WO2016033854A1 - 可抛式无导管药物输注系统 - Google Patents

可抛式无导管药物输注系统 Download PDF

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Publication number
WO2016033854A1
WO2016033854A1 PCT/CN2014/088615 CN2014088615W WO2016033854A1 WO 2016033854 A1 WO2016033854 A1 WO 2016033854A1 CN 2014088615 W CN2014088615 W CN 2014088615W WO 2016033854 A1 WO2016033854 A1 WO 2016033854A1
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WO
WIPO (PCT)
Prior art keywords
key
unit
disposable
catheterless
drug
Prior art date
Application number
PCT/CN2014/088615
Other languages
English (en)
French (fr)
Inventor
杨翠军
Original Assignee
上海移宇科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海移宇科技有限公司 filed Critical 上海移宇科技有限公司
Priority to US14/897,702 priority Critical patent/US10064992B2/en
Priority to EP14894195.8A priority patent/EP3023113B1/en
Priority to ES14894195T priority patent/ES2734217T3/es
Publication of WO2016033854A1 publication Critical patent/WO2016033854A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1586—Holding accessories for holding infusion needles on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/005—Parameter used as control input for the apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration

Definitions

  • the present invention relates to a medical device device, and more particularly to a disposable catheterless drug infusion system for continuously infusing a drug fluid into a patient.
  • a medical fluid infusion device is a medical device device that achieves treatment of a patient's condition by continuously injecting a drug into a patient.
  • the drug fluid infusion device is widely used for the treatment of diabetes, and the insulin is continuously infused into the skin of the patient according to the dose required by the human body, thereby simulating the secretion function of the pancreas to keep the blood sugar of the patient stable.
  • the drug fluid is usually stored in a pump.
  • the existing drug fluid infusion device usually injects the drug fluid into the patient from a catheter connected to the pump body. In actual use, the catheter is usually not only for the patient. The activities, etc., cause certain obstacles and are not aesthetically pleasing.
  • the industry has developed a catheter-free drug fluid infusion device for directly transferring a pump body through a medical adhesive tape to a patient's body, and delivering a drug fluid through an indwelling hose implanted in a subcutaneous tissue of the human body.
  • the catheter-free drug fluid infusion device integrates the pump body and a wireless control module in a box, and remotely manages the infusion of the drug fluid through a wireless handheld device, but this requires the patient to infuse the drug fluid to treat the condition using the device.
  • At least the pump body and the wireless remote control device are carried, and there are also problems such as possible wireless interference and high cost.
  • the existing drug fluid infusion device has the disadvantages of complicated operation, large volume, and heavy weight, and the patient carries Or wearing a lot of shortcomings such as inconvenience.
  • the normal human pancreas automatically monitors changes in blood glucose levels in the human body and automatically secretes the required insulin.
  • the device that can dynamically monitor the blood sugar changes in the human body by the glucose sensor implanted in the subcutaneous tissue of the human body is a "real-time dynamic blood glucose monitoring system"; in view of the comfort level of wearing, the indwelling hose and the glucose sensor usually implanted under the human skin are fine. Long and soft medical polymer material. Because of the particularity of the materials and shapes of the two components, they need to pierce the skin with a steel needle with a certain rigidity and carry them under the skin, and then retract the steel needles while leaving them under the subcutaneous tissue. For indwelling hoses and glucose sensors, this puncture indwelling process is similar, in addition, both are in the active area of the human body, and both require the same for both disposable and sterile production. of.
  • an object of the present invention is to provide a disposable catheterless drug infusion system that integrates a pump body and a wireless remote control device into one body and is easy to operate, and is used to solve the prior art.
  • Drug fluid infusion devices are bulky, costly, have many components, and are inconvenient to carry.
  • the present invention provides a disposable catheterless drug infusion system comprising: a button unit for receiving a user key command; and a key unit for outputting at least one working mode Selecting an instruction; the working mode includes a basal rate infusion mode, a programmable basal rate infusion mode, an infusion pause mode, a locking system mode, and a wireless control mode; a drug storage unit for storing a drug fluid; and an indwelling unit
  • the drug fluid is delivered to the patient when implanted under the skin of the patient, including an indwelling hose for implantation under the skin of the patient; and a drive unit for extracting from the drug storage unit when receiving the infusion instruction
  • the drug fluid is pushed to the patient by the indwelling unit; the control unit is respectively connected to the button unit, the key unit, the drug storage unit, the indwelling unit and the driving unit for receiving the button command and/or the working mode
  • an infusion command matching the button command and/or the working mode is
  • the button unit comprises a physical key and/or a touch key.
  • the physical key comprises a physical B key for setting a drug fluid infusion dose and a physical OK key usable as a confirmation key, and one of the entity B key and the entity OK key is provided with a button for distinguishing Physical contact.
  • the key unit includes a key and a keyhole.
  • the key is also provided with a handle for engaging and disengaging the key and the keyhole.
  • the key comprises a key housing, a built-in circuit built in the key housing and a latch embedded in the key housing, and the key housing is provided with an O ring Sealing ring.
  • the built-in circuit is an analog circuit including a resistor or/and a capacitor, or a digital integrated circuit with a built-in Flash or EEROM or a single-burn type, or a digital integrated circuit including an identification function, or includes authentication And/or digital integrated circuits with encryption functions, or digital-analog hybrid integrated circuits.
  • a slot is disposed in the lock hole, and a connector electrically connected to the built-in circuit is disposed in the slot, and an O-ring is disposed on a mating surface of the connector and the lock hole.
  • the keyhole is a sealed recess
  • the key is an inductive key
  • the inductive key includes a key housing and an inductive circuit disposed therein.
  • the sensing circuit includes a magnetic induction sensor, or a light sensing sensor, or an NFC tag, or an RFID tag.
  • a buzzer chamber is disposed in the housing of the disposable catheterless drug infusion system, and a buzzer sound for sounding and/or prompting is placed in the buzzer chamber and can be used for ultrasonic data.
  • the buzzer is transmitted.
  • the buzzer is electrically connected to the control unit through wires or contacts.
  • a vibration motor placement slot is disposed in the housing of the disposable catheterless drug infusion system, and a vibration motor is disposed in the vibration motor placement slot, and the vibration motor is guided by the wire and the control unit. Work through.
  • the disposable catheter-free drug infusion system is further provided with a status indicator light
  • the outer casing body is correspondingly provided with a light-transmitting groove, and the indicator light flashes through the light-transmitting groove to indicate the state of the system.
  • the disposable catheterless drug infusion system is further provided with a glucose sensor for monitoring dynamic blood glucose changes and a blood glucose monitoring module for processing a blood glucose available signal output by the glucose sensor; the glucose sensor is combined In the indwelling unit, the blood glucose monitoring module is coupled to a control unit that connects the indwelling unit.
  • the disposable catheterless drug infusion system comprises a controller and a pump body connected to the controller; the control unit, a button unit and a key unit are disposed on the controller; A medicine unit, a drive unit and a retention unit are disposed on the pump body.
  • the disposable catheterless drug infusion system of the present invention adopts an independent control structure design to enhance the convenience of use and carrying, that is, a control unit capable of processing user instructions, coordinating and managing device operation, and a user are disposed in the device.
  • the button unit and the key unit that interact with the device, that is, the button and the key are set on the device, and the drug fluid infusion management is implemented under the cooperation of the buzzer, the vibration motor and the indicator light to complete the treatment of the patient.
  • the indwelling unit is combined with the glucose sensor
  • the control unit is combined with the blood glucose monitoring module
  • the disposable catheterless drug infusion system of the present invention can simultaneously achieve blood glucose monitoring, and drug fluid infusion for the purpose of treating the patient.
  • the patient sticks the entire device to the skin, sets the infusion procedure of the drug fluid through the button and the key, and the user's instruction, or when the liquid in the pump body is used up, or the device malfunctions.
  • the system will prompt the user for the next step by buzzer, and/or vibration motor, and/or indicator light.
  • FIG. 1 is a schematic view showing the structure of a disposable catheterless drug infusion system of the present invention.
  • Figure 2 is a schematic illustration of the various components of the disposable catheterless drug delivery system of the present invention integrated into the same housing or housing.
  • FIG. 3 shows the controller and pump body as separable parts in the disposable catheterless drug infusion system of the present invention Schematic diagram.
  • FIG. 4 is a schematic exploded view showing the controller and the pump body in the disposable catheterless drug infusion system of the present invention.
  • Fig. 5 is a view showing another exploded structure of the controller and the pump body in the disposable catheterless drug infusion system of the present invention.
  • Figure 6 shows a schematic diagram of the internal structure of the controller housing.
  • Fig. 7 is a schematic enlarged view of a portion A in Fig. 6.
  • Figure 8 is a schematic view showing the corresponding structure of a key and a keyhole in an embodiment of the present invention.
  • 9 to 11 are respectively a schematic view showing the disassembly, combination and operation of the handle and the key.
  • Fig. 12 is an enlarged schematic view showing a portion B in Fig. 6.
  • Figure 13 is a schematic view showing the corresponding structure of the key and the keyhole in another embodiment of the present invention.
  • FIG. 14 to 15 are views showing the structure of a controller including a buzzer, a vibration motor, and an indicator lamp in the controller of the disposable catheterless drug infusion system of the present invention.
  • 16 to 17 are views showing the structure of a buzzer in a pump body of the disposable catheterless drug infusion system of the present invention.
  • the present invention provides a disposable catheter-free drug infusion system for achieving treatment of a patient's condition by continuously injecting a drug into a patient.
  • the drug fluid infusion device is widely used for diabetes.
  • the insulin is continuously infused into the skin of the patient according to the dose required by the human body to simulate the pancreas Secretion function to keep the patient's blood sugar stable.
  • 1 is a schematic view showing the structure of a disposable catheterless drug infusion system according to the present invention.
  • the disposable catheterless drug infusion system 1 comprises: a button unit, a key unit, and a drug storage unit. , indwelling unit, drive unit, and control unit.
  • the disposable catheterless drug infusion system 1 can integrate a button unit, a key unit, a retention unit, a drive unit, and a control unit in the same case or housing 10.
  • Fig. 2 is a schematic view showing the components of the disposable catheterless drug infusion system of the present invention integrated in the same casing or casing.
  • the disposable catheterless drug infusion system 1 includes a controller 101 and a pump body 102 connected or disconnected from the controller 101; the control unit and the button unit And a key unit is disposed on the controller 101; the medicine storage unit, the driving unit, and the retention unit are disposed on the pump body 102.
  • FIG. 3 is a schematic view showing the controller and the pump body as separable components in the disposable catheterless drug infusion system of the present invention.
  • FIG. 4 is a schematic exploded view of the controller and the pump body in the disposable catheterless drug infusion system of the present invention.
  • the disposable catheterless drug infusion system 1 includes control.
  • the pump body 102 and the controller 101 are combined with the hook 1022 provided in the pump body 102 through a hook insertion hole or a card slot 1011 provided in the controller 101, and are provided in the control.
  • the sealed insertion hole 1010 of the device 101 and the plug 1020 provided in the pump body 102 are electrically connected.
  • the hook 1022 is coupled to the hook arm 1023, and the hook 1022 is detached from the card hole or the card slot 1011 by the operation of the hook arm 1023.
  • FIG. 5 is a schematic diagram showing another exploded structure of the controller and the pump body in the disposable catheterless drug infusion system of the present invention.
  • the controller 101 is shown.
  • the outer casing is provided with a release button 1012 for releasing the hook 1022 from the card hole or the card slot 1011.
  • FIG. 6 is a schematic diagram showing the internal structure of the controller casing
  • FIG. 7 is an enlarged schematic view of the portion A in FIG. 6.
  • the sealing socket 1010 is provided with a connector placement slot. 1010.
  • a connector 1014 electrically connected to the control unit circuit is disposed in the connector placement slot 1013, and an O-ring 1015 is disposed on a mating surface of the connector 1014 and the sealing socket 1010.
  • the plug includes a plug body with an O-ring 1021 and a plug 1020 embedded in the plug body, and the plug is inserted into the sealed socket 1010.
  • the plug 1020 is inserted into the connector 1014 and electrically connected thereto.
  • the O-ring 1021 on the plug body is press-fitted with the sealing socket 1010 to achieve sealing and waterproofing.
  • the button unit is configured to receive a user button instruction.
  • the button unit comprises a physical key and/or a touch key.
  • the user key command is, for example, a function of turning on, off, or restarting a system by a user button, or a function of system infusion pause, system sleep, and system programming by combining keys.
  • the physical key includes a physical B key for setting a drug fluid infusion dose and a physical OK key usable as a confirmation key, one of the entity B key and the entity OK key
  • the touch key is, for example, a capacitive touch button, a resistive touch button, or a touch screen or the like. When the button is selected as a touch button, different buttons have different indications (such as color indications or graphic indications) for distinguishing.
  • the key unit is configured to output a selection instruction carrying at least one working mode, wherein the working mode includes a basal rate infusion mode, a programmable basal rate infusion mode, an infusion pause mode, a locking system mode, and a wireless Control mode.
  • the key unit may be multiple, that is, each key unit has a working mode pre-stored, for example, a key unit pre-stored with a basal rate infusion mode, which can be implemented according to the actual situation of the patient. Programmable key rate infusion mode key unit, etc.
  • the key unit includes a key 13 and a keyhole 12.
  • FIG. 8 is a schematic diagram showing the corresponding structure of the key and the keyhole in an embodiment of the present invention.
  • the key 13 is further provided with a handle 14 for engaging and separating the key 13 and the keyhole 12.
  • a handle 14 for engaging and separating the key 13 and the keyhole 12.
  • the key includes a key housing 130 and a latch 131 embedded in the key housing 130.
  • the interior of the key housing 130 has a built-in circuit.
  • the built-in circuit includes Analog circuit of resistance or / and capacitance, or digital integrated circuit with memory function including built-in Flash or EEROM or one-time programming type, or digital integrated circuit including identification function, or number including authentication and/or encryption function
  • FIG. 12 is an enlarged view of the portion B in FIG. 6 .
  • the locking hole 12 is provided with a slot 120.
  • the slot 120 is provided with a connector 121.
  • the connector 121 is The control unit is electrically connected, and the connector 121 is further configured to be electrically connected to a built-in circuit of the PCB board.
  • the plug 131 can be inserted into the connector 121. And electrically connected with it, thereby implementing communication between the key 13 and the control unit.
  • the key housing 130 is provided with an O-ring 132 on the upper ring.
  • An O-ring 122 is disposed on a mating surface of the connector 121 and the lock hole 12, When the key 13 is inserted into the lock hole 12, the O-ring 132 on the key housing 130 is press-fitted with the lock hole 12, and the O-ring 122 on the connector 121 and its corresponding keyhole surface Squeeze and waterproof.
  • FIG. 13 a corresponding structural diagram of a key and a keyhole in another embodiment of the present invention is shown.
  • the keyhole 12 is a sealed recess
  • the key 13 is an inductive key.
  • the inductive key includes a key housing 130 and an inductive circuit disposed therein, such that non-physical contact communication of the key 13 and a control unit built into the disposable catheterless infusion system can be implemented, in particular
  • the sensing circuit includes, for example, a magnetic induction sensor, or a light sensing sensor, or an NFC tag, or an RFID tag.
  • the drug storage unit is for storing a drug fluid.
  • the pharmaceutical fluid is insulin for the treatment of diabetes.
  • the drug stored in the drug storage unit will be different.
  • the indwelling unit is for delivering the drug fluid to a patient when implanted under the skin of a patient, including an indwelling hose for implantation under the skin of the patient.
  • the indwelling hose is inserted under the skin of the patient with the aid of a steel needle.
  • the steel needle is hollow inside; or the steel needle is a split needle, and the soft needle is soft.
  • the tube is disposed in the groove of the slit; similarly, as the terminal for transporting the drug fluid, it may also be a steel needle provided with a lumen.
  • the driving unit is configured to extract a drug fluid from the drug storage unit and push it to the patient's skin by the indwelling unit when receiving the infusion command output by the control unit.
  • the drive unit includes an ejection device and a subcutaneous tubing mounting mechanism for piercing the indwelling hose of the indwelling unit into the skin of the patient, the subcutaneous tubing being installed when the indwelling hose is implanted
  • the mechanism can use a steel needle to pierce the patient's skin with a steel needle and bring the indwelling hose under the skin, and then withdraw the steel needle through the needle returning device, so that the drug fluid in the drug storage unit is transported through the indwelling unit to The patient is under the skin.
  • the disposable catheterless drug infusion system is further provided with a glucose sensor for monitoring dynamic blood glucose changes and a blood glucose monitoring module for processing a blood glucose available signal output by the glucose sensor;
  • a glucose sensor is coupled to the indwelling unit, the blood glucose monitoring module being coupled to a control unit that connects the indwelling unit.
  • the glucose sensor is disposed on an outer surface of the indwelling hose, and the blood glucose monitoring module is disposed in a housing of the disposable catheterless drug infusion system, but is not limited thereto.
  • Other ways of enabling the combination of the glucose sensor and the indwelling unit, as well as other implementations in which the blood glucose monitoring module is combined with a control unit coupled to the indwelling unit, are also applicable to the present invention.
  • the control unit is respectively connected to the button unit, the key unit, the medicine storage unit, the retention unit and the driving unit, and is configured to output the button instruction and/or when receiving the selection instruction of the button instruction and/or the working mode. Or an operational mode matching infusion command to the drive unit to cause it to perform or suspend delivery of the drug fluid.
  • the control unit prestores a plurality of key commands and a working mode set by the corresponding key unit, the working mode including a basal rate infusion mode, a programmable basal rate infusion mode, and an infusion pause. Mode, lock system mode, and wireless control mode.
  • the control unit is, for example, a single chip microcomputer or other micro processor for receiving, transmitting, and feedbackting each unit signal and coordinating and managing each unit, for example, for managing the dose of the drug storage unit, and outputting a prompt when the dose is insufficient. And alarms, or alarms when equipment fails.
  • the control unit also manages functional modules such as a wireless transmission module, a power supply module, and the like.
  • a buzzer chamber is provided in the housing of the disposable catheterless drug delivery system, and a buzzer sound is provided in the buzzer chamber for alerting and/or prompting And a buzzer that can be used for ultrasonic data transmission.
  • the buzzer is electrically connected to the control unit through a wire or a contact, and the buzzer can prompt the user's instruction, or when the liquid medicine in the pump body 102 runs out quickly, or the device fails. Alarms can also be transmitted by ultrasound.
  • the housing of the disposable catheterless drug infusion system is provided with a vibration motor placement slot, and a vibration motor is placed in the vibration motor placement slot, and the vibration motor passes through the wire and The control unit is turned on.
  • the vibration motor may vibrate to prompt the user to perform the next operation and/or alarm when the user's instruction, or when the liquid medicine in the pump body is used up, or the device malfunctions.
  • the housing of the disposable catheterless drug infusion system is further provided with a status indicator light
  • the outer casing is correspondingly provided with a light-transmitting groove, and the indicator light passes through the transparent groove. Blinking indicates system status to prompt the user.
  • the disposable catheterless drug infusion system 1 includes a detachable controller 101 and a pump body 102, the control unit, the button unit, and the key unit are disposed. On the controller 101; the drug storage unit, the drive unit and the retention unit are disposed on the pump body 102.
  • FIG. 14 to 15 there is shown a structural diagram of a controller including a buzzer, a vibration motor and an indicator light in the controller of the disposable catheterless drug infusion system of the present invention, as shown in the above, the disposable type provided above
  • the catheterless drug infusion system includes a controller 101 and an embodiment of the pump body 102 connected or disconnected from the controller 101, wherein the controller 101 is provided with a first buzz chamber 150 in the housing, at the first A first buzzer 15 is placed in the buzzer chamber, and the first buzzer chamber 15 is electrically connected to the control unit circuit of the controller 101 through a wire.
  • FIGS. 16 to 17 a schematic diagram of a structure including a buzzer in a pump body of a disposable catheterless drug infusion system according to the present invention, wherein a second buzzing chamber 180 is disposed in a casing of the pump body 102, A second buzzer 18 is disposed in the second buzzing chamber 180, and the second buzzer 18 passes through the contact 181 and the built-in circuit of the pump body 102. Turn on the work.
  • a vibration motor placement slot 160 is disposed in the housing of the controller 101.
  • a vibration motor 16 is disposed in the vibration motor placement slot 160.
  • the vibration motor 16 is electrically connected to the control unit through a wire.
  • the vibration motor 16 may vibrate to prompt the user to perform the next operation and/or alarm when the user's instruction, or when the liquid medicine in the pump body 102 is used up, or the device malfunctions.
  • the status indicator light 17 is also disposed in the casing of the controller 101.
  • the outer casing body is correspondingly provided with a light-transmitting groove 170.
  • the indicator light 17 flashes through the light-transmitting groove to indicate the state of the system to prompt the user.
  • the disposable catheterless drug infusion system of the present invention adopts an independent control structure design to enhance the convenience of use and carrying, that is, a control unit capable of processing user instructions, coordinating and managing device operation is disposed in the device.
  • the button unit and the key unit that the user interacts with the device that is, the button and the key are set on the device, and the drug fluid infusion management is implemented under the cooperation of the buzzer, the vibration motor and the indicator light to complete the treatment of the patient.
  • the indwelling unit is combined with the glucose sensor
  • the control unit is combined with the blood glucose monitoring module
  • the disposable catheterless drug infusion system of the present invention can simultaneously achieve blood glucose monitoring, and drug fluid infusion for the purpose of treating the patient.
  • the present invention effectively overcomes various shortcomings in the prior art and has high industrial utilization value.

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Abstract

一种可抛式无导管药物输注系统（1），包括用于接收用户按键指令的按键单元；用于输出携带有至少一种工作模式的选择指令的钥匙单元，工作模式包括基础率输注模式、可编程基础率输注模式、输注暂停模式、锁定系统模式、及无线控制模式；用于储存药物流体的储药单元；用于在被植入患者皮下时将药物流体输送给患者的留置单元；用于接收到输注指令时将药物流体推送到患者皮下的驱动单元；以及用于在接收到按键指令和/或工作模式的选择指令时，输出与按键指令和/或工作模式匹配的输注指令给驱动单元令其执行或暂停药物流体的输送工作的控制单元。该系统将泵体和无线遥控设备集成为一体，实现了小体积、低成本、及携带方便的目的。

Description

可抛式无导管药物输注系统 技术领域
本发明涉及一种医疗器械装置，特别是涉及一种将药物流体连续输注到患者体内的可抛式无导管药物输注系统。
背景技术
药物流体输注器件是通过向患者体内持续注射药物，从而实现患者病症治疗的一种医疗器械装置。药物流体输注器件广泛的用于糖尿病的治疗，按照人体需要的剂量将胰岛素持续地输注到患者的皮下，以此来模拟胰腺的分泌功能从而保持患者血糖的稳定。药物流体通常储存在一个泵体内，现有的药物流体输注器件通常是将药物流体由一段连接到泵体的导管输注到患者体内，在实际的使用过程中，佩戴导管通常不仅会对患者的活动等造成一定的妨碍，而且也不美观。
针对上述药物流体输注器件的缺点，业界研制了一种将泵体直接通过医用胶布粘贴在患者身体上，通过植入人体皮下组织的留置软管输送药物流体的无导管药物流体输注器件，该种无导管药物流体输注器件将泵体和一个无线控制模块集成在一个盒体内，通过一个无线手持设备遥控管理药物流体的输注，但是，这需要患者使用该器件输注药物流体治疗病症时至少携带泵体和无线遥控设备，且其还存在可能的无线干扰及成本高的等问题，此外，现有的药物流体输注器件还存在操作复杂、体积大、重量重的不足，患者携带或佩戴十分不便等诸多缺点。
正常的人体胰腺可自动监测人体血液葡萄糖含量的变化，并自动分泌所需的胰岛素。通过植入人体皮下组织的葡萄糖传感器，能够实时动态监测人体血糖变化的装置为“实时动态血糖监测系统”；考虑到佩戴的舒适程度，通常植入人体皮下的留置软管和葡萄糖传感器均采用细长而柔软的医用高分子材料。正因为这两个部件的材料和形状的特殊性，他们都需要借助具有一定刚度的钢针刺破皮肤并连带将它们送入皮下，而后收回钢针，同时将它们留置于皮下组织。对于留置软管和葡萄糖传感器来说，这一穿刺留置过程都是相似的，此外，两者在人体的作用区域，以及两者对于一次性可抛式使用和无菌生产方面的要求都是相同的。
发明内容
鉴于以上所述现有技术的缺点，本发明的目的在于提供一种将泵体和无线遥控设备集成为一体且操作简便的可抛式无导管药物输注系统，用于解决现有技术中的药物流体输注器件体积大、成本高、部件多、及携带不便的问题。
为实现上述目的及其他相关目的，本发明提供一种可抛式无导管药物输注系统，包括：按键单元，用于接收用户按键指令；钥匙单元，用于输出携带有至少一种工作模式的选择指令；所述工作模式包括基础率输注模式、可编程基础率输注模式、输注暂停模式、锁定系统模式、及无线控制模式；储药单元，用于储存药物流体；留置单元，用于在被植入患者皮下时将所述药物流体输送给患者，包括用于被植入患者皮下的留置软管；驱动单元，用于接收到输注指令时，自所述储药单元中提取药物流体并藉由所述留置单元推送到患者皮下；控制单元，分别连接所述按键单元、钥匙单元、储药单元、留置单元以及驱动单元，用于在接收到按键指令和/或工作模式的选择指令时，输出与所述按键指令和/或工作模式匹配的输注指令给所述驱动单元令其执行或暂停药物流体的输送工作。
可选地，所述按键单元包括实体键和/或触摸键。其中，所述实体键包括用于设定药物流体输注剂量的实体B键和可用于作为确认键的实体OK键，所述实体B键和实体OK键中的一个键上设有便于区分按键的物理触点。
可选地，所述钥匙单元包括钥匙和锁孔。所述钥匙还设有一个用以结合和分离所述钥匙和锁孔的手柄。
在一可选的实施例中，所述钥匙包括钥匙壳体，内置于所述钥匙壳体中的内置电路及内嵌于所述钥匙壳体的插销，所述钥匙壳体上环设有O型密封圈。所述内置电路为包括有电阻或/及电容的模拟电路、或者包括内置Flash或EEROM或一次烧录型的具有存储功能的数字集成电路、或者包括身份识别功能的数字集成电路、或者包括鉴权及/或加密功能的数字集成电路、或者数模混合集成电路。所述锁孔内设有一放置槽，所述放置槽内设有电性连接于所述内置电路的连接器，所述连接器与所述锁孔的配合面上设置有O型密封圈，所述钥匙插入锁孔时所述插销插入所述连接器中并与其实现电性连接，所述钥匙壳体上的O型密封圈与所述锁孔进行挤压配合以实现密封防水。
在另一可选的实施例中，所述锁孔为一密封凹槽，所述钥匙为感应钥匙，所述感应钥匙包括钥匙壳体及设于其内的感应电路。所述感应电路包括磁感应传感器、或者光感应传感器、或者NFC标签、或者RFID标签。
可选地，所述可抛式无导管药物输注系统的壳体中设有蜂鸣腔，所述蜂鸣腔内放置有可用于发出报警和/或提示的蜂鸣音及可用于超声波数据传输的蜂鸣器。所述蜂鸣器通过导线或者触点与控制单元导通工作。
可选地，所述可抛式无导管药物输注系统的壳体中设有振动马达放置槽，所述振动马达放置槽内放置有振动马达，所述振动马达通过导线与所述控制单元导通工作。
可选地，所述可抛式无导管药物输注系统还设有状态指示灯，其外壳体上对应设有透光槽，所述指示灯通过透光槽闪烁指示系统状态。
可选地，所述可抛式无导管药物输注系统中还设有用于监测动态血糖变化的葡萄糖传感器和用于处理所述葡萄糖传感器输出的血糖可用信号的血糖监测模块；所述葡萄糖传感器结合于所述留置单元，所述血糖监测模块结合于连接所述留置单元的控制单元。
可选地，所述可抛式无导管药物输注系统包括控制器和与所述控制器连接的泵体；所述控制单元、按键单元和钥匙单元设置在所述控制器上；所述储药单元、驱动单元和留置单元设置在所述泵体上。
如上所述，本发明的可抛式无导管药物输注系统采用独立控制结构设计以增强使用及携带的便利性，即在器件内设置可处理用户指令，协调和管理器件运行的控制单元，用户与器件交互的按键单元和钥匙单元，也就是说，在器件上设置按键、钥匙，同时在蜂鸣器、振动马达以及指示灯的配合下实现药物流体输注管理，以完成对患者的治疗。在留置单元结合葡萄糖传感器，且控制单元结合血糖监测模块后，本发明所述的可抛式无导管药物输注系统可同时实现血糖监测，以及药物流体输注以达到对患者治疗的目的。具体来说，使用时，患者将整个器件粘贴到皮肤上，通过按键及钥匙设定药物流体的输注程序，并且对用户的指令、或者当泵体内的药液快用完、或者器件出现故障等时，系统就会通过蜂鸣器、和/或振动马达、和/或指示灯提示用户下一步的操作。
附图说明
图1显示为本发明的可抛式无导管药物输注系统架构示意图。
图2显示为本发明的可抛式无导管药物输注系统中各部件集成在同一个盒体或壳体内的示意图。
图3显示为本发明的可抛式无导管药物输注系统中控制器和泵体为可分离部件 的示意图。
图4显示为本发明的可抛式无导管药物输注系统中控制器和泵体一种分解结构示意图。
图5显示为本发明的可抛式无导管药物输注系统中控制器和泵体另一种分解结构示意图。
图6显示为控制器壳体内部结构示意图。
图7显示为图6中A处放大示意图。
图8显示为本发明中钥匙和锁孔在一种实施方式中的对应结构示意图。
图9至图11分别显示为手柄和钥匙的分解、结合及操作示意图。
图12显示为图6中B处放大示意图。
图13显示为本发明中钥匙和锁孔在另一种实施方式中的对应结构示意图。
图14至15显示为本发明可抛式无导管药物输注系统的控制器中包含蜂鸣器、振动马达和指示灯的结构示意图。
图16至17显示为本发明可抛式无导管药物输注系统的泵体中包含蜂鸣器结构示意图。
具体实施方式
以下由特定的具体实施例说明本发明的实施方式，熟悉此技术的人士可由本说明书所揭露的内容轻易地了解本发明的其他优点及功效。
请参阅图1至图17。须知，本说明书所附图式所绘示的结构、比例、大小等，均仅用以配合说明书所揭示的内容，以供熟悉此技术的人士了解与阅读，并非用以限定本发明可实施的限定条件，故不具技术上的实质意义，任何结构的修饰、比例关系的改变或大小的调整，在不影响本发明所能产生的功效及所能达成的目的下，均应仍落在本发明所揭示的技术内容得能涵盖的范围内。同时，本说明书中所引用的如“上”、“下”、“左”、“右”、“中间”及“一”等的用语，亦仅为便于叙述的明了，而非用以限定本发明可实施的范围，其相对关系的改变或调整，在无实质变更技术内容下，当亦视为本发明可实施的范畴。
本发明提供一种可抛式无导管药物输注系统，用于通过向患者体内持续注射药物以实现患者病症治疗，在实际的应用中，所述的药物流体输注器件广泛的用于糖尿病的治疗，按照人体需要的剂量将胰岛素持续地输注到患者的皮下，以此来模拟胰腺的 分泌功能从而保持患者血糖的稳定。请参阅图1，显示为本发明的可抛式无导管药物输注系统架构示意图，如图所示，所述可抛式无导管药物输注系统1包括：按键单元，钥匙单元，储药单元，留置单元，驱动单元，以及控制单元。
在本发明提供的一种实施例中，所述可抛式无导管药物输注系统1可将按键单元，钥匙单元，留置单元，驱动单元，以及控制单元集成在同一个盒体或壳体10内，请参阅图2所示之结构，图2显示为本发明的可抛式无导管药物输注系统中各部件集成在同一个盒体或壳体内的示意图。
在本发明提供的另一种实施例中，所述可抛式无导管药物输注系统1包括控制器101和与所述控制器101连接或分离的泵体102；所述控制单元、按键单元和钥匙单元设置在所述控制器101上；所述储药单元、驱动单元和留置单元设置在所述泵体102上。请参阅图3所示之结构，图3显示为本发明的可抛式无导管药物输注系统中控制器和泵体为可分离部件的示意图。
请参阅图4，显示为本发明的可抛式无导管药物输注系统中控制器和泵体一种分解结构示意图，如图所示，所述可抛式无导管药物输注系统1包括控制器101和泵体102时，所述泵体102和控制器101通过设于控制器101的卡勾插孔或卡槽1011与设于泵体102的卡勾1022相结合，并通过设于控制器101的密封插孔1010和设于泵体102的插头1020实现电性连接。在一种实施方式下，所述卡勾1022与卡勾手臂1023连接，藉由所述卡勾手臂1023的操作使所述卡勾1022自所述卡孔或卡槽1011中脱离。
在另一种实施方式下，请参阅图5，显示为本发明的可抛式无导管药物输注系统中控制器和泵体另一种分解结构示意图，如图所示，所述控制器101外壳体上设置有使所述卡勾1022自所述卡孔或卡槽1011进行脱离的释放按键1012。
请参阅图6及图7，图6显示为控制器壳体内部结构示意图，图7显示为图6中A处放大示意图，如图所示，所述密封插孔1010内设置有连接器放置槽1013，所述连接器放置槽1013中设置有与所述控制单元电路电性连接的连接器1014，所述连接器1014与所述密封插孔1010的配合面上设置有O型密封圈1015。
如图4及图5所示，所述插头包括环设有O型密封圈1021的插头主体及内嵌于所述插头主体中的插销1020，所述插头插置于所述密封插孔1010中时，所述插销1020插入所述连接器1014中并与其实现电性连接，所述插头主体上的O型密封圈1021与所述密封插孔1010进行挤压配合以实现密封防水。
所述按键单元用于接收用户按键指令。在可选的实施例中，所述按键单元包括实体键和/或触摸键。所述的用户按键指令例如为藉由用户按键实现系统的开启、关闭、重启的指令等功能，或者通过组合按键的方式来实现系统输注暂停、系统休眠及系统编程的指令等功能。
在一种实施例中，所述实体键包括用于设定药物流体输注剂量的实体B键和可用于作为确认键的实体OK键，所述实体B键和实体OK键中的一个键上设有便于区分按键的物理触点。在另一种实施例中，所述触摸键例如为电容式触摸按键、电阻式触摸按键、或触摸屏等。在按键选为触摸键时，不同的按键上具有不同标示(例如颜色标示或图形标示等)以作区分。
所述钥匙单元用于输出携带有至少一种工作模式的选择指令，其中，所述工作模式包括基础率输注模式、可编程基础率输注模式、输注暂停模式、锁定系统模式、及无线控制模式。在具体的实施例中，所述钥匙单元可以为多个，即每一个钥匙单元中预存有一种工作模式，比如，预存有基础率输注模式的钥匙单元，依据患者的实际情况设置的可以实现可编程基础率输注模式的钥匙单元等。
在具体的实施例中，所述钥匙单元包括钥匙13和锁孔12。请参阅图8，显示为本发明中钥匙和锁孔在一种实施方式中的对应结构示意图。
为便于携带或管理，所述钥匙13还设有一个用以结合和分离所述钥匙13和锁孔12的手柄14，请参阅图9至图11，分别显示为手柄和钥匙的分解、结合及操作示意图。
在一种实施例中，所述钥匙包括钥匙壳体130和嵌于所述钥匙壳体130的插销131，所述钥匙壳体130的内部具有内置电路，具体的，所述内置电路为包括有电阻或/及电容的模拟电路、或者包括内置Flash或EEROM或一次烧录型的具有存储功能的数字集成电路、或者包括身份识别功能的数字集成电路、或者包括鉴权及/或加密功能的数字集成电路、或者数模混合集成电路，所述内置电路布设在PCB板上。
请参阅图12，显示为图6中B处放大示意图，如图所示，所述锁孔12内设有放置槽120，所述放置槽120内设有连接器121，所述连接器121与所述控制单元进行电性连接，所述连接器121还用来与为PCB板的内置电路进行电性连接，当所述钥匙插入锁孔时，可以令所述插销131插入所述连接器121中并与其实现电性连接，进而实现钥匙13和控制单元之间的通信。为了实现防水，所述钥匙壳体130上环设有O型密封圈132。所述连接器121与所述锁孔12的配合面上设置有O型密封圈122， 当所述钥匙13插入锁孔12时，钥匙壳体130上的O型密封圈132与锁孔12挤压配合防水，而所述连接器121上的O型密封圈122与其对应的锁孔面挤压配合防水。
请参阅图13，显示为本发明中钥匙和锁孔在另一种实施方式中的对应结构示意图，如图所示，所述锁孔12为一密封凹槽，所述钥匙13为感应钥匙，所述感应钥匙包括钥匙壳体130及设于其内的感应电路，如此可以实现钥匙13和内置于所述可抛式无导管药物输注系统中的控制单元的非物理接触式通信，具体地，所述感应电路例如包括磁感应传感器、或者光感应传感器、或者NFC标签、或者RFID标签的电路。
所述储药单元用于储存药物流体。在本实施例中，所述的药物流体为用于糖尿病治疗的胰岛素。但并不局限于此，依据患者所需求的实际药物不同，所述储药单元内储存的药物将会不同。
所述留置单元用于在被植入患者皮下时将所述药物流体输送给患者，包括用于被植入患者皮下的留置软管。在实际的应用中，所述留置软管在钢针的辅助下刺入患者皮下，具体地，留置软管包覆钢针时，钢针为内部中空；或者钢针为剖口针，而软管设置于剖口的凹槽内；同样的，作为输送药物流体的终端，也可以直接就是设有内腔的钢针。
所述驱动单元用于接收到控制单元输出的输注指令时，自所述储药单元中提取药物流体并藉由所述留置单元推送到患者皮下。在具体的实施例中，所述驱动单元包括用于将留置单元之留置软管刺入患者皮肤内的弹射装置和皮下管路安装机构，当植入留置软管时，所述皮下管路安装机构可通过弹射装置利用钢针刺破患者皮肤并将留置软管带入皮下，随后通过回针装置将钢针抽回，如此则所述储药单元中的药物流体通过所述留置单元输送到患者皮下。
在具体的实施例中，所述可抛式无导管药物输注系统中还设有用于监测动态血糖变化的葡萄糖传感器和用于处理所述葡萄糖传感器输出的血糖可用信号的血糖监测模块；所述葡萄糖传感器结合于所述留置单元，所述血糖监测模块结合于连接所述留置单元的控制单元。于一具体的实施例中，所述葡萄糖传感器设置于所述留置软管的外表面，所述血糖监测模块设置于可抛式无导管药物输注系统的壳体中，但并不局限于此，凡是能够实现所述葡萄糖传感器与留置单元的结合的其他方式，以及所述血糖监测模块与连接所述留置单元的控制单元相结合的其他实现方式也应适用于本发明。
所述控制单元分别连接所述按键单元、钥匙单元、储药单元、留置单元以及驱动单元，用于在接收到按键指令和/或工作模式的选择指令时，输出与所述按键指令和/ 或工作模式匹配的输注指令给所述驱动单元令其执行或暂停药物流体的输送工作。在具体的实施例中，所述控制单元中预存有多种按键指令和对应钥匙单元设定的工作模式，所述工作模式包括基础率输注模式、可编程基础率输注模式、输注暂停模式、锁定系统模式、及无线控制模式等。所述控制单元例如为单片机或者其他的微型处理器，用来接收、传递、反馈各单元信号以及协调管理各单元，例如用于管理所述储药单元的药量，在药量不足时输出提示和报警，或者在设备故障时报警等等。所述控制单元还管理例如无线传输模块、电源模块等功能模块。
在一可选的实施例中，所述可抛式无导管药物输注系统的壳体中设有蜂鸣腔，所述蜂鸣腔内放置有可用于发出报警和/或提示的蜂鸣音及可用于超声波数据传输的蜂鸣器。所述蜂鸣器通过导线或者触点与控制单元导通工作，所述蜂鸣器可以对用户的指令、或者当泵体102内的药液快用完、或者器件出现故障等时进行提示和报警，亦可通过超声波传输数据。
在一可选的实施例中，所述可抛式无导管药物输注系统的壳体中设有振动马达放置槽，所述振动马达放置槽内放置有振动马达，所述振动马达通过导线与所述控制单元导通工作。所述振动马达可以对用户的指令、或者当泵体内的药液快用完、或者器件出现故障等时进行振动提示用户执行下一步操作和/或报警。
在一可选的实施例中，所述可抛式无导管药物输注系统的壳体中还设有状态指示灯，其外壳体上对应设有透光槽，所述指示灯通过透光槽闪烁指示系统状态以提示用户。
呈如上述，结合图3所示之结构，所述可抛式无导管药物输注系统1包括可分离的控制器101和泵体102的情况下，所述控制单元、按键单元和钥匙单元设置在所述控制器101上；所述储药单元、驱动单元和留置单元设置在所述泵体102上。
请参阅图14至15，显示为本发明可抛式无导管药物输注系统的控制器中包含蜂鸣器、振动马达和指示灯的结构示意图，如图所示，在上述提供的可抛式无导管药物输注系统包括控制器101和与所述控制器101连接或分离的泵体102的实施例中，所述控制器101壳体内设有第一蜂鸣腔150，在所述第一蜂鸣腔内放置有第一蜂鸣器15，所述第一蜂鸣腔15通过导线与所述控制器101的控制单元电路导通工作。
请参阅图16至17，显示为本发明可抛式无导管药物输注系统的泵体中包含蜂鸣器结构示意图，所述泵体102的壳体内设有第二蜂鸣腔180，所述第二蜂鸣腔180内放置有第二蜂鸣器18，所述第二蜂鸣器18通过触点181与所述泵体102的内置电路 导通工作。
所述控制器101壳体内设有振动马达放置槽160，所述振动马达放置槽160内放置有振动马达16，所述振动马达16通过导线与所述控制单元导通工作。所述振动马达16可以对用户的指令、或者当泵体102内的药液快用完、或者器件出现故障等时进行振动提示用户执行下一步操作和/或报警。
所述控制器101壳体内还设有状态指示灯17，其外壳体上对应设有透光槽170，所述指示灯17通过透光槽闪烁指示系统状态以提示用户。
综上所述，本发明的可抛式无导管药物输注系统采用独立控制结构设计以增强使用及携带的便利性，即在器件内设置可处理用户指令，协调和管理器件运行的控制单元，用户与器件交互的按键单元和钥匙单元，也就是说，在器件上设置按键、钥匙，同时在蜂鸣器、振动马达以及指示灯的配合下实现药物流体输注管理，以完成对患者的治疗。在留置单元结合葡萄糖传感器，且控制单元结合血糖监测模块后，本发明所述的可抛式无导管药物输注系统可同时实现血糖监测，以及药物流体输注以达到对患者治疗的目的。具体来说，使用时，患者将整个器件粘贴到皮肤上，通过按键及钥匙设定药物流体的输注程序，并且对用户的指令、或者当泵体内的药液快用完、或者器件出现故障等时，系统就会通过蜂鸣器、和/或振动马达、和/或指示灯提示用户下一步的操作。所以，本发明有效克服了现有技术中的种种缺点而具高度产业利用价值。
上述实施例仅例示性说明本发明的原理及其功效，而非用于限制本发明。任何熟悉此技术的人士皆可在不违背本发明的精神及范畴下，对上述实施例进行修饰或改变。因此，举凡所属技术领域中具有通常知识者在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本发明的权利要求所涵盖。

Claims (16)

  1. 一种可抛式无导管药物输注系统，其特征在于，包括：
    按键单元，用于接收用户按键指令；
    钥匙单元，用于输出携带有至少一种工作模式的选择指令；所述工作模式包括基础率输注模式、可编程基础率输注模式、输注暂停模式、锁定系统模式、及无线控制模式；
    储药单元，用于储存药物流体；
    留置单元，用于在被植入患者皮下时将所述药物流体输送给患者，包括用于被植入患者皮下的留置软管；
    驱动单元，用于接收到输注指令时，自所述储药单元中提取药物流体并藉由所述留置单元推送到患者皮下；
    控制单元，分别连接所述按键单元、钥匙单元、储药单元、留置单元以及驱动单元，用于在接收到按键指令和/或工作模式的选择指令时，输出与所述按键指令和/或工作模式匹配的输注指令给所述驱动单元令其执行或暂停药物流体的输送工作。
  2. 根据权利要求1所述的可抛式无导管药物输注系统，其特征在于：所述按键单元包括实体键和/或触摸键。
  3. 根据权利要求2所述的可抛式无导管药物输注系统，其特征在于：所述实体键包括用于设定药物流体输注剂量的实体B键和可用于作为确认键的实体OK键，所述实体B键和实体OK键中的一个键上设有便于区分按键的物理触点。
  4. 根据权利要求1所述的可抛式无导管药物输注系统，其特征在于：所述钥匙单元包括钥匙和锁孔。
  5. 根据权利要求4所述的可抛式无导管药物输注系统，其特征在于：所述钥匙包括钥匙壳体，内置于所述钥匙壳体中的内置电路及内嵌于所述钥匙壳体的插销，所述钥匙壳体上环设有O型密封圈。
  6. 根据权利要求5所述的可抛式无导管药物输注系统，其特征在于：所述内置电路为包括有电阻或/及电容的模拟电路、或者包括内置Flash或EEROM或一次烧录型的具有存储功能的数字集成电路、或者包括身份识别功能的数字集成电路、或者包括鉴权及/或加密功能的数字集成电路、或者数模混合集成电路。
  7. 根据权利要求5所述的可抛式无导管药物输注系统，其特征在于：所述锁孔内设有一放置槽，所述放置槽内设有电性连接于所述内置电路的连接器，所述连接器与所述锁孔的配合面上设置有O型密封圈，所述钥匙插入锁孔时所述插销插入所述连接器中并与其实现电性连接，所述钥匙壳体上的O型密封圈与所述锁孔进行挤压配合以实现密封防水。
  8. 根据权利要求4所述的可抛式无导管药物输注系统，其特征在于：所述锁孔为一密封凹槽，所述钥匙为感应钥匙，所述感应钥匙包括钥匙壳体及设于其内的感应电路。
  9. 根据权利要求8所述的可抛式无导管药物输注系统，其特征在于：所述感应电路包括磁感应传感器、或者光感应传感器、或者NFC标签、或者RFID标签。
  10. 根据权利要求4所述的可抛式无导管药物输注系统，其特征在于：所述钥匙还设有一个用以结合和分离所述钥匙和锁孔的手柄。
  11. 根据权利要求1所述的可抛式无导管药物输注系统，其特征在于：所述可抛式无导管药物输注系统的壳体中设有蜂鸣腔，所述蜂鸣腔内放置有可用于发出报警和/或提示的蜂鸣音及可用于超声波数据传输的蜂鸣器。
  12. 根据权利要求11所述的可抛式无导管药物输注系统，其特征在于：所述蜂鸣器通过导线或者触点与控制单元导通工作。
  13. 根据权利要求1所述的可抛式无导管药物输注系统，其特征在于：所述可抛式无导管药物输注系统的壳体中设有振动马达放置槽，所述振动马达放置槽内放置有振动马达，所述振动马达通过导线与所述控制单元导通工作。
  14. 根据权利要求1所述的可抛式无导管药物输注系统，其特征在于：所述可抛式无导管药物输注系统还设有状态指示灯，其外壳体上对应设有透光槽，所述指示灯通过透光槽闪烁指示系统状态。
  15. 根据权利要求1所述的可抛式无导管药物输注系统，其特征在于：所述可抛式无导管药物输注系统中还设有用于监测动态血糖变化的葡萄糖传感器和用于处理所述葡萄糖传感器输出的血糖可用信号的血糖监测模块；所述葡萄糖传感器结合于所述留置单元，所述血糖监测模块结合于连接所述留置单元的控制单元。
  16. 根据权利要求1所述的可抛式无导管药物输注系统，其特征在于：所述可抛式无导管药物输注系统包括控制器和与所述控制器连接的泵体；所述控制单元、按键单元和钥匙单元设置在所述控制器上；所述储药单元、驱动单元和留置单元设置在所述泵体上。
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HK1215205A1 (zh) 2016-08-19
EP3023113A1 (en) 2016-05-25
EP3023113B1 (en) 2019-06-19
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CN105311702B (zh) 2019-10-08

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