to be provided adjacent to each other, and may be in contact with each other depending on circumstances. More specifically, the drum member is placed on the injector so that the “side surface 370a on the rear side of the flange portion 370” and the “side surface 253a on the front side of the narrowed portion or the convex portion 253” are adjacent to or in contact with each other. It is preferable that it is provided with respect to the housing. In such an aspect, when a rear force is applied to the drum member, the flange member 370 and the narrowed portion or the convex portion 253 come into contact with each other. Cannot move backwards. That is, even if it tries to pull the drum member with a finger and pull it backward, it cannot be pulled. Here, if “the drum member can be pulled backward after the puncture member has been fired once”, the plunger can be retracted, so that the puncturable state can be obtained again. However, since the drum member cannot be pulled backward in such a manner, the puncturable state cannot be obtained again after puncturing. In that respect, it can be said that a sanitary puncture device is provided.

  Note that a flange member 375 similar to the flange member 370 may be further provided on the outer peripheral surface of the drum member, as shown in FIGS. 30 (a) and 30 (b). In this case, it is preferable that the narrowed portion or the convex portion 253 is sandwiched between the flange member 370 and the flange member 375. As a result, the flange member 370 and the narrowed portion 253 come into contact with each other even when a forward force is applied to the drum member as well as the rear, so that the drum member is relative to the housing. Can no longer move forward. In other words, the drum member is provided more stably with respect to the injector housing.

  The aspect in which the two flange members 370 and 375 are provided on the drum member is substantially equivalent to the aspect in which the annular groove 377 is provided between the flange members. Therefore, in place of providing the flange member on the outer peripheral surface of the drum member, the repuncture prevention function is provided even in the aspect in which the annular groove portion 377 is provided and the narrowed portion or the convex portion 253 is provided so as to be fitted into the annular direction groove portion 377. Can be obtained.

  Next, “a puncture device having a function of discharging a used lancet assembly more smoothly from an injector” will be described. Such a function is a function that allows the used lancet assembly after puncturing to be more easily removed from the injector. In particular, this feature allows the used lancet assembly to be ejected from the injector with some momentum, so that the puncture device can be in any orientation (for example, if the front end opening of the injector is pointing upwards). The lancet assembly can be discharged reliably. Members / parts that contribute to such a function are mainly “an ejector composed of an ejector pressing member and an ejector slide member” and “a spring member capable of applying a forward force to the ejector pressing member”.

FIG. 15 shows an ejector 270 including an ejector pressing member 274 and an ejector slide member 270a. As illustrated, the legs 274a of the ejector press member 274 by fit into openings 270a ₁ of the ejector slide member 270a, the ejector pressing member 274 and the ejector slide member 270a is combined. More specifically, as the ejector pressing member 274 is movable state back and forth relative to the ejector slide member 270a, the legs 274a of the ejector press member 274 is fitted to the opening portion 270a ₁ of the ejector slide member 270a It is out. The “spring member capable of applying a forward force to the ejector pressing member” is a spring member denoted by reference numeral 454 in FIG. 15B and FIG. 31A. As shown, the spring member 454 is provided inside of the protrusions 270a ₂ which would put the finger at the time of discharge. In particular, the spring member 454 is provided between the “rear side surface 274a ₁ of the leg portion of the ejector pressing member 274” and the “rear inner wall surface 270a ₃ inside the protruding portion 270a ₂ ”. Accordingly, the spring force of the spring member 454 can be applied to the ejector pressing member 274, and the forward movement of the ejector pressing member 274 is assisted. When the used lancet assembly is discharged, the ejector pressing member 274 moves forward and the lancet holder and the lancet body are pushed in order to slide the ejector 270 forward as a whole. The spring force of the member 454 (more specifically, “restoring force generated when the compressed spring is restored”) can be additionally applied to the ejector pressing member 274. As a result, the lancet holder and the lancet body are pushed more strongly forward, and the smooth discharge of the used lancet assembly is assisted.

  In particular, when the used lancet assembly is discharged, the puncture device is configured such that the spring member 454 is temporarily compressed and the compressed state of the spring member 454 is instantaneously released. Once the spring member 454 is compressed and the compressed spring member 454 is released, the used lancet assembly can be ejected from the injector vigorously. More specifically, at the time of discharging the used lancet assembly, “the lancet holder locking projection 116 (see FIG. 1A)” and “the stopper portion A282 or the stopper portion B284 of the holder locking member 280 provided on the injector” 7C and FIG. 8E) ”can be brought into contact with each other, and as a result, the spring member 454 can be temporarily compressed. When the discharging operation is subsequently performed, the contact state is instantaneously released. As a result, the compression state of the spring member 454 is instantaneously released, and the spring member 454 is used by the restoring force of the spring member 454. The lancet assembly is pushed out and discharged.

  In order to give a more detailed description, the “holder lock releasing function” provided in the puncture device of the present invention will be described. Such a “holder lock releasing function” exists in a form corresponding to the “holder lock function” described above. The holder lock release function is a function for releasing the used lancet assembly smoothly by releasing the holder lock function when discharging the used lancet assembly after puncturing from the injector. Members / parts contributing to the “holder lock releasing function” are mainly “release part A and / or release B” provided on the holder lock member 280 and “released part” provided on the ejector. As shown in FIG. 8E, the release part A286 and / or the release B288 are provided on the side surface part of the holder lock member 280. As illustrated, in the holder lock member 280, it is preferable that the release portion A286 is provided adjacent to the stopper portion A282 (that is, the release portion A286 and the stopper portion A282 are provided on the holder lock member 280). Preferably, the release part B288 is provided adjacent to the stopper part B284 (that is, the release part B288 and the stopper part). B284 is preferably arranged so as to be adjacent along the short direction / transverse direction of the holder lock member 280). More specifically, it is preferable that the release portion A286 is provided so as to protrude in the transverse direction of the holder lock member from the side surface of the holder lock member adjacent to the position where the stopper portion A282 is provided. B288 is preferably provided so as to protrude in the transverse direction of the holder lock member from the side surface of the holder lock member adjacent to the position where the stopper portion B284 is provided. The lock related to the stopper portion A can be preferably released by such a release portion A, and the lock related to the stopper portion B can be preferably released by the release portion B. In addition, the to-be-released part 272 is provided in the front side part of the ejector 270, as shown in FIG.

  Such “release part” and “released part” function when the ejector is slid after the puncture to discharge the used lancet assembly. Specifically, when the ejector is slid forward, the released portion 272 slides on the release portion A286 and / or the release portion B288, and the holder lock member 280 is centered on the front end portion 280b. And moved outwards to make a circular motion. As a result, the contactable state between the locking projection 116 of the lancet holder and the stopper part A282 and / or the stopper part B284 of the holder lock member 280 is released. Thereby, the lancet holder 102 can be smoothly discharged from the injector 200. In the case where both the stopper portion A282 and the stopper portion B284 are provided on the holder lock member 280, first, the released portion 272 of the ejector 270 slides and moves on the release portion B288, and then the release portion. Since it slides on A286, after the contactable state between the locking projection 116 and the stopper B284 is released, the contactable state between the locking projection 116 and the stopper A282 is released. Will be.

  The shape of the release portion B288 and the shape of the release portion 272 are designed to be related to each other so that the release portion 272 of the ejector 270 smoothly contacts and moves on the release portion B288 of the holder lock member 280. Has been. Similarly, the shape of the release portion A286 and the shape of the released portion 272 are related to each other so that the released portion 272 of the ejector smoothly contacts and moves on the release portion A286 of the holder lock member 280. Designed.

  In particular, as shown in FIG. 8D, it is preferable that the released portion 272 of the ejector is formed in an inverted triangular shape. In this case, as shown in FIG. 8E, the release part B288 of the holder lock member 280 is preferably formed in a semicircular shape, and the release part A286 of the holder lock member 280 has a continuous shape. Preferably it is formed. In this case, when the part 272 to be released moves in contact with the release part B288, the holder lock member 280 is once moved outward and then returned to the original position. When moving in contact with the release portion A286, the release A286 is continuously formed, so that the holder lock member 280 is held while being moved outward.

The “holder lock release function” has been described above. However, the spring member 454 effectively acts so as to be interlocked with the holder lock release function. That is, when the contact state between the locking projection 116 of the lancet holder and the stopper part A282 and / or the stopper part B284 of the holder lock member 280 is released during discharging, the contact is compressed due to the contact. Since the spring member 454 is released from the compression, a restoring force is generated in the spring member 454. The principle that the spring member 454 is compressed is explained as follows. At the time of discharging, a force to move forward acts on the protruding portion 270a ₂ on which the finger is placed at the time of discharging. However, the “projection 116 for locking the lancet holder” and the “stopper of the holder locking member 280” When the part A282 and / or the stopper part B284 "come into contact with each other, the forward movement of the ejector pressing member 274 is temporarily blocked. In this case, the front end of the spring member 454 is fixed by the “rear side surface 274a ₁ of the leg of the ejector pressing member 274”, whereas the rear end of the spring member 454 is “inside the protrusion 270a ₂ . It will continue to be pushed by the rear inner wall surface 270a ₃ ”, and a force for compressing the spring member 454 will act.

  Hereinafter, with reference to FIG. 31A to FIG. 31E, modes of discharging the used lancet assembly will be described over time. FIGS. 31A to 31E show changes over time of the used lancet assembly 100 and the injector 200 in alphabetical order.

FIG. 31A shows a state of the puncture device in a used state after puncture and before the ejector operation is performed. In such an embodiment, the locking projection 116 of the lancet holder and the stopper B284 of the holder locking member are in contact with each other, but the spring 454 is not compressed because the ejector 270 is not pressed forward. If a finger (for example, a thumb) is applied to the projecting portion 270a ₂ of the ejector 270 from this state and the projecting portion 270a ₂ is slid forward, the locking projection 116 and the stopper B284 are temporarily brought into contact with each other. Thus, the forward movement of the ejector pressing member 274 is temporarily blocked. That is, the rear side surface 274a ₁ of the leg portion of the ejector pressing member 274 is temporarily fixed. At this time, since the protruding portion 270a ₂ is continuously pressed forward, the spring member 454 is pushed forward by the rear inner wall surface 270a ₃ of the protruding portion 270a ₂ , and the spring member 454 is temporarily (The “spring member 454 temporarily compressed” is partially shown on the lower side of FIG. 31A).

When continuously pushing forward the protruding portion 270a ₂ Subsequently, due to the above-mentioned holder lock release function, is the contact between the stopper portion B284 of the locking protrusion 116 of the lancet holder holder locking component 280 would be released, that moment, since the rear side 274a ₁ of the legs of the ejector pressing member 274 moves quickly forward, so that the compressed state of the spring member 454 is released instantaneously. Therefore, due to the restoring force of the spring member 454, the ejector pressing member 274 is pressed, and the used lancet assembly is additionally pressed and vigorously moves in the discharging direction. FIG. 31B shows a mode in which the compressed state of the spring member 454 is instantaneously released and temporarily extended due to the release of the contact state between the locking projection 116 and the stopper B284.

When continuously pushing forward the protruding portion 270a ₂ Subsequently, the lancet holder and the lancet body is further pushed forward. At this time, the lancet body receives a direct force forward from the ejector, while the plunger does not receive a direct force from the ejector. Therefore, a relatively separating force acts between the rear end portion of the lancet body and the front end portion of the plunger, and finally the engagement state is released. At the time of release, since the forward movement of the pressing member 274 is temporarily blocked, a compressive force is temporarily applied to the spring member 454 as described above. A mode in which the spring member 454 is temporarily compressed when the engagement state between the rear end portion of the lancet body and the front end portion of the plunger is released is shown in FIG. 31C. When the engaged state is released, the compressed state of the spring member 454 is instantaneously released and temporarily extended, and the ejector pressing member 274 is pressed as described above, and the used lancet assembly is moved. In addition, it is pushed and moves in the discharge direction vigorously.

Further continuously pressed forward protrusions 270a ₂ subsequently, will be the stopper portion A282 and the locking protrusion 116 of the lancet holder of the holder lock member 280 abuts (stopper portion A282 and the lock protrusion The mutual contact state with 116 is shown in FIG. 31D), and the forward movement of the ejector pressing member 274 is temporarily blocked. That is, the rear side surface 274a ₁ of the leg portion of the ejector pressing member 274 is temporarily fixed. At this time, since the protruding portion 270a ₂ is continuously pressed forward, the spring member 454 is pushed forward by the rear inner wall surface 270a ₃ of the protruding portion 270a ₂ , and the spring member 454 is temporarily (The “spring member 454 temporarily compressed” is partially shown on the lower side of FIG. 31D).

When continuously pushing forward the protruding portion 270a ₂ Subsequently, due to the above-mentioned holder lock release function, is the contact between the stopper portion A282 of the locking protrusion 116 of the lancet holder holder locking component 280 It will be released. If the contact state is released, the rear side 274a ₁ of the legs of the ejector pressing member 274 to move rapidly forward, the compressed state of the spring member 454 is released instantaneously. Therefore, the ejector pressing member 274 is pressed due to the restoring force of the compressed spring member 454. As a result, the used lancet assembly is additionally pushed vigorously and moved in the discharging direction, and finally discharged from the injector (the state in which the used lancet assembly 100 is discharged from the injector 200 is shown in FIG. 31E. ).

  Although the embodiments of the present invention have been described above, the present invention is not limited thereto, and those skilled in the art will readily understand that various modifications can be made. For example, the “outer plate member” / “inner plate member” used in the indicator mechanism of the puncture member according to the present invention is not necessarily limited in appearance to having a “plate shape”. It may have various forms such as “prism-shaped member”, “columnar member”, or “bar shape”.

  In connection with the “straight advancement promotion mechanism” of the lancet assembly according to the present invention, a test for confirming the puncture trajectory of the puncture member was performed. Specifically, using a high speed camera (NAC K5), the movement of the puncture member at the time of puncture was photographed at high speed, and the obtained image was analyzed to confirm the “puncture trajectory of the puncture member”.

Table 1 below shows the puncture conditions and specifications of the puncture member in the confirmation test. “Example” in the table is a test example in the case of using a “lancet assembly having a straight advancement-protruding convex portion on the side surface of the lancet cap”. This is a test example in the case of using a “lancet assembly that does not have a straight advancement convex portion”.

  The graph showing the results obtained in Example 1 and Comparative Example 1 in the above table is shown in FIG. 27A, and the graph showing the results obtained in Example 2 and Comparative Example 2 is shown in FIG. ). These graphs represent the trajectory from when the puncture member (more specifically, the most advanced portion of the puncture member) exits from the puncture opening to return into the puncture opening at the time of puncture (“the puncture member The direction of movement is indicated by the direction of the arrow shown in the figure). The horizontal axis of the graph indicates the variation of the puncture trajectory in the transverse direction, while the vertical axis of the graph indicates the variation [in mm] of the puncture trajectory in the puncture direction. That is, “the fluctuation [in mm] of the puncture trajectory in the transverse direction” indicates “the deflection width of the puncture member at the time of puncture”, and if the deflection width is smaller, the straightness of the puncture member is better. become.

  As can be seen from the graphs of FIGS. 27A and 27B, the example has a smaller “variation in the puncture trajectory in the transverse direction”, that is, the “swing width of the puncture member at the time of puncture” than the comparative example. It has become. Therefore, it will be understood that the straightness of the puncture member of the puncture device according to the present invention is more excellent.

  When the puncture device composed of the lancet assembly and the injector as described above is used, blood can be collected with a smoother operation without causing an erroneous operation. Such a puncture device can be used not only for blood collection of a diabetic patient but also for various applications that require blood collection.

Cross-reference of related applications

  This application claims the priority under the Paris Convention based on Japanese Patent Application No. 2007-254369 (filing date: September 28, 2007, title of the invention: “lancet assembly and puncture device”). All the contents disclosed in the application are incorporated herein by this reference.

Claims (17)

A lancet assembly including a lancet and a lancet holder for receiving the lancet, and an injector capable of firing a puncture member when used in combination with the lancet assembly. The lancet holder is disposed inside the injector from the front end opening of the injector. A puncture device adapted to be loaded into an injector by being inserted into the lancet assembly,
Comprising an indicator mechanism comprising two plate members, an outer plate member and an inner plate member;
In the injector housing, the outer plate member and the inner plate member are accommodated adjacent to each other such that the outer plate member is located more outwardly with respect to the inner plate,
The outer plate member and the inner plate member can move back and forth along the puncture direction;
In the unloaded puncture device in which the lancet assembly is not inserted into the injector, the outer plate member and the inner plate member are located at the installation position of the window portion provided in the injector housing, and the outer plate member is visible from the window portion. And
When the lancet assembly is loaded into the injector, the outer plate member is pushed backward due to the lancet holder inserted into the injector, and the lancet holder is placed inside the injector until the puncture member can be fired. When inserted in the puncture device, the outer plate member moves to a position shifted rearward from the installation position of the window portion, and the inner plate member becomes visible from the window portion. . The lancet has a lancet body, a lancet cap, and a puncture member, and the metal puncture member is present in the resin lancet body and the lancet cap, and the tip of the puncture member is caused by the lancet cap. Covered, the lancet cap and the lancet body are joined together via the bridge member,
The injector can be engaged with the rear end portion of the lancet body, and is a plunger that fires the lancet body having the puncture member in the puncture direction, a lancet cap removal member that can come into contact with the lancet cap, and puncture when pressed when the puncture member is fired The puncture device according to claim 1, comprising a trigger lever that causes firing of the member, and an ejector for removing the lancet assembly from the injector after puncturing.   The puncture device according to claim 2, wherein the outer plate member is provided on the ejector, and the inner plate member is provided on the plunger. In the unloaded puncture device in which the lancet assembly is not loaded in the injector, the rear half of the inner plate member is located at the installation position of the window,
When the lancet assembly is loaded into the injector, the rear end of the lancet body engages with the front end of the plunger, and the plunger is retracted as the lancet holder is inserted into the injector. When the lancet holder is inserted into the injector until the inner plate member is moved backward and the puncture member can be fired, the front half of the inner plate member The puncture device according to claim 3, wherein the puncture device is located in a position where the front half of the inner plate member can be seen from the window portion.   When the plunger is moved forward when the puncture member is fired, the inner plate member where the front half is located at the installation position of the window portion is shifted forward and the puncture member is fired. In the used puncture member after being made, the rear half of the inner plate member is positioned at the installation position of the window portion, and the rear half of the inner plate member can be seen from the window portion. The puncture device according to claim 4.   The puncture device according to any one of claims 1 to 5, wherein the outer plate member and the inner plate member have different colors.   The puncture device according to claim 6, when dependent on claim 4, wherein the front half and the rear half of the inner plate member have different colors. The middle part of the trigger lever of the injector is pivoted on the inner wall of the injector housing,
The rear side of the trigger lever and the housing side of the injector so that the force acts on the front side of the trigger lever toward the outer side of the housing, while the force acts on the rear side of the trigger lever toward the inner side of the housing. A spring member is provided between the wall and
When puncturing, when the front side portion of the trigger lever is pressed toward the inside of the housing against the force in the outer direction of the housing, the trigger lever rotates around the intermediate portion, thereby causing the puncture member to fire. 8. The puncture device according to any one of claims 2 to 7, characterized in that it is caused. A lancet assembly comprising a lancet and a lancet holder for accommodating the lancet,
The lancet has a lancet body, a lancet cap, and a puncture member, and the metal puncture member is present in the resin lancet body and the lancet cap, and the tip of the puncture member is caused by the lancet cap. Covered, the lancet cap and the lancet body are joined together via the bridge member,
When the lancet body is fixed to the lancet holder and the lancet cap is pressed in the puncture direction, the bridge member is broken and the lancet cap is separated from the lancet body, and the lancet body with the tip of the puncture member exposed is obtained. And
The separated lancet cap is a lancet assembly that moves to a position deviating from the puncture trajectory of the puncture member when subsequently pressed in the puncture direction,
The lancet assembly is provided with a convex portion on a side surface of the lancet cap, and the puncture member comes into contact with the convex portion when the lancet body with the tip portion of the puncture member exposed is fired during puncturing.   The lancet assembly according to claim 9, wherein the puncture member contacts the convex portion when the puncture member launched in the puncture direction returns in a direction opposite to the puncture direction. The convex part is formed in an elongated shape along the puncture direction,
The lancet assembly according to claim 9 or 10, wherein the rear portion of the convex portion has a slope shape that gradually increases in a puncturing direction.   The lancet assembly according to claim 11, wherein an inclination angle of the slope shape with respect to a side surface of the lancet cap is 9 ° to 11 °. An injector capable of firing a puncture member by being used in combination with a lancet assembly,
The lancet assembly is a device composed of a lancet and a lancet holder that accommodates the lancet. The lancet has a lancet body, a lancet cap, and a puncture member, and the metal puncture member is a resin lancet body and lancet cap. The lancet cap is covered by the lancet cap, and the lancet cap and the lancet body are integrally connected via the bridge member.
The injector can be engaged with the rear end portion of the lancet body, and is a plunger that fires the lancet body having the puncture member in the puncture direction, a lancet cap removal member that can come into contact with the lancet cap, and puncture when pressed when the puncture member is fired A trigger lever that causes the firing of the member, and an ejector for removing the lancet assembly from the injector after puncturing,
A protrusion provided at the rear end of the plunger and protruding outward from the plunger in the transverse direction thereof;
Puncture depth comprising a cylindrical member having a step portion formed such that the height of the end portion differs stepwise, and a drum member engaged with the cylindrical member so as to be able to rotate integrally with the cylindrical member Comprising an adjustment mechanism,
When the plunger moves forward at the time of puncture, the protruding portion at the rear end of the plunger collides with the step portion of the cylindrical member, so that the plunger cannot move further forward.
By rotating the drum member and rotating the cylindrical member about its axis, the step part where the protrusion part collides can be changed to a step part of a different height, so that the plunger moves forward during puncture. You can change the distance you can move,
On the outer peripheral surface of the drum member, a groove portion is formed along the annular direction. On the other hand, a convex portion that fits into the groove portion is formed on the housing of the injector, and when the drum member rotates, the convex portion becomes the groove portion. The injector is guided along the inside, and the rotation of the drum member is restricted by the contact between the convex portion and the end portion of the groove portion. While a notch is formed in the rear end of the housing of the injector, the outer peripheral surface of the drum member has a scale in an annular direction,
The drum member is provided to fit inside the rear end of the housing of the injector so that the notch and the scale overlap each other,
The injector according to claim 13, wherein a numerical value of the scale exposed from the notch portion changes as the drum member rotates. While a flange member is provided on the outer peripheral surface of the drum member, a narrowed portion or a convex portion is provided on the inner wall of the housing of the injector,
When a rear force is applied to the drum member, the flange member and the narrowed portion or the convex portion are in contact with each other, and the drum member cannot move backward relative to the injector housing. The injector according to claim 13 or 14. A lancet assembly comprising a lancet and a lancet holder for receiving the lancet assembly, and an injector. The lancet holder is inserted into the injector from the front end opening of the injector, so that the lancet assembly can be loaded into the injector. A lancing device,
Comprising an ejector for removing the lancet assembly from the injector after puncturing,
The ejector consists of an ejector pressing member that allows the lancet assembly to be pushed forward after puncturing and an ejector slide member that allows the ejector to slide forward. ,
A puncture device, characterized in that a spring member capable of applying a forward force to an ejector pressing member is provided on the ejector. The lancet holder further comprises a locking projection on the outer wall surface adjacent to the opening end thereof, and the injector is a holder locking member provided on the inner wall of the housing on the front side of the injector, and the injector is provided on the surface thereof. It further comprises a holder lock member formed with a stopper portion projecting inwardly,
When the ejector slide part is slid forward and the loaded lancet assembly is ejected from the injector, the spring part is compressed by the stopper part and the locking projection part contacting each other, and then the contact is released. The puncture device according to claim 16, wherein the discharge of the lancet assembly is aided by the restoring force of the compressed spring member.

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