WO2024027372A1

WO2024027372A1 - Sensor assembly protection device, assembly process, and system for monitoring concentration of analyte

Info

Publication number: WO2024027372A1
Application number: PCT/CN2023/102596
Authority: WO
Inventors: 钱成; 刘海庆; 程永全; 耿勇
Original assignee: 苏州百孝医疗科技有限公司
Priority date: 2022-08-01
Filing date: 2023-06-27
Publication date: 2024-02-08
Also published as: CN115005816B; CN115005816A

Abstract

Disclosed herein is a sensor assembly protection device, comprising a sensor assembly and a protection device. The sensor assembly comprises a puncture needle. A sensor electrode is arranged in the puncture needle. An opening allowing the sensor electrode to pass through is formed on the side wall of the puncture needle. The protection device comprises a limiting piece. The limiting piece is separably connected to the sensor assembly. At least one part of the limiting piece is arranged opposite to at least one part of the opening. Also disclosed herein is an assembly process of the sensor assembly and the protection device. The sensor assembly and the protection device are positioned firstly, and then the sensor assembly and the protection device are assembled. Further disclosed herein is a system for monitoring the concentration of an analyte. The system comprises an implant, and the sensor assembly and the protection device. The implant is assembled and connected with the sensor assembly and the protection device.

Description

Sensor component protection device, assembly process and analyte concentration monitoring system

This disclosure claims priority to a Chinese patent with application number 202210915438.7 filed with the China Patent Office on August 1, 2022. The entire content of the above application is incorporated into this application by reference.

Technical field

The present application relates to the technical field of medical devices, for example, to an analyte concentration monitoring system.

Background technique

Some physiological diseases have a long course and are not cured. It is necessary to monitor the concentration of certain analytes in the host in real time to better track the treatment. For example, diabetes requires real-time monitoring of the host's blood sugar. Currently, monitoring technology has emerged that can be implanted into subcutaneous tissue for continuous monitoring of subcutaneous blood sugar. This technology penetrates a sensor electrode into the subcutaneous tissue. The sensor electrode undergoes an oxidation reaction between the patient's interstitial fluid and glucose in the body, and an electric current is formed during the reaction. signal, the electrical signal is converted into blood glucose readings through the transmitter, and the blood glucose readings are transmitted to the wireless receiver every 1 to 5 minutes. The corresponding blood glucose data is displayed on the wireless receiver and a map is formed for reference by patients and doctors. This technology is called an analyte concentration monitoring system.

The analyte concentration monitoring system includes a puncture needle. The puncture needle wraps the sensor electrode to assist the sensor electrode to enter the human body. After the sensor electrode enters the human skin, the puncture needle is separated from the sensor electrode. In order to facilitate the separation of the puncture needle from the sensor electrode, an opening is provided on the side wall of the puncture needle. When the puncture needle is separated from the sensor electrode, the opening can smoothly separate the sensor electrode and the puncture needle. However, the opening may also cause the sensor electrode to detach from the puncture needle under other circumstances. For example, shaking caused by transportation may cause the sensor electrode to detach from the puncture needle, and the sensor electrode may be damaged by collision.

Contents of the invention

This application provides a sensor component protection device that reduces the risk of damage to the sensor electrode when it is accidentally detached from the puncture needle opening.

Embodiments of the present application provide a sensor component protection device, including a sensor component and a protection device; the sensor component includes a puncture needle, a sensor electrode is provided inside the puncture needle, and an opening is provided on the side wall of the puncture needle to allow the sensor electrode to pass through; the protection device It includes a limiting piece, the limiting piece and the sensor assembly are detachably connected, and at least a part of the limiting piece is arranged opposite to at least a part of the opening.

This application also provides the assembly process of the above-mentioned sensor components and protection devices to realize the sensor components and the correct assembly of protective devices.

The embodiment of the present application provides an assembly process of the above-mentioned sensor component and protection device. The sensor component and the protection device are first positioned, and then the sensor component and the protection device are assembled.

Another embodiment of the present application provides an assembly process of the above-mentioned sensor component and protection device. The sensor component and the protection device are first positioned, and then the sensor component and the protection device are assembled; before the sensor component and the protection device are assembled, , first prop up multiple limiting walls.

The present application also provides an analyte concentration monitoring system including the above sensor assembly.

Embodiments of the present application provide an analyte concentration monitoring system, including an implanter, the above-mentioned sensor component and protection device, and the implanter, sensor component and protection device are assembled and connected.

Description of drawings

Figure 1 is a schematic structural diagram of a sensor component in Embodiment 1 of the present application;

Figure 2 is an overall schematic diagram of an embodiment of the present application;

Figure 3 is one of the structural cross-sectional views of Embodiment 1 of the present application;

Figure 4 is the second structural cross-sectional view of Embodiment 1 of the present application;

Figure 5 is a schematic structural diagram of the sensor assembly and the limiting member according to Embodiment 1 of the present application;

Figure 6 is a schematic diagram of the cooperation between the puncture needle and the stopper according to Embodiment 1 of the present application;

Figure 7 is a structural cross-sectional view of Embodiment 2 of the present application;

Figure 8 is a schematic diagram of the cooperation between the puncture needle and the stopper in Embodiment 3 of the present application;

Figure 9 is a schematic diagram of the cooperation between the puncture needle and the stopper in Embodiment 4 of the present application;

Figure 10 is a schematic diagram of the cooperation between the puncture needle and the stopper in Embodiment 5 of the present application;

Figure 11 is a front axial view of the structure of the limiting member according to Embodiment 1 of the present application;

Figure 12 is a top view of the limiting member according to Embodiment 1 of the present application;

Figure 13 is a negative axial view of the structure of the limiting member according to Embodiment 1 of the present application.

Among them: 1. Sensor component; 11. Puncture needle; 12. Sensor electrode; 13. Base; 131. Positioning slot; 2. Protection device; 21. Limiting piece; 211. Limiting part; 2111. First limit wall; 2112, second limiting wall; 2113, connecting bridge; 212, mounting part; 2121, first positioning feature; 2122, second positioning feature; 2123, connecting cavity; 213, connecting arm; 23, package; 24 , shell; 241, positioning block; 110, opening; 120, gap; 2110, limiting wall; 1234, second positioning structure.

Detailed ways

The following description and examples illustrate some exemplary embodiments of the disclosed application.

A sensor component protection device

The sensor component protection device includes a sensor component 1 and a protection device 2. The sensor assembly 1 includes a puncture needle 11. A sensor electrode 12 is provided inside the puncture needle 11. An opening 110 is provided on the side wall of the puncture needle 11. The sensor electrode 12 enters or leaves the puncture needle 11 through the opening 110. In some embodiments, as shown in Embodiment 1 in Figures 1 and 6, the cross-section of the puncture needle 11 consists of two straight sides and a semicircle connecting one side of the two straight sides, and the other side of the two straight sides is the opening. 110, the opening 110 extends to the lower end surface of the puncture needle 11, and the lower end surface of the puncture needle 11 is formed with a slope. The sensor component 1 needs to be attached to the surface of the user's skin during use. The sensor electrode 12 enters the user's skin, detects the concentration of analytes in the user's body through electrochemical reactions, generates electronic signals through electronic components, and sends the electronic signals to the emitter. on the receiver for analysis by users or medical staff. In some embodiments, electronics and/or transmitters are built into sensor assembly 1 . In other embodiments, the electronic components and/or emitters are assembled and connected with the sensor assembly 1 during use. For example, after the sensor assembly 1 is attached to the skin surface, the electronic components and/or emitters are then assembled with the sensor assembly 1 connect. In other embodiments, the electronic components and/or the emitter are also detachably connected to the sensor assembly 1, for example, after the sensor electrode 12 in the sensor assembly 1 reaches the end of its life, the electronic components and/or the emitter are connected to the sensor assembly 1. 1 is separated and then connected to another sensor component 1 for use. In some embodiments, the receiver is a smartphone, smart watch, dedicated device, etc. During the process of attaching the sensor component 1 to the skin, the puncture needle 11 wraps the sensor electrode 12 and penetrates into the human skin, and then the puncture needle 11 separates from the skin and detaches from the sensor component 1 . When the puncture needle 11 is detached from the sensor assembly 1, the opening 110 on the side wall of the puncture needle 11 allows the sensor electrode 12 to remain in the user's body without being affected by the detachment of the puncture needle 11. Only a part of the sensor electrode 12 enters the user's body. This part is located in the puncture needle 11 before entering the user's body. This part is hereinafter referred to as the body part. The other part of the sensor electrode 12 is located in the sensor assembly 1 and is connected with conductive contacts or electronic components. Equielectrical connection, this part is hereinafter referred to as the external part. An included angle is formed between the internal part and the external part of the sensor electrode 12, and a connecting part is formed between the internal part and the external part. In some embodiments, as shown in Embodiment 1 of Figure 5, the connecting part is curved. The opening 110 on the side wall of the puncture needle 11 can prevent the connection part of the sensor electrode 12 from being affected when the puncture needle 11 is detached from the sensor assembly 1 . In some embodiments, as shown in Embodiment 1 of FIG. 1 and FIG. 5 , when the puncture needle 11 is removed from the sensor assembly 1 , it is removed in the upward direction in the figure, and the opening 110 of the puncture needle 11 avoids the sensor. Electrode 12.

The protection device 2 includes a limiting member 21, and the limiting member 21 and the sensor assembly 1 are detachably connected. In some embodiments, the protective device 2 is separated before the sensor assembly 1 is attached to the skin; in other embodiments, the protective device 2 is separated earlier when the sensor assembly 1 is assembled, such as when the sensor assembly 1 is assembled with the implant. , or when the sensor component 1 is sterilized, packaged, etc. In some embodiments, the protection device 2 further includes a housing 24, which is detachably connected to the sensor assembly 1, and the housing 24 protects the sensor assembly 1 as a whole. In some embodiments, such as Embodiment 1 shown in Figures 2, 3 and 4, the limiting member 21 and the housing 24 are separated from the sensor assembly 1 together. In some embodiments, the limiting member 21 can be separated from the sensor assembly 1 when the housing 24 is connected to the sensor assembly 1 .

At least a portion of the limiting member 21 is disposed opposite to at least a portion of the opening 110 of the puncture needle 11 . The opening 110 in the side wall of the puncture needle 11 allows the sensor electrode 12 to be detached from the puncture needle 11 . However, the opening 110 also causes the sensor electrode 12 to be detached from the puncture needle 11 under other circumstances. For example, during transportation, the sensor electrode 12 is detached from the puncture needle 11 due to shaking of the carrier. When the sensor electrode 12 is not detached from the puncture needle 11 due to the removal of the puncture needle 11 from the sensor assembly 1, but is detached from the puncture needle 11 due to other reasons, the sensor electrode 12 may be knocked due to excessive shaking. Otherwise, other structures may be damaged or permanently deformed, causing the sensor electrode 12 to detach or deviate from the puncture needle 11 , making subsequent punctures of the puncture needle 11 difficult to complete. By disposing at least a part of the limiting member 21 opposite to at least a part of the opening 110 of the puncture needle 11 , the limiting member 21 can limit the shaking amplitude of the sensor electrode 12 , thereby limiting the sensor electrode in the puncture needle 11 . The protective effect of 12 can reduce the risk of damage to the sensor electrode 12 when it is accidentally detached from the opening 110 of the puncture needle 11 .

In some embodiments, the limiting member 21 is connected and matched with the side wall of the puncture needle 11 at the opening 110 of the puncture needle 11 to form a closed or nearly closed cavity. As shown in the third embodiment shown in Figure 8, the limiter 21 and the puncture needle 11 are combined to form a cavity, which can protect the sensor electrode 12 in the cavity. The sensor electrode 12 cannot shake significantly, thereby avoiding puncture. The opening 110 of the needle 11 may lead to the risk of accidental damage to the sensor electrode 12 . The connection and cooperation between the stopper 21 and the side wall of the puncture needle 11 can be abutting against each other to form a closed cavity in the cross section, or they can be approximately connected, for example, the gap between the two is less than 0.1 millimeter (mm). The cavity formed by the two is an approximately closed cavity. A closed or nearly closed cavity can protect the sensor electrode 12 within the cavity.

In some embodiments, a gap 120 is formed between the limiting member 21 and the puncture needle 11 . When the gap 120 is formed between the stopper 21 and the puncture needle 11 , the stopper 21 can limit the sensor electrode 12 from being displaced to a large extent due to shaking or other reasons, and can cause the sensor electrode 12 to move away from the puncture needle 11 . Play a protective role.

In some embodiments, the width of the gap 120 between the stopper 21 and the puncture needle 11 is 0.1 mm to 30 mm, 0.1 to 1 mm, 1 to 20 mm, 2 to 30 mm, 0.1 mm, 0.5 mm, 1 mm, 1.5 mm, 2 mm , 3mm, 5mm, 10mm, 15mm, 20mm, 25mm and 30mm. A smaller width of the gap 120 can limit the shaking amplitude of the sensor electrode 12 to a smaller range, but it will also increase the difficulty of coordination, assembly, and manufacturing between the limiter 21 and the puncture needle 11, and will also limit the limiter. 21 and the puncture needle 11, thereby limiting the connection relationship between the protection device 2 and the sensor assembly 1, etc. The definition of the width of the gap 120 between the limiting member 21 and the puncture needle 11 is affected by the shapes of the limiting member 21 and the puncture needle 11 . In some embodiments, such as Embodiment 4 shown in FIG. 9 , the opposite surfaces of the limiting member 21 and the puncture needle 11 are both flat surfaces, and Parallel to each other, the width of the gap 120 between the two is the plane distance between the two opposite surfaces. In some embodiments, as shown in Embodiment 5 of FIG. 10 , the opposing surfaces of the limiting member 21 and the puncture needle 11 are both non-planar. In these embodiments, the width of the gap 120 between the two can be understood as an average width, min-width, or max-width.

In some embodiments, the limiting member 21 is disposed around the puncture needle 11 . In some embodiments, as shown in Embodiment 1 of FIG. 6 , the inner surface of the limiting member 21 is circular and is arranged around the puncture needle 11 . In other embodiments, the inner surface of the limiting member 21 is oval, rectangular, polygonal, etc. In these embodiments, there is no need for circumferential positioning between the stopper 21 and the puncture needle 11 .

In some embodiments, the limiting member 21 is only provided corresponding to the opening 110 of the puncture needle 11 , as shown in FIGS. 9 and 10 . At this time, circumferential positioning is required between the limiting member 21 and the puncture needle 11 .

In some embodiments, at least a portion of the limiting member 21 is disposed opposite to at least a portion of the sensor electrode 12 . In these embodiments, the opening 110 of the puncture needle 11 is longer than the sensor electrode 12, and the sensor electrode 12 does not extend to the lower end of the puncture needle 11. At this time, at least a portion of the limiting member 21 is provided corresponding to at least a portion of the sensor electrode 12, Therefore, the limiting member 21 can limit the shaking amplitude of the sensor electrode 12 .

In some embodiments, the ratio of the length of the portion of the limiting member 21 opposite to the sensor electrode 12 and the length of the opening 110 is not less than one-tenth. In some embodiments, the length of the portion of the limiting member 21 opposite to the sensor electrode 12 is not less than 2 mm. The part of the limiter 21 that is opposite to the sensor electrode 12 plays a role in limiting the shaking of the sensor electrode 12. If the ratio of the length of this part to the length of the opening 110 is less than one-tenth, or the limiter 21 is opposite to the sensor electrode 12 If the length of the set part is not less than 2mm, the contact area between the limiter 21 and the sensor electrode 12 will be too small, and the damage to the sensor electrode 12 when it rocks to contact the limiter 21 may be greater than under normal circumstances. Sensor electrode 12 is damaged by shaking. In some embodiments, the ratio of the length of the portion of the limiting member 21 opposite to the sensor electrode 12 and the length of the opening 110 is 1:5, 1:4, 1:3, 1:2, or 1:1. In some embodiments, the length of the portion of the limiting member 21 opposite to the sensor electrode 12 is not less than 3 mm, 5 mm, or 10 mm. The length of the portion of the limiting member 21 that is opposite to the sensor electrode 12 refers to the size of the portion of the limiting member 21 that is opposite to the sensor electrode 12 along the length direction of the puncture needle 11 .

In some embodiments, the limiting member 21 is disposed opposite to the upper, middle or lower portion of the opening 110 of the puncture needle 11 . In some embodiments, the limiting member 21 is disposed opposite to the upper half or the lower half of the opening 110 of the puncture needle 11 . In some embodiments, the limiting member 21 is disposed opposite to the opening 110 of the puncture needle 11 along the entire length direction. In these embodiments, the limiting member 21 is disposed away from the connecting portion of the sensor electrode 12 .

In some embodiments, along the length direction of the puncture needle 11, the length of the limiting member 21 is greater than the length of the puncture needle 11, and only a part of the limiting member 21 is arranged opposite to the puncture needle 11, as shown in the implementation shown in Figure 7 Example 2.

In some embodiments, the sensor assembly 1 and the protection device 2 are disconnected by rotation. At this time, the positional relationship between the limiting member 21 and the puncture needle 11 will be limited, that is, the relationship between the limiting member 21 and the puncture needle 11 will be limited. The gap between them should be such that the stopper 21 will not interfere with the puncture needle 11 when it rotates with the protection device 2, as shown in the first embodiment of Figure 6. In some embodiments, the connection between the sensor assembly 1 and the protection device 2 is released by pulling, sliding, etc. This method of releasing the connection has less restrictions on the positional relationship between the limiting member 21 and the puncture needle 11 bracket. In some embodiments, before the sensor assembly 1 and the protection device 2 are disconnected, the limiting member 21 may first be disconnected from the housing 24 .

In some embodiments, the protection device 2 further includes a housing 24, and the limiting member 21 is integrally formed with the housing 24. In some embodiments, as shown in Embodiment 2 of FIG. 7 , the limiting member 21 is integrally formed with the housing 24 , and the limiting member 21 forms an open cavity. When the sensor assembly 1 is connected to the protection device 2 , the puncture The entire lower part of the needle 11 is located in this cavity, which not only protects the sensor electrode 12 but also the puncture needle 11 . In other embodiments, the limiting member 21 formed integrally with the housing 24 is only partially disposed with the opening 110 of the puncture needle 11 , and is disposed opposite the upper, middle or lower portion of the opening 110 of the puncture needle 11 .

In some embodiments, the limiting member 21 is connected to the housing 24 . In some embodiments, as shown in Figure 3, Figure 4, Figure 5, Figure 11, Figure 12 and Figure 13 in Embodiment 1, the limiting member 21 also includes a mounting portion 212, and the housing 24 is formed with a cavity and a mounting portion. 212 cooperates, and the mounting portion 212 is connected and fixed with the housing 24 . In some embodiments, the mounting portion 212 and the housing 24 are threadedly connected. In some embodiments, the mounting portion 212 is connected and fixed with the housing 24 through its own elasticity. In some embodiments, a non-detachable connection such as adhesive is used between the mounting portion 212 and the housing 24 . In some embodiments, as shown in Embodiment 1 of FIG. 3 and FIG. 4 , the protection device further includes an encapsulating member 23 , which cooperates with the mounting part 212 to encapsulate the limiting member 21 in the housing 24 . In some embodiments, the mounting part 212 is also provided with a connection cavity 2123. As shown in FIG. 13, the connection cavity 2123 cooperates with the package 23. For example, the upper end of the package 23 can extend into the connection cavity 2123. In some embodiments, as shown in Figure 5

In the first embodiment, the mounting portion 212 is cylindrical as a whole. In some embodiments, the limiting member 21 is annular, the outer edge is used to be installed and matched with the housing 24, and the inner wall surrounds the puncture needle 11.

In some embodiments, the protection device 2 and the sensor assembly 1 are respectively provided with second positioning structures 1234 that cooperate with each other to achieve circumferential positioning between the protection device 2 and the sensor assembly 1 . When the stopper 21 in the protection device 2 is not arranged around the puncture needle 11 , it is necessary to provide a second positioning structure 1234 that cooperates with each other on the shell 24 of the protection device 2 and the sensor assembly 1 respectively, so that the puncture needle 11 The opening 110 can cooperate with the protective device 2 in a specific circumferential position. In some embodiments, the base 13 of the sensor assembly 1 and the housing 24 of the protective device 2 are respectively provided with mutually matching structures to achieve circumferential positioning, such as rectangular, sector-shaped, polygonal and other shapes of convex parts and concave parts to cooperate. The structure may form a second positioning structure 1234. In some embodiments, the edge of the base 13 is provided with a plurality of positioning grooves 131, and the housing 24 is provided with a plurality of positioning blocks 241. The positioning grooves 131 and the positioning blocks 241 cooperate to achieve circumferential positioning between the protection device 2 and the sensor assembly 1. .

In some embodiments, the limiting member 21 and the outer shell 24 of the protective device 2 are respectively provided with first fitting parts. Positioning structure to achieve circumferential positioning between the limiting member 21 and the housing 24 of the protective device 2 . In some embodiments, as shown in Embodiment 1 of FIG. 5 , the mounting part 212 is cylindrical as a whole, and the mounting part 212 is provided with a first positioning feature 2121 (as shown in FIG. 11 ), and the first positioning feature 2121 is connected to the housing 24 The corresponding features cooperate to achieve circumferential positioning of the mounting portion 212 . The first positioning features 2121 and the corresponding features of the housing 24 form a first positioning structure. In Embodiment 1, the first positioning feature 2121 is a step surface formed on the outer edge of the mounting part 212, and the middle part of its elevation is a convex arc surface, which can achieve a guiding function. In some embodiments, as shown in FIGS. 11 and 12 , the mounting part 212 is also provided with a second positioning feature 2122 . The second positioning feature 2122 may be a groove formed on the outer edge of the mounting part 212 and may be connected with the first positioning feature 2122 . The positioning features 2121 are arranged opposite to each other. Correspondingly, the housing 24 is provided with corresponding features to cooperate with the first positioning features 2121 and the features on the housing 24 corresponding to the first positioning features 2121 to form the first positioning structure. In some embodiments, the shape of the mounting part 212 is a non-rotatable shape such as a fan ring, a cross, a rectangle, an angle, or multiple deformations. The housing 24 is provided with a correspondingly shaped cavity for loading the mounting part 212. The mounting part 212 The shape of the cavity corresponds to the shape of the housing 24 to form the first positioning structure.

In some embodiments, the material of the part of the limiting member 21 that is opposite to the opening 110 of the puncture needle 11 is an elastic material, such as silicone, rubber, etc. The use of elastic materials can reduce the impact of the sensor electrode 12 on contact with the limiting member 21 . damage and improve the protection effect of the sensor electrode 12. In some embodiments, the limiting member 21 is entirely made of elastic material. In some embodiments, the mounting portion 212 of the limiting member 21 is made of material with relatively high hardness. In some embodiments, the portion of the stopper 21 opposite to the opening 110 of the puncture needle 11 is chemically or physically treated to obtain softer surface properties. In some embodiments, the limiting member 21 is additionally provided with an elastic material, such as silicone, rubber, etc., on the surface of the portion opposite to the opening 110 of the puncture needle 11 . In other embodiments, the material of the part of the limiting member 21 that is opposite to the opening 110 of the puncture needle 11 is a non-elastic material, such as polypropylene (PP), polyethylene (Polyethylene, PE), acrylonitrile-butanil. Diallylene-styrene copolymer (Acrylonitrile Butadiene Styrene, ABS), polycarbonate (Polycarbonate, PC), etc. In these embodiments, the entire limiting member 21 can be made of the same material.

In some embodiments, the part of the limiting member 21 that is opposite to the opening 110 of the puncture needle 11 is provided with holes. These holes allow fluids such as gas or atomized liquid to pass through. When the limiting member 21 is set against the puncture needle 11, It will not affect the passage of these fluids. For example, when the fluid needs to be used to sterilize the puncture needle 11 and the sensor electrode 12 after the sensor assembly 1 and the protection device 2 are connected, the stopper 21 will not constitute an obstacle and will not affect the disinfection effect of the puncture needle 11 and the sensor electrode 12 . In some embodiments, the holes in the portion of the limiting member 21 that is opposite to the opening 110 of the puncture needle 11 are arranged in a mesh, linearly along the length direction of the puncture needle 11 , and arranged in a direction surrounding the puncture needle 11 .

In some embodiments, the limiting member 21 includes a limiting portion 211. The limiting portion 211 includes a first limiting wall 2111, a second limiting wall 2112, and a connecting bridge 2113. The connecting bridge 2113 connects the first limiting wall 2111 and the connecting bridge 2113. The second limiting wall 2112, the first limiting wall 2111 and the second limiting wall 2112 are connected to the mounting portion 212 through a connecting arm 213 respectively. connect.

The connecting bridge 2113 can be destroyed. Before the connecting bridge 2113 is destroyed, the internal space formed between the first limiting wall 2111 and the second limiting wall 2112 is small. For example, when both inner walls are arcs, an approximately cylindrical shape is formed between the two. A cavity with a smaller diameter, such as 0.5mm, 1mm or 2mm.

The first limiting wall 2111 and the second limiting wall 2112 can be opened by other tools, such as specific tooling, so that the gap between them becomes larger. At this time, when connected to the sensor assembly 1, it is not easy to interfere with the sensor assembly 1. Damage to the sensor assembly 1 can be avoided.

The connecting arm 213 can be configured to be elastic. After the tool that spreads the first limiting wall 2111 and the second limiting wall 2112 is removed, the connecting arm 213 uses its own elasticity to make the first limiting wall 2111 and the second limiting wall 2112 recovers or partially recovers to the shape before being stretched, so that the gap between the first limiting wall 2111 and the second limiting wall 2112 becomes smaller again, and the first limiting wall 2111 and the second limiting wall 2112 are reduced. and the sensor assembly 1, thereby better protecting the sensor electrode 12. The connecting arm 213 can also be configured to be plastic. After the tool for spreading the first limiting wall 2111 and the second limiting wall 2112 is removed, the first limiting wall 2111 and the second limiting wall 2112 remain stretched. state, at this time, you can also adjust the gap after the first limiting wall 2111 and the second limiting wall 2112 are stretched without being affected by the initial gap between the first limiting wall 2111 and the second limiting wall 2112 Size, for example by adjusting the size of the spreading tool. Regardless of whether the connecting arm 213 is elastic or plastic, the initial size of the limiting portion 211 can be made smaller and material can be saved.

In some embodiments, the connecting bridge 2113 can be destroyed by an additional tool, such as a cutting tool such as a knife. After the connecting bridge 2113 is destroyed, the tool can be used to open the first limiting wall 2111 and the second limiting wall 2112. In some embodiments, tools can be directly used to expand the first limiting wall 2111 and the second limiting wall 2112, and the connecting bridge 2113 is destroyed during the expanding process. In some embodiments, the connecting bridge 2113 is provided with features that cause it to be easily damaged, such as V-shaped grooves, scribed lines, etc.

In some embodiments, the first limiting wall 2111 and the second limiting wall 2112 have the same size and shape. In some embodiments, the first limiting wall 2111 and the second limiting wall 2112 are different in size and shape. For example, in the first embodiment, the first limiting wall 2111 and the second limiting wall 2112 are both fan-ring shaped, but the first limiting wall 2111 and the second limiting wall 2112 are larger.

In some embodiments, in FIG. 11 , the connecting bridge 2113 is disposed at the middle position in the vertical direction. In other embodiments, the connecting bridge 2113 can also be provided at the upper part, upper end surface, lower part, lower end surface, etc. The limiting part 211 is not limited to being composed of only two limiting walls 2110, but may also be composed of three, four or more limiting walls 2110. The limiting wall 2110 is not limited to being connected to the mounting part 212 through the connecting arm 213. The limiting wall 2110 may also be directly connected to the mounting part 212 at its lower part.

Assembly process of sensor components and protection devices

In some embodiments, the sensor assembly 1 and the protective device 2 are positioned prior to assembly so that the wearer The opening 110 of the lancet 11 is aligned with the limiting member 21 . The sensor assembly 1 and the protective device 2 can be positioned through automated optical inspection (AOI) or manual visual methods, or through a tooling with a positioning function. In some embodiments, after the housing 24 of the protection device 2 is assembled with the sensor assembly 1, the limiting member 21 is then assembled with the housing 24. In some embodiments, before the housing 24 of the protection device 2 is assembled with the sensor assembly 1 , the limiting member 21 is first assembled with the housing 24 .

In some embodiments, before assembling the limiting member 21 with the housing 24 , a tool is first used to spread the first limiting wall 2111 and the second limiting wall 2112 . In some embodiments, after assembling the limiting member 21 and the housing 24 and before assembling the sensor assembly 1 and the protection device 2 , a tool is first used to spread the first limiting wall 2111 and the second limiting wall 2112 . In some embodiments, before the first limiting wall 2111 and the second limiting wall 2112 are stretched apart, the connecting bridge 2113 is first destroyed, such as cut off.

An analyte concentration monitoring system

In some embodiments, an analyte concentration monitoring system includes an implanter and a sensor assembly 1, and the implanter and sensor assembly 1 are assembled and connected. The implanter is used to assist the sensor component 1 in fitting with the human body. In some embodiments, the implanter is provided with a driving mechanism for driving the sensor assembly 1 to move quickly toward the skin so that the puncture needle 11 can penetrate the skin. In some embodiments, after the sensor electrode 12 reaches the set position in the human skin, the implanter can also drive the puncture needle 11 to leave the human skin.

In some embodiments, the implanter is assembled and connected with the sensor component 1 and the protective device 2, and the protective device 2 and the implanter form a protective shell to protect the sensor component 1 inside. When it is necessary to attach the sensor component 1 to human skin, the protective device 2 is removed. In some embodiments, the connection between the implanter and the protective device 2 is rotated. In some embodiments, the connection between the implanter and the protective device 2 is released by pulling. In some embodiments, the protective device 2 is only used in the production, transportation, and storage process of the sensor component 1. The protective device 2 is removed from the sensor component 1 before the sensor component 1 is assembled and connected to the implanter.

In some embodiments, the implanter is also provided with a guide mechanism. During the process of disconnecting the protection device 2 from the implanter, the guide mechanism guides or limits the movement of the protection device 2 to prevent the protection device 2 from being disconnected during the process. The neutralizing puncture needle 11 collides. In some embodiments, when the protection device 2 and the sensor assembly 1 are disconnected, special tooling, manipulators, holding equipment and other devices are used to operate to avoid collision between the protection device 2 and the puncture needle 11 .

Unless otherwise defined, all terms (including technical and scientific terms) have their ordinary and customary meanings to those skilled in the art and are not intended to be limiting to a specific or specialized meaning unless expressly defined herein. It should be noted that the use of a particular term when describing certain features or aspects of the disclosure should not imply that the term is redefined herein to be limited to include any particular feature or aspect of the disclosure with which that term is associated. The terms and phrases used in this application and variations thereof, such as in the appended claims, are to be construed as open-ended unless expressly stated otherwise. As the aforementioned example, The term "including" shall mean "including but not limited to" or similar meaning.

Claims

A sensor component protection device, including a sensor component (1) and a protection device (2);

The sensor assembly (1) includes a puncture needle (11), a sensor electrode (12) is provided inside the puncture needle (11), and a side wall of the puncture needle (11) is provided to allow the sensor electrode (12) to pass through. opening(110);

The protection device (2) includes a limiter (21), the limiter (21) and the sensor assembly (1) are detachably connected, and at least a part of the limiter (21) is connected to the sensor assembly (1). At least a portion of the opening (110) is oppositely disposed.
The sensor component protection device according to claim 1, wherein the limiting member (21) is connected and matched with the side wall of the puncture needle (11) at the opening (110).
The sensor component protection device according to claim 1, wherein a gap (120) is formed between the limiting member (21) and the puncture needle (11).
The sensor component protection device according to claim 3, wherein the width of the gap (120) is 0.1 mm to 30 mm.
The sensor assembly protection device according to claim 1, wherein the limiting member (21) is arranged around the puncture needle (11).
The sensor component protection device according to claim 1, wherein at least a part of the limiting member (21) is arranged opposite to at least a part of the sensor electrode (12).
The sensor component protection device according to claim 6, wherein the ratio of the length of the part of the limiting member (21) opposite to the sensor electrode (12) and the length of the opening (110) is not less than ten one part.
The sensor component protection device according to claim 6, wherein the length of the portion of the limiting member (21) opposite to the sensor electrode (12) is not less than 2 mm.
The sensor component protection device according to claim 1, wherein the limiting member (21) is arranged opposite to the upper part, the middle part or the lower part of the opening (110).
The sensor component protection device according to claim 1, wherein the protection device (2) further includes a housing (24), and the limiting member (21) is integrally formed with the housing (24).
The sensor component protection device according to claim 1, wherein the protection device (2) further includes a housing (24), and the limiting member (21) is connected to the housing (24).
The sensor component protection device according to claim 11, wherein the limiting member (21) and the housing (24) are respectively provided with first positioning structures that cooperate with each other.
The sensor component protection device according to claim 11, wherein the limiting member (21) includes a limiting portion (211), a mounting portion (212) and a connecting arm (213), and the connecting arm (213) The limiting part (211) is connected to the mounting part (212).
The sensor component protection device according to claim 13, wherein the limiting part (211) includes a plurality of limiting walls (2110), and a connecting bridge (2113) is provided between the plurality of limiting walls (2110). ), the connecting bridge (2113) is configured to connect the plurality of limiting walls (2110) to form the limiting portion (211), the limiting wall (2110) and the connecting arm (213) connect.
The sensor component protection device according to claim 1, wherein the protection device (2) and the sensor component (1) are respectively provided with second positioning structures (1234) that cooperate with each other.
The sensor component protection device according to claim 1, wherein the material of the portion of the limiting member (21) opposite to the opening (120) is an elastic material.
The sensor component protection device according to claim 1, wherein the portion of the limiting member (21) opposite to the opening (120) of the puncture needle (11) is provided with a hole.
The sensor component protection device according to claim 1, wherein the connection between the sensor component (1) and the protection device (2) is released by turning or pulling.
An assembly process of the sensor component protection device according to any one of claims 1 to 18, including: first positioning the sensor component (1) and the protection device (2), and then positioning the sensor component (1) and the protection device (2) are assembled.
An assembly process of a sensor component protection device as claimed in claim 14, including: first positioning the sensor component (1) and the protection device (2), and then positioning the sensor component (1) and the protection device (2). The protection device (2) is assembled; before the sensor assembly (1) and the protection device (2) are assembled, a plurality of limiting walls (2110) are first opened.
An analyte concentration monitoring system, including an implanter, and a sensor component protection device as claimed in any one of claims 1 to 18, the implanter, the sensor component (1) and the protection device ( 2) Assemble the connections.