JP5498084B2 - Flow rate fluctuation monitoring device and biological component measuring device - Google Patents

Description

  The present invention relates to a flow rate fluctuation monitoring device and a biological component measurement device, and more specifically, a flow rate fluctuation monitoring capable of reliably and accurately monitoring a flow rate fluctuation of a fluid in a flow path through which a fluid that may cause a flow rate fluctuation flows. The present invention relates to a device and a biological component equipped with the flow rate fluctuation monitoring device, such as a biological component measuring device capable of measuring a blood sugar level, that is, a blood sugar level, such as an artificial pancreas device.

  In Patent Document 1, “a liquid delivery line for delivering a liquid is provided with a delivery unit that contains a rotor for continuously delivering a certain volume of the liquid, and the liquid is delivered to the liquid delivery line via the delivery unit. And the change in the flow rate of the liquid in the delivery unit in the unit time is monitored, and when the change in the flow rate occurs, the liquid flow rate in the unit time matches the reference flow rate. And a “liquid delivery device” for realizing the “liquid delivery method” (claims 1 and 10 of Patent Document 1 and (See FIG. 1).

Wherein the "liquid delivery method" and realizing "fluid delivery device", a syrup flow regulator 1 including a pulse encoder 1S for generating a pulse having a frequency corresponding to the rotational speed of the "rotor drive motor 1M, dilution water W _A the dilution water flow meter 21 which generates a pulse having a frequency corresponding to the flow rate, the carbonated water flow meter 26 for generating pulses of a frequency corresponding to the formed similarly to the dilution water flow meter 21 flow carbonated water W _C ... Monitoring the deviation from the dilution ratio based on the pulse corresponding to the flow rate of each liquid input from the pulse encoder 1S, the dilution water flow meter 21 and the carbonated water flow meter 26 in a predetermined pulse sampling period. And a flow rate monitoring unit 4 (see paragraph No. 0013 in Patent Document 1 and FIG. 1). However, when a large number of members are provided as in the invention described in Patent Document 1, an accurate result can be obtained only after all the members are normally and correctly operated, so that the apparatus is likely to be complicated.

  In addition to the beverage device described in Patent Document 1, medical devices can be cited as devices that need to monitor fluid flow fluctuations. In medical devices, a tube circuit is often used as a fluid flow path, and most of the wetted parts including the tube circuit are disposable in consideration of hygiene. If a large number of members are provided in a medical device that monitors flow rate fluctuations, a large number of disposable wetted parts are discarded, which increases raw materials and processes necessary for manufacturing and maintaining the apparatus.

  Therefore, there has been a demand for a flow rate fluctuation monitoring apparatus that has a small number of parts that come into contact with liquid and that can accurately and reliably detect liquid flow rate fluctuations. In addition, a biological component measuring device provided with such a flow rate fluctuation monitoring device has also been desired.

Japanese Patent Laid-Open No. 2003-118796

  The problem to be solved by the present invention is to monitor the flow fluctuation of the liquid in the flow path through which the liquid that may cause the flow fluctuation can be reliably and accurately monitored, and to monitor the flow fluctuation with a small number of parts in contact with the liquid. An apparatus and a biological component measuring apparatus that measures a biological component including the flow rate fluctuation monitoring apparatus, for example, an artificial pancreas apparatus that can measure a blood glucose level are provided.

As means for solving the problems,
Claim 1
A first flow path through which fluid A circulates;
A second flow path through which the fluid A flows at a flow rate less than the flow rate of the fluid A flowing through the first flow path;
A branch channel provided by branching at a coupling portion between the first channel and the second channel, the interface forming fluid B capable of forming an interface with the fluid A, and the fluid A; Is a branch channel that circulates in a state where the fluid A is divided into the interface-forming fluid B;
A detection unit that is provided only in the branch flow path and detects an interface between the interface forming fluid B and the fluid A that circulates;
The detection data output from the detecting unit, and an arithmetic unit for calculating the flow rate variation,
The second flow path and the branch flow path are flow rate fluctuation monitoring devices characterized by being connected only by the coupling portion,
Claim 2
The flow rate fluctuation monitoring device according to claim 1, wherein the fluid A is a liquid A and the interface forming fluid B is a gas B.
Claim 3
The gas B is (1) provided by the interface forming fluid supply section provided in the first flow path or provided in the branch flow path, or (2) the coupling from the middle of the first flow path. The flow rate according to claim 2, wherein the flow rate is formed by a fluid conversion unit that converts a part of the liquid A into a gas B provided in any part of the flow path to the detection unit via the unit. A fluctuation monitoring device,
Claim 4
The first flow path is
A first liquid supply section for supplying a first liquid necessary for forming the liquid A into the first flow path;
An interface-forming fluid supply unit that is provided on the downstream side of the first liquid supply unit and supplies the gas B into the first flow path;
A second liquid supply unit that is provided downstream of the interface forming fluid supply unit and supplies a second liquid that forms liquid A with the first liquid;
The coupling portion includes a separator that separates a gas-liquid mixture of the liquid A and the gas B obtained by mixing the first liquid and the second liquid and the liquid A not containing the gas B,
The second flow path distributes the fluid A separated by the separator and not containing the gas B,
The flow rate fluctuation monitoring device according to claim 2, wherein the branch flow channel distributes a gas-liquid mixture of a liquid A and a gas B obtained by mixing the first liquid and the second liquid. And
Claim 5
The separator for separating the mixture of the interface forming fluid B and the fluid A and the fluid A not including the interface forming fluid B is provided at a coupling portion between the first channel and the second channel. The flow rate fluctuation monitoring device described in
Claim 6
It is a biological component measuring apparatus provided with the flow volume fluctuation | variation monitoring apparatus of any one of Claims 1-5.

  According to the present invention, even if the flow rate of the fluid flowing through any one of the first flow channel, the second flow channel, and the branch flow channel varies, the flow rate of the fluid flowing through the first flow channel in particular varies. However, it is possible to provide a flow rate fluctuation monitoring device that can reliably and accurately monitor the flow rate fluctuation and that has a smaller number of parts in contact with liquid.

  In addition, according to the present invention, by providing the flow rate fluctuation monitoring device, even when a flow rate fluctuation of a liquid containing a biological component to be measured, such as glucose, occurs, the flow rate fluctuation can be reliably and accurately monitored. In addition, it is possible to provide a living body component measuring apparatus having a smaller number of parts in contact with liquid.

FIG. 1 is an explanatory diagram showing an example of a flow rate fluctuation monitoring apparatus according to the present invention. FIG. 2 is an explanatory view showing another example of the flow rate fluctuation monitoring apparatus according to the present invention. FIG. 3 is an explanatory view showing another example of the flow rate fluctuation monitoring apparatus according to the present invention. FIG. 4 is an explanatory view showing another example of the flow rate fluctuation monitoring apparatus according to the present invention. FIG. 5 is an explanatory view showing another example of the flow rate fluctuation monitoring apparatus according to the present invention. FIG. 6 is an explanatory diagram showing an example of a blood sugar level measuring unit according to the present invention. FIG. 7 is an explanatory view showing another example of the blood sugar level measuring unit according to the present invention. FIG. 8 is an explanatory view showing still another example of the blood sugar level measuring unit according to the present invention.

  An embodiment of a flow rate fluctuation monitoring apparatus according to the present invention will be described below with reference to FIG.

  A flow rate fluctuation monitoring device 1A shown in FIG. 1 includes a first flow path 2, a second flow path 3, a branch flow path 4, a gas mixer 5, a detection unit 6, and a calculation unit 7.

  The first flow path 2 is a flow path through which the fluid A flows.

  The fluid A is not particularly limited as long as it is a fluid, and examples thereof include liquid A such as water, oil, physiological saline, sol and various solutions, and gas.

  The second flow path 3 is a flow path through which the fluid A flows at a lower flow rate than the flow rate of the fluid A flowing through the first flow path 2. That is, the fluid A flowing in the first flow path 2 is divided into the second flow path 3 and the branch flow path 4 via the coupling portion 8 and flows in.

  The branch flow path 4 is provided by being branched by a joint 8 between the first flow path 2 and the second flow path 3, and an interface forming fluid B and a fluid A capable of forming an interface with the fluid A. Is a flow path through which the fluid A flows in a state of being divided by the interface forming fluid B. In other words, in this branch channel 4, the fluid A is divided by the interface forming fluid B in order of the fluid A, the interface forming fluid B, the fluid A, the interface forming fluid B, the fluid A, and the interface forming fluid B. Go. In this way, in order for the fluid A and the interface forming fluid B to divide and circulate, the branch channel 4 has a circular inner contour in a cross section perpendicular to an arbitrary axis of the channel. Note that the “joining portion” can be formed by joining the end of the first flow path and the end of the second flow path, but by branching the branch flow path in the middle of the flow path, In the flow direction, when the upstream side of the junction point of the branch channel is the first channel and the downstream side of the junction point of the branch channel is the second channel, the first channel is the second channel. And a portion branched into the branch flow path becomes a coupling portion.

The interface-forming fluid B is particularly limited as long as it is a fluid that can form an interface with the fluid A and can flow through the flow path together with the fluid A while maintaining the formed interface. If the fluid A is a water-based liquid or sol solution such as water, an aqueous solution, or a mixture of physiological saline and a body fluid sample collected from a living body, the interface forming fluid B Examples thereof include air, gas B such as various gases, oil, and various solutions and liquids such as sol that can form an interface with the fluid A. At this time, air as the gas B is particularly preferable as the interface forming fluid B. Since air is difficult to dissolve in a liquid and a sol solution in a short time, the interface forming fluid B easily forms interfaces with various fluids A. Furthermore, in the flow rate fluctuation monitoring apparatus according to the present invention, the interface forming fluid B may be determined according to the type of the fluid A. For example, when water, physiological saline, or a mixture of physiological saline and a body fluid collected from a living body such as blood is used as fluid A, various fluids that do not dissolve in oil, water, or physiological saline as interface forming fluid B A gas such as air can be used. For example, when oil is used as the fluid A, a liquid such as water or physiological saline, or various gases that do not dissolve in the oil, such as air, can be used as the interface forming fluid B. When the fluid A is air or a gas such as various gases, examples of the interface forming fluid B include water, aqueous solutions, oils, various solutions, sols, and gels.
In the present invention, the interface forming fluid B may be bubbles formed by vaporization of the fluid A. That is, a part of the fluid A, which is a liquid flowing in the branch channel 4, is vaporized by the gas mixer 5, or a gas dissolved in the fluid A is vaporized, and bubbles generated thereby are defined as fluid B. Also good. In order to use as a fluid B bubbles generated by vaporizing part of the liquid A or gas dissolved in the liquid A, the gas mixer 5 is branched from the outside of the branch channel 4. It is desirable to provide a heating means such as a nichrome wire heater for heating the liquid A, which is the fluid A flowing through the branch flow path 4 without introducing gas into the flow path 4. In this case, the heating means is an example of a fluid conversion section in the flow rate fluctuation monitoring device according to the present invention.
In order for the fluid A and the interface forming fluid B to form an interface in the branch channel 4, when the fluid A is the liquid A, the interface forming fluid B is not miscible with the liquid A or does not dissolve in each other. For example, when the fluid A is an aqueous liquid A such as water, a water-soluble alcohol, or an aqueous solution obtained by dissolving a biological component in the fluid A, the interface-forming fluid B may be an oily liquid B. it can.

  When the flow rate fluctuation monitoring apparatus 1A shown in FIG. 1 is incorporated into a biological component measuring apparatus such as an artificial pancreas apparatus, the fluid A is a mixed liquid of an aqueous liquid A such as physiological saline and a body fluid collected from a living body such as blood. The interface forming fluid B is preferably a gas.

  The gas mixer 5 is a member that supplies the interface forming fluid B into the branch flow path 4, and is an example of the interface forming fluid supply unit in the present invention. In this case, as an aspect of supplying the interface forming fluid B into the branch channel 4, an aspect of supplying the interface forming fluid B from the outside other than the branch channel 4 into the branch channel 4, and the fluid A is the liquid A In some cases, a part of the liquid A flowing in the branch flow path 4 is vaporized by the fluid conversion section, or the gas dissolved in the liquid A is vaporized by the fluid conversion section, thereby causing the interface formation fluid in the branch flow path 4. A mode of generating bubbles as B can be mentioned. As described above, in order to vaporize a part of the liquid A or vaporize the gas dissolved in the liquid A, the gas mixer 5 includes a heater that is a heating unit.

  As a suitable example of the interface forming fluid B supplied from the outside of the branch channel 4 into the branch channel 4 by the gas mixer 5, air can be mentioned. As a specific example of the gas mixer 5 that can send out air, for example, a centrifugal pump, a reciprocating pump, a screw pump, a rotary pump, a roller pump, or the like can be used. However, even when the interface forming fluid B is other than air, the above-described pump can be used as the interface forming fluid supply unit.

  The detection unit 6 is a sensor member that is provided on the downstream side of the gas mixer 5 in the branch channel 4 and detects an interface between the flowing interface forming fluid B and the fluid A.

  The detection unit in the flow rate fluctuation monitoring device according to the present invention may be formed so that the interface between the fluid A and the interface forming fluid B can be detected by passing through the detection unit. An optical sensor, an ultrasonic sensor, or the like can be employed. A suitable detection unit includes an optical sensor in consideration of simplification of the apparatus and operability. The detection unit 6 shown in FIG. 1 is an example of an optical sensor having a light emitting element and a light receiving element.

  The calculation unit 7 is configured to calculate a flow rate variation based on detection data output from the detection unit 6.

  As the calculation unit in the flow rate fluctuation monitoring apparatus according to the present invention, any appropriate member can be adopted as long as it has a calculation function capable of calculating the flow rate fluctuation of the fluid A. For example, an electronic computer or the like is used. Can do.

  Here, as a method for monitoring the flow of the fluid A or the interface forming fluid B by the flow rate fluctuation monitoring device according to the present invention, there are two preferable methods.

  In the first method for monitoring the flow of the fluid A or the interface forming fluid B, first, a measured value such as absorbance obtained by the detection unit is output to the calculation unit as detection data. Next, the calculation unit calculates a difference between the input measurement value and a preset threshold value. When the measured value exceeds the threshold value, it is determined that the interface forming fluid B is in circulation, and when the measured value does not reach the threshold value, it is determined that the fluid A is in circulation. The flow of A or interface forming fluid B can be monitored.

  In the second method of monitoring the flow of the fluid A or the interface forming fluid B, first, a measured value such as absorbance obtained by the detection unit is output to the calculation unit as detection data. Next, the calculation unit calculates a change rate of the measured value by differentiating the input measured value. A difference between the change rate and a preset threshold value is calculated. When the change rate exceeds the threshold value, it is determined that the flow of the fluid A is switched to the flow of the interface forming fluid B. When the change rate exceeds the threshold value again, the flow of the interface A fluid B The flow of the fluid A or the interface forming fluid B can be monitored by determining that the flow has been switched.

  The reason why the flow of the fluid A or the interface forming fluid B can be monitored by the method described above is that the fluid A flowing through the branch flow channel flows in a state of being divided into the interface forming fluid B.

  The flow rate of the fluid A correlates with a value obtained by integrating the number of times that the interface between the fluid A and the interface forming fluid B passes through the detection unit per unit time. As a method of calculating the flow rate fluctuation of the fluid A in the calculation unit, when it is determined that the flow of the fluid A is fluctuated by the above-described method of monitoring the flow of the fluid A or the interface forming fluid B, the unit By calculating the integrated value of the number of times of interface passage per time, the flow rate fluctuation of the fluid A can also be calculated using the integrated value. The unit time may be set short in seconds when it is necessary to quickly detect the flow rate fluctuation, and conversely, it may be as long as several minutes if there is a time allowance for detecting the flow rate fluctuation. May be set.

  As another method of calculating the flow rate fluctuation of the fluid A in the arithmetic unit, for example, a method of tracking a change with time of the flow rate of the fluid A can be cited. Specifically, after detecting an arbitrary interface in the interface between the interface forming fluid B and the fluid A detected by the detection unit, the time required to detect the nearest interface is measured, Since the flow rate of the fluid A per unit time can be calculated using the flow path diameter measured in advance, the change with time of the calculated flow rate of the fluid A may be tracked.

  In the first flow path, the second flow path, the coupling section, the branch flow path, the detection section, and the interface forming fluid supply section of the flow rate fluctuation monitoring device according to the present invention, the material of each member is the fluid that flows through the inside It is preferable to use a material that does not deform or change when A and / or the interface forming fluid B are in contact with each other.

  Further, the flow rate fluctuation monitoring device according to the present invention provides the flow rate and flow rate of the fluid A on a display member such as a CRT so that the operator can visually recognize the flow rate and flow rate fluctuation of the fluid A calculated by the calculation unit. It is good also as showing fluctuation. Further, when the flow rate of the fluid A varies, a notification member that notifies the operator by sounding an alarm or the like may be provided.

  Another embodiment of the flow rate fluctuation monitoring apparatus according to the present invention is shown in FIG. A gas mixing device 51 and a separator 9 are attached to the flow rate fluctuation monitoring device 1B shown in FIG. The flow rate fluctuation monitoring device 1B is different from the flow rate fluctuation monitoring device 1A in that a gas mixer 51 is provided and a separator 9 is provided at a connection point 8. Since the flow rate fluctuation monitoring device 1B and the flow rate fluctuation monitoring device 1A use the same members except for this difference, detailed description of the common members may be omitted.

  The gas mixer 51 is provided in the first flow path 2 and can supply the interface forming fluid B into the first flow path 2. The gas mixer 51 is an example of an interface forming fluid supply unit in the present invention. The interface forming fluid B supplied from the gas mixer 51 into the first flow path 2 is air, like the gas mixer 5. As a specific example of the gas mixer 51, as with the gas mixer 5, for example, a centrifugal pump, a reciprocating pump, a screw pump, a rotary pump, a roller pump, or the like can be used.

  The separator 9 is a member that is provided at a joint between the first flow path 2 and the second flow path 3 and separates the mixture of the interface forming fluid B and the fluid A into the fluid A that does not include the interface forming fluid B. is there. The separator 9 is an example of a coupling portion in the present invention. In the flow rate fluctuation monitoring device 1B, since the detection unit 6 is provided in the branch channel 4, the mixture of the interface forming fluid B and the fluid A is circulated through the branch channel 4 and does not include the interface forming fluid B. The fluid A is separated by the separator 9 so as to flow through the second flow path 3. When the fluid A is a liquid and the interface forming fluid B is a gas, the separator 9 converts a mixture of the liquid A and the gas B into a mixture of the liquid A and the gas B flowing into the branch channel 4. The liquid A flowing into the second flow path 3 and separated from the gas B is separated.

  In the flow rate fluctuation monitoring apparatus according to the present invention, it is not necessary to provide a separator as long as the flow rate fluctuation can be monitored by operating the detection unit and the calculation unit. In other words, if the flow rate variation of the liquid A containing the interface forming fluid B can be monitored by the detection unit and the calculation unit, a mixture of the fluid A and the interface forming fluid B in the second channel 3, for example, the liquid A And gas B may be circulated. If inconvenience occurs in the second flow path 3 when the interface forming fluid B flows, a separator may be provided as in the flow rate fluctuation monitoring device 1B.

  Subsequently, a modification of the flow rate fluctuation monitoring apparatus 1B shown in FIG. 2 is shown in FIG. FIG. 3 shows a flow rate fluctuation monitoring device 1C. The flow rate fluctuation monitoring device 1C is configured by attaching a first fluid supply unit 201 and a second fluid supply unit 202 to the first flow path 2 in the flow rate fluctuation monitoring device 1B. Since the flow rate fluctuation monitoring device 1C and the flow rate fluctuation monitoring device 1B have the same configuration except for the attached first fluid supply unit 201 and second fluid supply unit 202, detailed description of the same configuration is omitted. There is.

  The first fluid supply unit 201 is means for supplying a first fluid into the first flow path 2. The second fluid supply unit 202 is means for supplying a second fluid to the first fluid. In the first flow path 2, a gas mixer 51, which is an example of an interface forming fluid supply unit, is provided on the downstream side of the first fluid supply unit 201, and further, the second fluid supply is provided on the downstream side of the gas mixer 51. A unit 202 is provided. In the flow rate fluctuation monitoring device 1C, the fluid A is a mixture of two types of fluids supplied by the first fluid supply unit 201 and the second fluid supply unit 202. In the flow rate fluctuation monitoring device 1C, the first fluid is first divided by the interface forming fluid B in the first flow path 2, and the divided first fluid, the divided interface forming fluid B, and the divided first fluid are divided. , And in the order of the divided interface forming fluid B, the second fluid is supplied into the first fluid divided in this manner.

The first fluid and the second fluid are both liquids, or both are gases. The interface forming fluid B is a liquid or a gas. Furthermore, the interface forming fluid B is a fluid that forms an interface with the first fluid and the second fluid in the first flow path 2. In the preferred embodiment of the flow rate fluctuation monitoring device 1C shown in FIG. 3, the first fluid and the second fluid are liquids, and the interface forming fluid B is a gas. However, when the interface forming fluid B is a liquid, the first fluid and the second fluid are gases. The liquid A is divided into a first fluid that is a liquid and a second fluid that is a liquid. A diluent is used as the first fluid, and heparin- containing physiological saline and blood are mixed as the second fluid. This is because a mixed solution may be employed.
When the first fluid and the second fluid are liquid, it is preferable that the fluid is sufficiently mixed before reaching the separator 9. For example, when the first fluid that is liquid flows in a state of being divided by the interface forming fluid B that is gas, the second fluid supply unit 202 causes the first flow path 2 in which the first fluid and the gas flow. The second fluid is automatically supplied to the first fluid only by supplying the second fluid which is liquid. Furthermore, for example, when the first fluid and the second fluid are liquids and the interface forming fluid is a gas, the first fluid and the second fluid flow toward the separator while being divided by the gas. The mixing efficiency of the first fluid and the second fluid is improved. In order to efficiently mix the first fluid and the second fluid in the first flow path, for example, a coiled flow path is provided in the middle of the first flow path 2 from the second fluid supply unit 202 to the separator 9. It is preferable that the mixing of the fluids be promoted by interposing a mixer having the fluid and passing through the coiled flow path.

  The flow rate fluctuation monitoring device 1C according to one embodiment of the present invention is useful when a fluid A formed by mixing a plurality of types of fluids is produced in the first flow path. When the fluid A is composed of one type of fluid, or when a plurality of types of fluids are sufficiently mixed in advance and supplied to the first flow path as the fluid A, the flow rate fluctuation monitoring devices 1A and 1B and a flow rate described later are used. The variation monitoring devices 1D and 1E may be employed.

  In the following, the method of using the flow rate fluctuation monitoring apparatus 1A or 1B according to the present invention and the operation thereof will be described, and the flow rate fluctuation monitoring apparatus 1A or 1B according to the present invention will also monitor the flow rate fluctuation of fluid A, for example, liquid. ,explain.

  In order to use the flow rate fluctuation monitoring device 1 </ b> A or 1 </ b> B, first, the liquid A as the fluid A is circulated through the first flow path 2, the second flow path 3, and the branch flow path 4. At this time, the gas mixer 5 or 51 which is the interface forming fluid forming portion is operating. That is, the gas B as the interface forming fluid B is continuously supplied into the branch flow path 4 in the flow rate fluctuation monitoring device 1A or the first flow path 2 in the flow rate fluctuation monitoring device 1B. In a preferred embodiment, the gas mixer 5 or 51 supplies air into the flow path as the gas B at a constant interval.

  Note that when the liquid A is circulated through the first flow path 2, the second flow path 3 and the branch flow path 4, the gas mixer 5 or 51 does not operate, and in the branch flow path 4 in the flow rate fluctuation monitoring device 1A or The interface forming fluid B may not be supplied into the first flow path 2 in the flow rate fluctuation monitoring device 1B.

Since the flow rate fluctuation monitoring apparatus according to the present invention includes the first flow path, the second flow path, and the branch flow path, there are three types of flow rates. For example, as shown in FIGS. 1 and 2, the flow rate in a state where no flow rate variation occurs is defined as f _A for the flow rate of fluid A in the first flow path 2 and f _{B for} the flow rate of fluid A in the second flow path 3. and then, the flow rate of the fluid a branch channel 4 and f _D. The flow rate f _D of the branch flow path 4 shown in FIG. 2, the flow rate of interface formation fluid B supplied in the gas mixing device 51 is the flow rate of the flow rate is not taken into consideration, i.e. the fluid A only.

In the state shown in FIGS. 1 and 2, it can be said that it is in a steady state when there is no flow rate fluctuation in f _A , f _B, and f _D. However, the first flow path, the second flow path, and the branch flow path may all cause flow rate fluctuations.

  The flow rate fluctuation of each flow path in the flow rate fluctuation monitoring apparatus of the present invention is, for example, a situation in which the flow path is crushed by being sandwiched between other devices or instruments, and the fluid A having a predetermined flow rate stops flowing. Caused by. When the flow rate fluctuation occurs, the fluid A continues to circulate in a state where it is mechanically mistaken that the predetermined flow rate is circulated, so that the flow rate of the fluid A in which the flow rate fluctuation actually occurs is accurately determined. An unmonitored situation may occur. If the fluid A is continuously circulated in a state where the flow rate is misidentified, for example, in a biological component measuring device such as an artificial pancreas device connected to a living body, there is a possibility that the living body may be in danger. The flow rate fluctuation monitoring device according to the present invention can detect such a flow rate fluctuation reliably and accurately.

  As a method of calculating the flow rate fluctuation of the fluid A, as described above, the method of calculating the flow rate fluctuation of the fluid A using the integrated value by calculating the integrated value of the number of times of interface passage per unit time is adopted. Just do it. Further, as another method for calculating the flow rate fluctuation of the fluid A, a method of tracking the change with time of the flow rate of the fluid A described above may be employed.

Examples of flow rate fluctuations in the first channel, the second channel, and the branch channel include the following five types.
(1) _{f A} has changed, and if the _{f B} is constant, _{f D} varies.
(2) _{f A} is constant, and if the _{f B} fluctuates, _{f D} varies.
(3) When f _A is constant and f _D varies, f _B varies.
(4) _{f A} has changed, and if the _{f B} fluctuates synchronously with the variation of _{f A,} is _{f D} is constant.
(5) _{f A} has changed, and if the _{f B} fluctuates without change and synchronization of _{f A, f D} varies.
The flow rate fluctuation monitoring apparatus according to the present invention only needs to be able to monitor these five modes of flow rate fluctuation.

(1) When f _A fluctuates and f _B is constant, f _D fluctuates The flow rate f _A of the first flow path 2 shown in FIG. _B and is calculated by the sum of the flow rate f _D of the branch flow path 4. That, _{f D} is less than _{f A.} When the flow rate fluctuation occurs, f _B is constant, so the fluctuation amount of f _A coincides with the fluctuation amount of f _D. Accordingly, the flow rate variation ratio in f _D is greater than the flow rate variation ratio in f _A. In other words, the flow rate fluctuation monitoring devices 1 </ b> A and 1 </ b> B can amplify and monitor the flow rate fluctuation rate in the first flow path 2 using the branch flow path 4. Since the flow rate fluctuation monitoring devices 1A and 1B can detect the flow rate fluctuation by the detection unit 6 and the calculation unit 7 in the branch flow path 4, even if the flow rate fluctuation of f _A is very small in the first flow path 2. Therefore, it is possible to reliably and accurately monitor the flow rate fluctuation that occurs.

(2) is _{f A} is constant, and if the _{f B} fluctuates, if f _A of the _{f D} varies, since it is calculated by the sum of the _{f B} and _{f D,} is _{f A} constant in this case, f _D is reduced when the f _B increases, so that the increases f _D when f _B is reduced to the contrary. That is, when f _A is constant, the amount of change of f _B is consistent with the value obtained by reversing the sign of the variation of f _D. The flow rate fluctuation monitoring devices 1A and 1B can monitor the flow rate fluctuation of the second flow path 3 by monitoring the flow quantity of the branch flow path 4 even if the flow rate of the second flow path 3 is fluctuated. That is, the flow rate fluctuation monitoring devices 1A and 1B can monitor the flow rate fluctuation not only in the case (1) but also in the case (2).

(3) is _{f A} is constant, and the _{f D} varies, if f _{A where f B} fluctuates, because it is calculated by the sum of the _{f B} and _{f D,} when _{f A} is constant , _{f B} decreases when _{f D} is increased, _{f B} becomes possible to increase the contrary, _{f D} is reduced. That is, when f _A is constant, the amount of change of f _D is consistent with reversed values of the positive and negative variation of f _B. The flow rate fluctuation monitoring devices 1 </ b> A and 1 </ b> B can monitor the flow rate fluctuation of the second flow path 3 by monitoring the flow rate of the branch flow path 4. That is, the flow rate fluctuation monitoring devices 1A and 1B can monitor the flow rate fluctuation not only in the cases (1) and (2) but also in the case (3).

(4) When f _A is fluctuating and f _B is fluctuating in synchronization with f _A , f _D is constant. In the case of (4), the flow fluctuation monitoring device shown in FIG. It is good to use 1D. In the flow rate fluctuation monitoring device 1D shown in FIG. 4, a second detection unit 61 is interposed between the gas mixer 51 and the separator 9 in the first flow path in the flow fluctuation monitoring device 1B shown in FIG. The configuration is the same as that of the flow rate fluctuation monitoring device 1B shown in FIG. 2 except that the second calculation unit 71 for inputting the detection signal output from the second detection unit 61 is provided. The detailed description of the configuration common to the flow rate fluctuation monitoring device 1D and the flow rate fluctuation monitoring device 1B may be omitted.

  The second detection unit 61 is the same sensor member as the detection unit 6 and has the same function. Moreover, the said 2nd calculating part 71 is the same member as the said calculating part 7, The effect | action is also the same. The flow rate fluctuation monitoring device 1D calculates a flow rate fluctuation based on a sensor member that detects an interface between a fluid A, for example, a liquid A and an interface forming fluid B, for example, a gas B such as air, and detection data output from the detection unit. Since the means is also provided in the first flow path 2, fluctuations in the flow rate of the first flow path 2 can also be detected. Both the calculation unit and the calculation means can be realized by a computer.

Since f _A is calculated by the sum of f _B and f _D , in the case of (4), if f _D is constant, the fluctuation amount of f _A corresponds to the fluctuation amount of f _B. The flow rate fluctuation monitoring device 1D can monitor flow rate fluctuations occurring in the first flow path and the second flow path by monitoring the flow rates of the first flow path 2 and the branch flow path 4. This flow rate fluctuation monitoring device 1D can also be used in the cases (1) to (3).

(5) When f _A fluctuates and f _B fluctuates out of synchronization with f _A , f _D fluctuates In the case of (5), the flow rate fluctuation monitoring device shown in FIG. Use 1E. The flow rate variation monitoring device 1E shown in FIG. The flow rate fluctuation monitoring device 1E has the same configuration as that of the flow rate fluctuation monitoring device 1C except that it includes the determination unit 10. Since the configuration other than the determination unit 10 of the flow rate fluctuation monitoring device 1E is the same as the configuration of the flow rate fluctuation monitoring device 1D, the detailed description of the configuration other than the determination unit 10 may be omitted.

  The determination unit 10 is means for determining the case (5) based on the calculation results output from the calculation unit 7 and the calculation unit 71.

f _A, so is calculated by the sum of the _{f B} and _{f D,} case (5), when _{f B} fluctuates without change and synchronization of _{f A,} the fluctuation amount of the _{f D} is _{f A} And the difference between f _B and f _B. That is, the flow rate fluctuation of _{f D} does not match the flow rate variation of _{f A.} Therefore, when the calculation result calculated by the calculation unit 7 follows the calculation result calculated by the calculation unit 71, the determination unit 10 determines that the case is (1) and the calculation unit 7 calculates the calculation result. If the calculation result is constant, it is determined as the case of (4) above, and if the calculation result calculated by the calculation unit 7 does not follow the calculation result calculated by the calculation unit 71, the case of (5) It is preferable that it is set so as to discriminate. The flow rate fluctuation monitoring device 1E can monitor flow rate fluctuations occurring in the first flow path and the second flow path by monitoring the flow rates of the first flow path 2 and the branch flow path 4. But you may use the flow volume fluctuation | variation monitoring apparatus 1E in the case of said (1)-(4).

  Thus, the flow rate fluctuation monitoring apparatus according to the present invention can monitor the flow rate fluctuations in various modes.

  The flow rate fluctuation monitoring device according to the present invention can monitor the flow rate fluctuation accurately and accurately by being incorporated in a device having a flow path for monitoring the flow rate fluctuation. Examples of the device having a flow path for monitoring the flow rate variation include a biological component measuring device. Hereinafter, a biological component measuring apparatus including the flow rate fluctuation monitoring apparatus according to the present invention will be described as the present invention.

  The biological component measuring apparatus according to the present invention is an apparatus for measuring a biological component to be measured when performing a medical practice. Note that the biological component measurement apparatus of the present invention may be incorporated in a medical support apparatus that supports medical practice.

  Examples of the biological component include glucose, urea, uric acid, lactose, sucrose, lactate (lactic acid), ethanol, glutamic acid, ammonia, creatinine, oxygen, and the like. When performing medical practice, it is sometimes necessary to measure the pH value, oxygen concentration, etc. in the biological fluid. In the biological component measuring apparatus of the present invention, the concept of biological components includes the pH value, oxygen concentration, etc. of biological fluids.

  Examples of the biological component measurement device include an artificial pancreas device that supplies insulin to the living body according to the measured blood glucose level, an artificial dialysis device that performs dialysis, a urea concentration meter that measures the concentration of urea contained in the body fluid, A uric acid concentration meter that measures the concentration of uric acid contained in body fluids, a sugar content measuring device that measures sugar content such as lactose and sucrose in biological fluids, a lactic acid measurement device that measures lactate, and the glutamic acid concentration in the body A glutamic acid concentration meter that measures the concentration of ammonia, an ammonia concentration meter that measures the concentration of ammonia in body fluid, a creatinine concentration meter that measures the concentration of creatinine in body fluid, and the like.

  In these various biological component measuring devices, various sensors can be adopted as the biological component sensor for measuring the biological component according to the type of the biological component.

  Examples of the biological sensor (hereinafter also referred to as “biosensor”) include an enzyme sensor using an enzyme, a microorganism sensor using a microorganism, a hybrid sensor using an enzyme and a microorganism, and the like.

  The enzyme or microorganism immobilized in such a biosensor is selected according to the object to be measured, that is, the biological component. For example, β-D-glucose oxidase and Pseudomonas fluorescens when the measurement target is glucose, urease when the measurement target is urea, uricase when the measurement target is uric acid, and lactate when the measurement target is lactate. Lactate oxidase in some cases, lactase or β-galactosidase when the measurement target is lactose, alcohol oxidase when the measurement target is ethanol, Trichosporon brassicaes, glutamate dehydrogenase when the measurement target is glutamic acid, Escherichia coli, When the object to be measured is ammonia, nitrifying bacteria or the like is selected.

  In the biological component measuring apparatus according to the present invention, the measurable biological component may be one type or two or more types. When two or more types of biological components are measured, two or more types of biosensors may be connected in the middle of the body fluid transfer channel for transferring body fluid collected from the living body. Further, when measuring a plurality of biological components, the body fluid transfer channel can be branched into a plurality of channels, and one or more biosensors can be connected to each branch channel.

  The biological component measuring apparatus of the present invention is equipped with a flow path capable of forcibly or positively transferring body fluid in one direction and quantitatively in cooperation with the fluid transfer means and the flow path. ,preferable. The fluid flowing in the flow path is the fluid A, the mixture of the fluid A and the interface forming fluid B, and other fluids. Depending on the type of fluid to be circulated in the flow path, body fluids collected from the living body such as blood, urine, lymph, and cerebrospinal fluid, and other body fluids collected from the living body such as physiological saline and heparin-containing liquid Mixed liquid with body fluid dilution liquid, calibration liquid for calibrating biosensor, second calibration liquid for calibrating body fluid transfer flow path, second calibration liquid for simultaneously calibrating changes with time in biosensor and body fluid transfer flow path And waste liquid after measurement of biological components. Further, the flow path in the biological component measuring apparatus of the present invention is a generic term for a plurality of types of flow paths that have been functionally differentiated, and the flow rate fluctuation monitoring apparatus according to the present invention is incorporated. In addition, among a plurality of types of functionally differentiated flow paths, one flow path circulates a mixed liquid of body fluid collected from a living body and another liquid, another flow path circulates a calibration liquid, and another flow path. Is configured to circulate a liquid mixed with the gas of the non-quantitative portion in the flow rate fluctuation monitoring device. In the biological component measuring apparatus according to the present invention, these various liquids, fluid A, interface forming fluid B, and mixtures of fluid A and interface forming fluid B may be collectively referred to as fluids. It is easy to understand what kind of mode it is according to the context of the following description column.

  The living body component measuring apparatus according to the present invention can be provided with a wetted product as a member for collecting a body fluid containing a living body component from a living body, a member required for measuring a living body component, and a member required for sensor calibration. .

  Here, as the wetted product, for example, an indwelling needle, a catheter, a physiological saline tank, a physiological saline outlet pipe that is an example of a physiological saline outlet channel for extracting physiological saline from the physiological saline tank, and physiological saline Pipe that is an example of a flow path for introducing physiological saline derived from the outlet pipe into the catheter, various diluents added to the collected body fluid as necessary, for example, a diluent storage tank for storing a buffer solution, and diluent storage Calibration for calibrating a diluent outlet pipe that is an example of a diluent outlet passage that extracts the diluent from the tank, a diluent transfer passage that supplies the diluent to the fluid transfer means, and a biosensor that is an example of a biological component sensor Calibration liquid storage tank for storing the liquid, calibration liquid outlet pipe as an example of the calibration liquid outlet flow path for extracting the calibration liquid from the calibration storage tank, calibration liquid transfer passage for supplying the calibration liquid to the fluid transfer means, A flushing liquid storage tank for storing flushing liquid for cleaning the flow path and the flow path, a flushing liquid outlet pipe for extracting the flushing liquid from the flushing liquid storage tank, a flushing liquid transfer channel for supplying the flushing liquid to the fluid transfer means, and a biosensor Examples include a waste liquid storage tank for storing waste liquid discharged from the apparatus, and in some cases, an instrument that may come into contact with a biosensor or other fluid. In short, the liquid contact product includes all the members that make the biological component measurement apparatus according to the present invention operable.

  Hereinafter, an artificial pancreas device which is an example of a biological component measurement device according to the present invention will be described. This artificial pancreas device has an artificial pancreas device body and a glucose measurement unit (hereinafter referred to as “blood glucose level measurement unit”) that is detachably attached to the artificial pancreas device body.

  As shown in FIG. 6, the blood glucose level measurement unit 11A includes a flow rate fluctuation monitoring device 1A, a substrate 12, a physiological saline tank 13, a diluent tank 14, a calibration liquid tank 15, and a waste liquid container. The tank 16, the glucose sensor 17, the catheter 18, the mixing part 19, and various flow paths are provided. The various channels include a glucose measurement channel 20, a calibration solution transfer channel 21, a diluent transfer channel 22, a second diluent transfer channel 23, a waste solution transfer channel 24, and a blood transfer flow. A path 25, a physiological saline transfer flow path 26, a measurement liquid introduction path 27, and a measurement liquid discharge path 28 can be exemplified. Moreover, the 1st flow-path switching part 29 and the 2nd flow-path switching part 30 which can switch the distribution | circulation of the fluid in various flow paths are attached in the middle of the above-mentioned flow path. Various flow paths are detachably connected by a connector 31.

The substrate 12 has an opening 32 for allowing a fluid transfer member (not shown) that circulates a fluid in the flow path in a unidirectional and quantitative manner to act on the various flow paths. It has been established. In the blood glucose level measurement unit 11A, a roller (not shown) in a roller pump as a fluid transfer member is brought into contact with various flow paths from the back side of the substrate 12, and the various flow paths installed in the opening 32 are formed by the rollers. The fluid is circulated like a squeeze. The substrate 12 is connected to the flow rate fluctuation monitoring device 1A and a tank capable of storing various liquids, the various flow paths are disposed, and connected to an appropriate liquid contact product.
In addition, what is necessary is just to determine the shape, material, and magnitude | size of the board | substrate 12 suitably according to the environment where the blood glucose level measurement unit 11A is installed. For example, when the substrate is formed of a thin sheet having flexibility, the thickness of the substrate is usually 0.01 to 3 mm, preferably 0.05 to 0.5 mm. The hardness of the substrate is preferably 10 degrees or more and 90 degrees or less (JIS K 6253, durometer type A (Shore A)). The material of the substrate is not particularly limited. For example, soft PVC, various elastomers, silicone resins, fluororesins (PTFE, ETFE, PFA, FEP, etc.) and rubbers (natural rubber, NBR, CR, FKM, FFKM, VQM, etc.) Synthetic rubber, etc.).

  The physiological saline tank 13 can store physiological saline, the diluent tank 14 can store a diluted solution for diluting the collected blood, and the calibration solution tank 15 calibrates the sensor. Calibration liquid can be stored, and waste liquid tank 16 can store waste liquid such as fluid after measurement and calibration liquid after calibration.

  The glucose sensor 17 is a member that measures the concentration of glucose contained in a measurement liquid obtained by mixing blood and a diluent.

  The catheter 18 is a member that collects blood, and is used by being placed in a living body. In the embodiment shown in FIG. 6, a double lumen catheter is adopted as the catheter 18.

  The mixing unit 19 is a member that mixes the blood collected by the catheter 18 and the diluent stored in the diluent tank 14.

  The glucose measurement channel 20 is a channel through which a measurement solution obtained by mixing blood and a diluent with the mixing unit 19 flows. The glucose measurement channel 20 corresponds to the second channel 3 in the flow rate fluctuation monitoring device 1A. The calibration solution transfer channel 21 is a channel through which a calibration solution for calibrating the glucose sensor 17 flows. The diluent transfer channel 22 and the second diluent transfer channel 23 are channels through which a diluent for diluting blood or calibration solution flows. The waste liquid transfer flow path 24 is a flow path through which the measurement liquid after measurement and the calibration liquid after sensor calibration flow. The blood transfer channel 25 is a channel through which blood collected by the catheter 17 flows. The physiological saline transfer channel 26 is a channel through which physiological saline introduced into the catheter 17 flows. The measurement liquid introduction path 27 is a flow path for introducing the measurement liquid before the measurement into the glucose sensor 17, and the measurement liquid lead-out path 28 is a flow path for deriving the measurement liquid after the measurement from the glucose sensor 17.

  As for the diluted solution, it is preferable that the solution can maintain the pH of the measurement solution supplied to the glucose sensor 17 at a constant level, and examples thereof include a phosphate buffer solution. A solution such as a phosphate buffer is also referred to as a buffer. Therefore, in one embodiment shown in FIG. 6, it can be said that the diluent is a buffer. When a buffer solution is used as a diluent, the pH of the measurement solution is kept constant by the buffer solution, so that a stable glucose level measurement can be performed without depending on the patient with a glucose sensor sensitive to pH. it can.

As an embodiment of the biological component measuring apparatus in which the flow rate fluctuation monitoring apparatus according to the present invention is incorporated, as shown in FIG. 6, the measurement liquid mixed in the mixing unit 19, that is, the flow of the fluid A, that is, the liquid A road becomes the first flow path in the present invention, and the glucose measurement channel 20 is a second flow path in the present invention as described above, and branch flow path that branches in the invention of this the coupling portion 8 It becomes a flow path. Further, as shown in FIG. 6, the fluid A or the mixture of the fluid A and the interface forming fluid B flowing in the branch flow path 4 is stored in the waste liquid tank 16 that stores the waste liquid through the gas mixer 5 and the detection unit 6. It is transferred to. In FIG. 6, the coupling unit 8 is located downstream of the mixing unit 19 and upstream of the first switching unit 29, but the object of the biological component measuring apparatus according to the present invention can be achieved, and this As long as the operation of the flow rate fluctuation monitoring device according to the invention can be exerted, an appropriate design change can be adopted, and for example, it may be branched inside the mixing unit 19.

  The mixing unit 19 shown in FIG. 6 adopts various structures as long as the blood supplied from the blood transfer channel 25 and the diluent such as a buffer supplied from the diluent transfer channel 22 can be mixed. can do. In the blood sugar level measuring unit 11A in the artificial pancreas device which is one embodiment of the biological component measuring device of the present invention, the flow path from the mixing unit 19 to the glucose sensor 17 is short, so that blood and dilution before reaching the glucose sensor 17 are performed. It is preferable to employ a mechanism for sufficiently mixing the liquid.

  Hereinafter, a method of using the blood glucose level measurement unit 11A, which is an embodiment of the biological component measurement apparatus of the present invention, and its operation will be described with reference to FIG.

(I) Method for Measuring Glucose and Its Action First, the respective flow paths of the substrate 12 are respectively connected to the physiological saline tank 13, the catheter 18, the diluent tank 14, the calibration liquid tank 15, and the like. While being connected to the waste liquid tank 16 and the branch flow path 4, each flow path is arranged so that a roller pump (not shown) acts, and the first flow path switching unit 29 and the second flow path switching unit 30 are fluids. It is installed so that the distribution of can be switched. Connection of each flow path is performed by connecting the connector 31 in each flow path and the connector 31 of each wetted product. The connection between the connectors is an extremely simple operation. In this way, the pipe connection work of the biological component measuring device 11A is completed, and the biological component measuring device is ready to be driven.

  Next, the catheter 18 is placed in the living body. Subsequently, heparin-containing physiological saline is sent from the physiological saline tank 13 to the catheter 18. Further, the blood collected by the catheter 18 is mixed with heparin-containing physiological saline in the catheter 18. As a result, the heparin-containing blood in the catheter 18 is forcedly transferred through the blood transfer channel 25 by reaching the mixing unit 19 by being squeezed by the roller pump that contacts the various channels via the opening 32. To do.

  On the other hand, the diluting liquid is fed from the diluting liquid tank 14 through the diluting liquid transfer passage 22 by the roller pump. The sent dilution liquid reaches the mixing unit 19. By mixing in the mixing unit 19, the measurement liquid, that is, the fluid A in the present invention, that is, the liquid A is prepared.

  In the blood glucose level measurement unit 11A shown in FIG. 6, the blood collected from the catheter 18 is quantitative, but the diluent transfer channel 22 hangs down from the diluent tank 14 and is sandwiched between other devices. By being crushed, the diluted liquid to be transferred may not reach a predetermined flow rate, which may cause flow rate fluctuations. Further, flow rate fluctuations may occur in other channels, for example, the branch channel 4, the glucose measurement channel 20, the waste liquid transfer channel 24, and the like. Even if flow rates fluctuate in various flow paths, the blood glucose level measurement unit 11A includes the flow rate fluctuation monitoring device 1A that is one embodiment of the present invention, so that the operator can monitor the flow fluctuations. Can do.

  In the state shown in FIG. 6, the first flow path switching unit 29 disconnects the calibration liquid transfer flow path 21 from the glucose measurement flow path 20 and circulates between the blood transfer flow path 25 and the first flow path 2. It is in a state. In addition, since the branch flow path 4 is arranged on the upstream side of the first flow path switching unit 29, the branch flow path 4 is always in a flowable state regardless of the operation of the first flow path switching unit 29. Therefore, the measurement liquid flows through the first flow path 2 and is injected into the glucose sensor 17 via the connector 31. In addition, the measurement liquid prepared in the mixing part 19 will be distribute | circulated by dividing into the glucose measurement flow path 20 and the branch flow path 4 corresponding to the 2nd flow path 3 in the flow volume fluctuation | variation monitoring apparatus 1A. In the glucose sensor 17, glucose in the measurement liquid is measured. The measured glucose amount data is transferred to a display member (not shown) so that the operator can recognize it.

  The branch flow path 4 through which the measurement liquid flows acts in the same manner as the branch flow path 4 of the flow rate fluctuation monitoring apparatus described above. More specifically, the measurement liquid flowing through the branch flow path 4 is mixed with a fixed amount of gas, such as air, at a predetermined interval in the gas mixing section 5. That is, the measurement liquid is the fluid A, and the gas is the interface forming fluid B. The mixing of the gas is executed so that the measurement liquid flows while maintaining the state divided by the gas. Next, the measurement liquid mixed with gas passes through the detection unit 6. Here, an optical sensor including an issuing element and a light receiving element is used as the detection unit 6, and the passage of the gas-liquid interface is detected based on the difference in absorbance between the liquid and the gas. Subsequently, the detection data detected by the detection unit 6 is output to the calculation unit 7 to calculate the flow rate of the measurement liquid. The measurement liquid that has passed through the detection unit 6 is sent to the waste liquid tank 16 and stored in the waste liquid tank 16.

  On the other hand, the measurement liquid after measurement passes through the measurement liquid outlet path 28 and the waste liquid transfer flow path 24 and is sent through the waste liquid transfer flow path 24 by the roller pump. The sent measurement liquid reaches the waste liquid tank 16 and is stored in the waste liquid tank 16.

  Therefore, in the embodiment shown in FIG. 6, the flow rate fluctuation can be reliably and accurately monitored by the flow rate fluctuation monitoring device 1 </ b> A, so that the liquid does not circulate while being misidentified mechanically. By improving the accuracy of blood glucose level measurement, it is possible to provide the blood glucose level measurement unit 11A that is highly safe for the medical support device.

  The blood glucose level measurement unit 11A shown in FIG. 6 measures glucose in blood, but may measure body fluids other than blood. Examples of such body fluid include urine, sweat, and interstitial fluid.

  Furthermore, the catheter 18 in the biological component measuring apparatus 11A is connected to the living body component measuring apparatus 11A separately from the outside, but in the biological component measuring apparatus according to the present invention, for example, a blood collection means such as a catheter is used. You may mount beforehand in this biological component measuring apparatus. In this case, a connector attached to the introduction tube in the blood collecting means may be coupled to the connector 31 at the other end of the physiological saline transfer channel 26.

  As described above, the biological component measuring apparatus according to the present invention can not only measure biological components such as glucose but also includes the flow rate fluctuation monitoring apparatus according to the present invention, and thus can occur in various flow paths. Flow rate fluctuations can be reliably and accurately monitored. If the flow rate of fluid flowing into the sensor that measures biological components is fluctuating, accurate measurement of biological components cannot be performed, so the possibility of applying treatment to the living body based on inaccurate measurement results. There is. However, since the flow rate fluctuation monitoring device according to the present invention can reliably and accurately monitor the flow rate variation, the accuracy of the measurement result of the biological component is improved, and the biological component measurement device according to the present invention is further improved. Even if it is incorporated into a medical support device, safety can be ensured.

  FIG. 7 shows a modification of the blood glucose level measurement unit 11A shown in FIG.

  In the blood glucose level measurement unit 11B shown in FIG. 7, the difference from the blood glucose level measurement unit 11A is that the flow rate fluctuation monitoring device 1B is used instead of the flow rate fluctuation monitoring device 1A, and the blood and the diluent are mixed. In the mixing part 19, it is two points which improved the mixing efficiency using gas, and the structure and effect | actions other than this difference are the same as that of the blood glucose level measurement unit 11A. Description of members, usage methods, and actions that are common to the blood glucose level measurement unit 11A may be omitted.

  In the blood glucose level measurement unit 11B shown in FIG. 7, the mixing unit 19 introduces a gas inert to the diluent and blood, for example, air, as a method for improving the mixing efficiency of the diluent and blood. The diluent and blood may be mixed. As shown in FIG. 7, the gas mixer 51 in the flow rate fluctuation monitoring device 1B also serves as a member that improves the mixing efficiency. A gas flow path 33 is provided on the substrate 12. The gas flow path 33 is a tube having elasticity similar to the blood transfer path 18 and the like, and the gas flow path 33 is squeezed by a roller pump (not shown) in the opening 32 so that gas in the flow path, for example, air Can be supplied to the mixing unit 19 side. In the mixing unit 19 or on the upstream side of the mixing unit 19, the diluent and air are mixed, and blood is further mixed therewith. The separator 9 is provided on the downstream side of the mixing unit 19 to separate the measurement liquid and the measurement liquid in a state divided by gas. In this way, by supplying the gas from the gas mixer 51 to the mixing unit 19, the mixing efficiency of the blood and the diluent can be improved, and the residence time of the blood in the mixing unit 19 and the glucose measurement channel 20 can be shortened. As a result, the collected blood can be measured quickly. Furthermore, since the gas mixed in the gas mixing device 51 is also the interface forming fluid B of the flow rate fluctuation monitoring device 1B, not only the efficiency of biological measurement is improved but also the number of parts of the entire device can be revealed. ,preferable.

A modification of the blood glucose level measurement unit 11C shown in FIG. 6 is shown in FIG. Since the configuration of the blood glucose level measurement unit 11C shown in FIG. 8 is in common with the configuration of the blood glucose level measurement unit 11C shown in FIG. 7, the same configuration as the configuration of the blood glucose level measurement unit 11B in the blood glucose level measurement unit 11C is used. The description is omitted.
The blood glucose level measurement unit 11C shown in FIG. 8 is a flow path through which gas, for example, air reaches the mixing unit 19 from the diluent tank 14 by the gas mixer 51, and is upstream of the mixing unit 19 and at the opening 32. The blood glucose level measurement unit 11B shown in FIG. 7 has a structure in which gas, for example, air is sent out to the mixing unit 19 by the gas mixer 51b, whereas the blood glucose level measurement unit 11B shown in FIG. The measurement unit 11C and the blood glucose level measurement unit 11B have different structures.

  In the blood glucose level measurement unit 11C shown in FIG. 8, the flow path from the one end opening immersed in the diluent in the diluent tank 14 to the separator 9 via the separator 9 is used in the present invention. It corresponds to the first flow path, the dilution tank 14 corresponds to the first liquid supply unit in the present invention, the dilution liquid corresponds to the first liquid in the present invention, and the gas mixer 51 and the gas mixer 51 The flow path to the merging section A connected to the flow path upstream of the mixing section 19 and downstream of the opening section 32 corresponds to the interface forming fluid supply section in this invention. The air mixed in the flow path is the interface forming fluid in the present invention, and the catheter 18 corresponds to the second liquid supply unit in the present invention. The mixed liquid of the body fluid collected by the catheter 18 and physiological saline, that is, the collected sample. The liquid corresponds to the second liquid .

  In this blood glucose level measurement unit 11C, when air is injected from the merging portion A into the first flow path 2 located downstream of the opening 32 and upstream of the mixing portion 19, mixing occurs from the merging portion A. In the flow path up to the section 19, the dilution liquid and the air are separated in the state where the air and the dilution liquid are separated and the dilution liquid divided by the air and the air that divides the dilution liquid exist alternately. Is transferred to the mixing section 19.

  In the mixing unit 19, the collected sample solution sent out from the catheter 18 is supplied into the mixing unit 19 and the final sample solution and the diluted solution are mixed. Even if the sampled sample solution is supplied to the air in the mixing unit 19, the sampled sample solution is mixed with the diluent adjacent to the air.

  The mixing unit 19 may be a spiral channel that extends from the junction point between the blood transfer channel and the first channel that transfers air and diluent in a state where the air and diluent are divided to the separator 9. Good. If the mixing section 19 has a spiral flow path, in other words, a coil-shaped flow path, the liquid can be fed by the continuous flow method, and the diluting liquid and the collected sample liquid can be mixed during the transfer.

  In the blood glucose level measurement unit 11C shown in FIG. 8, the separator 9 is a gas-liquid separator. In the glucose measurement channel, which is the second channel in the present invention, the measurement liquid that does not contain gas and is a mixed liquid of the diluent and the collected sample liquid is pushed away. Another channel through which the liquid is extruded from the separator 9 is a branch channel 4. The branch channel 4 flows in a state where the measurement liquid corresponding to the liquid A and the air corresponding to the gas B are segmented or divided. Since the detection unit 6 is interposed in the branch flow path 4, the interface between the measurement liquid and the air divided and flowing through the branch flow path 4 is detected by the detection unit 6, and the flow rate fluctuation is calculated in the calculation unit 7. Is done.

1A, 1B, 1C, 1D, 1E Flow rate fluctuation monitoring device 2 1st flow path 201 1st fluid supply part 202 2nd fluid supply part 3 2nd flow path 4 Branch flow path 5, 51 Gas mixing device 6 Detection part 61 1st 2 Detection unit 7 Calculation unit 71 Second calculation unit 8 Coupling unit 9 Separator 10 Discrimination unit 11A, 11B Blood glucose level measurement unit 12 Substrate 13 Saline tank 14 Diluent tank 15 Calibration solution tank 16 Waste solution tank 17 Glucose sensor 18 Catheter 19 Mixing unit 20 Glucose measurement channel 21 Calibration solution transfer channel 22 Diluent transfer channel 23 Second Diluent transfer channel 24 Waste solution transfer channel 25 Blood transfer channel 26 Saline transfer channel 27 Measuring liquid introduction flow path 28 Measuring liquid outlet flow path 29 First flow path switch 30 Second flow path switch 31 Connector 32 Opening 33 Gas flow path 51 Gas mixing 61 the second detecting unit 71 and the second calculation unit 201 first fluid supply part 202 and the second fluid supply portion

Claims (6)

A first flow path through which fluid A circulates;
A second flow path through which the fluid A flows at a flow rate less than the flow rate of the fluid A flowing through the first flow path;
A branch channel provided by branching at a coupling portion between the first channel and the second channel, the interface forming fluid B capable of forming an interface with the fluid A, and the fluid A; Is a branch channel that circulates in a state where the fluid A is divided into the interface-forming fluid B;
A detection unit that is provided only in the branch flow path and detects an interface between the interface forming fluid B and the fluid A that circulates;
The detection data output from the detecting unit, and an arithmetic unit for calculating the flow rate variation,
The flow rate fluctuation monitoring apparatus, wherein the second flow path and the branch flow path are connected only by the coupling portion.   The flow rate fluctuation monitoring apparatus according to claim 1, wherein the fluid A is a liquid A and the interface forming fluid B is a gas B.   The gas B is (1) provided by the interface forming fluid supply section provided in the first flow path or provided in the branch flow path, or (2) the coupling from the middle of the first flow path. The flow rate according to claim 2, wherein the flow rate is formed by a fluid conversion unit that converts a part of the liquid A into a gas B provided in any part of the flow path to the detection unit via the unit. Fluctuation monitoring device. The first flow path is
A first liquid supply section for supplying a first liquid necessary for forming the liquid A into the first flow path;
An interface-forming fluid supply unit that is provided on the downstream side of the first liquid supply unit and supplies the gas B into the first flow path;
A second liquid supply unit that is provided downstream of the interface forming fluid supply unit and supplies a second liquid that forms liquid A with the first liquid;
The coupling portion includes a separator that separates a gas-liquid mixture of the liquid A and the gas B obtained by mixing the first liquid and the second liquid and the liquid A not containing the gas B,
The second flow path distributes the fluid A separated by the separator and not containing the gas B,
The flow rate fluctuation monitoring device according to claim 2, wherein the branch flow channel distributes a gas-liquid mixture of a liquid A and a gas B obtained by mixing the first liquid and the second liquid. .   The separator for separating the mixture of the interface forming fluid B and the fluid A and the fluid A not including the interface forming fluid B is provided at a coupling portion between the first channel and the second channel. Flow rate fluctuation monitoring device described in 1.   A biological component measuring apparatus provided with the flow volume fluctuation | variation monitoring apparatus of any one of Claims 1-5.

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