CZ36027U1 - System for measuring the physiological parameters of the recipient - Google Patents

Description

A system for measuring the recipient's physiological parameters

Field of technology

The application relates to a reusable system for rapid implantation of a biosensor into the recipient's tissue and measurement of the recipient's physiological parameters, the application belongs to the technical field of wearable medical devices.

Current state of the art

In some physiological diseases, the course of the disease is long and the disease state cannot be cured in the long term. It is necessary to monitor certain physiological parameters of the recipient in real time in order to better monitor the treatment. For example, diabetes requires real-time monitoring of the recipient's blood glucose. Accurate self-monitoring of blood glucose is the key to achieving good blood glucose control, it is useful to assess the degree of glucose metabolism disorders in diabetic patients, develop hypoglycemic programs, reflect the effect of hypoglycemic treatment, and adjust treatment programs.

Currently, the most used blood glucose meter in the market is the finger blood glucose meter, and patients need to draw blood from their finger tips to measure the blood glucose at that moment. However, one of the disadvantages of this method is that changes in blood glucose between the two measurements cannot be detected, and the patient may miss the maximum and minimum blood glucose values, which may cause some complications and irreversible damage to the patient; second, pricking the fingertips several times a day causes diabetics great pain. To solve these problems, a method that can continuously monitor patients' blood glucose levels is needed, so that patients can have a real-time overview of their blood glucose status and take timely measures to effectively control the disease, prevent complications, and gain a higher quality of life.

To solve the above problems, engineers have developed continuous blood glucose monitoring technology that can be implanted under the skin for continuous subcutaneous glucose monitoring. This technology uses a sensor electrode that penetrates the subcutaneous tissue. The electrode undergoes an oxidation reaction between the interstitial fluid and glucose in the patient's body, an electrical signal is generated during the reaction. The electrical signal is converted to a blood glucose value by the transmitter, and blood glucose values are transmitted to the wireless receiver every 1 to 5 minutes. Corresponding blood glucose readings are displayed on the receiver and a graph is created for patient and physician reference.

Currently, subcutaneously implanted continuous sensors for glucose monitoring usually use very thin metal wires or polymer foils as carriers. The metal wire can be platinum coated stainless steel wire. For example, the existing literature states that a stainless steel wire with a diameter of 0.16 mm to 0.25 mm is electroplated with platinum as a support for the sensor electrode. Because the stainless steel wire has sufficient hardness, the sensor electrode can directly penetrate the skin into the tissue without the help of auxiliary tools, but due to the greater hardness of the sensor electrodes, this implantation method causes larger wounds, stronger pain and stronger abnormal sensations after implantation under the skin, which still causes a big problem for diabetic patients.

To reduce the pain caused by the sensor electrodes, technicians change the carrier from a metal wire to a relatively soft platinum wire or platinum-coated nickel wire, or use a polymer film as a carrier. However, due to the insufficient rigidity of the carrier, it cannot penetrate the skin directly. Therefore, it is necessary to use auxiliary implantation tools to implant small and soft sensor electrodes into the subcutaneous tissue to reduce the presence or intensity of abnormal sensations after subcutaneous implantation.

Currently, many auxiliary implantation tools are manual or semi-automatic.

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Due to the inconsistency of the speed and force of each implantation and the slow speed of manual implantation, the implantation process takes a long time. This leads both to greater deviation of the sensor after implantation and to the patient's pain.

On the other hand, a traditional dynamic blood glucose transmitter is mainly composed of three parts: a coin cell battery, a circuit board, and a plastic shell. Due to waterproof requirements and size limitations, the coin cell battery and circuit board are usually located together in the transmitter, and both are usually integrated in a plastic casing, so the transmitter battery cannot be replaced. When the battery life is depleted, the transmitter is essentially unusable. In terms of cost, the cost of the plastic shell and transmitter circuit board is much higher than the cost of the battery, and also the life of the plastic shell and transmitter circuit board is much longer than the battery life. From an environmental point of view, the production and disposal of circuit boards can pose a potential environmental hazard. Therefore, this method greatly wastes circuit boards and plastic casings, increases material costs and wastes resources.

In order to solve the above problems, on the one hand, it is necessary to use a suitable method to penetrate the small, soft biosensor electrode into the subcutaneous tissue very quickly with an auxiliary implantation tool, the pain is extremely low, and the sensor electrode is left under the skin, and the implantation is carried out in the set needle tube , which reduces the risk of deviations caused by manual control. On the other hand, it is necessary to use a suitable method to separate the battery from the transmitter, so that the life of the circuit board and plastic shell is not limited by the life of the battery, which is very important to reduce costs and waste.

The essence of the technical solution

The technical problem to be solved by this technical solution are the aforementioned shortcomings of the prior art. A system for measuring the recipient's physiological parameters is provided here.

To solve the technical problems mentioned above, a technical solution is provided in this application:

The system for measuring physiological parameters of the recipient includes an implanter, a sensor base device and a transmitter, both said implanter and transmitter can be installed on the sensor base device;

Said implanter includes an upper implanter cover, a lower implanter cover, a button, a holder, a needle pusher seat, a puncture needle seat, a guide needle seat, a needle return spring, a drive spring, a needle pusher, a puncture needle, a guide needle and a guide stop block, wherein the upper the implanter cover and the lower implanter cover form the outer casing, and the button is located on the upper cover of the implanter, the holder, the needle pusher seat, the puncture needle seat and the guide needle seat are installed in the outer housing, the front end of the outer housing is connected to the sensor base device.

Said holder is fixed in an outer housing, the holder being a cylindrical structure with one open end facing the sensor base device. The upper part of the holder is a long cylinder, and the front end of the holder faces the sensor base device, the front end of the holder has a flexible holder rib that is stuck inside, and the flexible holder rib is configured as a guide needle seat, at the top of the rear end of the holder, a holder clip is configured to clamping of the needle shifter seat, on the outside of the holder there are a holder protrusion that can engage with the guide limiter block and a limit spring clip that can limit the movement of the needle shifter seat.

The indicated needle shifter seat is a cylindrical design with two open ends. The needle shifter seat is movable in the holder. The upper part of the needle shifter seat is formed by a sleeve. The long cylinder passes through the sleeve. The leading edge of the socket facing the base sensor device has

- 2 CZ 36027 UI ring edge, the socket has a built-in drive spring to push the needle pusher seat, the socket is also equipped with an elastic card connected to the clip of the holder, the said button can switch the elastic card. Both sides of the needle shifter seat are provided with rectangular holes, and the front end of the needle shifter seat is chamfered, there is a needle shifter protrusion on the upper part of the rear end of the needle shifter seat, the said needle shifter is located in the protrusion, and the upper position in the cylindrical structure of the needle shifter seat is along the entire length equipped with a rib.

Both sides of the lancing needle seat are equipped with an inclined holder, the end of the inclined holder has a spring pin that can be inserted into the rectangular hole, the upper part of the lancing needle seat has a sliding groove, and the sliding groove is snapped into the rib of the needle pusher seat, the lancing needle seat moves along the rib in the seat of the needle pusher, said lancing needle is located in the lancing needle seat.

The seat of the guide needle is a cylindrical structure with two open ends, there is a hook on the side of the guide limit block, which is connected to the protrusion of the holder, the guide limit block has a guide cylinder in the middle, and the guide cylinder passes through the seat of the guide needle. The end of the guide needle seat toward the sensor base assembly has a stop tab that is connected to the spring clip of the holder, the edge of the guide needle seat end deflecting into the sensor base assembly has an annular edge, and the guide needle seat has a built-in needle return spring that is used to pushing the guide needle seat away from the base sensor device. The guide needle seat is located in the needle shifter seat and can move through the needle shifter seat. There is a release tab on the top of the guide needle seat, and the movement of the guide needle seat can push the inclined holder with the release tab to release the spring pin from the rectangular hole, the side of the guide needle seat is also equipped with a release tab that can open the limiting spring clip, and the upper part of the guide needle seat is provided with a guide needle protrusion. The tip of the guide needle can be connected to the basic device of the sensor. Said guide needle is located in the protrusion of the guide needle.

Said basic sensor device includes a base and a tape, the base being placed on the tape; the top of the base is open, the base has a battery slot and a groove, the battery and the battery cover are installed in the battery slot, a swivel seat is installed in the groove, which is hung in the groove on the side near the battery slot. The swivel seat is equipped with a silicone seat. There is a pair of conductive rubbers in the said silicone saddle. A sensor passes through the silicone seat and the swivel seat. Said groove has a gap on the side near the battery slot and the tape is provided with a hole so that the sensor can pass through the gap and the tape hole.

Said transmitter includes a plastic shell and a circuit board assembly, the plastic shell is covered on the base, the circuit board assembly is installed inside the plastic shell, and the circuit board assembly has four conductive pins, these conductive pins can be in contact with the positive and negative electrodes of the battery and two conductive rubbers.

As another preferred solution, the top cover of the implanter is provided with a button hole and a button is placed in the button hole; the button hole has a ring structure inside, and this ring structure is provided with two L-shaped notches, the shorter slots of the two L-shaped notches are directed to the upper cover of the implanter, and the longer slots are arranged in the opposite direction; the lower surface of the button has a pair of protrusions. The button protrusion can be unscrewed from the notch by turning the button. There are trigger ribs at the bottom of the button that can switch the elastic card, and one trigger rib corresponds to one elastic card. When the tab of the button is unscrewed from the notch, the trigger rib is in the position of the elastic card.

As another preferred solution, there is a deep groove at the rear end of the bottom cover of the implanter, the button holder is arranged in the deep groove, the button holder cylinder is arranged on the button holder, the bottom part of the button is provided with a cylindrical hole, and the button holder cylinder is located in the cylindrical hole. A button spring is arranged in the cylindrical hole around the button holder cylinder.

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As another preferred solution, the silicone seat is provided with a first conductive rubber hole and a second conductive rubber hole, and two conductive rubbers are respectively installed in the first conductive rubber hole and the second conductive rubber hole; there are also two square holes in the silicone seat, two conductive rubbers, and the two square holes are spaced in a straight line, and the sensor passes through the two conductive rubbers.

As another preferred solution, there is a semicircular hole on both sides of the groove, a flexible extension rod on both sides of the end of the swivel saddle, and the outer side of the extension rod is provided with a cylindrical shaft, the cylindrical shaft rotates in the semicircular hole.

As another preferred solution, the electrode adapter is installed on the positive and negative poles of the battery, each electrode adapter is equipped with a battery connector, and the battery cover is provided with two round holes, one round hole corresponds to one battery connector, and the battery connector passes through the round hole and is located outside the battery cover .

As another preferred solution, four conductive pins are placed on the circuit board assembly, two conductive pins for the battery and two conductive pins for the rubbers, two conductive pins for the battery are respectively connected to the battery connector, and two conductive pins for the rubbers are respectively connected to the conductive rubber.

As another preferred solution, there is a clip hole at the end of the base, at the end of the plastic casing, a marginal projection is inserted into the clip hole in the base; on the side of the plastic casing there is a casing groove, the inner side wall of the groove is equipped with a flexible clip which is inserted into the casing groove.

As another preferred solution, the edge of the battery slot has sealing tape and the edge of the silicone seat has ribs.

Compared with the prior art, the system for measuring the physiological parameters of the recipient according to this application firstly solves the problem that diabetic patients need to prick their finger several times a day and collect blood from the finger. Through the sensor electrode inserted into the subcutaneous tissue, the blood glucose level can be monitored over a certain period of time, which can greatly reduce the patient's pain during the puncture and more accurately capture the change in the patient's blood glucose level. Second, with the help of an auxiliary implant tool, a small and soft sensor electrode is implanted into the subcutaneous tissue, which solves the problems of pain and foreign body sensations caused by the implantation of the sensor electrode into the recipient. Third, the linearly arranged automatic implanter can complete the implantation of the sensor electrode and the removal of the needle at a higher speed, which can greatly reduce the patient's pain during puncture. Fourth, the reasonable combination of components allows most components to be reused, which can reduce material waste, greatly reduce user costs and potential environmental hazards.

Clarification of drawings

Figure 1 is a schematic diagram of the working principle of this application;

Figure 2 is a schematic diagram of a device according to this application;

Figure 3 is a cross-sectional view of the initial state of the implanter;

Figure 4 is a schematic diagram of the working state of the basic sensor device;

Figure 5 is an exploded view of the implanter;

Figure 6 is a schematic diagram of the structure of the top cover of the implanter;

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Figure 7 is a schematic diagram of the structure of the lower cover of the implanter;

Figure 8 is a schematic diagram of a button structure;

Figure 9 is a sectional view of the holder;

Figure 10 is a schematic diagram of the internal structure of the holder;

The figure shows a schematic diagram of the structure of the needle shifter seat;

Figure 12 is a schematic diagram of the internal structure of the puncture needle seat and guide needle seat;

Figure 13 is a schematic view of the cross-sectional structure of the puncture needle seat and guide needle seat;

Figure 14 is an exploded view of the transmitter;

Figure 15 is an exploded view of the basic sensor device;

Figure 16 is a sectional view of a silicone seat;

Figure 17 is a schematic diagram of a base structure;

Figure 18 is a schematic diagram of a battery cover structure;

Figure 19 is a schematic diagram of the structure of the swivel seat and the silicone seat;

Figure 20 is a schematic diagram of an electrical system module according to this application.

An example of the implementation of a technical solution

In the following, the implementation according to the presented technical solution will be described and illustrated in detail with reference to specific examples. The content is an explanation of the presented technical solution, but is not a limitation of the scope of protection of this technical solution.

Figure 1 is a schematic diagram of the working principle of this application. Through the disposable implanter 200, the sensor 301 is partially implanted into the tissue of the recipient 100, and the outer part of the sensor 301 and the transmitter 400 are electrically connected by a contact. After 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 via wireless transmission.

The physiological parameter measurement system is structurally divided into three parts: the implanter 200, the basic sensor device 300, and the transmitter 400. as shown in Figure 2.

As shown in Figure 3, in the initial state, the sensor base device 300 and the implanter 200 are connected together by the frictional resistance between the guide needle 213 and the silicone seat 310. to maintain their initial position; the biosensor electrode is installed inside the implanter, it maintains its initial position through frictional resistance. At this time, the transmitter 400 is in an unused state.

As shown in Figure 4, after implantation, a part of the sensor 301 enters the tissue of the recipient, and a part is retained in the base device of the sensor 300. After the transmitter 400 is installed, the transmitter will "read" the signal of the biosensor, convert the signal into a physiological parameter and send it to the 500 receiver.

- 5 CZ 36027 UI receiver 500 can be a mobile phone, an operator or even a cloud.

A detailed description of the implanter 200 is as follows:

The implanter 200 is used to implant the sensor 301 into the tissue of the recipient, as shown in Figure 5, it mainly includes an implanter upper cover 201, an implanter lower cover 202, a button 203, a holder 204, a needle pusher seat 205, a puncture needle seat 206, a guide needle seat 207, a needle return spring 208. a driving spring 209. a needle pusher 211. a piercing needle 212. a guide needle 213 and a guide restrictor block 214. wherein the upper cover 201 of the implanter and the lower cover 202 of the implanter form the outer shell. The holder 204 and the guide restrictor block 214 are fixed in the outer casing. The needle pusher seat 205, the puncture needle seat 206, the guide needle seat 207 are located in the holder 204 and the guide limit block 214. The needle pusher seat 205 mainly drives the needle pusher 211 to move forward and activate the guide needle seat 207, and the guide needle seat 207 moves in the opposite direction, creating a sensor implantation process 301.

As shown in Figure 6 , the top cover 201 of the implanter is provided with a T-shaped structure 2011 (position 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 penetrate the body tissues "directly" to reduce the pain caused by the shaking.

The upper cover 201 of the implanter is provided with a position limiting structure 2012 which cooperates with the stop 2041 on the holder 204. on the one hand, it provides sufficient strength of the stop on the holder and on the other hand it prevents the holder from shifting due to the action of the drive spring 209.

At the front end of the top cover 201 of the implanter, there is a button hole 2013, and this round hole serves to accommodate the button 203. The button can be rotated and moved up and down in this round hole.

There are L-shaped notches 2014 on both sides of the button hole 2013, and the notch 2014 can be aligned with the button protrusion 2031 on the button 203. On the one hand, the notch can limit the movement of the button to the outside of the implanter upper cover 201 by the button protrusion 2031. On the other hand, this structure L-shaped can provide "lock" and "unlock" function. In the initial state, the button protrusion 2031 on the button 203 is located on the innermost side of the L-shaped structure. The button can only rotate in one direction and cannot be pressed. At this moment, it is in the "locked" state and works to prevent false actuation of the button 203. When the user rotates the button by a certain angle, the protrusion of the button 2031 is located at the open end of the L shape. At this moment, the button is in the "unlocked" state and can be pressed.

The L-shaped notch 2014 has a locking projection 2015. When the button projection 2031 on the button 203 is in the “lock” position, there is some interference between the locking projection 2015 and the button projection 2031, so that the button 203 cannot be easily turned to the “unlock” position. It is possible to prevent false activation of the button 203 during transportation, handling and application, etc.

As shown in Figure 7, 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 connected together by the frictional resistance between the guide needle 213 and silicone seat 310 to maintain its initial position.

A triangular rib 2022 is placed in the groove of the base 2021, and this triangular rib serves to limit the base and prevent the movement of the base.

The base groove 2021 is provided with a rectangular hole 2023 of medium size; in the initial state, this hole allows the pivot seat 309 in the base to pass through, but restricts the upward movement of the base.

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The bottom cover 202 of the implanter is provided with a limit stop 2024 at the front and back, and the limit stop 2024 is matched to the plane of the end and the back of the holder 204. After installing the holder in the bottom cover, the front and back of the holder are limited by the limit stop, and the top of the holder is limited by the top cover 201 the implanter. Therefore, the holder will be fixed in the upper and lower cover of the implanter and cannot be moved.

Limiting stop 2024 also has its function. During implantation, the needle pusher seat and the lancing needle seat move forward, the limit stop serves to limit the distance between the needle pusher seat and the lancing needle seat to ensure that the implant length does not exceed the set value.

The inner front portion of the bottom cover 202 of the implanter is provided with a positioning slot 2025 and this slot is used to position the guiding restriction block 214.

As shown in Figure 7 , the guide limiter block 214 is limited in the front and rear directions by the positioning slot 2025 inside the implanter bottom cover 202 , and the upper and lower positions are limited by the guide needle seat 207 and the implanter bottom cover 202 , respectively. The guide restrictor block is provided with a longer guide cylinder 2141. On the one hand, the cylinder can prevent the needle return spring 208 from twisting during installation and operation, which may cause the guide needle seat 204 to not move normally. On the other hand, when the guide needle seat 204 moves back, the cylinder can provide guidance for the guide needle seat.

At the end of the bottom cover 202 of the implanter is a deep groove 2026, and the deep groove 2026 serves to limit the push button holder 215 and prevent the push button holder 215 from moving under force.

As shown in Figure 8, the button 203 has two actuation ribs 2032. When the button is pressed down, the actuation ribs can switch the needle pusher seat spring tab 2051 to actuate the implanter.

The button 203 has a cylindrical hole 2033, and the cylindrical height is set shorter than the trigger rib 2032 to ensure that the trigger rib can function normally. The cylindrical hole serves to accommodate the button spring 210 and is adapted to the button holder cylinder 2151. When the driving force acting on the button spring is removed, the button returns to its original position under the action of the spring.

The upper surface of the button 203 has stripes to increase the frictional force so that the button can be turned more easily with the fingers.

On the top surface of the button 203 is a triangular arrow 2034. This arrow corresponds to the "lock" and "unlock" marks 2016 on the top cover and serves to indicate the state of the button. In the initial state, the triangular arrow 2034 points to the "lock" mark. When the button is rotated through a certain angle, the triangular arrow 2034 points to the "unlock" mark. At this point, the implanter can be started by pressing the button.

As shown in Figure 9, the upper part of the holder 204 has a long cylinder 2042. which cooperates with a sleeve 2052 on the upper part of the needle pusher seat 205. to provide a guide for the movement of the needle pusher seat and to prevent the vibration of the needle pusher seat and the puncture needle seat, thereby the puncture needle the needle can penetrate the body tissues "directly" to reduce the pain caused by shaking.

Additionally, the long cylinder 2042 is used to position the drive spring 209 to prevent the drive spring from twisting during installation and operation, which would cause the needle shifter seat 205 to not move normally.

As shown in Figure 10, the upper rear part of the holder 204 has two holder clips 2043 and the clips

- 7 CZ 36027 UI of holder 2043 are aligned with the elastic card 2051 of the needle shifter seat 205. When installing, the needle shifter seat is pulled back to the preset position, the elastic card 2051 will be caught by the clip of the holder 2043. Although the needle shifter seat tends to move forward under the action drive springs, the needle shifter seat remains stationary because the needle shifter seat elastic tab is captured by the retainer clip.

The center front portion of the holder 204 has two bent elastic holder ribs 2044 which cooperate with the guide needle seat restricting protrusion 2071 207 to limit rearward movement of the guide needle seat.

The middle front part of the holder 204 has two holder protrusions 2045. The holder protrusions 2045 cooperate with the hooks 2142 of the guide limiter block 214. so that the guide limiter block 214 and the holder 204 are integrated. Therefore, under the constraints of the holder 204, the guide limiter block 214, and the guide needle seat 207, the needle return spring 208 is in a biased state. When the bent elastic ribs of the holder 2044 are lowered, the seat of the guide needle retracts under the compressive force of the needle return spring 208.

On the side of the middle part of the holder 204 there are two limiting elastic clips 2046. The upper part of the clip has an inclined surface. As the needle shifter seat 205 moves forward, the inclined surface of the spring clip expands under the action of the needle shifter seat to allow the needle shifter seat to pass. When the needle shifter seat reaches the intended position, the spring clip springs back and clamps the needle shifter seat with a vertical surface so that the needle shifter seat cannot be moved back. This structure helps maintain the position of the needle pusher seat during the needle return process and prevents displacement of the sensor electrode after implantation.

As shown in Figure 11, there is a rectangular hole 2053 on both sides of the needle pusher seat 205, which is aligned with the spring pin 2061 on the puncture needle seat 206. After the puncture needle seat is installed in place, the spring clip is clamped into the rectangular hole needle pusher seats so that the puncture needle seat and the needle pusher seat remain relatively firm. Actuation of the drive spring 209 moves the needle pusher seat forward, simultaneously driving the lancing needle seat forward together to puncture the recipient tissue.

Both sides of the front part of the needle pusher seat 205 have a chamfered end 2054. When the needle pusher seat is moved to a preset position, the chamfered end expands the two bent elastic ribs 2044 of the holder 204 outwardly, releasing the guide needle seat 207, which is jammed by the holder, the seat the guide needle is retracted by the action of the needle return spring 208.

At the end of the needle pusher seat 205 is a needle pusher boss 2055, the needle pusher boss 2055 cooperates with the puncture needle seat 206. When the puncture needle seat is pushed into contact with the needle pusher boss 2055, it drives the needle pusher seat back together.

At the right end of the protrusion of the needle shifter 2055, there is a hole 2056 for fixing the needle shifter 211. The fixing method is not limited. There is an overflow groove 2057 at the left end of the needle shifter boss 2055, which can prevent glue from overflowing, thereby affecting fit and movement.

As shown in Figure 12, there are two spring pins 2061 on both sides of the puncture needle seat 206. After the puncture needle seat is installed in place, the spring clip is clamped into the rectangular hole 2053 of the needle pusher seat 205, so that the puncture needle seat and the seat the needle pushers remain relatively fixed.

The spring pin 2061 has an inclined retainer 2062 which cooperates with a release tab 2072 on the top of the guide needle seat 207. When the guide needle seat is inserted into the preset position, the release tab 2072 of the guide needle seat 207 pulls both bent flexible ribs of the puncture needle seat inward so that the lancing needle seat is separated from the needle pusher seat.

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On the upper part of the lancing needle seat 206 is a sliding groove 2063. which cooperates with the rib of the lancing needle seat 2058. so that the lancing needle seat still moves along a predetermined path, which reduces the pain caused by shaking.

There is a puncture needle hole 2064 on the left side of the puncture needle seat 206. The puncture needle hole 2064 is used to fix the puncture needle 212. The fixing method is not limited. There is an overflow groove 2065 on the right side, which can prevent glue from overflowing and thereby affect fit and movement.

As shown in Figure 13, there is a guide round hole 2073 in the center of the guide needle seat 207. The end of the guide round hole 2073 is reduced or closed to install the needle return spring 208. to prevent the needle return spring 208 from twisting during installation and operation, which would cause the guide needle seat to not move normally.

The upper part of the guide needle seat 207 is provided with a release tab 2072. When the guide needle seat is inserted into the preset position, the release tab 2072 of the guide needle seat 207 pulls both bent flexible ribs 2061 of the puncture needle seat 206 inward, so that the puncture needle seat is separated from 205 needle shifter seats.

The release tab 2074 is at the upper right of the limiting tab 2071 on both sides of the seat 207. When the guide needle seat moves to the preset position, the release tab 2074 contacts the restraining elastic clip 2046 of the holder, the action of the releasing tab 2074 causes the elastic clip to expand outward , releasing the needle shifter seat 205, and then the needle shifter seat is driven rearward together with the guide needle seat and the puncture needle seat.

On the front of the guide needle seat 207 is a guide needle tab 2075. Prior to implantation, the front portion of the tab cooperates with the pivot seat 309 in the base to limit movement of the pivot seat. After implantation, the guide needle seat is retracted and the restriction of the swivel seat is released.

On the left side of the protrusion of the guide needle 2075, there is a hole 2076 for fixing the guide needle 213, and the fixing method is not limited. On the right is an overflow groove 2077 that can prevent glue from overflowing and thus affect fit and movement.

The initial state before use is that the hook 2142 of the guide restriction block 214 and the protrusion 2045 of the holder 204 are connected to each other, and the holder 204 is restrained and fixed inside the upper cover 201 of the implanter and the lower cover 202 of the implanter, and the flexible rib 2044 of the holder clamps the restriction protrusion 2071 of the guide needle seat 207, the holder clip 2043 clamps the flexible card 2051 of the needle pusher seat 205, the flexible pin 2061 of the puncture needle seat 206 is inserted into the rectangular hole 2053 on the side of the needle pusher seat 205. so that the puncture needle seat 206 is relatively integrated with the needle pusher seat 205. In this at this time, the driving spring 209 in the sleeve 2052 is in a compressed state, the needle return spring 208 in the seat of the needle pusher 205 is in a compressed state, the front end of the puncture needle 212 is located in the guide needle 213. The needle pusher 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 needle pusher 211 is smaller than the inner diameter of the punctures of the needle 212, the diameter of the needle pusher 211 is the same as the sensor 301. The sensor 301 is a flexible needle-type electrode.

In use, the basic sensor device is placed on the human skin, the button 203 is pressed, the inclined surface of the elastic card 2051 is pressed by the trigger rib 2032 of the button 203 to be moved, the elastic card 2051 is separated from the holder clip 2043, and the drive spring 209 is released and drives the needle pusher seat 205 and the lancing needle seat 206 forward. The lancing needle 212 on the lancing needle seat 206 pierces the recipient's skin through the guide needle 213. As the needle pusher seat 205 moves forward, the needle pusher seat 205 slides over the inclined surface of the limiting elastic clip 2046. until it completely passes the restrictor spring clip 2046. the end of the needle shifter seat 205 is clamped by the vertical surface of the restrictor spring clip 2046, the tapered end 2054 of the needle shifter seat 205 abuts the spring rib 2044 of the holder, and the spring rib 2044 is separated

- 9 CZ 36027 UI from the restricting projection 2071 of the guide needle seat 207. The needle return spring 208 releases the compressive force and drives the guide needle seat 207 to move in the opposite direction, the release projection 2072 on the guide needle seat 207 pushes the inclined holder 2062 of the puncture seat needle 206 so that the spring pin 2061 is separated from the rectangular hole 2053. The guide needle seat 207 drives the lancing needle seat 206 to move in the opposite direction together, the lancing needle 212 is separated from the receiver and the guide needle 213 is separated from the silicone seat 310 .Since the needle shifter seat 205 does not move in the opposite direction at this time, the needle shifter 211 always acts on the sensor 301 in the lancing needle 212. The lancing needle 212 separates from the receiver while the sensor 301 remains in the receiver.

In order to prevent a part of the sensor 301 from protruding on the outside of the silicone seat 310 after the puncture needle seat 206 is extended, the needle pusher 211 should partially engage the silicone seat 310. When the guide needle 213 and the puncture needle seat 206 are pulled out, the end of the sensor 301 will not stick out.

When the guide needle seat 207 moves to the limiter spring clip 2046, the release tab 2074 opens the limiter spring clip 2046, and the guide needle seat 207 also hits the bottom of the needle pusher seat 205 at this time. This can drive the needle pusher seat 205 to move to a short distance in the opposite direction ensuring that the needle pusher 211 is pulled out engaging the silicone seat 310. At this point the implanter 200 can be removed and the transmitter 400 installed.

As shown in Figure 14, the transmitter hardware 400 includes a circuit board assembly 401 and a plastic housing 402. The size of the transmitter is approximately 32 mm x 16 mm x 5 mm. After installation in the base device of the sensor 300, it is convenient to stick the device to the recipient's skin and carry it with you.

Said circuit board assembly 401 includes four conductive pins which are generally made of a conductive metal, preferably brass. The conductive pins are pulled from the plastic jacket 402 and are aligned with the bottom surface of the jacket. After the transmitter 400 is inserted into the base sensor device 300, the conductive pins are connected to S+, S- on the sensor and V+, V- on the battery. The battery 304 in the base device of the sensor 300 will power the transmitter 400 , and the transmitter 400 can convert the signal value measured from the sensor 301 into corresponding physiological parameters and send them to the user receiver 500 .

The plastic shell 402 completely wraps the circuit board assembly (except for the 4 conductive pins), which can realize the waterproof effect. On the left side of the plastic shell is an edge protrusion 4021. On both sides is a groove 4022. When the transmitter is installed on the sensor base device, the edge protrusion 4021 and groove 4022 can fix the transmitter 400 on the base.

As shown in Figure 15, the basic device of the sensor 300 mainly includes a battery 304 and a sensor 301. The battery 304 and the transmitter 400 are connected by electrical contacts V+ and V-. Sensor 301 and transmitter 400 are connected by electrical contacts S+ and S-.

The basic device of the sensor 300 also includes the sensor 301. the base 302. the strap 303. the battery 304. the battery adapter 305, the battery connector 306, the battery cover 307, the waterproof sealing ring 308 for the battery connector, the swivel seat 309, the silicone seat 310, and the conductive rubber 311.

The battery adapter 305 may be a metal component such as nickel tape. The battery adapter 305 is connected to the battery 304 and the battery connector 306 by welding or the like.

There is an insulating paper on the outside of the battery 304 to prevent the positive and negative poles of the battery from conducting.

The battery connector 306 ie located on the battery adapter 305 and can be firmly pressed by installing the battery cover 307.

- 10 CZ 36027 UI

The 306 battery ie connector is flexible and can be electrically connected to the transmitter. The battery connector 306 may be a spring pin that is equipped with a spring inside. When the transmitter 400 is installed, the battery connector is pressed down to ensure reliable contact between the battery connector and the transmitter contact.

On the surface of the base 302 is a waterproof sealing ring 308, the waterproof sealing ring can be made of elastic materials such as silica gel, TPE or TPU. The waterproof sealing ring can be directly injected onto the base, or it can be glued onto the base later. The waterproof sealing ring is trapezoidal or triangular, which allows for better placement of the transmitter and better waterproofing. Combined with the bottom plane of the transmitter, it can be waterproof, and the waterproof level can reach IPX7.

In the unused state, the transmitter 400 is not installed on the base sensor device 300. Therefore, the transmitter 400 is in the off state and the battery 304 is not consumed. When the transmitter 400 is in use, it is inserted into the base sensor device 300 and the battery supplies power to the transmitter 400 through an electrical connection. After use, the transmitter is removed and the battery 304 is discarded along with the sensor.

As shown in Figure 16, a sensor 301 is implanted in the subcutaneous tissue of a living body and is configured to sense the original analyte signal. 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 conductive pins 4011 and 4012 of the battery on the transmitter 400.

The base 302 is attached to the recipient's skin on one side by a non-woven fabric tape 303 and is configured to be firmly connected to the transmitter 400 on the other side.

As shown in Figure 17, the base 302 has a 12 mm diameter battery slot 3021 in the middle, which is configured to accommodate a battery 304. The positive and negative poles of the battery are connected to the battery connector 306 through the battery adapter 305 and then routed through the battery connector to the external surface of the base.

The end of the base 302 is provided with a hole 3023 for the base clip. The upper part of the opening is a flat surface, and the lower part is beveled at a certain angle. The upper portion is configured to cooperate with the edge projection 4021 of the transmitter 400 to limit the transmitter. The chamfer on the bottom makes it easy to install the transmitter.

The base 302 has a slot 3024 on the right, which is configured to accommodate a pivot seat 309. After the sensor 301 is implanted, the pivot seat rotates clockwise to a certain angle, and finally engages the bottom surface of the slot. On the lower left side of the groove 3024 is a gap 3025 through which the sensor 301 can pass.

Semicircular holes 3026 are arranged on both sides of the groove 3024, and the semicircular hole is adapted to the cylindrical shaft 3092 of the rotary seat 309, so that the rotary seat can rotate along the axis of the hole.

Above the semi-circular hole 3026, an inclined surface is arranged, which is suitable for clamping the cylindrical shaft of the swivel seat into the semi-circular hole.

On both sides of the base 302 are spring clips 3027. The spring clips are configured to cooperate with grooves 4022 on both sides of the transmitter. When the transmitter is installed, the spring clips on both sides of the base open outward, and after the transmitter is installed, the spring clips retract. The bottom surface of the flexible clip is clamped to the groove 4022 of the transmitter, which limits the movement of the transmitter.

- 11 CZ 36027 UI

As shown in Figure 18, the battery cover 307 is configured to cooperate with the base 302 to secure the battery connector 306 and the battery 304. The battery cover 307 is provided with a groove 3071 on the battery cover in the middle, which is configured to receive the battery 304. At each end of the battery is a cylindrical hole with a stepped surface 3072 which corresponds to two cylindrical steps 3022 in the lower part of the base so that the battery connector is fixed. The two round holes 3073 in the upper part of the battery cover 307 allow the elastic parts of the battery connector to pass through so that they can be connected to the transmitter contacts.

As shown in Figure 19, the pivot seat 309 on one side provides support for the silicone seat 310 when not installed; on the other hand, when the installation is completed, the swivel seat 309 can rotate around the base until the installed state.

There are two extension rods 3091 on both sides of the swivel seat 309. The extension rods have some flexibility. When the extension rod is stressed, it can shrink inwards; after canceling the force, the extension rod can return to its original position.

The end of each extension rod is provided with a cylindrical shaft 3092 that fits the semicircular hole of the base.

Cylindrical shaft 3092 has an inclined surface on the side. When the swivel seat is installed in the base, the inclined surface of the cylindrical shaft contacts and guides the inclined surface of the base. The compression force causes the extension rod 3091 to bend inward, the cylindrical shaft is clamped into the semicircular hole of the base, and the extension rod can return to its original position. At this time, the degree of freedom of the swivel seat and the base is limited, and the swivel seat can only rotate around the axis of the cylindrical shaft.

The silicone seat 310 on one side serves to accommodate the conductive rubber 311, provides a deformation space for the conductive rubber, and limits the conductive rubber; on the other hand, after the silicone seat is connected to the transmitter, it can be waterproof, and the waterproof level can reach IPX7.

Said silicone seat 310 is provided with a first hole for conductive rubber 3101 and a second hole for conductive rubber 3102 in the middle. The round holes are used to place the conductive rubber 311.

There are two conductive rubbers 311. After implantation, the sensor 301 passes through the conductive rubber. Each conductive rubber is connected to electrical contacts S+ and S- on the sensor 301 and the transmitter 400. to realize a flexible electrical connection between the sensor and the transmitter. In addition to the role of electrical connection, the conductive rubber maintains the position of the sensor through friction under pressure.

Said silicone seat 310 also has two square holes 3103. The purpose of the square hole is to reduce the resistance when the guide needle and lancing needle are withdrawn from the silicone seat.

Said silicone seat 310 has a circle of trapezoidal or triangular ribs 3104 at the top, which can make the installation of the transmitter easier and better waterproof.

As shown in Figure 20, the electrical system includes an LC filter module for energy storage, 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. The positive and negative electrodes of the battery are connected to the LC filter module for energy storage, there is a connecting line between the LC filter module for energy storage and the VDD end of the SOC wireless module. The connection line has a dual control switch that can be connected to the Da end of the wireless SOC module or the fimction circuit power module, the function circuit power module is connected to the sensor excitation and adjustment 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. The Dc end of the wireless SOC module and the built-in ADC module are connected to the module to increase the accuracy of the ADC. The ADC accuracy enhancement module is connected to the sensor excitation and adjustment module, the positive and negative poles of the excitation module

- 12 CZ 36027 Ul and sensor adjustments are connected to the sensor accordingly.

In the SOC module, VDD is the SOC supply voltage. Da, Db and Dc are the digital output pins of the SOC module. The Daje pin is configured to control the opening and closing of switch S1 and control whether the battery supplies power to the power module of the functional circuit. Db is configured to select the level of the sensor drive circuit, and Dc can be configured to allow the sensor drive module to provide two drive voltage signals to the sensor that are high level and low level. The ADC accuracy enhancement module injects noise signals. Ainl and Ain2 are the ADC inputs, configured to sample the modified and noisy sensor voltage output from the module to increase the accuracy of the ADC.

The high-precision signal sampling method from the ADC precision enhancement module is characterized by including the following steps: Step 1: A noise voltage of 0 amplitude is inserted into the sampled signal, the ADC is sampled, and the result is Readl; Step 2: A noise voltage with amplitude ^Vad ^ ^ef (F _adc ^ _F is the ADC reference voltage, d is the target precision digit) is inserted into the sampled signal, the ADC is sampled, and the result is Read2; Step 3: The final result Read = (Readl+ Read2) /2, the accuracy of the obtained result can be increased by 1 digit.

In use, after the transmitter 400 is installed on the base 302, the battery on the base powers the transmitter via battery lead pin 4011 which is connected to V+V-. The electric circuit consists of a rubber conductive pin 4012, a conductive rubber 311 and a sensor 301, which are connected to the S+S- transmitter. When glucose oxidase on the sensor reacts with glucose inside the receiver, a weak current is generated. The transmitter can measure the current value through the above electrical circuit. Through the transmitter's internal algorithm, the measured current value is converted to the blood sugar value of the recipient. The blood sugar value is then transmitted to the corresponding display device via a wireless transmission module.

The above specific implementation further describes in more detail the goals, technical solutions and beneficial effects of this technical solution. It should be understood that the above descriptions are only a specific embodiment of this technical solution and are not intended to limit this technical solution. Any modification, equivalent replacement or improvement made in the spirit and principle of this technical solution shall be included within the scope of protection of this application.

Claims (9)

PROTECTION CLAIMS 1. A system for measuring physiological parameters of a recipient, characterized in that it includes an implanter (200), a basic sensor device (300) and a transmitter (400), wherein said implanter (200) and transmitter (400) are both installed on the basic sensor device (300); wherein said implanter (200) includes an implanter top cover (201), an implanter bottom cover (202), a button (203), a holder (204), a needle pusher seat (205), a puncture needle seat (206), a guide needle seat (207) ), a needle return spring (208), a drive spring (209), a needle pusher (211), a puncture needle (212), a guide needle (213) and a guide stop block (214), wherein the upper cover (201) of the implanter and the lower the cover (202) of the implanter forms the outer case, and the button (203) is located on the upper cover (201) of the implanter, the holder (204), the needle pusher seat (205), the puncture needle seat (206) and the guide needle seat (207) are installed in an outer housing, the front end of the outer housing being connected to the sensor base device (300); wherein said holder (204) is fixed in an outer housing, wherein the holder (204) is a cylindrical structure with one open end facing the base sensor device (300), the upper part of the holder (204) is a long cylinder (2042) and the front the end of the holder (204) faces the sensor base device (300), the front end of the holder (204) has a flexible holder rib (2044) that is stuck inward, and the flexible holder rib (2044) is configured as a seat of the guide needle (207), in on the upper part of the rear end of the holder, the holder clip (2043) is configured to clamp the needle shifter seat (205), on the outside of the holder (204) are the holder projections (2045) for connection with the guide limiter block (214), and the limiter spring clips (2046 ) to limit the movement of the needle shifter seat (205); wherein said needle shifter seat (205) is a cylindrical structure with two open ends, the needle shifter seat (205) is movable in a holder (204), the upper part of the needle shifter seat (205) is formed by a sleeve (2052), the sleeve (2052) is adapted for the passage of the long cylinder (2042), the front edge of the sleeve (2052) facing the sensor base device (300) has an annular edge, the sleeve (2052) has a built-in drive spring (209) to push the seat of the needle shifter (205), the sleeve (2052) is also provided with an elastic card (2051) connected to the holder clip (2043), the button (203) is adapted to switch the elastic card (2051), both sides of the needle shifter seat (205) are provided with rectangular holes (2055), and the front end of the seat the needle shifter (205) has a chamfered surface (2054), on the upper part of the rear end of the needle shifter seat (205) there is a needle shifter protrusion (2055), and the needle shifter (211) is located in the protrusion (2055) and the upper position in the cylindrical structure the needle shifter seat is all over the d rib provided (2058); where both sides of the puncture needle seat (206) are provided with an inclined holder (2062), the end of the inclined holder (2062) has a spring pin (2061) which is inserted into the rectangular hole (2053), the upper part of the puncture needle seat (206) has a sliding groove (2063) and the slide groove (2063) is snapped into the rib (2058) of the needle shifter seat (205), the puncture needle seat (206) is movable along the rib (2058) in the needle shifter seat (205), wherein said puncture needle ( 212) is located in the seat of the piercing needle (206); where the seat of the guide needle (207) is a cylindrical structure with two open ends, there is a hook (2142) on the side of the guide restrictor block (214) which is connected to the projection of the holder (2045), the guide restrictor block (214) has a guide cylinder ( 2141) and the guide roller (2141) passes through the seat of the guide needle (207), the end of the seat of the guide needle (207) facing the sensor base device (300) has a limit projection (2071) which is connected to the spring clip of the holder (2044), the edge the ends of the guide needle seat (207) deflecting into the sensor base assembly (300) have an annular rim and the guide needle seat (207) has a built-in needle return spring (208) to push the guide needle seat (207) away from the sensor base assembly (300 ), the guide needle seat (207) is located in the seat - 14CZ 36027 UI of the needle shifter (205) and is movable in the seat of the needle shifter (205), on the upper part of the seat of the guide needle (207) there is a release projection (2072) to release the spring pin (2061) from the rectangular hole (2053) by movement guide needle seat (207) and simultaneously pushing the inclined holder (2062) with the release tab (2072), the side of the guide needle seat (207) is also equipped with a release tab (2074) to open the restrictor spring clip (2046), and the upper part the guide needle seat (207) is provided with a guide needle protrusion (2075), the guide needle protrusion (2075) is connected to the sensor base device (300), and said guide needle (213) is located in the guide needle protrusion (2075); wherein said base sensor device (300) includes a base (302) and a tape (303), the base (302) is placed on the tape (303), the top of the base (302) is open, the base (302) has a battery slot (3021) ) and the groove (3024), while the battery (304) and battery cover (307) are installed in the battery slot (3021), a swivel seat (309) is installed in the groove (3024), which is suspended in the groove (3024) on side near the battery slot (3021), the rotating seat (309) is provided with a silicone seat (310), in said silicone seat (310) there is a pair of conductive rubbers (311), the sensor (301) passes through the silicone seat (310) and the rotating the seat (309), wherein the sensor (301) passes through two conductive rubbers (311), said groove (3024) has a gap (3025) on the side near the battery slot (3021), the tape (303) is provided with a hole, wherein the gap (3025 ) and the tape hole (303) are adapted for the passage of the sensor (301); and wherein said transmitter (400) includes a plastic shell (402) and a circuit board assembly (401), the plastic shell (402) is mounted on a base (302), the circuit board assembly (401) is installed inside the plastic shell (402), and the assembly circuit board (401) has four conductive pins, these conductive pins are in contact with the positive and negative electrodes of the battery (304) and two conductive rubbers (311). 2. System for measuring physiological parameters of the recipient according to claim 1, characterized in that the upper cover of the implanter (201) is provided with a button hole (2013) and a button (203) is placed in the button hole (2013); the button hole (2013) has a ring structure inside, and this ring structure is provided with two L-shaped notches (2014), the ends of the two L-shaped notches (2014) are directed to the top cover of the implanter (201); the lower surface of the button (203) has a pair of button protrusions (2031), while the notch (2014) of the button protrusion (2031) can be revealed by turning the button (203), in the lower part of the button (203) there are trigger ribs (2032) for switching the elastic card (2051), wherein one trigger rib (2032) corresponds to one elastic card (2051), when the button protrusion (2031) is in the notch exposed state (2014), the trigger rib (2032) is directly above the elastic card (2051). 3. System for measuring physiological parameters of the recipient according to claim 2, characterized in that there is a deep groove (2026) at the rear end of the lower cover (202) of the implanter, a button holder (215) is arranged in the deep groove (2026), on the button holder (215), the button holder cylinder (2151) is arranged, the lower part of the button (203) is provided with a cylindrical hole (2033), and the button holder cylinder (2151) is placed in the cylindrical hole (2033), and in the cylindrical hole (2033) there is around a button spring (210) is arranged on the cylinder of the button holder (2151). 4. The system for measuring physiological parameters of the recipient according to claim 1, characterized in that the silicone seat (310) is provided with a first hole for conductive rubber (3101) and a second hole for conductive rubber (3102) and the two conductive rubbers (311) are respectively installed in the first conductive rubber hole (3101) and the second conductive rubber hole (3102); there are also two square holes (3103) in the silicone seat (310), and two conductive rubbers (311) and two square holes (3103) are arranged in a straight line, and the sensor (301) passes through the two conductive rubbers (311). 5. The system for measuring physiological parameters of the recipient according to claim 1, characterized in that there is a semicircular hole (3026) on both sides of the groove (3024), a flexible extension rod (3091) on both sides of the end of the swivel seat (309) and an outer side extension rod (3091) is provided with a cylindrical shaft (3092), wherein the cylindrical shaft (3092) is rotatable in a semicircular hole (3026). - 15 CZ 36027 UI 6. The system for measuring physiological parameters of the recipient according to claim 1, characterized in that battery adapters (305) are installed on the positive and negative poles of the battery (304), and each battery adapter (305) is equipped with a battery connector (306) and a cover The battery (307) is provided with two round holes (3073), one round hole (3073) corresponds to one battery connector (306), and the battery connector (306) passes through the round hole (3073) and is extended outside the battery cover (307). 7. The system for measuring the physiological parameters of the recipient according to claim 1, characterized in that there are four conductive pins on the circuit board assembly (401), two conductive pins (4011) for the battery and two conductive pins (4012) for rubbers, while two conductive pins (4012) pins (4011) for the battery are respectively connected to the connector (306) of the battery and two conductive pins (4012) for the rubbers are respectively connected to the conductive rubber (311). 8. The system for measuring physiological parameters of the recipient according to claim 1, characterized in that at the end of the base (302) there is a hole for a clip (3023), at the end of the plastic casing (402) there is an edge protrusion (4021) inserted into the hole for a clip of the base (3023); on the side of the plastic shell (402) is a shell groove (4022), and the inner side wall of the groove (3024) is provided with an elastic clip (3027) which is inserted into the shell groove (4022). 9. System for measuring physiological parameters of the recipient according to claim 1, characterized in that the edge of the battery slot (3021) has sealing strips (308) and the edge of the silicone seat (310) has ribs (3104).