WO2015106489A1 - 无导管药物流体输注器件 - Google Patents

无导管药物流体输注器件 Download PDF

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Publication number
WO2015106489A1
WO2015106489A1 PCT/CN2014/073992 CN2014073992W WO2015106489A1 WO 2015106489 A1 WO2015106489 A1 WO 2015106489A1 CN 2014073992 W CN2014073992 W CN 2014073992W WO 2015106489 A1 WO2015106489 A1 WO 2015106489A1
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WO
WIPO (PCT)
Prior art keywords
infusion device
fluid infusion
drug fluid
built
circuit
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2014/073992
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English (en)
French (fr)
Inventor
杨翠军
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtrum Technologies Inc
Original Assignee
Medtrum Technologies Inc
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 Medtrum Technologies Inc filed Critical Medtrum Technologies Inc
Priority to EP14879227.8A priority Critical patent/EP3097932B1/en
Priority to US14/907,086 priority patent/US9861741B2/en
Publication of WO2015106489A1 publication Critical patent/WO2015106489A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • 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
    • 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
    • A61M5/44—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 having means for cooling or heating the devices or media
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B17/00—Pumps characterised by combination with, or adaptation to, specific driving engines or motors
    • F04B17/03—Pumps characterised by combination with, or adaptation to, specific driving engines or motors driven by electric motors
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B19/00—Machines or pumps having pertinent characteristics not provided for in, or of interest apart from, groups F04B1/00 - F04B17/00
    • F04B19/20—Other positive-displacement pumps
    • F04B19/22—Other positive-displacement pumps of reciprocating-piston type
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B23/00—Pumping installations or systems
    • F04B23/02—Pumping installations or systems having reservoirs
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B53/00—Component parts, details or accessories not provided for in, or of interest apart from, groups F04B1/00 - F04B23/00 or F04B39/00 - F04B47/00
    • F04B53/14—Pistons, piston-rods or piston-rod connections
    • F04B53/144—Adaptation of piston-rods
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
    • F04B53/00—Component parts, details or accessories not provided for in, or of interest apart from, groups F04B1/00 - F04B23/00 or F04B39/00 - F04B47/00
    • F04B53/16—Casings; Cylinders; Cylinder liners or heads; Fluid connections
    • 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
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • 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
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • 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
    • A61M2005/1726—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 the body parameters being measured at, or proximate to, the infusion site
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3653—General characteristics of the apparatus related to heating or cooling by Joule effect, i.e. electric resistance
    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6054—Magnetic identification systems

Definitions

  • the present invention relates to a medical device device, and more particularly to a catheterless drug fluid infusion device for continuously infusing insulin into a patient's body.
  • a drug fluid infusion device is a medical device device that achieves treatment of a patient's condition by continuously injecting a drug into a patient.
  • Pharmaceutical fluid infusion devices are widely used in the treatment of diabetes, and insulin is continuously infused into the skin of a patient at a dose required by the human body to simulate the secretory function of the pancreas to maintain the stability of blood sugar in the patient.
  • the drug fluid is typically stored in the pump body.
  • Existing drug fluid infusion devices typically infuse the drug fluid into the patient from a catheter that is connected to the pump body. During actual use, the catheter typically causes activity to the patient. Certain obstacles.
  • a catheter-free drug fluid infusion device that directly attaches the pump body through the medical adhesive tape to the patient's body is produced, but the catheter-free drug fluid infusion device integrates the pump body and the controller into a single body.
  • the cartridge is a disposable medical device device, which has the disadvantage of high cost.
  • the existing drug fluid infusion devices have the disadvantages of complicated operation, large volume, and heavy weight, and the patient is very inconvenient to carry or wear.
  • Diabetes patients need to wear at least two components at the same time when receiving insulin infusion therapy: a blood glucose probe and an insulin infusion system.
  • the blood glucose sensor of the blood glucose probe and the indwelling hose of the insulin infusion system need to be inserted and buried in the subcutaneous tissue of the human body.
  • both parts are made of slender and soft medical polymer material. Because of the particularity of the materials and shapes of the two components, they all need to be guided by a needle with a certain rigidity to help them smash the patient's skin and bring them under the skin, and then withdraw the introduce needles while they are Leave it in the subcutaneous tissue.
  • an object of the present invention is to provide a catheterless drug fluid infusion device for solving the problems of complicated operation, large volume, and high cost of a pharmaceutical fluid infusion device in the prior art. .
  • a catheterless drug fluid infusion device comprising: a controller comprising a first housing having a first built-in circuit, the first housing having a first a latching portion and a first interposing portion electrically connected to the first built-in circuit; and a pump body combined with the controller, including a second built-in circuit, a drug cartridge, a piston, a push rod, and a driving device And a second housing of the battery, the second housing has a second engaging portion correspondingly engaged with the first engaging portion, and a second insertion portion electrically connected to the second built-in circuit The second interposing portion is inserted into the first interposing portion to electrically connect the first built-in circuit and the second built-in circuit.
  • the first engaging portion is a card hole or a card slot.
  • the second engaging portion is a hook corresponding to the card hole or the card slot, and the hook is connected to a hook arm, and the hook is operated from the card hole by the operation of the hook arm Or detach from the card slot.
  • the second engaging portion is a hook corresponding to the card hole or the card slot, and the first housing is provided with a release for releasing the hook from the card hole or the card slot. button.
  • the first insertion portion is a sealed insertion hole.
  • a placement slot is disposed in the sealing socket, and a connector electrically connected to the first built-in circuit is disposed in the placement slot, and a contact type end surface of the connector and the sealing socket is provided with a type 0 Sealing ring.
  • the second insertion portion is a plug, and the plug includes a plug main body having a 0-type sealing ring and a plug embedded in the plug main body.
  • the pin is inserted into the connector and electrically connected thereto, and the 0-type sealing ring on the plug body is press-fitted with the sealing socket to achieve sealing and waterproofing.
  • the pump body has a main frame for the structure carrier and the second built-in circuit carrier, and the second built-in circuit disposed on the main frame is a three-dimensional printed circuit, and the three-dimensional printed circuit and the second plug The electrical connection is made.
  • the combination of signal line attributes on the second interposer includes a first combination of position detection, left position detection, right position detection, battery positive, occlusion detection, left side drive, right side drive, and battery negative;
  • the signal line attribute combination on the second interposer includes a reference electrode, a buzzer left-to-position detection, a common right-position detection, a battery positive electrode, a working electrode, a left side drive, a right side drive, and a second battery negative
  • a combination of signal lines on the second interposer includes position detection, left in position detection, right in position detection, battery positive, buzzer positive, left drive, right drive, and battery negative.
  • the ground connection position detecting common end, the left in-position detecting common end, and the right in-position detection on the second interposing portion a public end, a jam detection common end, and a battery negative pole;
  • the signal line attribute combination is a third combination, the ground connection position detecting common end on the second interposing portion, the left in-position detecting common end, The right-position detection common terminal, the jam detection common terminal, the buzzer negative electrode, and the battery negative terminal.
  • the battery of the catheterless drug fluid infusion device is a button cell.
  • the first built-in circuit of the controller comprises a control circuit and a program processing module.
  • a first buzzer cavity is disposed in the first housing, a first buzzer is disposed in the first buzzer cavity, and the first buzzer passes through a wire and a first built-in circuit of the controller Turn on the work.
  • a second buzzer is disposed in the second housing, a second buzzer is disposed in the second buzzer, and the second buzzer passes through the contact and the second of the pump body
  • the built-in circuit is turned on.
  • the pump body is further provided with a subcutaneous pipe mounting mechanism including a steel needle, a steel needle base, a spring, and a toggle switch.
  • the pump body is further provided with an indwelling hose provided with a steel needle, which assists the placement of the retention hose under the skin.
  • the steel needle is a hollow needle, and the indwelling hose covers the hollow needle; or the steel needle is a split needle, and the indwelling hose is placed in the groove of the split needle.
  • the outer surface of the indwelling hose is also provided with a blood glucose sensor.
  • the pump body is provided with a drug fluid outlet
  • the drug fluid outlet is provided with a drug injection plug composed of a plastic base, a silicone plug and a polymer film, and the drug injection plug passes through the buckle and the second The housing is connected, and the injection plug can be detached from the pump body when the plastic base is lifted.
  • the pump body is fixed with a medical tape for sticking on the skin of the patient.
  • the catheterless drug fluid infusion device of the present invention further comprises a skin heating device for heating the infusion site.
  • the pump body is further provided with an identification tag for the NFC tag, the RFID tag, or the identification chip.
  • the catheterless drug fluid infusion device of the present invention adopts a separable structural design to reduce the cost, that is, the active controller portion is used as the master controller, and the passive consumable portion is used as the pump body, that is, The active part is used as a reusable device, and the passive pump body part is used as a single-use device, and the two are packaged and used together to complete the treatment of the patient.
  • the patient first assembles the controller and the pump body, and then sticks the entire catheter-free drug fluid infusion device to the skin and uses it normally, when the liquid in the pump body runs out or the device fails.
  • the controller will The buzzer automatically prompts the patient to disassemble and discard the pump body part, then install and replace it with a new pump body, and re-stick it to the skin for further use.
  • Figure 1 shows a schematic representation of one embodiment of a catheterless drug fluid infusion device of the present invention.
  • Figure 2 is a schematic view showing an embodiment of the operation structure of the present invention.
  • Figure 3 shows an enlarged view of A in Figure 2.
  • Fig. 4 is a view showing the structure of the first interposing portion in the present invention.
  • Figure 5 shows an enlarged view of B in Figure 4.
  • Fig. 6 is a view showing the structure of the second interposing portion in the present invention.
  • Fig. 7 is a view showing the exploded structure of the first buzzing chamber and the buzzer in the present invention.
  • Fig. 8 is a view showing the mounting structure of the first buzzer chamber and the buzzer in the present invention.
  • FIG. 9 is a schematic exploded view of a battery mounting structure in an embodiment of the present invention.
  • Figure 10 is a schematic view showing the installation of a battery in an embodiment of the present invention.
  • Figure 11 is a schematic view showing another embodiment of the operation structure of the present invention.
  • Fig. 12 is a view showing an exploded structure of the buzzer provided in the second casing.
  • Fig. 13 is a view showing the mounting structure of the buzzer in the second casing.
  • Figure 14 is a schematic view showing the internal structure of a second casing in another embodiment of the present invention.
  • Figure 15 is a schematic view showing the subcutaneous pipe mounting mechanism of the present invention.
  • Figure 16 is a schematic cross-sectional view taken along line A-A of Figure 15.
  • Figure 17 is a view showing the structure of a steel needle, a retention hose, and a blood glucose sensor in the present invention.
  • Fig. 18 is a view showing the exploded structure of the injection plug of the present invention.
  • Fig. 19 is a view showing the mounting structure of the injection plug of the present invention.
  • Fig. 20 is a view showing the inclusion of a medical tape, a skin heating device, and an identification tag in the present invention.
  • Component symbol description is a description of the present invention.
  • the present invention provides a catheter-free drug fluid infusion device 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 the treatment of diabetes.
  • Insulin is continuously infused into the skin of the patient at a dose required by the human body to simulate the secretory function of the pancreas to keep the patient's blood sugar stable.
  • the catheterless drug fluid infusion device of the present invention comprises: a controller and a pump body. Wherein, the pump body is combined with the controller, specifically, the pump body and the controller are combined to realize the mechanical mechanism of the two by the engagement connection of the first engaging portion and the second engaging portion. In combination, the electrical connection between the first interposing portion and the second interposing portion is achieved.
  • the controller includes a first housing having a first built-in circuit, and the first housing is provided with a first engaging portion and a first insertion portion electrically connected to the first built-in circuit.
  • the pump body includes a second housing having a second built-in circuit, a cartridge, a piston, a push rod, a driving device, and a battery, and the second housing has a corresponding engagement to the first engaging portion a second engaging portion, and a second interposing portion electrically connected to the second built-in circuit, wherein the second interposing portion is correspondingly inserted in the first interposing portion to implement the first
  • the built-in circuit is electrically connected to the second built-in circuit.
  • FIG. 1 is a schematic view showing an embodiment of a catheter-free drug fluid infusion device according to the present invention.
  • the first engaging portion 111 is a card hole, and the card is The inside of the hole has a flange structure 1111.
  • the first engaging portion 111 may be a structure such as a card slot that can be engaged with each other.
  • the second engaging portion 121 is a hook corresponding to the card hole, and the hook is connected to a hook arm 123.
  • FIG. 2 is a schematic diagram showing an embodiment of the operation structure of the present invention
  • FIG. 3 is an enlarged schematic view of a portion of FIG. 2, as shown in the embodiment,
  • the operation of the hook arm 123 causes the hook to be detached from the card hole. Specifically, a certain gap is formed between the inner side of the hook arm 123 and the bottom of the pump body 12, and the hook arm is pressed. At 123 o'clock, the hook arm 123 opposes the hook to disengage it from the card hole.
  • FIG. 4 is a schematic structural view of a first insertion portion according to the present invention
  • FIG. 5 is an enlarged schematic view of a portion B of FIG.
  • the first insertion portion 112 is a sealed insertion hole.
  • a sealing groove 1121 is disposed in the sealing insertion hole.
  • the insertion groove 1121 is provided with a connector 13 electrically connected to the first built-in circuit.
  • An O-ring 131 is provided on a contact end surface of the connector 13 and the seal insertion hole.
  • the second insertion portion 122 is a plug.
  • FIG. 6 it is a schematic structural view of the second insertion portion according to the present invention.
  • the plug includes a ring with a 0-type sealing ring 1222 .
  • the latch 1223 has a wedge-shaped structure to facilitate assembly of the pump body 12, and when the plug is inserted into the sealed socket, the The latch is inserted into the electrical connector 13 and electrically connected thereto, and the 0-type sealing ring 1222 on the plug body is press-fitted with the sealing socket to achieve sealing waterproofing.
  • the second housing of the pump body 12 includes a bottom body of the pump body 12 and an upper casing of the pump body 12, and two hooks are disposed on the bottom of the pump body 12.
  • a hooking arm 123 corresponding to the first housing of the controller 11 is provided with a card hole and a sealing hole of two hooks, and a connector 13 is disposed in the sealing jack, and the pump body 12 is
  • the hook is inserted into the card hole at the same time Inserting the sealing socket, the hook is guided into the card hole through the front bevel edge guide, and forms a locking fit with the flange 1111 in the card hole, and the pump body 12 and the controller 11 are tightly connected together.
  • the two 0-type sealing rubber rings 1222 on the outer casing plug are pressed against the sealing socket to form a tight waterproof structure, and a certain gap is provided between the inner side of the hook arm 123 and the bottom body of the pump body 12,
  • the pump body 12 and the controller 11 can be separated by pressing the hook arm 123 therein.
  • the pump body 12 and the controller 11 are structurally connected by inserting a hook into the card hole, and the signal is connected by the connector 13 inserted into the sealed jack through the plug.
  • FIG. 7 is a schematic diagram showing the exploded structure of the first buzzing chamber and the buzzer in the present invention
  • FIG. 8 is a schematic view showing the installation structure of the first buzzing chamber and the buzzer in the present invention.
  • a first buzzer chamber 113 is disposed in the first housing, and a first buzzer 14 is disposed in the first buzzer chamber 113, and the first buzzer 14 passes through a wire (
  • the first built-in circuit of the controller 11 is turned on, and when the liquid medicine in the pump body 12 runs out quickly or the device fails, the controller 11 automatically passes through the first buzzer 14
  • the patient is prompted to disassemble and discard the pump body 12, and then replace it with a new pump body 12 and re-stick it to the skin for further use.
  • FIG. 9 and FIG. 10 are schematic diagrams showing the internal structure of a second housing according to an embodiment of the present invention.
  • the pump body 12 has a built-in structure carrier and a second built-in circuit carrier.
  • the main frame 124, the second built-in circuit disposed on the main frame 124 is a three-dimensional printed circuit (not labeled), and the three-dimensional printed circuit is electrically connected to the second interposing portion 122. That is, the pump body 12 has a main frame 124 for the structure carrier and the circuit carrier.
  • the main frame 124 is provided with a three-dimensional printed circuit, and the three-dimensional printed circuit is electrically connected to the second interposing portion 122.
  • the second interposing portion 122 of the plug having a plurality of signal lines, the signal lines
  • the combination of attributes includes position detection, left-to-position detection, right-position detection, battery positive, blockage detection, left-hand drive, right-hand drive, and battery negative. It should be specifically stated that, in the illustrations presented in this embodiment, the signal lines are not given to the signal lines of the respective attributes. In other words, the order of the signal line attributes in this embodiment is not limited thereto, and the arrangement is adjusted. Other embodiments that are sequential and include the signal line attributes described in this embodiment should be covered by the above-disclosed.
  • a main frame 124 can be built in the pump body 12, which can serve as both a structural carrier and a circuit carrier.
  • the main frame 124 has two important functions: Provides an inserted, fixed carrier for all functional components of the pump body 12; and an active controller Section 11 provides a three-dimensional printed circuit for the control of the pump body 12.
  • the main frame 124 selects a base material that satisfies the temperature requirements for hand soldering, even high temperature soldering in SMT.
  • the plug of the main frame 124 adopts a wedge shape.
  • the main frame plug is a latch in the second interposing portion 122.
  • Signal lines are distributed on both sides of the main frame 124 plug, and the signal lines include position detection, left position detection, right position detection, battery positive, blockage detection, left side drive, right side drive, and battery negative, preferably, in close proximity
  • the signal line on the side of the injection port is blocked detection, left side drive, right side drive and battery negative line from top to bottom, and the position signal on the other side is position detection, left position detection, right position in order from top to bottom. Detect and positive battery.
  • the main frame 124 and the ground line of the pump body 12 are distributed as shown in FIG. 9 and FIG. 10 .
  • a single button battery 15 is used, and the button battery 15 is placed on the button body 15 .
  • the battery frame 125 is disposed on the main frame 124.
  • the button battery 15 is fixed by the main frame 124 and the battery positive elastic piece 1252.
  • the battery positive electrode spring 1252 and the battery negative spring 1251 are electrically connected to the three-dimensional circuit on the main frame 124.
  • the ground line 1241 is connected to the position detecting common end, the left in-position detecting common end, the right in-position detecting common end, the jam detecting common end, and the battery negative pole.
  • FIG. 11 a schematic diagram of another embodiment of the operation structure of the present invention is shown.
  • the first housing of the controller 11 is further provided with the hook and the card.
  • the release button 114 for the detachment of the hole.
  • the pump body 12 and the controller 11 are also connected by a hook provided on the bottom of the pump body 12, and are also provided on the controller 11.
  • Two hooks are also disposed on the bottom case of a part of the second housing, and two buttons and a sealing jack are disposed on the controller 11, and the connector 13 is provided in the sealing jack, and the second shell is
  • the upper part of the other part of the body is provided with a plug, and the plug of the main frame 124 protrudes through the sealing gap of the plug of the pump body 12, and the plug body of the plug of the main body plug and the plug of the plug of the main frame 124 constitute the plug of the pump body 12, in the pump body
  • the pump body 12 and the control will be tightly connected. At this time, the two Type 0 sealing rubber rings on the housing plug are pressed against the sealing socket, and the pump body 12 can be separated and pressed by pressing the button on the controller 11.
  • Device 11. A connector placement slot in which the connector 13 is placed is disposed in the sealed insertion hole of the controller 11. When the plug is inserted into the sealing insertion hole, the main frame 124 is inserted into the connector 13 to realize a signal connection between the pump body 12 and the controller 11.
  • a 0-type sealing ring is also provided, and the double-type 0-ring on the outer casing plug and the 0-type sealing ring in the sealing socket realize the sealing and waterproofing when the controller 11 and the pump body 12 are used together.
  • FIG. 12 is a schematic exploded view showing the arrangement of the buzzer in the second casing
  • FIG. 13 is a schematic view showing the installation structure of the buzzer in the second casing, as shown in the figure.
  • a second buzzing chamber 113 is disposed in the second housing, and a second buzzer 14 is disposed in the second buzzing chamber 113.
  • the second buzzer 14 passes through the contact 141 and the pump body 12.
  • the three-dimensional printed circuit is turned on.
  • the second buzzer 14 automatically prompts the patient to disassemble, discard, and then replace the pump body 12 portion. Into the new pump body 12, re-stick on the skin and continue to use.
  • the plug of the main frame 124 in the second embodiment designed when the pump body 12 and the controller 11 are separated also adopts a wedge shape as shown.
  • Signal lines are distributed on both sides of the plug of the main frame 124 plug, and the signal lines include signal lines including position detection, left position detection, right position detection, battery positive, buzzer positive, left drive, right drive, and battery negative.
  • the signal line on the side close to the injection port is a buzzer positive electrode, a left side drive, a right side drive, and a battery negative electrode from top to bottom, and the signal line on the other side is position detection from top to bottom. Left in position detection, right in position detection and battery positive.
  • FIG. 14 is a schematic diagram showing the internal structure of a second housing according to another embodiment of the present invention.
  • the main frame 124 and the ground line of the pump body 12 are distributed as shown in FIG. 14 , which are presented in this figure.
  • a double button battery 15 is used, and the button battery 15 is placed in a battery slot provided on the main frame 124.
  • the two batteries are connected by the conductive elastic piece 1254, and pass through the ground wire 1241 and the battery on the main frame 124.
  • the positive trace 1253 is connected to the power supply.
  • the ground line 1241 is connected to the position detecting common end, the left in-position detecting common end, the right in-position detecting common end, the jam detecting common end, the buzzing negative pole, and the battery negative pole.
  • FIG. 15 is a schematic view showing the subcutaneous pipeline installation mechanism of the present invention
  • FIG. 16 is a schematic cross-sectional view taken along line AA of FIG. 15,
  • FIG. 17 is a view showing the steel needle, the indwelling hose and the blood glucose of the present invention.
  • Schematic diagram of the sensor as shown, the pump body 12 is further provided with a subcutaneous pipeline mounting mechanism 16 including a steel needle 161, a steel needle base 162, a spring 163, and a toggle switch 164.
  • An indwelling hose 165 provided with a steel needle 161 is also disposed in the pump body 12, and the steel needle 161 is implanted subcutaneously with the auxiliary indwelling hose 165.
  • the steel needle is a hollow needle, and the indwelling hose covers the hollow needle; or the steel needle is a split needle, and the indwelling hose is placed on the split needle Inside the groove.
  • the outer surface of the indwelling hose is further provided with a blood glucose sensor 166.
  • the steel needle 161 is a hollow needle or a split needle, and when the steel needle 161 is selected as a hollow needle The hollow needle and the indwelling hose 165 are disposed in such a manner that the indwelling hose 165 covers the hollow needle, and has a structure as shown in FIG. 17.
  • the split needle and the indwelling hose are arranged in such a manner that the indwelling hose is placed in a recess of the split needle (not shown).
  • a cartridge is disposed in the pump body 12 (not shown, that is, placed in the cartridge placement slot 126).
  • the drug fluid stored in the cartridge can be infused into the patient by the indwelling hose 165 or the steel needle 161 implanted under the skin, and the indwelling hose 165 and/or the steel needle 161 can be assisted by the subcutaneous tubing mounting mechanism 16.
  • the subcutaneous tubing mounting mechanism 16 includes a steel needle 161, a steel needle base 162, a spring 163, and a toggle switch 164 from a component, which structurally includes an ejection device and/or a needle return device.
  • the ejection device can be an automatic or manual device
  • the ejection device can be an automatic or manual device
  • the ejection device can be an automatic or manual device.
  • the subcutaneous tube mounting mechanism 16 can directly rupture the skin of the patient into the skin by the ejection device; when the indwelling hose 165 is implanted, the subcutaneous tube mounting mechanism 16 can pass
  • the ejection device uses a steel needle to break the patient's skin and bring the indwelling hose under the skin, and then the steel needle 161 is withdrawn through the needle return device.
  • the subcutaneous tubing mounting mechanism 16 can be placed either inside the pump body 12 or outside the pump body 12.
  • the subcutaneous tubing mounting mechanism 16 is placed inside the pump body 12 as shown in Figs.
  • the indwelling hose a hollow steel needle is selected, and the steel needle is placed in the soft placement.
  • the steel needle and the indwelling hose are located in the base of the steel needle.
  • the steel needle base is pushed downward, the steel needle breaks the patient's skin and enters the patient's body to implant the indwelling hose into the skin;
  • the toggle switch fixes it and the spring is in compression. At this point, the toggle switch is actuated to release the compression spring, thereby pushing the needle base up and pulling the needle out of the patient.
  • the blood glucose sensor can be integrated on the outer surface of the indwelling hose, as shown in Figure 17, where the indwelling hose and glucose sensor can be simultaneously implanted under the patient's skin.
  • the signal lines distributed on both sides of the plug of the main frame 124 include the reference electrode, the buzzer left position detection, and the public right position. Detection, battery positive, working electrode, left drive, right drive and battery negative.
  • the signal line on the side close to the injection port 129 is sequentially operated from top to bottom, the left side drive, the right side drive, and the battery negative electrode, and the signal line on the other side is a reference electrode from top to bottom.
  • the ground connection is connected to the position detection common end, the left-to-position detection common end, the right-position detection common end, the jam detection common end, and the battery negative pole.
  • FIG. 18 is a schematic exploded view showing the injection plug of the present invention
  • FIG. 19 is a schematic view showing the installation structure of the injection plug according to the present invention.
  • the medicine fluid outlet 127 is provided with a drug injection plug 128 composed of a plastic base 1281, a silicone plug 1282 and a polymer film 1283, and the injection plug 128 is buckled (ie, The hook 1284 and the snap-fit structure of the card hole 1271 are connected to the second housing, and the injection plug 128 can be detached from the pump body 12 when the plastic base 1281 is lifted. .
  • the catheter-free drug fluid infusion device of the present invention delivers the drug fluid into the patient
  • the drug fluid is filled into the pump body 12 through the injection port by means of a syringe to prevent filling of the drug fluid.
  • a leakage occurs in the process, and a drug injection plug 128 is disposed at the drug fluid outlet of the pump body 12.
  • the drug injection plug 128 is composed of a plastic base 1281, a silicone plug 1282, and a polymer film 1283.
  • the medicine plug 128 is connected to the bottom shell of the pump body 12 through the hook of the plastic base 1281, the silicone plug 128 prevents leakage around, the polymer film 1283 achieves a permeable and watertight function; the plastic base 1281 can lift the injection plug 128 Disassembled.
  • Reference numeral 129 in Figs. 18 and 19 is a dispensing port.
  • a schematic view including a medical tape, a skin heating device and an identification tag in the present invention there is shown a schematic view including a medical tape, a skin heating device and an identification tag in the present invention.
  • the pump body 12 is secured with a medical tape 17 for attachment to the patient's skin.
  • the catheterless drug fluid infusion device of the present invention further includes a skin heating device 18 for heating the infusion site.
  • the pump body 12 is further provided with an identification tag 19 which is an NFC tag, an RFID tag, or an identification chip.
  • the catheterless drug fluid infusion device of the present invention is adhered to the skin of the patient by the medical tape 17, since the pump body 12 is bulky and heavy relative to the controller 11, so The medical tape 17 needs to be pre-fixed on the bottom of the pump body 12, so that the entire catheter-free drug fluid infusion device can be reliably fixed on the patient.
  • the medical tape 17 is also followed. Discard and replace together, at the same time, the position of the new pump body 12 can be changed, so as to avoid the patient's physical discomfort caused by long-term adhesive tape and repeated needle sticking in the same place.
  • a skin heating device 18 and/or an identification tag 19 may also be provided between the medical tape and the bottom of the pump body 12.
  • the skin heating device 18 may be used to reduce the delay in the peak action time of the insulin when the patient is subjected to diabetes treatment for insulin infusion.
  • the identification tag 19 is used to store personalized information and identification of the pump body 12.
  • the identification tag 19 can be an NFC tag, an RFID tag or an identification chip.
  • the catheter-free drug fluid infusion device of the present invention adopts a detachable structure design to reduce the cost, that is, the active controller part is used as the main control unit, and the passive consumable part is used as the pump body, that is, The active part is used as a reusable device, and the passive pump body part is used as a single-use device, and the two are packaged and used together to complete the treatment of the patient.
  • the patient when used, the patient first assembles the controller and the pump body, and then sticks the entire catheter-free drug fluid infusion device to the skin and uses it normally.
  • control The device will automatically prompt the patient to disassemble and discard the pump body by buzzer, then replace it with a new pump body and re-stick it to the skin for further use. Therefore, the present invention effectively overcomes various shortcomings in the prior art and has high industrial utilization value.

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Abstract

一种无导管药物流体输注器件，包括控制器（11）以及与所述控制器（11）相结合的泵体（12），所述控制器（11）包括具有第一内置电路的第一壳体，所述第一壳体上开设有第一卡合部以及电性连接所述第一内置电路的第一插置部；所述泵体（12）包括具有第二内置电路、储药筒、活塞、推动杆、驱动装置、以及电池的第二壳体，所述第二壳体上具有对应卡合至所述第一卡合部的第二卡合部，以及电性连接于所述第二内置电路的第二插置部，所述第二插置部对应插置于所述第一插置部中以实现所述第一内置电路与第二内置电路的电性连接。所述无导管药物流体输注器件采用可分离式结构设计以降低成本，以解决现有技术中的药物流体输注器件操作复杂、体积大、以及成本高的问题。

Description

无导管药物流体输注器件 技术领域
本发明涉及一种医疗器械装置， 特别是涉及一种将胰岛素连续输注到患者体 内的无导管药物流体输注器件。 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， 导管通常会对患者的活动造成一定的妨碍。 针对这一不足产生了一种将泵体直接 通过医用胶布粘贴在患者身体上的无导管药物流体输注器件， 但这种无导管药物 流体输注器件将泵体和控制器集成在一个盒体内， 且该盒体为一次性使用的医疗 器械装置， 它存在成本高的缺点。 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。
糖尿病患者在接受胰岛素输注治疗时， 身上至少需要同时佩戴两个部件： 血 糖探头和胰岛素输注系统。 其中， 血糖探头的血糖传感器和胰岛素输注系统的留 置软管均需要插入并植埋于人体皮下组织。考虑到患者在佩戴使用时的舒适程度， 这两个部分都采用了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， 它们都需要借助具有一定刚度的导入针以辅助它们剌破患者的皮 肤并连带将它们送入皮下， 而后将导入针抽回， 同时将它们留置于皮下组织。 对 于血糖传感器和留置软管来说， 这一穿剌留置过程和实现这一过程的机械结构都 是相似的。 此外， 血糖传感器和留置软管在人体身上的作用区域， 以及两者对于 一次性可抛式使用和无菌生产等方面的要求都是相同的。 因此， 特别引入 "二合 一" 的理念， 即将血糖探头和胰岛素输注系统集成成为一体化、 同时具有血糖监 测和胰岛素给药治疗作用的微型系统。 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无导管药物流体 输注器件， 用于解决现有技术中的药物流体输注器件操作复杂、 体积大、 以及成 本高的问题。
为实现上述目的及其他相关目的，本发明提供一种无导管药物流体输注器件， 包括： 控制器， 包括具有第一内置电路的第一壳体， 所述第一壳体上开设有第一 卡合部以及电性连接所述第一内置电路的第一插置部； 以及与所述控制器相结合 的泵体， 包括具有第二内置电路、 储药筒、 活塞、 推动杆、 驱动装置、 以及电池 的第二壳体， 所述第二壳体上具有对应卡合至所述第一卡合部的第二卡合部， 以 及电性连接于所述第二内置电路的第二插置部， 所述第二插置部对应插置于所述 第一插置部中以实现所述第一内置电路与第二内置电路的电性连接。
优选地， 所述第一卡合部为卡孔或卡槽。 所述第二卡合部为对应所述卡孔或 卡槽的卡勾， 所述卡勾与一卡勾手臂连接， 藉由所述卡勾手臂的操作使所述卡勾 自所述卡孔或卡槽中脱离。 或者优选地， 所述第二卡合部为对应所述卡孔或卡槽 的卡勾， 所述第一壳体上设置有使所述卡勾自所述卡孔或卡槽进行脱离的释放按 键。
优选地， 所述第一插置部为密封插孔。 所述密封插孔内设置一放置槽， 所述 放置槽中设置有与所述第一内置电路电性连接的连接器， 所述连接器与所述密封 插孔的接触端面上设置有 0型密封圈。所述第二插置部为插头， 所述插头包括环 设有 0型密封圈的插头主体及内嵌于所述插头主体中的插销，所述插头插置于所 述密封插孔中时， 所述插销插入所述连接器中并与其实现电性连接， 所述插头主 体上的 0型密封圈与所述密封插孔进行挤压配合以实现密封防水。
优选地， 所述泵体内置有用于作为结构载体及第二内置电路载体的主框架， 所述主框架上设置的第二内置电路为三维印刷电路， 所述三维印刷电路与所述第 二插置部电性连接。
优选地， 所述第二插置部上的信号线属性组合包括位置检测、 左到位检测、 右到位检测、 电池正极、 堵塞检测、 左侧驱动、 右侧驱动和电池负极的第一种组 合； 或者所述第二插置部上的信号线属性组合包括参比电极、 蜂鸣左到位检测、 公共右到位检测、 电池正极、 工作电极、 左侧驱动、 右侧驱动和电池负极的第二 种组合； 或者所述第二插置部上的信号线属组合包括位置检测、 左到位检测、 右 到位检测、 电池正极、 蜂鸣正极、 左侧驱动、 右侧驱动和电池负极的第三种。 与 之对应地， 在所述信号线属性组合为第一种及第二种组合的情况下， 所述第二插 置部上的地线连接位置检测公共端、 左到位检测公共端、 右到位检测公共端、 堵 塞检测公共端和电池负极； 在所述信号线属性组合为第三种组合的情况下， 所述 第二插置部上的地线连接位置检测公共端、 左到位检测公共端、 右到位检测公共 端、 堵塞检测公共端、 蜂鸣负极和电池负极。
优选地， 所述无导管药物流体输注器件的电池为纽扣电池。
优选地， 所述控制器的第一内置电路包括控制电路及程序处理模块。 所述第 一壳体内设有第一蜂鸣腔， 在所述第一蜂鸣腔内放置有第一蜂鸣器， 所述第一蜂 鸣器通过导线与所述控制器的第一内置电路导通工作。 或者， 所述第二壳体内设 有第二蜂鸣腔， 所述第二蜂鸣腔内放置有第二蜂鸣器， 所述第二蜂鸣器通过触点 与所述泵体的第二内置电路导通工作。
优选地， 所述泵体还设有包括钢针、 钢针基座、 弹簧以及拨动开关的皮下管 路安装机构。 所述泵体内还设有配置有钢针的留置软管， 所述钢针辅助所述置留 软管植入皮下。 所述钢针为中空针， 所述留置软管包覆所述中空针； 或者所述钢 针为剖口针， 所述留置软管置于所述剖口针的凹槽内。 所述留置软管的外表面还 设有血糖传感器。
优选地， 所述泵体上开设有药物流体出口， 所述药物流体出口上设有由塑料 底座、 硅胶堵头及高分子薄膜组成的注药堵头， 注药堵头通过卡扣与第二壳体连 接， 在抬起所述塑料底座时可将所述注药堵头从所述泵体上拆卸下来。
优选地， 所述泵体上固定有用于粘贴在患者皮肤上的医用胶布。
优选地， 本发明的无导管药物流体输注器件还包括用于加热输注部位的皮肤 加热装置。
优选地， 所述泵体上还设有为 NFC标签、 RFID标签、 或身份识别芯片的身 份识别标签。
如上所述， 本发明的无导管药物流体输注器件采用可分离式结构设计以降低 成本， 即将有源的控制器部分作为主控机， 将无源的耗材部分作为泵体， 也就是 说， 将有源的部分作为可重复使用的装置， 将无源的泵体部分作为一次性使用的 装置， 两者分别包装、 配合使用、 共同完成对患者的治疗。 具体来说， 使用时， 患者先将控制器和泵体组装到一起， 然后将整个无导管药物流体输注器件粘贴在 皮肤上并正常使用， 当泵体内的药液快用完或者器件出现故障等时， 控制器就会 通过蜂鸣器自动提示病人将泵体部分自行拆分、丢弃，然后安装更换成新的泵体， 重新粘贴在皮肤上继续使用。 附图说明
图 1显示为本发明无导管药物流体输注器件的一种实施方式示意图。
图 2显示为本发明中操作结构的一种实施方式示意图。
图 3显示为图 2中 A处放大示意图。
图 4显示为本发明中第一插置部的结构示意图。
图 5显示为图 4中 B处放大示意图。
图 6显示为本发明中第二插置部的结构示意图。
图 7显示为本发明中第一蜂鸣腔和蜂鸣器的分解结构示意图。
图 8显示为本发明中第一蜂鸣腔和蜂鸣器的安装结构示意图。
图 9显示为本发明于一种实施方式中的电池安装结构分解示意图。
图 10显示为本发明于一种实施方式中的电池安装示意图。
图 11显示为本发明中操作结构的另一种实施方式示意图。
图 12显示为在第二壳体中设置蜂鸣器的分解结构示意图。
图 13显示为在第二壳体中设置蜂鸣器的安装结构示意图。
图 14显示为本发明于另一种实施方式中的第二壳体的内部结构示意图。 图 15显示为本发明中皮下管路安装机构的示意图。
图 16显示为图 15中 A-A处断面示意图。
图 17显示为本发明中钢针、 置留软管及血糖传感器的结构示意图。
图 18显示为本发明中注药堵头的分解结构示意图。
图 19显示为本发明中注药堵头的安装结构示意图。
图 20显示为在本发明中包括有医用胶布、皮肤加热装置及身份识别标签的示 意图。 元件符号说明
11 控制器
in 第一卡合部
1111 凸缘结构 112 第一插置部
1121 放置槽
113 第一蜂鸣腔
12 泵体
121 第二卡合部
122 第二插置部
1221 插头主体
1222 0型密封圈
1223 插销
123 卡勾手臂
124 主框架
1241 地线
125 电池槽内
1251 电池负极弹簧
1252 电池正极弹片
1253 电池正极走线
1254 导通弹片
126 储药筒放置槽
127 药物流体出口
128 注药堵头
1281 塑料底座
1282 硅胶堵头
1283 高分子薄膜
129 注药口
13 连接器
131 0型密封圈
14 第一、 第二蜂鸣器
141 触点
15 纽扣电池 16 皮下管路安装机构
161 钢针
162 钢针基座
163 弹簧
164 拨动开关
165 辅助留置软管
166 血糖传感器
17 医用胶布
18 皮肤加热装置
19 身份识别标签
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 20。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。
本发明提供一种无导管药物流体输注器件， 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。 本发明的无导管药物流体输注器 件， 包括： 控制器及泵体。 其中， 所述泵体与所述控制器相结合， 具体地， 所述 泵体与所述控制器相结合藉由第一卡合部与第二卡合部的卡合连接实现二者的机 械结合， 藉由所述第一插置部与第二插置部的连接实现二者的电性连接。 所述控制器包括具有第一内置电路的第一壳体， 所述第一壳体上开设有第一 卡合部以及电性连接所述第一内置电路的第一插置部。
所述泵体包括具有第二内置电路、 储药筒、 活塞、 推动杆、 驱动装置、 以及 电池的第二壳体，所述第二壳体上具有对应卡合至所述第一卡合部的第二卡合部， 以及电性连接于所述第二内置电路的第二插置部， 所述第二插置部对应插置于所 述第一插置部中以实现所述第一内置电路与第二内置电路的电性连接。
请参阅图 1，显示为本发明无导管药物流体输注器件的一种实施方式示意图， 如图所示， 于具体的实施例中， 所述第一卡合部 111为卡孔， 所述卡孔的内部具 有凸缘结构 1111， 但并不局限于此， 所述第一卡合部 111亦可为例如卡槽等能够 于卡勾相互卡合的结构。 相应地， 所述第二卡合部 121为对应所述卡孔的卡勾， 所述卡勾与一卡勾手臂 123连接。 请参阅图 2及图 3， 图 2显示为本发明中操作 结构的一种实施方式示意图， 图 3显示为图 2中 A处放大示意图， 如图所示， 在 本实施例中， 藉由所述卡勾手臂 123的操作使所述卡勾从所述卡孔中脱离， 具体 为，所述卡勾手臂 123内侧与泵体 12底壳之间设有一定的间隙，按压所述卡勾手 臂 123时， 所述卡勾手臂 123抵触所述卡勾， 以令其自所述卡孔中脱离。
于具体的实施例中， 请参阅图 4及图 5， 图 4显示为本发明中第一插置部的 结构示意图，图 5显示为图 4中 B处放大示意图，如图所示，所述第一插置部 112 为密封插孔， 具体地， 所述密封插孔内设置有放置槽 1121， 所述放置槽 1121中 设置有与所述第一内置电路电性连接的连接器 13， 所述连接器 13与所述密封插 孔的接触端面上设置有 0型密封圈 131。
相应地， 所述第二插置部 122为插头， 请参阅图 6， 显示为本发明中第二插 置部的结构示意图， 如图所示， 所述插头包括环设有 0型密封圈 1222的插头主 体 1221及内嵌于所述插头主体 1221中的插销 1223，所述插销 1223为楔形结构， 以利于泵体 12的装配，所述插头插置于所述密封插孔中时，所述插销插入所述连 接器 13中并与其实现电性连接，所述插头主体上的 0型密封圈 1222与所述密封 插孔进行挤压配合以实现密封防水。
于一种实施方式中， 如图所示， 所述泵体 12的第二壳体包括泵体 12底壳和 泵体 12上壳， 在所述泵体 12底壳设有两个卡勾和卡勾手臂 123， 在所述控制器 11 的第一壳体上对应设有两个卡勾的卡孔和密封插孔， 密封插孔内设有连接器 13， 将所述泵体 12与所述控制器 11相结合时， 所述卡勾插入卡孔的同时插头也 插入密封插孔， 卡勾通过前端斜边导向滑入卡孔中， 与卡孔中的凸缘 1111形成锁 紧配合， 将所述泵体 12和所述控制器 11将紧密的连接在一起， 此时， 外壳插头 上的两个 0型密封橡胶圈 1222与密封插孔进行挤压以形成严密的防水结构， 在 卡勾手臂 123 内侧与泵体 12底壳之间设有一定的间隙， 向内按压所述卡勾手臂 123即可分离所述泵体 12和控制器 11。 由上描述可知， 所述泵体 12和所述控制 器 11通过卡勾插入卡孔实现结构连接， 通过插头插入密封插孔内的连接器 13实 现信号连接。
请参阅图 7及图 8， 图 7显示为本发明中第一蜂鸣腔和蜂鸣器的分解结构示 意图， 图 8显示为本发明中第一蜂鸣腔和蜂鸣器的安装结构示意图， 如图所示， 所述第一壳体内设有第一蜂鸣腔 113， 在所述第一蜂鸣腔 113 内放置有第一蜂鸣 器 14， 所述第一蜂鸣器 14通过导线 （未予以标号）与所述控制器 11的第一内置 电路导通工作， 当泵体 12内的药液快用完或器件出现故障等时候， 控制器 11就 会通过第一蜂鸣器 14自动提示病人将泵体 12部分自行拆分、 丢弃， 然后安装更 换成新的泵体 12， 重新粘贴在皮肤上继续使用。
请参阅图 9及图 10，显示为本发明于一种实施方式中的第二壳体的内部结构 示意图，如图所示，所述泵体 12内置有用于作为结构载体及第二内置电路载体的 主框架 124，所述主框架 124布设的第二内置电路为三维印刷电路（未予以标号）， 所述三维印刷电路与所述第二插置部 122电性连接。即所述泵体 12内置有用于作 为结构载体及电路载体的主框架 124， 所述主框架 124上布设有三维印刷电路， 所述三维印刷电路与所述第二插置部 122电性连接， 从而实现将来自所述控制器 11密封插孔中的连接器 13的信号传输至所述三维印刷电路中， 为插头的所述第 二插置部 122上具有多根信号线， 该些信号线的属性组合包括位置检测、 左到位 检测、 右到位检测、 电池正极、 堵塞检测、 左侧驱动、 右侧驱动、 及电池负极。 需要特别声明的是， 于本实施例呈现的图示中， 并未针对各属性的信号线给予符 号标注， 换言之， 本实施例中的信号线属性的排序方式并不局限于此， 经调整排 列顺序的且包含本实施例中所述的信号线属性的其他实施方式应被上述揭露的情 况所涵盖。
于具体的实施方式中， 呈如图 9及图 10所示， 在所述泵体 12中内置有可同 时作为结构载体和电路载体的主框架 124， 主框架 124具有两个重要作用： 一则 为实施泵体 12 的所有功能零部件提供安插、 固定的载体； 再则为有源的控制器 11部分对泵体 12的控制提供三维印刷电路。 所述主框架 124选择能够满足手工 焊接、 甚至 SMT中高温焊接的温度要求的基体材料。 为防止泵体 12的外壳和主 框架 124装配时的干涉， 主框架 124的插头采用楔形， 于本实施例中所述主框架 插头即为第二插置部 122中的插销。 在主框架 124插头的两侧均分布信号线， 信 号线包括位置检测、 左到位检测、 右到位检测、 电池正极、 堵塞检测、 左侧驱动、 右侧驱动和电池负极， 优选情况下， 在靠近注药口一侧的信号线从上至下依次为 堵塞检测、 左侧驱动、 右侧驱动和电池负极， 在另一侧的信号线从上至下依次为 位置检测、 左到位检测、 右到位检测和电池正极。
泵体 12内置的主框架 124及地线分布如图 9和图 10所示，在泵体 12与控制 器 11分离式设计的一种实施方式中采用单节纽扣电池 15， 纽扣电池 15放置于主 框架 124上设有的电池槽内 125，纽扣电池 15通过主框架 124以及电池正极弹片 1252固定， 电池正极弹片 1252及电池负极弹簧 1251与主框架 124上的立体电路 导通。地线 1241连接到位置检测公共端、左到位检测公共端、右到位检测公共端、 堵塞检测公共端和电池负极。
于图 9及图 10中， 标号 126所示之位置为储药筒放置槽。
请参阅图 11， 显示为本发明中操作结构的另一种实施方式示意图， 于另一种 实施方式中，所述控制器 11的第一壳体上还设置有用于使所述卡勾和卡孔进行脱 离的释放按键 114。请参阅图 11， 在本图示展示的实例中， 所述泵体 12和控制器 11之间也通过在泵体 12底壳设有的卡勾实现结构连接， 同时在控制器 11上还设 有用以分离泵体 12和控制器 11连接的释放按键 114。 在为第二壳体一部分的底 壳上也设有两个卡勾，在控制器 11上对应设有两个按键和密封插孔，密封插孔内 设有连接器 13， 在为第二壳体另一部分的上壳设有插头， 主框架 124插头通过泵 体 12外壳插头的密封缝隙伸出来，为外壳插头的插头主体和为主框架 124插头的 插销组成泵体 12的插头，在泵体 12和控制器 11相互结合时，所述卡勾插入卡孔 的同时插头也插入密封插孔， 卡勾通过前端斜边导向滑入卡孔中， 与卡孔中的凸 缘形成锁紧配合， 将泵体 12和控制将紧密的连接在一起， 此时， 外壳插头上的两 个 0型密封橡胶圈与密封插孔进行挤压， 按下控制器 11上按键即可分离泵体 12 和控制器 11。 在控制器 11的密封插孔内设有放置连接器 13的连接器放置槽， 插 头插入密封插孔时，主框架 124插头插入连接器 13实现泵体 12和控制器 11之间 的信号连接， 连接器 13与控制器 11外壳接触的端面 （即 0型密封圈配合面）上 也设置了一个 0型密封圈， 外壳插头上的双 0型密封圈以及密封插孔内的 0型 密封圈实现了控制器 11和泵体 12配合使用时的密封防水。
请参阅图 12及图 13，图 12显示为第二壳体中设置蜂鸣器的分解结构示意图， 图 13显示为第二壳体中设置蜂鸣器的安装结构示意图，如图所示，所述第二壳体 内设有第二蜂鸣腔 113， 所述第二蜂鸣腔 113内放置有第二蜂鸣器 14， 所述第二 蜂鸣器 14通过触点 141与所述泵体 12的三维印刷电路导通工作，当泵体 12内的 药液快用完或器件出现故障等时候， 通过第二蜂鸣器 14 自动提示病人将泵体 12 部分自行拆分、丢弃，然后安装更换成新的泵体 12，重新粘贴在皮肤上继续使用。
为防止泵体 12外壳和主框架 124装配时的干涉，在泵体 12和控制器 11分离 时设计的第二种实施方式中主框架 124的插头也采用楔形， 如图所示。 在为主框 架 124插头的插销两侧均分布信号线， 信号线包括信号线包括位置检测、 左到位 检测、 右到位检测、 电池正极、 蜂鸣正极、 左侧驱动、 右侧驱动和电池负极， 优 选情况下在靠近注药口一侧的信号线从上至下依次为蜂鸣正极、 左侧驱动、 右侧 驱动和电池负极， 在另一侧的信号线从上至下依次为位置检测、 左到位检测、 右 到位检测和电池正极。
请参阅图 14，显示为本发明于另一种实施方式中的第二壳体的内部结构示意 图，泵体 12内置的主框架 124及地线分布如图 14所示，在本图示呈现的实例中， 采用双节纽扣电池 15， 所述纽扣电池 15放置于主框架 124上设有的电池槽内， 两节电池由导通弹片 1254连接， 并且通过主框架 124上的地线 1241以及电池正 极走线 1253接出供电。 地线 1241连接到位置检测公共端、 左到位检测公共端、 右到位检测公共端、 堵塞检测公共端、 蜂鸣负极和电池负极。
请参阅图 15至图 17， 图 15显示为本发明中皮下管路安装机构的示意图， 图 16显示为图 15中 A-A处断面示意图， 图 17显示为本发明中钢针、 留置软管及 血糖传感器的结构示意图， 如图所示， 所述泵体 12还设有包括钢针 161、 钢针基 座 162、弹簧 163以及拨动开关 164的皮下管路安装机构 16。所述泵体 12内还设 有配置有钢针 161的留置软管 165，所述钢针 161以辅助留置软管 165植入皮下。 于具体的实施方式中， 所述钢针为中空针， 所述留置软管包覆所述中空针； 或者 所述钢针为剖口针， 所述留置软管置于所述剖口针的凹槽内。 请参阅图 17， 于本 实施例中， 所述留置软管的外表面还设有血糖传感器 166。
于本实施例中， 所述钢针 161为中空针或剖口针， 当选用钢针 161为中空针 时，所述中空针和所述留置软管 165的配置方式为留置软管 165包覆所述中空针， 呈如图 17所示之结构， 在另一种实施例中， 即当选用钢针为剖口针时， 所述剖口 针和所述留置软管的配置方式为所述留置软管置于所述剖口针的凹槽内 （未予以 图示）。
于具体的实施方式中， 如图所示， 本发明的无导管药物流体输注器件中， 泵 体 12内储药筒（未予以图示， 即放置在所述储药筒放置槽 126中的储药筒）中存 储的药物流体可由植入皮下的留置软管 165或者钢针 161输注进入患者体内， 留 置软管 165和 /或钢针 161均可在皮下管路安装机构 16的辅助下植入皮下， 所述 的皮下管路安装机构 16从组成部件上讲包括钢针 161、 钢针基座 162、 弹簧 163 和拨动开关 164， 从结构上讲包括弹射装置和 /或回针装置， 其中弹射装置可以是 自动或手动装置， 回针装置可以是自动或手动装置。 当植入钢针时， 所述皮下管 路安装机构 16可通过弹射装置直接使钢针剌破患者皮肤植入皮下；当植入留置软 管 165时，所述皮下管路安装机构 16可通过弹射装置利用钢针剌破患者皮肤并将 留置软管带入皮下， 随后通过回针装置将钢针 161抽回。 所述皮下管路安装机构 16既可置于泵体 12的内部，也可置于泵体 12的外部。所述皮下管路安装机构 16 置于泵体 12的内部参考如图 15及图 16所示，下面以植入留置软管到患者皮下进 行说明： 选取中空的钢针， 钢针放置于留置软管的管内， 初始时， 钢针和留置软 管均位于钢针基座中， 当推动钢针基座向下运动， 钢针剌破患者皮肤进入患者体 内从而将留置软管植入皮下； 当钢针基座推动到最底部时， 拨动开关将其固定限 位， 且弹簧处于压缩状态。 此时， 触动拨动开关使压缩弹簧释放， 从而推动钢针 基座向上运动， 将钢针从患者体内中抽出。
由于血糖传感器和留置软管在人体身上的作用区域， 以及两者对于一次性可 抛式使用和无菌生产等方面的要求都是相同的， 在本发明的无导管药物流体输注 器件中， 可将血糖传感器集成在留置软管的外表面上， 如图 17所示， 此时留置软 管和葡萄糖传感器可被同时植入患者皮下。
本发明的无导管药物流体输注器件中， 若将血糖传感器集成在留置软管 165 外表面， 则主框架 124插头两侧分布的信号线包括参比电极、 蜂鸣左到位检测、 公共右到位检测、 电池正极、 工作电极、 左侧驱动、 右侧驱动和电池负极。 优选 情况下在靠近注药口 129—侧的信号线从上至下依次工作电极、 左侧驱动、 右侧 驱动和电池负极，在另一侧的信号线从上至下依次为参比电极、蜂鸣左到位检测、 公共右到位检测和电池正极， 此时， 地线连接到位置检测公共端、 左到位检测公 共端、 右到位检测公共端、 堵塞检测公共端和电池负极。
请参阅图 18及图 19， 图 18显示为本发明中注药堵头的分解结构示意图， 图 19显示为本发明中注药堵头的安装结构示意图， 如图所示， 所述泵体 12上开设 有药物流体出口 127， 所述药物流体出口 127上设有由塑料底座 1281、 硅胶堵头 1282及高分子薄膜 1283组成的注药堵头 128， 注药堵头 128通过卡扣 （即图 18 所示的卡勾 1284和卡孔 1271的卡扣结构） 与第二壳体连接， 在抬起所述塑料底 座 1281时可将所述注药堵头 128从所述泵体 12上拆卸下来。 于具体的实施方式 中， 本发明的无导管药物流体输注器件输送药物流体到患者体内时， 需借助注射 器将药物流体经注药口灌装到泵体 12 内， 为防止在灌装药物流体过程中发生泄 漏， 在泵体 12的药物流体出口设有一个注药堵头 128， 如图 18所示， 注药堵头 128由塑料底座 1281、 硅胶堵头 1282以及高分子薄膜 1283组成， 注药堵头 128 通过塑料底座 1281的卡勾与泵体 12底壳连接， 硅胶堵头 128防止四周漏液， 高 分子薄膜 1283实现透气不透水功能;抬起塑料底座 1281可将注药堵头 128拆卸。 于图 18及图 19中标号为 129的为注药口。
请参阅图 20， 显示为在本发明中包括有医用胶布、 皮肤加热装置及身份识别 标签的示意图，如图所示，所述泵体 12上固定有用于粘贴在患者皮肤上的医用胶 布 17。本发明无导管药物流体输注器件还包括用于加热输注部位的皮肤加热装置 18。所述泵体 12上还设有为 NFC标签、 RFID标签、或身份识别芯片的身份识别 标签 19。
于具体的实施方式中，本发明的无导管药物流体输注器件的通过医用胶布 17 粘贴在患者的皮肤上， 由于泵体 12部分相对于控制器 11而言体积大且重量重， 因此， 只需要将医用胶布 17预先固定在泵体 12底壳上， 就能够实现整个无导管 药物流体输注器件在患者身上的可靠固定，在丢弃和更换新的泵体 12时， 医用胶 布 17也随之一起丢弃和更换， 同时， 新泵体 12的粘贴位置可以变换， 如此可以 避免患者因同一个地方长时间粘贴胶布和因长期反复扎针而造成的身体不适。 在 医用胶布和泵体 12底壳之间还可设有皮肤加热装置 18和 /或身份识别标签 19， 对患者进行糖尿病治疗输注胰岛素时，皮肤加热装置 18可用于减少胰岛素高峰作 用时间的延迟； 身份识别标签 19用于存储泵体 12的个性化信息及身份识别， 身 份识别标签 19可以是 NFC标签、 RFID标签或身份识别芯片。 综上所述， 本发明的无导管药物流体输注器件采用可分离式结构设计以降低 成本， 即将有源的控制器部分作为主控机， 将无源的耗材部分作为泵体， 也就是 说， 将有源的部分作为可重复使用的装置， 将无源的泵体部分作为一次性使用的 装置， 两者分别包装、 配合使用、 共同完成对患者的治疗。 具体来说， 使用时， 患者先将控制器和泵体组装到一起， 然后将整个无导管药物流体输注器件粘贴在 皮肤上并正常使用， 当泵体内的药液快用完的时候， 控制器就会通过蜂鸣器自动 提示病人将泵体部分自行拆分、 丢弃， 然后安装更换成新的泵体， 重新粘贴在皮 肤上继续使用。 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

Claims

权利要求书
、 一种无导管药物流体输注器件， 其特征在于， 包括：
控制器， 包括具有第一内置电路的第一壳体， 所述第一壳体上开设有第一卡合部以 及电性连接所述内置电路的第一插置部；
泵体， 与所述控制器相结合， 包括具有第二内置电路、 储药筒、 活塞、 推动杆、 驱 动装置、 以及电池的第二壳体， 所述第二壳体上具有对应卡合至所述第一卡合部的第二 卡合部， 以及电性连接于所述第二内置电路的第二插置部， 所述第二插置部对应插置于 所述第一插置部中以实现所述第一内置电路与第二内置电路的电性连接。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述第一卡合部为卡孔 或卡槽。 、 根据权利要求 2 所述的无导管药物流体输注器件， 其特征在于： 所述第二卡合部为对应 所述卡孔或卡槽的卡勾， 所述卡勾与一卡勾手臂连接， 藉由所述卡勾手臂的操作使所述 卡勾卡合于所述卡孔或卡槽中或者自所述卡孔或卡槽中脱离。 、 根据权利要求 2 所述的无导管药物流体输注器件， 其特征在于： 所述第二卡合部为对应 所述卡孔或卡槽的卡勾， 所述第一壳体上设置有使所述卡勾自所述卡孔或卡槽进行脱离 的释放按键。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述第一插置部为密封 插孔。 、 根据权利要求 5 所述的无导管药物流体输注器件， 其特征在于： 所述密封插孔内设置一 放置槽， 所述放置槽中设置有与所述第一内置电路电性连接的连接器， 所述连接器与所 述密封插孔的接触端面上设置有 0型密封圈。 、 根据权利要求 6 所述的无导管药物流体输注器件， 其特征在于： 所述第二插置部为插 头， 所述插头包括环设有 0 型密封圈的插头主体及内嵌于所述插头主体中的插销， 所述 插头插置于所述密封插孔中时， 所述插销插入所述连接器中并与其实现电性连接， 所述 插头主体上的 0型密封圈与所述密封插孔进行挤压配合以实现密封防水。 、 根据权利要求 1 或 7所述的无导管药物流体输注器件， 其特征在于： 所述泵体内置有用 于作为结构载体及第二内置电路载体的主框架， 所述主框架上设置的第二内置电路为三 维印刷电路， 所述三维印刷电路与所述第二插置部电性连接。 、 根据权利要求 8 所述的无导管药物流体输注器件， 其特征在于： 所述第二插置部上的信 号线属性组合包括位置检测、 左到位检测、 右到位检测、 电池正极、 堵塞检测、 左侧驱 动、 右侧驱动和电池负极的第一种组合； 或者所述第二插置部上的信号线属性组合包括 参比电极、 蜂鸣左到位检测、 公共右到位检测、 电池正极、 工作电极、 左侧驱动、 右侧 驱动和电池负极的第二种组合； 或者所述第二插置部上的信号线属组合包括位置检测、 左到位检测、 右到位检测、 电池正极、 蜂鸣正极、 左侧驱动、 右侧驱动和电池负极的第 三种。 、 根据权利要求 9 所述的无导管药物流体输注器件， 其特征在于： 在所述信号线属性组 合为第一种及第二种组合的情况下， 所述第二插置部上的地线连接位置检测公共端、 左到位检测公共端、 右到位检测公共端、 堵塞检测公共端和电池负极； 在所述信号线 属性组合为第三种组合的情况下， 所述第二插置部上的地线连接位置检测公共端、 左 到位检测公共端、 右到位检测公共端、 堵塞检测公共端、 蜂鸣负极和电池负极。 1、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述电池为纽扣电 池。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述控制器的第一内 置电路包括控制电路及程序处理模块。 3、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述第一壳体内设有 第一蜂鸣腔， 在所述第一蜂鸣腔内放置有第一蜂鸣器， 所述第一蜂鸣器通过导线与所 述控制器的第一内置电路导通工作。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述第二壳体内设有 第二蜂鸣腔， 所述第二蜂鸣腔内放置有第二蜂鸣器， 所述第二蜂鸣器通过触点与所述 泵体的第二内置电路导通工作。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述泵体还设有包括 钢针、 钢针基座、 弹簧以及拨动开关的皮下管路安装机构。 、 根据权利要求 15 所述的无导管药物流体输注器件， 其特征在于： 所述泵体内还设有配 置有钢针的留置软管， 所述钢针辅助所述置留软管植入皮下。 、 根据权利要求 16所述的无导管药物流体输注器件， 其特征在于： 所述钢针为中空针， 所述留置软管包覆所述中空针； 或者所述钢针为剖口针， 所述留置软管置于所述剖口 针的凹槽内。 、 根据权利要求 15 或 16 所述的无导管药物流体输注器件， 其特征在于： 所述留置软管 的外表面还设有血糖传感器。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述泵体上开设有药 物流体出口， 所述药物流体出口上设有由塑料底座、 硅胶堵头及高分子薄膜组成的注 药堵头， 注药堵头通过卡扣与第二壳体连接， 在抬起所述塑料底座时可将所述注药堵 头从所述泵体上拆卸下来。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述泵体上固定有用 于粘贴在患者皮肤上的医用胶布。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 还包括用于加热输注 部位的皮肤加热装置。 、 根据权利要求 1 所述的无导管药物流体输注器件， 其特征在于： 所述泵体上还设有为 NFC标签、 RFID标签、 或身份识别芯片的身份识别标签。
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