WO2020221330A1 - 一种受体生理参数测量系统 - Google Patents

一种受体生理参数测量系统 Download PDF

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Publication number
WO2020221330A1
WO2020221330A1 PCT/CN2020/087964 CN2020087964W WO2020221330A1 WO 2020221330 A1 WO2020221330 A1 WO 2020221330A1 CN 2020087964 W CN2020087964 W CN 2020087964W WO 2020221330 A1 WO2020221330 A1 WO 2020221330A1
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WIPO (PCT)
Prior art keywords
seat
button
guide
thimble
bracket
Prior art date
Application number
PCT/CN2020/087964
Other languages
English (en)
French (fr)
Inventor
钱成
Original Assignee
苏州百孝医疗科技有限公司
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Publication date
Application filed by 苏州百孝医疗科技有限公司 filed Critical 苏州百孝医疗科技有限公司
Priority to ES202190027U priority Critical patent/ES1283120Y/es
Publication of WO2020221330A1 publication Critical patent/WO2020221330A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • A61B5/6833Adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848Needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04Constructional details of apparatus
    • A61B2560/0443Modular apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/06Accessories for medical measuring apparatus
    • A61B2560/063Devices specially adapted for delivering implantable medical measuring apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585Needle inserters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics
    • A61M2230/201Glucose concentration

Definitions

  • the application relates to a system for rapidly implanting a biosensor into a recipient tissue, which can be reused, and measuring the physiological parameters of the recipient, belonging to the technical field of wearable medical devices.
  • the patient may miss the peak and valley values of blood glucose, which may cause some complications and cause irreversible harm to the patient; second, multiple times a day
  • the fingertip puncture and blood sampling caused great pain to the diabetic patients.
  • a method that can continuously monitor the blood glucose of patients is needed, so that patients can understand their blood glucose status in real time, and can take timely measures to effectively control the disease, prevent complications, and obtain a higher quality of life.
  • a continuous blood glucose monitoring technology that can be implanted into subcutaneous tissue for continuous monitoring of subcutaneous glucose.
  • This technology uses a sensor electrode that penetrates into the subcutaneous tissue. The electrode oxidizes the patient’s interstitial fluid with glucose in the body. , An electrical signal is formed during the reaction. The electrical signal is converted into blood glucose readings through the transmitter, and the blood glucose readings are transmitted to the wireless receiver every 1-5 minutes. The corresponding blood glucose data is displayed on the receiver and the graph is formed for Reference for patients and doctors.
  • the metal wire can be a stainless steel wire coated with platinum.
  • a stainless steel wire with a diameter of 0.16 mm to 0.25 mm is electroplated with platinum as the carrier of the sensor electrode. Because the stainless steel wire has sufficient hardness, the sensor electrode can directly penetrate the skin into the tissue without the aid of auxiliary tools.
  • this implantation method causes larger wounds, stronger pain, and stronger abnormal sensations after implantation under the skin, which still causes great troubles for diabetic patients.
  • auxiliary implant tools are manual or semi-automatic. Since manual implantation has inconsistencies in the speed and strength of each implantation, and the speed is slow, the implantation process takes a long time. On the one hand, the deviation of the sensor after implantation is large, and on the other hand, it increases the pain of the patient.
  • the traditional dynamic blood glucose transmitter is mainly composed of three parts: button battery, circuit board and plastic shell. Due to waterproof requirements and volume limitations, the button battery and the circuit board are generally placed together in the transmitter, and the two are usually integrated into a plastic package, so the transmitter battery cannot be replaced. When the battery life is used up, the transmitter is basically unusable. From the perspective of cost, the cost of the transmitter's plastic casing and circuit board is much greater than the battery cost, and the lifetime of the transmitter's plastic casing and circuit board is much longer than the battery life. From the perspective of environmental protection, the manufacturing and disposal of circuit boards may bring potential hazards to the environment. Therefore, this method will greatly waste circuit boards and plastic enclosures, increase material costs and waste of resources.
  • the technical problem to be solved in this application is to provide a receptor physiological parameter measurement system in view of the above-mentioned shortcomings of the prior art.
  • a system for measuring physiological parameters of a recipient comprising an implanter, a sensor base device and a transmitter, and both the implanter and the transmitter can be installed on the sensor base device;
  • the implanter includes: an upper cover of the implanter, a lower cover of the implanter, a button, a stent, a thimble seat, a puncture needle seat, a guide needle seat, a return needle spring, a drive spring, a thimble, a puncture needle, a guide needle and a guide
  • the limit block wherein the upper cover of the implanter and the lower cover of the implanter form an outer shell, the button is located on the upper cover of the implanter, and the bracket, thimble seat, puncture needle seat and guide needle seat are all fitted in the outer shell in cooperation, The front end of the outer shell is connected to the sensor base device;
  • the bracket is fixed in the outer casing.
  • the bracket is a cylindrical structure with an open end, and its opening faces the sensor base device.
  • the upper part of the bracket is a long cylinder.
  • the front end of the bracket faces the sensor base device.
  • Ribs, the bracket elastic ribs are configured to limit and guide the needle seat, the upper part of the rear end has a bracket buckle configured to clamp the thimble seat, and the outside of the bracket has a bracket boss that can be buckled with the guide limit block and restricts the movement of the thimble seat
  • the limit elastic buckle ;
  • the thimble seat is a cylindrical structure with two ends open.
  • the thimble seat is movable in the bracket.
  • the upper part of the thimble seat is a sleeve.
  • the long cylinder penetrates the sleeve.
  • the front edge of the sleeve facing the sensor base device has a ring edge.
  • Both sides of the thimble seat are provided with rectangular holes, and the front end of the thimble seat
  • the upper part of the rear end of the thimble seat is provided with a thimble boss, the thimble is located in the thimble boss, and the top position in the cylindrical structure of the thimble seat is provided with ribs along its length;
  • Both sides of the puncture needle holder are provided with inclined brackets.
  • the ends of the inclined bracket have elastic pins that can be inserted into the rectangular holes.
  • the upper part of the puncture needle holder has a sliding groove, and the sliding groove is buckled into the rib of the thimble holder. Sliding in the thimble seat, the puncture needle is located in the puncture needle seat;
  • the guide needle seat is a cylindrical structure with two ends open, the side of the guide stop block has a hook that is buckled with the bracket boss, the guide stop block has a guide cylinder in the middle, and the guide cylinder penetrates the guide needle seat.
  • the end of the guide pin holder facing the sensor base device has a limiting boss that is buckled with the elastic buckle of the bracket, the edge of the end of the guide pin holder away from the sensor base device has a ring edge, and the guide pin holder is built-in to push it away from the sensor base device.
  • the return needle spring, the guide needle seat is pre-placed in the thimble seat, and can move through the thimble seat.
  • the upper part of the guide needle seat has a release boss.
  • the movement of the guide needle seat can press the inclined support through the release boss to make the elastic latch release Rectangular hole, the side of the guide needle seat is also provided with an unlocking boss that can open the limit elastic buckle, and the upper part of the guide needle seat is provided with a guide needle boss.
  • the guide needle boss can be connected with the sensor base device.
  • the needle is located in the guide needle boss;
  • the sensor base device includes a base and a tape, the base is located on the tape; the upper part of the base is an opening, the base has a battery slot and a groove, a battery and a battery cover are installed in the battery slot, and the groove is installed
  • the rotating seat is hinged in the groove on one side of the battery slot.
  • the rotating seat is provided with a silicone seat.
  • a pair of conductive rubber is arranged in the silicone seat.
  • a sensor is provided through the silicone seat and the rotating seat. The sensor can pass through the two Conductive rubber, the groove has an opening on one side of the battery slot, the tape is provided with a hole, and the sensor can pass through the opening and the hole of the tape;
  • the transmitter includes a plastic enclosure and a circuit board assembly, the plastic enclosure is covered on the base, the circuit board assembly is installed inside the plastic enclosure, and the circuit board assembly has four conductive pins that can contact the positive and negative electrodes of the battery And two conductive rubbers.
  • the upper cover of the implanter is provided with a button hole, and the button is located in the button hole;
  • the button hole has a ring structure inward, and the ring structure is provided with two L-shaped notches, two The shorter slot with the L-shaped notch faces the upper cover of the implanter, and the longer slot is arranged in the opposite direction;
  • the bottom surface of the button has a pair of button bosses, and the button bosses can be rotated out of the notch by turning the button, and the bottom surface of the button is still
  • trigger ribs that can toggle the elastic card, and one trigger rib corresponds to one elastic card. When the button boss is in the state of unscrewing the gap, the trigger rib is in the position of the elastic card.
  • a deep groove is provided at the rear end of the lower cover of the implanter, a button holder is arranged in the deep groove, a button holder cylinder is arranged on the button holder, a cylindrical hole is provided at the bottom of the button, and the button holder is arranged in a column.
  • a button spring is arranged around the button holder cylinder in the cylindrical hole.
  • the silicone seat is provided with a first conductive rubber hole and a second conductive rubber hole, and the two conductive rubbers are respectively installed in the first conductive rubber hole and the second conductive rubber hole; in the silicone seat Two square holes are also provided, two conductive rubbers and two square holes are distributed in a straight line, and the sensor passes through the two conductive rubbers.
  • a semicircular hole is provided on both sides of the groove, a flexible extension rod is provided on both sides of the end of the rotating seat, and the outer side of the extension rod is provided with a cylindrical shaft, The cylindrical shaft is placed in a semicircular hole to rotate.
  • an electrode adapter is installed on the positive and negative poles of the battery, each electrode adapter is equipped with an electrode connector, and the battery cover is provided with two round holes, one The hole corresponds to an electrode connecting piece, and the electrode connecting piece passes through the round hole and is placed outside the battery cover.
  • the four conductive pins on the circuit board assembly are two battery guide pins and two rubber guide pins, the two battery guide pins are respectively connected to an electrode connector, and the two rubber guide pins are respectively connected to one Conductive rubber.
  • the end of the base has a base snap opening
  • the end of the plastic shell has an edge boss inserted into the snap opening of the base
  • the side of the plastic shell has a shell snap groove
  • the The inner side wall of the groove is provided with an elastic buckle which is inserted into the housing groove.
  • the edge of the battery slot has a sealing strip
  • the edge of the silicone seat has ribs.
  • the receptor physiological parameter measurement system of the present application firstly solves the problem that diabetic patients need to puncture and collect blood from the fingertips multiple times a day. It uses a sensor electrode that penetrates into the subcutaneous tissue. Monitoring blood glucose within a certain period of time can greatly reduce the patient's puncture pain and more accurately grasp the patient's blood glucose level changes.
  • the small and soft sensor electrode is implanted into the subcutaneous tissue with the aid of an auxiliary implant tool, which solves the pain and foreign body sensation problems caused by the sensor electrode being implanted in the recipient.
  • the linearly arranged automatic implanter can complete the implantation of the sensor electrode and the withdrawal of the needle at a faster speed, which greatly reduces the patient's puncture pain.
  • a reasonable combination of parts allows most parts to be reused multiple times, reducing material waste, greatly reducing user costs, and reducing potential harm to the environment.
  • Figure 1 is a schematic diagram of the working principle of the application
  • Figure 2 is a schematic diagram of the application structure
  • Figure 3 is a sectional view of the initial state of the implanter
  • Figure 4 is a schematic diagram of the working state of the sensor base device
  • Figure 5 is an exploded view of the implanter
  • Figure 6 is a schematic diagram of the upper cover of the implanter
  • Figure 7 is a schematic diagram of the structure of the lower cover of the implanter.
  • Figure 8 is a schematic diagram of the button structure
  • Figure 9 is a sectional view of the bracket
  • Figure 10 is a schematic diagram of the internal structure of the stent
  • Figure 11 is a schematic diagram of the thimble seat structure
  • Figure 12 is a schematic diagram of the internal structure of the puncture needle holder and the guide needle holder;
  • Figure 13 is a schematic view of the cross-sectional structure of the puncture needle holder and the guide needle holder;
  • Figure 14 is an exploded view of the launcher
  • Figure 15 is an exploded view of the sensor base device
  • Figure 16 is a sectional view of the silicone seat
  • Figure 17 is a schematic diagram of the structure of the base
  • Figure 18 is a schematic diagram of the battery cover structure
  • Figure 19 is a schematic diagram of the structure of the rotating seat and the silicone seat
  • Figure 20 is a schematic diagram of the electrical system module of this application.
  • Figure 1 is a schematic diagram of the working principle of the application.
  • the sensor 301 is partially implanted into the recipient tissue 100, and the sensor 301 is electrically connected to the transmitter 400 through contact.
  • the transmitter detects the biological signal of the sensor 301, it converts the signal into a physiological parameter, and sends it to the receiver 500 of the user through wireless transmission.
  • the physiological parameter measurement system is divided into three parts in structure: the implanter 200, the sensor base device 300 and the transmitter 400, as shown in FIG. 2.
  • the sensor base device 300 and the implanter 200 are connected together by the frictional resistance between the guide pin 213 and the silicone seat 310 to maintain their initial position; the biosensor electrode is installed inside the implanter , Maintain its initial position by frictional resistance.
  • the transmitter 400 is in an unused state.
  • part of the sensor 301 enters the tissue of the recipient, and part is retained in the sensor base device 300.
  • the transmitter 400 will "read" the signal on the biosensor, convert the signal into a physiological parameter, and send it to the receiver 500, which can be a mobile phone, an operator or even the cloud.
  • the implanting device 200 is configured to implant the sensor 301 into the recipient tissue.
  • the structure mainly includes an implanter upper cover 201, an implanter lower cover 202, a button 203, a stent 204, a thimble seat 205, The puncture needle seat 206, the guide needle seat 207, the return needle spring 208, the drive spring 209, the thimble 211, the puncture needle 212, the guide needle 213 and the guide limit block 214, wherein the upper cover 201 of the implanter and the lower cover of the implanter 202 constitutes an outer casing.
  • the bracket 204 and the guide stop block 214 are fixed in the outer casing.
  • the thimble seat 205, the puncture needle seat 206 and the guide needle seat 207 are all located in the bracket 204 and the guide stop block 214.
  • the thimble seat 205 mainly drives The thimble 211 moves forward to trigger the guide needle seat 207, and the guide needle seat 207 moves in the reverse direction, forming the implantation process of the sensor 301.
  • the upper cover 201 of the implanter is provided with a T-shaped structure 2011 (limiting structure).
  • This structure is used to limit the guide needle seat 207 to prevent the guide needle seat from shaking, so that the puncture needle can be relatively "Straight" puncture into the body tissues to reduce the pain caused by shaking.
  • the upper cover 201 of the implanter is provided with a limiting structure 2012, which cooperates with the stopper 2041 on the stent 204, on the one hand, provides sufficient strength to the stopper of the stent, and on the other hand prevents the stent from displacing under the action of the drive spring 209 .
  • buttons 2013 there is a button hole 2013 at the front end of the upper cover 201 of the implanter, and the round hole is configured to place the button 203.
  • the button can be rotated and moved up and down in this round hole.
  • the notch 2014 can be matched with the button boss 2031 on the button 203.
  • the notch can restrict the button from moving to the outside of the upper cover 201 of the implanter through the button boss 2031.
  • this L-shaped structure can provide a "lock” and "unlock” function.
  • the button boss 2031 on the button 203 is located at the innermost side of the L shape.
  • the button is restricted to only rotate in one direction and cannot be pressed. At this time it is in the "locked” state. It has the function of preventing the button 203 from being triggered by mistake.
  • the button boss 2031 is located at the open end of the L shape. At this time, it is in the "unlocked” state and the button can be pressed.
  • the L-shaped notch 2014 has a locking boss 2015.
  • the lower cover 202 of the implanter is provided with a base groove 2021 at the bottom.
  • the base groove 2021 is used to assemble the sensor base 302. Before the sensor 301 is implanted, the sensor base device 300 and the implanter 200 are guided The friction resistance between the needle 213 and the silicone seat 310 is connected together to maintain its initial position.
  • a triangular rib 2022 is provided in the base groove 2021, and the triangular rib is used to limit the base and prevent the base from moving.
  • the base groove 2021 is provided with a rectangular opening 2023 with a moderate size; in the initial state, the opening allows the rotating seat 309 in the base to pass through, but restricts the base from moving upward.
  • the lower cover 202 of the implanter is provided with a limiting piece 2024 at the front and rear, and the limiting piece 2024 is matched with the plane of the end and the tail of the bracket 204.
  • the limit piece 2024 also has a function. When implanting, the thimble holder and puncture needle holder move forward. The limit piece is used to limit the advance distance of the puncture needle holder and thimble holder to ensure that the implant length will not exceed the set length value.
  • a positioning slot 2025 is provided at the front end of the lower cover 202 of the implanter, and the slot is used for positioning the guide limit block 214.
  • the guide stop block 214 is restricted by the positioning slot 2025 inside the lower cover 202 of the implanter, and the upper and lower positions are respectively guided by the needle seat 207 and the lower cover 202 of the implanter.
  • the guide limit block is provided with a longer guide cylinder 2141.
  • the cylinder can prevent the return pin spring 208 from twisting during installation and operation, which causes the guide needle seat 204 to not move normally.
  • the cylinder can provide guidance for the guide pin holder.
  • the deep groove 2026 is used to limit the button frame 215 and prevent the button frame 215 from shifting under force.
  • the button 203 has two trigger ribs 2032.
  • the trigger ribs can move the elastic card 2051 of the thimble holder to trigger the operation of the implanter.
  • the button 203 has a cylindrical hole 2033, and the cylindrical height is set shorter than the trigger rib 2032, so as to ensure that the trigger rib can work normally.
  • the cylindrical hole is used to store the button spring 210 and is matched with the button holder cylinder 2151 of the button holder 215. When the driving force of the pressing button spring is removed, the button returns to the initial position under the action of the spring.
  • the upper surface of the button 203 has a pattern 2033, which is used to increase the friction, so that the finger can turn the button more easily.
  • the button 203 has a triangular arrow 2034 on the upper surface. This arrow corresponds to the "lock” and “unlock” signs 2016 on the upper cover, and is used to indicate the state of the button. In the initial state, the triangular arrow 2034 is facing the “lock” sign. When the button is turned a certain angle, the triangular arrow 2034 is facing the "unlock” label. At this time, the button can be pressed down to trigger the operation of the implanter.
  • the upper part of the holder 204 has a long cylinder 2042, which cooperates with the sleeve 2052 on the upper part of the thimble seat 205 to provide guidance for the movement of the thimble seat and prevent the thimble seat and the puncture needle seat from shaking, thereby making the puncture needle It can pierce the human body more "straightly" and reduce the pain caused by shaking.
  • the long cylinder 2042 is used to position the drive spring 209 to prevent the drive spring from twisting during installation and operation, which may cause the thimble seat 205 to fail to move normally.
  • the upper rear section of the bracket 204 has two bracket buckles 2043, and the bracket buckles 2043 cooperate with the elastic card 2051 of the thimble seat 205.
  • the bracket buckle 2043 cooperates with the elastic card 2051 of the thimble seat 205.
  • the middle front section of the bracket 204 has two bent bracket elastic ribs 2044, which cooperate with the limiting boss 2071 of the guide needle base 207 to restrict the guide needle base from moving backward.
  • the middle front section of the bracket 204 has two bracket bosses 2045, and the bracket bosses 2045 cooperate with the hooks 2142 of the guide limit block 214, so that the guide limit block 214 and the bracket 204 are integrated. Therefore, under the constraints of the bracket 204, the guide stop block 214, and the guide needle seat 207, the return needle spring 208 is in a preloaded state. When the bent bracket elastic ribs 2044 of the bracket are triggered, the guide needle seat will retreat under the thrust of the return needle spring 208.
  • the top of the buckle has an inclined surface.
  • the elastic buckle inclined surface expands outward under the action of the thimble seat to allow the thimble seat to pass through.
  • the elastic buckle rebounds and clamps the thimble seat through a straight face, so that the thimble seat cannot be moved back.
  • This structure helps to maintain the position of the thimble seat during the stitch back process, and prevents the sensor electrode from being displaced after being implanted in place.
  • Both sides of the front section of the thimble seat 205 have a beveled end 2054.
  • the bevel will open the two bent bracket elastic ribs 2044 of the bracket 204 outwards, thereby releasing the clamping of the bracket.
  • the guide needle seat 207 that is held down is retracted backward under the action of the return needle spring 208.
  • thimble boss 2055 at the tail of the thimble seat 205.
  • the thimble boss 2055 cooperates with the puncture needle seat 206. When the puncture needle seat is retracted to contact with the thimble boss 2055, it will withdraw with the thimble seat.
  • thimble bonding hole 2056 at the right end of the thimble boss 2055.
  • the thimble bonding hole 2056 is used to bond the thimble 211, and the bonding method is not limited.
  • thimble overflow groove 2057 at the left end of the thimble boss 2055, which can prevent the glue from overflowing, thereby affecting the fit and movement.
  • the elastic bolt 2061 has a sloped bracket 2062, which cooperates with the release boss 2072 on the upper part of the guide needle seat 207.
  • the release boss 2072 of the guide needle seat 207 will The bent elastic ribs are tightened inward, thereby separating the puncture needle seat from the thimble seat.
  • puncture needle bonding hole 2064 on the left side of the puncture needle seat 206, and the puncture needle bonding hole 2064 is used to bond the puncture needle 212, and the bonding method is not limited.
  • puncture needle overflow groove 2065 on the right to prevent the glue from overflowing, which will affect the fit and movement.
  • the upper part of the guide needle seat 207 is provided with a release boss 2072.
  • the release boss 2072 of the guide needle seat 207 will turn the two bent elastic ribs 2061 of the puncture needle seat 206 toward Tighten inside, so that the puncture needle seat and the thimble seat 205 are separated.
  • An unlocking boss 2074 is provided on both sides of the guide needle seat 207 at the upper right of the limiting boss 2071.
  • the unlocking boss 2074 contacts the limit elastic buckle 2046 of the bracket, and the bracket Under the action of the unlocking boss 2074, the elastic buckle expands outward to release the thimble seat 205, and then the thimble seat is driven by the guide needle seat and the puncture needle seat to withdraw together.
  • the guide pin bonding hole 2076 is used to bond the guide pin 213, and the bonding method is not limited.
  • the initial state before use is that the hook 2142 of the guide stop block 214 and the bracket boss 2045 of the bracket 204 are buckled with each other, and the bracket 204 is limited and fixed inside the implanter upper cover 201 and implanter lower cover 202, and the bracket 204
  • the bracket elastic rib 2044 clamps the limit boss 2071 of the guide needle seat 207
  • the bracket buckle 2043 clamps the elastic card 2051 of the thimble seat 205
  • the elastic pin 2061 of the puncture needle seat 206 is inserted into the rectangular hole on the side of the thimble seat 205. 2053, so the puncture needle seat 206 is relatively integrated with the thimble seat 205.
  • the drive spring 209 in the sleeve 2052 is in a compressed state
  • the return needle spring 208 in the thimble seat 205 is in a compressed state
  • the front end of the puncture needle 212 is located at the guide needle In 213
  • the thimble 211 is located at the rear end of the puncture needle 212
  • the sensor 301 is located in the puncture needle 212
  • the diameter of the thimble 211 is slightly smaller than the inner diameter of the puncture needle 212
  • the diameter of the thimble 211 is the same as the sensor 301
  • the sensor 301 is a flexible electrode needle body
  • the end of the thimble seat 205 is caught by the straight surface of the limiting elastic buckle 2046, and the inclined end 2054 of the thimble seat 205 hits the elastic buckle 2044 of the bracket ,
  • the elastic ribs 2044 of the bracket are separated from the limiting boss 2071 of the guide needle seat 207, the return spring 208 releases the compression force, and drives the guide needle seat 207 to move in the reverse direction, and the release boss 2072 on the guide needle seat 207 squeezes the puncture needle
  • the inclined support 2062 of the seat 206 disengages the elastic plug 2061 from the rectangular hole 2053.
  • the guide needle seat 207 drives the puncture needle seat 206 to move in the opposite direction.
  • the puncture needle 212 separates from the receptor, and the guide needle 213 separates from the silicone seat 310.
  • the thimble 211 always acts on the sensor 301 in the puncture needle 212, so that the puncture needle 212 is separated from the receptor while the sensor 301 remains in the receptor;
  • the thimble 211 should partially extend into the silicone seat 310.
  • the unlocking boss 2074 supports the limit elastic buckle 2046, and the guide pin seat 207 also hits the bottom of the thimble seat 205 at this time, which can drive the thimble seat 205 to reverse. Move it a short distance to ensure that the thimble 211 extending into the silicone base 310 is pulled out. At this time, the implanter 200 can be removed and the transmitter 400 can be installed.
  • the hardware of the transmitter 400 includes a circuit board assembly 401 and a plastic housing 402.
  • the size of the transmitter is about 32mm*16mm*5mm. After being installed in the sensor base device 300, it is convenient to stick on the skin of the recipient and carry it with you.
  • the circuit board assembly 401 includes four conductive pins, and the conductive pins are generally conductive metal, preferably brass.
  • the conductive needle is drawn from the plastic shell 402 and is flush with the bottom surface of the plastic shell.
  • the conductive pins are respectively connected to the sensors S+, S- and the battery V+V-.
  • the battery 304 in the sensor base 300 will supply power to the transmitter 400, and the transmitter 400 can convert the signal value measured from the sensor 301 into corresponding physiological parameters and send it to the user receiving terminal 500.
  • the plastic shell 402 completely wraps the circuit board components (except for the 4 conductive pins), which can realize the waterproof effect.
  • the sensor base device 300 mainly includes a battery 304 and a sensor 301.
  • the battery 304 and the transmitter 400 are connected through electrical contacts V+ and V-.
  • the sensor 301 and the transmitter 400 are connected by electrical contacts S+S-.
  • the sensor base device 300 further includes a sensor 301, a base 302, a tape 303, a battery 304, a battery adapter 305, an electrode connector 306, a battery cover 307, a waterproof sealing ring 308 of the battery connector, a rotating seat 309, a silicone seat 310 and Conductive rubber and so on 311.
  • the battery adapter 305 may be a metal component such as a nickel tape.
  • the battery adapter 305 is connected to the battery 304 and the battery connector 306 by welding or the like.
  • insulating paper is provided on the outside of the battery to prevent the positive and negative poles of the battery from conducting.
  • the battery connector 306 is placed on the battery adapter 305 and can be compressed by the installation of the battery cover 307.
  • the battery connector 306 is flexible and can be electrically connected to the transmitter.
  • the battery connector 306 may be a spring pin with a spring inside.
  • the base 302 has a waterproof sealing ring 308 on the surface.
  • the waterproof sealing ring can be made of elastic materials such as silica gel, TPE or TPU.
  • the waterproof sealing ring can be directly injection molded on the base, or it can be glued on the base later.
  • the waterproof sealing ring is trapezoidal or triangular, which can better place the transmitter and better waterproof. When combined with the bottom plane of the transmitter, it can play a waterproof role, and the waterproof level can reach IPX7.
  • the transmitter 400 In the unused state, the transmitter 400 has not been installed on the sensor base device 300. Therefore, the transmitter 400 is in a power-off state and the battery 304 is not consumed.
  • the transmitter 400 When in use, the transmitter 400 is buckled into the sensor base device 300, and the battery on the sensor base device 300 supplies power to the transmitter 400 through an electrical connection. After use, the transmitter is removed and the battery 304 is discarded together with the sensor.
  • the sensor 301 is implanted in the subcutaneous tissue of the living body and is configured to sense the original signal of the analyte.
  • the sensor 301 includes at least one working electrode and one reference electrode.
  • the working electrode and the reference electrode S+S- are electrically connected through the conductive rubber 311 and the battery guide pin 4011 and the rubber guide pin 4012 of the transmitter 400, respectively.
  • the base 302 is fixed on the recipient's skin by a non-woven tape 303 on the one hand, and is configured to be fixedly connected to the transmitter 400 on the other hand.
  • the base 302 has a ⁇ 12mm battery slot 3021 in the middle, which is configured to place the battery 304.
  • the positive and negative electrodes of the battery are connected to the battery connector 306 through the battery adapter 305, and then lead to the outer surface of the base by the battery connector.
  • the base 302 has a base snap opening 3023 at the end.
  • the top of the opening is flat, and the bottom is provided with a certain angled slope.
  • the top surface is configured to cooperate with the edge boss 4021 of the transmitter 400 to limit the transmitter.
  • the bottom slope is easy to install the transmitter.
  • the base 302 has a groove 3024 on the right, and the groove is configured to place the rotating seat 309. After the sensor 301 is implanted, the rotating seat rotates clockwise to a certain angle, and finally fits with the bottom surface of the groove. There is an opening 3025 on the lower left side of the groove 3024 through which the sensor 301 can pass.
  • a semicircular hole 3026 is provided on both sides of the groove 3024, and the semicircular hole is matched with the cylindrical shaft 3092 of the rotating seat 309, so that the rotating seat can rotate along the axis of the hole.
  • An inclined surface is arranged above the semicircular hole 3026, and the inclined surface is convenient for the cylindrical shaft of the rotating seat to be clamped into the semicircular hole.
  • the two sides of the base 302 are provided with elastic buckles 3027.
  • the elastic buckles are configured to cooperate with the housing slots 4022 on both sides of the transmitter.
  • the elastic buckles on both sides of the base are opened outward, and the transmitter is installed. After being in place, the elastic buckle retracts. The bottom surface of the elastic buckle is stuck with the transmitter card slot, restricting the transmitter from moving.
  • the battery cover 307 is configured to cooperate with the base 302 to fix the battery connector 306 and the battery 304.
  • a battery cover groove 3071 is provided in the middle of the battery cover 307 and is configured to accommodate the battery 304.
  • the two round holes 3073 on the top of the battery cover 307 can allow the elastic parts of the battery connector to pass through, so as to contact the transmitter contacts.
  • the rotating seat 309 provides support for the silicone seat 310 on it when it is not installed; on the other hand, when the installation is completed, it can rotate around the base to the installed state.
  • extension rods 3091 There are two extension rods 3091 on both sides of the rotating seat 309.
  • the extension rods have certain elasticity. When the extension rods are stressed, they can contract inward; after the force is cancelled, the extension rods can return to the original position.
  • the cylindrical shaft 3092 has an inclined surface on its side surface.
  • the inclined surface of the cylindrical shaft contacts and guides the inclined surface of the base.
  • the extension rod 3091 shrinks inwardly, the cylindrical shaft is clamped into the semicircular hole of the base, and the extension rod can be restored to the original position.
  • the degree of freedom of the rotating seat and the base part is limited, and the rotating seat can only rotate around the cylinder axis.
  • the silicone seat 310 on the one hand, is used to store the conductive rubber 311, provide deformation space for the conductive rubber and limit the conductive rubber; on the other hand, after the silicone seat is combined with the transmitter plane, it can play a waterproof role, and the waterproof level can reach IPX7 .
  • the silicone base 310 has a first conductive rubber hole 3101 and a second conductive rubber hole 3102 in the middle.
  • the round hole is used to place the conductive rubber 311.
  • conductive rubbers 311 There are two conductive rubbers 311. After implantation, the sensor 301 passes through the conductive rubber. Each conductive rubber is connected to the electrical contacts S+ and S- of the sensor 301 and the transmitter 400, so as to realize the sensor and Flexible electrical connection between transmitters. In addition to the role of electrical connection, conductive rubber maintains the position of the sensor through friction under pressure.
  • the silica gel seat 310 also has two square holes 3103. The purpose of the square hole is to reduce the resistance when the guide needle and the puncture needle are withdrawn from the silicone seat.
  • the silicone base 310 has a trapezoidal or triangular rib 3104 on the top, which can make the installation of the transmitter lighter and better waterproof.
  • the electrical system includes an LC filter energy storage module, a wireless SOC module, a functional circuit power supply module, a sensor excitation and conditioning module, an ADC accuracy enhancement module, a battery and a sensor, and the positive and negative electrodes of the battery are respectively connected by lines LC filter energy storage module, there is a connection line between the LC filter energy storage module and the VDD end of the wireless SOC module, and the connection line has a dual control switch, which can be connected to the Da end of the wireless SOC module or the functional circuit power module,
  • the functional circuit power supply module is connected to the sensor excitation and conditioning module.
  • the Db end of the wireless SOC module is also connected to the sensor excitation and conditioning module.
  • the wireless SOC module has a built-in ADC module.
  • ADC Accuracy enhancement module The Dc end of the wireless SOC module and the built-in ADC module are both connected to the ADC Accuracy enhancement module, ADC accuracy enhancement module line is connected to sensor excitation and conditioning module, the positive and negative poles of sensor excitation and conditioning module are respectively connected to sensor;
  • VDD is the supply voltage of the SOC
  • Da, Db, and Dc are the digital output pins of the SoC module.
  • the Da pin is configured to control the opening and closing of the switch S1 to control whether the battery supplies power to the functional circuit power module.
  • Db is configured to select the level of the sensor excitation circuit, so that the sensor excitation module can provide the sensor with high-level and low-level excitation voltage signals.
  • Dc is configured to inject a noise signal into the ADC accuracy enhancement module.
  • Ain1 and Ain2 are ADC inputs, configured to sample the conditioned and noise-injected sensor voltage output by the ADC accuracy enhancement module.
  • the battery on the base supplies power to the transmitter through the battery guide pin 4011 connected to V+V-.
  • the rubber guide pin 4012, the conductive rubber 311 and the sensor 301 connected to the transmitter S+S- form an electrical circuit.
  • the transmitter can measure the current value through the above-mentioned electrical circuit. And through the internal algorithm of the transmitter, the measured current value is converted into the recipient's blood sugar value. Then through the wireless transmission module, the blood glucose value is transmitted to the corresponding display device.

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Abstract

本申请公开了一种受体生理参数测量系统,分为植入器、传感器底座装置和发射器,传感器底座装置固定于受体皮肤,植入器安装在传感器底座装置上配置成将传感器部分植入受体皮下组织,植入器拆卸后可在传感器底座装置上安装发射器,从而在某一时间段内进行动态生理参数监测。与现有技术相比,本申请的一种受体生理参数测量系统,第一、可以最大程度减轻患者穿刺痛苦,并且在某一时间段内对生理参数进行监测,对患者生理参数水平变化掌握更加准确。第二、对该系统的零部件合理组合后,大部分零件可以重复多次利用,减少物料浪费,大幅降低用户的使用成本,降低给环境带来潜在的危害。

Description

一种受体生理参数测量系统
相关申请的交叉引用
本申请要求于2019年04月30日提交中国专利局的申请号为CN201910359499.8、名称为“一种受体生理参数测量系统”的中国专利申请的优先权,其全部内容通过引用结合在本申请中。
技术领域
本申请涉及一种将生物传感器快速植入受体组织内,可重复使用,测量受体生理参数的系统,属于可穿戴医疗器械技术领域。
背景技术
一些生理性的疾病,病程长且病情迁延不愈,需要实时地对受体某些生理参数进行监测,以能更好地跟踪治疗。比如糖尿病,需要对受体血糖进行实时地监测。准确的血糖自我监测,是实现良好血糖控制的关键,有助于评估糖尿病患者糖代谢紊乱的程度,制定降糖方案,同时反映降糖治疗效果并指导对治疗方案的调整。目前市面上使用最多的是指血血糖仪,患者需要自行采集手指末梢血来测量该时刻的血糖水平。但这种方法缺陷其一在于无法获知两次测量之间的血糖水平变化,患者可能会遗漏血糖峰值和谷值,从而引起一些并发症,对患者造成不可逆的伤害;其二,每日多次的指尖穿刺采血,给糖尿病患者造成了很大的痛楚。为解决这些困扰问题,需要一个能够进行连续监测患者血糖的方法,使患者实时了解自己的血糖状况,能够及时采取措施,从而有效地控制病情,防止并发症,得到较高的生活质量。
为了解决上述问题,技术人员开发了可以植入皮下组织进行连续监测皮下葡萄糖的连续血糖监测技术,该技术通过一个刺入皮下组织的传感器电极,电极在患者的组织间液与体内葡萄糖发生氧化反应,反应时会形成电信号,通过发射器将电信号转换为血糖读数,并每隔1-5分钟将血糖读数传输到无线接收器上,在接收器上显示相应的血糖数据以及形成图谱,供患者及医生参考。
目前,皮下植入式的连续血糖监测传感器,通常采用非常细的金属丝或者聚合物薄片为载体。金属丝可以是涂敷铂的不锈钢丝,比如已有文献公开了采用直径为0.16mm~0.25mm的不锈钢丝上面电镀铂作为传感器电极的载体。由于不锈钢丝有足够的硬度,传感器电极能不借助辅助工具直接穿刺皮肤进入组织中。但该植入方法由于传感器电极硬度较大,所以造成创口较大,痛疼感较强,植入皮下后的异样感较强,依旧给糖尿病患者造成了很大的困扰。
为降低传感器电极带来的疼痛感,技术人员将金属丝载体改为比较柔软的铂金丝或者涂敷铂的镍丝等,或者采用的是聚合物薄片为载体。但由于载体的刚性不足,不能直接穿刺皮肤,因此需要借助辅助植入工具将细小而柔软的传感器电极植入皮下组织,以降低植入皮下后的存在感或异样感。
目前,许多辅助植入工具是手动或者半自动方式。由于人工手动植入存在每次植入速度和力度的不一致,并且速度较慢,植入过程花费时间长。一方面导致传感器植入后偏差值较大,另一方面增加了患者的痛楚。
另一方面,传统的动态血糖发射器主要由三部分组成:纽扣电池、线路板和塑封外壳。因防水需求和体积限制,一般将纽扣电池和线路板一起放置在发射器中,通常将两者一体 塑封成型,因此发射器电池不可更换。当电池寿命使用完毕,发射器基本不可再使用。而从成本角度,发射器塑封外壳和线路板成本远大于电池成本,且发射器塑封外壳和线路板寿命也远大于电池寿命。从环保角度,线路板的制造和废弃处理过程,可能会给环境带来潜在的危害。因此这种方式会极大浪费线路板和塑封外壳,增大物料成本和资源浪费。
为了解决上述问题,一方面,需采用一种合适的方式,将细小且柔软的生物传感器电极借助辅助植入工具,以极快的速度穿入皮下,让痛疼感降到极低,并将传感器电极留在皮下,植入动作都在设定的针管里进行,减少了人工操作带来的偏差风险。另一方面,需采用一种合适的方式,将电池从发射器中分离出来,使线路板和塑封壳体使用寿命不受电池寿命限制,对降低成本和浪费就显得非常有意义。
发明内容
本申请需要解决的技术问题是针对上述现有技术的不足,而提供一种受体生理参数测量系统。
为解决上述技术问题,本申请采用的技术方案是:
一种受体生理参数测量系统,包括植入器、传感器底座装置以及发射器,所述植入器和发射器均可安装于传感器底座装置;
所述植入器包括:植入器上盖、植入器下盖、按钮、支架、顶针座、穿刺针座、导向针座、回针弹簧、驱动弹簧、顶针、穿刺针、导向针和导向限位块,其中,植入器上盖和植入器下盖组成外部壳体,按钮位于植入器上盖,支架、顶针座、穿刺针座和导向针座均配合安装于外部壳体内,外部壳体的前端连接于传感器底座装置;
所述支架固定于外部壳体内,支架为一端开口的筒状结构,其开口朝向传感器底座装置,支架上部为长圆柱,支架的前端朝向传感器底座装置,支架的前端具有向内扣入支架弹性卡筋,支架弹性卡筋配置成限位导向针座,后端上部具有配置成卡住顶针座的支架卡扣,支架的外侧具有与可扣接导向限位块的支架凸台以及限制顶针座活动的限位弹性卡扣;
所述顶针座为两端开口的筒状结构,顶针座在支架内活动,顶针座上部为套筒,所述长圆柱贯穿套筒,套筒朝向传感器底座装置的前端边缘具有环边,套筒内置有推动顶针座的驱动弹簧,套筒上还设置有与支架卡扣扣接的弹性卡片,所述按钮可拨动弹性卡片,所述顶针座的两侧设有长方形孔,顶针座的前端为斜面端,顶针座后端靠上部位设有顶针凸台,所述顶针位于顶针凸台内,所述顶针座筒状结构内顶部位置沿其长度方向设有筋;
所述穿刺针座两侧具有斜面支架,斜面支架的端部具有可卡进长方形孔的弹性插销,穿刺针座的上部具有滑槽,滑槽扣入顶针座的筋,穿刺针座沿筋在顶针座内滑动,所述穿刺针位于穿刺针座内;
所述导向针座为两端开口的筒状结构,所述导向限位块侧部具有与支架凸台扣接的卡勾,导向限位块中间具有导向圆柱,导向圆柱贯穿于导向针座,导向针座朝向传感器底座装置的一端具有与支架弹性卡筋扣接的限位凸台,导向针座背离传感器底座装置一端的边缘具有环边,导向针座内置有推动其背离传感器底座装置活动的回针弹簧,导向针座预置于顶针座内,可穿过顶针座活动,导向针座的上部具有释放凸台,导向针座的活动可通过释放凸台挤压斜面支架,使弹性插销脱离长方形孔,导向针座的侧部还设有可撑开限位弹性卡扣的解锁凸台,导向针座上部设有导向针凸台,导向针凸台可与传感器底座装置连接,所述导向针位于导向针凸台内;
所述传感器底座装置包括底座和胶布,底座位于胶布上;所述底座上部为开口,底座 内具有电池槽和凹槽,所述电池槽内安装有电池以及电池盖,所述凹槽内安装有旋转座,旋转座靠电池槽的一侧铰接于凹槽内,旋转座内具有硅胶座,所述硅胶座内设置有一对导电橡胶,贯穿硅胶座和旋转座设置有传感器,传感器可穿过两个导电橡胶,所述凹槽靠电池槽的一侧具有开口,所述胶布开设有孔,传感器可穿过开口和胶布的孔;
所述发射器包括塑封外壳和线路板组件,所述塑封外壳盖合于底座上,所述线路板组件安装在塑封外壳内部,线路板组件上具有四个导电针,可接触电池的正负极以及两个导电橡胶。
作为进一步的优选方案,所述植入器上盖上开设有按钮孔,按钮位于按钮孔内;所述按钮孔向内具有环形结构,该环形结构上开设有两个L形的缺口,两个L形的缺口较短的槽朝向植入器上盖内,较长的槽方向相反设置;所述按钮底面具有一对按钮凸台,按钮凸台可通过按钮的转动旋出缺口,按钮底面还设置有可拨动弹性卡片的触发筋,一个触发筋对应一个弹性卡片,按钮凸台处于旋出缺口状态时,触发筋处于弹性卡片位置。
作为进一步的优选方案,所述植入器下盖后端开设有深槽,深槽内设有按钮架,按钮架上设有按钮架圆柱,所述按钮底部设有圆柱孔,按钮架圆柱置于圆柱孔内,圆柱孔内绕按钮架圆柱设有按钮弹簧。
作为进一步的优选方案,所述硅胶座上设置有第一导电橡胶孔和第二导电橡胶孔,两个导电橡胶分别安装在第一导电橡胶孔和第二导电橡胶孔内;所述硅胶座内还设置有两个方形孔,两个导电橡胶和两个方形孔呈直线分布,所述传感器穿过两个导电橡胶。
作为进一步的优选方案,所述凹槽内的两侧各开设有一个半圆孔,所述旋转座的端部两侧各设有一个韧性的伸出杆,伸出杆的外侧具有一个圆柱轴,圆柱轴置于半圆孔内转动。
作为进一步的优选方案,所述电池的正负极上分别安装有一个电极转接件,每个电极转接件上配置一个电极连接件,所述电池盖上开设有两个圆孔,一个圆孔对应一个电极连接件,电极连接件穿过圆孔部分置于电池盖外。
作为进一步的优选方案,所述线路板组件上的四个导电针为两个电池导针以及两个橡胶导针,两个电池导针分别连接一个电极连接件,两个橡胶导针分别连接一个导电橡胶。
作为进一步的优选方案,所述底座的端部具有底座卡扣开口,所述塑封外壳的端部具有插置于底座卡扣开口的边缘凸台;塑封外壳的侧部具有外壳卡槽,所述凹槽的内侧壁上具有卡入外壳卡槽的弹性卡扣。
作为进一步的优选方案,所述电池槽的边缘一圈具有密封条,所述硅胶座的边缘一圈具有筋位。
与现有技术相比,本申请的一种受体生理参数测量系统,第一、解决了糖尿病患者需要每日多次的指尖穿刺采血的问题,通过一个刺入皮下组织的传感器电极,在某一时间段内对血糖进行监测,可以较大程度减轻患者穿刺痛苦,并且对患者血糖水平变化掌握更加准确。第二、借助辅助植入工具将细小而柔软的传感器电极植入皮下组织,解决了传感器电极植入受体后带来的疼痛感和异物感问题。第三、线性布置的自动植入器,能以较快的速度完成植入传感器电极和退针动作,大幅度地减轻患者穿刺痛苦。第四、合理的零部件组合,使得大部分零件可以重复多次利用,减少物料浪费,大幅降低用户的使用成本,降低给环境带来潜在的危害。
附图说明
图1为本申请工作原理示意图;
图2为本申请结构示意图;
图3为植入器初始状态剖面图;
图4为传感器底座装置工作状态示意图;
图5为植入器爆炸图;
图6为植入器上盖结构示意图;
图7为植入器下盖结构示意图;
图8为按钮结构示意图;
图9为支架剖面图;
图10为支架内部结构示意图;
图11为顶针座结构示意图;
图12为穿刺针座以及导向针座内部结构示意图;
图13为穿刺针座以及导向针座截面结构示意图;
图14为发射器爆炸图;
图15为传感器底座装置爆炸图;
图16为硅胶座的剖视图;
图17为底座的结构示意图;
图18为电池盖结构示意图;
图19为旋转座和硅胶座结构示意图;
图20为本申请的电气系统模块示意图。
具体实施方式
下面结合具体实例对本申请的发明方法进行详细描述和说明。其内容是对本申请的解释而非限定本申请的保护范围。
图1为本申请工作原理示意图。通过一次性使用的植入器200,将传感器301部分植入到受体组织100内,传感器301受体外部分与发射器400通过接触实现电气连接。发射器检测到传感器301的生物信号后,将该信号转换成生理参数,并通过无线传输的方式发送至用户的接收器500。
生理参数测量系统从结构上分别为3个部分:植入器200、传感器底座装置300以及发射器400,如图2所示。
如图3所示,初始状态下,传感器底座装置300与植入器200通过导向针213与硅胶座310之间的摩擦阻力连接在一起,保持其初始位置;生物传感器电极安装在植入器内部,通过摩擦阻力保持其初始位置。此时发射器400处于未使用状态。
如图4所示,植入后,传感器301部分进入到受体组织内,部分被保留在传感器底座 装置300。装上发射器400后,发射器将“读取”生物传感器上的信号,并将该信号转换成生理参数,发送至接收器500,接收器500可以是手机、操作器甚至云端。
下面针对植入装置200进行详细介绍;
植入装置200配置成将传感器301植入受体组织内,如图5所示,结构上主要包括植入器上盖201、植入器下盖202、按钮203、支架204、顶针座205、穿刺针座206、导向针座207、回针弹簧208、驱动弹簧209、顶针211、穿刺针212、导向针213和导向限位块214,其中,植入器上盖201和植入器下盖202组成外部壳体,支架204和导向限位块214固定于外部壳体内,顶针座205、穿刺针座206和导向针座207均位于支架204和导向限位块214内,顶针座205主要带动顶针211向前活动触发导向针座207,导向针座207反向活动,形成传感器301的植入过程。
如图6所示,植入器上盖201内部设有T字型结构2011(限位结构),该结构用来限位导向针座207,防止导向针座晃动,从而使得穿刺针能有较为“笔直”地穿刺进人体组织内,减少由于晃动而带来的疼痛感。
植入器上盖201内部设有限位结构2012,该结构与支架204上的挡片2041配合,一方面给支架的挡片提供足够的强度,另一方面防止支架在驱动弹簧209的作用下位移。
植入器上盖201前端有一个按钮孔2013,该圆孔配置成放置按钮203。按钮可在此圆孔中转动以及上下移动。
按钮孔2013两侧有个L形的缺口2014,缺口2014可与按钮203上的按钮凸台2031配合。一方面,此缺口可通过按钮凸台2031限制按钮往植入器上盖201的外侧移动。另一方面,此L形结构可提供一个“锁”“解锁”功能。初始状态下,按钮203上的按钮凸台2031位于L形最里侧。按钮被限定了只能朝一个方向转动,不能被按下。此时处于“锁”状态。起到了防止按钮203误触发的功能。当按钮被用户旋转一定角度后,按钮凸台2031位于L形的开口端。此时处于“解锁”状态,按钮可以被按下。
L形缺口2014具有一个锁扣凸台2015,当按钮203上的按钮凸台2031位于“锁”位置时,锁扣凸台2015与按钮凸台2031之间存在一定过盈,因此按钮203不会轻易旋转到“解锁”位置。可以防止在运输以及取放等情况下,导致按钮203误触发。
植入器下盖202,如图7所示,底部设有底座凹槽2021,该底座凹槽2021用来装配传感器底座302,传感器301植入前,传感器底座装置300与植入器200通过导向针213与硅胶座310之间的摩擦阻力连接在一起,保持其初始位置。
底座凹槽2021内设有一片三角筋2022,该三角筋用来限位底座,防止底座移动。
底座凹槽2021内设有一个长方形开口2023,开口大小适中;在初始状态下,该开口允许底座内的旋转座309通过,但限制底座向上运动。
植入器下盖202内部前后均设有限位片2024,限位片2024与支架204端部以及尾部的平面配合。支架装入该下盖后,支架前后被限位片限位,支架上部被植入器上盖201限位,因此,支架将被固定在植入器上下盖中,无法移动。
限位片2024还有一个作用,当植入时,顶针座以及穿刺针座向前运动,该限位片用来限制穿刺针座以及顶针座的前进距离,确保植入长度不会超出设定值。
植入器下盖202内部前端设有定位卡槽2025,该卡槽用来定位导向限位块214。
如图7所示,导向限位块214前后被植入器下盖202内部的定位卡槽2025限位,上下 分别被导向针座207以及植入器下盖202下位。导向限位块设有较长的导向圆柱2141,一方面,该圆柱可以防止回针弹簧208安装以及运行过程中扭动,导致导向针座204不能正常运动。另一方面,当导向针座204后退时,该圆柱可以给导向针针座提供导向。
植入器下盖202尾部有一个深槽2026,该深槽2026用来限位按钮架215,防止按钮架215在受力时发生位移。
如图8所示,按钮203具有两根触发筋2032,当按钮下压时,该触发筋能够拨动顶针座的弹性卡片2051,从而可触发植入器运作。
按钮203具有圆柱孔2033,圆柱高度设置比触发筋2032矮,从而保证触发筋能正常工作。该圆柱孔用来存放按钮弹簧210,并与按钮架215的按钮架圆柱2151配合。当下压按钮弹簧的驱动力撤走时,按钮在弹簧作用下回到初始位置。
按钮203上表面具有纹路2033,该纹路用来提高摩擦力,从而使手指能更轻松的转动该按钮。
按钮203上表面具有一个三角箭头2034。该箭头与上盖的“锁”“解锁”的标志2016相对应,用来指示按钮所处状态。初始状态下,三角箭头2034正对着“锁”标志。当按钮转过一定角度后,三角箭头2034正对着“解锁”标注。此时按钮可以下压,触发植入器运作。
如图9所示,支架204上部具有一个长圆柱2042,该长圆柱与顶针座205上部的套筒2052配合,给顶针座的运动提供导向,防止顶针座及穿刺针座晃动,从而使得穿刺针能有较为“笔直”地穿刺进人体组织内,减少由于晃动而带来的疼痛感。
另外,该长圆柱2042用来定位驱动弹簧209,防止驱动弹簧安装以及运行过程中扭动,导致顶针座205不能正常运动。
如图10所示,支架204上部后段具有两根支架卡扣2043,该支架卡扣2043与顶针座205弹性卡片2051相配合。安装时,拉动顶针座向后,当拉到预设位置时,顶针座弹性卡片2051会被支架卡扣2043卡住。虽然顶针座在驱动弹簧作用下,有向前运动的趋势,但由于顶针座弹性卡片被支架卡扣卡住,顶针座保持静止状态。
支架204中部前段具有两个折弯的支架弹性卡筋2044,该卡筋与导向针座207的限位凸台2071配合,限制导向针座向后运动。
支架204中部前段具有两个支架凸台2045,支架凸台2045与导向限位块214的卡勾2142配合,从而导向限位块214与支架204合为一体。因此,回针弹簧等208在支架204、导向限位块214以及导向针座207三者的约束下,处于预加载状态。当支架的折弯的支架弹性卡筋2044被触发时,导向针座将在回针弹簧208的推力下向后退。
支架204中部侧面有2个限位弹性卡扣2046,该卡扣顶部具有斜面,顶针座205向前运动时,弹性卡扣斜面在顶针座作用下,向外张开,使得顶针座通过。当顶针座到达预定位置时,弹性卡扣回弹,并通过直面卡住顶针座,使得顶针座无法后退。该结构有利于在回针过程中保持顶针座位置,防止传感器电极在植入到位后发生位移。
如图11所示,顶针座205两侧具有一个长方形孔2053,该长方形小孔与穿刺针座206上的弹性插销2061配合。穿刺针座装入到位后,弹性卡扣卡入顶针座长方形孔内,从而使得穿刺针座与顶针座保持相对固定。顶针座在驱动弹簧209作用下,向前运动时,能够带着穿刺针座一起向前运动,刺穿受体组织。
顶针座205前段两侧各具有一个斜面端2054,当顶针座运动到预设位置时,该斜面会 将支架204的两个折弯的支架弹性卡筋2044向外张开,从而释放被支架卡住的导向针座207,导向针座在回针弹簧208作用下向后回撤。
顶针座205尾部有个顶针凸台2055,顶针凸台2055与穿刺针座206配合,当穿刺针座回退到与顶针凸台2055接触时,会带着顶针座一起后撤。
顶针凸台2055右端有一个顶针粘接孔2056,顶针粘接孔2056用来粘接顶针211,粘接方式不限。顶针凸台2055左端有个顶针溢胶槽2057,可来防止胶水溢胶,从而影响配合以及运动。
如图12所示,穿刺针座206两侧有2个弹性插销2061,穿刺针座装入到位后,通过弹性卡扣卡入顶针座205长方形孔内2053,从而使得穿刺针座与顶针座保持相对固定。
弹性插销2061带有斜面支架2062,与导向针座207上部释放凸台2072配合,当导向针座后撤到预设位置时,导向针座207的释放凸台2072会将穿刺针座的两个折弯的弹性卡筋向内收紧,从而使穿刺针座与顶针座分离。
穿刺针座206顶部有个滑槽2063,与顶针座的筋2058配合,使得穿刺针座保持预定的轨道上运动,减少由于晃动而带来的疼痛感。
穿刺针座206左侧有一个穿刺针粘接孔2064,穿刺针粘接孔2064用来粘接穿刺针212,粘接方式不限。右侧有一个穿刺针溢胶槽2065,可来防止胶水溢胶,从而影响配合以及运动。
如图13所示,导向针座207中间具有一个导向圆孔2073,导向圆孔2073尾部变小或封闭,用来安装回针弹簧208,防止回针弹簧安装以及运行过程中扭动,导致导向针座不能正常运动。
导向针座207上部设有释放凸台2072,当导向针座后撤到预设位置时,导向针座207的释放凸台2072会将穿刺针座206的两个折弯的弹性卡筋2061向内收紧,从而使穿刺针座与顶针座205分离。
导向针座207两侧在限位凸台2071的右上方设有解锁凸台2074,当导向针座运动到预设位置时,解锁凸台2074与支架的限位弹性卡扣2046相接触,支架的弹性卡扣在解锁凸台2074的作用下,向外张开,从而释放顶针座205,继而顶针座在导向针座以及穿刺针座带动下,一起后撤。
导向针座207前部有个导向针凸台2075,未植入前,该凸台前面与底座中的旋转座309配合,限制旋转座运动。植入后,导向针座后撤,旋转座限位解除。
导向针凸台2075左侧有一个导向针粘接孔2076,导向针粘接孔2076用来粘接导向针213,粘接方式不限。右侧有一个导向针溢胶槽2077,可来防止胶水溢胶,从而影响配合以及运动。
使用前的初始状态为导向限位块214的卡勾2142与支架204的支架凸台2045相互扣接,支架204限位固定于植入器上盖201和植入器下盖202内部,支架204的支架弹性卡筋2044卡住导向针座207的限位凸台2071,支架卡扣2043卡住顶针座205的弹性卡片2051,穿刺针座206的弹性插销2061卡入顶针座205侧面的长方形孔2053,因此穿刺针座206相对和顶针座205为一体,此时,套筒2052内的驱动弹簧209处于压缩状态,顶针座205内的回针弹簧208处于压缩状态,穿刺针212前端位于导向针213内,顶针211位于穿刺针212后端,传感器301位于穿刺针212内,顶针211直径略小于穿刺针212内径,顶针211直径与传感器301相同,传感器301为柔性的电极针体;
使用时,将传感器底座装置300置于人体皮肤,按下按钮203,通过按钮203的触发筋2032按压弹性卡片2051的斜面,将其拨动,弹性卡片2051脱离支架卡扣2043,驱动弹簧209释放压缩力,带动顶针座205和穿刺针座206向前运动,穿刺针座206上的穿刺针212经过导向针213插入受体皮肤,随着顶针座205的向前运动,顶针座205滑过限位弹性卡扣2046的斜面,直到完全通过限位弹性卡扣2046,顶针座205的端部被限位弹性卡扣2046的直面卡住,顶针座205的斜面端2054撞击到支架弹性卡筋2044,支架弹性卡筋2044脱离导向针座207的限位凸台2071,回针弹簧208释放压缩力,带动导向针座207反向移动,而导向针座207上的释放凸台2072挤压穿刺针座206的斜面支架2062,使弹性插销2061脱离长方形孔2053,导向针座207带动穿刺针座206一同反向移动,穿刺针212脱离受体,导向针213脱离硅胶座310,由于顶针座205此时未反向移动,因此,顶针211一直作用于穿刺针212内的传感器301,使得穿刺针212脱离受体而传感器301保留在受体内;
为了避免穿刺针座206拔出后,部分传感器301暴露于硅胶座310外,因此顶针211应当部分伸入硅胶座310内,当导向针213和穿刺针座206拔出,传感器301的端部则不会暴露在外;
当导向针座207移动至限位弹性卡扣2046时,解锁凸台2074撑开限位弹性卡扣2046,导向针座207此时也撞击到顶针座205底部,从而可以带动顶针座205也反向移动一小段距离,确保伸入硅胶座310内的顶针211拔出即可,此时就可以取下植入器200,安装发射器400。
如图14所示,发射器400,其硬件包括线路板组件401和塑封外壳402。发射器大小约32mm*16mm*5mm,装入传感器底座装置300后,方便贴于受体皮肤上,随身携带。
所述的线路板组件401,包含四个导电针,导电针一般采用导电金属,优选为黄铜。导电针从塑封外壳402中引出,与塑封外壳底面齐平。当发射器400扣入到传感器底座装置300后,导电针分别与传感器S+、S-以及电池V+V-相连。传感器底座300中的电池304会给发射器400供电,发射器400可将从传感器301测得的信号值,转换成相应的生理参数,发送至用户接收端500。
塑封外壳402,将线路板组件(除4个导电针外),完全包裹,可实现防水作用。塑封外壳左侧具有边缘凸台4021,两侧各有一个外壳卡槽4022,当发射器装入传感器底座上后,边缘凸台4021和外壳卡槽4022可将发射器400固定在底座上
如图15,传感器底座装置300主要包括电池304和传感器301。其中电池304和发射器400通过电气触点V+和V-连接。传感器301和发射器400通过电气触点S+S-连接。
传感器底座装置300又包括传感器301、底座302、胶布303、电池304、电池转接件305、电极连接件306、电池盖307、电池连接件的防水密封圈308、旋转座309、硅胶座310和导电橡胶等311。
电池转接件305可以是镍带等金属部件。电池转接件305与电池304以及电池连接件306和通过焊接等方式连接。
电池304,电池外部设有绝缘纸,防止电池正负极导通。
电池连接件306置于电池转接件305上,通过电池盖307的安装可压紧。
电池连接件306具有弹性,可与发射器实行弹性电气连接。优选地,电池连接件306可以是弹簧pin针,内部设有弹簧,当发射器400装入时,下压电池连接件的触点,从而 保证电池连接件触点与发射器触点可靠接触。
底座302,表面有一圈防水密封圈308,防水密封圈可以是硅胶、TPE或TPU等弹性材料。防水密封圈可以直接注塑在底座上,也可以通过后期粘接在底座上。防水密封圈呈梯形或者三角形,能更好地安置发射器,且能更好地防水。当与发射器底部平面结合后,可起到防水作用,防水等级可达到IPX7。
未使用状态下,发射器400还未装入传感器底座装置300上,因此,发射器400处于断电状态,电池304也未耗电。当使用时,发射器400扣入传感器底座装置300上,传感器底座装置300上的电池通过电气连接给发射器400供电。当使用完后,取下发射器,电池304同传感器一起废弃。
如图16所示,传感器301植入生物体皮下组织,配置成感测被分析物的原始信号。传感器301至少包括1个工作电极和一个参比电极。工作电极和参比电极S+S-分别通过导电橡胶311以及发射器400的电池导针4011和橡胶导针4012实现电气连接。
底座302,一方面通过无纺布材质的胶布303固定在受体皮肤上,另一方面配置成固定连接发射器400。
如图17所示,底座302,中部有个φ12mm的电池槽3021,配置成放置电池304。电池正负极通过电池转接件305连接至电池连接件306,再由电池连接件引到底座外表面。
底座302,端部设有一个底座卡扣开口3023。开口顶部为平面,底部设有一定角度的斜面。顶面配置成和发射器400的边缘凸台4021配合,限位发射器。底部斜面便于发射器安装。
底座302,右部有个凹槽3024,该凹槽配置成放置旋转座309。当传感器301植入后,旋转座顺时针旋转一定角度,最终与凹槽底面贴合。所述凹槽3024左下侧有一个开口3025,传感器301可以从该开口通过。
凹槽3024两侧各设有一个半圆孔3026,半圆孔与旋转座309的圆柱轴3092配合,使得旋转座可以沿着该孔轴线旋转。
半圆孔3026上方设有斜面,该斜面为了便于旋转座圆柱轴卡入半圆孔中。
底座302两侧设有弹性卡扣3027,弹性卡扣配置成和发射器两侧的外壳卡槽4022配合,当发射器装入时,底座两侧的弹性卡扣向外张开,发射器装入到位后,弹性卡扣缩回。弹性卡扣底面与发射器卡槽卡死,限制发射器移动。
如图18所示,电池盖307,配置成同底座302配合,固定电池连接件306以及电池304。电池盖307中间设有电池盖凹槽3071,配置成容纳电池304。两端各有一个圆柱孔台阶面3072,通过与底座底面对应的2个圆柱台阶3022配合,使得电池连接件固定。电池盖307顶部的2个圆孔3073,可以使得电池连接件的弹性部件通过,从而可以和发射器触点接触。
如图19所示,所述的旋转座309,一方面,在未安装状态下,给其上的硅胶座310提供支撑;另一方面,当安装完成,其可以绕着底座旋转至安装状态。
旋转座309两侧有2个伸出杆3091,该伸出杆具有一定弹性,伸出杆受力时,可向内侧收缩;施加力取消后,伸出杆能恢复到原位置。
出杆端部各有1个圆柱轴3092,与底座半圆孔配合。
圆柱轴3092,侧面具有一个斜面,当旋转座装入底座时,圆柱轴斜面与底座斜面接触 及导向。在挤压力作用下,伸出杆3091向内侧收缩,圆柱轴卡入底座半圆孔内,并且伸出杆能恢复到原位置。此时限制了旋转座与底座部分自由度,旋转座仅可绕圆柱轴线转动。
硅胶座310,一方面,用来存放导电橡胶311,给导电橡胶提供变形空间并限位导电橡胶;另一方面,硅胶座与发射器平面结合后,可起到防水作用,防水等级可达到IPX7。
所述的硅胶座310,中间有第一导电橡胶孔3101和第二导电橡胶孔3102。该圆孔用来放置导电橡胶311。
所述的导电橡胶311,共有2个,植入完成后,传感器301穿过导电橡胶,每个导电橡胶分别与传感器301的以及发射器400的电气触点S+,S-连接,从而实现传感器与发射器之间的弹性电气连接。导电橡胶除了当电路连接作用外,在压力作用下,通过摩擦力,保持传感器的位置。
所述的硅胶座310,还有2个方形孔3103。该方形孔目的是为了减少导向针以及穿刺针撤离硅胶座时候的阻力。
所述的硅胶座310,顶部有一圈梯形或者三角形的筋位3104,该筋位能使得发射器安装更轻便,且能更好地防水。
如图20所示,电气系统包括LC滤波储能模块、无线SOC模块、功能电路电源模块、传感器激励及调理模块、ADC精度增强模块、电池和传感器,所述电池的正极和负极分别通过线路连接LC滤波储能模块,LC滤波储能模块与无线SOC模块的VDD端之间具有连接线,该连接线上具有双控开关,双控开关可连接无线SOC模块的Da端或功能电路电源模块,功能电路电源模块线路连接传感器激励及调理模块,所述无线SOC模块的Db端也线路连接传感器激励及调理模块,无线SOC模块具有内置ADC模块,无线SOC模块的Dc端和内置ADC模块均连接ADC精度增强模块,ADC精度增强模块线路连接传感器激励及调理模块,传感器激励及调理模块的正负极分别线路连接传感器;
其中,SOC模块中,VDD为SOC的供电电压,Da、Db和Dc为SoC模块数字输出引脚。Da引脚配置成控制开关S1的断开和闭合,以此控制电池是否向功能电路电源模块供电。Db配置成选择传感器激励电路的电平,可以使传感器激励模块向传感器提供高电平和低电平两种激励电压信号。Dc配置成向ADC精度增强模块注入噪声信号。Ain1和Ain2为ADC输入,配置成采样ADC精度增强模块输出的经过调理和噪声注入后的传感器电压。
ADC精度增强模块的高精度信号采样方法,其特征在于,包括以下步骤,步骤一:采样信号中注入一个幅值为0的噪声电压,进行ADC采样,结果为Read1;步骤二:采样信号中注入一个幅值为
Figure PCTCN2020087964-appb-000001
的噪声电压(V ADC_REF为ADC参考电压,d为目标精度位数),进行ADC采样,结果为Read2;步骤三:最终结果Read=(Read1+Read2)/2,得到的结果精度可增强1位。
使用时,将发射器400安装在底座302上后,底座上的电池通过与V+V-相连的电池导针4011向发射器供电。与发射器S+S-相连的橡胶导针4012、导电橡胶311以及传感器301形成一条电气回路。当传感器上的葡萄糖氧化酶与受体内部的葡萄糖发生反应时,会产生微弱的电流。发射器可通过上述电气回路,测量出电流值。并通过发射器内部算法,将所测得的电流值,转化成受体血糖值。然后通过无线传输模块,将血糖值传输到相应的显示设备上。
以上所述的具体实施方式,对本申请的目的、技术方案和有益效果进行了进一步详细说明,所应理解的是,以上所述仅为本申请的具体实施方式而已,并不用于限制本申请, 凡在本申请的精神和原则之内,所做的任何修改、等同替换或改进等,均应包含在本申请的保护范围之内。

Claims (9)

  1. 一种受体生理参数测量系统,其特征在于:包括植入器(200)、传感器底座装置(300)以及发射器(400),所述植入器(200)和发射器(400)均能安装于传感器底座装置(300);
    所述植入器(200)包括植入器上盖(201)、植入器下盖(202)、按钮(203)、支架(204)、顶针座(205)、穿刺针座(206)、导向针座(207)、回针弹簧(208)、驱动弹簧(209)、顶针(211)、穿刺针(212)、导向针(213)和导向限位块(214),其中,植入器上盖(201)和植入器下盖(202)组成外部壳体,按钮(203)位于植入器上盖(201),支架(204)、顶针座(205)、穿刺针座(206)和导向针座(207)均配合安装于外部壳体内,外部壳体的前端连接于传感器底座装置(300);
    所述支架(204)固定于外部壳体内,支架(204)为一端开口的筒状结构,其开口朝向传感器底座装置(300),支架(204)上部为长圆柱(2042),支架(204)的前端朝向传感器底座装置(300),支架(204)的前端具有向内扣入的支架弹性卡筋(2044),支架弹性卡筋(2044)配置成限位导向针座(207),后端上部具有配置成卡住顶针座(205)的支架卡扣(2043),支架(204)的外侧具有能扣接导向限位块(214)的支架凸台(2045)以及限制顶针座205活动的限位弹性卡扣(2046);
    所述顶针座(205)为两端开口的筒状结构,顶针座(205)在支架(204)内活动,顶针座(205)上部为套筒(2052),所述长圆柱(2042)贯穿套筒(2052),套筒(2052)朝向传感器底座装置(300)的前端边缘具有环边,套筒(2052)内置有推动顶针座(205)的驱动弹簧(209),套筒(2052)上还设置有与支架卡扣(2043)扣接的弹性卡片(2051),所述按钮(203)能拨动弹性卡片(2051),所述顶针座(205)的两侧设有长方形孔(2053),顶针座(205)的前端为斜面端(2054),顶针座(205)后端靠上部位设有顶针凸台(2055),所述顶针(211)位于顶针凸台(2055)内,所述顶针座(205)筒状结构内顶部位置沿其长度方向设有筋(2058);
    所述穿刺针座(206)两侧具有斜面支架(2062),斜面支架(2062)的端部具有能卡进长方形孔(2053)的弹性插销(2061),穿刺针座(206)的上部具有滑槽(2063),滑槽(2063)扣入顶针座(205)的筋(2058),穿刺针座(206)沿筋(2058)在顶针座(205)内滑动,所述穿刺针(212)位于穿刺针座(206)内;
    所述导向针座(207)为两端开口的筒状结构,所述导向限位块(214)侧部具有与支架凸台(2045)扣接的卡勾(2142),导向限位块(214)中间具有导向圆柱(2141),导向圆柱(2141)贯穿于导向针座(207),导向针座(207)朝向传感器底座装置(300)的一端具有与支架弹性卡筋(2044)扣接的限位凸台(2071),导向针座(207)背离传感器底座装置(300)一端的边缘具有环边,导向针座(207)内置有推动其背离传感器底座装置(300)活动的回针弹簧(208),导向针座(207)预置于顶针座(205)内,能穿过顶针座(205)活动,导向针座(207)的上部具有释放凸台(2072),导向针座(207)通过释放凸台(2072)挤压斜面支架(2062),使弹性插销(2061)脱离长方形孔(2053),导向针座(207)的侧部还设有能撑开限位弹性卡扣(2046)的解锁凸台(2074),导向针座(207)上部设有导向针凸台(2075),导向针凸台(2075)能与传感器底座装置(300)连接,所述导向针(213)位于导向针凸台(2075)内;
    所述传感器底座装置(300)包括底座(302)和胶布(303),底座(302)位于胶布(303)上;所述底座(302)上部为开口,底座(302)内具有电池槽(3021)和凹槽(3024),所述电池槽(3021)内安装有电池(304)以及电池盖(307),所述凹槽(3024)内安装有旋转座(309),旋转座(309)靠电池槽(3021)的一侧铰接于凹槽(3024)内,旋转座(309) 内具有硅胶座(310),所述硅胶座(310)内设置有一对导电橡胶(311),贯穿硅胶座(310)和旋转座(309)设置有传感器(301),传感器(301)能穿过两个导电橡胶(311),所述凹槽(3024)靠电池槽(3021)的一侧具有开口(3025),所述胶布(303)开设有孔,传感器(301)能穿过开口(3025)和胶布(303)的孔;
    所述发射器(400)包括塑封外壳(402)和线路板组件(401),所述塑封外壳(402)盖合于底座(302)上,所述线路板组件(401)安装在塑封外壳(402)内部,线路板组件(401)上具有四个导电针,能接触电池(304)的正负极以及两个导电橡胶(311)。
  2. 根据权利要求1所述的一种受体生理参数测量系统,其特征在于:所述植入器上盖(201)上开设有按钮孔(2013),按钮(203)位于按钮孔(2013)内;所述按钮孔(2013)向内具有环形结构,该环形结构上开设有两个L形的缺口(2014),L形的缺口(2014)一端朝向植入器上盖(201)内;所述按钮(203)底面具有一对按钮凸台(2031),按钮凸台(2031)能通过按钮(203)的转动旋出缺口(2014),按钮(203)底面还设置有能拨动弹性卡片(2051)的触发筋(2032),一个触发筋(2032)对应一个弹性卡片(2051),按钮凸台(2031)处于旋出缺口(2014)状态时,触发筋(2032)处于弹性卡片(2051)正上方。
  3. 根据权利要求2所述的一种受体生理参数测量系统,其特征在于:所述植入器下盖(202)后端开设有深槽(2026),深槽(2026)内设有按钮架(215),按钮架(215)上设有按钮架圆柱(2151),所述按钮(203)底部设有圆柱孔(2033),按钮架圆柱(2151)置于圆柱孔(2033)内,圆柱孔(2033)内绕按钮架圆柱(2151)设有按钮弹簧(210)。
  4. 根据权利要求1所述的一种受体生理参数测量系统,其特征在于:所述硅胶座(310)上设置有第一导电橡胶孔(3101)和第二导电橡胶孔(3102),两个导电橡胶(311)分别安装在第一导电橡胶孔(3101)和第二导电橡胶孔(3102)内;所述硅胶座(310)内还设置有两个方形孔(3103),两个导电橡胶(311)和两个方形孔(3103)呈直线分布,所述传感器(301)穿过两个导电橡胶(311)。
  5. 根据权利要求1所述的一种受体生理参数测量系统,其特征在于:所述凹槽(3024)内的两侧各开设有一个半圆孔(3026),所述旋转座(309)的端部两侧各设有一个韧性的伸出杆(3091),伸出杆(3091)的外侧具有一个圆柱轴(3092),圆柱轴(3092)置于半圆孔(3026)内转动。
  6. 根据权利要求1所述的一种受体生理参数测量系统,其特征在于:所述电池(304)的正负极上分别安装有一个电极转接件(305),每个电极转接件(305)上配置一个电极连接件(306),所述电池盖(307)上开设有两个圆孔(3073),一个圆孔(3073)对应一个电极连接件(306),电极连接件(306)穿过圆孔(3073)部分置于电池盖(307)外。
  7. 根据权利要求6所述的一种受体生理参数测量系统,其特征在于:所述线路板组件(401)上的四个导电针为两个电池导针(4011)以及两个橡胶导针(4012),两个电池导针(4011)分别连接一个电极连接件(306),两个橡胶导针(4012)分别连接一个导电橡胶(311)。
  8. 根据权利要求1所述的一种受体生理参数测量系统,其特征在于:所述底座(302)的端部具有底座卡扣开口(3023),所述塑封外壳(402)的端部具有插置于底座卡扣开口(3023)的边缘凸台(4021);塑封外壳(402)的侧部具有外壳卡槽(4022),所述凹槽(3024)的内侧壁上具有卡入外壳卡槽(4022)的弹性卡扣(3027)。
  9. 根据权利要求1所述的一种受体生理参数测量系统,其特征在于:所述电池槽(3021) 的边缘一圈具有密封条(308),所述硅胶座(310)的边缘一圈具有筋位(3104)。
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