JP4682361B2 - Puncture device integrated biosensor - Google Patents

Description

  The present invention relates to a puncture device integrated biosensor. More specifically, a puncture device having a configuration in which a puncture device for piercing the skin to obtain a body fluid (blood, etc.) and a biosensor for collecting and analyzing the body fluid taken out on the surface of the skin are integrated. The present invention relates to a body type biosensor.

Conventionally, a diabetic patient himself collects blood and measures a blood glucose level which is a glucose level in blood. In this case, the patient uses a blood collection device called a lancet that attaches and detaches a blood collection needle. is doing. In such a measurement method, the patient must carry a set of measuring instruments consisting of several points such as a blood glucose analyzer, a lancet, a blood collection needle and an analytical element, and combine them when necessary to perform the measurement. However, it takes a lot of training and it takes a considerable amount of time before the patient can make reliable measurements. Actually, measurements at sites other than the fingertips and forearms (abdominal wall, earlobe, etc.) are difficult even for an expert. In recent years, biosensors that can be measured with a sample volume of 1 μl or less have been developed due to the need for less invasive specimen supply with less pain. The work of supplying accurately becomes very difficult. As a result, the measurement fails, and the patient who is the subject has the inconvenience of having to puncture again and replacing the biosensor and restart the measurement.
JP-A-9-266898 Japanese Patent Publication No. 8-20412

Thus, several biosensors with integrated puncture devices have been devised. First, in the biosensor integrated with a puncture device disclosed in Patent Document 3, the puncture needle and the biosensor are placed in different positions inside a pen-type (two-color ballpoint pen-like) measuring device equipped with a puncture needle drive unit. The blood glucose is measured by placing the tip of the pen-like measuring device against the skin of the subject and puncturing it, exposing the biosensor to the tip, and collecting blood. However, this method does not eliminate the troublesomeness of setting the needle and the biosensor in the measuring device.
JP 2000-217804 A

Further, in the puncture device integrated biosensor disclosed in Patent Document 4, the puncture needle is left to the external drive, and the puncture needle moves in parallel along the longitudinal direction of the elongated piece-like biosensor. It has a structure. However, in this type, since the puncture needle moves in the blood collection conveyance path and the reagent layer of the biosensor, there is a risk that the surface of the puncture needle is contaminated with the reagent before the puncture needle pierces the skin of the subject.
Republished 2002-056769

  In addition, there are many problems such as inadequate consideration for infectious diseases and the like after disposal, and the biosensor unit with integrated puncture device cannot withstand the impact of driving during puncture. ing.

  The object of the present invention is to form an extremely simple structure while maintaining sufficient strength to withstand impacts caused by puncture performed by the user himself / herself. The object is to provide a biosensor with an integrated puncture device that enables reliable measurement even with a small amount of sample liquid.

  An object of the present invention is to provide at least one electrode or a hollow columnar structure in a biosensor formed by penetrating or embedding at least two electrodes or a substrate for forming the same vertically with respect to the substrate. It is achieved by a puncture device-integrated biosensor characterized in that the tip portion located at the blood collection port of the substrate for forming the same has a single-edged, double-edged, or needle-like structure capable of puncturing a subject. The

  The biosensor integrated with a puncture device according to the present invention is extremely configured because the puncture member is integrated with the electrode while maintaining sufficient strength to withstand the impact of the puncture performed by the user himself / herself. It is simple and easy to assemble, and by miniaturizing as a whole, it has an excellent effect that measurement can be reliably performed even with a small amount of sample liquid. Since such a biosensor can be used as a cartridge, it can be easily carried by simple packaging and has an effect of being hygienic after use.

  The puncture device-integrated biosensor of the present invention is constituted by an electrode system composed of at least two arranged vertically on an electrically insulating substrate such as plastic. This biosensor will be described in more detail.

At least two electrodes of the biosensor are penetrated or embedded perpendicular to the substrate. Specifically, a method of arranging two flat electrodes at intervals, a method of forming three or more flat electrodes at intervals and forming a hollow prismatic structure, or a plate electrode having a curved surface Examples include a method of forming a hollow cylindrical structure by arranging two or more at intervals. Each of these three types of electrodes will be described.

  The two flat electrodes are preferably arranged in parallel. In addition, the hollow prismatic structure is formed by arranging three or more flat plate members, all or a part of which are electrodes, and the side surfaces thereof being adjacent to or in contact with each other in parallel. Is formed by arranging two or more bending members, each of which is part or all of an electrode, and arranging the side surfaces thereof in parallel and adjacent to each other.

  When a part of the plate member is an electrode, the part other than the electrode (electrode forming substrate) is made of an insulating material, for example, an inorganic material such as plastic, metal, ceramics, biodegradable material, paper, etc. Preferably, polyethylene terephthalate is used.

  The electrode forming a part of the plate-like member is formed by depositing a conductive material on the surface of the electrode forming substrate or by bonding the electrode member and the electrode forming substrate.

  Film formation of the conductive material on the electrode forming substrate surface is performed by a screen printing method, a vapor deposition method, a sputtering method, a foil bonding method, a plating method, etc., and the bonding between the electrode member and the electrode forming substrate is Done by glue. In particular, when the electrode members are in parallel contact with each other when forming the prismatic structure, a structure that avoids contact between the electrodes is desirable, and a conductive material is formed on the surface of the electrode forming substrate.

  Examples of the conductive material include carbon, silver, silver / silver chloride, platinum, gold, nickel, copper, palladium, titanium, iridium, lead, tin oxide, and platinum black. As carbon, carbon nanotubes, carbon microcoils, carbon nanohorns, fullerenes, dendrimers, or derivatives thereof can be used.

  The electrode (formation substrate) used in the present invention has a single-edged, double-edged, or needle-like structure that can puncture a subject at the tip portion located at at least one blood sampling port of two or more used electrodes. have. By adopting such a structure, a separate component such as a puncture needle is not required, so the biosensor has a very simple structure, its assembly is simple, and the whole is miniaturized so that even a small amount of sample liquid can be used. It has an excellent effect of making it possible to perform measurement reliably.

  The puncture device is preferably provided with a photocatalytic function effective for antibacterial and antiviral effects on its surface for the purpose of hygienic storage and use. The surface of the puncture device is deposited on the surface of the puncture device by vapor deposition or sputtering. A titanium film is formed.

  The electrode may be a two-pole method formed by a working electrode and a counter electrode, or a three-pole method formed by a working electrode and a counter electrode, a reference electrode, or an electrode having more poles, or a single plate-like member. Two or more poles can be formed.

  A substrate is used to form the columnar structure. The material of the substrate is sufficient if it is electrically insulative, and the electrode (forming substrate) is disposed by penetrating or being embedded perpendicularly to the substrate. At this time, a spacer can also be provided between the electrodes (forming substrate). When the electrode (formation substrate) penetrates the substrate, the opposite side of the electrode from the substrate is the terminal that sends the electrical signal from the biosensor to the measurement device, and the electrode (formation substrate) penetrates the substrate If not, a terminal is provided on a part of the substrate, preferably a side surface.

  A reagent layer is formed on the electrode (forming substrate) as necessary. The reagent layer is preferably immobilized on the electrode surface or the plate-like member surface. In this case, the reagent layer is formed by a screen printing method or a dispenser method, and is immobilized on the surface of the electrode (forming substrate) by an adsorption method with drying or a covalent bonding method. The reagent varies depending on the detection target. For example, when the puncture device integrated biosensor is configured for blood glucose level measurement, a reagent containing glucose oxidase as an oxidase and potassium ferricyanide as a mediator is employed. When these reagents are dissolved by blood, the enzyme reaction is started. As a result, potassium ferricyanide coexisting in the reagent layer is reduced, and potassium ferrocyanide which is a reduced electron carrier is accumulated. The amount is proportional to the substrate concentration, ie the glucose concentration in the blood. The reduced electron carrier accumulated for a certain time is oxidized by an electrochemical reaction. The glucose concentration (blood glucose level) is calculated from the anode current measured at this time.

  The puncture device integrated biosensor having the above configuration enables puncture by directly piercing the puncture device portion into the skin of the subject. The blood that has bleed is transferred to the biosensor electrode reaction part by capillary action that works between the electrodes (forming substrate). At this time, depending on the blood, the electrode may not be sufficiently covered, for example, when the hematocrit value is high. Therefore, the electrode (formation substrate) portion away from the blood collection introducing portion is preferably covered with a resist. In this case, the resist film is formed by a screen printing method or the like. Accordingly, even when the electrode area is accurately defined and the hematocrit value is high, the electrode can be filled at a minimum, so that the sample liquid can be transferred without being influenced by the state. On the other hand, when the hematocrit value is low and blood transfer is performed smoothly, it is necessary to stop capillary action in order to prevent excessive blood collection. As this means, there is a method of providing a through hole in an electrode (forming substrate) and stopping the progress of capillary action by providing an air exhaust hole, or a method of keeping the distance between electrodes (forming substrate) close to the substrate. Can be mentioned.

  As a blood collection method, a suction blood collection method or a vacuum blood collection method may be mentioned in addition to the method using the capillary phenomenon. For example, a biosensor integrated with a puncture device that uses suction blood collection is designed to maintain airtightness using an electrically insulating member between electrodes (formation substrate), and a syringe-like structure on the back side of the biosensor substrate. For example, a device in which an aspirator is arranged, an external attachment type assembled at the time of use, or a membrane in which a blood collection port can be provided with a diaphragm can be used.

  In addition, as a puncture device integrated biosensor using a vacuum blood sampling method, for example, an electrical insulating member is used between the electrodes (forming substrate) to maintain airtightness, and the blood sampling port is covered with a diaphragm. And using a commercially available vacuum blood collection tube and incorporating it into a biosensor with an integrated puncture device, or an external attachment type assembled at the time of use. .

  Moreover, the operability in use can be improved by using the biosensor with the puncture device according to the present invention as a cartridge type to which a measuring device can be attached. Furthermore, if this is a disposable type, it is possible to realize the same ease of use as that of a disposable blood glucose sensor currently on the market. In addition, in the case of such a puncture device integrated biosensor, it is preferable in production and use that the packaging form is simple. In consideration of prevention of infectious diseases after use, it is desirable that a simple packaging form that can be repackaged when discarded is taken.

The cartridge described above can be used for blood collection not only by the user himself but also by puncture using an external puncture drive. In such a case, it is desirable to provide a puncture drive in a measurement device that reads an electrical signal from a cartridge- type puncture device integrated biosensor .

Packaging Form As a packaging form of the puncture device integrated biosensor, first, packaging of individual puncture device integrated biosensors, particularly one that protects the puncture blood collection part at the tip of the puncture device integrated biosensor. As such a package, a cap-shaped simple package that protects the tip is preferable. Thereby, the puncture blood collection part can be protected hygienically and safely until use. Furthermore, by having such a form, repackaging after use is possible, and it is possible to prevent infectious diseases that are a concern after disposal, and as another method of use, body fluid after puncture collection is stored. It is also possible.

As a second packaging form, there is a container in which a plurality of cartridge-type puncture device integrated biosensors that are simply packaged can be carried together. The cartridge-type puncture device integrated biosensor of the present invention is extremely small even if it includes the bulk of simple packaging, so even if a plurality of packages are stored together in a container, the overall size of the packaging container is small. Become. Specifically, it is desirable that the pocket size is easy to carry.

As a third packaging form, a packaging container itself is capable of individually packaging and storing cartridge-type puncture device integrated biosensors . In this case, for example, a cartridge-type puncture device integrated biosensor is stored separately in a well-shaped tray, and individually wrapped with a packaging film or the like in order to maintain airtightness.

Measuring device for measuring device puncture device integrated biosensor is easy to carry and has operability and durability for repeated and reliable measurement using cartridge type puncture device integrated biosensor. Those are preferred.

  Specifically, a form in which a cartridge-type puncture device integrated biosensor is slid sideways or inserted in a vertical direction into an introduction portion at the lower part of the measurement apparatus is preferable. At this time, the terminal of the biosensor is connected to the connector of the measuring device so that measurement is possible. After that, when the user decides the puncture portion and starts puncturing, puncturing, blood sampling and measurement are automatically performed, and finally the measurement result is derived.

An example of structural features will be described in more detail. This measuring device is a measuring unit that measures electrical values in the introduction part of a biosensor integrated with a puncture device , a connector, an electrochemical measurement circuit, a memory part, an operation panel, and an electrode of the biosensor, and a measurement value in the measurement part. The display unit to be displayed has a basic configuration, and furthermore, radio waves such as Bluetooth (registered trademark) can be mounted on the apparatus as a wireless means.

In addition, an illumination function can be provided in consideration of use by a dark place or a low vision person. In this case, it is preferable that the user can improve the operability when attaching and puncturing the cartridge-type puncture device integrated biosensor . For example, the puncture device integrated biosensor of the measuring apparatus is preferable. by that the light for illumination from the introduction portion is irradiated, the user can easily introduce the puncture device integrated-type biosensor measuring device, even after further piercing device integrated-type biosensor attached, the illumination from the inlet portion The form in which the puncture part is illuminated is good. Therefore, it is preferable that a material such as a spacer or a diaphragm for fixing the electrode plate member of the cartridge-type puncture device integrated biosensor having an illumination function is a transparent material.

  In addition to the automatic illumination function of the display unit and puncture unit in the dark place, the measurement device includes a voice guide function and a voice recognition function corresponding to visual impairment due to diabetes, a measurement data management function using a built-in radio clock, measurement data A communication function for a medical institution, a charging function, and the like can be provided.

  The measuring method in the measuring unit of the measuring device is not particularly limited, and potential step chronoamperometry, coulometry, cyclic voltammetry, or the like can be used.

From the above, the puncture device integrated-type biosensors and cartridge lancing device integrated-type biosensor of the present invention, those of the package is not to limit the user, i.e. so as to be corresponding to the universal standard Yes.

  Next, the present invention will be described with reference to examples.

  FIG. 1 shows a configuration example of a biosensor with a puncture device according to the present invention. FIG. 1a shows each component of the biosensor. Fig. 1a (i) shows the outer part when the upper electrode is formed, Fig. 1a (ii) shows the inner part when the upper electrode is formed, and Fig. 1a (iii) shows the inner part when the lower electrode is formed. Yes. As shown in FIG. 1 a (i), a piercing blade 7 is provided with both blades near the tip of the electrode (forming) substrate 1. Further, there is a bent portion 9, and this portion serves as a stopper. By passing through the substrate 4, the electrode (for formation) substrate 1 is fixed to the substrate 4, and the substrate protruding portion of the electrode serves as a terminal to the measuring device. . Resist 2 defining the electrode area is provided on the surface of each of the two electrodes 1 serving as the electrode reaction part 5 (FIGS. 1a (ii) and 1a (iii)), of which the lower electrode (for formation) A reagent layer 3 is provided on the inner portion of the substrate (FIG. 1a (iii)). Further, in FIG. 1a (ii), as in FIG. 1a (i), a puncture blade 7 is provided with both blades in the vicinity of the tip of the electrode (forming) substrate 1. FIG. 1b shows a perspective view of an example of a biosensor that combines the individual members shown in FIG. 1a. FIG. 1c shows a longitudinal section through the center line in FIG. 1b. The blood flowing out by the upper and lower two puncture blades 7 and 7 is sent from the puncture blood collection port 8 to the electrode reaction part 5 of the biosensor, so that it mixes with and reacts with the reagents arranged there. The result is measured electrochemically.

  FIG. 2 shows another configuration example of the puncture device integrated biosensor of the present invention. The shape of the puncture blade 7 of the puncture device-integrated biosensor electrode shown in FIG. 1 has a corner, and the upper and lower two square puncture blades 7 and 7 puncture deeply with fewer cuts than the blade shown in FIG. It has features that can be done. 2a (i) shows the outer part when the upper electrode is formed, FIG. 2a (ii) shows the inner part when the upper electrode is formed, and FIG. 2a (iii) shows the inner part when the lower electrode is formed. Yes. As shown in FIG. 2 a (i), a square blade 7 for puncture is provided with both blades in the vicinity of the tip of the electrode 1. Further, in FIG. 2a (ii), as in FIG. 2a (i), a puncture square blade 7 is provided with both blades in the vicinity of the tip of the electrode 1. FIG. 2b is a perspective view showing an example of a biosensor in which the individual members shown in FIG. 2a are combined. FIG. 2c shows a longitudinal section through the center line in FIG. 2b.

  FIG. 3 shows another configuration example of the biosensor with a puncture device according to the present invention. Since the puncture blade 7 of the puncture device integrated biosensor electrode shown in FIG. 1 is provided only on the upper electrode (formation) substrate, and the puncture location can be reduced to one location, the burden on the user can be reduced. Have. 3a (i) is the outer part when forming the electrode of the upper electrode (for forming) substrate, FIG. 3a (ii) is the inner part when forming the electrode of the upper electrode (for forming) substrate, and FIG. 3a (iii) is the lower electrode. An inner portion of the substrate for forming (for forming) electrodes is shown. As shown in FIG. 3 a (i), a puncture blade 7 is provided near the tip of the electrode (formation) substrate 1. Further, in FIG. 3a (ii), as in FIG. 3a (i), a puncture blade 7 is provided with both blades in the vicinity of the tip of the electrode (formation) substrate 1. FIG. 3b is a perspective view showing an example of a biosensor in which the individual members shown in FIG. 3a are combined. FIG. 3c shows a longitudinal section through the center line in FIG. 3b.

  FIG. 4 shows a biosensor integrated with a puncture device in which three electrode (formation) substrates are vertically arranged at a distance from the substrate. 4a is a configuration diagram, FIG. 4b is a cross-sectional view along AA ′ in FIG. 4a, FIG. 4c is a front view, and FIG. 4d is a rear view. In FIG. 4a, three electrode (formation) substrates are arranged at intervals on the substrate to form a triangular prism shape. The tip of each electrode substrate is square and has a double-edged blade 7. In such a form, blood obtained by puncturing with a triangular prism-shaped puncturing blade is quickly sent to the electrode reaction unit 5, so that it mixes with and reacts with the reagent arranged there. The result is measured electrochemically.

  FIG. 5 shows a biosensor integrated with a puncture device in which two curved electrode (formation) substrates are vertically arranged with a distance from the substrate. 5a is a structural view, FIG. 5b is a longitudinal sectional view of the center line in FIG. 5a, FIG. 5c is a front view, and FIG. 5d is a rear view. In FIG. 5a, two electrode (formation) substrates are arranged on the substrate at an interval to form a hollow cylindrical shape. The tip of each electrode substrate is a double-edged puncture blade 7. In such a form, blood obtained by puncturing with a cylindrical puncture blade is quickly sent to the electrode reaction unit 5, so that it mixes with and reacts with the reagent arranged there. The result is measured electrochemically.

  FIG. 6 shows an example of use of the cylindrical puncture device integrated biosensor shown in FIG. 6a shows a state before use, FIG. 6b shows a state in which the tip of the cylindrical puncture device integrated biosensor 13 is punctured into the skin 14 of the subject, FIG. 6c shows that the subject 14 bleeds after puncturing, FIG. 6d shows a state in which blood collection 26 is transferred from the puncture blood collection port of puncture device-integrated biosensor 13 to the electrode reaction part by capillary action, and the measurement state is shown. It shows how it is in. Further, as shown in these drawings, the electrode area is defined by a resist inside the cylindrical electrode.

  FIG. 7 shows that the tip of the cylindrical puncture device integrated biosensor shown in FIG. 5 is covered with a diaphragm, and an electrically insulating member is used to maintain airtightness between curved electrode (formation) substrates. A vacuum blood collection type puncture device integrated biosensor constructed as shown in FIG. 7a is a block diagram, FIG. 7b is a longitudinal sectional view of the center line in FIG. 7a, FIG. 7c is a sectional view along BB ', FIG. 7d is a front view, and FIG. In FIG. 7a, two electrode (formation) substrates 1 and 1 are arranged on the substrate with a space between them and filled with an electrical insulating member 12, thereby forming a columnar shape without a gap. ing. And the diaphragm 11 is provided so that the front-end | tip of a cylinder may be plugged up, and the atmosphere of an electrode reaction part is maintaining the vacuum state.

  FIG. 8 shows an example of use of the vacuum blood collection type puncture device integrated biosensor shown in FIG. 8a shows a state before use, and FIG. 8b shows a state in which the tip of the cylindrical puncture device integrated biosensor 13 is punctured into the skin 14 of the subject, and the vacuum atmosphere extends to the skin 14 as the puncture portion. FIG. 8c shows a state in which the subject 14 bleeds after the puncture, and the blood collection 26 is transferred from the puncture blood collection port of the puncture device-integrated biosensor 13 to the electrode reaction part and enters the measurement state. Further, as shown in these drawings, the electrode area is defined by a resist inside the cylindrical electrode. With such a configuration, the time required for blood collection can be shortened, so the burden on the user can be reduced.

It is a figure which shows one structural example of the biopsy sensor integrated with a facing puncture device based on this invention. It is a figure which shows the other structural example of the biopsy sensor integrated with a facing puncture device based on this invention. It is a figure which shows the other structural example of the biopsy sensor integrated with a facing puncture device based on this invention. It is a figure which shows one structural example of the prism-shaped puncture device integrated biosensor which concerns on this invention. It is a figure which shows the example of 1 structure of the cylindrical puncture device integrated biosensor which concerns on this invention. It is a figure which shows the usage example of the cylindrical puncture device integrated biosensor which concerns on this invention. It is a figure which shows one structural example of the vacuum blood collection type puncture device integrated biosensor which concerns on this invention. It is a figure which shows one usage example of the vacuum blood collection type puncture device integrated biosensor which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Electrode (formation) board | substrate 2 Resist 3 Reagent layer 4 Board | substrate 5 Electrode reaction layer 6 Terminal 7 Puncture part 8 Puncture blood collection port 9 Stopper 10 Capillary phenomenon stop part 11 Diaphragm 12 Electrical insulation member 13 Puncture instrument integrated biosensor 14 Subject 26 Blood collection

Claims (18)

  Blood sampling of at least one electrode or a substrate for forming the same in a biosensor in which a facing structure or a hollow columnar structure is formed by penetrating or embedding at least two electrodes or the substrate for forming the substrate perpendicularly to the substrate A biosensor with an integrated puncture device, wherein a tip portion located in the mouth has a single-edged, double-edged, or needle-like structure capable of puncturing a subject.   The puncture device integrated biosensor according to claim 1, wherein a terminal for sending an electric signal to the measuring device is provided on the opposite side of the substrate from the electrode.   The puncture device integrated biosensor according to claim 1, wherein a terminal for sending an electric signal to the measuring device is formed on a side surface of the substrate in which the electrode is embedded.   The puncture device-integrated biosensor according to claim 1, wherein the electrode is formed by forming a film on the electrode forming substrate or by bonding the electrode forming substrate and the electrode member.   The puncture device integrated biosensor according to claim 1, wherein an electrode area is defined by a resist.   The biosensor with integrated puncture device according to claim 1, wherein a reagent layer is formed on the electrode.   The puncture device integrated biosensor according to claim 1, wherein a puncture device provided with a photocatalytic function is used.   The biosensor with integrated puncture device according to claim 1, further comprising a body fluid collection stop portion due to a capillary phenomenon.   The biosensor according to claim 1, wherein the substrate is transparent.   The biosensor according to any one of claims 1 to 9, which is a cartridge type. The cartridge-type puncture device integrated biosensor according to claim 10, which is a disposable type . The cartridge type puncture device integrated biosensor according to claim 10, wherein the biosensor is in a packaged state . The cartridge-type puncture device integrated biosensor according to claim 12, wherein the biosensor is packaged in a repackable state . A puncture device-integrated biosensor package containing a plurality of cartridge-type puncture device-integrated biosensors according to any one of claims 10 to 13. Cartridge puncture device one integrated biosensor and, integrated biosensor introduction part puncture device set by inserting the puncture device integrated-type biosensor according to any one of claims 10 to 13, the puncture device integrated-type bio Connector part that captures electrical signals at sensor electrodes, measurement part that measures electrical values via the connector part, operation panel part for measurement, display part that displays measurement values in the measurement part, measurement values A measurement device for a biosensor integrated with a puncture device, comprising a memory unit to store, a drive unit for a puncture needle, a drive unit trigger unit, and a puncture start button for starting puncture with a puncture needle.   The measurement device for a biosensor with integrated puncture device according to claim 15, wherein a potential step chronoamperometry method, a coulometry method, or a cyclic voltammetry method is applied as a measurement method in the measurement unit. 17. The measuring device for a puncture device integrated biosensor according to claim 15 or 16, wherein the insertion port of the cartridge type puncture device integrated biosensor can be illuminated.   The puncture according to any one of claims 15 to 17, comprising at least one of a voice guide function and a voice recognition function, a measurement data management function using a built-in radio clock, a communication function of measurement data to a medical institution, and a charging function. Instrument-integrated biosensor measurement device.

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