JP2017012375A - Blood glucose level measuring device - Google Patents

Abstract

A blood glucose level measuring apparatus capable of improving the possibility of collecting a necessary amount of blood and the possibility of measuring a blood glucose level by a single puncture and measurement operation.
An opening is defined, a housing having a contact surface capable of contacting the living body surface so as to cover the opening, and a living body surface attached to the housing and contacting the contact surface. A pressing member 20 that presses toward the opening 12, and a blood glucose level measurement unit 40 that is located in the housing 10 and measures a blood glucose level from blood collected in the housing 10 through the opening 12.
[Selection] Figure 1

Description

  The present invention relates to a blood glucose level measuring apparatus.

  Conventionally, it has a puncture needle that punctures a subject's finger to bleed, and a measurement chip that reacts with glucose in the blood in contact with the blood of the subject, and measures blood glucose levels based on the reaction of the measurement chip to glucose A blood glucose level measuring apparatus is known.

  As this type of blood glucose level measuring apparatus, Patent Document 1 discloses a puncture means for puncturing a subject's finger to bleed, a pressure band for pressing a finger on both sides of the puncture site, and information on blood as electrical signals. A body fluid analyzer comprising means for converting and means for determining a measured value by means of an electrical signal is disclosed.

  Patent Document 2 discloses a body fluid including a member (compression unit) having an opening for pressing a finger by the subject himself, a puncture device for puncturing the subject's finger, and an analysis unit for measuring the glucose concentration of the specimen. A collection system is disclosed.

Japanese Patent No. 3604808 Japanese Patent No. 3659919

  In the blood glucose level measuring devices disclosed in Patent Literature 1 and Patent Literature 2, the amount of blood that bleeds from the abdomen of a finger as a living body surface varies depending on individual differences among subjects, and the amount necessary for blood glucose level measurement May not be secured. In such a case, the blood sugar level could not be measured by a single puncture and measurement operation, and it was necessary to redo the puncture and measurement operation, resulting in a heavy burden on the subject.

  Thus, in view of the above problems, an object of the present invention is to improve the possibility of collecting blood necessary for measurement by one puncture and measurement operation and the possibility of measuring blood sugar level. It is to provide a value measuring device.

  The blood glucose level measuring apparatus according to the first aspect of the present invention defines an opening, a housing including a contact surface that can be contacted with a biological surface so as to cover the opening, and is attached to the housing. A pressing member that presses the living body surface that is in contact with the contact surface toward the opening, and a blood glucose measuring unit that is located in the housing and measures blood glucose from blood collected in the housing through the opening These are provided.

  As one embodiment of the present invention, the housing includes an annular insertion portion into which a finger can be inserted, the contact surface is formed on an inner surface of the insertion portion, and the pressing member is disposed in the insertion portion. It is preferable that it is attached to.

  As one embodiment of the present invention, it is preferable that the pressing member is provided at a position facing the contact surface on the inner surface of the insertion portion.

  As one embodiment of the present invention, the housing includes a mouse-like main body portion that supports the insertion portion, communicates with the opening portion, and defines a hollow portion that houses the blood glucose level measurement portion. preferable.

  As one embodiment of the present invention, the pressing member is a balloon member that expands when a fluid is supplied therein, and preferably includes a fluid supply member that supplies fluid to the balloon member.

  As one embodiment of the present invention, it is preferable that a puncture member capable of puncturing the living body surface through the opening is detachably mounted in the housing.

  As one embodiment of the present invention, it is preferable that a measurement chip that contacts blood collected in the housing through the opening and reacts with a predetermined component in the blood is detachably mounted in the housing. .

  The blood glucose level measuring apparatus according to the second aspect of the present invention defines an opening, a housing including a contact surface with which a biological surface can come into contact so as to cover the opening, and is located in the housing. A puncture member that punctures and bleeds the living body surface through the opening, a pressing member that is attached to the housing and presses the living body surface that is in contact with the contact surface toward the opening, and the inside of the housing A measuring chip that is in contact with blood collected in the housing through the opening and reacts with a predetermined component in the blood, and is located in the housing and reacts to the measuring chip with respect to the predetermined component. And a blood sugar level measuring unit for measuring the blood sugar level.

  According to the present invention, there is provided a blood sugar level measuring apparatus capable of improving the possibility of collecting blood necessary for measurement by one puncture and measurement operation and the possibility of measuring blood sugar level. Can do.

It is a figure which shows the blood glucose level measuring device as one Embodiment of this invention, and the replacement | exchange unit with which this blood glucose level measuring device is detachably mounted | worn. FIG. 2 is a cross-sectional view of a blood glucose level measuring device set in which a replacement unit is attached to the blood glucose level measuring device shown in FIG. 1, and FIG. 2 (a) shows a state before a finger is punctured by a puncture member; (B) shows a state after a finger is punctured by the puncture member. 3A is a diagram showing details of the fluid supply member shown in FIG. 1, and FIG. 3B is a partial cross-sectional view of the blood sugar level measuring apparatus shown in FIG. 1, including a cross section of the insertion portion. . FIG. 4A is a view showing a blood collection assisting tool used in the experiment. FIG. 4B is a graph showing experimental results. It is a table | surface which shows experimental conditions. It is a table | surface which shows the experimental result of the experiment conducted on the experimental condition shown in FIG. It is a graph which shows the experimental result of the experiment conducted on the experimental condition shown in FIG.

  Hereinafter, an embodiment of a blood glucose level measuring apparatus according to the present invention will be described with reference to FIGS. In addition, the same code | symbol is attached | subjected to the common member in each figure.

  FIG. 1 is a diagram showing a blood sugar level measuring apparatus 1 as an embodiment of the present invention and a replacement unit 2 that is detachably attached to the blood sugar level measuring apparatus 1. FIG. 2 is a cross-sectional view of the blood glucose level measuring device set 100 in which the replacement unit 2 is attached to the blood glucose level measuring device 1, and FIG. 2 (a) shows a state before a finger is punctured by the puncture member 70. FIG. 2B shows a state after a finger is punctured by the puncture member 70. 3A is a diagram showing details of the fluid supply member 30, and FIG. 3B is a partial cross-sectional view of the blood sugar level measuring apparatus 1 including a cross-section of the insertion portion 14. As shown in FIG.

  As shown in FIGS. 1 to 3, the blood sugar level measuring apparatus 1 includes a housing 10, a pressing member 20, a fluid supply member 30, a blood sugar level measuring unit 40, a power button 50 a, an operation button 50 b, and a display. 50c. As shown in FIG. 2, the replacement unit 2 includes a replacement unit housing 60, a puncture member 70, a biasing member 80, and a measurement chip 90.

  The housing 10 is an exterior member of the blood glucose level measuring apparatus 1, and defines a hollow portion 10a therein. In this hollow portion 10a, a blood glucose level measuring unit 40 described later is accommodated. The replacement unit 2 can be attached to and detached from the housing 10, and when the replacement unit 2 is mounted, the replacement unit 2 is mounted in the hollow portion 10a through the bottom surface opening 11 (see the two-dot chain line in FIG. 1). 11 through the hollow portion 10a.

  The housing 10 includes a contact surface 13 that defines a substantially circular opening 12 on the outer surface thereof. An abdomen of a finger F as a living body surface on which a puncture wound is formed can contact the contact surface 13 so as to cover the opening 12.

  Specifically, the housing 10 according to the present embodiment has an annular insertion portion 14 into which the finger F can be inserted, and a mouse shape that supports the insertion portion 14 and defines a hollow portion 10a that houses the blood glucose level measurement portion 40. The contact surface 13 is formed at a position on the main body 15 side of the inner surface of the insertion portion 14. The opening 12 defined by the contact surface 13 communicates with the hollow portion 10 a of the main body 15.

  The insertion portion 14 of the present embodiment has a substantially cylindrical shape (see FIG. 3B and the like), and an insertion port 16 for inserting a fingertip is provided at one end thereof. Further, the other end of the insertion portion 14 is closed, and an abutting wall 17 is provided in which the position of the finger F in the insertion direction is positioned when the fingertip strikes.

  The main body portion 15 of the present embodiment includes a top wall portion 15a that supports the insertion portion 14, a rear end wall portion 15b that is formed continuously behind the top wall portion 15a, and a side wall of the top wall portion 15a. And a side wall portion 15c formed continuously. The ceiling wall portion 15a has a curved ceiling wall front portion on which the palm is placed, a flat plate ceiling wall rear portion connected to the rear end of the ceiling wall front portion and connected to the insertion portion 14, In the outer surface of the rear part of the top wall, on both sides of the insertion portion 14, a recess portion 18 is formed on which a finger next to the finger F inserted into the insertion portion 14 is placed. Further, a power button 50a and an operation button 50b are provided on the side wall portion 15c. The bottom opening 11 described above is formed on the bottom side of the main body 15.

  The pressing member 20 is attached to the housing 10 and presses a finger F as a living body surface that has contacted the contact surface 13 toward the opening 12. Specifically, the pressing member 20 of this embodiment is attached in the insertion portion 14 of the housing 10. More specifically, the pressing member 20 of the present embodiment is provided at a position facing the opening 12 of the contact surface 13 in the inner surface of the insertion portion 14.

  Note that the pressing member 20 of the present embodiment is a balloon member 20a that is expanded by supplying a fluid such as gas or liquid therein, and can be expanded by supplying air as a fluid from a fluid supply member 30 described later. . As described above, since the balloon member 20a as the pressing member 20 of the present embodiment is attached to the inner surface of the insertion portion 14 at a position facing the opening 12 of the contact surface 13, air is supplied from the fluid supply member 30 to the air. Is supplied, the balloon member 20a can be expanded so that the distance from the opening 12 is reduced. The fluid supplied into the balloon member 20a can be discharged by the fluid supply member 30, and the balloon member 20a contracts when the fluid is discharged.

  The fluid supply member 30 supplies fluid to the balloon member 20a as the pressing member 20, and as shown in FIG. 3, the fluid supply member 30 of the present embodiment includes an electric air supply pump 31 and this A pipe member 32 that connects the air supply pump 31 and the balloon member 20a, supplies air discharged from the air supply pump 31 into the balloon member 20a, and a pressure gauge 33 that measures the internal pressure of the balloon member 20a. ing.

  The blood glucose level measurement unit 40 is located in the hollow portion 10 a in the housing 10 and measures the blood glucose level from the blood collected in the hollow portion 10 a through the opening 12 of the housing 10. Specifically, as shown in FIG. 2, the blood glucose level measurement unit 40 includes an optical measurement unit 41 including an irradiation unit and a light receiving unit, and a blood glucose level based on a signal obtained from the measurement light received by the optical measurement unit 41. And a control unit 42 for calculating. The irradiating unit of the optical measuring unit 41 irradiates the measuring chip 90 in the replacement unit 2 with irradiation light, and the light receiving unit of the optical measuring unit 41 receives the transmitted light transmitted through the measuring chip 90 as measuring light. Convert to signal. In addition, as an irradiation part of the optical measurement part 41, a light emitting diode, a halogen lamp, a laser, etc. can be used, It is good also as a thing containing a condensing lens as needed. Further, as the light receiving unit of the optical measuring unit 41, a photodiode, a CCD, a CMOS, or the like can be used. The control unit 42 controls not only the calculation of the blood sugar level but also the operation of the pressing member 20 described above, and a CPU or the like can be used as the control unit 42.

  The control unit 42 activates the blood glucose level measuring device set 100 when the power button 50a is pressed. Moreover, the control part 42 will start the puncture and measurement by the blood glucose level measuring device set 100, if the operation button 50b is pressed down. Specifically, a pressing operation by the pressing member 20, a puncturing operation by the puncture member 70 of the replacement unit 2, a movement operation of the replacement unit 2 in the housing 10, a blood glucose level measurement by the blood glucose level measurement unit 40, and the like are executed. Can be made. The control unit 42 may execute any one of these operations each time the operation button 50b is pressed, or may execute all the series of operations when the operation button 50b is pressed once. Good. Further, a separate operation button 50b may be provided for each operation. Further, the control unit 42 displays the blood glucose level measured by the blood glucose level measurement unit 40 on the display 50c. A liquid crystal or the like can be used for the display 50c.

  The replacement unit housing 60 accommodates the puncture member 70, the biasing member 80, and the measurement chip 90, and is attached to the inner surface of the housing 10. Specifically, as shown in FIG. 2, the replacement unit housing 60 includes a first housing portion that houses the puncture member 70 and the biasing member 80, and a second housing portion that houses the measurement chip 90. Yes. As shown in FIG. 2A, when the replacement unit housing 60 punctures the finger F inserted into the insertion portion 14 with the puncture member 70 through the opening 12, the first housing portion is It becomes a position communicating with the opening 12 through the through hole 60a. In addition, as shown in FIG. 2B, the replacement unit housing 60 is configured so that when the blood is brought into contact with the measurement chip 90 after puncturing by the puncturing member 70, the second housing portion is connected to the opening 12 through the through hole 60b. It becomes the position to communicate. In other words, the replacement unit 2 can move by sliding in these two positions within the housing 10.

  The puncture member 70 can move into the insertion portion 14 through the opening 12 by the urging force stored in the urging member 80 such as a coil spring, and can puncture the finger F inserted into the insertion portion 14. it can. As shown in FIG. 2 (a), the puncture member 70 is brought into contact with a stopper member 19 mounted in the housing 10 in a state before the puncture, for example, so that the movement of the puncture member 70 is restricted. It is in the state located in 60, ie, the hollow part 10a. For example, when the operation button 50 b is pressed, the stopper member 19 and the puncture member 70 are separated from each other, and the puncture member 70 moves toward the opening 12 by the urging force of the urging member 80.

  The measurement chip 90 comes into contact with blood and reacts with a predetermined component in the blood, and exhibits a color reaction with a concentration corresponding to the amount of the predetermined component. The measurement chip 90 reacts with glucose in the blood and exhibits a color reaction with a concentration corresponding to the amount of glucose. The concentration of the color reaction of the measuring chip 90 can be detected by the optical measuring unit 41 described above. In addition, as shown in FIG. 2B, after the finger F is punctured with the puncture member 70, the second accommodating portion in which the measurement chip 90 is accommodated is a position that communicates with the opening 12. The blood that bleeds from the puncture wound of the finger F is supplied into the main body 15 of the housing 10 through the opening 12 and comes into contact with the measurement chip 90. Specifically, blood that has bleed from the puncture wound of the finger F passes through the opening 12, is then drawn into the through hole 60 b of the second housing portion by capillary force, and is supplied to the measurement chip 90. Thereby, blood can be brought into contact with the measuring chip 90.

  The blood glucose level measuring device set 100 in which the replacement unit 2 is attached to the blood glucose level measuring device 1 has the above-described configuration. Hereinafter, a procedure for measuring a blood glucose level by the blood glucose level measuring device set 100 will be described.

  First, the replacement unit 2 is attached to the blood glucose level measuring apparatus 1, and then the palm F is inserted into the insertion portion 14 from the insertion port 16, and the palm is placed on the outer surface of the top wall portion 15 a of the main body portion 15. Is placed. At this time, the finger adjacent to the finger F to be inserted into the insertion portion 14 is placed in the recess portion 18. In addition, there is no restriction | limiting in particular in the finger F which inserts in the insertion part 14 and extract | collects blood, However, From a viewpoint of the ease of bleeding, it is preferable to set it as the 2nd finger-5th finger rather than a 1st finger. Moreover, in this embodiment, the recessed part 18 is provided symmetrically on both sides of the insertion part 14 so that it can be easily used with either hand.

  Next, the finger F inserted into the insertion portion 14 is pressed by the pressing member 20. Specifically, as shown in FIG. 2A, when the pressing member 20 punctures the puncture member 70 into the abdomen of the finger F inserted into the insertion unit 14, the abdomen of the finger F opens the opening 12. The dorsal side of the finger F is pressed so that it touches the contact surface 13. As a result, the finger F in the insertion portion 14 is sandwiched between the pressing member 20 and the contact surface 13. As a result, the position of the finger F within the insertion portion 14 is fixed in a state where the belly of the finger F is in contact with the edge of the opening 12.

  Thereafter, the puncture member 70 is actuated, for example, by pressing the operation button 50b. Specifically, the puncture member 70 is moved by the urging force of the urging member 80, and the distal end portion thereof protrudes from the opening 12 into the insertion portion 14. Thereby, the puncture member 70 can be punctured to the belly of the finger F inserted into the insertion portion 14. The puncture member 70 used here is a solid needle and has an outer diameter of 0.2 mm to 0.36 mm.

  After puncturing the finger F by the puncture member 70, as shown in FIG. 2 (b), the replacement unit 2 in the main body 15 of the housing 10 is slid backward to replace the opening 12 with the replacement unit housing. 60 to communicate with the through-hole 60b.

  In this state, the control unit 42 operates the pressing member 20 to cover the abdomen of the finger F as the living body surface on which the puncture wound is formed, covering the opening 12 and contacting the contact surface 13 in the insertion unit 14. Further pressing toward the opening 12 is performed. More specifically, the control unit 42 of the present embodiment drives the air supply pump 31 of the fluid supply member 30, supplies air into the balloon member 20a through the tube member 32, and expands the balloon member 20a. As a result, the balloon member 20 a presses the belly of the finger F toward the opening 12.

  As described above, the pressing member 20 fixes the finger F in the insertion portion 14 so that the position of the finger F does not shift before and during the puncturing by the puncture member 70. 2B, in the state of FIG. 2B, the finger F is pressed toward the opening 12 with a pressure larger than the predetermined pressure. In other words, the pressure with which the finger F is pressed toward the opening 12 by the pressing member 20 is greater than the state before the finger F is punctured (see FIG. 2A) (see FIG. 2A). FIG. 2 (b)) is larger.

  Thus, when the abdomen of the finger F on which the puncture wound is formed is pressed toward the opening 12 in a state where the puncture wound is located in the opening 12, the periphery of the puncture wound on the abdomen of the finger F is substantially It can be pressed against the edge of the circular opening 12 to squeeze out blood from the puncture wound.

  Here, as a method of squeezing out blood from the puncture wound, there are a method of sandwiching the belly of the finger F from two directions on both sides, a method of handling the finger F from the base to the tip, and the like. However, it is difficult to obtain a predetermined amount of bleeding necessary for blood glucose level measurement by the method of sandwiching the belly of the finger F from both directions on both sides. Further, the method of handling from the base of the finger F toward the tip has an advantage that it is easy to obtain a predetermined blood loss necessary for blood glucose level measurement, but if a configuration that realizes this is adopted, the configuration of the blood glucose level measurement device Will be complicated. On the other hand, if the method of pressing the periphery of the puncture wound against the edge of the opening 12 as in this embodiment, it is easy to obtain a predetermined amount of blood necessary for blood glucose level measurement, and the configuration is further simplified. be able to.

  Note that the edge of the opening 12 in the present embodiment is substantially circular, but it is sufficient that the edge of the opening surrounds the puncture wound and contacts the belly of the finger F within a range of 360 degrees. It is not something that can be done. For example, the opening 12 can be a polygon such as a rectangle or an ellipse. However, if the substantially circular opening 12 is used as in the present embodiment, blood can be efficiently sent to the puncture wound, and therefore it is preferable that the substantially circular opening 12 be used. Moreover, in this embodiment, although the contact surface 13 which divides the opening part 12 is formed in the inner surface of the cyclic | annular insertion part 14, it is not restricted to this structure, For example, the contact surface which divides an opening part is used. It is also possible to use one end of the cylindrical portion. In such a case, the one end surface of the cylindrical portion constitutes a contact surface that defines the opening. In the case of such a contact surface, the thickness of the cylindrical portion is preferably 3 mm or more in order to reduce pain when the one end surface of the cylindrical portion having a small surface area is pushed into the skin of the finger. However, if the contact surface 13 is provided on the inner surface of the annular insertion portion 14 as in the present embodiment, the entire region of the belly of the finger F abuts on the inner surface of the insertion portion 14 around the opening 12, so that the finger F The pressure applied to the skin is dispersed, and pain can be further reduced.

  The diameter of the opening 12 (the inner diameter of the edge of the opening 12) is preferably 5 mm or more from the viewpoint of ease of bleeding, and from the viewpoint of applying pressure so as to efficiently send blood to the puncture wound. It is preferable that it is 10 mm or less. Furthermore, it is more preferable to set it as 6-9 mm, and it is especially preferable to set it as 7-8 mm.

  As shown in FIG. 2B, when the finger F is further pressed toward the opening 12 by the pressing member 20, the periphery of the puncture wound on the belly of the finger F is pressed against the edge of the opening 12. Blood is squeezed out. The blood squeezed out from the puncture wound reaches the through hole 60b through the opening 12, and is drawn into the through hole 60b by capillary force. Then, the blood drawn into the through hole 60 b by the capillary force reaches the measurement chip 90 and comes into contact with the measurement chip 90. Thereafter, the blood sugar level is measured by the blood sugar level measuring unit 40, and the control unit 42 displays the measurement result of the blood sugar level measured by the blood sugar level measuring unit 40 on the display 50c.

  As described above, according to the blood glucose level measuring device set 100, the pressing member 20 can press the finger F toward the opening 12, and thus a necessary amount of blood is collected by one puncture and measurement operation. The certainty that can be done can be improved. Furthermore, since it can suppress that a test subject's finger | toe F shifts from the opening part 12, the reliability which can measure a blood glucose level can also be improved. Moreover, since the main-body part 15 of the housing 10 is a shape like a mouse | mouth, a test subject tends to put a finger when measuring a blood glucose level. Therefore, it is possible to further suppress the displacement of the subject's finger from the opening 12.

  The pressing of the finger F by the pressing member 20 is performed by continuously applying pressure at a constant predetermined pressure for a predetermined time. The experiment shows that even if the compression is continued for a certain period of time or longer, it does not continue to bleed. Therefore, after the compression for a predetermined time, the pressing by the pressing member 20 is released. Preferably, this pressing operation is repeated a plurality of times. That is, the control unit 42 causes the pressing member 20 to perform a first pressing operation that continues to press the finger F at a predetermined predetermined pressure for a predetermined time, and after releasing the compression, the control unit 42 releases a predetermined time interval. The pressing member 20 is again made to perform the second pressing operation that continues to press the finger F for a predetermined time at a predetermined predetermined pressure. In this way, by performing the second compression operation in addition to the first compression operation, the amount of blood necessary for measuring the blood glucose level can be collected more reliably. Note that the pressure value and time in the first compression operation may be set differently from the pressure value and time in the second compression operation.

  More preferably, when the amount of blood collected after the first compression operation is a predetermined amount or more, the second compression operation is not performed, and when the amount of blood collected after the first compression operation is less than the predetermined amount, the second compression operation is performed. Execute. For example, the control unit 42 determines whether or not the amount of blood collected after the first compression operation is equal to or greater than a predetermined amount and an instruction for the second compression operation by the pressing member 20 when the blood amount is less than the predetermined amount. Executed.

Finally, the outline of the experiment mentioned in the above paragraph will be described. First, for 20 healthy non-elderly persons, when the diameter of the opening 12 was set to 8 mm, the condition of the pressing force necessary for collecting 0.8 μL of blood was verified by experiments. The blood volume of 0.8 μL is set as an amount necessary for measuring the blood sugar level. FIG. 4A shows a blood collection aid used in this experiment, which is a cylindrical member having an inner diameter of 8 mm and a wall thickness of 3 mm. In this experiment, on the subject's second finger abdomen, one end surface of the blood collection aid was pressed so as to surround the puncture wound, and the compression load (kgf) and the amount of blood (μL) bleeding from the puncture wound were determined. Confirmed the relationship. FIG. 4B is a graph showing the results. Note that the compression load shown on the horizontal axis of FIG. 4B shows the compression load when this blood collection aid is used, and the pressure applied to the abdomen of the finger is shown on the horizontal axis of FIG. The value of the compression load is divided by the area (44.745 mm ² ) of one end face of the blood collection aid.

As shown in FIG. 4 (b), in the blood collection assisting tool shown in FIG. 4 (a), bleeding of 0.8 μL or more of all the subjects is obtained by the pressure in the range of 0.3 kgf to 1.5 kgf. Recognize. That is, it can be seen that 0.8 μL of bleeding can be obtained with a compression load of 1.5 kgf or more regardless of individual differences among subjects. Note that when a compression load of 1.5 kgf is applied with the blood collection aid shown in FIG. 4A, the pressure applied to the abdomen of the finger is 0.0335 kgf / mm ² . Also, from this experiment, it was found that the predetermined time for which pressing is continued at a constant pressure is preferably about 5 seconds.

  Then, a final confirmation experiment was performed to verify the validity of the results of the above-described experiment. In this experiment, the relationship between the puncture depth and the compression method was verified for 11 healthy elderly people. FIG. 5 is a table showing the experimental conditions. As shown in FIG. 5, in this experiment, two types (0.8 mm, 1.5 mm) of puncture needles having different puncture depths are used. All the puncture needles have an outer diameter of 0.3 mm (30 gauge).

In addition, as a compression method, a method of performing a second compression operation again under the same condition after a predetermined time interval after performing a first compression operation of pressing at a constant pressure for a certain period of time and bleeding. Specifically, the first and second compression operations that continue to be pressed for 5 seconds with a compression load of 1.5 kgf or 2.0 kgf using the blood collection aid shown in FIG. (Conditions 1 to 4). In addition, when a compression load of 2.0 kgf is applied with the blood collection aid shown in FIG. 4A, the pressure applied to the abdomen of the finger is 0.0447 kgf / mm ² , and in this experiment, 1.5 kgf and 2.0 kgf The reason why the compression load is employed, that is, the reason why the compression load of 1.5 kgf or more is employed is based on the above-described experimental results shown in FIG.

  In this experiment, five points were randomly selected from the second to fourth fingers of both hands, and the four conditions (conditions 1 to 4) shown in FIG. 5 were randomly assigned to each finger to collect blood. The blood was sucked with a capillary having a known inner diameter, and the blood volume was measured in terms of volume. In the interval between the first compression operation and the second compression operation, blood that bleeds due to the first compression operation is collected, and after the second compression operation, blood that bleeds due to the second compression operation is collected. That is, the bleeding for the first compression operation and the bleeding for the second compression operation were collected separately. In this experiment as well, 0.8 μL is set as the blood volume necessary for blood glucose level measurement.

  FIG. 6 is a table showing experimental results for each condition in this experiment. The “success rate” in FIG. 6 means the probability that a blood volume of 0.8 μL or more could be collected. In addition, “average” in FIG. 6 means an average value of the collected blood volume. Furthermore, the “standard deviation” in FIG. 6 means the standard deviation of the collected blood volume.

  As can be seen from FIG. 6, in any of the conditions, 0.8 μL or more of blood can be collected with a high probability by the first compression operation (indicated as “first time” in FIG. 6). This can also be understood from the fact that the average value of the blood volume collected after the first pressing operation is significantly higher than 0.8 μL. That is, it can be seen that the blood collection method according to the present embodiment, in which the edge of the opening is pressed around the puncture wound to squeeze blood, is useful.

  In particular, in any case, the “success rate” becomes 100% by executing the second compression operation (indicated as “second time” in FIG. 6) in addition to the first compression operation. I understand that. That is, by performing the second compression operation in addition to the first compression operation, it was possible to reliably collect a blood volume of 0.8 μL or more under any condition. Therefore, it can be understood that it is an effective means to perform the second compression operation after a predetermined time after the first compression operation.

  Further, as shown in FIG. 6, it can be seen that the amount of collected blood is larger when the puncture depth of the puncture needle is deeper. Specifically, the average blood volume collected under conditions 3 and 4 using a puncture needle with a puncture depth of 1.5 mm was collected under conditions 1 and 2 using a puncture needle with a puncture depth of 0.8 mm. The blood volume is higher than the average.

  FIG. 7A shows the amount of blood collected in the first compression operation (denoted as “first compression” in FIG. 7A) (expressed as “blood collection” in FIG. 7A) for each condition. It is the graph shown in. In FIG. 7A, the horizontal line indicated by the alternate long and short dash line is a line indicating the blood volume “0.8 μL”. As described above, it can be understood from the result of FIG. 7A that the blood volume of 0.8 μL or more can be collected with a high probability in the first compression operation under any condition.

  FIG. 7B shows the amount of blood collected in the second compression operation (indicated as “second compression” in FIG. 7B) (indicated as “blood amount” in FIG. 7B) for each condition. It is the graph shown in. In FIG. 7B, the horizontal line indicated by the alternate long and short dash line is a line indicating the blood volume “0.8 μL”. As in the first compression operation, it can be understood from FIG. 7B that a blood volume of 0.8 μL or more can be collected with high probability in the second compression operation under any condition. This shows the usefulness of performing the second compression operation again after a certain time after the first compression operation.

  FIG. 7C shows the sum of the blood volume collected by the first compression operation and the blood volume collected by the second compression operation (indicated as “total blood collection amount” in FIG. 7C) for each condition. It is the graph shown in. In FIG. 7C, the horizontal line indicated by the alternate long and short dash line is a line indicating the blood volume “0.8 μL”. In any case, the total blood collection amount is 0.8 μL or more, and the usefulness of performing the second compression operation in addition to the first compression operation can be understood.

  The blood glucose level measuring apparatus according to the present invention is not limited to the configuration described in the above-described embodiment, and can be appropriately changed without departing from the gist of the invention described in the claims. For example, the blood glucose level measuring apparatus 1 of the present embodiment has a configuration that can be reused by replacing the replacement unit 2, but is not limited to this configuration, and the puncture member and the measurement chip are not detachable. The blood sugar level measuring device may be a disposable product that cannot be reused as a whole. Specifically, in the blood sugar level measuring apparatus 1 according to the present embodiment, the puncture member 70 that can puncture the abdomen of a finger as a living body surface through the opening 12 and the blood collected in the housing 10 through the opening 12 are contacted. Thus, the measurement chip 90 that reacts with a predetermined component in the blood is detachably mounted in the housing 10 in an integrated state as the replacement unit 2, and the blood glucose level measurement device set 100 is configured. After the use of the blood glucose level measuring device set 100, the replacement unit 2 is removed from the blood glucose level measuring device 1, the replacement unit 2 is discarded, and the blood glucose level measuring device 1 is equipped with a new replacement unit 2. Reused by That is, the blood glucose level measuring apparatus 1 of the present embodiment is configured to be reusable, unlike the replacement unit 2 that is a so-called disposable part. On the other hand, it is good also as a disposable blood glucose level measuring device provided with a puncture member and a measurement chip as a whole.

  The present invention relates to a blood glucose level measuring apparatus.

1: Blood glucose level measuring device 2: Replacement unit 10: Housing 10a: Hollow portion 11: Bottom opening 12: Opening portion 13: Contact surface 14: Insertion portion 15: Main body portion 15a: Top wall portion 15b: Rear end wall portion 15c : Side wall part 16: Insertion port 17: Butting wall 18: Depression part 19: Stopper member 20: Pressing member 20 a: Balloon member 30: Fluid supply member 31: Air supply pump 32: Pipe member 33: Pressure gauge 40: Blood glucose level Measuring unit 41: Optical measuring unit 42: Control unit 50a: Power button 50b: Operation button 50c: Display 60: Replacement unit housing 60a: Through hole 60b in the first housing part: Through hole 70 in the second housing part: Puncture member 80: Energizing member 90: Measuring chip 100: Blood glucose level measuring device set F: Finger

Claims (8)

A housing that defines an opening, and includes a contact surface on which a living body surface can contact so as to cover the opening;
A pressing member attached to the housing and pressing the living body surface that is in contact with the contact surface toward the opening;
A blood sugar level measuring device, comprising: a blood sugar level measuring unit that is located in the housing and measures blood sugar level from blood collected in the housing through the opening. The housing includes an annular insertion part into which a finger can be inserted,
The blood glucose level measuring apparatus according to claim 1, wherein the contact surface is formed on an inner surface of the insertion portion, and the pressing member is attached in the insertion portion.   The blood pressure measuring device according to claim 2, wherein the pressing member is provided at a position facing the contact surface in the inner surface of the insertion portion.   The said housing is provided with the mouse-like main-body part which divides the hollow part which communicates with the said opening part, and accommodates the said blood glucose level measurement part while supporting the said insertion part. The blood glucose level measuring device according to 1. The pressing member is a balloon member that is expanded by supplying a fluid therein,
The blood glucose level measuring apparatus according to claim 1, further comprising a fluid supply member that supplies fluid to the balloon member.   The blood sugar level measuring apparatus according to any one of claims 1 to 5, wherein a puncture member capable of puncturing the living body surface through the opening is detachably mounted in the housing.   7. The measuring chip that contacts blood collected in the housing through the opening and reacts with a predetermined component in blood is detachably mounted in the housing. The blood glucose level measuring apparatus according to any one of the above. A housing that defines an opening, and includes a contact surface on which a living body surface can contact so as to cover the opening;
A puncture member that is located in the housing and punctures and bleeds the biological surface through the opening;
A pressing member attached to the housing and pressing the living body surface in contact with the contact surface toward the opening;
A measuring chip located in the housing, in contact with blood collected in the housing through the opening, and reacting with a predetermined component in the blood;
A blood sugar level measuring apparatus, comprising: a blood sugar level measuring unit that is located in the housing and measures a blood sugar level based on a response of the measuring chip to the predetermined component.

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