JP2007296327A - Biological component measurement unit, biological component measurement unit package, medical support instrument kit, and medical support instrument kit package - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a biological component measurement unit 2 for a medical support device capable of improving workability and capable of measuring a body fluid component by a hygienic operation. Comprising a substrate 3 that can be detachably mounted on the medical support apparatus main body 1 having a fluid transfer means for circulating a fluid to be unidirectionally flowed, and the flow path was collected from (1) body fluid collection means It can be freely attached to and detached from the body fluid outlet flow path for leading the fluid. (2) When the substrate 3 is mounted on the medical support apparatus body 1, the fluid in the flow path can be transferred in one direction in cooperation with the roller 1A. (3) A biological component measurement unit 2 for a medical support device that is detachable from a measurement liquid introduction channel 8i that introduces a fluid into the biological component sensor 4A for measuring a biological component contained in the fluid to be transferred.
[Selection] Figure 1

Description

  The present invention relates to a biological component measurement unit, a biological component measurement unit package, a medical support instrument kit, and a medical support instrument kit package, and more particularly, can be attached to a medical support device body equipped with a sensor with one touch. The biological component measuring unit that can measure the biological component, for example, blood glucose level with a sanitary operation, can be stored for a long time in a sterilized state, and the biological component is sterilized at the time of use. Biological component measurement unit package that can take out the measurement unit, can be attached to the medical support device body with one touch, improving workability, and can measure biological components such as blood glucose level with hygienic operation In addition, medical care that can be easily prepared for operation of the medical support device by arranging the wetted parts outside the main body of the medical support device援器 tool kit, and a long period of time remains sterile can be saved, a medical support instrument kit package that can be taken out medical support instrument kit in a sterile condition during use.

  2. Description of the Related Art Conventionally, for example, an artificial pancreas device used in an ICU connects a pipe provided in an instrument for collecting body fluid from a living body and a predetermined pipe provided in the device when blood glucose level measurement is started by this device. It was necessary to make various pipe connections. Since there are a large number of pipes for connecting various containers inside and outside the apparatus and various apparatuses inside and outside the apparatus, it takes a long time to connect the pipes. In addition, since bodily fluids adhere to these devices, there is a risk of nosocomial infection to the operator and / or patient through the bodily fluid adhesion.

  Therefore, for example, an instrument for measuring blood glucose level used in such an artificial pancreas device can be accurately and easily connected to a pipe, and is hygienic without hospital infection during operation. Improvement in workability has been demanded.

  For example, as an example of completing piping and the like for measuring blood in advance at the medical site before medical work, “the support member (20; 220); and the blood treatment attached to the support member (20; 220)” A device (40; 240); and a plurality of fluid circuits (50, 60, 70, 80, 90, 100; 250, 260, 270, 280, 290) interconnected to the support member (20; 220). And at least one of these fluid circuits (50, 60, 70, 80, 90, 100; 250, 260, 270, 280, 290) is arranged in a U shape with respect to the support member (20; 220). Each of the U-shaped portions (54, 84, 94, 104; 254, 264, 274, 284) extends from the support member (20; 220) so as to cooperate with the peristaltic pump, and the fluid circuit. (5 , 60, 70, 80, 90, 100; 250, 260, 270, 280, 290) at least one of which is fluidly coupled to the blood processing device (40; 240). 210) "has been proposed (see Patent Document 1).

  However, Patent Document 1 does not describe measuring a glucose component in blood. Further, in Patent Document 1, there is a description of a sensor or the like (blood processing apparatus) that measures some component in blood. However, this blood processing apparatus is merely described as “the term“ blood processing apparatus ”used in this specification”. blood treatment device) means any device for removing components from the blood stream and / or introducing components into the blood stream, such as plasmapheresis, oxygenation, hemodialysis ( Including hemodialysis, hemofiltration and hemodiafiltration treatment devices. (Patent Document 1, paragraph number [0006]), the device is used for artificial dialysis.

  Further, Patent Document 1 does not describe that the sensors are calibrated again, for example, in order to measure components in blood.

JP-A-6-292722 (Claim 1)

  The present invention eliminates such conventional problems, can improve workability, and can measure a biological component such as a blood glucose level by a hygienic operation, such as a blood glucose level measuring unit. Provided are a biological component measurement unit package, for example, a blood glucose level measurement unit package, a medical support instrument kit and a medical support instrument kit package capable of performing hygienically and hygienically to operate the medical support device. That is the issue.

As means for solving the above problems,
Claim 1
“A substrate that can be detachably mounted on a medical support apparatus main body having a fluid transfer means for circulating fluid existing in the channel in one direction in cooperation with the channel, and a channel mounted on the substrate. With
The flow path is
(1) It is detachable from the bodily fluid outlet channel for extracting the fluid collected from the bodily fluid collecting means,
(2) When the substrate is mounted on the medical support device body, the fluid in the flow path can be transferred in one direction in cooperation with the fluid transfer means,
(3) It is detachable from the measurement liquid introduction channel for introducing the fluid into the biological component sensor for measuring the biological component contained in the transferred fluid.
A biological component measurement unit characterized by including a body fluid transfer channel,
Claim 2
"The channel is
(1) It can be freely attached to and detached from the diluent outlet channel for leading the diluent contained in the diluent reservoir.
(2) The diluent can be supplied to the body fluid transfer channel on the upstream side of the measurement solution introduction channel for introducing fluid into the biological component sensor.
The biological component measuring unit according to claim 1, further comprising a dilution liquid transfer channel,
Claim 3
3. The biological component measuring unit according to claim 2, wherein the flow path includes a mixing unit that mixes the fluid collected from the body fluid collecting unit and the diluent supplied from the diluent transfer channel. ,
Claim 4
"The channel is
(1) including a gas flow path capable of supplying a gas into the diluent transfer flow path or the mixing means,
The biological component measurement unit according to claim 3, further comprising a gas-liquid separator at a site downstream of the mixing means and upstream of the biological component sensor.
Claim 5
"The channel is
(1) It is detachable from the calibration liquid outlet channel for extracting the calibration liquid stored in the calibration liquid storage tank,
(2) The calibration liquid can be supplied to the body fluid transfer channel on the upstream side of the measurement solution introduction channel for introducing a fluid into the biological component sensor.
The biological component measurement unit according to any one of claims 1 to 4, comprising a calibration liquid transfer channel.
Claim 6
"The channel is
(1) It is detachable from the body fluid dilution liquid outlet flow channel for extracting the body fluid dilution liquid stored in the body fluid dilution liquid storage tank,
(2) It is detachable from a body fluid diluent introduction channel for introducing a body fluid diluent into the body fluid collecting means.
The biological component measurement unit according to any one of claims 1 to 5, comprising a bodily fluid diluent transfer channel,
Claim 7
"The channel is
(1) It is detachable from the second calibration liquid outlet flow path for deriving the second calibration liquid stored in the second calibration liquid storage tank.
(2) The second calibration liquid can be supplied to the downstream side of the body fluid outlet channel and to the upstream side of the fluid transfer means.
The biological component measurement unit according to any one of claims 1 to 6, comprising a second calibration liquid transfer channel.
Claim 8
“When the substrate is mounted on the medical support apparatus main body, the flow path is formed by the flow path opening / closing means provided in the medical support apparatus main body, and the flow path between the body fluid transfer flow path and the dilution liquid transfer flow path. The biological component measurement unit according to claim 2, further comprising a flow path opening / closing portion that is opened and closed.
Claim 9
“A biological component measurement unit package comprising the biological component measurement unit according to any one of claims 1 to 8, which is packaged in a sterilized state inside and outside with a packaging material”,
Claim 10
"The biological component measuring unit according to any one of claims 1 to 8,
Necessary when using the medical support device, a wetted product other than the medical support device main body and the biological component measurement unit,
A medical support instrument kit characterized by comprising:
Claim 11
“A medical support instrument kit package comprising the medical support instrument kit according to claim 10, which is packaged in a sterilized state with an internal / external cut-off state using a packaging material”.

  In this invention, the flow path mounted on the substrate includes a bodily fluid transfer flow path, and one end of the bodily fluid transfer flow path is detachable from the bodily fluid discharge flow path for leading the fluid collected from the bodily fluid collection means. In addition, the other end of the body fluid transfer channel is detachable from a measurement solution introduction channel for introducing a fluid into the biological component sensor. Therefore, by attaching the substrate to a medical support device main body, for example, an artificial pancreas device main body, and attaching a body fluid outlet channel and a measurement liquid introduction channel to the body fluid transfer channel, the medical support device can immediately measure a body fluid component. Can be. In other words, the trouble of piping the body fluid transfer channels one by one as in the prior art is solved by the present invention, and piping for attaching a biological component measurement unit such as a blood glucose level measurement unit to the medical support device body such as an artificial pancreas device body, etc. Can be simplified and workability can be improved. Also, since the work of piping and the like is simplified, for example, unsanitary operations caused by dirt on the piping and the like are reduced. Therefore, according to this invention, workability | operativity can be improved and the biological component measurement unit which can measure a biological component, for example, a blood glucose level, can be provided with hygienic operation.

  Further, after the work of measuring the biological component, for example, glucose measurement, it is necessary to remove the pipe of the used biological component measuring unit, for example, the blood glucose level measuring unit, simply by removing the substrate from the medical support device body, for example, the artificial pancreas device body. Therefore, it is possible to discard the biological component measurement unit, for example, the blood glucose level measurement unit, without the operator touching the body fluid or the like adhering to the pipe or the like. Therefore, also from this viewpoint, workability can be improved, and a biological component measurement unit such as a blood glucose level measurement unit that can measure a blood glucose level with a hygienic operation can be provided.

  In the present invention, a biological component measurement unit is provided in which the body fluid transfer channel and the diluent transfer channel are mounted on a substrate. In this biological component measurement unit, the bodily fluid transfer channel has the above-described function, one end of the dilute solution transfer channel is detachable from the dilute solution discharge channel, and the other end is the bodily fluid transfer channel. It is formed so that a diluent can be supplied. Therefore, the substrate is attached to the medical support device body, for example, the artificial pancreas device body, the body fluid discharge channel and the measurement solution introduction channel are mounted on the body fluid transfer channel, and one end of the diluent transfer channel is used as the diluent discharge channel. By mounting, the medical support device can be immediately brought into a state in which a body fluid component can be measured. In other words, the trouble of piping the body fluid transfer channel and the diluent transport channel one by one as in the prior art is solved by the present invention, and the biological component measuring unit such as the blood glucose level measuring unit is added to the medical support device body such as the artificial pancreas device body. It is possible to simplify the work of piping and the like when attaching the hood, and to improve workability. For the purpose of reducing the factor that interferes with the measurement of the biological component by the biological component sensor within the error range, the diluent is, for example, a phosphate buffer. When the biological component sensor is, for example, a glucose sensor, the phosphate buffer adjusts the pH in the fluid collected from the body fluid collecting means to ensure accurate measurement in the biological component sensor. The purpose of this diluent is to improve the fluidity of the fluid flowing through the body fluid transfer channel. To achieve this purpose, the diluent may contain a surfactant. In addition to improving the fluidity of the fluid, the diluent containing a surfactant also exhibits an effect of promoting mixing of the body fluid and the diluent. By improving the fluidity of the fluid, it is possible to reduce the time from when the body fluid is collected by the body fluid collecting means until the measurement by the biological component sensor, that is, the time constant is reduced.

  Mixing of the fluid flowing through the body fluid transfer channel and the diluent flowing through the diluent transfer channel is realized by mixing means mounted on the substrate.

  In the present invention, the body fluid transfer channel, the diluent transfer channel, the mixing unit, the gas channel for supplying gas to the mixing unit, and the downstream of the mixing unit and upstream of the biological component sensor. There is provided a biological component measuring unit that mounts the gas-liquid separator on the substrate. This biological component measurement unit can be used as a medical support device by attaching it to the medical support device body with a single touch in the same manner as the biological component measurement unit, and the fluid flowing through the body fluid transfer channel by the mixing means Mixing with the diluent flowing through the diluent transfer channel can be performed quickly and smoothly, and accurate biological component measurement can be performed. When the gas is fed into the mixing means, mixing of the fluid sent to the body fluid transfer channel by the formed bubbles and the diluent sent by the diluent transfer channel is achieved in a short time. As a result, the time constant can be reduced, and variations in the output from the biological component measurement sensor due to the concentration gradient can be eliminated.

  In the present invention, there is provided a biological component measurement unit in which the body fluid transfer channel and the calibration solution transfer channel are mounted on a substrate, and further a diluent transfer channel is mounted as necessary. This biological component measurement unit can be mounted on the medical support device body in a clean state with a single touch, as well as the biological component measurement unit described above, and the biological component sensor can be calibrated. Therefore, accurate biological component measurement can be performed.

  In this invention, the body fluid measurement flow path having the body fluid transport channel and the body fluid diluent transport channel mounted on the substrate, and further having a diluent transport channel, a mixing means, a gas channel, and a gas-liquid separator, if necessary. Units are provided. The bodily fluid dilution flow path mounted on the substrate is detachable from the bodily fluid dilution flow path for deriving the bodily fluid dilution liquid stored in the bodily liquid dilution storage tank. Therefore, after the biological component measurement unit is attached to the medical support apparatus main body with a single touch, the body fluid dilution liquid lead-out path and the body fluid dilution liquid transfer path are connected, and the medical support apparatus can be used.

  The purpose of this bodily fluid diluent is to prevent coagulation of bodily fluids such as blood that circulate in the bodily fluid transfer channel, and to smoothly circulate the fluid obtained by diluting the bodily fluid with the bodily fluid dilute solution in the bodily fluid transfer channel. To do. Examples of the diluted body fluid that achieves such an object include an aqueous solution containing an anticoagulant such as heparin when the body fluid is blood. In addition, when the purpose is to prevent blood coagulation, it may be possible to employ simple physiological saline or distilled water that does not contain an anticoagulant as a bodily fluid diluent.

  In this invention, the body fluid transfer channel and the second calibration solution transfer channel are mounted on the substrate, and if necessary, a diluent transfer channel, a mixing means, a gas channel, a gas-liquid separator, and a body fluid diluent A biological component measurement unit having a transfer channel is provided. The second calibration liquid passing through the second calibration liquid transfer channel is intended to calibrate the body fluid transfer channel and the biological component sensor, contains biological components at a known concentration, and measures biological components. Examples thereof include liquids that do not have an adverse effect, such as pure water, purified water, physiological saline, and the like, containing biological components at a known concentration.

  By including the second calibration liquid transfer channel, it is possible to calibrate a decrease in measurement accuracy in the biological component sensor due to deterioration over time when a fluid containing body fluid is circulated through the body fluid transfer channel.

  In this invention, when this biological component measurement unit is mounted on the medical support apparatus body, the biological component that can automatically open and close the flow path mounted on the substrate by the flow path opening and closing means mounted on the medical support apparatus body. A measurement unit is provided.

  Further, according to the present invention, since the biological component measurement unit in the biological component measurement unit package is sterilized, the biological component measurement unit contained therein is taken out from the biological component measurement unit package, and this is placed in the medical support device body. The medical support device can be operated by loading, and after the operation of the medical support device is finished, the used biological component measurement unit is removed from the medical support device body and discarded, so the operability is good. Hygienic and less chances for the operator to come into contact with bodily fluids such as the patient's blood, and a safe biological component measurement unit package is provided.

  According to the present invention, when a medical support device body, for example, an artificial pancreas device main body is attached to form a medical support device, the wetted product is necessary for operating the medical support device and is in contact with the body fluid and the liquid necessary for medical support. Are arranged on the board, so that the necessary medical equipment can be efficiently and efficiently prepared by simply removing the necessary wetted parts from the board and attaching the wetted parts to the medical equipment body. A medical support instrument set that can be provided.

  According to this invention, it is possible to provide a medical support instrument kit package that can be prepared in a hygienic and operable manner in a state where the medical support device can be operated.

  The biological component measurement unit according to the present invention is formed so as to be able to efficiently and hygienically prepare the operation of the medical support device for measuring the biological component that needs to be measured in performing a medical practice. The

  Here, in conducting medical practice, biological components that require qualitative or quantitative analysis include, for example, glucose, urea, uric acid, lactose, sucrose, lactate (lactic acid), ethanol, glutamic acid, ammonia, creatinine, Examples include oxygen. When performing medical practice, it is sometimes necessary to measure the pH value, oxygen concentration, etc. in the biological fluid. In the present invention, the concept of the biological component includes the pH value of the biological fluid, the oxygen concentration, and the like.

  The medical support device is a device necessary for accurately grasping the state of a living body when performing a medical practice. Examples of such medical support devices include an artificial pancreas device that supplies insulin to the living body, an artificial dialysis device that performs dialysis, a urea concentration meter that measures the concentration of urea contained in the body fluid of the living body, and a body fluid of the living body. Uric acid concentration meter for measuring uric acid concentration, sugar content measuring device for measuring sugar content such as lactose and sucrose in biological fluids, lactate measuring device for measuring lactate, etc., glutamic acid concentration meter for measuring glutamic acid concentration in living body Examples thereof include an ammonia concentration meter that measures the ammonia concentration in body fluid, a creatinine concentration meter that measures the concentration of creatinine in body fluid, and the like.

  These various medical support devices are necessary for accurately performing medical practice. The present invention relates to a biological component measurement unit capable of efficiently and sanitarily preparing for operation of such a medical support apparatus. Examples of the biological component sensor used when measuring the biological component by the medical support device equipped with the biological component measuring unit include various sensors 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 object is glucose, urease when the measurement object is urea, uricase when the measurement object is uric acid, and lactate when the measurement object 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 medical support apparatus including the biological component measurement unit 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 measurement unit according to the present invention is attached to the medical support apparatus main body to make the medical support apparatus operable.

  When this substrate is attached to the medical support device body provided with the sensor, the fluid transfer means attached to the medical support device body and the flow path cooperate with each other to force or actively apply the body fluid in the biological component measurement unit. Thus, it is possible to mount a flow path that can be transported in one direction and quantitatively. The fluid flowing in the flow path is a body fluid collected from the living body, such as blood, urine, lymph fluid, spinal fluid, etc., depending on the type of fluid to be circulated in the flow path. It is a mixture of body fluids and other fluids such as physiological saline and heparin-containing fluids for diluting body fluids, is a gas such as air, is a mixed fluid of gas and liquid, and is used to calibrate a biosensor. It is a second calibration liquid for calibrating the body fluid transfer channel, or for simultaneously calibrating changes with time in the biosensor and the body fluid transfer channel, and after the measurement of the biological component is completed. It can be a waste liquid. Furthermore, the flow path mounted on the substrate in the present invention is a collective term for a plurality of types of flow paths having a plurality of functions. Among the multiple types of functionally differentiated flow paths, a certain flow path circulates a mixed liquid of body fluid collected from a living body and other liquids, a certain flow path circulates gas, and a certain flow path uses a calibration liquid. It is distributed. These various liquids, gases, and mixtures of gases and liquids are sometimes collectively referred to as fluids in the present invention, and it is easily understood depending on the context how the fluids are.

  In addition to the flow path, the substrate in the biological component measurement unit includes a liquid contact product that is not provided in the medical support device main body but is necessary for the operation of the medical support device and is in contact with the fluid at a predetermined position. Can be made. When these wetted parts and the flow path are arranged on the substrate, a medical support instrument kit according to the present invention is formed.

  Here, as the liquid contact 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 that extracts the physiological saline from the physiological saline, a physiological saline outlet Pipe, which is an example of a flow path for introducing physiological saline derived from a pipe into a catheter, various diluents added to the collected body fluid as needed, 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, catheter And a flushing liquid storage tank for storing a flushing liquid for cleaning 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 discharged waste liquid, and a device that may come into contact with a biosensor or other fluid depending on circumstances. In short, this wetted product can be brought into a state where the medical support device can be operated when the biological component measurement unit according to the present invention is mounted on the medical support device main body, but all the contacts not included in the medical support device main body. Liquid products are included.

  In the following, a glucose measurement unit (which may be referred to as a “blood glucose level measurement unit” hereinafter), which is an example of a biological component measurement unit, is further required for the medical support apparatus in addition to the biological component measurement unit. The present invention will be described in further detail by describing an artificial pancreatic device support instrument kit, which is an example of a medical support instrument kit equipped with a wetted product that is not included in the medical support device body.

  FIG. 4 shows an artificial pancreas device body 1 which is an example of a medical support device body. A blood sugar level measuring unit 2 which is an example of a biological component measuring unit of the present invention is attached to an artificial pancreas apparatus main body 1. The artificial pancreas device main body 1 has a front portion 1I for an operator to operate the artificial pancreas device, and has a mounting base 11 that protrudes from the front portion 1I in a substantially horizontal direction toward the operator side.

  The position of the mount base 11 in the artificial pancreas device main body 1 is desirably a position where the operator can easily operate by hand while standing without standing down when the operator stands in front of the mount base 11. When the operator stands and operates by hand, the mounting base 11 has a mounting surface 11A that is inclined obliquely upward from the operator side toward the front part 1I of the artificial pancreas device. Is preferred. The shape of the mounting surface 11A is not particularly limited, but is rectangular in this embodiment. The inclination angle θ of the mounting surface 11A, that is, the angle θ formed between the lower end horizontal line of the mounting surface 11A and the mounting surface 11A is preferably set to 60 degrees or more and 90 degrees or less. When the mounting surface 11A is formed with such an inclination angle θ, bubbles existing in various flow paths to be mounted on the substrate mounted on the mounting surface 11A can be easily moved upward in the flow path. The air bubbles can be easily separated, and the operator can easily see and the operation is inexpensive. If any operator having different height can be prevented from hindering the operation, the artificial pancreas device main body is formed by, for example, forming the mounting table 11 so as to be movable up and down by an elevating device. The blood glucose level measuring unit 2 can be vertically mounted at the height position of the operator's eyes in the front portion 1I of 1 or the position where there is no hindrance to the operation by hand.

  The mounting table 11 is equipped with fluid transfer means, which will be described later, and flow path opening / closing means such as a first flow path switch and a second flow path switch.

  The fluid transfer means according to the present invention is a fluid that exists in the flow path in cooperation with the flow path in the blood glucose level measurement unit 2 when the blood glucose level measurement unit 2 according to the present invention is mounted on the mount base 11. Various structures are included within the scope of the present invention as long as they have a mechanical configuration capable of transporting in one direction. Furthermore, the fluid transfer means is a variety of machines having an action of opening and closing the flow path in cooperation with various flow paths in the blood glucose level measurement unit 2, for example, a glucose measurement flow path which is an example of a body fluid transfer flow path. Various mechanical structures can be adopted as long as they have a mechanical structure. For example, the fluid transfer means corresponding to the blood glucose level measuring unit 2 according to this embodiment may be a fluid in one or more flow paths in the blood glucose level measuring unit 2 such as blood, a diluent such as a buffer, For example, as shown in FIG. 7, an example of a flow path, for example, a body fluid transfer flow path, is formed in a structure capable of performing a physical action on the flow path so as to transfer waste liquid or the like toward a predetermined site. A roller 1A for forming a blood transfer flow path 4B and an elastic flexible pipe, a shaft 1K for supporting the roller 1A, and a rotating shaft 1J for coupling and supporting the shaft 1K. A rotating ironing means that includes a plate 3E and has a ironing action on the flow path can be mentioned. According to this rotating ironing means, the roller 1A also rotates around the rotating shaft 1J by the rotation of the rotating shaft 1J, and the flow path can be ironed by the rotational movement of the roller 1A. An apparatus having a combination of a fluid flexible pipe, for example, a flexible pipe, a roller 1A, a shaft 1K, a rotating shaft 1J, and a restraining plate 3E for rubbing the flexible pipe is referred to as a roller pump 18.

  In the present invention, the fluid transfer means has a structure similar to the structure having the squeezing action shown in FIG. 7 as a structure having the same structure as that of the peristaltic pump except the flow path for transferring the fluid. In addition to the structure having the squeezing action, a fluid transfer mechanism having a pressing action shown in FIG. Can do.

  As shown in FIG. 8, the fluid transfer mechanism having the pressing action includes a pressing member 20 that can be projected and retracted from an upper end opening of the opening 3 </ b> F in an opening 3 </ b> F provided in the substrate 3 in the blood glucose level measurement unit 2. And an eccentric rotating cam 21 that rotatably contacts one end of the presser 20. In the fluid transfer mechanism, when the eccentric rotating cam 21 rotates eccentrically by the rotation shaft 22, the presser 20 performs a reciprocating linear motion so that the opening 3F protrudes and retracts. On the other hand, as will be described later, the flow path disposed on the substrate 3, for example, the blood transfer flow path 4B includes the first poppet valve 23 and the second poppet valve 24 in the flow path. Reference numeral 25 denotes a pressing plate for pressing the flow path. According to this fluid transfer mechanism, the first poppet valve is reduced when the inner volume in the flow path space sandwiched between the first poppet valve 23 and the second poppet valve 24 is reduced by the pressing element 20 pressing the flow path. While 23 is closed, the second poppet valve 24 is opened, and the fluid existing in the flow path space flows out of the second poppet valve 24. When the pressure element 20 is retracted after the internal volume in the flow path space is minimized, the first poppet valve 23 is opened when the internal volume of the flow path space is restored to the maximum volume. The second poppet valve 24 is closed, so that fluid flows into the flow path space through the first poppet valve 23. Therefore, by repeating the reciprocating linear motion of the presser 20, in other words, forward and backward, the inflow and discharge of the fluid into the internal space are repeated and the fluid is positively or forcibly transferred in the flow path. become. Since the fluid transfer mechanism shown in FIG. 8 repeats the inflow and the discharge of the fluid into the internal space in cooperation with the flow path, the fluid transfer mechanism and the flow having a valve such as the poppet valve are used. It can be said that the path has a pumping action. Therefore, in the present invention, the fluid transfer means provided on the mounting base in the main body of the artificial pancreas apparatus includes a mechanism in which a pump action is achieved in cooperation with the flow path.

  In any case, in the artificial pancreas device main body 1 which is an embodiment of the present invention, the fluid transfer means acts on all the flow paths that need to transfer the fluid and flows the fluid in all the flow paths. A multi-roller in which a plurality of long rollers having an axis parallel to the axis of the rotating shaft is supported on one rotating shaft so as to be able to be forcibly transferred is adopted. By the squeezing motion of the long roller, the fluid in all the flow paths where the fluid needs to be transferred can be transferred. The flow rate per unit time of the fluid transferred in the flow path can be determined by the unit cross-sectional area of the flow path. That is, the flow rate when the fluid is transferred by being squeezed by the multi-roller can be appropriately determined by adjusting the inner diameter of the flow path.

  As shown in FIG. 1, this blood glucose level measurement unit 2 which is an embodiment of the biological component measurement unit of the present invention is a substrate 3, glucose which is an example of a flow path, and glucose which is an example of a body fluid transfer flow path The measurement channel 4 includes a calibration liquid transfer channel 5 which is an example of a channel, a diluent transfer channel 6 which is an example of a channel, and a mixing unit 7.

  The substrate 3 is not particularly limited in material as long as the various flow paths can be mounted or provided. In this embodiment, the substrate 3 is made of a hard synthetic resin, and in some cases, it is soft and flexible. It may be made of resin. The substrate 3 can be formed using a material such as a PVC sheet material, a hard film such as hard PVC, PET, or a soft PVC material that can be easily bonded to a PVC flow path. As a manufacturing method of the substrate 3, machining from a raw material plate may be performed, but molding is preferable in consideration of price, reduction of waste materials such as processing waste, and mass productivity. As the molding process, a molding process such as compression molding or injection molding, which is generally suitable for medium-volume / mass production, is desirable.

  On the other hand, the flow path mounted on the substrate 3 can also be formed of a soft and soft soft synthetic resin. This flow path can be formed of the same material as the substrate 3.

  Mounting of the flow path (hereinafter sometimes referred to as “tube”) to the substrate can be performed by fixedly placing the tube at a predetermined position of the substrate serving as the base by an appropriate means. The substrate and the flow path may be separate from each other, or the substrate and the flow path may be integrated. The substrate with flow path in which the substrate and the flow path are integrated, for example, by using a hollow and high-precision molding method without bonding the tube by DSI (abbreviation of die slide injection), and tube piping is also integrally formed. It can be manufactured by the method. In addition, after forming the pipe using a core made of a soluble material, the core in the pipe is melted, and a molding method based on a melt core method in which hollow molding is performed is used to form the substrate with a flow path. Can be formed. The substrate 3 is preferably an elastic soft material so that dimensional accuracy can be afforded.

  As illustrated in FIG. 6, the substrate 3 is provided with fixing holes 3 </ b> C through which fixing pins 12 standingly formed at appropriate positions on the mounting surface 11 </ b> A, for example, near the four corners of the mounting surface 11 </ b> A are inserted. Yes. Therefore, by inserting the fixing pin 12 into the fixing hole 3C, the blood sugar level measuring unit 2 can be easily mounted on the mounting table 11 with one touch. Also in this respect, the operability of the blood glucose level measurement unit 2 is improved.

  These fixing pins 12 are projections erected at predetermined positions on the surface of the mounting table 11 as shown in FIG. 6 so that the substrate 3 can be aligned and mounted. Design changes may be made as appropriate.

  As an example of the design change, as shown in FIG. 5, when the substrate 3 is mounted on the mounting table 11, a fixed shaft 3D is mounted on each of the upper and lower portions, and the fixed shaft 3D. The substrate 3 can be removably mounted on the mounting table 11 by being locked to the fixing pin 12. The fixed shaft 3D forms a cylindrical insertion space by bending the upper side and the lower side opposite to the substrate 3 formed on a rectangular sheet, and the fixed shaft 3D is inserted into the cylindrical insertion space. By doing so, it can be mounted on the substrate 3.

  As an example of another design change, there is a substrate fixing method shown in FIGS. Tube holders 12E and 12F are provided on the upstream side and the downstream side of the opening 3A of the tube 4G crossing the opening 3A of the substrate 3, and the tube holders 12E and 12F and the tube 4G are fixed by bonding or the like. Both or one of the tube holders is also fixed to the substrate 3. Then, the tube holders 12E and 12F are provided with notches or recesses in the portions close to both ends so as to face the mating tube holders 12F and 12E, thereby forming the fixing pin insertion holes 12G and 12H. The fixing pin insertion holes 12G and 12H are preferably matched to the shape of the fixing pin so as to fit the fixing pin exactly. On the other hand, the fixing pins 12A, 12B, 12C, and 12D are disposed in the portions of the mounting base 11 on which the substrate 3 is to be mounted, where the fixing pin insertion holes 12G and 12H are to be fitted. The distance between the fixing pins is arranged such that there is no slack in the tube when the fixing pin insertion holes 12G and 12H are fitted into the protrusions, and the substrate 3 is fixed by two tube holders. First, as shown in FIG. 13, the fixing pins on the side to be fitted into the tube holder, the fixing pins 12A and 12B are shaped so that the tube holder 12E fits securely, for example, a shape where the tip of a slightly longer cylinder is pointed. That's fine. The fixing pins 12C and 12D into which the tube holder is fitted later are drawn to the upper part of the fixing pin by pulling the fixing pin insertion hole 12H of the tube holder 12F and pressed from above so that the fixing pins 12C and 12D are inserted into the fixing pin insertion hole 12H A shape that can be fitted, for example, a shape having a relatively short cylindrical tip rounded, or a hemispherical shape is preferable. The combination of the tube holders 12E and 12F and the fixing pins 12A, 12B, 12C, and 12D allows the substrate 3 to be easily attached to and detached from the mounting table 11. In particular, it is convenient because the tube and the substrate are not easily displaced even if the tube is rubbed by the roller 1A. Further, FIG. 19 shows a cross-sectional view of the same state as the state of FIG. 17 of the embodiment in which the shapes of the tube holder 12F and the fixing pin 12C are different. In FIG. 19, a part of the roller 1A that exhibits the iron pump mechanism is also illustrated to show the shape of the tube 4G. A portion in contact with the fixing pin 12C at the bottom of the tube holder 12F in FIG. 19 is formed on a guide surface that is inclined obliquely. In this way, if the tube holder 12F is pushed from the top to the bottom as shown by the arrow in the state of FIG. 19, the fixing pin 12C can be easily formed on the projection 12I formed in a hemispherical shape or a dome shape. The fixing pin insertion hole 12H can be fitted. And tube holder 12F does not remove easily by tension of tube 4G. The guide surface is not limited to an inclined surface, and may be a curved surface. As shown in FIG. 20, the tube 4G and the tube holders 12E and 12F are closed by the opening lid 11C by closing the opening lid 11C on the mounting surface 11A after the base 3 is mounted on the mounting surface 11A. The tube holders 12E and 12F and the tube 4G can be securely fixed so as not to be detached from the mounting surface 11A even if the tube 4G is restrained and stretched somewhat by the squeezing of the tube 4G by the rotation of the roller 1A.

  An example of a specific mounting method will be described. As shown in FIG. 13, four fixing pins 12A, 12B, 12C, and 12D are arranged. Note that the rollers are not shown in FIGS. This fixing pin is fitted with four fixing pin insertion holes 12G and 12H formed in tube holders 12E and 12F attached to the upstream and downstream of the tube 4G attached to the substrate 3 crossing the opening 3B of the substrate 3. The tube is tensioned and fitted so that it does not come off due to the tension of the tube. 14 is a cross-sectional view of the AA ′ cross section of FIG. 13, and FIG. 15 is a partial cross-sectional view of the vicinity of the roller opening showing the substrate 3 disposed on the mounting surface shown in FIG. . 16 shows a state in which the tube holder 12E is fitted into the fixing pins 12A and 12B, and FIG. 17 shows a state in which the tube holder 12F is further pulled to the right side of the drawing and is about to fit into the protruding portion 12I of the fixing pin 12C. FIG. If the tube holder 12F is pushed downward from above, the tube holder 12F is fitted into the fixing pins 12C and 12D. FIG. 18 shows a state in which the tube holder 12F is fitted into the fixing pin 12C and the substrate 3 is fixed to the mounting surface 11A.

  As shown in FIG. 6, the substrate 3 is provided with a roller opening 3A and two openings 3B. The opening position of the roller opening 3A is determined so that various flow paths arranged so as to cross the roller opening 3A can be squeezed by the rollers in the mounting table 11. The opening positions of the two openings 3B are determined so that the first flow path switch 1B and the second flow path switch 1C can protrude the protruding portions from the substrate 11, respectively. The roller opening 3A of the substrate 3 is suppressed from above by an opening lid 11C disposed on the mounting surface 11A of the mounting table 11 after the substrate 3 is attached, and this opening lid 11C is the squeeze pump. It plays the role of the restraining plate 3E. FIG. 20 shows a cross section in a state in which the tube holders 12E, 12F are completely fitted into the fixing pins 12A, 12B, 12C, 12D of the mounting base 11A, and the opening lid 11C installed on the mounting base 11A is closed. The tube 4G is sandwiched between the roller 1A and the opening lid 11C to serve as a crushing iron pump.

In the present embodiment, since the roller opening 3A is opened in the substrate 3, a glucose measurement channel 4B, which is an example of a channel, for example, a body fluid transfer channel, a diluent transfer channel 6, and a waste solution transfer flow. Each of the rollers in the multi-roller directly contacts the path 4C and the saline feed channel 10 and the glucose measuring channel can be directly squeezed by the roller. It is not necessary to further open the roller opening 3A on the substrate 3 as long as the substrate can be transferred by, for example, when the substrate is formed of a flexible and thin sheet, the roller opening 3A is not provided. The roller may squeeze the flow path through the substrate. In this way, when the tube breaks, the substrate formed of a thin sheet serves as a cover that covers the mounting table, so that the liquid that has flowed out of the broken tube enters the medical support device main body 1. It is convenient because there is nothing to do. Further, when the flow path is directly squeezed by the roller, the flow path is stretched downstream by the roller, and the extended portion of the tube overlaps the adjacent flow path, so that the flow path receives a large tensile force. There is a risk of disconnection. If the roller is made to squeeze through the substrate formed of a flexible and thin sheet between the channel and the roller without providing the opening 3A, such a disconnection of the channel is prevented. Can do. In this case, the thickness of the substrate formed of the flexible and thin sheet may be 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)). If it is this range, the fluid in a flow path can be efficiently transferred, when a roller squeezes a flow path through a board | substrate.

  The material of the substrate is not particularly limited as long as the fluid in the flow path can be transferred by the roller squeezing the flow path through the substrate. Examples include soft PVC, various elastomers, silicone resins, fluororesins (PTFE, ETFE, PFA, FEP, etc.), rubbers (natural rubber, synthetic rubbers such as NBR, CR, FKM, FFKM, VQM, etc.).

  As shown in FIG. 1, the substrate 3 includes a body fluid transfer channel for transferring a fluid having a body fluid to a biological component sensor, for example, a glucose measurement channel 4 and a calibration solution transfer flow for transferring a calibration solution to the biological component sensor. A path 5, a diluent transfer channel 6 for transferring the diluent to the body fluid transfer channel, and a mixing means 7 for mixing the fluid having the body fluid and the diluent are mounted. The glucose sensor 4A, which is an example of a biological component sensor, is not included in the glucose measurement channel 4 on the substrate 3. The glucose measurement channel 4 is provided with a connector 9i that is connected to the measurement solution introduction channel 8i and the measurement solution extraction channel 8j of the glucose sensor 4A outside the blood glucose level measurement unit 2.

  The glucose measurement channel 4 which is an example of a body fluid transfer channel is a glucose sensor as an example of a biological component sensor via a connector 9i by using, for example, a roller 1A (see, for example, FIG. 5) in a fluid transfer unit for collected blood. In order to be transferred to 4A, for example, it is formed in a tubular shape with a flexible material, and in this embodiment, a blood transfer channel 4B that transfers the collected blood to a mixer 7 which is an example of a mixing unit; It includes a sample liquid transfer channel 4D that sends out a blood-containing sample liquid obtained by mixing blood and diluent with the mixer 7 to the glucose sensor 4A. A waste liquid transfer channel 4 </ b> C that transfers the fluid that has been measured by the glucose sensor 4 </ b> A as a waste liquid via the connector 9 i is also mounted on the substrate 3.

  The connector 9i is configured such that the sample liquid transfer flow path 4D is connected to the measurement liquid introduction flow path 8i of the glucose sensor 4A, and the waste liquid transfer flow path 4C is connected to the measurement liquid discharge flow path 8j of the glucose sensor 4A. That's fine. For example, two connectors may be integrated and connectable, or two connectors may be connected separately. The connection of the flow path in the connector 9i is preferably liquid-tight so that there is no leakage. For example, the flow path corresponding to the connector 9i is connected by pressure contact with the connector 9i portion and the measurement liquid introduction flow path 8i and the measurement liquid discharge flow path 8j side of the glucose sensor 4A, or a combination of a bolt and a nut It is preferable that they are in close contact with a liquid-tight bonding means such as The use of the blood glucose level measuring unit 2 is most preferably a pressure-contact type connector that can be attached and detached with one touch. The advantage of this embodiment is that if only the glucose sensor 4A is replaced, other measurement items such as pH value and lactic acid value can be measured easily. In addition, when the sensor such as the glucose sensor 4A is expensive, only the blood glucose level measuring unit 2 of this aspect can be used as a disposable type without disposing the sensor.

  A connector 9a is attached to one end of the blood transfer channel 4B, and this connector 9a can be detachably coupled to a connector provided at an end of a blood outlet channel such as a blood sampling channel in the catheter 1E. It is formed as possible. The blood outlet channel is an example of a body fluid outlet channel in the present invention. One end of the blood transfer channel 4B, to which the connector 9a is attached, extends outside the substrate 3. Sites other than one end of the blood transfer channel 4B are arranged on the surface of the substrate 3 together with other channels in a well-organized manner, and the central portion of the blood transfer channel 4B is stretched so as to cross the roller opening 3A with tension. Established.

  After all, in this embodiment, the substrate 3 is an example of a body fluid transfer channel that is detachably coupled to the blood collection channel by a connector 9a, and an example of a biological component sensor. A body fluid transfer channel, for example, a glucose measurement channel 4 formed by a sample solution transfer channel 4D that can be detachably coupled to a measurement solution introduction channel 8i for introducing body fluid into the glucose sensor 4A by a connector 9i is mounted. Yes.

  In this embodiment, a double lumen catheter is employed as the catheter 1E.

  As shown in FIG. 1, the sample liquid transfer channel 4 </ b> D is arranged on the surface of the substrate 3 together with other channels in a well-organized manner. An intermediate portion of the sample liquid transfer channel 4D is disposed with a tension across the opening 3B (see FIGS. 5 and 6) in order to interpose the first channel switch 1B.

  The glucose sensor 4A coupled to the glucose measurement channel 4 is formed by, for example, applying an osmium polymer on a carbon electrode, drying at room temperature, overlaying an enzyme solution thereon, and using a cross-linking agent such as glutaraldehyde. An immobilized biosensor can be mentioned. When the biosensor is employed as the glucose sensor 4A, since a peroxidase enzyme is immobilized on the osmium polymer, an oxidation reaction occurs with hydrogen peroxide, and subsequently a reduction reaction occurs between the osmium polymer, peroxidase and the electrode. The reaction condition at this time is 0 mV with respect to the silver-silver chloride electrode. Therefore, by using glucose oxidase as an enzyme in the oxidation reaction system, glucose detection and concentration measurement can be easily performed. In addition to the above, the glucose sensor 4A may employ a glucose sensor using an osmium (II) -bipyridine complex, a glucose sensor using a ruthenium complex, a glucose sensor having a tris-type osmium complex-introduced polypyrrole-modified electrode, or the like. it can.

  Among these various glucose sensors, the biosensor using an osmium polymer is preferable. A preferred glucose sensor as this biosensor is preferably a thin film sensor comprising a working electrode such as platinum, silver or carbon and an enzyme film layer containing peroxidase in an osmium polymer layer.

  The substrate 3 is further provided with the waste liquid transfer channel 4C. The waste liquid transfer flow path 4C is a flow path for leading the liquid measured by the glucose sensor 4A to the waste liquid tank 1H as a waste liquid. A connector 9e is attached to one end of the waste liquid transfer channel 4C, and this connector 9e can be detachably coupled to a connector provided at an end of an introduction pipe for introducing the waste liquid into the waste liquid tank 1H. Formed as follows. One end of the waste liquid transfer channel 4C to which the connector 9e is attached extends to the outside of the substrate 3. Sites other than one end of the waste liquid transfer channel 4C are arranged on the surface of the substrate 3 together with other channels in a well-organized manner. A middle portion of the waste liquid transfer channel 4C is disposed so as to cross the roller opening 3A.

  As shown in FIG. 1, the mixer 7 is housed in a portion other than the blood glucose level measurement unit 2, for example, a diluent tank 1 </ b> F that is an example of a diluent storage tank provided in the artificial pancreas apparatus body. A diluent transfer channel 6 for transferring the diluted solution to the mixer 7 is coupled.

  A connector 9b is attached to one end of the diluent transfer channel 6, and this connector 9b is provided at the end of a lead-out pipe which is a diluent lead-out channel for leading the diluent in the diluent tank 1F. It is formed so that it can be detachably coupled to the connector. One end of the diluent transfer channel 6 to which the connector 9b is attached extends to the outside of the substrate 3. Sites other than one end of the dilution liquid transfer channel 6 are arranged on the surface of the substrate 3 together with other channels in a well-organized manner, and the central portion is arranged with tension so as to cross the roller opening 3A. The end opposite to the one end to which the connector 9b is coupled is coupled to the mixer 7.

  The dilution liquid may be any liquid that can dilute the blood transferred by the blood transfer channel 4B and more preferably can maintain the pH of the sample liquid supplied to the glucose sensor 4A constant. For example, a phosphate buffer can be illustrated. A solution such as a phosphate buffer is also referred to as a buffer. Therefore, it can be said that the diluent in this embodiment is a buffer. When a buffer solution is used as a diluent, the pH of the sample solution is kept constant by the buffer solution, so a stable glucose level measurement can be performed without relying on the observer with a sensitive glucose sensor. Can do.

  As shown in FIG. 1, the first flow path switch 1 </ b> B includes a calibration liquid tank that is an example of a calibration liquid storage tank provided in a part other than the blood glucose level measurement unit 2, for example, an artificial pancreas apparatus body. A calibration liquid transfer channel 5 for transferring the calibration liquid stored in 1G to the sample liquid transfer channel 4D is mounted. A connector 9c is coupled to one end of the calibration liquid transfer channel 5, and this connector 9c is provided at the end of a lead-out pipe which is a calibration liquid lead-out channel for leading out the calibration liquid in the calibration liquid tank 1G. It is formed so that it can be detachably coupled to the connector. One end of the calibration liquid transfer channel 5 to which the connector 9 c is attached extends to the outside of the substrate 3. Sites other than one end of the calibration liquid transfer channel 5 are arranged on the surface of the substrate 3 together with other channels in a well-organized manner. Further, a second flow path switching unit 1C is interposed in the middle of the calibration liquid transfer flow path 5. The calibration liquid stored in the calibration liquid tank 1G can flow through the calibration liquid transfer flow path 5 and the sample liquid transfer flow path 4D without passing through the fluid transfer means, and reach the glucose sensor 4A. That is, the fluid that has been measured by the glucose sensor 4A is squeezed by a roller that is an example of a fluid transfer means, flows through the waste liquid transfer channel 4C, reaches the waste liquid tank 1H, and is stored. At this time, since a negative pressure is generated in the calibration liquid transfer channel 5 and the sample liquid transfer channel 4D, the calibration liquid stored in the calibration liquid tank 1G is sucked and the calibration liquid transfer channel 5 and the sample liquid transfer flow. It can circulate through the path 4D and reach the glucose sensor 4A. The calibration liquid stored in the calibration liquid tank 1G flows through the calibration liquid transfer channel 5 and the sample liquid transfer channel 4D and reaches the glucose sensor 4A, thereby performing calibration in the glucose sensor 4A. Therefore, this calibration solution is preferably a buffer solution containing a predetermined concentration of glucose.

  A second diluent transfer channel 6A is attached to the second channel switch 1C. A connector 9d is attached to one end of the second diluent transfer channel 6A, and this connector 9d is provided at the end of a second outlet pipe for leading the diluent, for example, a buffer solution, in the diluent tank 1F. It is formed so that it can be detachably coupled to the connector. One end of the second dilution liquid transfer channel 6 </ b> A to which the connector 9 d is attached extends to the outside of the substrate 3. Sites other than one end of the second diluent transfer flow path 6A are arranged on the surface of the substrate 3 together with other flow paths in a well-organized manner. As in the case of the calibration liquid stored in the calibration liquid tank 1G, the dilution liquid in the dilution liquid tank 1F is transferred to the second dilution liquid transfer channel 6A and the sample liquid without using the fluid transfer means. It can flow through the flow path 4D and reach the glucose sensor 4A. The zero point in the glucose sensor 4A is determined by sending the diluent in the diluent tank 1F to the glucose sensor 4A through the second diluent transfer channel 6A, the calibration solution transfer channel 5 and the sample solution transfer channel 4D. can do.

  On this substrate 3, a physiological saline tank 1D installed in a part other than the blood glucose level measurement unit 2, for example, the artificial pancreas apparatus main body 1 (note that this physiological saline tank is abbreviated as a saline tank). A saline solution containing heparin (which may be abbreviated as a saline solution regardless of whether heparin is contained or not) in the catheter 1E. A flow path 10 is attached. The physiological saline tank 1D is an example of a bodily fluid diluent storage tank in the present invention, and the saline feed channel 10 is an example of a bodily fluid transfer channel in the present invention.

  A connector 9f is attached to one end of the saline feed channel 10. The connector 9f is detachably attached to a connector other than the blood glucose level measuring unit 2, for example, a connector attached to an end portion of a lead-out pipe for leading the raw water in the raw water tank 1D attached to the artificial pancreas apparatus main body 1. Formed so that it can be bonded to. One end of the saline feed channel 10 to which the connector 9f is attached extends to the outside of the substrate 3. Further, a connector 9g is attached to the other end of the saline feed channel 10. The connector 9g is formed so that it can be detachably coupled to a connector attached to an introduction tube provided in the catheter 1E. The other end of the saline feed channel 10 to which the connector 9g is attached extends to the outside of the substrate 3. The central portion of the saline feed flow channel 10, that is, the portion other than the one end and the other end extending outside the substrate is arranged on the surface of the substrate 3 together with the other channels in a well-organized manner. It arrange | positions so that 3 A of opening parts may be traversed.

  The example of the blood sugar level measuring unit shown in FIG. 3 is another embodiment in which the position where the calibration liquid storage tank of the blood sugar level measuring unit described in the example shown in FIG. 1 is installed is changed. The calibration liquid tank 1L, which is an example of the calibration liquid storage tank, is an example of the second calibration liquid storage tank in the present invention, and is installed in a part other than the blood glucose level measurement unit 2, for example, the artificial pancreas apparatus main body 1. And an introduction pipe for introducing physiological saline and a lead-out pipe for deriving calibration liquid. A connector is attached to each of the introduction pipe for introducing the physiological saline and the outlet pipe for extracting the calibration liquid. The saline water transfer channel connected to the third channel switch 1M interposed between the saline water transfer channel 10A and the saline water transfer channel 10C for deriving the saline in the physiological saline tank 1D. A connector 9j is attached to one end of 10B. The connector 9j is formed so as to be detachably connectable to a connector attached to an introduction pipe for introducing the physiological saline into the calibration liquid tank 1L. Further, a connector 9k is attached to one end of the second calibration liquid transfer channel 4B3 connected to the blood transfer channels 4B1 and 4B2 via the fourth channel switch 1N. The connector 9k is formed so that it can be detachably coupled to a connector attached to a lead-out tube for leading out the calibration liquid. One end where the connector 9j of the raw water transfer channel 10B is attached and one end where the connector 9k of the second calibration liquid transfer channel 4B3 is attached extend to the outside of the substrate 3. Sites other than one end of the saline feed channel 10B and one end of the second calibration liquid transfer channel 4B3 are arranged on the surface of the substrate 3 together with other channels in a well-organized manner. The purpose of the calibration liquid stored in the calibration liquid tank 1L, that is, the second calibration liquid in the present invention, is to calibrate almost the entire glucose measurement channel 4. Examples of the second calibration solution include a physiological saline solution containing a known concentration of glucose, an aqueous solution, and the like.

  Various mechanical structures are employed for the third flow path switch 1M and the fourth flow path switch 1N as long as the flow state can be changed. For example, a three-way switching valve, two two-way switching valves, a rotary valve, and a flow path switch (FIG. 5) that is an embodiment of the first flow path switch 1B described later can be employed.

  The calibration liquid tank 1L is provided with a calibration liquid suction device 1P so that the saline in the physiological saline tank 1D can be sucked into the saline feeding channel 10B. The calibration liquid suction apparatus 1P has the same or similar structure as the catheter 1E, and the dilution ratio between blood and saline in the catheter 1E is the same as the dilution ratio between calibration liquid and saline in the calibration liquid suction apparatus 1P. Such a structure is preferable.

  As an example of the design change, as shown in FIG. 3, flushing flow paths 30 </ b> A, 30 </ b> B, and 30 </ b> C can be added so that the inside of the catheter 1 </ b> E and the blood transfer flow path 4 can be cleaned. The flushing liquid tank 1Q is installed in a part other than the blood glucose level measurement unit 2, for example, the artificial pancreas apparatus main body 1, and includes a lead-out tube for leading out the flushing liquid. A connector 9l is attached to one end of the flushing liquid transfer channel 30A. The connector 9l is detachably attached to a part other than the blood glucose level measuring unit 2, for example, a connector attached to an end of a lead-out tube for leading out the flushing liquid in the flushing liquid tank 1Q attached to the artificial pancreas apparatus main body 1. It is formed so that it can be combined. One end of the flushing liquid transfer channel 30A to which the connector 9l is attached extends to the outside of the substrate 3. The flushing liquid transfer channel 30A is provided with a branch pipe, for example, a Y-order pipe (not shown), and is branched into a flushing liquid transfer channel 30B and a flushing liquid transfer channel 30C. The flushing liquid transfer channel 30B is connected to the saline feed channel 10C via the fifth channel switch 1R. The flushing liquid transfer channel 30C is connected to the blood transfer channel 4B1 via the sixth channel switch 1S. The portions other than the one end portion of the flushing liquid transfer channels 30A, 30B, and 30C that extend to the outside of the substrate are arranged on the surface of the substrate 3 together with the other channels in a well-organized manner. It is arranged to cross.

  In the blood sugar level measuring apparatus shown in FIG. 3, if the catheter 1E is left attached to the living body even during calibration of the blood sugar level measuring apparatus, the catheter 1E and the blood transfer channel 4B1 contain saline. Blood remains. If blood stays in such a state, blood or the like may be coagulated. In particular, when raw saline is not used, or when the dilution amount of raw saline is small, coagulation of components in blood tends to occur. In the embodiment of the invention shown in FIG. 3, the catheter 1E and the blood at the start of the calibration operation or immediately before the start so that the measurement can be resumed as soon as the calibration is completed so that the blood coagulation or alteration in the sample is prevented. A flushing liquid introduction facility is provided for the purpose of cleaning the inside of the transfer channels 4B1, 4B2, and 4D. The flushing liquid introduction facility includes a flushing liquid tank 1Q, a roller pump 18, flushing liquid flow paths 30A, 30B, and 30C, a fifth flow path switch 1R, and a sixth flow path switch 1S.

  The fifth flow path switch 1R and the sixth flow path switch 1S employ various mechanical structures as long as the flow state can be changed. For example, a three-way switching valve, two two-way switching valves, a rotary valve, and a flow path switch (FIG. 5) that is an embodiment of the first flow path switch 1B described later can be employed.

  As the flushing liquid, any liquid may be used as long as it does not adversely affect the living body and does not denature or coagulate blood or body fluids or interfere with sensor measurement. Saline or Ringer's solution can be preferably used. There is no problem with distilled water if the amount is small. In addition, a liquid in which an anticoagulant such as heparin, fusan or urokinase and / or a thrombolytic agent is mixed with them is also suitable for use. However, anticoagulants and / or thrombolytic agents affect the antithrombotic mechanism for unstable human bodies such as during emergency intensive care, and conversely blood and body fluids tend to coagulate. In some cases, it may be preferable not to use an anticoagulant when a large amount of flushing is to be performed because bleeding may occur in the viewer due to the inherent anticoagulability or thrombolytic properties.

  Next, the first flow path switching unit 1B will be described in detail below.

  The first flow path switch 1B changes from the flow state (1) between the blood transfer flow path 4B and the sample liquid transfer flow path 4D to the flow state (2) between the calibration liquid transfer flow path 5 and the sample liquid transfer flow path 4D. Various mechanical structures are adopted as long as they are formed so as to switch to the distribution state (1) from the distribution state (2).

  In the embodiment shown in FIG. 5, a branch pipe, for example, a Y-shaped pipe (not shown) is interposed in the middle of the sample liquid transfer channel 4D, and the first branch and the second branch of the Y-shaped pipe are provided. Is interposed in the sample liquid transfer flow path 4D, and the third branch of the Y-tube is coupled to the calibration liquid transfer flow path 5. As shown in FIG. 5, the first flow path switch 1 </ b> B is located above the surface of the substrate 3 through the opening 3 </ b> B opened in the substrate 3 when the blood glucose level measurement unit 2 is mounted on the mounting table 11. Are disposed between the pair of first fixing members 13, 13 facing each other and the pair of first fixing members 13, 13, and moved toward the first fixing member 13, And a first movable member 14 formed so as to be movable toward the other first fixed member 13. As shown in FIG. 5, a blood transfer channel 4 </ b> B upstream of the Y-shaped tube that is coupled to the Y-shaped tube is disposed between the first fixed member 13 and the first movable member 14. Then, between the other first fixed member 13 and the first movable member 14, the calibration liquid transfer channel 5 that is coupled to the Y-shaped tube is disposed. When the first movable member 14 moves and the first movable member 14 and one of the first fixed members 13 sandwich and tighten the blood transfer channel 4B, for example, the blood transfer channel 4B is blocked, thereby The flow state (2) between the calibration solution transfer channel 5 and the sample solution transfer channel 4D is realized, and on the other hand, the first movable member 14 moves and the first movable member 14 and the other first fixed member 13 move. For example, when the calibration liquid transfer flow path 5 is sandwiched and tightened, the calibration liquid transfer flow path 5 is closed, thereby realizing the flow state (1) between the blood transfer flow path 4B and the sample liquid transfer flow path 4D. Is done.

  As described above, the first flow path switch 1B, which is an example of the flow path opening / closing means, is not limited to the combination of the pair of first fixed members 13 and the first movable member 14 as long as the flow state can be changed. For example, a three-way switching valve, two two-way switching valves, a rotary valve, or the like can be employed.

  One new matter in the present invention is that when a substrate in a biological component measurement unit according to the present invention, for example, a blood glucose level measurement unit is mounted on a mounting base of a medical support device body, for example, an artificial pancreas device body, the substrate is disposed on the substrate. The channel is opened and closed by the channel and the channel opening / closing means provided on the mounting base. As a result, the blood glucose level measurement unit 2 does not have the function of opening and closing the flow channel when not mounted on the mounting table, but the function of opening and closing the flow channel is realized when mounted on the mounting table. As will be described below, the second flow path switch 1C also has the same function as the first flow path switch 1B.

  Next, the second flow path switching unit 1C will be described in detail below.

  The second flow path switching unit 1C is in a flow state in which the second diluent transfer path 6A and the calibration liquid transfer path 5 from the second flow path switching unit 1C to the first flow path switching unit 1B are in communication with each other. Various mechanical structures are adopted as long as they are formed so as to switch between (a) and the flow state (b) in which the flow from the calibration liquid tank 1G to the first flow path switching unit 1B is made.

  In the embodiment shown in FIG. 5, a branch pipe, for example, a Y-shaped pipe (not shown) is interposed in the middle of the calibration liquid transfer channel 5, and the first branch and the second branch of the Y-shaped pipe Is interposed in the calibration liquid transfer flow path 5, and the third branch of the Y-tube is coupled to the second dilution liquid transfer flow path 6A. Then, as shown in FIG. 5, the second flow path switching unit 1 </ b> C is provided on the surface of the substrate 3 through the other opening 3 </ b> B opened in the substrate 3 when the blood glucose level measurement unit 2 is mounted on the mounting table 11. The pair of second fixing members 15, 15 that face each other and project between the pair of first fixing members 15, 15 that are opposed to each other, and move toward the one second fixing member 15. And a second movable member 16 formed so as to be movable toward the other second fixed member 15. As shown in FIG. 5, the calibration liquid transfer channel 5 toward the calibration liquid tank 1 </ b> G connected to the Y-shaped tube between the one second fixed member 15 and the second movable member 16. Between the other second fixed member 15 and the second movable member 16, the second diluent transfer channel 6 </ b> A connected to the Y-shaped tube is disposed. When the second movable member 16 moves and the second movable member 16 and one second fixed member 15 sandwich and tighten the second diluent transfer channel 6A, for example, the second diluent transfer channel 6A is tightened. Is closed, thereby realizing a flow state (b) in which the calibration liquid in the calibration liquid tank 1G can be transferred to the first flow path switching unit 1B. On the other hand, when the second movable member 16 moves and the second movable member 16 and the other second fixed member 15 sandwich, for example, the calibration liquid transfer flow path 5 and tighten it, the calibration liquid transfer flow path 5 As a result, the flow state (a) between the second diluent transfer channel 6A and the calibration solution transfer channel 5 from the second channel switch 1C to the first channel switch 1B is realized.

  As described above, the second flow path switching unit 1C is not limited to the combination of the pair of second fixed members 15 and the second movable member 16 as long as the flow state can be changed. Individual two-way switching valves, rotary valves, and the like can be employed.

  Next, the mixer 7 will be described in detail.

  The mixer 7 can employ various structures as long as it can mix the blood supplied from the blood transfer channel 4B and the diluent such as a buffer supplied from the diluent transfer channel 6. In this blood glucose level measurement unit 2, since the flow path from the mixer 7 to the glucose sensor 4A is short, it is preferable to employ a mechanism that sufficiently mixes the blood and the diluent before reaching the glucose sensor 4A.

  An example of a suitable mixer 7 is a mixer having the structure shown in FIGS.

  As shown in FIGS. 9 to 11, the mixer 7 has, for example, an uneven portion 7 </ b> B in which the unevenness continues along the flow direction of the fluid on the inner wall forming the internal flow space of the rectangular parallelepiped mixer body 7 </ b> A. . As shown in FIG. 11 which is an AA cross section in FIG. 10, the uneven portion 7 </ b> B has a central shape formed in a rhombus shape. More specifically, the concavo-convex portion 7B is a V-shaped concavo-convex portion that is initially formed in a V-shape along the fluid flow direction, in other words, a plurality of convex portions that are initially formed in a V-shape. And a V-shaped concavo-convex part comprising a V-shaped concave part formed between these convex parts, and an inverted V-shaped concavo-convex part formed in an inverted V shape from the center of the inside, in other words, reverse An inverted V-shaped concavo-convex portion including a plurality of convex portions formed in a V shape and concave portions formed between the convex portions is provided. The diluent transfer channel 6 and the blood transfer channel 4B are connected to the internal circulation space.

  In the mixer 7 provided with the uneven portion 7B, for example, the blood and the diluent introduced into the mixer body 7A collide with the first convex portion in the uneven portion 7B, and the blood and the diluted solution The flow is disturbed, and the disturbed blood and the diluent get over the first convex portion and reach the next concave portion. In the next concave portion, the blood and the diluent are collided by the next convex portion, and the liquid flow is disturbed. In addition, since the uneven portion 7B is formed in a V shape and an inverted V shape, the blood and the diluted solution are divided into a component in the straight direction and a component in the oblique direction of the uneven portion 7B. By dividing the flow, the blood and the diluted solution become turbulent. In this way, the blood and the diluent are disturbed by colliding with the convex part, and the blood and the diluent are separated by repeating the straight direction component and the diagonal component of the concave and convex part 7B. Can be mixed.

  In the present embodiment, the mixer 7 mixes the diluent and blood. However, the mixer 7 is not limited to this, and in order to improve the mixing efficiency, the gas is inert to the blood and the diluent. For example, air may be introduced to mix the diluent and blood. Such an embodiment is illustrated in FIG. In this embodiment, a gas flow path 4E is further provided on the substrate 3 in addition to the embodiment shown in FIG. The gas flow path 4E is an elastic tube similar to the blood transfer path 4B and the like, and the gas flow path 4E is squeezed by a roller in the roller opening 3A so that the gas, for example, air in the flow path is mixed by the mixer 7. It can be supplied to the side. In the mixer 7 or on the upstream side of the mixer 7, the diluent and air are mixed, and blood is further mixed therewith. In this case, a gas-liquid separator 17 is provided at the subsequent stage of the mixer 7 to separate the liquid and gas, which are a mixture of the diluted liquid and blood, and the gas and excess liquid are discharged from the exhaust flow path 4F. Is done. By sending air to the mixer 7 in this way, the mixing efficiency of the blood and the diluent can be improved, and the residence time of the blood in the mixer 7 and the sample liquid transfer path 4D can be shortened. Blood can be measured quickly.

  An example of the structure of the mixer 7 that can introduce air into the mixer 7 as described above and promote the mixing of blood and diluent is the mixer 8 shown in FIG. . As shown in FIG. 12, the mixer 8 includes a mixing chamber 8B and a gas chamber 8C inside a rectangular parallelepiped mixer body 8A. Inside the mixing chamber 8B, a breathable partition plate 8D is provided along the flow direction of the liquid or gas. The breathable partition plate 8D partitions the inside of the mixer body 8A into a mixing chamber 8B and a gas chamber 8C. The air-permeable partition plate 8D is not particularly limited as long as it has a structure capable of ejecting fine bubbles into the mixing chamber 8B. For example, a porous plate-like member can be exemplified, and more specifically, And a porous hydrophobic polymer film, a porous ceramic plate, a synthetic resin sponge, and the like.

  In the mixing chamber 8B, a diluent path 8E for introducing the diluent supplied from the diluent transfer channel 6, a body fluid path 8F for introducing blood supplied from the blood transfer channel 4B, and a gas-liquid separator 17 are provided. Is provided on the way, and a discharge path 8G connected to the sample liquid transfer channel 4D is provided. It is preferable that the dilution liquid path 8E, the body fluid path 8F, and the discharge path 8G are provided on the opposite sides of the mixer main body 8A.

  The gas chamber 8C is provided with a gas passage 8H through which an external gas, for example, air is circulated to the gas chamber 8C.

  The operation of the mixer 8 will be described below. First, the diluent and blood are introduced into the mixing chamber 8B from the diluent channel 8E and the body fluid channel 8F, respectively. On the other hand, air is introduced from the gas path 8G into the gas chamber 8C. The air introduced into the gas chamber 8C becomes fine bubbles when passing through the air-permeable partition plate 8D. These fine bubbles are introduced into the mixing chamber 8B. The fine bubbles introduced into the mixing chamber 8B stir the diluted solution and blood introduced into the mixing chamber 8B. The stirred diluent and blood are mixed well. The well mixed liquid is discharged from the mixing chamber 8B through the discharge path 8G.

  The diluted diluent and blood and fine bubbles are separated by the gas-liquid separator provided downstream of the discharge path 8G of the mixer 8, that is, at the rear stage of the mixer 8.

  Prior to using the blood glucose level measurement unit described above, all wetted parts such as a catheter 1E, a physiological saline tank 1D, a diluent tank 1F, a calibration liquid tank 1G, a waste liquid tank 1H, etc. Are arranged in a well-organized manner, a medical support instrument kit which is an example of the present invention is formed. The biological component sensor may be provided in the medical support instrument body or may be a wetted product. For example, the medical support device kit is sterilized with, for example, ethylene oxide and packaged with a packaging material so as to be in an internal / external blocking state, or the medical support device kit is packaged with a packaging material so as to be in an internal / external blocking state. By sterilizing with ethylene oxide or the like, a medical support instrument kit package is formed.

Hereinafter, the operation of the artificial pancreas apparatus equipped with the blood glucose level measurement unit 2 of the present invention will be described.
(1) Action when Measuring Glucose Before operating the artificial pancreas device, the blood glucose level measuring unit 2 is attached to the artificial pancreas device body 1. Specifically, a fixing hole 3C of the substrate 3 is inserted into the fixing pin 12 formed on the mounting table 11, and the fixing shaft 3D is mounted on the mounting table 11 as described above. The substrate 3 is fixed to the substrate. Next, each flow path of the substrate 3 is connected to the physiological saline tank 1D, the catheter 1E, the dilution liquid tank 1F, the calibration liquid tank 1G, and the waste liquid tank 1H, respectively. Are set in the roller pump 18, the first flow path switch 1B and the second flow path switch 1C. This set is performed by connecting the connector in each flow path and the connector at the end of the flow path belonging to the blood glucose level measurement unit 2. Connecting the connectors is an extremely simple operation. In this way, the pipe connection work of the artificial pancreas device is completed. In this embodiment, since the blood glucose level measurement unit 2 includes the substrate 3 and the glucose measurement flow path 4, each flow path can be obtained simply by attaching the substrate 3 to the artificial pancreas apparatus body 1 in this way. Therefore, it is possible to simplify the operation of piping and the like, improve workability, and reduce unsanitary operations caused by dirt on the piping, for example. Moreover, each flow path can be easily set to the roller pump 18 provided on the mount 11 of the artificial pancreas apparatus at a time.

  The artificial pancreas device catheter 1E thus configured is placed in the patient's body. Next, as shown in FIG. 1, heparin-containing physiological saline is sent from the physiological saline tank 1D to the catheter 1E which is a double lumen catheter. In addition, blood collected by the catheter 1E is mixed with heparin-containing physiological saline and blood in the catheter 1E. The heparin-containing blood in the catheter 1E is forcibly transferred in the blood transfer channel 4B squeezed by the roller in the fluid transfer means, and reaches the mixer 7.

  On the other hand, it is squeezed by the roller 1A, and the diluent is fed from the diluent tank 1F through the diluent transfer passage 6. The diluted liquid that has been sent is sent to the mixer 7. At this time, as shown in FIGS. 10 and 10, in the mixer 7, the blood and the diluted solution are mixed while colliding with the uneven portion 7 </ b> B. A sample solution is prepared by mixing.

  At this time, the first flow path switch 1B makes the calibration liquid transfer flow path 5 non-permeable to the sample liquid transfer flow path 4D, and makes the blood transfer flow path 4B and the sample liquid transfer flow path 4D flow. (This state is the distribution state (1).) Accordingly, the sample liquid flows through the sample liquid transfer channel 4D and is injected into the glucose sensor 4A via the connector 9i. In the glucose sensor 4A, glucose in the sample solution is measured. The measured glucose amount data is transferred to a control unit (not shown) of the artificial pancreas apparatus body 1.

  On the other hand, the sample liquid after measurement is squeezed by the roller 1A through the measurement liquid outlet channel 8j, the connector 9i, and the waste liquid transfer channel 4C, and is forcibly discharged out of the glucose sensor 4A. The discharged sample liquid is sent through the waste liquid transfer channel 4C. The sent sample liquid reaches the waste liquid tank 1H and is stored in the waste liquid tank 1H.

  Therefore, in this embodiment, the blood glucose level measurement unit 2 includes the substrate 3 and the glucose measurement channel 4 so that, for example, each channel is mounted on the substrate in advance before the glucose measurement operation. Therefore, just by attaching the substrate to the artificial pancreas device body, it is not necessary to individually pipe each flow path, and the work such as piping when attaching the blood glucose level measurement unit to the artificial pancreas device body can be simplified. Workability can be improved. Also, since the work of piping and the like is simplified, for example, unsanitary operations caused by dirt on the piping and the like are reduced. Therefore, the workability can be improved, and the blood sugar level measuring unit 2 that can be operated hygienically and can measure the blood sugar level can be provided.

  Thus, after the measurement of the patient's glucose is completed, the catheter 1E placed in the body is taken out, and if necessary, the patient's blood existing in the catheter and each flow path is discharged to the waste liquid tank 1H, and then the substrate. 3 are removed from the glucose sensor 4A, the physiological saline tank 1D, the catheter 1E, the dilution liquid tank 1F, the calibration liquid tank 1G, and the waste liquid tank 1H, respectively. In this way, the operation of removing the substrate 3 from the artificial pancreas device main body 1 is completed.

Thus, after each glucose measurement operation, each flow path is mounted in advance on the substrate, and therefore, the operation of removing the used blood glucose level measurement unit 2 from the pipe simply by removing the substrate from the main body of the artificial pancreas device. Therefore, it is possible to discard the blood glucose level measurement unit 2 without touching the body fluid or the like attached to the piping or the like. Therefore, also from this viewpoint, the workability can be improved, and the blood glucose level measurement unit 2 that can be operated in a sanitary manner can be provided.
(2) Action when Washing the Glucose Sensor 4A The blood glucose level measurement unit 2 is mounted on the artificial pancreas apparatus body 1 in the same manner as when measuring the glucose. The catheter 1E may or may not be placed in the patient's body.

  First, as shown in FIG. 1, the diluent is sent from the diluent tank 1F to the second diluent transfer channel 6A via the second channel switch 1C and the first channel switch 1B. To be liquidated. The diluent is sent from the second diluent transfer channel 6A to the calibration solution transfer channel 5 by the second channel switch 1C.

  Next, the sample flow path 4D side is selected and closed by the first flow path switch 1B. Thus, the diluent sent from the second diluent transfer channel 6A to the sample solution transfer channel 4D via the calibration solution transfer channel 5 is sent into the glucose sensor 4A. The diluted solution thus sent cleans the inside of the glucose sensor 4A.

  The diluted liquid after washing is squeezed by the roller 1A corresponding to the waste liquid transfer channel 4C through the waste liquid transfer channel 4C and discharged out of the glucose sensor 4A. The discharged diluted liquid is further fed through the waste liquid transfer channel 4C, reaches the waste liquid tank 1H, and is stored in the waste liquid tank 1H.

The artificial pancreas apparatus that has finished washing the glucose sensor 4A is used for measuring glucose of the patient, or the blood glucose level measuring unit 2 is removed as described above, and its use is stopped.
(3) Action at the time of calibrating the glucose sensor 4A The blood glucose level measuring unit 2 is loaded into the artificial pancreas apparatus main body 1 in the same manner as when measuring the glucose. The catheter 1E may or may not be placed in the patient's body.

  Next, as shown in FIG. 1, the calibration liquid is sent from the calibration liquid tank 1G to the sample liquid transfer flow path 4D via the calibration liquid transfer flow path 5 by the second flow path switch 1C. .

  Next, the flow path from the first flow path switch 1B to the mixer 7 is closed by the first flow path switch 1B, and the flow path from the first flow path switch 1B to the glucose sensor 4A is calibrated. The liquid transfer channel 5 is brought into a flow state. Thus, the calibration liquid sent from the calibration liquid transfer channel 5 to the sample liquid transfer channel 4D is sent into the glucose sensor 4A. The sent calibration solution reaches the glucose sensor 4A. At this time, in the glucose sensor 4A, data is measured in a state where the calibration liquid is fed. The measured data is transferred to a control unit (not shown) of the artificial pancreas apparatus main body 1. The calibration solution is fed and data is measured until it is confirmed that a predetermined calibration value has been reached.

  When calibration is completed, the calibration liquid is squeezed by the roller 1A and discharged out of the glucose sensor 4A. The discharged calibration liquid is fed through the waste liquid transfer channel 4C. The sent calibration liquid reaches the waste liquid tank 1H and is stored in the waste liquid tank 1H.

The artificial pancreas device for which the calibration of the glucose sensor 4A has been completed is used for measuring the glucose of the patient, or the blood glucose level measuring unit 2 is removed as described above and stopped.
(4) Action when Calibrating Artificial Pancreas Device The blood glucose level measuring unit 2 is loaded into the artificial pancreas device body 1 in the same manner as when measuring the glucose. The catheter 1E may or may not be indwelled in the patient's body (in some cases, blood diluted with saline is simply referred to as blood).

  Next, as shown in FIG. 3, the saline water transfer channel 10A and the saline water transfer channel 10B are opened, and the saline water transfer channel 10C side is blocked. This operation can be easily performed by using a three-way valve as the third flow path switching unit 1M. Similarly, the fourth flow path switching unit 1N opens the second calibration liquid transfer flow path 4B3 and the blood transfer flow path 4B2, and blocks the blood transfer flow path 4B1 side. As a result, the calibration liquid is derived from the calibration liquid suction apparatus 1P and fed into the glucose sensor 4A while supplying raw water to the calibration liquid suction apparatus 1P. At this time, in the glucose sensor 4A, data is measured in a state where the calibration liquid is fed. The measured data is transferred to a control unit (not shown) of the artificial pancreas apparatus main body 1. The calibration solution is fed and data is measured until it is confirmed that a predetermined calibration value has been reached.

  When calibration is completed, the calibration liquid is squeezed by the roller 1A and discharged out of the glucose sensor 4A. The discharged calibration liquid is fed through the waste liquid transfer channel 4C. The sent calibration liquid reaches the waste liquid tank 1H and is stored in the waste liquid tank 1H.

  After the calibration of the entire artificial pancreas device is completed, the artificial pancreas device is used for measuring the glucose of the patient, or the blood glucose level measuring unit 2 is removed as described above and stopped.

As described above, there are many biosensors using enzymes and microorganisms as described above, such as blood glucose level measurement sensors. If calibration is not performed in several hours to several tens of hours, correct measurement values cannot be obtained. There are many cases. In addition, many of the so-called disposable types of fluid transfer pumps and fluid transfer pumps and fluid transfer pumps are used from a hygienic point of view, and inexpensive tubes such as PVC tubes and polyethylene tubes are used. There are many. The flow paths and pumps made of these inexpensive tubes, etc., change the flow rate of the blood volume or dilute due to changes over time such as the thickness of the flow path in use, changes in operating temperature during measurement, changes in pump performance, etc. There may be a change in the ratio. Such a change in blood flow rate or a change in dilution ratio cannot be dealt with only by calibration of the sensor. Therefore, in one embodiment of the present invention, the calibration liquid is introduced from the sample channel 4B1 as close to the catheter 1E as possible, and the blood transfer channel, the saline feed channel, the roller pump 18 and the glucose sensor 4A are collectively combined. By calibrating, accurate calibration as the artificial pancreas device 1 can be performed. For this reason, it is preferable to arrange | position the 4th flow-path switching device 1N of the blood transfer flow path 4B1 and the 2nd calibration liquid transfer flow path 4B3 in the blood transfer flow path 4B1 near the exit of the catheter 1E. Furthermore, when saline is introduced into the catheter 1E, during calibration, the same amount of saline as that during blood collection is introduced into the calibration fluid suction device 1P by the third flow path switch 1M, and the calibration fluid Calibration is simple and convenient if the dilution ratio with saline is the same as the dilution ratio of blood.
(5) Action when washing the catheter and blood transfer channel The blood glucose level measurement unit 2 is mounted on the artificial pancreas apparatus body 1 in the same manner as in the case of measuring the glucose. At this time, the catheter 1E is placed in the patient's body.

  Next, as shown in FIG. 3, the flushing liquid in the flushing liquid tank 1 </ b> Q is circulated through the flushing liquid flow path 30 </ b> A by the roller pump 18. The flushing liquid is switched from the fifth channel switch 1R and / or the sixth channel switch 1S to the blood transfer channel 4B1 by switching the fifth channel switch 1R and / or the sixth channel switch 1S. / Or introduced into the saline feed channel 10C. Part of the introduced flushing liquid reaches the glucose sensor 4A through the blood transfer channel 4, and is further discharged to the drainage tank 1H through the drainage transfer channel 4C. Further, a part of the flushing liquid flows into the living body through the catheter 1E. In this way, the blood transfer flow path, the inside of the sensor, the catheter flow path, and the like are washed with the flushing liquid, and blood clots and gelled blood are discharged from the catheter 1E (this operation is called clotting removal). .) Then, if the blood transfer channel 4, the glucose sensor 4A, and the catheter 1E are filled with the flushing liquid, and there is no risk that the biological component is coagulated in the blood transfer channel 4, the glucose sensor 4A, and the catheter 1E, The biological component measuring apparatus 1 is calibrated by switching the fifth flow path switch 1R and the sixth flow path switch 1S and introducing the calibration liquid from the second calibration liquid flow path 4B3 to the blood transfer flow path 4B1 and downstream thereof. . The fifth flow path switch 1R and the sixth flow path switch 1S block the blood transfer flow path 4B1, the saline feed flow path 10C, and the flushing liquid flow path 30A during normal measurement of biological components. Preferably it is.

  During the calibration operation, it is preferable that the flow rate of the flushing liquid is smaller than that at the time of removing the clotting (the operation of introducing the flushing liquid in this state is referred to as “clotting prevention”). For example, in a normal artificial pancreas device, in removing clotting, a flushing solution of 5 to 500 ml / hour, preferably 100 to 300 ml / hour is introduced for about 1 to 60 seconds, preferably about 3 to 20 seconds. At the time of prevention, it is desirable to introduce it at 0.5 to 60 ml / hour, preferably 1 to 20 ml / hour. In the case of adopting a microbiological component measuring apparatus, a smaller amount of flushing liquid may be introduced as long as clotting removal and prevention of clotting in the flow path can be performed. If there is no concern about coagulation of blood components or the like even if blood remains in the blood transfer channel 4B1 between the sixth channel switch 1S and the fourth channel switch 1N, the flushing solution is transferred to the blood. Calibration may be started simultaneously with introduction into the channel 4B1 and the catheter 1E. Usually, a flushing solution that does not harm the living body even if it enters the living body, such as physiological saline, may be used. Further, when it is desired not to make the flushing liquid enter the living body as much as possible, the introduction of the flushing liquid may be stopped after the blood transfer channel 4B1 and the catheter 1E are filled with the flushing liquid.

  The flushing liquid pump may be one of the multi-pumps, but the flow rate is often larger than the flow rate of the pump such as blood, and may be provided separately. As a pump for the flushing liquid, there are a tube pump, a peristaltic pump, the pump shown in FIG. 7, the diaphragm type pump, the so-called pillow type reciprocating pump in which the elastic tube of the pump shown in FIG. Preferably used. These pumps are preferably pumps having a backflow prevention function.

  When used in a medical field where strict hygiene standards are used, the blood glucose level measurement unit 2 and blood glucose level measurement in which the blood glucose level measurement unit 2 is packaged with a packaging material, for example, a bag, sealed inside and outside. It is preferable to use it as a unit package. That is, the blood glucose level measurement unit package is configured such that the blood glucose level measurement unit 2 is housed in a packaging material in a state where the inside and outside are cut off. The blood glucose level measurement unit 2 may be sterilized with, for example, ethylene oxide before being stored in the package, or may be sterilized with the package after being stored in the package. The blood glucose level measuring unit 2 is sterilized by a normal sterilization method such as heating and ultraviolet irradiation.

  The packaging material only needs to be able to accommodate the blood glucose level measurement unit 2, and examples thereof include bags made of resin such as polyethylene and polypropylene.

  According to this blood glucose level measurement unit package, since the stored blood glucose level measurement unit is sterilized, the blood glucose level measurement unit package or the contained blood glucose level measurement unit is taken out and loaded into the body of the artificial pancreas apparatus By doing so, the artificial pancreas device can be operated, and after the operation of the artificial pancreas device is finished, the used blood glucose level measurement unit is removed from the main body of the artificial pancreas device and discarded. Thus, the operator has fewer opportunities to come into contact with bodily fluids such as blood of the patient, and a safe blood sugar level measurement unit package is provided.

  The blood glucose level measurement unit in this embodiment measures glucose in blood, but may measure body fluids other than blood that can measure glucose. Examples of such body fluid include urine, sweat, and interstitial fluid.

  The blood glucose level measurement unit in this embodiment employs a multi-roller as the fluid transfer means. For example, one long shaft having an axis parallel to the axis of the rotating shaft is provided on one rotating shaft. Alternatively, a roller in which the roller is supported by a shaft may be employed. In this case, the squeezing motion of the one roller can transfer the fluid in all the channels that need to transfer the fluid.

  Furthermore, the blood collection means, for example, the catheter in this embodiment is provided separately from the artificial kidney device main body and the blood glucose level measurement unit. For example, the blood collection means may be mounted on the blood glucose level measurement unit in advance. Good. In this case, a connector attached to the introduction tube in the blood collecting means may be coupled to the connector 9g at the other end of the saline feed channel 10.

FIG. 1 is a block diagram showing an example of a blood sugar level measuring unit according to the first aspect of the present invention. FIG. 2 is a block diagram showing another example of the blood sugar level measuring unit according to the fourth aspect of the present invention. FIG. 3 is a block diagram showing another example of the blood sugar level measuring unit according to the seventh aspect of the present invention. FIG. 4 is a schematic diagram of an artificial pancreas device body on which a blood glucose level measurement unit is mounted. FIG. 5 is a schematic view of the substrate of the blood sugar level measuring unit according to the present invention. FIG. 6 is a schematic view of a mounting base of an artificial pancreas device body on which a blood sugar level measuring unit according to the present invention is mounted and a blood sugar level measuring unit. FIG. 7 is a schematic view showing a cross-sectional structure in the vicinity of the roller opening of the blood sugar level measuring unit according to the present invention. FIG. 8 is an explanatory view showing another example of the fluid transfer means. FIG. 9 is a schematic view of a mixer of the blood sugar level measuring unit according to the present invention. FIG. 10 is a schematic diagram showing a cross-sectional structure of the mixer of the blood sugar level measuring unit according to the present invention. FIG. 11 is a schematic diagram showing a cross-sectional structure taken along line AA of FIG. FIG. 12 is a schematic diagram showing a cross-sectional structure of a modified example of the mixer of the blood sugar level measuring unit according to the present invention. FIG. 13 is a front view of the vicinity of the roller opening on the mounting surface of the artificial pancreas device body. FIG. 14 is a cross-sectional view taken along line A-A ′ of FIG. FIG. 15 is a cross-sectional view of the vicinity of the roller opening on the mounting surface in a state in which the substrate to be mounted on the mounting surface of the artificial pancreas device main body is arranged on the upper portion of the mounting surface in addition to FIG. . FIG. 16 is a cross-sectional view of a state in which the tube holder on one side is fitted into the fixing pin from the state of FIG. FIG. 17 is a cross-sectional view of a state in which the tube holder not yet fitted into the fixed pin is stretched from the state of FIG. 16 and the tube holder is being fitted into the fixed pin that has not been fitted yet. FIG. 18 is a cross-sectional view of a state in which the tube holder is completely fitted into the fixing pin of the mounting table. FIG. 19 is a cross-sectional view of the same state as that of FIG. The shape of a part of fixing pin and a tube holder is different from FIG. 17, and a part of roller is illustrated. FIG. 20 is a cross-sectional view of the state in which the tube holder is completely fitted into the fixing pin of the mounting base from the state of FIG. 19 and the opening lid installed on the mounting base is closed.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Artificial pancreas apparatus main body 1A Roller 1B 1st flow path switch 1C 2nd flow path switch 1D Saline tank 1E Catheter 1F Diluent tank 1G, 1L Calibration liquid tank 1H Waste liquid tank 1I Front part 1J Rotation Axis 1K Axis 1M 3rd flow path switch 1N 4th flow path switch 1P Calibration liquid suction device 1Q Flushing liquid tank 1R 5th flow path switch 1S 6th flow path switch 2 Blood glucose level measurement unit 3 Substrate 3A Roller Opening 3B opening 3C fixing hole 3D fixing pin 3E presser plate 3F opening 4 glucose measurement channel 4A glucose sensor 4B, 4B1, 4B2 blood transfer channel (glucose measurement channel)
4B3 Second calibration liquid transfer flow path 4C Waste liquid transfer flow path 4D Sample liquid transfer flow path 4E Gas flow path 4F Exhaust flow path 4G tube 5 Calibration liquid transfer flow path 6 Diluent liquid transfer flow path 6A Second dilution liquid transfer flow path 7 Mixer 7A Mixer body 7B Concavity and convexity 8 Mixer 8A Mixer body 8B Mixing chamber 8C Gas chamber 8D Breathable partition plate 8E Dilution liquid path 8F Body fluid path 8G Discharge path 8H Gas path 8i Measurement liquid introduction path 8j Measurement liquid derivation Channels 9a, 9b, 9c, 9d, 9e, 9f, 9g, 9h, 9i, 9j, 9k, 9l Connector 10, 10A, 10B, 10C Raw water transfer channel 11 Mounting base 11A Mounting surface 11B Opening 11C Opening Part cover 12 Fixing pin 12A, 12B, 12C, 12D Fixing pin 12E, 12F Tube holder 12G, 12H Fixing pin insertion hole 12I Fixing pin projection 13 DESCRIPTION OF SYMBOLS 1 Fixed member 14 1st movable member 15 2nd fixed member 16 2nd movable member 17 Gas-liquid separator 20 Presser 21 Eccentric rotating cam 22 Rotating shaft 23 1st poppet valve 24 2nd poppet valve 25 Holding plate 30A, 30B , 30C Flushing flow path

Claims (11)

A substrate that can be detachably mounted on a medical support apparatus main body having a fluid transfer means for circulating fluid existing in the channel in one direction in cooperation with the channel, and a channel mounted on the substrate. Prepared,
The flow path is
(1) It is detachable from the bodily fluid outlet channel for extracting the fluid collected from the bodily fluid collecting means,
(2) When the substrate is mounted on the medical support device body, the fluid in the flow path can be transferred in one direction in cooperation with the fluid transfer means,
(3) It is detachable from the measurement liquid introduction channel for introducing the fluid into the biological component sensor for measuring the biological component contained in the transferred fluid.
A biological component measurement unit comprising a body fluid transfer channel. The flow path is
(1) It can be freely attached to and detached from the diluent outlet channel for leading the diluent contained in the diluent reservoir.
(2) The diluent can be supplied to the body fluid transfer channel on the upstream side of the measurement solution introduction channel for introducing fluid into the biological component sensor.
The biological component measurement unit according to claim 1, comprising a dilution liquid transfer channel.   The biological component measurement unit according to claim 2, wherein the flow path includes a mixing unit that mixes the fluid collected from the body fluid collecting unit and the diluent supplied from the diluent transfer channel. The flow path is
(1) including a gas flow path capable of supplying a gas into the diluent transfer flow path or the mixing means,
The biological component measurement unit according to claim 3, further comprising a gas-liquid separator at a site downstream of the mixing means and upstream of the biological component sensor. The flow path is
(1) It is detachable from the calibration liquid outlet channel for extracting the calibration liquid stored in the calibration liquid storage tank,
(2) The calibration liquid can be supplied to the body fluid transfer channel on the upstream side of the measurement solution introduction channel for introducing a fluid into the biological component sensor.
The biological component measurement unit according to any one of claims 1 to 4, comprising a calibration liquid transfer channel. The flow path is
(1) It is detachable from the body fluid dilution liquid outlet flow channel for extracting the body fluid dilution liquid stored in the body fluid dilution liquid storage tank,
(2) It is detachable from a body fluid diluent introduction channel for introducing a body fluid diluent into the body fluid collecting means.
The biological component measurement unit according to any one of claims 1 to 5, comprising a body fluid diluent transfer channel. The flow path is
(1) It is detachable from the second calibration liquid outlet flow path for deriving the second calibration liquid stored in the second calibration liquid storage tank.
(2) The second calibration liquid can be supplied to the downstream side of the body fluid outlet channel and to the upstream side of the fluid transfer means.
The biological component measurement unit according to claim 1, comprising a second calibration liquid transfer channel.   When the substrate is mounted on the medical support device body, the flow channel is opened and closed between the body fluid transfer channel and the diluent transfer channel by a channel opening / closing means provided in the medical support device body. The biological component measuring unit according to claim 2, further comprising a flow path opening / closing portion where   A biological component measurement unit package comprising the biological component measurement unit according to any one of claims 1 to 8 which is packaged in a sterilized state and inside / outside blocking state with a packaging material. The biological component measurement unit according to any one of claims 1 to 8,
Necessary when using the medical support device, a wetted product other than the medical support device main body and the biological component measurement unit,
A medical support instrument kit comprising:   A medical support instrument kit package comprising: the medical support instrument kit according to claim 10, which is packaged in a sterilized state, inside and outside, with a packaging material.

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