JP4808461B2 - Biological component measurement unit, biological component measurement unit package, medical support instrument kit, and medical support instrument kit package - Google Patents

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 specifically, can be attached to the medical support device main body with a single touch to improve workability. In addition, a biological component measurement unit that can measure biological components such as blood glucose levels with hygienic operations, can be stored for a long time in a sterilized state, and the biological component measuring unit is taken out in a sterilized state when used A living body component measuring unit package that can be attached to a medical support device body with a single touch, improving workability, and capable of measuring biological components such as blood glucose level with a sanitary operation, and a medical support device A medical support instrument kit that can arrange the wetted parts outside the main body and easily prepare for operation of the medical support device. The present invention also relates to a medical support instrument kit package that can be stored for a long period of time in a sterilized state and can be taken out in a sterilized state at the time of 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).

JP-A-6-292722 (Claim 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, for example, that the sensors are calibrated in order to measure, for example, components in blood.

  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. , 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 make the medical support device operable That is the issue.

As means for solving the above problems,
According to a first aspect of the present invention, there is provided a substrate that can be detachably mounted on a medical support device main body having a fluid transfer means for circulating a fluid existing in the channel in one direction in cooperation with the channel, and the substrate is attached to the substrate A flow path,
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) provided with a biological component sensor for measuring a biological component contained in the fluid to be transferred,
(4) A biological component measurement unit comprising a biological component measurement channel that allows a fluid whose biological component measurement has been completed by the biological component sensor to be discharged as waste liquid,
Claim 2 is characterized in that 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) 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) The biological component measurement according to (1) above, further comprising a diluent feeding channel capable of supplying the diluent to a site upstream of the biological component sensor in the biological component measuring channel. Unit,
Claim 3 is the biological component measurement unit according to claim 2, wherein the biological component measurement channel includes mixing means for mixing the body fluid and the diluent supplied from the diluent feeding channel. ,
Claim 4 is characterized in that 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) 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) Any one of the above-mentioned claims 1 to 3, further comprising a calibration liquid feeding flow path capable of supplying the calibration liquid to a site upstream of the biological component sensor in the biological component measurement flow path. The biological component measurement unit according to item,
According to a fifth aspect of the present invention, the biological component measurement flow path is provided in the medical support apparatus main body when the substrate is mounted on the medical support apparatus main body on the upstream side of the junction with the dilution liquid supply flow path. A biological component measurement channel opening / closing part that is opened / closed by a channel opening / closing means, and the dilution liquid feeding channel is located upstream of the junction with the biological component measurement channel. When mounted on the medical support apparatus main body, the liquid supply flow path opening / closing part is opened and closed by the flow path opening / closing means provided in the medical support apparatus main body. The biological component measurement channel opening / closing part is closed when in the state, and the biological component measurement channel opening / closing part is open when the dilution liquid feeding channel opening / closing part is closed. The biological component measurement unit according to Item 1 or 2,
Claim 6 is a biological component measurement unit package comprising the biological component measurement unit according to any one of claims 1 to 5 which is packaged in a sterilized state inside and outside with a packaging material. And
Claim 7 is a substrate that can be detachably mounted on a medical support device body having fluid transfer means for circulating fluid existing in the flow channel in one direction in cooperation with the flow channel,
(1) It is detachable from the body fluid outlet channel for extracting body fluid collected from the body 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) provided with a biological component sensor for measuring a biological component contained in the fluid to be transferred,
(4) A biological component measurement flow path that allows a fluid whose biological component measurement has been completed by the biological component sensor to be discharged as waste liquid, and a medical support device main body and the biological body that are necessary for using the artificial pancreas device It is a medical support instrument kit characterized by arranging liquid contact products other than the component measurement flow path,
An eighth aspect of the present invention is a medical support instrument kit package, wherein the medical support instrument kit according to the seventh aspect is packaged in a sterilized state in a state where the inside and outside are blocked with a packaging material.

  According to the present invention, for example, since each flow path is mounted on the substrate of the biological component measurement unit in advance before the biological component measurement, for example, glucose measurement, the substrate is attached to the medical support device, for example, the artificial pancreas device body. Therefore, it is not necessary to individually pipe each flow path, and work such as piping when attaching a biological component measurement unit such as a blood glucose level measurement unit to a medical support device such as an artificial pancreas device main body can be simplified. 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, for example, after the work of measuring a biological component such as glucose, if the fluid in the flow channel is discharged in advance from each flow channel attached to the substrate of the used biological component measurement unit, the medical support device main body such as the artificial pancreas By simply removing the substrate from the apparatus main body, there is no need to remove the piping of the used biological component measurement unit, for example, the blood glucose level measurement unit, and the biological component attached to the piping or the like is not touched by the operator. A measurement unit, for example, a blood glucose level measurement unit can be discarded. 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.

  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 is attached to a medical support device main body, for example, an artificial pancreas device main body, the wetted product necessary for operating the medical support device and in contact with the body fluid and the liquid required for medical support is provided. Since it is arranged on the substrate, it is necessary to efficiently and well prepare a medical support device that can be operated simply by taking out the necessary wetted product from this substrate and attaching the wetted product to the medical support device body. It is possible to provide a medical support device set capable of

  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 living body component measuring unit according to the present invention can measure living body components that need to be measured in performing medical practice, and can efficiently and hygienically prepare the operation of the medical support device. Formed.

  Here, biological components that require qualitative or quantitative analysis in conducting medical practice include, for example, glucose, urea, uric acid, lactose, sucrose, lactate (lactic acid), ethanol, glutamic acid, ammonia, creatinine, oxygen Etc. 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. A uric acid concentration meter that measures the concentration of uric acid, a sugar content measuring device that measures sugar content such as lactose, sucrose, and lactate in biological fluids, a glutamic acid concentration meter that measures glutamic acid concentrations in the body, and an ammonia concentration in body fluids Examples thereof include an ammonia concentration meter for measuring, a creatinine concentration meter for measuring the concentration of creatinine in body fluids, 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 that measures the biological component by 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, and a hybrid sensor using an enzyme and a microorganism.

  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 object to be measured is glucose, urease when the object to be measured is urea, uricase when the object to be measured is uric acid, and lactate as the object to be measured. Lactate oxidase in some cases, lactase or β-galactosidase when the measurement target is lactose, alcohol oxidase when the measurement target is ethanol, Trichosporon brassicaes, glutamate dehydrogenase when the measurement target is glutamic acid, Escherichia coli, When the object to be measured is ammonia, nitrifying bacteria or the like is selected.

  In the biological component measurement unit according to the present invention, the measurable biological component may be one type or two or more types. When there are two or more biological components to be measured, it is preferable to arrange two or more types of biosensors in the middle of the biological component measurement channel for transferring body fluid collected from the living body. Moreover, when measuring a several biological component, the said biological component measurement flow path can be branched into plurality, and one or two or more biosensors can be attached to each branch flow path.

  By attaching the biological component measurement unit according to the present invention to the medical support apparatus main body, the medical support apparatus can be operated.

  When the substrate in this biological component measurement unit is attached to the medical support apparatus main body, the fluid transfer means and the flow path attached to the medical support apparatus main body jointly or positively force the body fluid in one direction, Further, at least fixed or installed flow paths that can be quantitatively transferred. The fluid flowing through 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 passed through the flow path. And other liquids such as physiological saline, dilution liquid, and the like, a calibration liquid for calibrating the biosensor, and a waste liquid after measurement of biological components. In the present invention, these various liquids may be collectively referred to as a fluid, and it is easily understood depending on the context what kind of fluid the fluid is.

  Further, in addition to the flow path, the liquid component that is not equipped in the medical support apparatus main unit but is necessary for the operation of the medical support apparatus and in contact with the fluid is arranged at a predetermined position on the substrate in the biological component measurement unit. can do. 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 for extracting physiological saline from the physiological saline, and a physiological saline derived from the physiological saline outlet pipe as a catheter Pipes to be introduced, various diluents added to the collected body fluid as necessary, for example, a diluent storage tank for storing a buffer solution, a diluent outlet pipe for extracting the diluent from the diluent storage tank, and the diluent Diluent transfer flow path for supplying fluid transfer means, calibration liquid storage tank for storing calibration liquid for calibrating biosensor, calibration liquid outlet pipe for extracting calibration liquid from calibration storage tank, and supply of calibration liquid to the fluid transfer means Calibration fluid transfer flow path, waste fluid storage tank for storing waste fluid discharged from the biosensor, and instruments that may come into contact with other fluids. 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.

  Hereinafter, a glucose measurement unit which is an example of a biological component measurement unit, and a medical support instrument which is equipped with a wetted part which is necessary for the medical support device and which is not included in the medical support device body. The invention will be described in further detail by describing an artificial pancreas device support instrument kit that is an example of a kit.

  As shown in FIG. 1, a blood glucose level measurement unit that is an example of a biological component measurement unit of the present invention is attached to an artificial pancreas device body 1 that is an example of a medical support device body. The artificial pancreas device main body 1 has a front portion 1J for an operator to operate the artificial pancreas device, and has a mounting base 11 protruding from the front portion 1J in the horizontal direction toward the operator.

  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 table 11 has a mounting surface 11A that is inclined obliquely upward from the operator side toward the front portion 1J 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 by the virtual horizontal line extending horizontally from the front surface 1J and the front surface 1J inclined from the lower horizontal line of the mounting surface 11A is 60 degrees. It is preferable to set it to 80 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 cheaper. In addition, if it is possible to prevent any of the operators having different heights from hindering the operation, for example, if the mounting table 11 can be formed to be movable up and down by an elevating device, The blood glucose level measuring unit 2 can also be vertically mounted at the height position of the operator's eyes in the front portion 1J of the artificial pancreas apparatus main body 1 or at a position where there is no hindrance for 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.

  When the blood sugar level measuring unit 2 according to the present invention is mounted on the mounting base 11, the fluid transfer means in this invention is configured to remove the fluid existing in the flow path in cooperation with the flow path in the blood sugar level measuring unit 2. Various structures are included within the scope of this invention as long as they have a mechanical configuration that can be transferred in one direction. Furthermore, this fluid transfer means has various mechanical structures as long as it has various mechanical structures that act to open and close the flow paths in cooperation with various flow paths in the blood glucose level measurement unit 2, such as a glucose measurement flow path. A structure can be adopted. 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, It 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. For example, as shown in FIG. 5, a flow path such as a blood transfer flow path 4B is formed. A rotating ironing means having an ironing action on the flow path, comprising a roller 1A for rubbing a flexible pipe forming a shaft, a shaft 1K for supporting the roller 1A, and a rotating shaft 1J for connecting and supporting the shaft 1K. 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. A device having a combination of a fluid, for example, a flexible pipe and a roller 1A for squeezing the flexible pipe, a shaft 1K, and a rotating shaft 1J is called a roller pump.

  In the present invention, the fluid transfer means is a mechanism similar to the structure having an ironing action as shown in FIG. 5, and is a mechanism in the peristaltic pump except for the flow path for transferring the fluid, and in the ironing pump, the fluid is transferred. In addition to the mechanism having the squeezing action, a fluid transfer mechanism having the pressing action shown in FIG. 10 can be given.

  As shown in FIG. 10, 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. When the eccentric rotating cam 21 is eccentrically rotated by the rotating shaft 22, the fluid transfer mechanism performs a translational movement so that the pressing element 20 protrudes and retracts from the opening 3F. 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 translational movement of the pressing element 20, in other words, the forward and backward movements, 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. is there. Since the fluid transfer mechanism shown in FIG. 10 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, according to the present invention, the fluid transfer means provided on the mounting base in the main body of the artificial pancreas device also includes a mechanism that performs a pump action 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 a single rotating shaft so that it can be actively transferred. 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. 3, the blood glucose level measurement unit 2 according to an embodiment includes a substrate 3, a glucose measurement channel 4 that is an example of a channel, and an example of a biological component measurement channel, The calibration liquid feeding channel 5 is an example of a channel, the diluent feeding channel 6 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. In this embodiment, the substrate 3 is made of a hard synthetic resin, and in some cases, a soft and flexible soft synthetic resin resin. It may be made.

  The substrate 3 is provided with a fixing hole 3C through which a fixing pin 12 standingly formed at an appropriate position of the mounting surface 11A, for example, near the four corners of the mounting surface 11A is inserted. 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.

  As shown in FIG. 2, these fixing pins 12 are protrusions erected at predetermined positions on the surface of the mounting table 11, 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. 4, when this board 3 is mounted on the mounting table 11, a fixed shaft 3D is attached to each of the upper side portion and the lower side portion. 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 shown in FIG. 2, 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 the roller in the mounting table 11 can squeeze various flow paths arranged to cross the roller opening 3A. The opening positions of the two openings 3B are determined so that the protruding portions of the first flow path switch 1B and the second flow path switch 1C can protrude from the substrate 11, respectively.

  In the present embodiment, since the roller opening 3A is opened in the substrate 3, each roller in the multi-roller directly contacts the flow path, for example, the glucose measurement flow path, and the glucose measurement flow path is As long as the fluid in the flow path can be transferred by the fluid transfer means, it is not necessary to further open the roller opening 3A in the substrate 3, for example, the substrate is flexible. When the roller is formed of a thin sheet, the roller may squeeze the flow path through the substrate without providing the roller opening 3A.

  The substrate 3 is equipped with a glucose measurement channel 4, a calibration solution feeding channel 5, a diluted solution feeding channel 6, and a mixing means 7.

  As shown in FIG. 3, the glucose measurement channel 4 is flexible, for example, so that the collected blood can be transferred to a glucose sensor 4A as an example of a biological component sensor by, for example, a roller 1A in a fluid transfer unit. In this embodiment, the blood and the diluting liquid are mixed by the blood transfer channel 4B for transferring the collected blood to the mixer 7 which is an example of the mixing means, and the mixer 7 in this embodiment. A sample liquid transfer channel 4D for sending the blood-containing sample solution obtained to the glucose sensor, and a waste liquid transfer channel 4C for transferring the fluid whose measurement has been completed by the glucose sensor as waste liquid.

  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. One end of the blood transfer channel 4B, to which the connector 9a is attached, extends outside the substrate 3. Parts 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 part is stretched so as to cross the roller opening 3A with tension. Is done. In this embodiment, a double lumen catheter is employed as the catheter 1E.

  As shown in FIG. 3, the sample solution 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 tension so as to cross the opening 3B in order to interpose the first channel switch 1B.

  The glucose sensor 4A coupled to the glucose measuring 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 material 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 to the waste liquid tank 1H as waste liquid. A connector 9e is attached to one end of the waste liquid transfer channel 4c, and the 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. It is formed as possible. One end of the waste liquid transfer channel 4c, to which the connector 9e is attached, extends outside 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. The middle portion of the waste liquid transfer channel 4c is disposed so as to cross the roller opening 3A.

  As shown in FIG. 3, the mixer 7 is accommodated 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 dilute solution flow path 6 for transferring the dilute solution to the mixer 7 is coupled.

  A connector 9b is attached to one end of the diluent feeding 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 dilute solution flow path 6 to which the connector 9 b is attached extends to the outside of the substrate 3. Sites other than one end of the dilute solution flow path 6 are arranged on the surface of the substrate 3 in a well-organized manner together with other flow paths, and the central portion thereof has tension so as to cross the roller opening 3A. An end opposite to one end where the connector 9b is connected is connected 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 the diluent, the pH of the sample solution is kept constant by the buffer solution, so that a stable blood glucose level can be measured with a glucose sensor sensitive to pH.

  As shown in FIG. 3, the first flow path switch 1 </ b> B includes a calibration liquid tank that is an example of a component liquid storage tank installed in a part other than the blood glucose level measurement unit 2, for example, an artificial pancreas apparatus body. A calibration solution transfer channel 5 for transferring the calibration solution stored in 1G to the sample solution 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, in the middle of the calibration liquid transfer channel 5, a second channel switch 1C is interposed.

  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 flow path 6A, and this connector 9d is provided at the end of a second outlet pipe for leading the diluent in the diluent tank 1F, for example, a buffer solution. 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.

  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.

  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.

  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 illustrated embodiment, a branch tube, for example, a Y-shaped tube (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 tube are the sample. The third branch of the Y-shaped tube is connected to the calibration liquid transfer flow path 5 and is interposed in the liquid transfer flow path 4D. Then, as shown in FIG. 4, 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 opposing first fixing members 13, 13 and the first fixing member 13 and the first fixing member 13, and move 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. 4, a blood transfer channel 4 </ b> B connected to the Y-shaped tube is disposed between the one first fixed member 13 and the first movable member 14, and the other first fixed member. Between the 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. 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 solution transfer channel 5 is sandwiched and tightened, the calibration solution transfer channel 5 is closed, thereby realizing the flow state (1) between the blood transfer channel 4B and the sample solution transfer channel 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 technical idea of the present invention is that when the substrate in the blood glucose level measurement unit according to the present invention is mounted on, for example, a mounting base of the artificial pancreas apparatus body, the flow path provided on the base plate and the flow provided on the mounting base. The flow path is opened and closed by the path opening and closing means. 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 switch 1B is made.

  In the illustrated embodiment, a branch pipe, for example, a Y-shaped pipe (not shown) is interposed in the middle of the calibration liquid transfer flow path 5, and the first branch and the second branch of the Y-shaped pipe are calibrated. The third branch of the Y-shaped tube is interposed in the liquid transfer channel 5 and coupled to the second diluent transfer channel 6A. Then, as shown in FIG. 4, 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. A pair of second fixing members 15, 15 facing each other and protruding between the second fixing member 15 and the second fixing member 15, projecting further upward, toward one second fixing member 15. And a second movable member 16 formed to be movable toward the other second fixed member 15. As shown in FIG. 4, between the one second fixed member 15 and the second movable member 16, the calibration solution transfer flow path 5 that is coupled to the Y-shaped tube toward the calibration solution tank 1 G. 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 adopt various structures as long as the blood supplied from the blood transfer channel 4B and the diluent such as a buffer supplied from the diluent feeding channel 6 can be mixed. . 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.

  6-8, the mixer 7 has the uneven | corrugated | grooved part 7B in which an unevenness | corrugation continues along a flow direction on the inner wall which forms the internal distribution space of 7 A of mixer main bodies of rectangular parallelepiped shape, for example. . As shown in FIG. 8 showing an AA cross section in FIG. 7, the uneven portion 7B is particularly 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. Note that the dilute solution flow 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 portion, and by repeating the division into the component in the straight direction and the component in the oblique direction of the concave and convex portion 7B, the blood and the diluent Can be mixed.

  In the present embodiment, the mixer 7 mixes the diluent and blood. However, the present invention is not limited to this, and in order to improve the mixing efficiency, a gas, for example, air is also introduced and diluted. You may make it mix a liquid and blood. In this case, a gas-liquid separator or the like may be appropriately provided at the subsequent stage of the mixer 7 so that the liquid (diluent and blood) and gas are separated again.

  As a structure capable of promoting the mixing of blood and diluent by introducing air into the mixer 7 as described above, for example, the mixer 8 shown in FIG. 9 can be cited. As shown in FIG. 9, 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 channel 8E for introducing the diluent supplied from the diluent channel 6; a body fluid channel 8F for introducing blood supplied from the blood channel 4B; and a gas-liquid separation A discharge path 8G connected to the sample liquid feeding flow path 4D, provided with a vessel (not shown) in the middle, 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 measuring 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. 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, 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 provided in 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. 3, 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 positively transferred through 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 feeding channel 6. The diluted liquid that has been sent is sent to the mixer 7. At this time, as shown in FIGS. 7 and 8, in the mixer 7, the blood and the diluted solution are mixed while colliding with the uneven portion 7B. 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. 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 and 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 physiological saline tank 1D, the catheter 1E, the diluent 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. 3, the diluting solution is fed from the diluting solution tank 1F through the diluting solution feeding channel 6 via the second channel switching device 1C and the first channel switching device 1B. Is done. The diluent is sent from the diluent feeding channel 6 to the sample solution feeding channel 4D by the second channel switching unit 1C.

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

  The diluted solution after washing is squeezed by the roller 1A and discharged out of the glucose sensor 4A. The discharged diluent is sent through the waste liquid transfer channel 4C. The sent dilution liquid reaches the waste liquid tank 1H and is stored in the waste liquid tank 1H.

The artificial pancreas device that has finished washing the glucose sensor 4A is used for measuring the glucose of the patient, or the blood glucose level measuring unit 2 is removed as described above and 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. 3, 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. As a result, the calibration solution sent from the calibration solution transfer channel 5A to the sample solution 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 solution 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 the predetermined calibration value has been reached.

  When the calibration is completed, the calibration solution is squeezed by the roller 1A and discharged out of the glucose sensor 4A. The discharged calibration liquid is sent 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.

  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 artificial pancreas device main body 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 shows a schematic diagram of an artificial pancreas device body on which a blood glucose level measuring unit according to the present invention is mounted. FIG. 2 shows a schematic diagram of a mounting base of an artificial pancreas apparatus body on which a blood sugar level measuring unit according to the present invention is mounted and a blood sugar level measuring unit. FIG. 3 is a block diagram showing functions of the blood sugar level measuring unit according to the present invention. FIG. 4 shows a schematic diagram of the substrate of the blood sugar level measuring unit according to the present invention. FIG. 5 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. 6 shows a schematic diagram of the mixer of the blood sugar level measuring unit according to the present invention. FIG. 7 is a schematic view showing a cross-sectional structure of the mixer of the blood sugar level measuring unit according to the present invention. FIG. 8 is a schematic view showing a cross-sectional structure taken along the line AA of FIG. FIG. 9 is a schematic view showing a cross-sectional structure of a modification of the mixer of the blood sugar level measuring unit according to the present invention. FIG. 10 is an explanatory view showing another example of the fluid transfer means.

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 Calibration liquid tank 1H Waste liquid tank 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 flow path 4A glucose sensor 4B blood transfer flow path 4C waste liquid transfer flow path 4D sample liquid transfer flow path 5 calibration liquid transfer liquid Flow path 6 Diluent liquid flow path 6a Second dilute liquid 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 Diluent liquid path 8F Body fluid path 8G Discharge path 8H Gas path 9a, 9b, 9c, 9d, 9e, 9f, 9g Connector 11 Mounting base 12 Fixing pin 13 First fixing member 14 First movable member 15 Second fixed member 16 Second movable member 20 Presser 21 Eccentric rotation cam 22 Rotating shaft 23 First poppet valve 24 Second poppet valve 25 Holding plate

Claims (8)

A substrate that can be detachably mounted on a medical support device main body having fluid transfer means for circulating a fluid existing in the channel in one direction in cooperation with the channel, and a channel mounted on the substrate. ,
The flow path is detachable from (1) a bodily fluid discharge flow path for extracting a fluid collected from the bodily fluid collection means, and (2) when the substrate is mounted on the medical support apparatus body, the fluid transfer means; The fluid in the flow path can be jointly transferred in one direction, and (3) a biological component sensor for measuring a biological component contained in the transferred fluid is provided, and (4) the biological component is measured by the biological component sensor. A biological component measurement unit comprising a biological component measurement channel that allows the completed fluid to be discharged as waste liquid. The flow path is detachable from (1) a diluting liquid outlet flow path for deriving the diluting liquid stored in the diluting liquid storage tank, and (2) when the substrate is mounted on the medical support device body, the fluid It is possible to transfer the fluid in the flow path in one direction in cooperation with the transfer means, and (3) dilute liquid feed capable of supplying the dilute liquid to a site upstream of the biological component sensor in the biological component measurement flow path. The biological component measurement unit according to claim 1, further comprising a liquid flow path. The biological component measuring unit according to claim 2, wherein the biological component measuring channel includes a mixing unit that mixes the body fluid and the diluent supplied from the diluent feeding channel. The flow path is detachable from (1) a calibration liquid outlet flow path for deriving a calibration liquid stored in a calibration liquid storage tank, and (2) when the substrate is mounted on the medical support device body, the fluid It is possible to transfer the fluid in the flow path in one direction in cooperation with the transfer means, and (3) a calibration liquid feed capable of supplying the calibration liquid to a site upstream of the biological component sensor in the biological component measurement flow path. The biological component measurement unit according to any one of claims 1 to 3, further comprising a liquid channel. When the substrate is mounted on the medical support apparatus body on the upstream side of the junction with the diluent feeding liquid flow path, the biological component measurement flow path is provided by flow path opening / closing means provided in the medical support apparatus body. A biological component measurement channel opening / closing part that opens and closes the channel, and the diluent feeding channel is located upstream of the junction with the biological component measurement channel, and the substrate is disposed on the medical support device body When mounted, the medical support device main body includes a dilute solution feeding channel opening / closing part that is opened and closed by a channel opening / closing means provided in the medical support device main body, and when the diluting solution sending channel opening / closing part is open, 3. The component measurement channel opening / closing part is in a closed state, and the biological component measurement channel opening / closing part is formed in an open state when the diluent feeding channel opening / closing part is in a closed state. The biological component measurement unit described. A living body component measuring unit package comprising the living body component measuring unit according to any one of claims 1 to 5 in a sealed state and a sterilized state with a packaging material. The body fluid was collected from the body fluid collecting means on the substrate that can be detachably mounted on the medical support apparatus main body having the fluid transfer means for circulating the fluid existing in the flow path in one direction in cooperation with the flow path. It can be attached to and detached from the body fluid outlet channel for leading body fluid. (2) When the substrate is mounted on the medical support device body, the fluid in the channel can be transferred in one direction in cooperation with the fluid transfer means. (3) a biological component sensor that measures a biological component contained in the fluid to be transferred, and (4) a biological component measurement channel that enables the fluid whose biological component has been measured by the biological component sensor to be discharged as waste liquid. A medical support instrument kit comprising: a medical support device main body and a wetted product other than the biological component measurement channel necessary for using the artificial pancreas device. A medical support instrument kit package comprising the medical support instrument kit according to claim 7, which is packaged in a sterilized state with an internal / external cut-off state using a packaging material.

Images