Needle-assisting device, implantable analyte monitoring device, and implantable analyte monitoring system

Abstract

Provided are a needle-assisting device, an implantable analyte monitoring device, and an implantable analyte monitoring system. The needle-assisting device comprises a housing assembly, and a needle insertion support, a fixing plate and an implantation needle assembly that are arranged in the housing assembly. The needle insertion support comprises a sleeve, an accommodating groove, and at least two elastic clamping jaws arranged in the sleeve. A groove opening of the accommodating groove and a sleeve opening of the sleeve are oriented away from each other, and the accommodating groove is configured to accommodate a sensor assembly. The needle insertion support is arranged in the housing assembly, such that the needle insertion support can move in a first direction and can be limited to a first position and a second position of the housing assembly. The housing assembly and the needle insertion support can be separated by means of a trigger button on the housing assembly, and a through hole is formed at the bottom of the sleeve. The fixing plate can be locked to the elastic clamping jaws, and the housing assembly enables the separation of the fixing plate from the elastic clamping jaws. The implantation needle assembly comprises a needle base and an implantation needle connected to the needle base. The needle base is circumferentially clamped between the elastic clamping jaws and arranged between the elastic clamping jaws and the bottom of the sleeve, and the needle base can move towards the fixing plate.

Description

Needle assist device, implantable analyte monitoring device, and implantable analyte monitoring system

[0001] This application claims priority to the Chinese patent application filed with the China Patent Office on November 20, 2023, with application number 202323128737.5, and claims priority to the Chinese patent application filed with the China Patent Office on November 30, 2023, with application number 202323240976.X. The entire contents of the above applications are incorporated by reference into this application. Technical Field

[0002] The present application relates to the technical field of medical devices, for example, to a needle aid, an implantable analyte monitoring device, and an implantable analyte monitoring system. Background Art

[0003] With the development of society and the advancement of science and technology, medical device technologies are gradually moving towards intelligent and information-based technologies. Implantable analyte monitoring systems, such as continuous glucose monitoring (CGM), are gaining widespread attention due to their importance in glycemic control for diabetics.

[0004] The implantable analyte monitoring system includes an implantable analyte monitoring device and a needle assisting device.

[0005] The implantable analyte monitoring device is configured to be implanted on the surface of the skin to obtain target analyte data in the human body. It includes a sensor and a transmitter. One end of the sensor is implanted in the subcutaneous tissue of the human body and is configured to react with interstitial fluid glucose and generate an electrical signal. The other end is connected to the transmitter and is configured to transmit the electrical signal to the signal processing module. The connection between the sensor and the transmitter needs to be installed and fixed, and the electrical signal must be connected at the same time. The implantable analyte monitoring device can be worn on the human body for 7 to 14 consecutive days and continuously monitor changes in the human body's blood sugar. In order to prevent the user from affecting work, life and exercise during wearing, the sensor needs to be effectively fixed to ensure that the sensor can stably collect biological signals and transmit them to the transmitter.

[0006] Related technologies use a clamping spring to secure the sensor and maintain electrical signal communication. However, this method of securing and connecting the sensor can lead to fatigue after prolonged use. Relying solely on the elasticity of the clamping spring to secure the sensor and maintain signal communication lacks stability, especially after exercise or prolonged use. This can lead to poor contact, which can cause the transmitter to be unable to reliably receive and process electrical signals, shortening the lifespan of the implantable analyte monitoring device.

[0007] During the manufacturing process of implantable analyte monitoring devices, the implant needle and sensor implant, which enter the human subcutaneous tissue, must be sealed with a sterilization assembly to ensure that the sensor implant and the implant needle are sterile before use, preventing bacterial infection during use. However, how to quickly and effectively remove the needle cap used during sterilization is a challenge that needs to be addressed.

[0008] Implanting an implantable analyte monitoring device into the subcutaneous tissue of the human body requires the aid of a needle aid (implantation device). Currently, implantation devices such as patent CN102573616B disclose a medical device insertion device, which includes a sheath, a device support portion movable between proximal and distal positions, a tip support portion movable between proximal and distal positions, a handle movable between proximal and distal positions, and a driver. The insertion device is operated with one hand, and the external force applied by the hand to the shell implants the insertion electrode of the sensor into the subcutaneous tissue of the human body through the implantation needle. At the same time as the implantation, the spring inside the shell is compressed to store energy, and the stored energy spring rebounds to cause the implantation needle to withdraw from the skin. The implantation device in the related art has problems such as complex structure and insufficient convenience of use. Summary of the Invention

[0009] The present application provides a needle assist device, an implantable analyte monitoring device, and an implantable analyte monitoring system. The structure of the needle assist device is simplified, the stability of the implantable analyte monitoring device is improved, the implantable analyte monitoring system is easy to sterilize, and is simple and quick to use, thereby improving user experience.

[0010] The first aspect of the present application provides a needle assist device, comprising:

[0011] The shell assembly has a firing button on its outer peripheral side;

[0012] A needle insertion bracket is disposed in the housing assembly, comprising a sleeve, a receiving groove, and at least two elastic claws disposed in the sleeve, the notch of the receiving groove and the barrel opening of the sleeve facing away from each other, the receiving groove being configured to accommodate a sensor assembly, the needle insertion bracket being movable in a first direction and being limited to a first position and a second position of the housing assembly, the firing button being capable of separating the housing assembly and the needle insertion bracket to move from the first position to the second position, and a through hole being provided at the bottom of the sleeve;

[0013] a fixing plate, disposed in the housing assembly, capable of being locked with the elastic claw, and the housing assembly is capable of separating the fixing plate from the elastic claw;

[0014] An implant needle assembly includes a needle seat and an implant needle connected to the needle seat. The needle seat is circumferentially clamped between the elastic claws and is arranged between the elastic claws and the bottom of the sleeve. The needle seat can move toward the fixed plate. The implant needle can be inserted into the through hole and plugged into the sensor assembly. The sensor electrode of the sensor assembly is inserted into the implant needle.

[0015] In some possible implementations, a rib is provided on the inner side of the housing assembly, and a flange is provided on the outer periphery of the needle insertion bracket. When the needle insertion bracket is located at the first position, the rib abuts against the flange.

[0016] In some possible implementations, the following further comprises:

[0017] a first elastic member, disposed in a first accommodating space formed by the sleeve and the housing assembly, with two ends thereof respectively abutting against the bottom of the sleeve and the housing assembly;

[0018] The second elastic member is arranged in a second accommodating space formed by the needle seat and the sleeve. The opening of the needle seat faces the bottom of the sleeve. Both ends of the second elastic member respectively abut against the bottom of the sleeve and the top of the needle seat.

[0019] In some possible embodiments, a first limit block and a second limit block are provided inside the shell assembly, and the first limit block and the second limit block are spaced apart along the first direction. A first limit buckle and a second limit buckle are provided on the outer periphery of the sleeve, and the first limit buckle is connected to the first limit block so that the needle insertion bracket is located in the first position, and the second limit buckle is connected to the second limit block so that the needle insertion bracket is located in the second position, and the firing button can separate the first limit buckle and the first limit block.

[0020] In some possible implementations, the first limiting buckle is elastic along the radial direction of the sleeve, and the firing button can drive the first limiting buckle to move along the radial direction of the sleeve.

[0021] In some possible implementations, one of the needle insertion bracket and the housing assembly is provided with a guide groove, and the other is provided with a guide rib, and the guide rib is slidably connected to the guide groove.

[0022] In some possible implementations, a step is provided on an inner side of the elastic claw, and the needle seat is provided between the step and the bottom of the sleeve.

[0023] In some possible implementations, the elastic claw is clamped to the fixing plate or the fixing plate is hinged to one of the elastic claws.

[0024] In some possible implementations, an elastic clamping arm is provided in the accommodating groove, and the sensor assembly is clamped by the elastic clamping arm.

[0025] In some possible embodiments, the shell assembly includes an upper shell and a top cover and a protective cover detachably connected to both ends of the upper shell, the top cover can separate the fixing plate from the elastic claw, the firing button is connected to the upper shell, and the protective cover is arranged toward the accommodating groove.

[0026] In some possible implementations, a first support base is further included, and the first support base is fixedly connected to the upper shell, and the connection method includes but is not limited to a snap connection, a slide connection, and glue dispensing.

[0027] In some possible implementations, at least one guide post is provided in the needle insertion bracket, and the guide post is configured to cooperate with the fixing plate.

[0028] In some possible implementations, a pull ring is provided on the firing button, and the pull ring is configured to prevent the user from accidentally triggering the firing button.

[0029] The second aspect of the present application also provides an implantable analyte monitoring device that can effectively install and fix the sensor to ensure that the implantable analyte monitoring device can still ensure stable connection of electrical signals after long-term use.

[0030] The implantable analyte monitoring device comprises an upper cover and a lower shell connected to each other to form a housing, a circuit board is installed inside the housing, and a signal input end of the circuit board is connected to a sensor through a socket;

[0031] The sensor includes an implant end and a signal connection end, and a fixing component is provided on the lower shell for fixing the signal connection end inside the shell;

[0032] The socket includes a base and a terminal mounted on the base. The base is provided with a slot configured to engage the signal connection end. One end of the terminal extends into the slot and contacts the contact on the signal connection end, while the other end passes through the base and is electrically connected to the circuit board.

[0033] In some possible implementations, contacts configured to transmit signals are provided on one or both side surfaces of the signal connection end.

[0034] In some possible implementations, the fixing assembly includes a slot portion, which is located on the upper end surface of the lower shell and arranged along the extension direction of the signal connection end, and the slot portion engages and fixes the bottom of the signal connection end.

[0035] In some possible implementations, the fixing assembly includes clamping members, and at least one pair of clamping members clamps and fixes the signal connection end.

[0036] In some possible implementations, at least one limiting groove corresponding to the clamping member is defined on both sides of the slot, and the clamping member is inserted into the limiting groove.

[0037] In some possible implementations, a connecting portion configured for signal transmission is provided between the signal connection end and the implantation end, and a pressing groove is provided between the connecting portion and the signal connection end, and the pressing groove engages with the base.

[0038] In some possible implementations, the terminal is integrally bent and formed, and includes a crimping portion connected to the contact, a connecting portion connected to the circuit board, and a conducting portion disposed between the crimping portion and the connecting portion;

[0039] The crimping portion is a hook-shaped structure with an end portion extending obliquely toward the conducting portion.

[0040] In some possible embodiments, a second mounting groove is provided on the base, the conductive portion of the terminal is fixed in the second mounting groove, a third mounting groove connected to the second mounting groove is provided on the top of the base, the connecting portion of the terminal passes through the third mounting groove and is connected to the circuit board, a first mounting groove is provided between the second mounting groove and the slot, the crimping portion of the terminal is provided in the first mounting groove, and the outermost side of the crimping portion extends from the first mounting groove into the slot and is connected with the contact.

[0041] In some possible implementations, one of the lower shell and the upper cover is provided with a first buckle, and the other is provided with a first slot corresponding to the position of the first buckle, and the lower shell and the upper cover are buckled together by engaging the first buckle with the first slot.

[0042] In some possible implementations, the lower shell and the upper cover are fastened and sealed by glue or elastic members.

[0043] In some possible implementations, a second buckle is provided on one of the lower shell or the upper cover, and the housing fixes the circuit board inside the housing through the second buckle.

[0044] In some possible implementations, a second buckle is provided on one of the lower shell or the upper cover, the second buckle engages with one of the upper end surface or the lower end surface of the circuit board, and the first buckle supports the other side of the circuit board.

[0045] In some possible implementations, the lower shell is provided with a positioning post, which is inserted into a positioning hole of the circuit board to position the circuit board, and the circuit board is fixed by buckling the lower shell and the upper cover.

[0046] In some possible embodiments, the upper cover opening is configured to pass through a fixed implant needle seat, and the lower shell opening is configured to pass through a needle cap. The needle cap and the implant needle seat are detachably connected to form a sterilization cavity, and the implantation needle and the implantation end of the sensor on the implant needle seat are both extended into the sterilization cavity.

[0047] A third aspect of the present application further provides an implantable analyte monitoring system that can quickly and effectively remove the needle cap used for sterilization when using the implantable analyte monitoring device, thereby reducing the risk of bacterial infection. The implantable analyte monitoring system comprises the needle aid described in the first aspect and the implantable analyte monitoring device described in the second aspect.

[0048] An implantable needle seat and a needle cap are provided on the implantable analyte detection device, and the implantable analyte detection device is installed in a needle assist device, which includes an upper shell, a top cover, and a protective cover detachably connected to the upper shell and the top cover. A needle assist component configured to realize needle assist and needle withdrawal actions is provided inside the needle assist device, and the protective cover is connected to the needle cap used for sterilization through a connector.

[0049] As an optional solution, the connecting member includes a base and a first fastener. A fixing hole is opened on the protective cover. One end of the first fastener passes through the fixing hole and extends into the protective cover to be fastened to the upper end surface of the bottom plate of the protective cover, and the other end is connected to the base. The base abuts against the lower end surface of the bottom plate of the protective cover.

[0050] As an optional solution, the connecting member further includes a second fastener, one end of which passes through the fixing hole and is engaged with the needle cap, and the other end of the second fastener is connected to the base. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] FIG1 is an exploded view of a needle assist device provided in an embodiment of the present application;

[0052] FIG2A is a schematic diagram of a needle assist device in an initial state provided by an embodiment of the present application;

[0053] FIG2B is a schematic diagram of another needle assisting device in an initial state provided by an embodiment of the present application;

[0054] FIG3 is a schematic diagram of the needle assisting device provided in an embodiment of the present application in a needle-retracted state;

[0055] FIG4 is a cross-sectional view of the needle insertion bracket, needle seat and fixing plate provided in an embodiment of the present application;

[0056] FIG5 is a schematic diagram of a needle insertion bracket provided in an embodiment of the present application;

[0057] FIG6 is a schematic diagram of the connection between the needle insertion bracket and the fixing plate provided in an embodiment of the present application;

[0058] FIG7 is a cross-sectional view of an upper shell provided in an embodiment of the present application;

[0059] FIG8 is a cross-sectional view of a top cover provided in accordance with an embodiment of the present application;

[0060] FIG9 is a schematic diagram of a sensor assembly and an implant needle provided in accordance with an embodiment of the present application;

[0061] FIG10 is a schematic diagram of a sensor assembly provided in accordance with an embodiment of the present application;

[0062] FIG11 is an exploded view of another needle assist device provided in an embodiment of the present application;

[0063] FIG12 is a schematic diagram of the connection between another needle insertion bracket and a fixing plate provided in an embodiment of the present application;

[0064] FIG13 is a schematic diagram of another needle assisting device in a needle withdrawal state provided by an embodiment of the present application;

[0065] FIG14 is a cross-sectional view of another needle insertion bracket, needle seat and fixing plate provided in an embodiment of the present application;

[0066] FIG15 is a schematic diagram of another needle insertion bracket provided in an embodiment of the present application;

[0067] FIG16 is a schematic diagram of the overall structure of an implantable analyte monitoring device provided in an embodiment of the present application;

[0068] FIG17 is an exploded view of an implantable analyte monitoring device provided in an embodiment of the present application;

[0069] FIG18A is a cross-sectional view of an implantable analyte monitoring device provided in an embodiment of the present application;

[0070] FIG18B is a cross-sectional view of another implantable analyte monitoring device provided in an embodiment of the present application;

[0071] FIG18C is a schematic diagram of the interior of an implantable analyte monitoring device provided in an embodiment of the present application;

[0072] FIG19 is a schematic diagram of the assembly structure of the lower housing and sensor of the implantable analyte monitoring device provided in an embodiment of the present application;

[0073] FIG20 is a schematic diagram of the assembly structure of the socket and sensor of the implantable analyte monitoring device provided in an embodiment of the present application;

[0074] FIG21 is a schematic diagram of the socket structure provided in this embodiment;

[0075] FIG22 is a schematic diagram of a structure in which the base and the terminal are separated according to an embodiment of the present application;

[0076] FIG23 is an exploded view of a sealing assembly (in the dashed box) of an implantable analyte monitoring device provided in an embodiment of the present application;

[0077] FIG24 is an exploded view of another implantable analyte monitoring device provided in an embodiment of the present application;

[0078] FIG25 is a schematic structural diagram of an implantable analyte monitoring device, an implant needle, and a needle cap provided in an embodiment of the present application;

[0079] FIG26 is a schematic diagram of the assembly structure of the lower housing and sensor of another implantable analyte monitoring device provided in an embodiment of the present application;

[0080] FIG27 is a schematic diagram of the assembly structure of a circuit board and a sensor of another implantable analyte monitoring device provided in an embodiment of the present application;

[0081] FIG28 is a schematic diagram of another socket structure provided in an embodiment of the present application;

[0082] FIG29 is a schematic diagram of the disassembled structure of another base, terminal and fixed solder piece provided in an embodiment of the present application;

[0083] FIG30 is a diagram showing the connection between a needle cap, a connector, and a protective cover provided in an embodiment of the present application;

[0084] FIG31 is a schematic structural diagram of another needle assisting device provided in an embodiment of the present application;

[0085] FIG32 is a diagram showing the connection between the needle cap and the protective cover of the implantable analyte monitoring system provided in an embodiment of the present application;

[0086] FIG33 is a schematic diagram of the connector structure of the implantable analyte monitoring system provided in an embodiment of the present application;

[0087] Figure 34 is an enlarged view of the details of area A in Figure 32;

[0088] Figure 35 is a partial structural diagram of another needle cap, connector and protective cover provided in an embodiment of the present application.

[0089] In the above figure:

[0090] 1. Housing assembly; 110. Rib; 12. First stopper; 13. Second stopper; 14. Guide rib; 15. Hook; 2. Firing button; 21. Pull ring; 3. Needle support; 31. Sleeve; 32. Receiving groove; 33. Elastic claw; 331. Step; 332. Slot; 34. Through hole; 35. Flange; 36. First stopper; 37. Second stopper; 38. Guide groove; 39. Elastic Clamping arm; 4. Fixing plate; 41. Groove; 42. Buckle; 43. First connecting portion; 5. Implant needle assembly; 51. Needle seat; 52. Implant needle; 6. First elastic member; 7. Second elastic member; A. First accommodating space; B. Second accommodating space; 100. Sensor assembly; 101. Transmitter; 102. Sensor electrode; 201. First support base; 301. Guide post; 11. Implantable analyte monitoring device;

[0091] 111, upper cover;

[0092] 112, lower shell; 1121, slot portion; 1122, clamping member; 1123, first buckle; 1124, second buckle; 1125, mounting seat; 116, first sealing ring; 1126, sealing groove; 1127, second protrusion;

[0093] 113, sensor; 1131, implant end; 1132, signal connection end; 1133, contact; 1134, groove; 1135, connecting portion; 1136, first protrusion;

[0094] 114. Circuit board; 1141. Battery; 1142. Signal input terminal;

[0095] 115. Socket; 1151. Base; 1152. Terminal; 11521. Crimping portion; 11522. Conducting portion; 11523. Connecting portion; 1153. Slot; 1154. Limiting groove; 1155. Groove portion; 1156. First mounting groove; 1157. Second mounting groove; 1158. Third mounting groove; 1159. Fixing piece;

[0096] 170, skin patch; 180, needle cap plug;

[0097] 1000. Implantable analyte monitoring system;

[0098] 121, upper shell; 122, protective cover; 1221, card holder; 123, top cover;

[0099] 130. Implant needle holder;

[0100] 140, needle cap; 142, connecting groove; 143, reinforcing rib; 144, third protrusion

[0101] 150, connecting member; 151, base; 152, first fastener; 153, second fastener;

[0102] 16. Needle assist assembly. DETAILED DESCRIPTION

[0103] The technical solutions of the embodiments of the present application will be described below in conjunction with the accompanying drawings. The described embodiments are only part of the embodiments of the present application, rather than all the embodiments.

[0104] In the description of this application, unless otherwise specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integration; mechanical connections, electrical connections; direct connections, indirect connections through an intermediate medium, and internal connections between two components or interactions between two components. The meanings of the above terms in this application can be understood based on actual circumstances.

[0105] In this application, unless otherwise specified or limited, a first feature being "above" or "below" a second feature may include the first feature being in direct contact with the second feature, or may include the first feature being in contact with the second feature through another feature between them instead of being in direct contact. Moreover, a first feature being "above," "above," and "above" a second feature may include the first feature being directly above or obliquely above the second feature, or may simply mean that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may include the first feature being directly below or obliquely below the second feature, or may simply mean that the first feature is lower in level than the second feature.

[0106] This embodiment provides a needle assist device, as shown in Figures 1 to 3, comprising a housing assembly 1, a firing button 2, a needle insertion bracket 3, a fixing plate 4, and an implant needle assembly 5. The firing button 2 is disposed on the outer peripheral side of the housing assembly 1. The needle insertion bracket 3 is disposed within the housing assembly 1 and comprises a sleeve 31, a receiving groove 32, and at least two elastic claws 33 disposed within the sleeve 31. The notch of the receiving groove 32 and the barrel opening of the sleeve 31 face away from each other. The receiving groove 32 is configured to accommodate a sensor assembly 100. The needle insertion bracket 3 is disposed within the housing assembly 1 and is movable in a first direction and can be limited to a first position and a second position within the housing assembly 1. The firing button 2 can separate the housing assembly 1 and the needle insertion bracket 3 to move from the first position to the second position. A through hole 34 is provided at the bottom of the sleeve 31. The fixing plate 4 is disposed within the housing assembly 1 and can be locked with the elastic claws 33. The housing assembly 1 can separate the fixing plate 4 from the elastic claws 33. The implant needle assembly 5 includes a needle hub 51 and an implant needle 52 connected to the needle hub 51. The needle hub 51 is circumferentially sandwiched between the elastic claws 33 and disposed between the elastic claws 33 and the bottom of the sleeve 31. The needle hub 51 is movable toward the fixed plate 4. The implant needle 52 is capable of passing through the through hole 34 and being plugged into the sensor assembly 100. The sensor electrode 102 of the sensor assembly 100 is disposed through the implant needle 52. In this embodiment, the first direction is the X direction.

[0107] The steps for using the needle aid include:

[0108] Initial state: The needle insertion bracket 3 is in the first position away from the skin. The fixing plate 4 and the elastic claw 33 are locked, and the elastic claw 33 is constrained by the fixing plate 4. The sensor assembly 100 is disposed in the receiving groove 32 of the needle insertion bracket 3. The implantation needle 52 is inserted into the through hole 34 and plugged into the sensor assembly 100. The sensor electrode 102 of the sensor assembly 100 is inserted into the implantation needle 52.

[0109] Firing state: Activating firing button 2 separates housing assembly 1 and needle holder 3, causing needle holder 3 to move from a first position away from the skin to a second position closer to the skin. Sensor assembly 100 and implant needle 52 follow needle holder 3 to the second position, and the sensor body's electrodes are implanted subcutaneously along with implant needle 52. The moment needle holder 3 moves to the second position, elastic claw 33 separates from fixing plate 4, causing it to lose its restraint and elastically deform radially outward along sleeve 31, increasing the space formed by elastic claw 33. Needle holder 51 loses its circumferential restraint and moves toward fixing plate 4, i.e., away from the skin, driving implant needle 52 back. The skin patch attached to the sensor body secures sensor assembly 100 to the skin surface. The user removes the needle aid, completing the implantation of sensor assembly 100.

[0110] As shown in Figures 2A, 2B, and 5, the sensor assembly 100 is installed in the receiving groove 32, and the trigger button 2 is actuated to implant the sensor assembly 100 subcutaneously. This facilitates operation and improves the user experience. The above structure is simple and compact, easy to manufacture, and low in cost. Compared with Figure 2B, the shape of the implant needle seat 130 in Figure 2A has changed, allowing the needle seat 51 to more firmly fix the implant needle seat 130.

[0111] As shown in Figures 2A, 2B to 7, the housing assembly 1 is internally provided with a first stopper 12 and a second stopper 13, which are spaced apart along a first direction. A first stopper 36 and a second stopper 37 are provided on the outer periphery of the sleeve 31. In the initial state, the first stopper 36 engages with the first stopper 12, positioning the needle support 3 in the first position. Upon pressing the trigger button 2, the second stopper 37 engages with the second stopper 13, positioning the needle support 3 in the second position, preventing the needle support 3 from separating from the housing assembly 1. The trigger button 2 disengages the first stopper 36 from the first stopper 12, thereby separating the housing assembly 1 from the needle support 3. The needle support 3 moves until it engages with the second stopper 37 and the second stopper 13, limiting the needle support 3 to the second position of the housing assembly 1. The spacing between the first stopper 12 and the second stopper 13 along the first direction defines the travel range of the needle support 3.

[0112] In the initial state, the firing button 2 abuts against the side of the first limiting buckle 36, and the bottom of the first limiting buckle 36 abuts against the first limiting block 12. The first limiting buckle 36 is elastic along the radial direction of the sleeve 31 and can be elastically deformed inward. The firing button 2 can drive the first limiting buckle 36 to move radially inward along the sleeve 31, so that the first limiting buckle 36 is separated from the first limiting block 12. Optionally, each of the first limiting buckle 36 and the first limiting block 12 is provided with at least one and is correspondingly arranged, and each of the second limiting buckle 37 and the second limiting block 13 is provided with at least two and is correspondingly arranged.

[0113] The sleeve 31 is elastically connected to the housing assembly 1, and the needle hub 51 is elastically connected to the elastic claw 33 and the bottom of the sleeve 31 in a first direction. Under the elastic force, the sleeve 31 and the needle hub 51 move in the first direction. Exemplarily, the needle assist device also includes a first elastic member 6 and a second elastic member 7. The first elastic member 6 is disposed within a first accommodating space A formed by the sleeve 31 and the housing assembly 1, with its ends abutting the bottom of the sleeve 31 and the housing assembly 1, respectively. The second elastic member 7 is disposed within a second accommodating space B formed by the needle hub 51 and the sleeve 31, with the opening of the needle hub 51 facing the bottom of the sleeve 31, and its ends abutting the bottom of the sleeve 31 and the top of the needle hub 51, respectively. In the initial state, both the first elastic member 6 and the second elastic member 7 are in a compressed state. In the firing state, the needle support 3 and the housing assembly 1 are no longer constrained, and the first spring expands and contracts to reset, driving the needle support 3 from the first position to the second position. When the needle holder 51 loses the restraint of the elastic claw 33, the second accommodating space B opens wider, and the second elastic member 7 retracts and resets, driving the needle holder 51 away from the bottom of the sleeve 31 and retracting the implant needle 52. After the elastic deformation of the second elastic member 7 is restored, the implant needle assembly 5 is fully retracted. For example, both the first elastic member 6 and the second elastic member 7 are springs.

[0114] One of the needle support 3 and the housing assembly 1 is provided with a guide groove 38, and the other with a guide rib 14. The guide rib 14 is slidably connected to the guide groove 38 to improve the movement accuracy of the needle support 3 along the first direction. Optionally, multiple guide grooves 38 and multiple guide ribs 14 are provided, and the two are arranged in a corresponding manner. In this embodiment, the guide groove 38 is provided on the outer side of the sleeve 31, and the guide rib 14 is provided on the inner side of the housing assembly 1.

[0115] A step 331 is provided on the inner side of the elastic claw 33, and the needle seat 51 is provided between the step 331 and the bottom of the sleeve 31. After the elastic claw 33 loses the constraint of the fixed plate 4, the opening formed between the multiple elastic claws 33 increases, the elastic claw 33 deforms outward, and the step 331 separates from the sleeve 31 along with the elastic claw 33.

[0116] As shown in Figures 4, 6, and 8, the elastic claw 33 is engaged with the fixed plate 4, or the fixed plate 4 is hingedly connected to one of the elastic claws 33. For example, the elastic claw 33 is provided with a slot 332, and the fixed plate 4 is provided with a buckle 42, which is engaged with the slot 332. The buckles 42 and slots 332 are identical in number and arranged in a corresponding manner. As shown in Figure 5, an elastic clamping arm 39 is provided within the accommodating groove 32, and the sensor assembly 100 is clamped to the elastic clamping arm 39 to improve connection reliability and prevent slippage.

[0117] As shown in Figures 5 and 7, a rib 110 is provided on the inner side of the housing assembly 1, and a flange 35 is provided on the outer periphery of the needle support 3. In this embodiment, the flange 35 is provided on the outer periphery of the sleeve 31. When the needle support 3 is in the first position, the rib 110 abuts against the flange 35. After the user completes the implantation, when the needle support 3 is pushed toward the first position, the flange 35 of the needle support 3 abuts against the rib 110, preventing the elastic claw 33 of the needle support 3 from re-engaging with the fixing plate 4, thus avoiding secondary use.

[0118] As shown in Figures 1 to 3, the shell assembly 1 includes an upper shell 121 and a top cover 123 and a protective cover 122 that are detachably connected to both ends of the upper shell 121. The top cover 123 can separate the fixing plate 4 from the elastic claw 33. The firing button 2 is connected to the upper shell 121, and the protective cover 122 is arranged toward the accommodating groove 32. When the sensor assembly 100 is installed in the accommodating groove 32, the protective cover 122 is removed to expose the sensor assembly 100 to the outside. The upper shell 121 is open at both ends, and the top cover 123 and the protective cover 122 block the ends of the upper shell 121. The top cover 123 is provided with a hook 15, and the fixed plate 4 is provided with a groove 41. In the initial position, the fixed plate 4 is clamped between the elastic claw 33 and the top cover 123, and the fixed plate 4 and the elastic claw 33 are locked by hinges or snaps. At the moment of needle assistance, the hook 15 hooks the groove 41 to separate the elastic claw 33 from the fixed plate 4 to achieve unlocking. Optionally, there can be multiple hooks 15 and grooves 41, and the two can be the same in number and arranged accordingly. The upper shell 121 is provided with a first limit block 12, a second limit block 13, a guide rib 14 and a rib 110, and adopts a split structure for easy processing and manufacturing. The first direction is the centerline direction of the upper shell 121. The top cover 123 and the protective cover 122 are both connected to the upper shell 121 by structures such as threads or snaps. The firing button 2 is connected to the upper shell 121.

[0119] As shown in Figures 9 and 10, the sensor assembly 100 includes a transmitter 101 and a sensor electrode 102. The transmitter 101 is arranged in the accommodating groove 32 and is detachably connected to the needle insertion bracket 3. The sensor electrode 102 has a part arranged inside the transmitter 101 and electrically connected to the transmitter 101 circuit and a part extending out of the transmitter 101 and arranged to be implanted subcutaneously. Please refer to the relevant technology and will not repeat it here.

[0120] As shown in Figures 11 to 15, this application also provides another exemplary embodiment of the needle assist device. The firing button 2 may be provided with a pull ring 21, which is configured to prevent the user from accidentally triggering the firing button 2. That is, the firing button 2 is an anti-accidental touch button. Before using the needle assist device, the pull ring 21 must be removed before the firing button 2 can be pressed.

[0121] FIG11 also shows a change in the structure of the needle insertion bracket 3. At least one guide column 301 can be provided in the needle insertion bracket 3. On the basis of the original elastic claw 33, the guide column 301 is added (as shown in FIG12 ), which can more reliably lock the sliding path of the needle insertion bracket 3 and the fixed plate 4, thereby facilitating stable needle withdrawal.

[0122] Since the guide column 301 is added to the needle insertion bracket 3, the structure of the fixing plate 4 that can be locked with the needle insertion bracket 3 also needs to be changed (as shown in Figure 11). A connection structure that can cooperate with the guide column 301 can be added to the fixing plate 4. Exemplarily, as shown in Figure 12, the connection method between the elastic claw 33 and the fixing plate 4 can be the same as the connection method in Figures 4 and 6. The fixing plate 4 also includes at least one first connecting portion 43 (as shown in Figures 11 and 12). The elastic claw 33 is provided corresponding to the first connecting portion 43 in the needle insertion bracket 3. The first connecting portion 43 is connected to the elastic claw 33 in a sliding groove or a snap connection or abutment to make the connection between the needle insertion bracket 3 and the fixing plate 4 more stable, so as to facilitate more accurate positioning of the fixing plate 4 on the needle insertion bracket 3. Among them, the number of guide columns 301 and first connecting portions 43 in Figures 11 and 12 can be set according to needs and is not limited.

[0123] In this embodiment, as shown in Figure 11, the needle inserter further includes a first support base 201, which is matingly connected to the upper shell 121. The first support base 201 and the upper shell 121 are fixedly connected using methods including, but not limited to, a slide connection, a snap-fit ​​connection, and adhesive dispensing. The provision of the first support base 201 reduces the contact area between the needle inserter and the skin, thereby improving implantability.

[0124] In one or more embodiments, a connector 150 is provided at the bottom of the protective cover 122 , and the protective cover 122 is connected to the needle cap 140 (sealing cap) via the connector 150 , which can help to remove the needle cap 140 .

[0125] As shown in Figure 16, this embodiment provides an implantable analyte monitoring device 11, which is mainly used for monitoring dynamic changes in blood glucose, but is not limited to this. The implantable analyte monitoring device 11 can also be used for monitoring other related targets such as lactate, acetylcholine, amylase, bilirubin, cholesterol, and chorionic gonadotropin.

[0126] As shown in FIG16 , the implantable analyte monitoring device 11 comprises an upper cover 111 and a lower shell 112, which engage with each other to form a housing. A circuit board 114 is mounted within the housing, and a signal input terminal 1142 of the circuit board 114 is connected to a sensor 113 via a socket 115. The sensor 113 comprises an implant terminal 1131 and a signal connection terminal 1132. The lower shell 112 is provided with a fixing assembly configured to secure the signal connection terminal 1132 within the housing. The socket 115 comprises a base 1151 and a terminal 1152 mounted on the base 1151. The base 1151 defines a slot 1153 configured to engage the signal connection terminal 1132. One end of the terminal 1152 extends into the slot 1153 and contacts a contact 1133 on the signal connection terminal 1132. The other end of the terminal 1152 passes through the base 1151 and is electrically connected to the circuit board 114.

[0127] As shown in Figures 17, 18A, 18B and 18C, the sensor 113 includes an implantation end 1131 and a signal connection end 1132. A connecting portion 1135 is provided between the implantation end 1131 and the signal connection end 1132. The implantation end 1131 is located outside the shell. During use, the implantation end 1131 enters the subcutaneous tissue of the human body together with the implantation needle, and then the implantation needle quickly rebounds and exits the subcutaneous tissue of the human body, while the implantation end 1131 of the sensor 113 remains under the subcutaneous tissue of the human body for detecting the interstitial fluid glucose value. The bioelectrode on the implantation end 1131 converts the biosignal of the interstitial fluid glucose value into an electrical signal, and transmits the electrical signal to the signal connection end 1132 through the connecting portion 1135. The signal connection end 1132 transmits the electrical signal to the circuit board 114. A signal processing module and a signal transmission module are provided on the circuit board 114. The signal processing module processes the collected signal and sends the signal to a user terminal such as a mobile phone or a computer through the signal transmission module. The user can realize real-time query of the monitoring data through the terminal. 18B and 18C , a first protrusion 1136 may be provided on the top of the electrode of the sensor 113. Compared to FIG18A , the structure of the sensor 113 in FIG18B and 18C has been changed, which can facilitate positioning and installation of the sensor 113 in the implant needle 52.

[0128] In one or more embodiments, a connecting portion 1135 for signal transmission is provided between the signal connection end 1132 and the implantation end 1131 , and a pressing groove 1134 is provided between the connecting portion 1135 and the signal connection end 1132 , and the pressing groove 1134 engages with the base 1151 .

[0129] In one or more embodiments, contacts 1133 configured to transmit signals are provided on one or both sides of the signal connection end 1132 .

[0130] In this embodiment, the signal connection terminal 1132 has a strip-shaped structure and is arranged vertically with the lower shell 112. Contacts 1133 for electrical connection to the implant terminal 1131 can be provided on one or both sides of the signal connection terminal 1132. The number of contacts 1133 is generally two, but can also be three or another number, the specific number being determined by the number of electrodes on the implant terminal 1131 and the desired function.

[0131] As shown in FIG. 17 , the socket 115 is mounted on the circuit board 114 . The function of the socket 115 is to connect the signal between the circuit board 114 and the sensor 113 and to further fix the sensor 113 .

[0132] In order to adapt to the scenario where the implantable analyte monitoring device 11 can continuously monitor human analyte data for multiple days, especially to ensure that the user's daily activities such as work, life, and exercise are not affected during the use of the implantable analyte monitoring device 11, higher requirements are placed on the installation and fixation of the sensor 113 and the stability of the signal.

[0133] To solve the installation problem of sensor 113, referring to Figure 19, the fixing assembly includes a slot portion 1121. The slot portion 1121 is located on the upper end surface of the lower shell 112 and is arranged along the extension direction of the signal connection terminal 1132. The slot portion 1121 engages and fixes the bottom of the signal connection terminal 1132. A strip-shaped fixing rib is provided along the upper end surface of the lower shell 112. The slot portion 1121 is recessed along the extension direction of the fixing rib and matches the specifications of the signal connection terminal 1132. The bottom of the signal connection terminal 1132 is fixed by the engagement of the slot portion 1121. Alternatively, the slot portion 1121 can be directly provided on the lower shell 112 to engage and fix the bottom of the signal connection terminal 1132.

[0134] Continuing to refer to Figure 19, the fixing assembly also includes at least one pair of clamping members 1122, and the at least one pair of clamping members 1122 is composed of two clamping members 1122 respectively arranged along both sides of the slot portion 1121. The at least one pair of clamping members 1122 clamps and fixes the signal connection end 1132 to achieve vertical fixation of the middle and top of the signal connection end 1132.

[0135] Continuing with reference to FIG19 , a through hole is provided through the center of the lower shell 112, configured to pass through the implant needle and sensor 113. A mounting seat 1125 is provided on the upper end surface of the lower shell 112, located at the outer edge of the through hole. A slot is provided on the mounting seat 1125, opposite the through hole, and configured to pass through the sensor 113 and the implant needle. A sealing groove 1126 is recessed on the upper end surface of the mounting seat 1125, through which the connecting portion 1135 of the sensor 113 extends into the slot and connects to the implant end 1131. During the sterilization process, to ensure a sealed implant end 1131, glue is poured into the sealing groove 1126, isolating the implant end 1131 from the signal connection end 1132 of the sensor 113. To ensure stable signal connection of the sensor 113, as shown in FIG20 , the signal connection between the sensor 113 and the circuit board 114 is achieved via the socket 115.

[0136] In one or more embodiments, at least one limiting groove 1154 corresponding to the clamping member 1122 is defined on both sides of the slot 1153 , and the clamping member 1122 is inserted into the limiting groove 1154 .

[0137] For example, as shown in Figure 21, the socket 115 includes a base 1151 and a terminal 1152. The base 1151 is made of insulating material. A slot 1153 is set in the middle position of the bottom of the socket 115 along the length direction of the socket 115. At least one limiting groove 1154 corresponding to the position and specification of the clamping member 1122 is set on both sides of the slot 1153. When the socket 115 is plugged into the signal connection terminal 1132 of the sensor 113, the signal connection terminal 1132 is inserted and engaged in the slot 1153, and at the same time, the clamping member 1122 is engaged and fixed in the limiting groove 1154.

[0138] As shown in FIG21 , a groove portion 1155 is provided on the side wall of the base 1151 near the implant end 1131. Correspondingly, as shown in FIG17 , a press groove 1134 is provided between the communication portion 1135 and the signal connection end 1132. The width of the press groove 1134 is the same as the width of the side wall of the base 1151. Thus, when the base 1151 is engaged with the sensor 113, the groove portion 1155 and the press groove 1134 engage with each other. Alternatively, the base 1151 may be provided without the groove portion 1155. In this case, the depth of the press groove 1134 may be increased so that the press groove 1134 can make room for the side wall of the base 1151.

[0139] As shown in FIG22 , the terminal 1152 can be made of copper, silver, or other conductive metal materials that are integrally bent and formed. The terminal 1152 includes a crimping portion 11521 connected to the contact 1133, a connecting portion 11523 connected to the circuit board 114, and a conducting portion 11522 disposed between the crimping portion 11521 and the connecting portion 11523. The crimping portion 11521 is a hook-shaped structure with an end portion extending obliquely toward the conducting portion 11522. One end of the conducting portion 11522 is connected to the crimping portion 11521, and the other end is connected to the connecting portion 11523. The conducting portion 11522 conducts the electrical signal from the crimping portion 11521 to the connecting portion 11523. The connecting portion 11523 is connected to the signal input terminal 1142 on the circuit board 114, transmitting the electrical signal to the circuit board 114 for signal processing.

[0140] As shown in Figure 22, the crimping portion 11521 is configured as a hook-shaped structure, and the hook tip of the crimping portion 11521 extends toward the conducting portion 11522. During the crimping process between the crimping portion 11521 and the contact 1133, the outermost position of the crimping portion 11521 relative to the conducting portion 11522 contacts the contact 1133. At the same time, the contact 1133 squeezes the outermost position of the crimping portion 11521, causing the crimping portion 11521 to produce elastic deformation and move closer to the conducting portion 11522. Under the action of the elastic force, the crimping portion 11521 can maintain long-term and stable contact with the contact 1133, thereby improving the stability of the signal.

[0141] As shown in Figures 21 and 22, a second mounting groove 1157 is vertically opened on the base 1151, and the conducting portion 11522 of the terminal 1152 is fixed in the second mounting groove 1157. A third mounting groove 1158 connected to the second mounting groove 1157 is opened on the top of the base 1151, and the connecting portion 11523 of the terminal 1152 passes through the third mounting groove 1158 and is welded to the circuit board 114. During welding, the connecting portion 11523 is ensured to be connected to the signal input port of the circuit board 114. Not only can the entire socket 115 be connected and fixed to the circuit board 114, but also the signal conduction between the socket 115 and the circuit board 114 can be realized. A first mounting groove 1156 is opened between the second mounting groove 1157 and the slot 1153. The first mounting groove 1156 is to ensure that the outermost position of the crimping portion 11521 can extend into the slot 1153 and abut against the contact 1133 on the signal connection end 1132. In one or more embodiments, the crimping portion 11521 of the terminal 1152 is disposed in the first mounting groove 1156 , and the outermost side of the crimping portion 11521 extends from the first mounting groove 1156 into the slot 1153 to contact and connect with the contact 1133 .

[0142] When irradiation sterilization is used for sterilization, the electron beam will cause charge accumulation when irradiating electronic components, thereby damaging the electronic components. Therefore, during irradiation sterilization, the circuit board 114 is not assembled in the shell, and the circuit board 114 is assembled after the irradiation sterilization is completed.

[0143] In one or more embodiments, one of the lower shell 112 and the upper cover 111 is provided with a first snap fastener 1123, and the other is provided with a first slot corresponding to the position of the first snap fastener 1123. The lower shell 112 and the upper cover 111 are snapped together by the first snap fastener 1123 engaging with the first slot.

[0144] Optionally, the lower shell 112 and the upper cover 111 are fastened and sealed by glue or elastic parts.

[0145] In one or more embodiments, a second buckle 1124 is provided on one of the lower shell 112 or the upper cover 111 , and the housing fixes the circuit board 114 inside the housing through the second buckle 1124 .

[0146] In one or more embodiments, the second clip 1124 engages with one of the upper end surface or the lower end surface of the circuit board 114 , and the first clip 1123 supports the other end surface of the circuit board 114 .

[0147] In one or more embodiments, the upper cover opening is configured to pass through a fixed implant needle seat, and the lower shell opening is configured to pass through a needle cap, and the needle cap and the implant needle seat are detachably connected to form a sterilization cavity, and the implantation needle and the implantation end of the sensor on the implant needle seat are both extended into the sterilization cavity.

[0148] In order to achieve the installation and fixation of the upper cover 111 and the lower shell 112, referring to Figure 19, two or more first clips 1123 are set along the edge position of the upper end surface of the lower shell 112, and slots corresponding to the positions of the first clips 1123 are set on the side wall of the upper cover 111. The first clips 1123 are engaged with the slots on the upper cover 111 to achieve the snap connection between the lower shell 112 and the upper cover 111.

[0149] In order to achieve the installation and fixation of the circuit board 114, referring to Figure 19, a plurality of second clips 1124 are set along the edge position of the upper end surface of the lower shell 112, and the height difference between the second clips 1124 and the first clips 1123 is equal to or slightly less than the thickness of the circuit board 114. The lower end surface of the circuit board 114 is supported by the first clip 1123 and the upper end surface is limited by the second clip 1124 to achieve the installation and fixation of the circuit board 114.

[0150] As shown in FIG29 , the socket 115 may further include at least one fixing solder tab 1159, which is inserted into the base 1151 through a corresponding mounting slot on the base 1151. At least one fixing solder tab 1159 is provided on the other side of the terminal 1152 to secure the socket 115 to the circuit board 114. For example, as shown in FIG28 and FIG29 , compared to the socket and circuit board connection method of FIG20 , 21 , and 22 , in addition to securing the socket 115 to the circuit board 114 via the terminal 1152, fixing solder tab 1159 is further provided to more stably secure the circuit board 114.

[0151] As shown in Figure 17, the battery 1141 is located on the lower end surface of the circuit board 114. The purpose is to ensure that the battery 1141 and the socket 115 are located in the same direction, which can effectively save the space occupied by the battery 1141, ensure that the internal layout of the entire implantable analyte monitoring device 11 is more reasonable, and reduce the volume of the implantable analyte monitoring device 11.

[0152] As shown in Figures 23 to 30, the present application also provides another embodiment of an implantable analyte monitoring device. In this embodiment, the shape of the implant needle seat 130 is adjusted, as shown in Figure 23. In Figures 13 and 23, by changing the shape of the implant needle seat 130 and providing at least one groove on the implant needle seat 130, the needle seat 51 can be more firmly fixed to the implant needle seat 130. A first protrusion 1136 (as shown in Figure 23) can be provided on the top of the electrode of the sensor 113 to facilitate positioning with the hollow groove of the implant needle.

[0153] In one or more embodiments, a second protrusion 1127 is provided on the sealing groove 1126 to facilitate positioning with the first sealing ring 116 .

[0154] In one or more embodiments, one or more third protrusions 144 are provided on the bottom of the needle cap 140 to facilitate connection between the needle cap 140 and the connector 150 .

[0155] In one or more embodiments, a needle cap plug 180 is further provided at the bottom of the needle cap 140 , and the needle cap plug 180 can be inserted into the needle cap 140 to facilitate the processing of the needle cap 140 parts.

[0156] A skin patch 170 may also be provided at the bottom of the lower shell 112, which is configured to contact the user's skin so that the device fits the human skin better and is not easy to fall off.

[0157] This embodiment further includes a first sealing ring 116 . The first sealing ring 116 can be coated with a film on the second protrusion 1127 , and the implant needle and the first sealing ring 116 form a first seal.

[0158] By providing a second sealing ring on the needle cap 140 and engaging the needle cap 140 with the implant needle hub 130 , the second sealing ring of the needle cap 140 is brought into contact with the bottom of the lower shell 112 , thereby achieving a second seal.

[0159] The implantable analyte monitoring device provided in the present application can effectively install and fix the sensor through the fixing component arranged on the lower shell, and further limit and fix the sensor through the socket, and realize the signal connection between the sensor and the circuit board through the terminals on the socket. It can be suitable for scenarios where the implantable analyte monitoring device is used for a long time, extend the service life of the implantable analyte monitoring device, and improve the stability of signal transmission.

[0160] As shown in FIG31 , this embodiment provides an implantable analyte monitoring system 1000, which is primarily used for monitoring dynamic changes in blood glucose. However, this implantable analyte monitoring device 11 is not limited thereto; it can also be used to monitor other related targets, such as lactate, acetylcholine, amylase, bilirubin, cholesterol, and human chorionic gonadotropin. The implantable analyte monitoring device 11 in this embodiment is the sensor assembly 100 described in the aforementioned embodiment, and the sensor 113 corresponds to the sensor electrode 102 described in the aforementioned embodiment.

[0161] The implantable analyte monitoring system 1000 includes the above-mentioned implantable analyte detection device, on which an implantable needle seat 130 and a needle cap 140 are provided, and the implantable analyte detection device is installed in a needle assisting device, which includes an outer shell (i.e., an upper shell 121 and a top cover 123) and a protective cover 122 detachably connected to the outer shell, the protective cover 122 being connected to the needle cap 140 used for sterilization through a connector 150, and a needle assisting assembly 16 configured to realize needle assisting and needle withdrawing actions is provided inside the outer shell.

[0162] As shown in FIG31 , the monitoring system includes a shell and a protective cover 122 detachably connected to the shell. A needle assisting assembly 16 configured to implement needle assisting and needle withdrawing actions is disposed inside the shell, and an implantable analyte monitoring device 11 is disposed at the bottom of the needle assisting assembly 16.

[0163] As shown in Figure 31, the needle-assisting assembly 16 includes a needle-assisting unit and a needle-retraction unit. The needle-assisting unit is configured to puncture the implantation needle and the implantation end 1131 into the patient's subcutaneous tissue after pressing the firing button 2 on the top cover 123. The needle-retraction assembly retracts the implantation needle, while the implantation end 1131 remains in the patient's subcutaneous tissue. It is worth noting that the implanter is a conventional medical component in the medical field.

[0164] When producing and preparing the monitoring device, the implantation end 1131 and the implantation needle of the sensor 113 that will enter the human body need to be sterilized to prevent bacteria and viruses on the implantation end 1131 and the implantation needle from entering the human body and causing infection.

[0165] To achieve sterilization, as shown in Figures 31 and 32, a needle cap 140 is provided on the monitoring system. The needle cap 140 is detachably connected to the implant needle seat 130. The implant end 1131 and the implant needle that need to be sterilized are inserted into the needle cap 140. The implant needle seat 130, the mounting seat 1125, the sealant filled in the sealing groove 1126, the lower shell 112, and the sealing ring together seal the open end of the needle cap 140 to form a sterilization cavity. The sterilization operation of the implant end 1131 and the implant needle is completed in the sterilization cavity. After the irradiation sterilization is completed, the bacteria and viruses on the implant end 1131 and the implant needle are effectively killed and meet the standard of being able to enter the human body. At the same time, because the implant needle and the implant end 1131 are sealed in the needle cap 140, the implant end 1131 and the implant needle can be stored under sterile conditions.

[0166] During use, the needle cap 140 needs to be removed before the needle is inserted, so that the implant needle and the implant end 1131 can be exposed to the air, making it easier for the implant needle and the implant end 1131 to enter the subcutaneous tissue of the human body. If the needle cap 140 is removed manually, since the implant needle will be exposed to the air, improper operation may cause the implant needle to pierce the skin of the operator, posing a safety hazard, and may also cause contamination of the implant needle. Improper operation may also cause the needle cap 140 to contact and collide with the implant needle. In severe cases, the implant needle may be deformed or bent, which poses a great risk to the implant needle entering the subcutaneous tissue of the human body. Therefore, how to quickly and effectively remove the needle cap 140 is also a problem that the monitoring system needs to solve.

[0167] To address the aforementioned issue of needle cap 140 removal, as shown in FIG32 , this embodiment secures needle cap 140 to protective cover 122 via a connector 150. Protective cover 122 is threadably connected to the bottom of upper housing 121 and is also secured to upper housing 121 via a snap or other means. When protective cover 122 is removed from upper housing 121, it pulls needle cap 140 away from implantable analyte monitoring device 11 via connector 150, enabling quick and effective removal of needle cap 140.

[0168] In one or more embodiments, the connecting member 150 includes a base 151 and a first fastener 152. A fixing hole is opened through the protective cover 122. One end of the first fastener 152 passes through the fixing hole and extends into the protective cover 122 to be fastened to the upper end surface of the bottom plate of the protective cover 122. The other end of the first fastener 152 is connected to the base 151, and the base 151 abuts against the lower end surface of the bottom plate of the protective cover 122.

[0169] In one or more embodiments, the connector 150 further includes a second fastener 153 , one end of the second fastener 153 passes through the fixing hole and is engaged with the needle cap 140 , and the other end of the second fastener 153 is connected to the base 151 .

[0170] Exemplarily, as shown in FIG33 , the connector 150 includes a base 151, a first fastener 152, and a second fastener 153. A fixing hole is provided through the protective cover 122. In this embodiment, the specifications of the base 151 are larger than those of the fixing hole, thereby ensuring that the base 151 is always located on the outside of the protective cover 122 and does not enter the inside of the protective cover 122 through the fixing hole.

[0171] To ensure that the connector 150 and the protective cover 122 do not deflect relative to each other when the protective cover 122 and the needle cap 140 are removed, referring to Figure 34, hooks are protruding from the top of the first fastener 152 and the second fastener 153, and at least one latch 1221 corresponding to the first fastener 152 is provided on the outside of the fixing hole of the protective cover 122. The bottom of the connector 150 abuts against the bottom of the protective cover 122 through the base 151, and the top of the connector 150 engages with the latch 1221 through the latch of the first fastener 152 to achieve the connection between the connector 150 and the protective cover 122, effectively preventing the connector 150 and the protective cover 122 from deflecting relative to each other.

[0172] To ensure that the connector 150 and needle cap 140 do not deflect relative to each other when the protective cover 122 and needle cap 140 are removed, referring again to FIG34 , at least one reinforcing rib 143 is vertically disposed on the sidewall of the needle cap 140. Connecting grooves corresponding in position and size to the second fastener 153 are disposed on either side of the reinforcing rib 143. One end of the second fastener 153 extends through the fixing hole into the protective cover 122, where the fastener engages with the connecting groove to connect the second fastener 153 to the needle cap 140. The provision of the reinforcing rib 143 prevents the second fastener 153 and needle cap 140 from slipping and causing relative deflection during rotation.

[0173] In one embodiment, the needle cap 140 shown in FIG. 35 may not include structures such as the reinforcing rib 143 and the connecting groove 142 , and may be fixed to the connecting member 150 via the third protrusion 144 .

[0174] The implantable analyte monitoring system provided in the present application connects the needle cap and the protective cover by providing a connector. When in use, the needle cap used for sterilization can be removed at the same time as the protective cover is removed, thereby simplifying the operation, reducing the risk of exposure, and improving the safety of the implantable analyte monitoring system during use.

[0175] The above embodiments of the present application are merely examples for the purpose of clearly illustrating the present application, and are not intended to limit the embodiments of the present application. For those skilled in the art, other variations or modifications in different forms may be made based on the above description. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present application shall be included within the scope of protection of the claims of the present application.

Claims

1. A needle assist device, comprising: A shell assembly (1) is provided with a firing button (2) on the outer peripheral side; A needle insertion bracket (3) is arranged in the housing assembly (1), the needle insertion bracket (3) comprises a sleeve (31), a receiving groove (32) and at least two elastic claws (33) arranged in the sleeve (31), the notch of the receiving groove (32) and the barrel mouth of the sleeve (31) are away from each other, the receiving groove (32) is configured to accommodate the sensor assembly (100), the needle insertion bracket (3) can move along a first direction and can be limited to a first position and a second position of the housing assembly (1), the firing button (2) can separate the housing assembly (1) and the needle insertion bracket (3) to move from the first position to the second position, and a through hole (34) is provided at the bottom of the sleeve (31); A fixing plate (4) is arranged in the housing assembly (1) and can be locked with the elastic claw (33), and the housing assembly (1) can separate the fixing plate (4) from the elastic claw (33); An implant needle assembly (5) comprises a needle seat (51) and an implant needle (52) connected to the needle seat (51); the needle seat (51) is circumferentially clamped between the elastic claws (33) and is arranged between the elastic claws (33) and the bottom of the sleeve (31); the needle seat (51) can move toward the fixing plate (4); the implant needle (52) can be inserted into the through hole (34) and plugged into the sensor assembly (100); and the sensor electrode (102) of the sensor assembly (100) is inserted into the implant needle (52).

2. The needle assisting device according to claim 1, wherein: A rib plate (110) is provided on the inner side of the housing assembly (1), and a flange (35) is provided on the outer periphery of the needle insertion bracket (3); when the needle insertion bracket (3) is located at the first position, the rib plate (110) abuts against the flange (35).

3. The needle assist device according to claim 1, further comprising: A first elastic member (6) is disposed in a first accommodating space (A) formed by the sleeve (31) and the housing assembly (1), with two ends thereof respectively abutting against the bottom of the sleeve (31) and the housing assembly (1); The second elastic member (7) is arranged in a second accommodating space (B) formed by the needle seat (51) and the sleeve (31), the opening of the needle seat (51) faces the bottom of the sleeve (31), and the two ends of the second elastic member (7) are respectively in contact with the bottom of the sleeve (31) and the top of the needle seat (51).

4. The needle assisting device according to claim 1, wherein: The shell assembly (1) is provided with a first limit block (12) and a second limit block (13) inside, and the first limit block (12) and the second limit block (13) are arranged at intervals along the first direction. The outer periphery of the sleeve (31) is provided with a first limit buckle (36) and a second limit buckle (37), and the first limit buckle (36) is clamped on the first limit block (12) so that the needle insertion bracket (3) is located in the first position, and the second limit buckle (37) is clamped on the second limit block (13) so that the needle insertion bracket (3) is located in the second position, and the firing button (2) can separate the first limit buckle (36) and the first limit block (12).

5. The needle assisting device according to claim 4, wherein: The first limiting buckle (36) is elastic in the radial direction of the sleeve (31), and the firing button (2) can drive the first limiting buckle (36) to move in the radial direction of the sleeve (31).

6. The needle assisting device according to claim 1, wherein: One of the needle insertion bracket (3) and the housing assembly (1) is provided with a guide groove (38), and the other is provided with a guide rib (14), and the guide rib (14) is slidably connected to the guide groove (38).

7. The needle assisting device according to claim 1, wherein: A step (331) is provided on the inner side of the elastic claw (33), and the needle seat (51) is provided between the step (331) and the bottom of the sleeve (31).

8. The needle assisting device according to claim 1, wherein: The elastic claw (33) is clamped with the fixing plate (4) or the fixing plate (4) is hinged with one of the elastic claws (33).

9. The needle assisting device according to claim 1, wherein: An elastic clamping arm (39) is provided in the accommodating groove (32), and the sensor component (100) is clamped on the elastic clamping arm (39).

10. The needle assisting device according to any one of claims 1 to 9, wherein: The housing assembly (1) comprises an upper shell (121) and a top cover (123) and a protective cover (122) detachably connected to both ends of the upper shell (121); the top cover (123) is capable of separating the fixing plate (4) from the elastic claw (33); the firing button (2) is connected to the upper shell (121); and the protective cover (122) is arranged toward the receiving groove (32).

11. The needle assisting device according to claim 10, further comprising a first supporting seat (201), wherein the first supporting seat (201) is fixedly connected to the upper shell (121).

12. The needle assisting device according to any one of claims 1 to 9, wherein a pull ring (21) is provided on the firing button (2), and the pull ring (21) is configured to prevent a user from accidentally triggering the firing button (2).

13. The needle assisting device according to any one of claims 1 to 9, wherein at least one guide column (301) is provided in the needle insertion bracket (3), and the guide column (301) is configured to cooperate with the fixing plate (4).

14. An implantable analyte monitoring device, comprising an upper cover (111) and a lower shell (112) connected to each other to form a shell, wherein: A circuit board (114) is installed inside the housing, and a signal input end (1142) of the circuit board (114) is connected to a sensor (113) via a socket (115); The sensor (113) comprises an implantation end (1131) and a signal connection end (1132); the lower shell (112) is provided with a fixing component configured to fix the signal connection end (1132) inside the shell; The socket (115) comprises a base (1151) and a terminal (1152) mounted on the base (1151); a slot (1153) configured to engage with the signal connection terminal (1132) is provided on the base (1151); one end of the terminal (1152) extends into the slot (1153) to contact a contact (1133) on the signal connection terminal (1132); and the other end of the terminal (1152) passes through the base (1151) to be electrically connected to the circuit board (114).

15. The device according to claim 14, wherein: Contacts (1133) configured to transmit signals are arranged on one or both side surfaces of the signal connection end (1132).

16. The device according to claim 14, wherein: The fixing assembly comprises a slot portion (1121), the slot portion (1121) being located on the upper end surface of the lower shell (112) and arranged along the extension direction of the signal connection end (1132), and the slot portion (1121) being engaged with and fixed to the bottom of the signal connection end (1132).

17. The device according to claim 14 or 16, wherein: The fixing assembly comprises a clamping member (1122), and at least one pair of the clamping members (1122) clamps and fixes the signal connection end (1132).

18. The device according to claim 17, wherein: At least one limiting groove (1154) corresponding to the clamping member (1122) is provided on both sides of the slot (1153), and the clamping member (1122) is inserted into the limiting groove (1154).

19. The device according to claim 14, wherein: A connecting portion (1135) configured to perform signal transmission is provided between the signal connection end (1132) and the implantation end (1131), and a pressing groove (1134) is provided between the connecting portion (1135) and the signal connection end (1132), and the pressing groove (1134) is engaged with the base (1151).

20. The device according to claim 14, wherein: The terminal (1152) is integrally bent and formed, and comprises a crimping portion (11521) connected to the contact (1133), a connecting portion (11523) connected to the circuit board (114), and a conducting portion (11522) arranged between the crimping portion (11521) and the connecting portion (11523); The crimping portion (11521) is a hook-shaped structure with an end portion extending obliquely toward the conducting portion (11522).

21. The device according to claim 20, wherein: A second mounting groove (1157) is provided on the base (1151), and the conducting portion (11522) of the terminal (1152) is fixed in the second mounting groove (1157). A third mounting groove (1158) communicating with the second mounting groove (1157) is provided on the top of the base (1151). The connecting portion (11523) of the terminal (1152) passes through the third mounting groove (1158) and is connected to the circuit board (114). A first mounting groove (1156) is provided between the second mounting groove (1157) and the slot (1153). The crimping portion (11521) of the terminal (1152) is provided in the first mounting groove (1156), and the outermost side of the crimping portion (11521) extends from the first mounting groove (1156) into the slot (1153) to contact and connect with the contact (1133).

22. The device according to claim 14, wherein: One of the lower shell (112) and the upper cover (111) is provided with a first snap buckle (1123), and the other is provided with a first slot corresponding to the position of the first snap buckle (1123); the lower shell (112) and the upper cover (111) are snap-connected by the first snap buckle (1123) snapping into the first slot.

23. The device according to claim 22, wherein: One of the lower shell (112) or the upper cover (111) is provided with a second buckle (1124), and the shell fixes the circuit board (114) inside the shell through the second buckle (1124).

24. The device according to claim 23, wherein: The second buckle (1124) is engaged with one of the upper end surface or the lower end surface of the circuit board (114), and the first buckle (1123) supports the other surface of the circuit board (114).

25. The device according to any one of claims 14 to 24, wherein a connecting portion (1135) for signal transmission is provided between the signal connection end (1132) and the implantation end (1131).

26. An implantable analyte monitoring system, comprising an implantable analyte monitoring device (11) as described in any one of claims 14 to 25, wherein an implantable needle seat (130) and a needle cap (140) are arranged on the implantable analyte detection device (11), and the implantable analyte detection device (11) is installed in a needle assisting device as described in any one of claims 1 to 13, the needle assisting device comprising a shell and a protective cover (122) detachably connected to the shell, a needle assisting assembly (16) configured to realize needle assisting and needle withdrawing actions is arranged inside the shell, and the protective cover (122) is connected to the needle cap (140) used for sterilization through a connector (150).

27. The system of claim 26, wherein: The connecting member (150) comprises a base (151) and a first fastener (152); a fixing hole is formed through the protective cover (122); one end of the first fastener (152) passes through the fixing hole and extends into the protective cover (122) to be fastened to the upper end surface of the bottom plate of the protective cover (122); the other end of the first fastener (152) is connected to the base (151); and the base (151) is in contact with the lower end surface of the bottom plate of the protective cover (122).

28. The system of claim 27, wherein: The connecting member (150) further comprises a second fastener (153), one end of the second fastener (153) passes through the fixing hole and is snap-connected with the needle cap (140), and the other end of the second fastener (153) is connected to the base (151).

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