Patent Application
20100331730
The present invention relates to a circuit board for body fluid collection, a method for producing the circuit board for body fluid collection, a method for using the circuit board for body fluid collection, and a biosensor including the circuit board for body fluid collection.
Diabetes mellitus includes insulin-dependent (type I) diabetes and non-insulin-dependent (type II) diabetes. The former type of diabetes necessitates regular administration of insulin. Therefore, for a patient with the former type of diabetes, there has been employed a treatment method in which a patient collects his or her blood, measures his or her blood sugar level, and administers to himself or herself insulin at a dosage in accordance with the blood sugar level.
There has been known, for mainly such patients, a blood-sugar-level measuring device which allows a patient to personally collect blood on his/her own and to measure a blood sugar level.
For example, there has been proposed a fluid collecting device including a reaction zone which is provided at the center of a main body and into which electrodes are inserted; a puncture needle outwardly protruding from the center of the main body; and a capillary channel providing communication between the electrodes and the puncture needle (ref: for example, Patent Document 1 shown below).
In the above-described fluid collecting device of Patent Document 1, the puncture needle and the reaction zone are formed integrally with the main body, and therefore the measurement preparation is easy. However, with this fluid collecting device, the electrode which is a member separate from the reaction zone has to be inserted into the reaction zone to perform a measurement on the blood component. Therefore, there is a disadvantage in that blood detection accuracy becomes unstable and accurate measurement cannot be performed.
Moreover, in type I diabetes, depending on symptoms, the patient has to measure the blood-sugar level several times per day, to be specific, before every meal or after every meal.
However, with the above-described fluid collecting device of Patent Document 1, only one puncture needle is provided in one device, and therefore in order to avoid repetitive use of the puncture needle, the measurement can be performed only once.
Therefore, when the measurement is performed several times as described above with the above-described fluid collecting device, it is necessary that the used fluid collecting device is disposed and a new fluid collecting device is prepared afterwards. Thus, with such a fluid i collecting device, the measurement preparation as described above is complicated, and an increase in running costs is inevitable.
An object of the present invention is to provide a circuit board for body fluid collection that allows accurate measurement on a body fluid component with a simple structure, and even allows easy measurement a plurality of times with one circuit board for body fluid collection; a method for producing the same; a method for using the same; and a biosensor including the circuit board for body fluid collection.
To achieve the above-described object, a circuit board for body fluid collection of the present invention includes a plurality of measurement units including a puncture needle and an electrode for making contact with a body fluid collected by puncturing with the puncture needle, the plurality of measurement units being arranged in parallel in a predetermined direction; and a support portion extending along the parallel arrangement direction and supporting the plurality of measurement units, wherein the support portion can be rolled so that the plurality of measurement units are arranged radially.
The circuit board for body fluid collection includes the measurement unit including the puncture needle and the electrode. Thus, by causing a body fluid to flow out by puncturing with the puncture needle, the body fluid that was caused to flow out is easily brought into contact with the electrode in the measurement unit. As a result, with the circuit board for body fluid collection, a measurement on a component in body fluid can be performed easily with a simple structure.
Furthermore, with the circuit board for body fluid collection, by using the plurality of measurement units provided in one circuit board for body fluid collection, a measurement on a component in the body fluid can be performed a plurality of times.
Moreover, with the circuit board for body fluid collection, by rolling the support portion and thereby arranging the plurality of measurement units radially, after one measurement unit is used, the used measurement unit can be changed to an unused measurement unit that is at an upstream side of and adjacent to the used measurement unit in the rotational direction, by rotating the circuit board for body fluid collection in a circumferential direction. Therefore, at every measurement in a plurality of measurements, the measurement unit can be changed easily.
It is preferable that, in the circuit board for body fluid collection of the present invention, the plurality of measurement units extend outwardly with respect to the support portion when the plurality of measurement units are arranged radially.
With the circuit board for body fluid collection, the plurality of measurement units allow reliable puncturing and measurement at an outside of the support portion that was rolled.
It is preferable that, in the circuit board for body fluid collection of the present invention, the plurality of measurement units extend inwardly with respect to the support portion when the plurality of measurement units are arranged radially.
With the circuit board for body fluid collection, the plurality of measurement units allow reliable puncturing and measurement at an inside of the support portion that was rolled.
It is preferable that the circuit board for body fluid collection of the present invention further includes a reinforcing portion that is disposed in a spaced apart relationship to the support portion, and connects, between the plurality of measurement units, the plurality of measurement units that are adjacent to each other.
With the circuit board for body fluid collection, even though the plurality of measurement units are arranged radially, because the plurality of measurement units are connected with the reinforcing portion, the plurality of measurement units can be reliably supported. Therefore, reliable puncturing and measurement by the measurement unit can be achieved.
It is preferable that the circuit board for body fluid collection of the present invention further includes engage portions at one end portion and at the other end portion of the support portion in the parallel arrangement direction for retaining the rolling of the support portion.
With the circuit board for body fluid collection, when the support portion is rolled, the rolling of the support portion is retained by engaging the engage portion at the one end portion of the support portion with the engage portion at the other end portion of the support portion in the parallel arrangement direction. Thus, the plurality of measurement units can be reliably arranged radially.
A circuit board for body fluid collection includes: a plurality of measurement units including a puncture needle and an electrode for making contact with a body fluid collected by puncturing with the puncture needle, the plurality of measurement units being arranged in parallel in a predetermined direction; and a support portion extending along the parallel arrangement direction and supporting the plurality of measurement units, wherein the plurality of measurement units are arranged radially by bending a boundary between the plurality of measurement units and the support portion, and rolling the support portion.
The circuit board for body fluid collection includes the measurement unit including the puncture needle and the electrode. Thus, by causing a body fluid to flow out by puncturing with the puncture needle, the body fluid that was caused to flow out is easily brought into contact with the electrode in the measurement unit. As a result, with the circuit board for body fluid collection, a measurement on a component in body fluid can be performed easily with a simple structure.
Furthermore, with the circuit board for body fluid collection, by using the plurality of measurement units provided in one circuit board for body fluid collection, a measurement on a component in the body fluid can be performed a plurality of times.
Moreover, with the circuit board for body fluid collection, by rolling the support portion and thereby arranging the plurality of measurement units radially, after one measurement unit is used, the used measurement unit can be changed to an unused measurement unit that is at an upstream side of and adjacent to the used measurement unit in the rotational direction, by rotating the circuit board for body fluid collection in a circumferential direction. Therefore, at every measurement in a plurality of measurements, the measurement unit can be changed easily.
It is preferable that, in the circuit board for body fluid collection of the present invention, the plurality of measurement units extend outwardly with respect to the support portion.
With the circuit board for body fluid collection, the plurality of measurement units allow reliable puncturing and measurement at an outside of the support portion that was rolled.
It is preferable that, in the circuit board for body fluid collection of the present invention, the plurality of measurement units extend inwardly with respect to the support portion.
With the circuit board for body fluid collection, the plurality of measurement units allow reliable puncturing and measurement at an inside of the support portion that was rolled.
Furthermore, a biosensor of the present invention includes the above-described circuit board for body fluid collection, and a determination unit that is electrically connected to the electrodes and performs a measurement on a component of the body fluid.
With the biosensor, a measurement on a component in body fluid can be easily performed in such a way that the body fluid that was caused to flow out by the above-described circuit board for body fluid collection is brought into contact with the electrode, and then a measurement is performed with the determination unit that is electrically connected to the electrode.
Furthermore, a method for producing a circuit board for body fluid collection of the present invention includes the steps of: preparing a metal substrate; forming an insulating layer on the metal substrate; forming an electrode for making contact with a body fluid on the insulating layer; and forming, by trimming the metal substrate, a plurality of measurement units including a puncture needle for collecting a body fluid by puncturing and the electrode, the plurality of measurement units being arranged in parallel in a predetermined direction, and a support portion extending along the parallel arrangement direction and supporting the plurality of measurement units, wherein in the step of forming the plurality of measurement units and the support portion, the metal substrate is trimmed so that by rolling the support portion, the plurality of measurement units can be arranged radially.
With the method for producing a circuit board for body fluid collection, by rolling the support portion, the plurality of measurement units can be arranged radially. Thus, by arranging the circuit board for body fluid collection in such a manner, after one measurement unit is used, the used measurement unit can be changed to an unused measurement unit that is at an upstream side of and an adjacent to the used measurement unit in the rotational direction, by rotating the circuit board for body fluid collection in a circumferential direction. Therefore, at every measurement in a plurality of measurements, the measurement unit can be changed easily.
Moreover, with the method for producing a circuit board for body fluid collection, by trimming the metal substrate, the plurality of measurement units and the support portion are arranged in parallel in a predetermined direction. Therefore, yields of the circuit board for body fluid collection can be improved, and an improvement in production efficiency allows reduction in costs.
Furthermore, a method for using a circuit board for body fluid collection of the present invention, in which the above-described circuit board for body fluid collection produced by the method for producing a circuit board for body fluid collection is used, includes the steps of: bending a boundary between the plurality of measurement units and the support portion, and rolling the support portion, thereby arranging the plurality of measurement units radially.
With the method for using a circuit board for body fluid collection, by bending a boundary between the plurality of measurement units and the support portion, and rolling the support portion that was bent, the plurality of measurement units can be arranged radially. Therefore, the plurality of measurement units can be arranged radially by easy procedures.
With the circuit board for body fluid collection according to the present invention, a measurement on a component in body fluid can be performed a plurality of times with the measurement unit that is provided in a plural number in one circuit board for body fluid collection while an easy measurement on a component in body fluid is achieved with a simple structure. Furthermore, at every measurement in a plurality of measurements, the measurement unit can be easily changed.
Furthermore, with the biosensor according to the present invention, a measurement on a component in body fluid can be easily performed.
Furthermore, with the method for producing the circuit board for body fluid collection according to the present invention, the measurement unit can be changed easily at every measurement in a plurality of measurements, while costs are reduced by improving yields of the circuit board for body fluid collection.
Furthermore, with the method for using the circuit board for body fluid collection, a plurality of measurement units can be arranged radially by easy procedures.
A circuit board for blood collection 1 shown in
A plurality of the circuit boards for blood collection 1 are arranged, for example, in parallel in a frame portion 36 of an elongated sheet extending in the longitudinal direction (up and down directions in
The joint portions 37 are extended from widthwise both end portions of the frame portion 36 to widthwise both end portions of the circuit board for blood collection 1 so as to be removable therefrom.
The circuit board for blood collection 1 integrally includes a support portion 5 extending along the width direction, and a plurality (32 units) of measurement units 2 that are supported by the support portion 5 and extending along the longitudinal direction.
The support portion 5 is formed into a generally belt shape extending in the width direction when viewed from top, and has a gear 18, and a slit portion 16 as an engage portion formed therein.
The gear 18 is formed at a substantially entire face of the other end face in the longitudinal direction (end face at the upstream side in the puncture direction) of the support portion 5 (except for widthwise both end portions) so that the gear 18 can be engaged with a gear plate 24 (
The slit portions 16 are provided at widthwise both end portions of the support portion 5. To be specific, the slit portion 16 at a widthwise one end portion (in
The measurement unit 2 is disposed, as shown in
As shown in
The downstream side end face in the puncture direction of the upstream-side portion 3 is formed, as shown in
The downstream-side portion 4 is disposed, as shown in
The measurement unit 2 includes one puncture needle 6 and a conductive pattern 7.
The puncture needle 6 is provided to collect blood by puncturing. That is, the puncture needle 6 is disposed, in the downstream-side portion 4, adjacent to the electrode portion 28 at a downstream side in the puncture direction, and formed integrally with the electrode portion 28. To be specific, the puncture needle 6 protrudes from a center in the width direction of the downstream side end portion in the puncture direction of the electrode portion 28 toward the downstream side in the puncture direction. The puncture needle 6 is formed into a generally triangle shape (isosceles triangle) with its distal end 29 (downstream side end portion in the puncture direction) tapered along the puncture direction to form an acute angle when viewed from top.
Angle θ1 (ref:
The conductive pattern 7 includes three electrodes 8, three terminals 9, and three wirings 10.
The three electrodes 8 are provided to be brought into contact with blood that is collected by the puncturing with the puncture needle 6, and are disposed adjacently in the width direction and in the puncture direction in the electrode portion 28.
To be more specific, two electrodes 8a among the three electrodes 8 are disposed to face each other with a space provided therebetween in the width direction in the electrode portion 28. The two electrodes 8a are formed into a generally circular shape when viewed from top.
The remaining one electrode 8b is disposed in the electrode portion 28 at a downstream side in the puncture direction to face the two electrodes 8b with a space provided therebetween. The electrode 8b is formed into a generally rectangular shape, and extends over the two electrodes 8b in the width direction when viewed from top.
The three electrodes 8 correspond to a working electrode, a counter electrode, and a reference electrode, respectively. The diameter of the two electrodes 8a is, for example, 100 μm to 5 mm, and the length of a side of the one electrode 8b is, for example, 100 μm to 2.5 mm. The three electrodes 8 are disposed, for example, within 0.2 to 5 mm, or preferably 0.5 to 3 mm of the distal end 29 of the puncture needle 6 in the puncture direction. When the space between the distal end 29 of the puncture needle 6 and the electrodes 8 is too short, the electrodes 8 sting the skin along with the puncture needle 6, and a chemical agent 30 (described later) applied to the surface of the electrodes 8 may be dispersed into the body, which may hinder accurate measurements. On the other hand, when the space between the distal end 29 of the puncture needle 6 and the electrodes 8 is too long, a structure for utilizing aspiration or capillarity to introduce blood from the puncture needle 6 to the electrodes 8 becomes necessary.
The three terminals 9 are provided in correspondence with the three electrodes 8, and are disposed at the base portion of the upstream-side portion 3 to be connected to a CPU 25 to be mentioned later.
To be more specific, two terminals 9a correspond to the two electrodes 8a, and are disposed to face each other with a space provided therebetween in the width direction in the base portion of the upstream-side portion 3. The remaining one terminal 9b corresponds to the one electrode 8b, and is disposed at an upstream side in the puncture direction with respect to the two terminals 9a to face thereto with a space provided therebetween.
The three terminals 9 are formed into a generally tapered shape when viewed from top, and the width thereof gradually widens toward a downstream side in the puncture direction. To be specific, the widthwise internal end edges of the two terminals 9a facing each other are arranged in parallel along the puncture direction. The widthwise external end edge of the two terminals 9a, and widthwise both end edges of the remaining one terminal 9b are formed along directions that cross the puncture direction.
The length of a side of the three terminals 9 is, for example, 0.5 to 5 mm.
The three wirings 10 are provided so as to run through the upstream-side portion 3 and the downstream-side portion 4, and are arranged in parallel with a space provided therebetween in the width direction. The three wirings 10 are provided along the puncture direction so as to electrically connect respective electrodes 8 and the terminals 9 corresponding to the electrodes 8. The respective electrodes 8, respective terminals 9, and the wirings 10 that allow connection between them are provided continuously and integrally. The length of the wirings 10 in the width direction is, for example, 0.01 to 2 mm, and the length of the wirings 10 in the puncture direction is, for example, 2 to 28 mm.
The measurement unit 2 has a connector portion 15 as a reinforcing portion, a first bending portion 45, and a stopper portion 31.
The connector portion 15 is disposed at a downstream side in the puncture direction in a spaced apart relationship to the support portion 5, and allows connection between the downstream-side portions 4 of the measurement units 2 that are adjacent to each other. To be specific, the connector portion 15 is extended between the middle portions of the downstream-side portions 4 so as to wind like a generally S-shape when viewed from top. The connector portion 15 is formed, as shown in
The first bending portion 45 is provided, as shown in
The first bending portion 45 is formed at an adjacent portion where the upstream-side portion 3 and the downstream-side portion 4 are adjacent to each other, by a cutting portion 32 that is cut finely toward an inner side in the width direction, as an hourglass portion that is narrow in width.
In this fashion, the first bending portion 45 is formed as a fragile portion between the upstream-side portion 3 and the downstream-side portion 4, and therefore the first bending portion 45 is provided so that the downstream-side portion 4 is bendable with respect to the upstream-side portion 3.
The stopper portion 31 is provided, in the downstream-side portion 4, at a downstream side end portion in the puncture direction of the electrode portion 28, so as to prevent the puncture needle 6 to deeply pierce the skin excessively. To be specific, the stopper portion 31 is formed, in the electrode portion 28, such that the furthest downstream tip in the puncture direction of the generally regular pentagon shape when viewed from top is dented toward an upstream side in the puncture direction. That is, the stopper portion 31 is provided, in the electrode portion 28, so as to protrude from both outer sides in the width directions (both widthwise outer sides and an oblique upstream side in the puncture direction) of the puncture needle 6 interposed therebetween. The end edge of the stopper portion 31 at a downstream side in the puncture direction and the distal end 29 of the puncture needle 6 are spaced apart by, for example, 0.3 to 2 mm.
In the circuit board for blood collection 1, a second bending portion 14 is formed at an adjacent portion (that is, corresponding to a boundary between the support portion 5 and the plurality of measurement units 2) where the support portion 5 and the plurality of measurement units 2 are adjacent to each other. The second bending portion 14 is provided so that the support portion 5 is bendable with respect to the plurality of measurement units 2.
The circuit board for blood collection 1 includes, as shown in
The metal substrate 11 is formed of a metal foil and the like, as shown in
Examples of the metal material that forms the metal substrate 11 include nickel, chromium, iron, and stainless steel (SUS304, SUS430, and SUS316L). In view of rigidity and retaining the bent form to be mentioned later of the support portion 5 at the time of rolling, stainless steel is preferably used. The thickness of the metal substrate 11 is, for example, 10 to 300 μm, or preferably 20 to 100 μm. When the thickness is below 10 μm, the skin puncturing (described later) may not be performed because of insufficient strength. On the other hand, when the thickness exceeds 300 μm, the puncturing may cause pain and damage the skin excessively, or the first bending portion 45 and/or the second bending portion 14 may not be bent smoothly.
From the metal substrate 11, the upstream-side portion 3, the downstream-side portion 4 (electrode portion 28, and puncture needle 6), and the support portion 5 are formed. Because the puncture needle 6 is formed from the metal substrate 11 made of the above-described metal material, reliable puncturing can be achieved. Furthermore, because the gear 18 of the support portion 5 is formed from the metal substrate 11 made of the above-described metal material, reliable rotation of the circuit board for blood collection 1 can be achieved.
The insulating base layer 12 is formed, in the upstream-side portion 3 and in the downstream-side portion 4, on the surface of the metal substrate 11 corresponding to the upstream-side portion 3 and the downstream-side portion 4; in the support portion 5, on the surface of the metal substrate 11, at a downstream portion in the puncture direction of the metal substrate 11 continuously over the width direction thereof; and in the connector portion 15, so as to correspond to the outline shape of the connector portion 15.
Furthermore, the insulating base layer 12 is formed, as shown in
Examples of the insulating material that forms the insulating base layer 12 include synthetic resins such as polyimide resin, polycarbonate resin, polyethylene resin, polyethyleneterephthalate resin, epoxy resin, and fluorocarbon resin. In view of mechanical durability, and chemical resistance, preferably, polyimide resin is used. The thickness of the insulating base layer 12 is, for example, 3 to 50 μm, or preferably 5 to 25 μm. When the thickness is below 3 μm, there may be a case where an insulation defect such as pinholes is caused. On the other hand, when the thickness exceeds 50 μm, cutting and trimming may become difficult.
The conductive pattern 7 is formed, as shown in
Examples of the conductive material that forms the conductive pattern 7 include metal materials such as iron, nickel, chromium, copper, gold, silver, platinum, and alloys thereof. The conductive material is selected appropriately in view of adhesiveness to the insulating base layer 12 and the insulating cover layer 13, and easy workability. Two or more conductive materials may be laminated as well. The thickness of the conductive pattern 7 is, for example, 5 to 50 μm, or preferably 10 to 20 μm.
The insulating cover layer 13 is provided on the surface of the insulating base layer 12 so as to cover the wirings 10. The peripheral end portion of the insulating cover layer 13 is, as shown in
The insulating cover layer 13 is formed, as shown in
Then, as shown in
Then, as described above, the connector portion 15 is formed from the insulating base layer 12 and the insulating cover layer 13. Therefore, because the insulating material (synthetic resin) that forms the insulating base layer 12 and the insulating cover layer 13 is softer than the metal material in the circuit board for blood collection 1 formed, the measurement unit 2 can be flexibly connected. Also, at the time of rolling the circuit board for blood collection 1 to be mentioned later, the measurement unit 2 can be flexibly connected while stretching the winding portion of the connector portion 15.
The first bending portion 45 and the second bending portion 14 are formed from the above-described metal substrate 11, insulating base layer 12, and insulating cover layer 13.
Next, with reference to
In this method, first, as shown in
Next, in this method, as shown in
Afterwards, in this method, as shown in
The conductive pattern 7 can also be formed only of the metal thin film 34 by chemical vapor deposition or sputtering.
Upon formation of the conductive pattern 7, a different type of metal plating layer may also be formed on the surface of the electrodes 8 and the surface of the terminals 9 by further electrolytic plating or electroless plating, although not shown in the drawings. The thickness of the metal plating layer is preferably 0.05 to 10 μm.
Next, in this method, as shown in
Afterwards, as shown in
For the trimming of the metal substrate 11, for example, discharge processing, laser processing, mechanical punching processing (for example, punching processing), or etching processing is used. In view of easy cleaning after processing, etching processing (wet etching) is preferably used.
By such trimming, with the circuit board for blood collection 1, the plurality of measurement units 2 can be arranged radially by rolling the support portion 5.
In this way, the circuit board for blood collection 1 including the plurality of measurement units 2 and the support portion 5 can be produced in a plural number and in an arranged state within the frame portion 36.
In the obtained circuit board for blood collection 1, as shown in
Depending on the type of the chemical agent 30, it is also possible to, after the plating layer of a different metal is formed on the surface of the electrodes 8 as described above, further form a coating of a different metal in advance, and provide a predetermined potential difference therebetween. To be specific, for example, after a gold plating layer is formed, silver or silver chloride is applied on the surface of the gold plating layer.
Furthermore, by cutting the joint portion 37 and separating it from the frame portion 36, the circuit board for blood collection 1 is obtained.
Next, with reference to
To use the circuit board for blood collection 1, first, the joint portion 37 is cut as described above and the circuit board for blood collection 1 is separated from the frame portion 36, thereby preparing one circuit board for blood collection 1 as shown in
Next, in this method, as shown in
The angle (bending angle) θ2 between the plurality of measurement units 2 and the support portion 5 is, for example, 45 to 135°, or preferably 60 to 120°. When the bending angle θ2 is outside the above range, there may be a case where reliable puncturing with the measurement unit 2 that performs the measurement cannot be performed, or puncturing with the measurement unit 2 that performs the measurement is inhibited (interrupted) by neighboring measurement units 2.
Next, in this method, as shown in
To be specific, the support portion 5 is rolled so that the respective measurement units 2 are extended outwardly in the radial direction with respect to the support portion 5. Furthermore, as shown in
In this fashion, the support portion 5 is rolled, and the circuit board for blood collection 1 in which the plurality of measurement units 2 extend outwardly in the radial direction with respect to the support portion 5 can be obtained.
Next, with reference to
in
That is, the blood-sugar-level measuring device 19 includes a casing 41, a blood collection unit 42, a determination unit 43 (omitted in
The casing 41 is prepared to accommodate the members of the blood-sugar-level measuring device 19, and is formed into a box. To be specific, the casing 41 accommodates the blood collection unit 42 and the determination unit 43; and the display unit 44 is provided on the surface of the casing 41. The casing 41 has a front side opening 33, an upper side opening 22, and a bending guide portion 49 formed therewith.
The front side opening 33 is formed in the front wall of the casing 41 so as to extend in the left and right directions to form a generally rectangular shape when viewed from the front, and to expose some (a few units) of the measurement units 2 when the circuit board for blood collection 1 advances forward, as described later.
The upper side opening 22 is formed at a center in the left-right directions of a front side of the upper wall of the casing 41 as a long hole that extends in front and rear directions. To be specific, the upper side opening 22 is formed so that the driving shaft 21, to be described later, is inserted slidably in front and rear directions.
The bending guide portion 49 is provided at a center in the left and right directions of the front wall of the casing 41 and at an upper end edge of the upper side opening 22 of the front wall, and is formed into a generally flat plate. The bending guide portion 49 is provided such that its front end edge is swingable in up and down directions with its back end edge as the supporting point, and is disposed to extend obliquely forward toward a lower side from the front wall of the casing 41 so as to usually block ahead of the upper side opening 22. The bending guide portion 49 closes, when puncturing with the circuit board for blood collection 1, so as to block ahead of the upper side opening 22 (ref:
Furthermore, regarding the bending guide portion 49, when puncturing with the circuit board for blood collection 1, an angle between the direction along the bending guide portion 49 and the front and rear directions when the bending guide portion 49 is viewed from a side is not particularly limited as long as the angle allows a patient easy usage, and is adjusted to an appropriate angle, for example, to be specific, 15 to 60°, or preferably 20 to 45°.
The blood collection unit 42 includes, as shown in
The driving shaft 21 is disposed so that its axis extends toward up and down directions, and its lower end portion is integrally formed with the gear plate 24.
The gear plate 24 is formed into a generally disc shape, and the driving shaft 21 is integrally inserted to the center of the gear plate 24. On the upper face of the gear plate 24, a plurality of driving grooves 40 extending radially from the center is formed. In this fashion, in the gear plate 24, the gear 18 of the support portion 5 engages with the driving grooves 40. That is, the gear plate 24 is engaged in such a manner that the gear plate 24 is removable along up and down directions from, but not rotatable relative to the gear 18, and is provided so as to allow the circuit board for blood collection 1 to rotate in a circumferential direction with the center of the gear plate 24 (axis of the driving shaft 21) as the center.
The guide portion 23 is provided at a peripheral end of the upper side opening 22 of the upper wall of the casing 41. To be specific, the guide portion 23 is provided so as to guide advancing and retreating of the driving shaft 21 in front and rear directions.
The circuit board for blood collection 1 is provided so as to be capable of advancing and retreating in front and rear directions with the driving shaft 21, and rotatable in a circumferential direction with the engagement with the gear plate 24. The circuit board for blood collection 1 is disposed so that the electrodes 8 and the terminals 9 face downward. When the circuit board for blood collection 1 advances, a few measurement unit 2 at the front side expose themselves from the front side opening 33, and among them, the puncture needle 6 of the measurement unit 2 at the foremost side is brought into contact with the bending guide portion 49.
The determination unit 43 is electrically connected to the electrodes 8, and includes a contact portion 26 and a CPU 25.
The contact portion 26 is provided slidably with respect to the terminals 9 so that when the circuit board for blood collection 1 performs a measurement, the contact portion 26 is brought into contact with the terminals 9 (ref:
The CPU 25 is electrically connected to the contact portion 26 via signal wirings 48, and is also connected to the display unit 44. The CPU 25 calculates a glucose level as a blood-sugar level based on changes in the resistance value between the electrodes 8 detected at the contact portion 26 when the circuit board for blood collection 1 performs a measurement.
The display unit 44 is provided at a rear side of the upper wall of the casing 41; includes, for example, LED; and displays the blood-sugar level measured by the CPU 25.
When using the blood-sugar-level measuring device 19, first, as shown in
At this time, in the blood-sugar-level measuring device 19, all of the measurement units 2 in the circuit board for blood collection 1 are accommodated in the casing 41 without being exposed from the front side opening 33.
In this method, next, as shown in
At this time, the circuit board for blood collection 1 is allowed to advance toward a front side to expose a few measurement units 2 out of the measurement units 2 from the front side opening 33, and the foremost measurement unit 2 is brought into contact with the bending guide portion 49, which causes the downstream-side portion 4 to be bent toward an obliquely lower side with respect to the upstream-side portion 3 at the first bending portion 45. Then, the puncture needle 6 of the downstream-side portion 4 that was bent is used to puncture the finger.
Because the bending guide portion 49 is disposed at the above-described predetermined angle when viewed from a side, the bending angle at the first bending portion 45 is, for example, 15 to 60°, or preferably 20 to 45°.
At this time, upon puncturing with the puncture needle 6, when the stopper portion 31 abuts on the skin, further puncturing is restricted. Thus, the puncturing depth of the puncture needle 6 is, for example, 0.5 to 1.5 mm.
Next, in this method, as shown in
At this time, the measurement unit 2 that was bent by the bending guide portion 49 is brought away from the bending guide portion 49, modifying the bending angle. To be specific, the bending angle at the first bending portion 45 is, for example, 15 to 60°, or preferably 15 to 40°.
The bleeding in a trace amount at the punctured portion can be accelerated as necessary by pressing (stressing) in the proximity of the punctured portion.
Next, in this method, as shown in
Then, the surface of the electrodes 8 is brought into contact with the blood collected by the puncturing with the puncture needle 6, and the blood is reacted with the chemical agent 30. At this time, the contact portion 26 is brought into contact with the terminals 9, and at the same time, a voltage is applied to the electrodes 8 from the contact portion 26 via the terminal 9. Then, a change in the resistance value between the electrodes 8 at the time of the voltage application is detected by the contact portion 26, and based on the change in the resistance value detected by the contact portion 26, the CPU 25 calculates a glucose level as a blood-sugar level. Then, the blood-sugar level measured by the CPU 25 is displayed at the display unit 44.
Afterwards, in this method, although not shown, by rotating the driving shaft 21 and the gear plate 24 in a circumferential direction with the center of the gear plate 24 as the center to rotate the circuit board for blood collection 1, an unused measurement unit 2 that is disposed at an upstream side of and adjacent to the used measurement unit 2 in the rotational direction is disposed at the foremost side. Afterwards, the steps shown in the above-described
Then, with the circuit board for blood collection 1, and the blood-sugar-level measuring device 19 including the circuit board for blood collection 1, by causing bleeding by puncturing with the puncture needle 6, and allowing the electrodes 8 of the measurement unit 2 to be brought into contact with the blood that was caused to bleed, a blood-sugar level can be simply measured by the CPU 25 that is electrically connected with the electrodes 8.
As a result, the circuit board for blood collection 1 and the blood-sugar-level measuring device 19 are capable of simply measuring a blood-sugar level with a simple structure.
Furthermore, with the circuit board for blood collection 1, based on the plurality of measurement units 2 provided in one circuit board for blood collection 1, multiple measurements of a blood-sugar level can be achieved.
Furthermore, with the circuit board for blood collection 1, by rolling the support portion 5 and arranging the plurality of measurement units 2 radially, with rotation of the circuit board for blood collection 1 in a circumferential direction after using one measurement unit 2, the used measurement unit 2 can be changed to an unused measurement unit 2 that is at an upstream side of and adjacent to the used measurement unit 2 in the rotational direction. Therefore, for every measurement in the multiple measurements, the measurement unit 2 can be changed easily.
Furthermore, according to the above-described method for producing the circuit board for blood collection 1, by trimming the metal substrate 11, a plurality of measurement units 2 that are arranged in parallel in the width direction, and the support portion 5 are formed. Therefore, the space for providing the circuit board for blood collection 1 that is arranged in parallel in the frame portion 36 is made compact to achieve space-saving, yields of the circuit board for blood collection 1 can be improved, and an improvement in production efficiency allows a decrease in costs.
Furthermore, according to the above-described method for using the circuit board for blood collection 1, by bending the second bending portion 14 at the boundary between the plurality of measurement units 2 and the support portion 5, and rolling the support portion 5 that was bent, the plurality of measurement units 2 can be arranged radially. Therefore, the plurality of measurement units 2 can be arranged radially by easy procedures.
Furthermore, by bending the second bending portion 14, when using the measurement unit 2, unnecessary contact or damage by the measurement unit 2 that is adjacent to the measurement unit 2 that performs the measurement can be prevented, and only the measurement unit 2 that performs the measurement can be used.
Furthermore, with the circuit board for blood collection 1, the plurality of measurement units 2 arranged at an outside in the radial direction of the rolled support portion 5 allows reliable puncturing and measurement.
Furthermore, with the circuit board for blood collection 1, even though the plurality of measurement units 2 are arranged radially, because the respective measurement units 2 are connected by the connector portion 15, the plurality of measurement units 2 can be reliably supported. Therefore, reliable puncturing and measurement by the measurement unit 2 can be achieved.
Furthermore, with the circuit board for blood collection 1, by engaging the slit portion 16 at the widthwise one end portion with the slit portion 16 at the other end portion of the support portion 5 when rolling the support portion 5, compared with the case where an adhesive is used for adhesion, rolling of the support portion 5 can be reliably and easily retained. Therefore, the plurality of measurement units 2 can be reliably arranged radially.
Although the support portion 5 is bent upward with respect to the plurality of measurement units 2 in which the electrodes 8 and the terminals 9 are exposed upward in the above description of
In the above descriptions of
By rolling the support portion 5 so that the measurement units 2 extend inwardly in the radial direction with respect to the support portion 5, with the plurality of measurement units 2, reliable puncturing and measurement can be achieved at the inside of the rolled support portion 5 in the radial direction.
Although the connector portion 15 is formed into a generally S-shape when viewed from top in the description above, the form is not particularly limited, and the connector portion 15 can be formed into an appropriate shape. For example, as shown in
When the support portion 5 is provided so that the measurement units 2 extend outwardly in the radial direction with respect to the support portion 5, preferably, the connector portion 15 is formed into a generally S-shape when viewed from top (
As shown in
Although the connector portion 15 is formed from the insulating base layer 12 and the insulating cover layer 13 in the above description, the layer structure of the connector portion 15 is not limited thereto. For example, although not shown, the connector portion 15 may also be formed from only one of the insulating base layer 12 and the insulating cover layer 13.
Although 32 units of the measurement unit 2 are provided in the circuit board for blood collection 1 in the description above with reference to
The size of the circuit board for blood collection 1 is appropriately selected according to the size of the casing 41 or the number of the measurement unit 2 in the description above with reference to
The length in the width direction (or the length between widthwise both end portions of the support portion 5) of the circuit board for blood collection 1 is, for example, 50 to 300 mm, or preferably 80 to 150 mm. When the length in the width direction of the circuit board for blood collection 1 is below the above-described range, the number of the measurement unit 2 may become excessively small. On the other hand, when the length in the width direction of the circuit board for blood collection 1 exceeds the above-described range, the yields of the circuit board for blood collection 1 may decrease and cause an increase in costs.
In the description above with reference to
Furthermore, the gear 18 may be formed so as to engage, like a key, with the driving grooves 40 of the gear plate 24 formed into a key.
In the description above, the circuit board for blood collection 1 and the blood-sugar-level measuring device 19 including the circuit board for blood collection 1 are given as examples of the circuit board for body fluid collection and the biosensor including the circuit board for body fluid collection of the present invention. That is, description is given using blood as the body fluid collected by puncturing with the puncture needle of the circuit board for body fluid collection.
However, the body fluid is not particularly limited as long as it is a liquid in a living body, and examples thereof include extracellular fluid and intracellular fluid. Examples of the extracellular fluid include, other than blood mentioned above, a blood plasma; an intercellular fluid; a lymph fluid; moistures in dense connective tissue, bone, and cartilage; and a transcellular fluid. A measurement on a specific component of the above-described body fluid can be performed with the circuit board for body fluid collection and the biosensor including the circuit board for body fluid collection.
First, an elongated sheet metal foil made of SUS 304, in which a metal substrate was defined, and having a thickness of 50 μm and a width of 300 mm was prepared (ref:
Then, on the surface of the metal substrate, a varnish of a photosensitive polyimide resin precursor (photosensitive polyamic acid resin) was applied, and dried by heating to form a coating. The coating was then exposed to light, and developed to be formed into a pattern. Thereafter, the coating was heated in a nitrogen atmosphere to 400° C., to form an insulating base layer having a thickness of 10 μm in the abovementioned pattern (ref:
Then, on the surface of the insulating base layer, metal thin films formed of a chromium thin film and a copper thin film were formed sequentially by sputtering. Subsequently, a dry film resist was laminated on the surface of the metal thin film, exposed to light, and developed to form a plating resist in a pattern. Then, a plating layer formed of copper was formed on the surface of the metal thin film exposed from the plating resist using the metal thin film as a seed film by electrolytic copper plating, thereby forming a conductive pattern including electrodes, terminals, and wirings (ref:
The conductive pattern had a thickness of 12 μm, the two electrodes (8a) had a diameter of 0.3 mm, and the long side of the one electrode (8b) had a length of 1.0 mm, and the short side of the one electrode (8b) had a length of 0.6 mm. The length of a side of the two terminals (9a) was 3 mm, and the length of a side of the one terminal (9b) was 1 mm. The width of the wirings was 100 μm; the length of the wirings that connect the two electrodes 8a and the two terminals 9a was 3 mm; and the length of the wiring that connects the one electrode 8b and the one terminal 9b was 7 mm.
Afterwards, a varnish of a photosensitive polyimide resin precursor (photosensitive polyamic acid resin) was applied on the surface of the insulating base layer so as to cover the conductive pattern, and dried by heating to form a coating. The coating was then exposed to light, and developed to be formed into a pattern. Thereafter, the coating was heated under a nitrogen atmosphere at 400° C., thereby forming an insulating cover layer having a thickness of 5 μm (ref:
Thereafter, an electrolytic nickel plating layer (thickness 0.5 μm), and an electrolytic gold plating layer (thickness 2.5 μm) were sequentially formed on the surface of the electrodes and the terminals.
Then, a dry film resist was laminated on the surface of the metal substrate, exposed to light, and developed to form an etching resist in a pattern. Then, the metal substrate exposed from the etching resist was wet-etched using ferric chloride as the etching solution, and trimmed into the above-described pattern, i.e., a plurality of measurement units arranged in parallel in the width direction including a puncture needle; a support portion in which the gear and the slit portion are formed; and the first bending portion and the second bending portion (ref:
The length from the distal end of the puncture needle to the one electrode (8b) (the electrode nearest from the distal end) was 1.8 mm; the angle at the distal end of the puncture needle was 20°; the width of the bulging portion of the stopper portion was 0.4 mm; the end edge at the downstream side in the puncture direction of the stopper portion and the distal end of the puncture needle were spaced apart by 1.4 mm.
The circuit board for blood collection was thus obtained. The circuit board for blood collection had a length in the width direction of 2.7 mm, and had a length in the puncture (longitudinal) direction of 10 mm.
Afterwards, in the obtained circuit board for blood collection, a chemical agent containing glucose oxidase and a potassium ferricyanide solution was applied on the electrode in respective measurement units by inkjet (ref:
Thereafter, by cutting the joint portion, the circuit board for blood collection was detached from the frame portion, and the circuit board for blood collection was disposed so that the electrodes and the terminals are facing upward (ref:
Then, the support portion was rolled so that the respective measurement units extend outwardly in the radial direction with respect to the support portion, and the slit portions at the widthwise both end portions of the support portion was engaged with each other, so as to retain the rolling of the support portion. The plurality of measurement units were thus arranged radially (ref:
The rolled circuit board for blood collection was mounted along with the driving shaft, the gear plate, and the guide, in the casing provided with a display unit (ref:
To mount the circuit board for blood collection, the driving grooves of the gear plate integrally formed with the driving shaft was engaged with the gear, and the driving shaft was inserted in the guide portion slidably.
(Blood-Sugar Level Measurement with Blood-Sugar-Level Measuring Device)
First, the above-described blood-sugar-level measuring device was prepared, and then the finger of the patient himself/herself was brought to a lower side of the bending guide portion (ref:
Next, the driving shaft was slid to a front side, to expose the puncture needle from the front side opening, and the patient himself/herself punctured his/her finger with the puncture needle (ref:
Next, the driving shaft was slid to a rear side, and the puncture needle was withdrawn from the finger, thus causing a trace amount of bleeding from the punctured portion (ref:
Then, the bending guide portion was opened, and the driving shaft was slid toward a front side again to expose the electrode of the foremost measurement unit from the front side opening, so as to bring the electrode closer and into contact with the punctured portion (ref:
Then, glucose was oxidized by the blood, and ferricyanide ions reacted. At the same time, a voltage was applied from the contact portion to the electrodes via the terminals. Then, a change in the resistance value between the electrodes at the time of the voltage application was detected by the contact portion, and the CPU calculated a glucose level as a blood-sugar level based on the change in the resistance value. Then, the blood-sugar level measured by the CPU was displayed at the display unit.
Afterwards, in this method, the driving shaft was rotated, and the gear plate was rotated with the center of the gear plate as the center in a circumferential direction, to rotate the circuit board for blood collection, thereby disposing an unused measurement unit disposed at an upstream side of and adjacent to the used measurement unit in the rotational direction at the foremost position. Thereafter, the above-described steps were performed, thus measuring a blood-sugar level a plurality of times (32 times in total).
While the illustrative embodiments of the present invention are provided in the above description, such is for illustrative purpose only and it is not to be construed as limiting the scope of the present invention. Modification and variation of the present invention that will be obvious to those skilled in the art is to be covered by the following claims.
A circuit board for body fluid collection; a method for producing the same; a method for using the same; and a biosensor including the same of the present invention are suitably used, for example, in the field where a blood-sugar level in blood is measured.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2008-073542 | Mar 2008 | JP | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/JP2009/050830 | 1/21/2009 | WO | 00 | 9/8/2010 |
