HK1143051B - Assistance device - Google Patents

Description

Auxiliary tool

Technical Field

The present invention relates to an auxiliary device used when a skin is punctured with a puncture means and a component to be measured in blood is measured with a measurement means.

Background

For patients suffering from diseases such as diabetes, it is required to control blood glucose level so as to maintain a normal level. In order to manage the blood glucose level, the skin of a finger or palm is first punctured with a puncture means to allow a minute amount of blood to flow out, and the blood is collected with a blood collection portion of a measurement means and then measured with a blood glucose meter. Methods for measuring blood glucose levels include optical measurement and electronic measurement. After the blood glucose level is measured, a suitable amount of insulin is injected into the patient using an insulin-filled syringe in accordance with the instructions of the physician.

However, most of the diabetic patients are elderly, and some of them have fingers that cannot normally operate. In addition, some patients may have abnormal finger movements, impaired vision, or blindness due to diabetic complications. For these patients, one cannot properly use the lancing assembly and the assay assembly.

In view of the above, the present applicant has proposed in patent document 1 an auxiliary tool including: a measurement unit case holding section from which the measurement unit is removable; a lancet holder formed with a hole for holding a lancet in an upright state, the lancet being attached to a puncture device for use; a protective cap removing section for removing the protective cap from the lancet; and a lancet removing section for removing the lancet from the puncture device. The components with the above functions are arranged in the order of their use. With the aid of the above configuration, it is possible to easily manage the components used for the blood glucose level management operation.

However, for patients who cannot normally operate their fingers or who can normally use only one hand, the blood glucose meter and the lancet need to be more convenient to use, and the blood glucose meter and the lancet need to be more convenient to use not only when the measurement unit and the lancet are attached but also after the measurement unit and the like are attached.

That is, the puncture set is intended to ensure that a predetermined blood collection site such as a fingertip or a palm is reliably punctured at the site. In addition, in general, the blood glucose meter needs to be held with one hand and then blood on a fingertip or the like punctured with the other hand is brought into contact with a blood collection portion of the blood glucose meter, that is, so-called "point contact" is performed. However, for patients who cannot normally operate their hands or who only use one hand, especially for patients who shake their hands holding the device, the above-mentioned puncturing or point contact operation is not easy to be performed, and may cause mental stress to the patient.

[ patent document 1 ] Japanese patent application laid-open No. 2001-2457673

Disclosure of Invention

The purpose of the present invention is to provide an aid which can facilitate the above-mentioned operation when a component to be measured in blood is measured by a measuring unit such as a blood glucose meter and brought into contact with the blood point when the skin is punctured by a puncture unit.

In order to achieve the above object, the auxiliary tool of the present invention is used in the following two cases: puncturing the skin by using a puncture assembly with a blood taking needle; when a component to be measured in blood is measured by a measuring instrument equipped with a measuring unit having a blood collecting section. The auxiliary tool includes a main body and a cover body coupled to the main body so as to be openable and closable. The blood collection device is characterized in that a puncture guide portion is provided in one of the main body and the cover, the blood collection needle is positioned at a skin puncture position by the puncture guide portion, and a blood collection guide portion is provided in the remaining one of the main body and the cover, and the measurement unit is positioned at a skin puncture site by the blood collection guide portion.

In the case of the above configuration, the skin is punctured with the lancet positioned by the puncture guide portion provided in one of the main body and the lid, and then the measurement unit is positioned at the blood obtained by the puncturing operation and brought into point contact with the blood by the blood collection guide portion provided in the remaining one, so that the puncturing operation and the measurement operation can be reliably and easily performed even for patients with weak eyesight or patients with hand trembling.

In order to promote the blood flow by pressing the skin when the main body is in contact with the skin, when a conical bleeding promoting portion having a gradually increasing diameter is provided in the direction of the main body toward the skin, if the amount of blood obtained by puncturing alone is insufficient, the amount of blood necessary for measurement can be obtained by the action of the bleeding promoting portion.

Further, when the auxiliary tool is provided with a fixing mechanism for fixing the main body to the blood collection site, the puncture operation or the point contact operation can be performed in a state where the auxiliary tool is reliably fixed to a predetermined blood collection site.

In addition, when the auxiliary tool is provided with a biasing mechanism for biasing the lid body in the opening direction and a holding mechanism for holding the lid body in a state of covering the main body, the lid body can be easily opened and closed.

In this case, when the center line of the hole of the puncture guide portion and the center line of the hole of the blood collection guide portion are aligned with each other in a state where the cover covers the main body, the positions of the blood collection needle and the measurement unit can be reliably aligned with each other.

Further, when the hole of the puncture guide and the hole of the blood collection guide are projected on a plane, when one cross-sectional portion provided on the cover is positioned in the other cross-sectional portion provided on the main body, the cover can be reliably opened and closed with respect to the main body.

The fixing mechanism can adopt the following structure: the ring shape is formed by the mutual engagement of 2 ring pieces bent into an arc shape, and the diameter of the ring shape can be adjusted by providing a saw-toothed engaging recess on one of the 2 ring pieces.

The body may be attachable to or detachable from the fixing mechanism, or a positioning mechanism may be provided to position the body in an orientation such that a plurality of different angles are formed between the body and the fixing mechanism.

Drawings

Fig. 1 is a perspective view of an auxiliary tool according to embodiment 1.

Fig. 2 is a perspective view of the auxiliary tool shown in fig. 1 with the lid body opened.

Fig. 3 is an exploded perspective view of the auxiliary tool shown in fig. 1.

Fig. 4 is a perspective view showing an example of the blood glucose meter and the puncture assembly set.

Fig. 5 is a side sectional view showing a state where the measurement unit is inserted into the blood glucose meter shown in fig. 4.

FIG. 6 is a side view showing an example of the puncture set and the measurement set.

Fig. 7 is a side sectional view of the auxiliary tool shown in fig. 1.

Fig. 8 is an exploded side sectional view of the auxiliary tool shown in fig. 1.

Fig. 9 (a) is a bottom view of a main body constituting the auxiliary tool shown in fig. 1, and fig. 9 (B) is a top view of a fixing ring constituting the auxiliary tool shown in fig. 1.

Fig. 10 (a) is a partial side cross-sectional view showing the case where the aid shown in fig. 1 is fixed to a fingertip, and fig. 10 (B) is a partial side cross-sectional view showing the case where the lancet is brought into contact with the skin from the state shown in fig. 10 (a).

Fig. 11 is a side cross-sectional view showing a state in which the lid is opened and the main body is pressed with a finger from the state shown in fig. 10 (B).

Fig. 12 (a) is a partial side sectional view showing a state in which the measurement unit is inserted into the blood collection guide of the auxiliary device from the state shown in fig. 11, and fig. 12 (B) is a partial side sectional view showing a state in which the measurement unit is moved from the state shown in fig. 12 (a) and the distal end of the measurement unit is brought into contact with the blood drop point.

Fig. 13 (a) is a side view showing a modified example of the auxiliary tool shown in fig. 1, and fig. 13 (B) is a bottom view showing a modified example of the auxiliary tool shown in fig. 13 (a).

Fig. 14 is an exploded perspective view of another modified embodiment of the auxiliary tool shown in fig. 1.

Fig. 15 is a perspective view of an auxiliary tool according to embodiment 2 of the present invention.

Fig. 16 is a perspective view of the auxiliary tool shown in fig. 15 with the cover opened.

Fig. 17 is a side sectional view of the auxiliary tool shown in fig. 15.

Fig. 18 is a perspective view showing another example of the blood glucose meter and the measurement unit.

Fig. 19 is a perspective view showing another example of the lancet assembly and the lancet.

Fig. 20 is a perspective view showing a modified example of the auxiliary tool shown in fig. 15.

Fig. 21 is a side view showing a modified embodiment of the fixing ring.

Detailed Description

Preferred embodiments of the auxiliary tool of the present invention will be described in detail below with reference to the accompanying drawings.

Fig. 1 is a perspective view of an auxiliary tool 10 according to embodiment 1, and shows an example in which a lid 11 is used to cover. Fig. 2 is a perspective view of the auxiliary tool 10 shown in fig. 1 with the lid 11 opened, and fig. 3 is an exploded perspective view of the auxiliary tool 10 shown in fig. 1. In a measuring instrument for measuring a component to be measured in blood, for example, when a blood glucose meter (measuring unit) 12 for measuring a blood glucose level and a puncture unit 14 for puncturing a fingertip or the like of a patient before measurement is performed by the blood glucose meter 12 are used, the measurement operation and the puncture operation are facilitated by guiding the action parts of the blood glucose meter 12 and the puncture unit 14 to a predetermined part of the skin by the auxiliary tool 10.

Before describing the auxiliary device 10 of the present embodiment, the blood glucose meter 12 and the puncture set 14 will be described, and the blood glucose meter 12 and the puncture set 14 described below are one example of applications of the auxiliary device 10 of the present embodiment, and the auxiliary device 10 may be used for a measurement set, a puncture set, and the like having other configurations.

As shown in fig. 4, the blood glucose meter 12 measures the blood glucose level after the measurement unit 20 of the meter unit 18 is attached to the distal end thereof, and the measurement result is displayed on the display 12 a. The meter assembly 18 includes: an assay module 20 having a function of a test strip; a measurement unit case 22 having a cylindrical shape and accommodating the measurement unit 20; and a sealing member 24 for sealing the opening of the measurement unit case 22.

As shown in fig. 5, the measurement module 20 includes: a capillary tube (blood collection portion, blood point contact portion) 20a having a small diameter and opening toward the front end; and a test piece 20b provided so as to close the other opening of the capillary 20 a. The reagent that reacts with the glucose component in the blood is held in the test strip 20 b.

As shown in fig. 4 and 5, when measuring the blood glucose level, the measurement unit 20 is attached to the blood glucose meter 12 with the cover 12b removed after the seal 24 is peeled off, and blood is collected by the capillary 20a as a blood collection portion, and the cover 12b is connected to the blood glucose meter main body by a tape.

The blood glucose meter 12 works as follows: when the power switch 12c is turned on once and when blood comes into contact with the power switch, automatic measurement is started, and the color development change of the blood collected by the test strip 20b of the measurement unit 20 is detected, and the obtained blood glucose level is displayed on the display 12a by a predetermined calculation. The measurement results are stored in a memory provided inside the apparatus, and the measurement results stored in the past can be sequentially displayed by operating a call button. By operating the lever 12e to protrude the pin 12f, the used measurement unit 20 can be removed from the blood glucose meter 12 and discarded by a predetermined method.

As shown in fig. 6, the lancet assembly 14 has a substantially rod shape, and a lancet 30 of a lancet assembly 28 is attached to the tip of the lancet assembly 14 to puncture the skin, thereby obtaining a small amount of blood. The lancet assembly 28 includes a lancet 30 and a protective cap 32 covering a front end of the lancet 30, and the lancet 30 includes a needle 30a inside a lancet housing 30f thereof and a hub 30b for holding the needle 30a, and the needle 30a is maintained in a sterile state by the protective cap 32 at the front thereof and the hub 30b at the rear thereof. The lancet case 30f has a multi-step cylindrical shape and a flange 30c, and a 2 nd distal end portion 30e located at the distal end of the lancet 30 has a smaller diameter than the measuring unit 20.

When the lancet 30 is attached to the lancet assembly 14, the spring inside the lancet assembly 14 is compressed, and the compressed state is released by pressing the lancet button 14a, and at this time, the needle 30a is instantaneously projected to penetrate the skin to an appropriate depth, and the projecting amount of the needle 30a can be adjusted by operating the dial 14 b. The used lancet 30 is removed from the puncture set 14 and discarded by a predetermined method. In addition, the protective cap 32 has a cylindrical shape and a flange 32a at its front end.

Next, the auxiliary tool 10 according to the present embodiment will be described.

As shown in fig. 1 to 3, the auxiliary tool 10 includes: a fixing ring 36 serving as a fixing means for fixing the auxiliary tool 10 to a predetermined blood collection site such as a fingertip; a main body 38 coupled to an upper portion of the fixing ring 36; the lid 11 is connected to the main body 38 via a hinge 40 so as to be openable (turnable). The components constituting the hinge portion 40 other than the shaft pin 42 and the coil spring 44 are made of a resin material, for example, polypropylene. The entire auxiliary tool 10 including the hinge portion 40 may be made of a resin material, or the hinge portion 40 may be a resin hinge portion formed of a thin resin for connecting the main body 38 and the lid body 11.

The main body 38 includes: a blood collection guide 46 which is cylindrical and provided at a substantially central portion of the main body 38; and an outer edge portion 48 which is substantially cylindrical and is provided on the outer periphery of the blood collection guide portion 46. The main body 38 has the following functions: the measurement unit 20 mounted on the blood glucose meter 12 is guided to a bleeding site on the skin punctured by the puncture unit 14.

As shown in fig. 7 and 8, the blood collection guide 46 has a hole portion formed in a plurality of different diameters on the inner peripheral side thereof, and includes, in order from the lid body 11 side in the axial direction thereof: a guide hole portion 50 for inserting the measurement member 20; a hole 52 having a smaller diameter and a shorter length than the guide hole 50; a conical hole portion 54 having a larger diameter toward the lower side from the hole portion 52. The annular contact surface 56 formed by trimming the opening on the lower end side (the side having the larger diameter) of the conical hole portion 54 is a skin contact surface for contacting the skin of the subject when the auxiliary device 10 is used (see fig. 10).

An annular recessed groove 60 is formed on the outer peripheral side of the hole 52 or the conical hole 54 of the blood collection guide 46 on the lower surface side opposite to the upper surface 58 of the outer edge portion 48, and the annular recessed groove 60 is a portion into which a cylindrical coupling portion 62 of the fixing ring 36 is fitted when the fixing ring 36 is coupled to the main body 38.

As shown in fig. 9a and 9B, since a plurality of (4 in the present embodiment) positioning rib portions (positioning means) 64 are provided on the outer peripheral surface of the blood collection guide portion 46 in the annular groove portion 60 on the main body 38 side so as to extend in the axial direction, and a plurality of (12 in the present embodiment) positioning groove portions (positioning means) 66 are provided on the inner peripheral surface of the coupling portion 62 on the fixed ring 36 side so as to correspond to the positioning rib portions 64, the fixed ring 36 can be coupled to the main body 38 at a desired angle by the engagement action between the positioning rib portions 64 and the positioning groove portions 66. In other words, the orientation of the main body 38 relative to the fixing ring 36 can be appropriately changed.

As shown in fig. 12 (B), since the inner diameter of the guide hole portion 50 is set slightly larger than the outer diameter of the measurement unit 20, the measurement unit 20 can be reliably positioned. Further, by providing 3 projections 68 on the bottom of the guide hole 50 (the upper surface of the flange constituting the hole 50) so as to project upward at the same interval, the capillary 20a at the tip of the measurement unit 20 can be adjusted to an appropriate height so as not to contact the skin, and therefore can be brought into contact with a desired blood spot (see fig. 12B).

As shown in fig. 2, a predetermined number (4 in the present embodiment) of curved indication groove portions 55 are formed in a recessed manner on the annular upper end surface of the blood collection guide portion 46 protruding from the upper surface 58 of the outer edge portion 48, and a patient with poor eyesight can confirm the position and orientation of the hole portion 50 of the main body 38 by touching the indication groove portions 55 with a hand.

An end portion 48a recessed from the upper surface 58 is formed at one end of the outer edge portion 48 surrounding the blood collection guide portion 46, and a main body side hinge portion 40a constituting the hinge portion 40 is formed at the end portion 48a, and the shaft pin 42 is inserted into the hinge portion 40. A holding mechanism 70 for holding the lid body 11 in the state of closing the lid body 38 is formed at the other end opposite to the body-side hinge portion 40a, and the holding mechanism 70 is a depressible member integrally formed with the outer edge portion 48 and is normally in a normal position, but when the lid body 11 is closed on the body 38, it is acted on by a holding piece 72 projecting from the lid body 11, and is once swung to the arrow X2 side and then returned to the normal position on the arrow X1 side, so that the tip end projecting portion 72a of the holding piece 72 is held by a slit 70a in the middle of the holding mechanism 70, and the lid body 11 can be held at the position of the lid body 38. Further, when the held state of the lid body 11 needs to be released, the holding mechanism 70 can be lightly pressed downward to be inclined in the arrow X2 direction, and at this time, the distal end convex portion 72a is disengaged from the slit 70a, so that the lid body 11 can be automatically opened by the biasing force of the coil spring (biasing mechanism) constituting the hinge portion 40.

The lid 11 is coupled to the main body 38 so as to be openable and closable by another lid-side hinge portion 40b corresponding to the main-body-side hinge portion 40a into which the shaft pin 42 is inserted. The cover 11 includes: a puncture guide portion 74 having a cylindrical shape and provided at a substantially central portion of the cover 11; and an outer edge portion 76 that is substantially cylindrical and is provided on the outer periphery of the puncture guide 74. The cover 11 has the following functions: before the measurement by the blood glucose meter 12, the lancet assembly 14 is used to puncture the skin, and the cap 11 guides and positions the lancet 30 mounted on the lancet assembly 14.

As shown in fig. 7 and 8, the puncture guide 74 has 2 holes with different diameters formed on the inner peripheral side, and a 1 st guide hole 78 and a 2 nd guide hole 80 for inserting the lancet 30 are sequentially formed from above in the axial direction. The 1 st guide hole 78 and the 2 nd guide hole 80 have predetermined inner diameters, and can guide the 1 st tip portion 30d of the lancet 30 and the 2 nd tip portion 30e (see fig. 6) having a smaller diameter at the tip of the 1 st tip portion, respectively. The lancet case 30f is guided by the puncture guide portion 74 to guide the needle 30a to the blood collection position.

An annular groove 84 is formed on the outer peripheral side of the 2 nd guide hole portion 80 of the puncture guide portion 74 on the lower surface side opposite to the upper surface 82 of the outer edge portion 76, and the annular groove 84 is an interference preventing portion that corresponds to the protruding end of the blood collection guide portion 46 of the main body 38 and prevents interference with the cover 11 when the cover is closed on the main body 38.

Therefore, as shown in fig. 7, when the lid 11 is closed on the main body 38, not only the protruding end of the blood collection guide portion 46 of the main body 38 on which the indication groove portion 55 is provided is inserted into the annular groove portion 84, but also the lower surface of the lid 11 is supported by the upper surface of the outer edge portion 48 constituting the main body 38, and therefore, the lid 11 can be held in close contact with the main body 38 while covering the same by the holding action of the holding piece 72 of the holding mechanism 70. At this time, the axes of the 1 st guide hole portion 78 and the 2 nd guide hole portion 80 of the cover 11 coincide with the axes of the guide hole portion 50, the hole portion 52, and the conical hole portion 54 of the main body 38.

The fixing ring 36 is a fixing mechanism for fixing the auxiliary tool 10 to the fingertip of the user (patient) by being fitted over the fingertip, and includes a pair of left and right arcuate ring pieces 86 and 88 extending downward from the connecting portion 62 connected to the main body 38, and is formed into a ring shape by engagement between the arcuate ring pieces 86 and 88. That is, the auxiliary tool 10 can be wound around and fixed to the fingertip according to the required diameter by engaging any one of the engaging convex portion 86a formed on the tip of one ring piece 86 of the fixing ring 36 and the engaging concave portion 88a formed in the zigzag shape on the other ring piece 88. Further, a protective sheet 90 is provided inside the portion of the ring piece 88 where the engaging recess 88a is formed, in order to prevent the user from feeling pain due to the contacting of the serrated engaging recess 88a with the fingertip.

Next, a basic case of a use example of the auxiliary tool 10 having the above-described configuration will be described.

First, the user (patient) presses the unused meter unit 18 with the seal 24 removed, thereby attaching the measurement unit 20 to the distal end of the blood glucose meter 12, and then removes the measurement unit case 22, whereby the pin 12f is housed inside the blood glucose meter 12. An unused lancet assembly 28 is then mounted on the forward end of the spike assembly 14. By the above operation, the receptacle 30b of the lancet 30 compresses a spring, not shown, in the puncture unit 14 and engages with a predetermined engagement portion, thereby completing the preparation operation before blood collection. At this time, the user should remove the protective cap 32 from the lancet 30.

Next, the user fixes the auxiliary tool 10 to a predetermined blood sampling site, for example, a tip of an index finger or a middle finger. That is, as shown in fig. 1 and 10 (a), the fingertip F is inserted through the ring pieces 86 and 88 of the fixing ring 36 constituting the auxiliary tool 10 such that the finger pad faces the main body 38, and the ring pieces 86 and 88 are adjusted by the engagement between the engaging convex portion 86a and the engaging concave portion 88a, thereby fixing the auxiliary tool 10 to the fingertip F. In this case, the ring pieces 86 and 88 of the auxiliary tool 10 can be engaged with each other more tightly or loosened by pressing the ring pieces 86 and 88 from both sides, so that the auxiliary tool 10 can be easily and reliably fixed to a predetermined position on the fingertip F even by a user with weak eyesight.

When the preparation is completed, the skin is first punctured with the puncture set 14. In the present embodiment, the cover 11 is set to the position of the cap main body 38 when or after the auxiliary tool 10 is fixed to the fingertip.

Then, the tip of the lancet 30 attached to the puncture unit 14 is inserted through a hole provided in the auxiliary tool 10 to a position where it can contact the finger pad side of the fingertip F. That is, as shown in fig. 10B, when the tip end of the lancet 30 is inserted into the 1 st guide hole 78 constituting the puncture guide 74 provided in the cover 11 and the 2 nd tip end portion 30e on the tip end side of the lancet 30 is inserted into the 2 nd guide hole 80 through the 1 st guide hole 78, the tip end of the 2 nd tip end portion 30e is guided by the 2 nd guide hole 80 and positioned in a state of being appropriately contacted with the skin on the fingertip F as a blood collection site (see fig. 10B). That is, the position and height of the lancet 30 are made to be appropriate with respect to a certain prescribed position under the fingertips F.

In this case, in order to accurately guide and position the 2 nd leading end portion 30e of the lancet 30, the inner diameter of the 2 nd guide hole portion 80 constituting the puncture guide portion 74 may satisfy the following condition: if the outer diameter of the 2 nd leading end portion 30e is 4mm, the inner diameter of the 2 nd guide hole portion 80 is about 4.2 mm. In addition, since the lancet 30 is actually positioned by the 2 nd guide hole portion 80 and the 2 nd tip portion 30e, the gap between the 1 st guide hole portion 78 and the 1 st tip portion 30d can be set slightly larger than the gap (about 0.2 mm) between the 2 nd guide hole portion 80 and the 2 nd tip portion 30e, and for example, if the outer diameter of the 1 st tip portion 30d is 5.6mm, the inner diameter of the 1 st guide hole portion 78 can be about 6 mm. This makes it easy to insert the lancet 30 into the 1 st and 2 nd guide holes 78, 80, and also makes it easy and reliable to locate the blood collection position of the needle 30a protruding from the distal end of the lancet 30 at the substantially center position of the conical hole 54 (see fig. 10B).

Accordingly, when the lancet button 14a is pressed in a state where the lancet 30 is positioned at a predetermined position by the auxiliary tool 10, the compression state of the coil spring in the puncture set 14 is released, and the hub 30b and the needle 30a instantaneously protrude forward, and the skin is pierced inside the conical hole portion 54 of the main body 38, so that a minute amount of blood flows out. The hub 30b and the needle 30a are returned to the inside of the lancet 30 by a return spring, not shown.

After the puncture assembly 14 is pulled out from the auxiliary tool 10, the cover 11 is opened from the main body 38 by operating the holding mechanism 70. In this case, the auxiliary tool 10 can easily open the lid 11 by the biasing force of the coil spring 44 by simply pushing the holding mechanism 70 to the arrow X2 side.

Next, as shown in fig. 11, when the body 38 is pressed in the direction of arrow Y1 by the finger F2 of the other hand, the skin around the part punctured by the lancet 30 is appropriately pressed by the contact surface 56 and the inner surface of the conical hole portion 54, and thus a biasing force in the direction of arrow Y2 of the conical hole portion 54 is generated on the punctured part of the skin. This promotes the flow of a sufficient amount of blood from the skin-punctured site on the fingertip F, thereby forming a proper and sufficient amount of blood drop B required for measurement by the blood glucose meter 12. Further, the fingertip F may be pressed by a method of tightly engaging the ring pieces 86 and 88 constituting the fixing ring 36.

As described above, in the present embodiment, the main body 38 constituting the auxiliary tool 10 can function as a bleeding promoting portion, and particularly, the conical hole portion 54 and the contact surface 56 can function as a bleeding promoting portion for promoting bleeding from a punctured site. In the auxiliary tool 10, since the hole inside the contact surface 56 for pressing the fingertip F is defined as the conical hole 54, a sufficient space can be secured, and the blood drop B formed as described above can be effectively prevented from adhering to the auxiliary tool 10. When the blood drop B adheres to the auxiliary tool 10, for example, the blood penetrates between the contact surface 56 and the skin, and the blood drop B having an appropriate size cannot be formed.

Next, the tip of the measurement unit 20 attached to the blood glucose meter 12 is brought into contact with the blood droplet B formed by the puncturing operation. That is, as shown in fig. 12 (a) and 12 (B), the tip of the measurement unit 20 is inserted into the guide hole portion 50 of the blood collection guide portion 46 of the main body 38, and the capillary 20a as a blood collection portion at the tip of the measurement unit 20 is brought into point contact with the blood drop B formed in the conical hole portion 54. Therefore, blood permeates into the test paper 20b (see fig. 5) through the capillary 20a, and the blood glucose level can be automatically measured by an optical method by developing the color with a reagent. Since the measured blood glucose level is displayed on the display 12a, the user can confirm the value.

In this case, as described above, the auxiliary tool 10 is provided so that the axis of the puncture guide portion 74 (the 1 st guide hole portion 78 and the 2 nd guide hole portion 80) for guiding and positioning the lancet 30 and the axis of the blood collection guide portion 46 (the guide hole portion 50 or the conical hole portion 54) for guiding and positioning the measurement unit 30 overlap each other, so that the capillary 20a of the measurement unit 20 can be reliably positioned at the substantially center position of the blood drop B formed by the puncture operation of the lancet 30 and the point contact operation can be performed, and the blood glucose level measurement operation can be performed more easily and reliably.

Further, by appropriately setting the height of the projection 68, the capillary 20a at the distal end of the measurement unit 20 can be reliably brought into contact with only blood without contacting the skin (see fig. 12B). In this case, the distance between the tip of the blood collection tube and the skin is preferably about 0.1mm to 1.0mm, that is, the distance between the tip of the measurement unit (the tip of the capillary 20 a) and the skin is preferably about 0.1mm to 1.0 mm. When the projections 68 are formed to be slightly higher in advance, for example, and then the height is adjusted according to the state of the measuring unit 20 or the user's fingertip F to be used, the position of the capillary 20a at which the height is set can be appropriately changed. In addition, in performing the above point contact operation, after the lancing operation is completed with the lancet 30, in addition to pressing the main body 38 with the finger F2 of the other hand, it is also possible to promote bleeding from the punctured site and make the blood and the capillary 20a point contact by pressing the measuring unit 20 in contact with the protrusion 68 with ease. For example, even when the measurement unit 20 cannot be brought into proper point contact with blood due to insufficient pressing with the finger F2, bleeding can be promoted by directly pressing the measurement unit 20 against the main body 38, and the measurement operation can be reliably performed.

After the series of measurement operations are completed, the auxiliary tool 10 can be removed from the fingertip by pulling the one side ring piece 88 (or 86) of the fixing ring 36 constituting the auxiliary tool 10 to release the ring pieces 86, 88. Further, the lancet 30 is removed from the puncture assembly 14, the measurement unit 20 at the front end of the blood glucose meter 12 is inserted into the measurement unit housing 22, and the operating lever 12e is operated to protrude the pin 12f, so that the measurement unit 20 can be removed from the blood glucose meter 12, and then the seal 24 is closed. The removed lancet 30, the measurement unit 20, and the measurement unit case 22 are discarded by a predetermined method.

As described above, when the auxiliary tool 10 according to the present embodiment is used, the auxiliary tool 10 can be reliably fixed to a designated blood collection site at the time of blood collection. Further, in the auxiliary tool 10, since the axis of the puncture guide 74 for guiding and positioning the lancet 30 and the axis of the blood collection guide 46 for guiding and positioning the measurement unit 20 are provided so as to overlap each other, the position where blood is collected by the lancet 30 and the position where blood is measured (point contact) by the measurement unit 20 can be accurately overlapped with each other, and the puncture operation and the measurement operation can be reliably and easily performed even for users with weak eyesight or users with shaky hands, for example.

In addition, in a state where the cover body 11 has covered the main body 38, the center line of the hole portion (the 1 st guide hole portion 78 and the 2 nd guide hole portion 80) constituting the puncture guide portion 74 for inserting the lancet 30 and the center line of the hole portion (the guide hole portion 50, the hole portion 52, and the conical hole portion 54) constituting the blood collection guide portion 46 for inserting the measurement unit 20 are overlapped with each other, so that the positions of the lancet 30 and the measurement unit 20 can be further matched. Further, when the hole of the puncture guide 74 for inserting the blood collection needle 30 and the hole of the blood collection guide 46 for inserting the measurement unit 20 are projected on a plane, the cross-sectional portion of the hole of the puncture guide 74 provided in the cover 11 is positioned within the cross-sectional portion of the hole of the blood collection guide 46 provided in the main body 38, and therefore, the cover 11 can be reliably and easily opened and closed with respect to the main body 38.

As shown in fig. 13 (a), the auxiliary tool 10 in the present embodiment may be changed to an auxiliary tool 10a by changing the fixing ring 36 to 36 a. Since the ring piece 89 is provided on the fixed ring 36a and the ring piece 89 has the mounting surface 89a formed by making a part of the outer peripheral surface thereof substantially flat, the mounting surface 89a can be brought into abutment against the surface of a table or the like to hold the auxiliary 10a in a stable state when the auxiliary 10a is used. The operation of the spike assembly 14 or the blood glucose meter 12 may be facilitated. At this time, as shown in fig. 13 (B), if the width of the mounting surface 89a is increased to be wider than the width of the loop piece 89 to become the mounting surface 89B, the stability of the auxiliary tool 10a can be further improved. Of course, the auxiliary tool 10 is configured to have a part of the outer peripheral surface of the ring piece 88 wider to be equal to the width of the mounting surface 89b, which contributes to improvement in the installation stability of the auxiliary tool 10.

As the coupling structure between the cover 11 and the main body 38, in addition to the structure having the hinge portion 40, for example, as shown in fig. 14, the auxiliary tool 10b may be manufactured by changing the cover 11 and the main body 38 into the cover 11a and the main body 38a, in which the cover 11a and the main body 38a are detachably coupled to each other by the hinge portion 41 so as to be openable and closable. In the auxiliary tool 10b, the hinge portion 41b on the lid 11a side is provided with the integrally formed pivot pin 41c, and the pivot pin can be fitted into the hinge portion 41a on the main body 38a side, so that the main body 38a and the lid 11a can be detachably coupled to each other. Therefore, since the main body 38a or the cover 11a can be replaced independently, the main body 38a or the cover 11a having the puncture guide or the blood collection guide with a different shape can be easily replaced depending on the type of the blood collection needle or the measurement unit. Of course, when one of the main body 38a and the cover 11a is broken, it can be easily replaced.

Next, the auxiliary tool 100 according to embodiment 2 will be described. Fig. 15 is a perspective view of the auxiliary tool 100 according to embodiment 2, and shows an example of use in which the lid 101 is closed. Fig. 16 is a perspective view of the auxiliary tool 100 shown in fig. 15 with the lid 101 opened, and fig. 17 is a side sectional view of the auxiliary tool 100 shown in fig. 15. In fig. 15 and the like, the same reference numerals as those in fig. 1 to 14 denote the same or similar structures, and therefore, they have the same functions and the same effects, and thus, detailed description thereof will be omitted.

When the blood glucose meter 102 and the puncture set 104 having a slightly different structure from those of the blood glucose meter 12 and the puncture set 14 (see fig. 4 and 6) are used, the auxiliary tool 100 can be effectively used.

As shown in fig. 18, a measurement unit 106 made of a strip-shaped electrode sensor is attached to the tip of the blood glucose meter 102, and the measurement unit 106 is replaced with the measurement unit 20 of the blood glucose meter 12 (see fig. 4), and the blood glucose level is measured by a point contact method of the measurement unit 106 with blood, and the measurement result is displayed on the display 102 a.

As shown in fig. 19, the puncture device 104 has substantially the same shape as the puncture device 14 (see fig. 6), and is substantially rod-shaped, and the protective cap 104b connected to the distal end of the main body 104a of the puncture device 104 is removed, and the lancet 108 is attached to the distal end of the main body 104a covered with the protective cap 104 b. Then, by pressing the lancet button 104c, the needle 108a provided at the distal end of the lancet 108 protrudes from the hole portion at the distal end of the protective cap 104b, and punctures the skin. Further, the protective cap 104b has a larger sectional area than the measuring member 106.

In order to correspond to the shapes of the blood glucose meter 102, the measurement unit 106 of the puncture unit 104, and the lancet 108, not only the main body 110 for replacing the main body 38 of the auxiliary device 10 is provided with the puncture guide 112, but also the cover 101 for replacing the cover 11 is provided with the blood collection guide 116.

In the structure of the main body 110, the blood collection guide 46 of the main body 38 is actually replaced with the puncture guide 112.

As shown in fig. 17, a plurality of holes having different diameters are formed on the inner peripheral side of the blood collection guide 112, and the following are provided in order from the lid body 101 side in the axial direction: a conical guide hole portion 118 into which the puncture set 104 is inserted, the diameter of which decreases downward; a hole portion 52; a conical bore portion 54. The conical guide hole portion 118 has a shape corresponding to the conical shape of the tip of the protective cap 104b of the puncture assembly 104, and the conical guide hole portion 118 has the following functions: lancet 108 attached to lancet assembly 104 is guided to be positioned substantially at the center of conical hole portion 54.

In the structure constituting the cover 101, the guide for puncturing 74 of the cover 11 is actually replaced with the guide for blood collection 116. A slit-shaped guide hole 120 having a substantially rectangular cross section is formed in the blood collection guide 116, and the elongated measurement unit 106 attached to the distal end of the blood glucose meter 102 is guided and positioned by the guide hole 120. Of course, the axes of the conical guide hole 118, the hole 52, and the conical hole 54 constituting the puncture guide 112 of the main body 110 and the axis of the guide hole 120 constituting the blood collection guide 116 of the lid body 101 overlap. That is, the center point 106a at the front end of the measuring unit 106 is guided so as to move along the center line of the protective cap 104 b.

Therefore, when the auxiliary tool 100 according to the present embodiment is used, first, in a state where the cover 101 is opened, the puncture set 106 with the lancet 108 mounted therein is guided to a predetermined position by the puncture guide 112, and the distal end surface of the protective cap 104b is brought into contact with the skin. Further, after the puncture operation is completed, since the measurement unit 106 can be accurately positioned at the site where blood is punctured and bleeds by the blood lancet 108 via the lid 101 through the lid 101 for blood sampling guide portion 116, the puncture operation and the measurement operation can be reliably and easily performed even by a user with weak eyesight or a user whose hand is trembling, for example, as in the case of the auxiliary tool 10 according to embodiment 1.

As shown in fig. 20, the auxiliary tool 100 in the present embodiment may be replaced with an auxiliary tool 100a by replacing the blood collection guide 116 provided on the lid body 101 with a blood collection guide 116a having an insertion guide 122 with a tapered recess on the side for inserting the measurement unit 106. In the auxiliary tool 100a, when the measurement unit 106 mounted on the blood glucose meter 102 is inserted into the guide hole portion 120, the measurement unit 106 can be inserted into the guide hole portion 120 more easily by the insertion guide portion 122, so that the blood glucose meter 102 can be used more easily. Of course, insertion guides similar to the insertion guide 122 may be provided for other guides constituting the auxiliary tools 10 and 100, that is, the blood collection guide 46 and the puncture guides 74 and 112.

As shown in fig. 21, the fixing ring 36b having the ring pieces 126 and 128 and the fixing state releasing lever 130 may be used as the fixing ring 36 for fixing the auxiliary tools 10 and 100 to the blood collection site. At this time, the ring pieces 126 and 128 can be engaged by pressing the side portion of the fixed state release lever 130, and the auxiliary tool can be easily fixed. An engaging protrusion 126a is formed at the tip of the ring piece 126, and an engaging recess 128a for engaging with the engaging protrusion 126a is formed in the other ring piece 128. The fixed state of the auxiliary tool can be easily released by pulling the fixed state release lever 130 in the direction of arrow a. Of course, the fixing ring as the fixing means may be configured to have a large diameter and to be fixed to the wrist of the user. Further, it is needless to say that the fixing rings 36 and 36a may be replaced with only a tape or the like as the fixing mechanism.

In the present invention, a measurement unit (e.g., blood glucose meter), a puncture unit, a measurement unit, a blood collection needle, or the like having various shapes other than the above-described one may be used, and in this case, the shape of the puncture guide or the blood collection guide may be appropriately changed as needed. Further, the lancet is not limited to being composed of a needle and a housing, and may be provided without a housing. Further, the lancet assembly and the lancet may be integrally assembled from the beginning.

As the measurement unit using the auxiliary tool 10 or 100, in addition to the blood glucose meter, a measurement unit that measures different components in blood, for example, protein, cholesterol, inorganic ions such as ethanol and sodium ions, hemoglobin, or the like, depending on the purpose of measurement may be mentioned.

The auxiliary tool of the present invention is not limited to the above-described embodiments, and various configurations can be adopted for the auxiliary tool without departing from the gist of the present invention.

Claims (7)

1. An auxiliary tool, which is characterized in that,

the auxiliary appliance is used in the following cases: piercing the skin with a lancing assembly (14, 104) having a lancet (30, 108); when a component to be measured in blood is measured by a measuring instrument equipped with a measuring unit (20, 106) having a blood collecting section,

the auxiliary tool comprises a main body (38, 38a, 110) and a cover body (11, 11a, 101), wherein the cover body (11, 11a, 101) is connected to the main body (38, 38a, 110) in an openable and closable manner,

a puncture guide (74, 112) is provided on one of the main body (38, 38a, 110) and the cover (11, 11a, 101), and the lancet (30, 108) is positioned on the skin to be punctured by the puncture guide (74, 112),

a blood collection guide (46, 116a) is provided on the remaining one of the main body (38, 38a, 110) and the lid (11, 11a, 101), and the measurement unit (20, 106) is positioned on the skin punctured by the lancet (30, 108) by the blood collection guide (46, 116 a).

2. The accessory according to claim 1,

the main body (38, 38a, 110) is provided with a conical bleeding promoting portion (54) having a diameter gradually increasing toward the skin, and the conical bleeding promoting portion is configured to press the skin to promote blood flow when the main body (38, 38a, 110) is brought into contact with the skin.

3. The accessory according to claim 1,

a fixing mechanism (36, 36a, 36b) for fixing the main body (38, 38a, 110) to the blood collection site is also provided.

4. The accessory according to claim 1,

a biasing mechanism (44) for biasing the lid (11, 11a, 101) in the opening direction thereof and a holding mechanism (70) for holding the lid (11, 11a, 101) in a state of covering the main body (38, 38a, 110) are also provided.

5. The accessory according to claim 1,

the center line of the hole of the puncture guide (74, 112) and the center line of the hole of the blood collection guide (46, 116a) are set so as to be overlapped when the lid (11, 11a, 101) is in a state of covering the main body (38, 38a, 110).

6. An accessory according to claim 3,

the fixing mechanism (36, 36a, 36b) is formed by mutually clamping two ring pieces (86, 88, 126, 128) bent into an arc shape to form a ring-shaped structure, one of the two ring pieces (86, 88, 126, 128) is provided with a clamping concave part (88a, 128a) in a sawtooth shape, and the diameter of the fixing mechanism (36, 36a, 36b) can be adjusted.

7. An accessory according to claim 3,

the main body (38, 38a, 110) is attachable to or detachable from the securing mechanism (36, 36a, 36b), and the accessory further comprises a positioning mechanism (64, 66), the positioning mechanism (64, 66) being configured to position the orientation of the main body (38, 38a, 110) such that the main body (38, 38a, 110) and the securing mechanism (36, 36a, 36b) form a plurality of different angles therebetween.