JP4255556B2 - Lancet integrated measuring device - Google Patents

Description

[0001]
[Technical field to which the invention belongs]
The present invention relates to a measurement device for measuring a specific component contained in a specimen, such as blood glucose concentration (hereinafter referred to as “blood glucose level”), and a lancet-integrated measurement device having a lancet.
[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 can be fitted with a puncture needle and is a device for making a small hole in the skin of a patient's fingertip, etc. By supplying a specimen to the above-mentioned sensor through the hole thus opened, the blood sugar level can be relatively easily adjusted. Self-measurement can be performed. 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 consisting of several points, such as a blood glucose level measuring device, a lancet, a puncture needle, and a sensor, is carried and measured by combining them when necessary.
[0005]
The exploded perspective view of FIG. 1 shows a conventional example of a blood glucose level measurement sensor. A silver paste is printed on the insulating substrate 1 by screen printing to form leads 2 and 3, and then an electrode system including the measuring electrode 4 and the counter electrode 5 is formed using a conductive carbon paste containing a resin binder. It is formed by printing. Subsequently, an insulating layer 6 made of an insulating paste is formed by printing. On the measurement electrode 4 and the counter electrode 5, a reagent layer 7 made of glucose oxidase as an enzyme and potassium ferricyanide as an electron acceptor is formed. And it has the structure covered with the cover 9 which has the air hole 11 through the spacer 8 which has the sample supply hole 10. FIG.
At the time of measurement, when the sample is spotted on one end of the capillary formed by the sample supply hole 10 of the spacer 8, the sample is supplied into the capillary having the other end as the air hole 11, and the reagent is dissolved to cause an oxidation-reduction reaction. . At this time, when a voltage is applied to the measurement electrode 4 and the counter electrode 5 via the lead portions 2 and 3, an oxidation current proportional to the glucose concentration is generated. This oxidation current is converted into a blood glucose level in the apparatus body and displayed.
[0006]
On the other hand, FIG. 2 and FIG. 3 show a conventional example of a lancet for attaching and detaching a disposable puncture needle. The lancet 12 can replace the puncture needle 14 in the case 13 for each measurement. The puncture needle 14 protrudes from a needle launch port 16 provided at the distal end portion of the case 13 by a spring member 15. The patient selects a fingertip or an earlobe and punctures the puncture needle 14 to collect blood. FIG. 2 shows a state in which the spring member 15 is compressed and the puncture needle 14 is prepared for blood collection. FIG. 3 shows a state in which the spring member 15 in the compressed state is released and the puncture needle 14 protrudes from the needle firing port 16 to puncture the blood collection site. In this case, the puncture needle 14 protrudes from the needle firing port 16 by the spring member 15 released from the compressive force, and the protruding operation is restricted by the stopper 17 provided on the puncture needle 14 side and the stopper catch 18 provided on the main body case 13. It has a structure to do.
[0007]
[Problems to be solved by the invention]
In the conventional blood glucose measurement method described above, the patient who is the subject must always carry two instruments, a lancet and a blood glucose measurement device, as a set. The operation method also requires a long training, and it takes a considerable amount of time until a reliable measurement can be performed by the patient himself. In addition, measurement at sites other than the fingertips and forearms (abdominal wall, earlobe, etc.) is difficult even for a skilled person. In recent years, a sensor capable of measuring with a sample volume of 1 μL or less has been developed due to the need for supplying a less invasive specimen with less pain. In such a trace amount, the specimen is supplied accurately. The work to do becomes very difficult. As a result, the measurement failed, and the patient as the measurement subject had to puncture again, replace the sensor, and restart the measurement. The present invention has been devised in view of such drawbacks, and an object thereof is to provide a measuring apparatus that is excellent in portability, simple in operation, and capable of reliably measuring without failure.
[0008]
[Means for Solving the Problems]
In order to achieve the above object, the present invention provides a puncture needle positioned at an opening of a lancet section for supplying a specimen, a sensor is positioned in the vicinity of the opening , the puncture needle is driven by a pressing body , and the sensor is operated by the pressing body . Is a lancet-integrated measuring apparatus equipped with a mechanism for moving and supplying a specimen. Furthermore, the lancet unit has a puncture needle firing mechanism unit that projects the puncture needle at a fixed distance, a sensor moving mechanism unit that moves the sensor, and a switching mechanism that switches the projection of the puncture needle and the movement of the sensor, and the projecting and moving operation Is a lancet-integrated measuring apparatus that can be performed with at least one pressing body. The switching mechanism includes a switching plate, for example, and by rotating the switching plate, a state where the pressing body acts on the puncture needle firing mechanism portion and a state where the pressing body acts on the sensor moving mechanism portion can be selected. . The switching mechanism includes, for example, a knob having an inclined portion, and a rotating body that has an inclined portion that engages with the inclined portion of the knob and is integrated with the switching plate. The switching plate is rotated together with the rotating body by moving the inclined portion of the rotating body along the portion. The pressing body may include a first pressing body that acts on the puncture needle firing mechanism that causes the puncture needle to project at a fixed distance, and a second pressing body that acts on the sensor moving mechanism that moves the sensor. Good. The first and second pressing bodies may have a pressing body guide for distinguishing these pressing bodies. The sensor moving mechanism section includes, for example, a socket section for connecting a sensor and a flexible hollow tube that is continuous with the socket section.
[0009]
DETAILED DESCRIPTION OF THE INVENTION
A lancet-integrated measuring apparatus according to an embodiment of the present invention will be described with reference to the drawings.
[0010]
(Embodiment 1) FIG. 4 shows an overall view in a measurement standby state of the present lancet-integrated measuring apparatus as seen through the inside of the lancet section. The lancet-integrated measuring apparatus has a lancet part in which a puncture part 19 having a spring member 27 and a sensor holding part 20 are held in parallel, and the puncture part 19 and the sensor holding part 20 are disposed above the lancet part . A switching plate 21 is provided. The body of the lancet-integrated measuring device, based on the signal detected by the sensor 29, has a built-in electronic control unit for calculating the concentration of an analyte, a display unit 22 for displaying the concentration of the calculated specific substance Is provided. Furthermore, a pressing body 23 for driving the puncture portion 19 and the sensor holding portion 20 is provided on the upper part of the main body of the lancet-integrated body fluid measuring device. The opening 24 is set according to the driving position of the puncture needle 25. The puncture portion 19 is composed of a puncture needle 25, a support rod 26, and a spring member 27. The support element 26 is a push of a pressing body 23, and a spring member 27 is driven by a driving force transmitted from the pressing rod 28 to the switching plate 21. You can move up and down. Pushing in this case refers to an act of pushing in the pressing body 23 installed in the lancet-integrated measuring apparatus main body. The sensor holding part 20 is constituted by a socket part 30 and a hollow tube 31 and can move up and down like the support bar 26. Further, the lancet portion has a cap 40, and this cap 40 is removable when the puncture needle 25 and the sensor 29 are replaced.
[0011]
FIG. 5 is an enlarged view of the sensor 29, the socket portion 30, and the hollow tube 31. The sensor 29 can be connected by being inserted into the socket portion 30. As a result, the sensor 29 can be used in a disposable manner. A lead wire 32 is drawn from the socket portion 30 through the hollow tube 31. The hollow tube 31 is made of a flexible resin so that the sensor can be moved to the opening 24 along the wall surface of the lancet body. Preferably, a tube made of polystyrene resin, polyester resin, polyamide resin, vinyl chloride resin, silicon resin, or the like can be used. The lead wire 32 drawn through the hollow tube 31 is also preferably flexible.
[0012]
FIG. 6 is an exploded view of a mechanism for switching between the puncture unit 19 and the sensor unit 20. For ease of understanding, the structure is shown separately. An inclined portion 41b is installed on the knob 41a, and is connected to the semicircular switching plate 21 via a rotating body 41c having a protruding portion 41d having an inclination. The inclined portion 41b installed on the knob 41a is fitted to the inclined protrusion 41d on the rotating body 41c, and moves along the inclined protruding portion 41d to rotate the rotating body 41c. By this rotation, the puncture needle 25 and the sensor unit 20 can be switched by rotating the switching plate 21 connected to the rotating body 41c. At this time, the switching plate 21 has a semicircular structure, and the switching plate 21 rotates 180 ° for each push.
[0013]
FIG. 7 is an exploded view of the lancet portion during the first push of the pressing body. The first push in this case refers to the act of pushing the first pressing body 23 in the sample measurement. The driving force transmitted from the pressing rod 28 to the switching plate 21 by the pressing of the pressing body 23 is transmitted only to the support bar 26 to which the puncture needle 25 is attached, and the puncture needle 25 passes through the opening 24 and punctures the skin. . After puncturing, the spring member 27 can return to its original position by the repulsive force. The spring member 27 may be a compression coil spring made of metal or resin, but is not particularly limited as long as it is an elastic body.
[0014]
FIG. 8 is an exploded view of the lancet portion at the time of the second push of the pressing body 23. The second push in this case refers to the act of pushing the pressing body 23 for the second time during sample measurement. The driving force transmitted from the pressing rod 28 to the switching plate 21 by the pressing of the pressing body 23 is transmitted only to the hollow tube 31 to which the sensor 29 is attached. The sensor 29 can be moved to the opening 24 along the line. Since the spring member 27 is not attached to the hollow tube 31, the sensor 29 can be stopped at any position of the opening 24. At this time, it is preferable to set the length of the hollow tube 31 so that the sensor 29 can be stopped at the position of the opening 24 where it can come into contact with an arbitrary amount of body fluid 33 discharged from the skin by the puncture needle 25. Furthermore, a stopper can be provided so that the sensor 29 can be fixed at a predetermined position.
In this way, it is possible to cause the sensor 29 to suck the discharged body fluid and start measurement.
[0015]
After the measurement is completed, the cap 40 is removed, and the puncture needle 25 and the sensor 29 are removed. Hold the socket 30 and push the sensor holding unit 20 upward to the same position as in the measurement standby state. At this time, the switching plate 21, the pressing pressure rod 28, and the pressing body 23 are also pushed upward as the sensor holding portion is pushed up. Next, the cap 40 is attached and stored. In the case of continuous measurement, the puncture needle 25 and the sensor 29 may be replaced, returned to the initial position, the cap 40 may be attached, and the next measurement may be waited.
[0016]
(Embodiment 2) FIG. 9 is an overall view of a lancet-integrated measuring apparatus having two pressing bodies. The lancet driving pressing body 34 and the sensor moving pressing body 35 are separated. The lancet driving pressing body 34 is connected to an internal support bar 26 coupled to the puncture needle 25, and a spring member 27 is mounted around the internal support bar 26. A sensor moving pressure rod 28 is connected to the sensor moving pressure body 35 . At the tip of the pressing rod 28, the sensor unit 20 is installed in parallel with the support rod 26. The lancet driving pressing body 34 and the sensor moving pressing body 35 are provided with a projecting pressing body guide 39 so that they can be distinguished from each other. Thereby, it is possible to provide a lancet-integrated measuring device that is easy to use for measurement in a dark place and a blind person.
[0017]
First, the measurer pulls the lancet driving pressing body 35 upward to prepare for launching the puncture needle 25. At this time, the internal support bar 26 coupled to the puncture needle 25 is pulled up, the spring member 27 is compressed, and the circular stopper 36 below the support bar is hooked by the hook 37. Subsequently, when the puncture needle firing button 38 installed on the lancet driving pressing body 34 is pressed, the hook 37 is released, and the puncture needle 25 is fired by the repulsive force of the spring member 27 to puncture the skin and discharge the body fluid.
[0018]
Subsequently, the driving force transmitted to the pressing rod 28 by the push operation of the sensor moving pressing body 35 is transmitted to the hollow tube 31 equipped with the sensor 29, and the flexible material of the hollow tube 31 allows the lancet body. The sensor 29 can be moved to the opening 24 along the wall surface. Since the spring member is not attached to the hollow tube 31, the sensor 29 can be stopped at an arbitrary position of the opening 24. At this time, it is preferable to set the length of the hollow tube 31 so that the sensor 29 can be stopped at the position of the opening 24 where it can come into contact with an arbitrary amount of body fluid discharged from the skin by the puncture needle 25. In this way, it is possible to cause the sensor 29 to suck the discharged body fluid and start measurement. After the measurement is completed, the puncture needle and the sensor may be removed or exchanged and stored or placed in a standby state for the next measurement as in (Example 1).
[0019]
【The invention's effect】
The lancet-integrated measuring device of the present invention can improve portability and can be measured by only pushing the pressing body twice, so that the operability is greatly improved. Further, the operation of bringing the sensor into contact with the discharged body fluid can be performed semi-automatically, and the positional accuracy is improved, so that there is no failure in supplying the specimen. As a result, even an inexperienced measurer does not need to repeat the measurement.
[0020]
[Brief description of the drawings]
FIG. 1 is an exploded perspective view of a blood glucose level measuring sensor. FIG. 2 is a schematic view of a preparation state of a blood collection needle detachable lancet. FIG. 3 is a schematic diagram of a blood collection state of a blood collection needle removable lancet. Overall view of the measuring device (measurement standby state) [Fig. 5] Enlarged view of the sensor, socket, and hollow tube [Fig. 6] Exploded view of the switching mechanism [Fig. 7] Exploded view at the time of the first push [Fig. Exploded view when pushing [Fig. 9] Overall view of a lancet integrated measuring device with two pressing bodies [Explanation of symbols]
1: substrate 2: lead 3: lead 4: measuring electrode 5: counter electrode 6: insulating layer 7: reagent layer 8: spacer 9: cover 10: specimen supply hole 11: air hole 12: lancet 13: case 14: puncture needle 15 : Spring member 16: Needle launch port 17: Stopper 18: Stopper receiving 19: Puncture part 20: Sensor holding part 21: Switching plate 22: Display part 23: Press body 24: Opening part 25: Puncture needle 26: Support rod 27: Spring member 28: Press rod 29: Sensor 30: Socket portion 31: Hollow tube 32: Lead wire 33: Body fluid 34: Puncture needle driving press body 35: Sensor moving press body 36: Circular stopper 37: Hook 38: Puncture Needle firing button 39: Pressing body guide 40: Cap 41a: Knob 41b: Inclined portion 41c: Rotating body 41d: Inclined protrusion

Claims (6)

The puncture needle is positioned at the opening of the lancet section for supplying the specimen, the sensor is positioned in the vicinity of the opening , the puncture needle is driven by the first pushing means of the pressing body , and the second pushing means of the pressing body is used. A mechanism for supplying a specimen by moving the sensor ; and
The lancet section has a puncture needle firing mechanism section for projecting the puncture needle at a certain distance, a sensor moving mechanism section for moving the sensor, and a switching mechanism for switching the projection of the puncture needle and the movement of the sensor, and the projection and movement operations are at least A lancet-integrated measurement device that can be performed with a single pressing body . The switching mechanism includes a switching plate, and by rotating the switching plate, a state where the pressing body acts on the puncture needle firing mechanism and a state where the pressing body acts on the sensor moving mechanism can be selected. The lancet-integrated measuring apparatus according to claim 1 . The switching mechanism includes a knob having an inclined portion, and a rotating body that has an inclined portion that engages with the inclined portion of the knob and is integrated with the switching plate. The lancet-integrated measuring apparatus according to claim 2 , wherein the switching plate is rotated together with the rotating body by moving the inclined portion of the rotating body along the portion. The puncture needle is positioned at the opening of the lancet section for supplying the specimen, the sensor is positioned in the vicinity of the opening, the puncture needle is driven by the first pushing means of the pressing body, and the second pushing means of the pressing body is used. A mechanism for supplying a specimen by moving the sensor; and
A first pressing member acting on the puncture needle firing mechanism for projecting operate puncture puncture needle at a constant distance, and a second pressing member acting on the sensor moving mechanism for moving the sensor, which comprise, La Nsetto integrated measurement apparatus. The lancet-integrated measuring apparatus according to claim 4 , wherein the first pressing body and the second pressing body have a projecting pressing body guide for distinguishing between them.   The lancet integrated type according to any one of claims 1 to 5, wherein the sensor moving mechanism portion includes a socket portion for connecting a sensor and a hollow tube formed to be flexible and continuous with the socket portion. measuring device.

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