JP2012200419A - Liquid chemical dosing apparatus and blocking detection method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To accurately detect blocking with a simple configuration and to make an apparatus compact on the whole.SOLUTION: Blocking of a puncture part 5 or flow passage part 13 is detected by detecting a piston 11 being incapable of moving from the most retracted position to the most pressed-in position within an upper-limit time T2 set on the basis of a preset reciprocation time T1, so that the blocking is accurately detected and no pressure sensor is needed, thus making the apparatus compact on the whole.

Description

  The present invention relates to a drug solution administration device and an occlusion detection method, and is suitable for application when, for example, a drug solution is administered into the body.

  2. Description of the Related Art Conventionally, a device that administers a drug solution (insulin) is a portable device that is used by adhering to a user's skin. A so-called syringe pump type device has been proposed that is administered into the body by being pushed out (see, for example, Patent Document 1).

Special table 2010-501283 gazette

  By the way, in a device for administering a chemical solution as described above, the chemical solution filled in the outer cylinder is denatured, or a cannula inserted into the user's body is deformed, and the flow path through which the chemical solution flows is blocked. However, there is a possibility that the drug solution cannot be normally administered to the user.

  In order to notify the user that the flow path is blocked, there is an apparatus that detects a current of a motor that operates a piston that pushes out a chemical solution filled in an outer cylinder at predetermined intervals.

  In such a device, when the current is equal to or greater than a predetermined threshold, the pressure in the outer cylinder has exceeded a certain value, that is, the operation is stopped and the user is notified that the chemical has not been delivered normally. An apparatus designed to do this has been proposed.

  In such a device, since the pressure in the outer cylinder is detected based on the current of the motor that operates the piston, the load on the motor increases due to the increase in the friction force of the outer cylinder and the piston, and the current increases. In this case, the pressure in the outer cylinder cannot be detected accurately.

  On the other hand, in order to accurately detect the pressure of the flow path through which the chemical solution flows, it may be considered to use a pressure sensor in the flow path. However, since an apparatus that allows a user to hold for a long time is required to be further downsized, the provision of a pressure sensor is an adverse effect of downsizing.

  The present invention has been made in consideration of the above points, and an object of the present invention is to propose a drug solution administration device and an occlusion detection method that can be miniaturized.

  In order to solve this problem, the present invention provides a chemical solution administration device for administering a chemical solution into a user's body, the chemical solution storage unit for storing the chemical solution, and the chemical solution from the chemical solution storage unit into the user's living body. A flow path section that forms a flow path for feeding liquid, a cylinder section provided in the middle of the flow path section, a piston that slides in the cylinder section, a drive section that slides the piston in the cylinder section, and a piston control The flow control unit includes an inflow path that connects the chemical solution storage unit and the cylinder unit, and an outflow path that connects the cylinder unit and the living body of the user. The first control unit that controls the flow direction of the chemical solution provided on the inflow path so that the chemical solution flows from the chemical solution storage unit to the cylinder unit, and the chemical solution flows from the cylinder unit to the living body of the external user. , The direction of flow of the chemical solution provided on the outflow path The drive control unit includes a piston detection unit that detects a movement of the piston from the most retracted position to the most depressed position within a predetermined period of time. And a blockage detection unit that detects that the channel portion is blocked when the movement of the piston within the predetermined time cannot be performed.

  The present invention also relates to a method for detecting occlusion in a chemical solution administration device that administers a chemical solution into a user's body, wherein the flow channel unit forms a flow channel for feeding the chemical solution from the chemical solution storage unit to the user's body. There is a piston that slides inside the cylinder part to which one end is connected. When the piston moves from the most retracted position to the most pushed position in the cylinder, the chemical solution is passed through the flow path part by the user. A drive control step for controlling the drive unit so that the piston moves from the most retracted position to the most depressed position in a predetermined time via a drive unit that drives the piston so as to feed liquid into the body; And a blockage detecting step for detecting that the flow path portion is blocked when the piston cannot move from the most retracted position to the most pushed position in a time set based on the time.

  As a result, the blockage can be detected because the piston has not moved in the time set from the position where the piston is most retracted to the position where the piston is pushed most, so the blockage can be accurately detected with a simple configuration.

  According to the present invention, since the blockage can be detected when the piston cannot move from the position where the piston is most retracted to the position where the piston is pushed most, the blockage can be accurately detected with a simple configuration. Thus, the entire apparatus can be miniaturized.

It is a basic diagram which shows the structure of a chemical | medical solution administration apparatus. It is a disassembled perspective view of a chemical | medical solution administration apparatus. It is a basic diagram which shows the mode of the sending of the chemical | medical solution by a sending part. It is a basic diagram which shows the structure of the drive part in 1st Embodiment. It is sectional drawing of the drive part in 1st Embodiment. It is a basic diagram which shows the mode of a deformation | transformation of a vibrating body. It is a basic diagram which shows the electric constitution of a chemical | medical solution administration apparatus. It is a basic diagram which shows the structure of the functional structure of CPU. It is a flowchart which shows the obstruction | occlusion detection processing procedure in 1st Embodiment. It is a basic diagram which shows the structure of the drive part in 2nd Embodiment. It is a flowchart which shows the obstruction | occlusion detection processing procedure in 2nd Embodiment.

  Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.

<1. First Embodiment>
[1-1. Configuration of drug administration device]
As shown in FIG. 1, the drug administration device 1 is a portable device that is used by being attached to a user's skin, and has a lower housing portion that is open on the upper side and has a space inside. 2 and the upper housing part 3 fitted in the opening of the lower housing part 2 are formed into a flat and substantially rectangular parallelepiped shape.

  The size of the drug solution administration device 1 may be reduced to such an extent that it can be attached to the user's skin, and examples thereof include a substantially rectangular parallelepiped shape having a width of 32 mm, a length of 44 mm, and a height of 11 mm.

  The lower housing part 2 is provided with a sticking part 4 made of double-sided tape or the like on the bottom surface 2A. The medicinal-solution administration device 1 is held by the user by attaching the adhesive portion 4 to the user's skin.

  The medicinal solution administration device 1 has a puncture portion made of a needle, a cannula or the like for puncturing the user's skin in order to administer the medicinal solution filled therein to the bottom surface 2A of the lower casing portion 2 into the user's body. 5 and an injection part 6 which is an injection path for injecting a chemical into a chemical storage part (FIG. 2) provided inside.

  As shown in FIG. 2, the drug solution administration device 1 includes an injection unit 6, a drug solution storage unit 7, a substrate unit 8, and a delivery unit 9 in a space formed by the lower housing unit 2 and the upper housing unit 3. The

  The chemical solution storage unit 7 is a container formed of a flexible material. As a material which comprises the chemical | medical solution storage part 7, it is preferable that a polyolefin is included, for example. As a material for forming the flexible bag 2, polyethylene or polypropylene, a styrene thermoplastic elastomer such as a styrene-butadiene copolymer or a styrene-ethylene-butylene-styrene block copolymer, or an ethylene-propylene copolymer is particularly preferable. And a soft resin obtained by blending and softening an olefin-based thermoplastic elastomer such as an ethylene-butene copolymer or a propylene-α-olefin copolymer. Although the capacity | capacitance of the container of the chemical | medical solution storage part 7 is not specifically limited, For example, a 2 mL capacity | capacitance is mentioned when size reduction etc. are considered. And a chemical | medical solution is filled from the outside through the injection | pouring part 6. FIG. Examples of the drug solution stored in the drug storage unit 7 include insulin, various hormones, analgesics such as morphine, or anti-inflammatory drugs. The substrate unit 8 is provided with a power supply unit 44 (FIG. 7) for supplying power supply power, a circuit for controlling the sending unit 9, and the like.

  As shown in FIGS. 2 and 3, the delivery unit 9 includes a piston 11, a drive unit 12 that reciprocates the piston 11 according to the control of the CPU 41 (FIG. 7), and a drug solution from the drug solution storage unit 7 to the puncture unit 5. The flow path portion 13 that forms the flow path through which the gas flows, the cylinder 14 that has one end connected to the flow path portion 13 and the piston 11 that is inserted from the other end slides inside, and opens and closes the flow path of the flow path portion 13 It is set as the structure containing the restriction | limiting part 15 which restrict | limits the flow of a chemical | medical solution.

  The piston 11 is driven by the drive unit 12 and slides with a predetermined stroke in the cylinder 14. Examples of the material of the piston 11 include stainless steel, copper alloy, aluminum alloy, titanium material, thermoplastic elastomer such as polypropylene and polycarbonate, and the diameter thereof is, for example, about 0.8 mm. The piston 11 slides in the cylinder 14 to send a certain amount of chemical solution, and its stroke is, for example, about 2 mm.

  The flow path portion 13 includes a suction pipe 13A that forms an inflow path, a delivery pipe 13B that forms an outflow path, and a connection pipe 13C for connecting to a cylinder section. One end of the suction pipe 13A is connected to the medicine storage section 7, and the other end is connected to the connection pipe 13C. The delivery tube 13B has one end connected to the puncture unit 5 and the other end connected to the connection tube 13C. The connection pipe 13C has ends connected to the suction pipe 13A and the delivery pipe 13B, respectively, and the cylinder 14 is connected to the center portion.

  The restricting portion 15 includes a suction side lid portion 21 and a suction side pressing portion 23 constituting a first restriction portion, and a sending side lid portion 22 and a sending side pushing portion 24 constituting a second restriction portion.

  The suction-side lid portion 21 and the delivery-side lid portion 22 are elastically deformable members, and are spaced apart from each other end of the suction tube 13A and the delivery tube 13B by a predetermined distance. The suction-side pressing portion 23 and the delivery-side pressing portion 24 are actuators that operate according to the control of the CPU 41 (FIG. 7). The suction-side lid portion 21 and the delivery-side lid portion 22 are connected to the suction pipe 13A and the delivery pipe 13B. By pressing against the ends, the other ends of the suction pipe 13A and the delivery pipe 13B are respectively closed.

  The cylinder 14 has an inner diameter larger than the diameter of the piston 11, one end is connected to the connection pipe 13 </ b> C, and the piston 11 is inserted from the other end side to slide inside. The difference in diameter between the cylinder 14 and the piston 11 is, for example, about 0.01 mm.

  When sending the chemical solution from the chemical solution storage unit 7 to the outside, the delivery unit 9, as shown in FIG. 3, when the piston 11 comes to the most pushed position (hereinafter also referred to as the most pushed position), the suction side pressing unit. 23 is separated from the suction side lid 21 to open the flow path between the suction pipe 13A and the connection pipe 13C, and the delivery side pressing part 24 is pressed against the other end of the delivery pipe 13B by the delivery side pressing part 24. The flow path between 13B and the connecting pipe 13C is closed (FIG. 3A).

  The delivery section 9 slides the piston 11 in the cylinder 14 to the position where the piston 11 is most retracted from the most pushed position (hereinafter also referred to as the most retracted position) (hereinafter, this sliding direction is also referred to as the retracting direction). ), And the chemical stored in the chemical storage 7 is sucked into the cylinder 14 through the suction pipe 13A and the connection pipe 13C (FIG. 3B).

  When the piston 11 is moved to the most retracted position, the delivery part 9 presses the suction side cover part 21 against the other end of the suction pipe 13A by the suction side pressing part 23, thereby causing the flow between the suction pipe 13A and the connection pipe 13C. The path is closed (FIG. 3C), the sending side pressing part 24 is separated from the sending side cover part 22, and the flow path between the sending pipe 13B and the connecting pipe 13C is opened (FIG. 3D).

  The delivery unit 9 slides the piston 11 in the cylinder 14 from the most retracted position to the most pushed position (hereinafter, this sliding direction is also referred to as the pushing direction), and connects the chemical solution sucked into the cylinder 14. It sends out into a user's body via the pipe | tube 13C, the delivery pipe | tube 13B, and the puncture part 5 (FIG.3 (E) and (F)).

  The delivery unit 9 can administer about 1 μL of a chemical solution into the user's body by the operation of reciprocating the piston 11 (FIGS. 3A to 3F), and repeatedly perform this operation at a set cycle and interval. Thus, the drug solution can be administered to the user at a desired administration rate and dosage.

  As shown in FIG. 4 and FIG. 5 which is a cross-sectional view thereof, the drive unit 12 includes a support body 31, a shaft support body 32, a shaft body 33, a vibrating body 34, a moving body 35, a shaft contact body 36, and a tightening body. 37.

  The support 31 is a conductive member, and supports each part of the drive unit 12 via a shaft support 32 provided on one end side thereof. The support 31 is provided with movement restricting portions 31A and 31B projecting in the direction of the moving body 35 such that opposing surfaces are separated by a predetermined distance (a distance obtained by combining the stroke of the piston 11 and the width of the protruding portion 35B). The movement restricting portions 31A and 31B restrict the movement of the piston 11. The support 31 is electrically connected to the substrate unit 8.

  The shaft support 32 is made of an insulating member, and is provided with a hole through which the shaft 33 is inserted. The shaft 33 has a substantially cylindrical shape, is inserted through the hole of the shaft support 32, and is supported so as to be movable in the axial direction. A vibrating body 34 made of, for example, a voltage element is brought into contact with one end of the shaft body 33.

  When a voltage is applied based on the control of the CPU 41 (FIG. 7), the vibrating body 34 is bent so that the central portion is pushed out with respect to the peripheral portion. At this time, the bending direction differs depending on the direction of the applied voltage. Specifically, for example, when a voltage is not applied, the surface is planar, and a voltage is applied in the direction of (FIG. 6A) and FIG. 6B (this direction is assumed to be a positive direction). Then, the shaft body 33 is deformed so as to be pushed out, and the shaft body 33 is deformed so as to be pulled back by applying a voltage in a direction opposite to that shown in FIG. 6 (C)).

  The shaft body 33 is sandwiched by a predetermined frictional force so as to be surrounded by the moving body 35 and the shaft contact body 36 via the fastening body 37 on the opposite side of the vibration body 34 with the shaft support body 32 interposed therebetween. .

  The moving body 35 is made of a conductive member, and the piston 11 is connected to the opposite side of the shaft facing portion 35 </ b> A facing the shaft contact body 36.

  The movable body 35 is a protrusion having a predetermined width so as to come into contact with the opposing surfaces of the movement restriction portions 31A and 31B when the movement body 35 moves between the movement restriction portions 31A and 31B of the support 31. 35B is provided. The moving body 35 is electrically connected to the substrate unit 8.

  When the voltage applied to the vibrating body 34 gradually changes in the positive direction, the driving unit 12 extends the vibrating body 34 and moves the shaft body 33 in the pushing direction. At this time, the moving body 35, the shaft contact body 36, the tightening body 37, and the piston 11 move in the pushing direction together with the shaft body 33 by the frictional force between the shaft body 33, the moving body 35, and the shaft contact body 36.

  Thereafter, when the voltage applied to the vibrating body 34 suddenly changes in the negative direction, the driving unit 12 contracts the vibrating body 34 and moves the shaft body 33 in the retracting direction. At this time, the moving body 35, the shaft abutting body 36, the tightening body 37, and the piston 11 are slipped by the inertial force overcoming the frictional force between the shaft body 33 and the moving body 35 and the shaft abutting body 36. , Stay in that position.

  In this manner, the drive unit 12 moves the piston 11 by a minute amount in the pushing direction by this one operation. The minute amount is, for example, about 0.2 μm. The drive unit 12 repeats this a predetermined number of times to move the piston 11 from the most retracted position to the most pushed position. For example, the drive unit 12 can be moved 2 mm by moving 10,000 times. At this time, the drive unit 12 can prevent the piston 11 from moving in the pressing direction from the most pressed position by the protrusion 35B coming into contact with the movement limiting unit 31A.

  On the other hand, when the voltage applied to the vibrating body 34 suddenly changes in the positive direction, the driving unit 12 extends the vibrating body 34 and moves the shaft body 33 in the pushing direction. At this time, the moving body 35, the shaft abutting body 36, the tightening body 37, and the piston 11 are slipped by the inertial force overcoming the frictional force between the shaft body 33 and the moving body 35 and the shaft abutting body 36. , Stay in that position.

  When the voltage applied to the vibrating body 34 gradually changes in the negative direction, the driving unit 12 contracts the vibrating body 34 and moves the shaft body 33 in the retracting direction. At this time, the moving body 35, the shaft contact body 36, the tightening body 37, and the piston 11 move in the retracting direction together with the shaft body 33 due to the frictional force between the shaft body 33, the moving body 35, and the shaft contact body 36.

  In this way, the drive unit 12 moves the piston 11 by a small amount in the pullback direction by this single operation. The minute amount is, for example, about 0.2 μm. The drive unit 12 repeats this a predetermined number of times to move the piston 11 from the most pushed position to the most retracted position. The predetermined number of times is, for example, 10,000 times, whereby the 2 mm piston 11 can be moved. At this time, the drive unit 12 can prevent the piston 11 from moving in the retracting direction from the most retracted position by the protrusion 35B coming into contact with the movement restricting unit 31B.

[1-2. Electrical configuration of drug solution administration device]
As shown in FIG. 7, the drug solution administration device 1 includes a CPU (Central Processing Unit) 41, a ROM (Read Only Memory) 42, a RAM (Random Access Memory) 43, a power supply unit 44, and an interface unit (I / F unit) 45. The notification unit 46, the drive unit 12, and the restriction unit 15 are connected via a bus 47.

  CPU41, ROM42, RAM43, the power supply part 44, and the alerting | reporting part 46 are distribute | arranged on the board | substrate part 8 (not shown). A battery is applied to the power supply unit 44. As the notification unit 46, a speaker for notification by voice, an LED for notification by light, and the like are applied.

  The interface unit 45 is provided with a button (not shown) or the like that is arranged in the upper casing unit 3 or the lower casing unit 2 and receives a user input command. In addition, a communication unit including an antenna and a communication circuit for performing wireless communication instead of the interface unit 45 is installed, and an input command by wireless communication is received from an operation unit (not shown) separate from the pump. But you can.

  The CPU 41 performs overall control by reading the basic program stored in the ROM 42 into the RAM 43 and executing it, and executes various processes by reading out and executing various application programs stored in the ROM 42 into the RAM 43. The user operates the drug solution administration device 1 and issues a command to the CPU 61 that is a control unit. The CPU 61 reads the basic program and controls the drive unit 12 and the restriction unit 15 to administer the drug to the user. The

  As described above, since the support 31 and the moving body 35 are connected via the shaft support 32 that is an insulator, they are not electrically connected via the shaft support 32.

  On the other hand, the support body 31 and the moving body 35 are electrically connected to the substrate portion 8, respectively, and a circuit through which electricity flows when the support body 31 and the moving body 35 come into contact is formed.

  That is, the support 31 and the moving body 35 are electrically connected when the projection 35A of the moving body 35 contacts the movement restricting portion 31A or 31B of the support 31.

  The CPU 41 can detect that the protrusion 35 </ b> A of the contact moving body 35 has contacted the movement restricting portion 31 </ b> A or 31 </ b> B of the support 31 by detecting that electricity flows through the support 31 and the moving body 35. .

[1-3. Blockage detection process)
In the drug solution administration device 1, the puncture unit 5 is deformed by the body movement of the user, or the drug solution such as the drug solution is denatured, so that the puncture unit 5 and the flow path unit 13 are blocked, and the drug solution is accurately supplied to the user. It may be impossible to administer.

  Therefore, the CPU 41 performs a blockage detection process for detecting whether the puncture unit 5 and the flow path unit 13 are blocked, and detects blockage of the puncture unit 5 and the flow path unit 13.

  The CPU 41 develops a liquid feeding program loaded with the blockage detection algorithm stored in the ROM 42 in the RAM 43 and executes processing. When executing the processing, the CPU 41 functions as a setting unit 51, a drive control unit 52, a piston detection unit 53, a blockage detection unit 54, and a notification control unit 55 as shown in FIG.

  In the drug solution administration device 1, after the drug solution storage unit 7 is filled with the drug solution from the outside via the injection unit 6, the affixing unit 4 is affixed to the user's skin and the puncture unit 3 is punctured into the user's skin. The dose and the administration rate are input via the interface unit 45.

  The setting unit 51 calculates the number of reciprocations N of the piston 11 based on the input dose and the volume stroke of the piston 11. For example, when the dose is 2 mL and the volume stroke of the piston 11 is 0.5 μL, the setting unit 51 calculates the number of reciprocations N of the piston 11 as 4000.

  The setting unit 51 calculates the reciprocation time T1 of the piston 11 based on the input administration speed and the volume stroke of the piston 11. For example, when the administration rate is 1 μL / s and the volume stroke of the piston 11 is 0.5 μL, the setting unit 51 calculates the reciprocation time T1 of the piston 11 as 0.5 s.

  Therefore, in the chemical solution administration device 1, when the puncture unit 5 and the flow path unit 13 are not closed, the piston 11 can be reciprocated in 0.5 s that is the reciprocation time T1.

  However, when the puncture unit 5 or the flow path unit 13 is blocked, if the piston 11 is moved in the pushing direction, the chemical liquid drawn into the cylinder 14 cannot be pushed out, and the internal pressure in the cylinder 14 increases. A force in the pullback direction is applied to the piston 11.

  For this reason, the drive unit 12 tries to move the piston 11 in the pushing direction by the frictional force of the moving body 35 and the shaft abutting body 36 together with the shaft body 33 by gradually increasing the applied voltage to the vibrating body 34. The force applied to the piston 11 becomes greater than the frictional force, and the amount of movement of the piston 11 decreases or does not move at all.

  Therefore, when the puncture unit 5 and the flow path unit 13 are not closed, the drive unit 12 is most retracted in a time sufficient for reciprocating the piston 11 during the reciprocation time T1 (for example, half the time of T1). While the puncture portion 5 and the flow path portion 13 are closed, the position can be moved from the position to the most pushed-in position. It becomes impossible to move from the retracted position to the most pushed position.

  Therefore, the setting unit 51 determines the upper limit time for determining that the puncture unit 5 and the flow path unit 13 are closed with respect to the time required for the piston 11 to move from the most retracted position to the most depressed position ( Hereinafter, this is also referred to as an indentation upper limit time) T2. This indentation upper limit time T2 is set to be, for example, at least half the round trip time T1 and less than the round trip time T1 (about 0.5 to 0.7 times the round trip time T1). By setting the upper limit time T2 to be less than the round trip time T1, the closed state can be detected within the round trip time T1.

  Furthermore, the upper limit time for determining that the puncture section 5 and the flow path section 13 are closed with respect to the time required for the piston to move from the most pushed position to the most retracted position (hereinafter referred to as pulling back). T3 is also calculated. The withdrawal upper limit time T3 is a time obtained by subtracting the pushing upper limit time T2 from the round-trip time T1.

  For example, when the upper limit time T2 is set to 0.7 times the round trip time T1, the setting unit 51 calculates the push upper limit time T2 as 0.35 s and the pullback upper limit time T3 as 0.15 s.

  By the way, since the support 31 is integrally formed of a conductive material, the projecting portion 35B of the movement restricting portion 31A or 31B is detected only by detecting that the support 31 and the moving body 35 are electrically connected. It is impossible to determine which one is in contact.

  Therefore, if the drive unit 12 is driven in a state where the projecting portion 35B is in contact with the movement restricting portion 31B, the support 31 and the moving body 35 are in contact even if the piston 11 is not moving at all. It may be erroneously detected that the body 35 has moved and the protruding portion 35B has come into contact with the movement restricting portion 31A. At this time, the piston does not operate at all due to blockage or the like, but by determining that it is in contact, the piston reaches the most pushed position within the push upper limit time T2, and makes a mistake in judging that it is not closed. It will end up.

  In order to prevent such a misjudgment, the protrusion 35B moves from the state where the protrusion 35B is in contact with the movement restricting part 31A or 31B to the movement restricting part within the pushing upper limit time T2 and less than the pulling upper limit time T3. It is necessary to confirm that they have left 31A and 31B.

  Therefore, the setting unit 51 calculates a time T4 (hereinafter, also referred to as an operation confirmation time) T4 for confirming that the protruding portion 35B has left the state where it is in contact with the movement restricting portion 31A or 31B. This operation confirmation time T4 is set to be less than the pushing upper limit time T2 and less than the pulling upper limit time T3 (for example, about 0.2 times the pushing upper limit time T2).

  For example, when the operation confirmation time T4 is set to 0.2 times the pushing upper limit time T2, the setting unit 51 calculates the operation confirmation time T4 as 0.07 s.

  The drive control unit 52 controls the drive unit 12 to move the piston 11 with the number of reciprocations N and the reciprocation time T1 calculated by the setting unit 51, and starts the pushing operation of the piston 11 via the drive unit 12. Note that the case where the piston 11 is in the most retracted position when the push-in operation is started and the movable body restricting portion 31B and the projecting portion 35B are in contact will be described. However, the piston 11 is not in the most retracted position. Alternatively, the pushing operation may be started after the piston 11 is moved to the most retracted position based on the control of the drive control unit 52.

  When the drive unit 12 starts moving the piston 11 from the most retracted position based on the control of the drive control unit 52, the piston detection unit 53 causes the support 31 and the moving body 35 to move after the operation confirmation time T4 elapses from the start of the pushing operation. Detect whether or not they are touching.

  The blockage detection unit 54 determines that the piston 11 is not moving when the piston detection unit 53 detects that the support 31 and the moving body 35 are in contact after the operation confirmation time T4 has elapsed from the start of the pushing operation. At this time, the drive control unit 52 stops the operation of the drive unit 12. The notification control unit 55 controls the notification unit 46 to notify the user through the notification unit 46 that the puncture unit 5 and the flow path unit 13 are closed.

  On the other hand, when the piston detection unit 53 detects that the support 31 and the moving body 35 are not in contact after the operation confirmation time T4 has elapsed from the start of the pushing operation, the support 31 from the start of the pushing operation until the pushing upper limit time T2 has elapsed. It is detected whether the moving body 35 has contacted.

  The blockage detection unit 54 determines that the puncture unit 5 and the flow path unit 13 are blocked when the pressing upper limit time T2 has elapsed from the start of pressing without detecting that the support 31 and the moving body 35 are in contact with each other. As described above, the drive control unit 52 stops the operation of the drive unit 12, and the notification control unit 55 notifies the user via the notification unit 46 that the puncture unit 5 and the flow path unit 13 are closed. Notice.

  On the other hand, the blockage detection unit 54 determines that the piston 11 has moved to the most pushed position when it can be detected that the support 31 and the moving body 35 are in contact between the start of the pushing operation and the pushing upper limit time T2.

  Then, the drive control unit 52 starts the pull-back operation of the piston 11 via the drive unit 12.

  The piston detection unit 53 detects whether or not the support 31 and the moving body 35 are in contact after the operation confirmation time T4 has elapsed since the start of the pull-back operation, as in the pushing operation of the piston 11.

  When the piston detection unit 53 detects that the support 31 and the moving body 35 are in contact after the operation confirmation time T4 has elapsed from the start of pulling back, the drive control unit 52 stops the operation of the drive unit 12, and the notification control unit 55 Notifies the user through the notification unit 46 that the puncture unit 5 and the flow path unit 13 are closed.

  On the other hand, when the piston detection unit 53 detects that the support 31 and the moving body 35 are not in contact after the operation confirmation time T4 has elapsed since the start of the pull-back operation, the piston detection unit 53 and the support 31 It is detected whether the moving body 35 has contacted.

  The blockage detection unit 54 determines that the piston 11 is not moving when the piston detection unit 53 cannot detect that the support 31 and the moving body 35 are in contact between the start of the pull back operation and the pull back upper limit time T3. . At this time, the drive control unit 52 stops the operation of the drive unit 12, and the notification control unit 55 notifies the user via the notification unit 46 that the puncture unit 5 and the flow path unit 13 are closed.

  The drive control unit 52, the piston detection unit 53, the blockage detection unit 54, and the notification control unit 55 repeatedly perform the above-described processing while the piston 11 is reciprocated by the number of reciprocations N. The drive control unit 52 stops the drive unit 12 and ends the process when the piston 11 is normally reciprocated by the reciprocation number N.

[1-4. Blockage detection processing procedure
Next, the procedure of the above-described blockage detection process will be described using the flowchart of the routine RT1 shown in FIG. When the dose and the dose rate are input via the interface unit 45 (step SP1), the CPU 41 calculates the reciprocation number N of the piston 11 based on the input dose and the volume stroke of the piston 11 (step SP2). ).

  The CPU 41 calculates a reciprocating time T1, a pushing upper limit time T2, and a pulling upper limit time T3 (step SP3), and calculates an operation confirmation time T4 (step SP4). Then, the CPU 41 starts the pushing operation of the piston 11 via the driving unit 12 (step SP5), and after the operation confirmation time T4 has elapsed from the pushing operation start (step SP6), is the support 31 and the moving body 35 in contact with each other? Whether or not is detected (step SP7).

  When the CPU 41 detects that the support 31 and the moving body 35 are in contact (YES in step SP7), the CPU 41 stops the operation of the drive unit 12 and notifies that it is closed (step SP8). End the process. On the other hand, when the CPU 41 detects that the support body 31 and the moving body 35 are not in contact (NO in step SP7), has the support body 31 and the moving body 35 contacted between the start of the pressing operation and the elapse of the pressing upper limit time T2? Whether or not is detected (steps SP9 and SP10).

  When the CPU 41 cannot detect that the support body 31 and the moving body 35 have contacted each other between the start of the pressing operation and the pressing upper limit time T2 (YES in step SP9), the CPU 41 stops the operation of the driving unit 12 and closes it. (Step SP8), and the process ends. On the other hand, when the CPU 41 can detect that the support body 31 and the moving body 35 are in contact (YES in step SP10), the CPU 41 starts the pullback operation of the piston 11 via the drive unit 12 (step SP11). After the operation confirmation time T4 has elapsed (step SP12), it is detected whether or not the support 31 and the moving body 35 are in contact (step SP13).

  When the CPU 41 detects that the support 31 and the moving body 35 are in contact (YES in step SP13), the CPU 41 stops the operation of the drive unit 12 and notifies that it is closed (step SP14). Exit. On the other hand, when the CPU 41 detects that the support 31 and the moving body 35 are not in contact (NO in step SP14), the support 31 and the moving body 35 have contacted each other from the start of the pull back operation until the upper limit time T3 elapses. (Steps SP15 and SP16).

  If the CPU 41 cannot detect that the support 31 and the moving body 35 are in contact with each other (YES in step SP15), the CPU 41 stops the operation of the drive unit 12 and notifies that it is closed (step S14). End the process. On the other hand, if the CPU 41 can detect that the support 31 and the moving body 35 are in contact (YES in step SP16), the CPU 41 determines whether the piston 11 has been reciprocated by the number of reciprocations N (step SP17).

  When the piston 11 has not been reciprocated by the reciprocation number N, the CPU 41 waits until the reciprocation time T1 has elapsed from the start of pushing (steps SP18 and 19), and returns to step SP5 when the reciprocating time T1 has elapsed from the start of pushing. On the other hand, the CPU 41 ends the process when the piston 11 is reciprocated by the reciprocation number N.

<2. Second Embodiment>
[2-1. Configuration of drug administration device]
The drug solution administration device 100 in the second embodiment is provided with a drive unit 112 instead of the drive unit 12 of the drug solution administration device 1 in the first embodiment, and other parts are the same as the drug solution administration device 1. is there.

  The drive unit 112 is provided with a support 131 instead of the support 31 of the drive unit 12 in the first embodiment, as shown in FIG. This part is the same as that of the drive unit 12.

  In the support 131, the movement restricting portions 131A and 131B made of a conductive material are connected to the support body main body 131C made of an insulating member.

  The movement restricting portions 131A and 131B are provided in the direction of the moving body 35 such that the opposing surfaces are separated by a predetermined distance (a distance that combines the stroke of the piston 11 and the width of the protruding portion 35B), and each of the movement restricting portions 131A and 131B is electrically connected to the substrate. Connected to the unit 8.

  In the substrate part 8, a circuit is formed in which electricity flows when the moving body 35 and the movement restricting parts 131A and 131B come into contact with each other.

  Then, the CPU 41 can determine which of the movement restricting portions 31A or 31B is in contact with the protruding portion 35B by detecting that electricity flows through either of the movement restricting portions 131A or 131B.

  Therefore, the CPU 41 can determine whether the piston 11 is located at the most retracted position or the most pushed-in position by detecting which of the movement restricting portions 131A or 131B the moving body 35 has contacted.

[2-2. Blockage detection process)
The CPU 41 develops a liquid feeding program loaded with the blockage detection algorithm stored in the ROM 42 in the RAM 43 and executes processing. When executing the process, the CPU 41 functions as a setting unit 51, a drive control unit 52, a blockage detection unit 54, and a notification control unit 55 as shown in FIG.

  In the drug solution administration device 1, after the drug solution storage unit 7 is filled with the drug solution from the outside via the injection unit 6, the affixing unit 4 is affixed to the user's skin and the puncture unit 5 is punctured to the user's skin. The dose and the administration rate are input via the interface unit 45.

  The setting unit 51 calculates the number of reciprocations N of the piston 11 based on the input dose and the volume stroke of the piston 11. The setting unit 51 calculates the reciprocating time T1, the pushing upper limit time T2, and the pulling upper limit time T3 of the piston 11 based on the input administration speed and the volume stroke of the piston 11.

  However, unlike the first embodiment described above, the setting unit 51 calculates the operation confirmation time T4 because it is possible to determine which of the protrusions 35B is in contact with the movement restriction unit 131A or 131B. There is nothing.

  The drive control unit 52 controls the drive unit 12 to move the piston 11 with the number of reciprocations N and the reciprocation time T1 calculated by the setting unit 51, and starts the pushing operation of the piston 11 via the drive unit 12. Note that the case where the piston 11 is in the most retracted position when the push-in operation is started and the support body restricting portion 131B is in contact with the protruding portion 35B will be described. However, the piston 11 is not in the most retracted position. Alternatively, the pushing operation may be started after the piston 11 is moved to the most retracted position based on the control of the drive control unit 52.

  The blockage detection unit 54 detects whether the support 131A and the moving body 35 are in contact between the start of the pressing operation and the elapse of the pressing upper limit time T2.

  The blockage detection unit 54 determines that the puncture unit 5 and the flow path unit 13 are blocked when the pressing upper limit time T2 has elapsed from the start of pressing without being able to detect that the support 131A and the moving body 35 are in contact with each other. The drive control unit 52 stops the operation of the drive unit 12, and the notification control unit 55 notifies the user through the notification unit 46 that the puncture unit 5 and the flow path unit 13 are closed.

  On the other hand, the blockage detection unit 54 determines that the piston 11 has moved to the most pushed-in position when it is possible to detect that the support 131A and the moving body 35 have been in contact from the pushing start to the pushing upper limit time T2. In this case, the drive control unit 52 starts the pull-back operation of the piston 11 via the drive unit 12.

  The blockage detection unit 54 detects whether the support 131B and the moving body 35 are in contact between the start of the pull back operation and the pull back upper limit time T3. The occlusion detection unit 54 determines that the piston 11 is not moving when it is not possible to detect that the support 131B and the moving body 35 are in contact with each other between the start of the pull back operation and the pull back upper limit time T3. At this time, the drive control unit 52 stops the operation of the drive unit 12, and the notification control unit 55 notifies the user via the notification unit 46 that the puncture unit 5 and the flow path unit 13 are closed.

  The drive control unit 52, the blockage detection unit 54, and the notification control unit 55 repeatedly perform the above-described process while the piston 11 is reciprocated by the number of reciprocations N. The drive control unit 52 stops the drive unit 12 and ends the process when the piston 11 is normally reciprocated by the reciprocation number N.

[2-3. Blockage detection processing procedure

  Next, the procedure of the above-described blockage detection process will be described using the flowchart of the routine RT2 shown in FIG. When the dose and the dose rate are input via the interface unit 45 (step SP21), the CPU 41 calculates the number of reciprocations N of the piston 11 based on the input dose and the volume stroke of the piston 11 (step SP22). ).

  The CPU 41 calculates the reciprocating time T1, the pushing upper limit time T2, and the pulling upper limit time T3 (step SP23), and starts the pushing operation of the piston 11 via the drive unit 12 (step SP24).

  The CPU 41 detects whether or not the movement limiting unit 131A and the moving body 35 have contacted from the start of the pressing operation until the pressing upper limit time T2 has elapsed (steps SP25 and SP26), and that the movement limiting unit 131A and the moving body 35 have contacted each other. Cannot be detected (YES in step SP25), the operation of the drive unit 12 is stopped and the fact that it is closed is notified (step SP27), and the process is terminated.

  On the other hand, when the CPU 41 can detect that the support 131A and the moving body 35 are in contact (YES in step SP26), the CPU 41 starts the pull-back operation of the piston 11 via the drive unit 12 (step SP28).

  The CPU 41 detects whether or not the movement restricting unit 131B and the moving body 35 have been in contact between the start of the pulling-back operation and the elapse of the pull-up upper limit time T3 (steps SP29 and SP30), and the movement limiting unit 131B and the moving body 35 have been in contact with each other. If this cannot be detected (YES in step SP29), the operation of the drive unit 12 is stopped and a notification that the drive unit 12 is closed is issued (step SP31), and the process ends.

  On the other hand, if the CPU 41 can detect that the support 31 and the moving body 35 are in contact (YES in step SP30), the CPU 41 determines whether the piston 11 has been reciprocated by the number of reciprocations N (step SP32).

  When the piston 11 has not been reciprocated by the number of reciprocations N, the CPU 41 waits until the reciprocation time T1 has elapsed from the start of pushing (steps SP33 and 34), and returns to step SP24 when the reciprocating time T1 has elapsed from the start of pushing. On the other hand, the CPU 41 ends the process when the piston 11 is reciprocated by the reciprocation number N.

<3. Operation and effect>
In the above-described configuration, the chemical liquid administration devices 1 and 100 include a cylinder section 14 having one end connected to the flow path section 13 for delivering the chemical liquid from the chemical liquid storage section where the chemical liquid (chemical liquid) is stored to the user's body. When the piston 11 slides on the other end side, the drug solution is delivered into the user's body.

  In the drug solution administration devices 1 and 100, by detecting that the piston 11 cannot move from the most retracted position to the most pushed position within the pushing upper limit time T2 set based on the reciprocating time T1, the puncture unit 5 or blockage of the flow path portion 13 is detected.

  Thereby, the drug solution administration apparatuses 1 and 100 increase the frictional force between the piston and the cylinder as in the case of detecting the blockage based on the pressure in the outer cylinder detected from the current applied to the drive unit that drives the piston. As a result, no detection error due to an increase in power occurs, so that the blockage can be detected more accurately.

  Further, in the drug solution administration apparatuses 1 and 100, the support bodies 31 and 131 and the moving body 35 are made of a conductive material, and the protrusion 35B of the moving body 35 that moves together while holding the piston 11 has the movement restricting sections 31A and 131A, It is detected whether or not the moving body 35 is in contact with the support bodies 31 and 131 by detecting the current that flows when contacting the 31B and 131B.

  And when the chemical | medical solution administration apparatuses 1 and 100 detect that the mobile body 35 is contacting the support bodies 31 and 131, it can detect that the piston 11 was moved to the most retracted position or the most pushed position. .

  Thereby, since the chemical | medical solution administration apparatuses 1 and 100 can detect the position of piston 11 even if it does not use the pressure sensor for the pressure of a flow-path part, they can be reduced in size by not using a pressure sensor.

  Further, in the drug solution administration device 1, the movement restricting portions 31 </ b> A and 31 </ b> B are integrally formed of a conductive member together with the support 31, and it is impossible to determine which of the movement restricting portions 31 </ b> A or 31 </ b> B is in contact with the protruding portion 35 </ b> B. Even if it exists, it detects that it has left | separated after operation | movement confirmation time T4 progress from the state which the protrusion part 35B is contacting the movement restriction | limiting part 31A or 31B.

  As a result, the medicinal solution administration device 1 moves from the state in which the protruding portion 35B is in contact with one movement restricting portion 31A or 31B to the other movement restricting portion as the moving body 35 moves even if the piston 11 has not moved at all. It is possible to prevent erroneous detection that the protruding portion 35B is in contact with 31A or 31B.

  According to the above configuration, in the drug solution administration device 1, the entire device can be miniaturized because the pressure sensor need not be used to detect the position of the piston 11.

<4. Other Embodiments>
In the above-described embodiment, the case where the diameter of the piston 11 is 0.8 mm, the inner diameter of the cylinder 14 is 0.81 mm, and the gap between the piston 11 and the cylinder 14 is 5 μm has been described. The present invention is not limited to this, and the inner diameter of the cylinder 14 may be up to 3 mm, and the gap between the piston 11 and the cylinder 14 may be 2 to 20 μm.

  In the above-described embodiment, the drive units 12 and 112 are applied to move the piston 11 back and forth. However, if the piston 11 is moved back and forth, for example, the gear rotates. A DC motor attached to the shaft may be rotated, and the piston 11 may be reciprocated by a feed screw via the gear.

  In the above-described embodiment, the restricting portion 15 includes the suction side lid portion 21, the delivery side lid portion 22, the suction side pressing portion 23, and the sending side pressing portion 24, and the suction side pressing portion 23 and the sending side pressing portion. The suction side lid part 21 and the delivery side lid part 22 are pressed against the other ends of the suction pipe 13A and the delivery pipe 13B via 24, and the chemical liquid flows from the chemical liquid storage part 7 into the user's body through the flow path part 13. The case where the restriction was made was described. The present invention is not limited to this, but an automatic valve or a one-way valve is provided in place of the restriction unit 15, and the flow path of the flow path section 13 is limited to flow from the chemical solution storage section 7 to the user's body. Also good.

  In the above-described embodiment, the case where the puncture unit 5 and the flow channel unit 13 are separately configured has been described. However, the flow channel through which the chemical solution flows from the chemical solution storage unit 7 to the outside is integrally formed as the flow channel unit. You may do it.

  In the above-described embodiment, the case where the blockage is detected based on the movement of the piston 11 during the pull back operation (steps SP12 to 15 and SP29 to SP31) has been described, but the present invention is not limited to this. The occlusion may not be detected during the pull back operation. However, since the reciprocation of the piston 11 must be completed within the reciprocation time T1, a notification is given if the piston 11 does not return within the predetermined time.

  The present invention can be applied to the medical field, for example.

  DESCRIPTION OF SYMBOLS 1 ... Chemical solution administration apparatus, 2 ... Lower housing | casing part, 3 ... Upper housing | casing part, 4 ... Pasting part, 5 ... Puncture part, 6 ... Injection | pouring part, 7 ... Chemical liquid storage part, 8 ... ... substrate part, 9 ... delivery part, 11 ... piston, 12 ... drive part, 13 ... flow path part, 14 ... cylinder, 15 ... restricting part, 31 ... support, 32 ... shaft support Body, 33... Shaft body, 34... Vibrating body, 35... Moving body, 41... CPU, 42... ROM, 43 ... RAM, 44. Information part, 47 …… Bus.

Claims (5)

A drug solution administration device for administering a drug solution into a user's body,
A chemical solution storage section for storing the chemical solution;
A flow path section that forms a flow path for feeding a chemical liquid from the chemical liquid storage section into the user's living body; and
A cylinder part provided in the middle of the flow path part;
A piston sliding in the cylinder part;
A drive section for sliding the piston in the cylinder section;
A drive control unit for controlling the piston;
Have
The flow path section is composed of an inflow path connecting the chemical solution storage section and the cylinder section, and an outflow path connected to the cylinder section and a user's living body,
The flow path unit includes a first control unit that controls a flow direction of the chemical solution provided on the inflow path so that the chemical solution flows from the chemical solution storage unit to the cylinder unit, and the user from the cylinder unit to the outside A second restricting portion for restricting a flow direction of the chemical solution provided on the outflow path so that the chemical solution flows into the living body of
The drive control unit includes a piston detection unit that detects a movement of the piston from a position where the piston is most retracted in the cylinder unit to a position where the piston is most pushed in a predetermined time, and the piston detection unit is configured to perform a predetermined time of the piston. And a blockage detection unit that detects that the channel portion is blocked when the movement within the channel is not detected. The drive unit is
A moving part that moves together with the piston;
When the piston moves in the direction from the most retracted position to the most depressed position, the piston is brought into contact with the moving portion so that the piston does not move more than the most depressed position, thereby restricting the movement of the piston. A first movement restriction unit that
When the piston moves in the direction from the most pushed-in position to the most retracted position, the piston is brought into contact with the moving portion so that the piston does not move more than the most retracted position. A second movement restriction unit for restriction;
Have
The occlusion detector
Based on the time from the state in which the moving unit is in contact with the second movement limiting unit to the time when the moving unit is in contact with the first movement limiting unit. The drug solution administration device according to claim 1, wherein the piston detection unit detects whether the piston is moving within a set time, thereby detecting that the flow path is closed. . The moving part, the first and second movement restricting parts are conductive members,
The blockage detection unit makes contact between the moving unit and the first or second movement limiting unit by detecting a current that flows when the moving unit contacts the first or second movement limiting unit. The drug solution administration device according to claim 2, wherein it is detected. The first and second movement restriction portions are integrally formed of a conductive member,
The blockage detection unit confirms that the movement restriction unit is in contact with one of the first and second movement restriction units, and then moves the movement restriction unit within a time shorter than the set time. 4. The drug solution administration device according to claim 3, wherein when it is not possible to detect that the channel portion is separated from the first and second movement restriction units, the channel unit is detected to be blocked. A method for detecting occlusion in a drug solution administration device for administering a drug solution into a user's body,
One end is slid inside the cylinder where one end is connected to the flow path section that forms the flow path for sending the chemical liquid from the chemical liquid storage section that stores the chemical liquid into the user's body, and from the most retracted position of the cylinder The position at which the piston is most retracted in a predetermined time via a drive unit that drives the piston that sends the liquid medicine into the user's body through the flow path when moving to the most pushed position. A drive control step for controlling the drive unit to move to the most pushed position from
A blockage detecting step for detecting that the channel portion is blocked when the piston cannot move from the most retracted position to the most pushed position in a time set based on the predetermined time; and An occlusion detection method comprising:

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