JP4457192B2 - Lancet integrated measuring device - Google Patents

Description

[0001]
[Technical field to which the invention belongs]
A lancet-integrated measuring apparatus for measuring a specific component contained in a specimen such as blood glucose concentration (hereinafter referred to as “blood glucose level”) and having a function of adjusting the depth of a puncture body .
[0002]
[Prior art]
The measuring apparatus used in the present invention has various uses such as medical science and sports science. As an example of sample measurement, self-measurement of blood glucose level by a diabetic patient is given. In order to treat diabetes, it is necessary to keep the blood glucose level of the patient in a normal range, and blood glucose level management by the patient himself is an important treatment method. In particular, when the blood glucose level is maintained in a normal range by insulin injection by the patient himself, appropriate blood glucose level measurement by the patient himself is indispensable.
[0003]
Portable blood glucose level measuring devices used for such a purpose are already on the market, and an example thereof is disclosed in, for example, Japanese Patent Publication No. 8-20412. This blood glucose level measuring apparatus is used by inserting a disposable sensor having an enzyme electrode into a main body. By supplying blood, which is a specimen, to the sensor using capillary action, an anodic current is generated through an enzyme reaction and an electrochemical reaction. This anode current is converted into a blood glucose level in the apparatus body and displayed.
[0004]
In the case of blood glucose level measurement by the patient himself, the patient generally supplies the specimen using an instrument called a lancet as disclosed in, for example, Japanese Patent Laid-Open No. 9-266898. This lancet is composed of a puncture body and a drive mechanism of the puncture body, and is a device for making a small hole in the skin of a patient's fingertip or the like. Blood glucose level can be measured easily and conveniently. The supply in this case refers to an act of attaching a sample at a fingertip or the like to the sample introduction port of the sensor. In such a measurement method, a set of measuring instruments such as a blood glucose level measuring device, a lancet, and a sensor is carried and carried in combination and measured when necessary.
[0005]
On the other hand, Japanese Patent Application No. 10-166894 discloses a lancet-integrated blood sugar level measuring device in which the blood sugar level measuring device and the lancet are integrated. This lancet-integrated blood glucose level measuring device is a blood glucose level measuring device comprising a main body and a mounting body mounted on the main body for use. The mounting body includes a skin contact surface, and a skin contact surface. It is possible to move between the sensor arranged along the surface, the advancing position where the tip protrudes from the skin contact surface, and the retracted position where the tip is recessed from the skin contact surface, and the retracting position side by the elastic body A puncture body that is biased by the body, and the main body is in contact with the electrodes of the sensor provided in the mounting body when the mounting body is mounted, and is connected to the terminals. And an electronic circuit for determining a measurement value based on the electrical signal obtained in this way, and a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position.
[0006]
The mounting body is provided as a disposable consumable, for example. In the measurement, the user wears the mounting body on the main body. If while pressing the skin contact surface to the skin such as the fingertip or earlobe Ru actuates the drive mechanism of the body, scratches its tip from the skin contact surface puncture body in the retracted position is caused to advance projects to the skin Add. The puncture body returns to the retracted position by the action of the next instantaneous elastic body. If the apparatus is kept as it is, the specimen is supplied from the skin to the sensor, and the sensor outputs a reaction current. This current is converted into a specific component concentration in the specimen by an electronic circuit, and displayed on a display device disposed on the surface of the main body, for example.
[0007]
Thus, in the lancet-integrated blood glucose level measuring device, since the puncture body and the sensor are integrated in advance in the mounting body, the measurer only needs to mount the mounting body on the main body for measurement. Compared with the case where the lancet and the measuring device are used separately, the usability is remarkably improved.
[0008]
[Problems to be solved by the invention]
In the above-described conventional lancet-integrated blood glucose measurement device, the measurement operation is simple and the measurement failure due to an operation error is reduced. However, the measurement failure due to insufficient sample amount or excess cannot be resolved. Further, the measurer differs in skin hardness depending on age, sex, occupation, etc., and when using a puncture body of the same length, the amount of specimen obtained is completely different. In recent years, a sensor capable of measuring with a sample volume of 1 μL or less has been developed to meet the need for supplying less invasive specimens with less pain. It was necessary to deal with individual differences. The invention of the present application was devised in view of the above-mentioned drawbacks. A lancet-integrated measurement device that can eliminate individual differences in the amount of specimen due to skin hardness and the like, reduce patient pain, and perform measurement reliably. The issue is to provide.
[0009]
[Means for Solving the Problems]
In order to achieve the above object, according to the present invention, there is provided a measuring apparatus comprising a main body and a mounting body that is mounted on the main body, and the mounting body has a puncture body and a sensor that can be moved forward and backward. and, wherein the body has a driving mechanism for assume a advanced position to the puncture body moves forward driving the puncture body, upper Symbol mounting body, provided with a mechanism for adjusting the puncture depth of the puncture barb member The puncture body has a puncture body guide shaft on the rear side, the drive mechanism has a pressing rod for applying a drive force to the puncture body guide shaft, and the mechanism for adjusting the puncture depth of the puncture body is stepwise. An adjusting mechanism, wherein the stepwise adjusting mechanism has a ring-shaped structure movable in the forward and backward directions, and the pressing rod interferes with an end surface of the ring-shaped structure, and the pressing rod moves forward and backward. Adjust the puncture depth by changing the driving distance Nsetto integrated measuring device is provided. The distance between the forward and backward driving of the ring-shaped structure is a lancet-integrated measuring device fixed by a stopper for determining the position in stages. The stopper is fixed to the mounting body and has unevenness, and the ring-shaped structure has unevenness, and the ring-shaped structure is stepped by engaging both unevennesses. Fixed to. When the ring-shaped structure is provided on the mounting body, for example, when the mounting body is not mounted on the main body, the fixing position by the stopper can be selected, or when the ring-shaped structure is provided on the main body, It is comprised so that the fixed position by the said stopper can be selected from the outside. Moreover, the said mounting body has a spring member for retracting | retreating the said puncture body which advanced. The sensor is provided on the bottom wall of the mounting body, and the spring body is configured to be incorporated above the sensor.
[0010]
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 is an exploded view of a lancet-integrated measuring apparatus according to the present invention. As shown in FIG. 1, a measuring apparatus 1 according to the present invention is used in combination of a main body 2 and a mounting body 3. The main body 2 is provided with switch buttons, an LCD display 4 and the like on its upper surface. A cylindrical portion 5 extends from the front portion of the main body 2, and a cap-shaped mounting body 3 corresponding to the outer shape of the front cylindrical portion 7 of the main body 2 is attached to the front end portion thereof. Yes. The cap-shaped mounting body 3 is mounted with a puncture body 6 having a puncture body guide shaft 10 and a sensor 9 that responds to a specimen. The main part of the cap-shaped mounting body 3 can be produced by resin molding. Preferably, polystyrene resin, polyester resin, polyamide resin, vinyl chloride resin, silicon resin, or the like can be used. Inside the main body 2 described above, a drive mechanism for driving the puncture body 6 forward, and a circuit such as a microcomputer are incorporated. Furthermore, the code | symbol 8 comprises a part of said drive mechanism, and has shown the press part for a user to press manually. Here, the lancet includes a puncture body 6 and a drive mechanism for the puncture body 6.
[0011]
The depth adjustment mechanism of the puncture body 6 may be provided on any of the attachment body 3及beauty measuring constant apparatus 1 main body 2. At this time, when installing to the mounting body 3 is installed a ring-like structure 11b to the tubular portion 7 When installing on the puncture body guide shaft 10 a ring-like structure 11a, to the body 2 of the measurement device 1 Is preferred. Further, the depth adjustment mechanism of the puncture body 6 can be adjusted stepwise, and the stepwise puncture depth is 2 to 5 steps, and the depth is preferably 0.5 mm to 3.0 mm. .
[0012]
As shown in FIG. 2, the sensor 9 has an insulating base plate 28 having a working electrode 26 and a counter electrode 27 formed on the upper surface thereof, and an insulating base plate 28 so that a part of the working electrode 26 and the counter electrode 27 is exposed. a stacked plate-like spacers 30, a plate-like cover 31 which is further laminated on the plate-like spacer 30 is constituted by a through hole 19 which is puncture body 6 may pass, it communicates with the through hole 19 and a sample passageway 29 in the thickness Te, and a configuration in which the reaction section is formed on the inner wall of the sample channel 29. At the time of actual measurement, the puncture body 6 protrudes through the through-hole 19, damages the skin, and supplies the specimen. At this time, since the through-hole 19 is a hole through which the puncture body 6 passes, the through-hole 19 is very close to the wound on the skin, that is, the liquid discharge part. Therefore, the sample discharged from the wound can be easily introduced into the sample passage 29 of the sensor 9 through the through hole 19 by capillary action, and the reaction can be started.
[0013]
Hereinafter, the detailed structure and advantages of the depth adjustment mechanism of the puncture body of the present invention will be described using examples.
[0014]
Example 1
An example in which the depth adjusting mechanism is installed on the mounting body will be described below. FIG. 3 shows a cross-sectional view of the cylindrical portion 5 formed to extend to the mounting body 3 and the main body 2, and FIG. 4 shows an exploded view of the ring-shaped structure 11a. The cap-shaped mounting body 3 formed of polyester resin corresponds to the outer shape of the front cylindrical portion 7 of the main body 2, and a through-hole 19 through which the puncture body 6 passes at the bottom wall of the mounting body 3 during measurement. A puncture body 6 having a spring member 18 is integrally incorporated above the sensor 9 and the sensor 9.
[0015]
The puncture body 6 is connected to a puncture body guide shaft 10 that receives the forward and backward driving forces of the puncture body 6. Further, in the cylindrical portion 5, there are provided a push rod 12 capable of moving forward and backward to transmit the forward and backward driving force of the puncture body from the pressing body, and a pin 17 which is in contact with the sensor 9 and transmits an electrical signal after the specimen reaction. Two connectors 16 are incorporated. The connector 16 is connected to the microcomputer of the main body 2 by lead wires 13.
[0016]
A ring-shaped structure 11a is incorporated around the puncture body guide shaft 10 above the puncture body 6 of the cap-shaped mounting body 3 , and the depth of the puncture body 6 can be adjusted by the ring-shaped structure 11a. It is. The ring-shaped structure 11a has a protruding stopper 14. The ring-shaped structure 11a and the protrusion-shaped stopper 14 are made of silicon resin. Due to the unevenness of the stopper 14, 0.5 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm The depth of the puncture body 6 that punctures the skin or the like can be fixed in five stages. With this stopper 14, it is possible to puncture with an arbitrary depth of the puncture body 6 with high accuracy.
[0017]
The measurer sets the ring-shaped structure 11 a to a target length in advance and then attaches the attachment 3 to the main body 2. At the time of puncturing, the puncture body driving force transmitted from the pressing body is transmitted to the pressing rod 12, and this pressing rod 12 punctures the distance 15 between the distal end portion of the puncture body guide shaft 10 and the distal end portion of the ring-shaped structure 11a. Since the guide shaft 10 is pushed, this distance 15 becomes the driving distance for the advancement and retraction of the puncture body. Thereby, it can measure at the depth of the puncture body 6 suitable for the measurer, and can prevent pain and measurement failure.
[0018]
(Example 2)
An example in which the depth adjusting mechanism is installed on the mounting body will be described below. FIG. 5 shows a cross-sectional view of the cylindrical portion 5 formed to extend to the mounting body 3 and the main body 2 , and FIG. 6 is a cross-sectional perspective view of the protruding structure 20 having the ring-shaped structure 11 b and the stopper 14. Show. As in Example 1, a cap-like attachment body 3 molded with polyester resin corresponds to the outer shape of the front cylinder portion 7 of the body 2, the puncture body when the measurement is on the bottom wall of the instrumentation adherend 3 A sensor 9 having a through hole 19 through which 6 passes, and a puncture body 6 having a spring member 18 are integrally incorporated above the sensor 9.
[0019]
In the front cylindrical portion 7 of the main body 2, two protruding structures 20 having stoppers 14 are installed, and the protruding structure 20, the connector 16, and the puncture body guide shaft 10 pass through. Further, a retractable ring-shaped structure 11b is arranged. A tunnel space 22 is provided between the tubular portion 5 and the front tubular portion 7 so that the ring-shaped structure 11b can move forward and backward. As shown in FIG. 7, the ring-shaped structure 11 b includes a connector through-hole 23 through which a connector passes, a projecting-structure through-hole 25 through which a projecting-shaped structure 20 having a stopper 14 passes, and a puncture body guide shaft 10. It is constituted by a puncture body guide shaft through-hole 24 through which is penetrated. The ring-shaped structure 11b has a thickness of 0.5 mm, 1.0 mm, 1.5 mm, 2 and 2 depending on the unevenness of the stopper 14 and the ring-shaped structure 11b before and after mounting the mounting body 3 on the main body 2. The depth of the puncture body 6 that punctures the skin or the like can be fixed by moving forward and backward so as to slide in five stages of 0.0 mm and 2.5 mm. In this way, it is possible to puncture accurately with an arbitrary depth of the puncture body 6.
[0020]
At the time of puncturing, the puncture body driving force transmitted from the pressing body is transmitted to the pressing rod 12, and the pressing rod 12 is punctured by a distance 21 between the distal end portion of the puncture body guide shaft 10 and the distal end portion of the ring-shaped structure 14. Since the guide shaft 10 is pushed, this distance 21 becomes the driving distance for the advancement and retraction of the puncture body. Thereby, it can measure with the length of the puncture body 6 suitable for the measurer, and can prevent pain and measurement failure. In addition, since the depth adjustment mechanism is installed in the main body 2, the puncture depth of the puncture body 6 can be adjusted regardless of whether or not the mounting body 3 is attached to the main body 2, thereby reducing the manufacturing cost of the mounting body 3. Obviously, the economic burden on the measurer can be reduced.
[0021]
【The invention's effect】
The present invention provides a lancet-integrated measurement device that can eliminate individual differences in the amount of specimen due to skin hardness and the like, reduce pain in the patient, and perform measurement reliably. it can. As a result, measurement failure due to insufficient or excessive sample volume can be prevented, and the need for re-measurement is eliminated, so the economic burden on the measurer can be reduced.
[Brief description of the drawings]
[Fig. 1] Front view of a lancet-integrated measuring device [Fig. 2] Exploded view of a sensor [Fig. 3] Cross-sectional view of a mounting body and a cylindrical portion extending from the main body (depth adjustment mechanism is installed on the mounting body)
FIG. 4 is an exploded view of a ring-shaped structure (a depth adjustment mechanism is installed on the mounting body).
FIG. 5 is a cross-sectional view of a cylindrical portion that extends from the mounting body and the main body (a depth adjustment mechanism is installed in the main body).
FIG. 6 is a cross-sectional perspective view of a protruding structure having a ring-shaped structure and a stopper (a depth adjustment mechanism is installed in the main body).
FIG. 7 is a plan view of a ring-shaped structure (a depth adjustment mechanism is installed in the main body).
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1: Measuring apparatus 2: Main body 3: Wearing body 4: LCD display device 5: Cylindrical part 6: Puncture body 7: Front cylindrical part 8: Press part 9: Sensor 10: Puncture body guide shaft 11a: Ring-shaped structure Body (installed on the body)
11b: Ring-shaped structure (installed in the main body)
12: Pressing rod 13: Lead wire 14: Stopper 15: Driving distance of the puncture body (when the ring-shaped structure is installed on the wearing body)
16: Connector 17: Pin 18: Spring member 19: Through hole 20: Protruding structure 21: Driving distance of the puncture body (when the ring-shaped structure is installed in the main body)
22: Tunnel space 23: Connector through hole 24: Puncture body guide shaft through hole 25: On-projection structure through hole 26: Working electrode 27: Counter electrode 28: Insulating base plate 29: Sample passage 30: Plate spacer 31: Plate shape cover

Claims (7)

A lancet-integrated measuring device comprising a main body and a mounting body to be used by being attached to the main body,
The wearing body has a puncture body and a sensor that can be advanced and retracted, and
The main body has a drive mechanism for driving the puncture body forward so that the puncture body takes an advanced position,
Upper Symbol mounting body, provided with a mechanism for adjusting the lancing depth of the lancet,
The puncture body has a puncture body guide shaft at the rear,
The drive mechanism has a pressing rod that applies a driving force to the puncture body guide shaft,
The mechanism for adjusting the puncture depth of the puncture body is a stepwise adjustment mechanism,
The stepwise adjustment mechanism has a ring-shaped structure movable in the forward and backward directions,
The lancet-integrated measuring apparatus according to claim 1, wherein the puncture depth is adjusted by the pressing rod interfering with an end face of the ring-shaped structure and a distance of forward and backward driving of the pressing rod is changed. Distance forward and backward driving of the ring-like structure, the lancet-integrated measuring apparatus according to claim 1, characterized in that it is fixed by a stop for determining the stepwise position. The stopper is fixed to the wearing body and has irregularities,
3. The lancet-integrated measuring apparatus according to claim 2, wherein the ring-shaped structure has irregularities, and the ring-shaped structures are fixed in a stepwise manner by engaging both irregularities. The ring-shaped structure is provided on the mounting body, and a fixing position by the stopper can be selected in a state where the mounting body is not mounted on the main body . The lancet-integrated measuring device according to any one of the above. The lancet-integrated measuring apparatus according to claim 2 , wherein the ring-shaped structure is provided on the main body, and a fixing position by the stopper can be selected from the outside of the main body. The lancet-integrated measuring apparatus according to any one of claims 1 to 5, wherein the mounting body includes a spring member for retracting the advanced puncture body. The lancet-integrated measuring apparatus according to claim 6, wherein the sensor is provided on a bottom wall of the mounting body, and the spring member is incorporated above the sensor.

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