WO2008100118A1

WO2008100118A1 - Biological information measuring apparatus and manufacturing method thereof

Info

Publication number: WO2008100118A1
Application number: PCT/KR2008/000920
Authority: WO
Inventors: Jung Chul Park; Jun Heong Park
Original assignee: Cha, Cheol Ung
Priority date: 2007-02-16
Filing date: 2008-02-16
Publication date: 2008-08-21
Also published as: KR20080076434A

Abstract

A biological information measuring apparatus for diabetic patients and a manufacturing method thereof are provided. The apparatus includes a fine needle array having strength and ductility increased through coating, an integrated blood sugar measurement strip integrally formed with the fine needle array, and a detection electrode having an increased surface area and installed on the strip to be operated by a small amount of blood. Therefore, it is possible to minimize error in use, and reduce pain and fear experienced during use of the conventional blood sampler.

Description

[DESCRIPTION] [Invention Title] BIOLOGICAL INFORMATION MEASURING APPARATUS AND MANUFACTURING METHOD

THEREOF [Technical Field]

The present invention relates to a biological information measuring means, and more particularly, to a biological information measuring apparatus for diabetic patients and a manufacturing method thereof. [Background Art]

Diabetes is generally classified into type 1 diabetes or type 2 diabetes. The type 1 diabetes, which results from inappropriate synthesis and secretion of insulin in the pancreas, is a serious illness in which blood sugar can be maintained by insulin injections only, and the type 2 diabetes may result from stress or obesity, other than causes due to the pancreas.

Since the type 1 diabetes is a serious disease, if a type 1 diabetic patient does not measure his/her blood sugar level and perform treatment at appropriate time intervals, his/her condition of a disease may take a serious turn. Even in the case of the type 2 diabetes, in which the patient' s condition does not take a sudden turn, it is strongly recommended that he/she frequently measures his/her blood sugar level using a self blood sugar measurement device.

The blood sugar measurement device used in self blood sugar measurement is a device having a portable compact size and operated by a small battery. The portable blood sugar measurement device is a medical instrument absolutely required to the type 1 diabetes patient whose blood sugar level frequently changes between low and high blood sugar levels. The self blood sugar measurement enables inspection and observation of variation in blood sugar level due to an amount of food eaten, a type of food eaten, quantity of motion, stress, and so on, to provide an indicator for blood sugar management. Therefore, regular blood sugar management enables analysis of causes of high and low blood sugar levels and thus facilitates rapid treatment. Therefore, it is possible for the diabetic patient to maintain his/her health and prevent risk of complications of the kidney, the nervous system, and the vascular system related to the diabetes through continuous and systematic blood sugar management using the self blood sugar measurement device.

The conventional measurement method using a blood sugar measurement device is performed by inserting a disposable inspection strip for blood sugar measurement into a measurement meter, and dropping a drop of blood on the inspection strip. The surface of the inspection strip is coated with a chemical substance bonded to glucose in the blood to analyze the amount of the glucose in the blood and convert the amount into a measurable signal.

The blood sugar level analysis through synthesis with the chemical substance may generally use spectroscopy and an electrochemical method. The spectroscopy uses oxidation of sugar by glucose oxidase and peroxidase, and determines the amount of blood sugar using a color difference represented after reaction. The electrochemical method uses a theory of measuring flow of electrons transmitted by continuous oxidation/reduction reaction between glucose oxidase and an electron acceptor to determine concentration of the blood sugar. Recently, since the electrochemical method can reduce an error occurred by other materials in the blood, reduce a blood sugar measurement time, and simplify operation thereof, it has mainly been the preferred choice in treating the diabetes.

All blood-gathering methods using the self blood sugar measurement device are performed similarly, regardless of blood sugar analysis methods. In order to gather the blood used for the self blood sugar measurement device, a blood sampler having needles several millimeters in diameter is used. The blood sampler performs the blood sugar analysis by instantly projecting needles from the blood sampler using a spring and a button to pierce holes in the patient' s skin, and then supplying the blood drawn through the holes into a strip mounted on the blood sugar measurement meter. In this process, the size of the needles used in the blood sampler causes pain and fear to a user such that the patient is subject to trouble due to frequent blood sugar measurement .

The amount of the blood to be transmitted to the strip of the blood sugar measurement device differs depending on functions of various products, and conventionally varies between 0.3 and 4μl . The conventional blood sampler may be a burden to some diabetic patients who must directly gather the blood, but feel uneasy about blood- sampling, thereby making it difficult to collect a sufficient amount of blood for blood sugar measurement. In addition, when the amount of the blood is insufficient or the blood cannot be accurately transmitted to a suction hole of the strip, it is difficult to accurately perform the blood sugar measurement which may require restart of the measurement . In addition, since the shape of the blood sugar suction hole is limited to improve blood analysis functions of the strip, it is difficult for a user to precisely transmit the blood to the blood suction hole of the strip during the process of supplying the blood to the strip. Further, incorrect transmission of the blood or insufficiency of the blood during the above process may frequently cause failure of the inspection and thus require restart of the inspection. Such a re-inspection increases pain of the user and requires additional cost to the user. [Disclosure] [Technical Problem]

In order to solve the foregoing and/or other problems, it is an object of the present invention to provide a biological information measuring apparatus for diabetic patients and a manufacturing method thereof capable of minimizing pain of a user and readily collecting the blood. In addition, it is another object of the present invention to provide a biological information measuring apparatus for diabetic patients and a manufacturing method thereof capable of precisely transmitting the collected blood to induce a reduction in measurement time. Further it is still another object of the present invention to provide a biological information measuring apparatus for diabetic patients and a manufacturing method thereof capable of preventing non- operation or malfunction due to lack of collected blood, and preventing damage to a user' s body generated during the process of collecting the blood, to thereby stably collect the blood. [Technical Solution]

One aspect of the present invention provides a biological information measuring apparatus for diabetic patients including: a nonmetallic needle structure having sharp tips arranged on a substrate; a piercing part vertically formed through a portion of the needle structure to the substrate disposed under the needle structure; an attachment reinforcement layer formed to include the surface of the needle structure; and a blood sampling means formed of a non-oxidation metal layer formed on the entire surface of the attachment reinforcement layer.

Another aspect of the present invention provides a biological information measuring apparatus for diabetic patients including: a substrate having a plurality of connection electrodes; a three- dimensional detection electrode pair disposed adjacent to each other on the substrate and connected to the connection electrodes; an enzyme layer formed on the detection electrode pair; and an integrated inspection strip having a fine needle array structure disposed on the enzyme layer corresponding to a region where the detection electrode pair is formed and having through-holes formed in needles, respectively. Still another aspect of the present invention provides a biological information measuring apparatus for diabetic patients including: an integrated inspection strip including an enzyme layer formed on a three-dimensional detection electrode pair, a fine needle array formed on the enzyme layer, and connection electrodes connected to the detection electrode pair; and a blood sugar meter having a coupling part for enabling detachable coupling and electrical connection of the integrated inspection strip, and starting measurement when the blood is sampled through the connection electrode of the integrated inspection strip, informing of completion of the blood sampling when the blood for inspection is completely sampled, and calculating and displaying a blood sugar level through electrical variation of the inspection strip.

Yet another aspect of the present invention provides a method of manufacturing a biological information measuring apparatus for diabetic patients including: forming a nonmetallic needle array structure including sharp tips arranged on a substrate, and through- holes vertically formed through from the sharp tips to the substrate; sputtering a metal for assisting attachment of a metal to the entire surface of the structure; and forming a film of a metal or an alloy which is harmless to a human body and non-oxidized, on the metal coating layer.

Still yet another aspect of the present invention provides a method of manufacturing a biological information measuring apparatus for diabetic patients including: forming a three-dimensional detection electrode having a predetermined surface area on a substrate; forming a connection electrode on the substrate using a screen printing method in consideration of connection to the detection electrode! forming an insulating layer exposing the detection electrode and distal ends of the connection electrode on the structure; coating a porous metal on the detection electrode; forming an enzyme layer on the detection electrode; and adhering a fine needle array structure on the enzyme 1ayer. [Advantageous Effects]

As can be seen from the foregoing, a blood sampler for a blood sugar measurement device is replaced with a fine needle to minimize pain and fear experienced by a user during use of a conventional blood sampler and integrally form the fine needle with an inspection strip, thereby simplifying structure of products to reduce manufacturing costs.

In addition, the present invention provides a fine needle, which functions as a conventional fine needle for supplying medicines, coated with a metal and having high strength to secure stability and reliability during a sampling process.

Further, an electrode in a strip of the present invention has a three-dimensional structure and is designed with an ultra-small size through porous metal plating to adjust the size of the strip.

Furthermore, the size of the electrode of the present invention can be reduced to remarkably reduce an amount of required blood, thereby lessening pain of a user.

In addition, the electrode of the present invention can be reduced in size to narrow a blood suction path to thereby shorten a blood sugar measurement time, and a gap between the fine needle and the electrode can be minimized to minimize a blood path to thereby reduce an inspection time.

Further, the present invention can make a user feel a blood sampling process in a strip attachment process as no more than a rough feeling during a process of inserting the strip into the blood sugar measurement device, and not feel pain being pierced by a fine needle. [Description of Drawings]

The above and other objects, features and advantages of the present invention will be more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a perspective view of a fine needle array used in a blood sampler of the present invention;

FIG. 2 is a plan view of the fine needle array; FIG.3 is a cross-sectional view of the fine needle array;

FIG. 4 is a cross-sectional view of the fine needle array, in which a metal coating is performed in order to reinforce functions of the fine needle array;

FIG. 5 is a perspective view of an integrated inspection strip; FIG. 6 is an exploded perspective view of the integrated inspection strip;

FIG. 7 is a perspective view of a comb-shaped three-dimensional electrode;

FIG. 8 is a plan view of the comb-shaped three-dimensional electrode;

FIG. 9 is a cross-sectional view of the comb-shaped three- dimensional electrode;

FIG. 10 is a cross-sectional view of an electrode disposed on a conventional strip; FIG. 11 is a cross-sectional view for comparing surface areas;

FIG. 12 is a perspective view of a spiral three-dimensional electrode;

FIG. 13 is a perspective view of a three-dimensional electrode using stamping; FIG. 14 is a perspective view of a three-dimensional electrode and a connection electrode disposed on an insulating substrate; FIGS. 15 to 20 are cross-sectional views showing a method of forming a three-dimensional electrode;

FIG. 21 is a perspective view of an insulating layer applied on a substrate, other than a three-dimensional electrode! FIG. 22 is a perspective view of an insulating layer and an enzyme layer applied on a three-dimensional electrode;

FIG. 23 is a perspective view of a fine needle protection cover installed on an integrated inspection strip;

FIG. 24 is a transparent view for determining a position of a fine needle!

FIG. 25 is a perspective view of a blood sugar meter employing an integrated inspection strip;

FIGS. 26 to 28 are perspective views showing a sequence in which an integrated inspection strip is mounted; FIG. 29 is a perspective view of an example of using an integrated inspection strip with one hand; and

FIG. 30 is a perspective view of an example of using an integrated inspection strip with both hands. description of Major Reference Numerals> 10: fine needle 11: conventional fine needle

12: metal coating 21: insulating layer

22: enzyme layer 31, 32: three-dimensional electrode

33: operation electrode 34: reference electrode

35: auxiliary electrode 41: insulating substrate 42: metal seed layer 43: photosensitive resin layer

50: integrated inspection strip

51: fine needle protection cover

60: blood sugar meter 61: liquid crystal display

62: main operation button 63: auxiliary operation button 70: strip insertion device 71: electrode connection part

72: strip fixing part [Modes of the Invention]

Exemplary embodiments of a fine needle having high strength used as a blood sampler of the present invention will now be described in detail with reference to the accompanying drawings. Recently, a fine needle has been developed as a needle array having needles with a height of hundreds of urn in order to inject medicinal water into a human body without pain to attenuate stimulation of pain spots. To describe briefly, a single large long needle is replaced with a plurality of small short needles to inject the same amount of material and reduce pain to a human body.

However, a fine needle for injecting medicinal water is formed of silicon or polymer and manufactured through a semiconductor manufacturing process. In the case of the silicon fine needle, while the silicon fine needle has strength sufficient to pierce the skin, the silicon fine needle is brittle so that a sharp tip can be broken due to impact, and so on, and thus a portion of the needle can remain in the human body to cause serious problems. In addition, the manufacturing process of the silicon fine needle is very complicated and manufacturing costs thereof are also very high. Further, while the polymer fine needle can be simply manufactured at a low cost in comparison with the silicon fine needle, strength of the polymer fine needle is insufficient to pierce the skin, which may cause buckling of the tip of the needle.

In embodiments of the present invention, in order to use the fine needle for injecting medicinal water as a blood sampler and solve the problems of the conventional fine needle, a fine needle coated with a metal is used.

FIG. 4 shows an improved fine needle array, in which a metal coating is performed. Referring to FIG. 4, a fine needle in accordance with the present invention is subject to a metal coating process of coating a metal 12 on a fine needle 11 manufactured by the conventional method. The metal coating is applied to the silicon fine needle and the polymer fine needle using the same process.

At this time, since crystalline structures and surface characteristics of the metal and the fine needle are different from each other, the metal may be fastened to the fine needle through an attachment reinforcement layer. In addition, the attachment reinforcement layer may be coated with titanium or chrome to a thickness of tens of nm. The metal coating may be performed through sputtering metal coating. The sputtering metal coating is a method of uniformly coating a thin film on the entire surface of a target object including side surfaces, which will be appropriate to the present invention in which side surfaces of the fine needle should be coated. At this time, since titanium used in the sputtering metal coating process can be readily oxidized in air, functions of the attachment reinforcement layer for increasing attachment between two different materials may be lost due to the oxidation. Therefore, a needed metal may be coated in a vacuum state after coating the attachment reinforcement layer through the sputtering metal coating.

The metal coated for increasing strength and ductility of the fine needle must be selected as a metal which is harmless to the human body and is not oxidized even when exposed to the air for a long time. The metal may be nickel or gold. In addition, when an easily oxidized metal is selected to reduce manufacturing costs, a thin metal film formed of gold, aluminum, and so on, stable in the air may be additionally coated to supplement the easily oxidized metal. The coating metal may be a single metal such as nickel, gold, aluminum, and so on, but not limited thereto, may be an alloy, which is anti- oxidative and harmless to the human body.

FIG. 5 is a perspective view of an inspection strip coupled to a fine needle 10, and FIG. 6 is an exploded perspective view of the inspection strip. The inspection strip uses an electrochemical method, and may generally include two parts. One part is a fixed enzyme layer 21 that chemically reacts with blood to generate measurable current, and the other part is electrodes 31 to 35 for transmitting the generated current .

The present invention can minimize a blood transmission path by locating an electrode of a strip integrated with the fine needle just under the fine needle in order to reduce an inspection time of a conventional blood sugar measurement device which consumes a blood sugar inspection time of 5 to 20 seconds. In addition, the size of the used electrode is adjusted to be equal to the fine needle array such that the entire surface of the electrode is in uniform contact with the blood. As a result, it is possible to additionally reduce the inspection time.

In accordance with the present invention, the blood transmitted through the fine needle reacts with glucose oxidase and an electron acceptor to transmit an electron to the surface of the electrode. At this time, in order to increase the current generated by the flow of the electron to an extent that blood sugar can be analyzed, the electrode having a sufficient surface area is needed.

The electrode used in the inspection strip of the present invention has a size reduced to 1/5 to 1/20 of the size of the electrode used in the conventional inspection strip, accordingly the electrode used in the inspection strip of the present invention must have the same surface area as the electrode in the conventional inspection strip in order that the inspection strip of the present invention perform the same performance. To this end, the surface area of the electrode may be increased by replacing the conventional two- dimensional electrode with a three-dimensional comb-shaped electrode. As shown in a perspective view and a plan view of FIGS. 7 and 8, the conventional electrode is replaced with the three-dimensional comb shaped electrode to increase the entire surface area.

Referring to a cross-sectional view of reference line B-B' of

FIG. 9, it will be appreciated that the surface area of the comb- shaped electrodes 31 and 32 in contact with the enzyme layer 21 can be increased in comparison with the conventional single electrode 35 of

FIG. 10.

In FIG. 11, enlargement of the entire surface area of the comb- shaped electrode is quantitatively analyzed. Provided that a width a and a gap b are equal and a height c is twice of the width a, it will be appreciated that the surface area corresponding to d can be increased to 2.5 times in the comb-shaped electrode.

In addition, in order to secondarily enlarge the surface area after manufacturing the comb-shaped electrode, platinum black may be electroplated. The platinum black is porous metal coating, and thus, the surface area can be increased to 2 to 10 times by adjusting various parameters during the electroplating. As described above, the surface area can be maximally increased 25 times through the three- dimensional shape variation and the porous metal plating. In other words, a flat area region required for making the electrode can be reduced to 1/25. Therefore, it is possible to reduce manufacturing costs of the biological information measuring apparatus.

While the present invention describes the three-dimensional comb-shaped electrode, not being limited thereto, the surface region can be increased through various three-dimensional shapes such as a spiral shape of FIG. 12. In addition, as shown in FIG. 13, after making a simple electrode through screen printing, a three-dimensional electrode can be manufactured by a stamping method using a rubber mold having a comb shape. While moving paths of electrons generated from the enzyme layer through the stamping method are increased, a semiconductor manufacturing process can be omitted to reduce manufacturing costs. After making the three-dimensional electrode, the platinum black is used for the porous metal plating, but other metals may also be used for the porous electroplating.

The method of manufacturing a comb-shaped electrode uses a UV etching process used for manufacturing a semiconductor. Since other processes are used for manufacturing large parts, where there is no need for using the semiconductor manufacturing processes, the screen printing method is used to reduce manufacturing costs.

FIG. 14 shows a completed comb-shaped electrode disposed on an insulating substrate.

FIGS. 15 to 20 are cross-sectional views showing a method of manufacturing an electrode, taken along the reference line C-C .

First, as shown in FIG. 15, a metal seed layer 42 is formed on an insulating substrate 41 by a sputtering method. The seed layer is used as a bottom electrode for generating an electrode through electroplating in a comb-shaped mold formed after an etching process. As a second step (see FIG. 16), a photosensitive resin layer 43 is applied on the metal seed layer 42, and then the photosensitive resin layer is selectively exposed and developed to expose the metal seed layer 42, in which an electrode pattern is to be formed, thereby forming a pattern 43 of the photosensitive resin layer as shown in FIG. 17. After removing the photosensitive resin layer of a region in which a metal electrode layer is to be formed, as shown in FIG. 18 to perform a fourth step, metal electrode layers 31 and 32 are formed on the exposed region of the metal seed layer 42 to have a predetermined thickness using the electroplating method. A fifth step (see FIG. 19) is performed to remove the photosensitive resin layer and the metal seed layer using acetone and etching solution, respectively. A sixth step (see FIG. 20) is performed to form an operation electrode 33, a reference electrode 34, and an auxiliary electrode 35 to a size of several mm using screen printing. The comb-shaped electrode in um size and the connection electrode in mm size are separately manufactured to make it possible to reduce manufacturing costs and time. A seventh step is, as shown in FIG. 21, performed to attach an insulating layer 22 on the generated electrode using adhesive. In an eighth step, platinum black is electroplated to increase surface areas of the operation electrode 31 and the reference electrode 32. Since the photosensitive layer of the electrode is removed, it is possible to electroplate the entire surface including side surfaces. In addition, since the electrode of the connection part is insulated by attaching the insulating layer 22, it. is possible to prevent the platinum black from being plated on unnecessary parts. The electrode part, which is not applied with the insulating layer 22, is dipped into an electroplating solution, and current is supplied to only the connection electrodes 33 and 35 connected to the operation electrode 31 and the reference electrode 32 to selectively perform the electroplating. In a ninth step, as shown in FIG. 22, a reagent, in which glucose oxidase and an electron acceptor are mixed, is applied on a region emptied during attachment of the insulting layer 22 by screen printing, and then dried. After applying the adhesive in the ninth step, except in a region in which enzyme is applied, a fine needle array 10 is attached. As a result, an integrated strip in which the fine needle 10 is integrally formed with the inspection strip as shown in FIG. 5 is completed. In a tenth step, finally, a plastic protection cover 51 is added to protect the fine needle 10. FIG. 23 is a perspective view of the completed strip, and FIG. 24 is a transmission view for determining a position of a fine needle. The protection cover 51 can be slightly pushed in a sliding manner before a user uses the integrated inspection strip, and then recapped after the measurement to enable safety separation and disposal of the used strip from the blood sugar meter.

FIG. 25 is a perspective view of a blood sugar meter employing an integrated inspection strip, which externally includes three parts. A liquid crystal display 61 is a display device for displaying various information to a user, for example, a resultant value after blood sugar inspection, and so on. A main operation button 62 and an auxiliary operation button 63 are switches for adjusting the blood sugar meter. A strip insertion device 70 is installed at a front surface of the blood sugar meter such that the blood sugar meter functions as a support frame when a user pushes a fine needle for sampling the blood. FIGS. 26 to 28 are perspective views showing a sequence in which an integrated inspection strip is mounted. First, as shown in FIG. 26, an end of the inspection strip having three electrodes is inserted into an electrode connection part 71 of the strip insertion device 70. Then, as shown in FIG. 27, an opposite end of the strip is closely inserted into a strip fixing part 72. The fine needle protection cover 51 of the strip is pushed up as shown in FIG. 28 to complete preparation for blood sugar measurement. When a user pushes the fine needle to a part of his/her body to be measured for blood sampling, the blood is instantly transmitted to the electrode while the fine needle is pushed. Therefore, since the user can see the beginning of the blood sampling through electrical variation of the connection electrode of the strip, the blood sugar measurement can be started without separate operation. In addition, by generating a predetermined signal including a sound signal when a needed amount of blood is adsorbed, it is possible to inform the user of the blood sampling completion. As a result, it is possible to prevent user' s mistakes, which may be caused due to direct treatment of the blood during use of the conventional blood sugar measurement device.

In addition, the biological information measurement device can provide a simple measurement method.

Referring to FIG. 29, when a user' s finger is measured, measurement is started just after a user grips the blood sugar measurement device with his/her thumb and forefinger. In addition, referring to FIG. 30, when a user wants to measure another part of his/her body, the user can hold the blood sugar meter with one hand and push the fine needle to a desired part. A theory of transmitting the blood to the blood sugar measurement device through the fine needle uses a capillary tube phenomenon and a pressure difference caused by user' s push power to rapidly detect the blood, thereby reducing an inspection time.

Claims

[CLAIMS] [Claim 1]

A biological information measuring apparatus, comprising: a nonmetallic needle structure having sharp tips arranged on a substrate; a piercing part vertically formed through a portion of the needle structure to the substrate disposed under the needle structure; an attachment reinforcement layer formed to include the surface of the needle structure; and a blood sampling means formed of a non-oxidation metal layer formed on the entire surface of the attachment reinforcement layer.

[Claim 2]

The biological information measuring apparatus according to claim 1, wherein the needle structure has a height of hundreds of urn.

[Claim 3]

The biological information measuring apparatus according to claim 1, wherein the needle structure is formed of a material including silicon or polymer.

[Claim 4]

The biological information measuring apparatus according to claim 1, wherein the attachment reinforcement layer is formed of titanium or chrome to have a thickness of tens of nm.

[Claim 5]

The biological information measuring apparatus according to claim 1, wherein the attachment reinforcement layer is formed by sputtering metal coating.

[Claim 6]

The biological information measuring apparatus according to claim 1, wherein the non-oxidation metal layer is formed of a single metal or an alloy metal selected from metals which are harmless to a human body, including nickel, gold, and aluminum.

[Claim 7]

The biological information measuring apparatus according to claim 1, wherein the non-oxidation metal layer is formed of a plurality of arbitrary metal layers, and at least a surface layer is a non-oxidation metal layer which is harmless to a human body.

[Claim 8]

A biological information measuring apparatus, comprising: a substrate having a plurality of connection electrodes; a three-dimensional detection electrode pair disposed adjacent to each other on the substrate and connected to the connection electrodes respectively; an enzyme layer formed on the detection electrode pair! and an integrated inspection strip having a fine needle array structure disposed on the enzyme layer corresponding to a region where the detection electrode pair is formed and having through-holes formed in needles, respectively.

[Claim 9]

The biological information measuring apparatus according to claim 8, wherein the three-dimensional detection electrode pair has a surface area at least two times of a two-dimensional flat structure electrode.

[Claim 10] The biological information measuring apparatus according to claim 8, wherein the opposite electrode structure of the three- dimensional structure detection electrode pair is at least one of an engaged prominence and depression shape, a closely disposed spiral shape, and an opposite electrode shape, a portion of which is removed in a fine pattern.

[Claim 11]

The biological information measuring apparatus according to claim 8, further comprising a porous metal layer formed between the three-dimensional detection electrode pair and the enzyme layer.

[Claim 12]

The biological information measuring apparatus according to claim 8, further comprising a platinum black plating layer on a surface of the three-dimensional detection electrode pair.

[Claim 13]

The biological information measuring apparatus according to claim 12, wherein the platinum black plating layer increases a surface area of the three-dimensional detection electrode pair to 2 to 10 times.

[Claim 14]

The biological information measuring apparatus according to claim 13, wherein the detection electrode pair including the platinum black plating layer has a surface area 4 to 25 times larger than that of a two dimensional detection electrode.

[Claim 15] The biological information measuring apparatus according to claim 8, wherein the fine needle array structure includes a needle structure formed of a non-metal material, and a metal coating layer formed on a surface of the structure.

[Claim 16] The biological information measuring apparatus according to claim 15, wherein the metal coating layer includes an attachment reinforcement layer for coupling the needle structure formed of a non- metal material to a metal material, and a non-oxidation metal layer which is harmless to a human body, formed on the attachment reinforcement layer.

[Claim 17]

The biological information measuring apparatus according to claim 8, further comprising a protection cover disposed on the substrate to selectively expose the fine needle array structure.

[Claim 18]

The biological information measuring apparatus according to claim 17, wherein the protection cover is fastened to a side surface of the substrate to be movable along the substrate in a sliding manner.

[Claim 19]

A biological information measuring apparatus, comprising: an integrated inspection strip including an enzyme layer formed on a three-dimensional detection electrode pair, a fine needle array formed on the enzyme layer, and connection electrodes connected to the detection electrode pair; and a blood sugar meter having a coupling part for enabling detachable coupling and electrical connection of the integrated inspection strip, and starting measurement when the blood is sampled through the connection electrode of the integrated inspection strip, informing of completion of the blood sampling when the blood for inspection is completely sampled, and calculating and displaying a blood sugar level through electrical variation of the inspection strip.

[Claim 20]

The biological information measuring apparatus according to claim 19, wherein the fine needle array of the integrated inspection strip has a metal coating layer formed on a surface thereof to increase strength and ductility.

[Claim 21]

The biological information measuring apparatus according to claim 19, wherein the integrated inspection strip further includes a protection cover for selectively exposing the fine needle array.

[Claim 22]

A method of manufacturing a biological information measuring apparatus, comprising: forming a nonmetallic needle array structure including sharp tips arranged on a substrate, and through-holes vertically formed through from the sharp tips to the substrate; sputtering a metal for assisting attachment of a metal to the entire surface of the structure; and forming a film of a metal or an alloy which is harmless to a human body and non-oxidized, on the metal coating layer.

[Claim 23]

The method according to claim 22, wherein forming the nonmetallic needle array structure includes forming the structure using a silicon or polymer material.

[Claim 24]

The method according to claim 22, wherein sputtering the metal for assisting attachment of the metal includes coating titanium to a thickness of tens of nm in a vacuum state.

[Claim 25]

The method according to claim 22, wherein forming the film of a metal or an alloy which is harmless to a human body and non-oxidized, on the metal coating layer includes at least one metal layer forming step of finally coating any one of a metal or an alloy including nickel, gold, and aluminum.

[Claim 26]

A method of manufacturing a biological information measuring apparatus, comprising: forming a three-dimensional detection electrode having a predetermined surface area on a substrate; forming a connection electrode on the substrate using a screen printing method in consideration of connection to the detection electrode; forming an insulating layer exposing the detection electrode and distal ends of the connection electrode on the structure; coating a porous metal on the detection electrode; forming an enzyme layer on the detection electrode; and adhering a fine needle array structure on the enzyme layer.

[Claim 27]

The method according to claim 26, wherein forming the three- dimensional detection electrode includes: forming a detection electrode seed layer on the substrate; forming a photosensitive resin layer pattern on the detection electrode seed layer, and electroplating the exposed detection electrode seed layer to a desired thickness; and etching unnecessary parts of the photosensitive resin layer pattern and the detection electrode seed layer to remove the parts.

[Claim 28]

The method according to claim 26, wherein forming the three- dimensional detection electrode includes: screen printing a conductive material on the substrate to form a detection electrode pattern! and applying a mold having a fine structure on the detection electrode pattern, and forming a metal material thereon to form the three-dimensional detection electrode having a desired thickness.

[Claim 29]

The method according to claim 26, wherein forming the insulating layer on the structure includes adhering an insulating material formed along the structure onto the substrate structure using adhesive.

[Claim 30]

The method according to claim 26, wherein coating the porous metal on the detection electrode includes electroplating platinum black on the detection electrode part exposed at the substrate structure protected by the insulating layer.

[Claim 31]

The method according to claim 26, wherein forming the enzyme structure on the detection electrode includes applying a reagent including glucose oxidase and an electron acceptor on a region of the detection electrode exposed by the insulating layer and drying the reagent .

[Claim 32]

The method according to claim 26, wherein forming the three- dimensional detection electrode includes forming the three-dimensional detection electrode as an electrode pair structure having at least one of an engaged prominence and depression shape, a closely disposed spiral shape, and an opposite electrode shape, a portion of which is removed.

[Claim 33] The method according to claim 32, wherein an electrode pattern width and an electrode spacing of the adjacent electrode patterns of the electrode pair are several to hundreds of urn

[Claim 34] The method according to claim 26, wherein adhering the fine needle array structure on the enzyme layer further includes separately preparing a fine needle array structure manufactured by: forming a nonmetallic needle array structure including sharp tips arranged on a second substrate, and through-holes vertically formed through from the sharp tips to the second substrate; sputtering a metal for assisting attachment of a metal to the entire surface of the structure; and forming a film of a metal or an alloy which is harmless to a human body and non-oxidized, on the metal coating layer.