A biological monitoring sensor implant device and a continuous blood glucose monitor

Abstract

The present application discloses a biological monitoring sensor implant device and a continuous blood glucose monitor. The implant device includes a housing and an auxiliary needle assembly disposed in the housing. One end of the housing is provided with an opening. The implant device also includes a trigger cover disposed at one end of the auxiliary needle assembly. The trigger cover has a top portion for contacting the skin. The auxiliary needle assembly can move toward the opening synchronously with the trigger cover, and move relative to the trigger cover when the top portion is stopped, so that the auxiliary needle assembly can move relative to the trigger cover to have a first proximal position and a first distal position. The trigger cover can prevent the auxiliary needle assembly from being accidentally touched, and after being accidentally triggered, the auxiliary needle assembly can be reset by a simple operation without affecting the next implantation operation. Therefore, a recovery measure is provided after the implant device is accidentally triggered, giving the user more opportunities for trial and error, thereby avoiding the problem of the entire product being scrapped due to a single erroneous operation, reducing the cost of use, and improving the user experience.

Description

Technical Field

[0001] The present application belongs to the field of medical equipment technology, and specifically relates to a biological monitoring sensor implant device and a continuous blood glucose monitor. Background Art

[0002] A biosensor is an instrument that is sensitive to bioactive substances and converts the concentration of the sensed bioactive substances into electrical signals for detection. Among them, glucose sensors are a more common type of biosensor. CGM (continuous glucose monitoring) is a technical means to indirectly reflect blood sugar levels by continuously monitoring the glucose concentration of the interstitial fluid of the subcutaneous tissue through a glucose sensor.

[0003] When in use, the user needs to place the CGM product shell on the skin and then press the trigger button. At this time, the puncture needle and sensor pin inside the shell move toward the skin and pierce the human skin. The biological enzymes on the sensor produce an electrochemical reaction with the subcutaneous tissue fluid, which is converted into an electrical signal and provided to the user by converting it into a blood sugar value.

[0004] In order to ensure the cleanliness of the puncture needle and sensor, CGM products are usually disposable products, that is, after the user presses the trigger button to move the puncture needle and sensor to complete the implantation action, the product cannot be used again. However, since the trigger button is generally set on the outer surface of the shell, it is very easy to accidentally touch the trigger button during the transportation of the CGM product or when the user picks up and holds the shell, causing the puncture needle and sensor to complete the implantation movement in advance when the user does not press the shell on the skin, thereby causing the product to be scrapped. This not only leads to a poor user experience of the existing monitoring device applicator, but also increases the user's usage cost.

[0005] Therefore, CGM products are usually equipped with a safety lock to prevent users from accidentally triggering them before use. Therefore, the safety lock needs to be released before the sensor is implanted. However, during the period from when the user touches the safety lock to the formal implantation, since the user's hand is always holding the implant device and the user has a certain fear in his heart before the implantation, there is still a risk of the implant device being accidentally triggered.

[0006] In addition, once the implant device is triggered by mistake, the internal puncture needle quickly completes the implantation and withdrawal action, and this action is irreversible. Therefore, the puncture needle cannot be reset and reused, which directly leads to the scrapping of the implant device. At this time, the sensor is not implanted subcutaneously in the patient, so the implant device is wasted, greatly increasing the cost of use. Summary of the invention

[0007] The present application provides a biological monitoring sensor implant device and a continuous blood glucose monitor to solve at least one of the above-mentioned technical problems.

[0008] The technical solution adopted in this application is:

[0009] A biological monitoring sensor implant device comprises a shell and an auxiliary needle assembly disposed in the shell, one end of the shell is provided with an opening, the implant device also comprises a trigger cover disposed at one end of the auxiliary needle assembly, the trigger cover has an abutment top portion for contacting the skin, the auxiliary needle assembly can move toward the opening synchronously with the trigger cover, and move relative to the trigger cover when the abutment top portion is stopped, so that the auxiliary needle assembly can move relative to the trigger cover to have a first proximal position and a first distal position.

[0010] The trigger cover is arranged inside the shell, the shell is provided with a limiting portion, and the trigger cover is provided with a stopping portion, and the stopping portion abuts against the limiting portion.

[0011] One end of the trigger cover and one end of the shell are located on the same end surface.

[0012] The trigger cover has a first clamping structure, and the auxiliary needle assembly has a second clamping structure, and the first clamping structure and the second clamping structure are clamped and matched.

[0013] One of the outer wall of the trigger cover and the inner wall of the shell is provided with a guide rib, and the other is provided with a guide groove matched with the guide rib, and the guide groove and the guide rib extend toward the opening.

[0014] The auxiliary needle assembly includes a pushing member and a piercing member, the piercing member can move relative to the pushing member to have a second proximal position and a second distal position, the pushing member is provided with a limiting structure for limiting the piercing member at the second proximal position, and the trigger cover is provided with an unlocking structure, when the auxiliary needle assembly moves to the first proximal position, the unlocking structure can release the limiting structure to allow the piercing member to move to the second distal position.

[0015] The pushing member has a guide portion, a guide channel is provided in the guide portion, the puncture member is placed in the guide channel, the limiting structure includes an abutment wing arranged on the guide portion, the abutment wing has a stop protrusion protruding toward the inside of the guide channel, the stop protrusion and the puncture member are stopped and limited to limit the movement of the puncture member to the distal position.

[0016] The piercing member has a matching plane, and the stop protrusion is in abutment with the matching plane.

[0017] The unlocking structure comprises an unlocking rib disposed on the trigger cover, and the unlocking rib can abut against the abutting wing to move the stop protrusion and disengage from the piercing member.

[0018] The trigger cover is provided with a slideway, the abutment wing is located in the slideway and moves along the slideway, and the unlocking rib is located at one end of the slideway.

[0019] The abutting wing extends obliquely toward the outside of the guide channel to have a fixed end and a free end, the stopping protrusion is arranged at the free end, and the unlocking structure can abut against the free end.

[0020] One of the inner wall of the guide channel and the outer wall of the piercing member is provided with a guide slide bar, and the other is provided with a guide slide groove matched with the guide slide bar.

[0021] The puncture member includes a needle body and a needle seat, and the implantation device also includes a tension spring, one end of the tension spring is connected to the needle seat, and the other end is connected to the pushing member.

[0022] The implant device also includes a trigger member, which has a connecting end and an operating end, the connecting end is hinged to the shell, and the trigger member also has a pushing top portion, which can push the auxiliary needle assembly to move the auxiliary needle assembly toward the opening.

[0023] The needle-assisting assembly includes a pushing member and a transmission member disposed in the shell, the transmission member is fixedly connected to the pushing member, the pushing top portion has a positioning column, the transmission member is provided with a positioning slide, the positioning column is disposed in the positioning slide, and when the operating end rotates around the connecting end, the positioning column can slide in the positioning slide.

[0024] The present application also discloses a continuous blood glucose monitor, comprising the above-mentioned biological monitoring sensor implantation device, and also comprising a skin fixing base fixed to the auxiliary needle assembly facing the opening end, the skin fixing base comprising a base, a sensor and a sensor electronic unit, the sensor is fixed to the base, and the sensor electronic unit is detachably connected to the base.

[0025] Due to the adoption of the above technical solution, the beneficial effects achieved by this application are as follows:

[0026] 1. The present application sets a trigger cover at one end of the needle-assisting assembly. The trigger cover can serve as an anti-accidental touch component of the implant device, realize the anti-accidental touch of the needle-assisting assembly, and can reset the needle-assisting assembly through simple operation after the accidental triggering, without affecting the next implantation operation. Since the trigger cover is connected to the needle-assisting assembly, when the user does not press the top of the trigger cover against the skin, the trigger cover is not stopped, so the needle-assisting assembly can move toward the opening together with the trigger cover. At this time, although the implantation action is completed, the needle withdrawal action of the puncture member inside the needle-assisting assembly will not be triggered, so the implantation device will not be scrapped. The user can push the needle-assisting assembly and the trigger cover back to their original position without affecting the next use of the implantation device. Only when the user presses the top of the trigger cover against the skin, so that the trigger cover cannot move with the needle-assisting assembly, and the needle-assisting assembly moves to the first proximal position alone, can the trigger cover trigger the needle withdrawal movement of the puncture member to complete the complete implantation and needle withdrawal action. Through the above design, a recovery measure is provided after the implant device is triggered by mistake. Before the implant device is correctly triggered and implanted with the correct operation method, the user is given more opportunities for trial and error, thereby avoiding the problem of the entire product being scrapped due to a single erroneous operation, reducing the cost of use and improving the user experience.

[0027] 2. As a preferred embodiment of the present application, the trigger cover is placed inside the shell, the shell is provided with a limiting portion, the trigger cover is provided with a stopping portion, and the stopping portion abuts against the limiting portion. After the limiting portion and the stopping portion cooperate, a limit is formed on the trigger cover. When the user triggers it by mistake, the trigger cover moves toward the opening together with the auxiliary needle assembly. At this time, a part of the trigger cover extends from the opening. At this time, the user can intuitively see the position of the trigger cover and know the status of the trigger cover and the auxiliary needle assembly, and can directly push the trigger cover from bottom to top to push the trigger cover and the auxiliary needle assembly back to reset. After the trigger cover is reset, the stopping portion cooperates with the limiting portion to stop, and the trigger cover cannot continue to move upward, thereby giving the user a prompt to reset in place through force feedback.

[0028] 3. As a preferred embodiment of the present application, one of the outer wall of the trigger cover and the inner wall of the shell is provided with a guide rib, and the other is provided with a guide groove that cooperates with the guide rib, and the guide groove and the guide rib extend toward the opening. The guide rib and the guide groove cooperate to form a movement limit for the trigger cover, so that it can only move along the axial direction of the shell and will not rotate, thereby improving the reliability of the movement of the trigger cover.

[0029] 4. As a preferred embodiment of the present application, the needle-assisting assembly includes a pushing member and a piercing member. The piercing member can move relative to the pushing member to have a second proximal position and a second distal position. The pushing member is provided with a limiting structure for limiting the piercing member at the second proximal position. The trigger cover is provided with an unlocking structure. When the needle-assisting assembly moves to the first proximal position, the unlocking structure can release the limiting structure to allow the piercing member to move to the second distal position. The limiting structure limits the piercing member so that it moves synchronously with the pushing member. When the implantation is completed, the piercing member is located at the first proximal position. At this time, the piercing member is triggered by the unlocking structure, thereby releasing the limitation of the limiting structure and allowing the piercing member to move relative to the pushing member. At this time, the pushing member still stays at the first proximal position, while the piercing member retracts to the second distal position on its own to complete the needle withdrawal operation. The unlocking structure is located at the first proximal position and on the movement path of the puncture member. Therefore, when the pushing member carries the puncture member to the first proximal position, the unlocking structure can automatically trigger and unlock the puncture member without the user having to perform additional needle withdrawal operations. The implantation and needle withdrawal steps are automatically completed in one step, which simplifies the user's operating steps, reduces the operating difficulty, and greatly improves the user experience.

[0030] 5. As a preferred embodiment of the present application, the implant device also includes a trigger, which has a connecting end and an operating end, the connecting end is hinged with the shell, and the trigger also has a push top, which can push the push member so that the push member and the implant assembly move toward the opening. The connecting end of the trigger of the present application is hinged with the shell, so that the trigger can rotate relative to the shell to achieve the switching of the initial position and the auxiliary needle position, that is, the trigger triggers the implant device by rotating. Compared with the method of pressing a button, the transmission is carried out by means of a hinged shaft, which not only improves the operating feel, but also the distance between the operating end and the connecting end is far, so the length of the force arm is longer, making it easier and more labor-saving for the user to operate the trigger. The trigger is hingedly connected to the shell, which can make the trigger obtain a more significant visual effect. When the user holds the shell, he can consciously avoid the trigger with his fingers, thereby reducing the probability of mis-triggering caused by accidentally touching the trigger when holding the implant device. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0032] Figure 1 This is a structural explosion view of a monitor according to one embodiment of the present application;

[0033] Figure 2 for Figure 1 A cross-sectional view of the monitor;

[0034] Figure 3 Figure 2 Magnified view of area A in the middle;

[0035] Figure 4 This is a schematic diagram of the structure of a trigger member in one implementation mode of the present application;

[0036] Figure 5 This is a schematic diagram of the structure of a housing in one embodiment of the present application;

[0037] Figure 6 This is a schematic diagram of the structure of a transmission member in one implementation manner of the present application;

[0038] Figure 7 for Figure 6 A schematic diagram of the structure on the other side of the middle transmission member;

[0039] Figure 8 This is a schematic diagram of the structure of a push member in one implementation mode of the present application;

[0040] Fig. 9 This is a schematic diagram of the structure of a trigger cover in one embodiment of the present application;

[0041] Fig.10 This is a schematic diagram of the structure of a skin fixing seat according to an embodiment of the present application;

[0042] Fig.11 for Fig.10 Schematic diagram of the structure of the middle base;

[0043] Fig.12 for Fig.10 Schematic diagram of the structure of the sensor electronic unit;

[0044] Fig.13 A cross-sectional view of a piercing member according to an embodiment of the present application;

[0045] Fig.14 for Fig.13 Schematic diagram of the structure of the middle needle body;

[0046] Fig.15 for Fig.13 Schematic diagram of the structure of the middle needle seat.

[0047] in:

[0048] 1 housing; 11 opening; 12 guide protrusion; 13 hinge seat; 14 limit portion;

[0049] 2 needle-assisting assembly; 21 transmission member; 211 positioning slideway; 212 positioning rib; 213 limiting rib; 214 avoiding notch; 215 guide groove; 216 initial end; 217 trigger end; 218 first clamping part; 22 pushing member; 221 guide part; 2211 guide channel; 2212 abutting wing; 2213 stop protrusion; 2214 reinforcing rib; 2215 guide slide; 222 second clamping part; 223 second clamping structure; 2231 guide surface; 23 puncture member; 231 needle body; 232 needle seat; 2321 matching plane; 2322 guide slide;

[0050] 3 trigger member; 31 push top; 311 positioning column; 32 connecting end; 321 articulated arm; 322 articulated shaft; 33 operating end;

[0051] 4 trigger cover; 41 abutting top; 42 slideway; 43 unlocking rib; 44 first clamping structure; 45 guide groove; 46 stopper;

[0052] 5 skin fixing seat; 51 base; 511 mounting position; 512 first clamping rib position; 52 sensor; 53 sensor electronic unit; 531 second clamping rib position; 532 positioning structure;

[0053] 6. Tension spring. DETAILED DESCRIPTION

[0054] In order to more clearly illustrate the overall concept of the present application, a detailed description is given below in an illustrative manner in conjunction with the accompanying drawings.

[0055] In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application may also be implemented in other ways different from those described herein. Therefore, the scope of protection of the present application is not limited to the specific embodiments disclosed below.

[0056] In addition, in the description of the present application, it should be understood that the terms "top", "bottom", "inside", "outside", "axial", "radial", "circumferential", etc., indicating orientations or positional relationships are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0057] In this application, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or a communication; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0058] In the present application, unless otherwise clearly specified and limited, the first feature "above" or "below" the second feature may be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. In the description of this specification, the description with reference to the terms "implementation method", "example", "one embodiment", "example" or "specific example" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in an appropriate manner in any one or more embodiments or examples.

[0059] like Figures 1 to 15 As shown, a biological monitoring sensor implant device includes a shell 1 and an auxiliary needle assembly 2 placed in the shell 1, one end of the shell 1 is provided with an opening, and the implant device also includes a trigger cover 4 arranged at one end of the auxiliary needle assembly 2, the trigger cover 4 has an abutment top portion 41 for contacting the skin, the auxiliary needle assembly 2 can move toward the opening synchronously with the trigger cover 4, and move relative to the trigger cover 4 when the abutment top portion 41 is stopped, so that the auxiliary needle assembly 2 can move relative to the trigger cover 4 to have a first proximal position and a first distal position.

[0060] It can be understood that the first distal position is the initial position of the auxiliary needle assembly 2. When in use, the opening of the shell 1 is placed close to the patient's skin. When the user triggers the trigger, the auxiliary needle assembly 2 performs an implantation action, that is, moves toward the opening to the position where the puncture needle pierces the patient's skin. At this time, the auxiliary needle assembly 2 reaches the first proximal position.

[0061] The present application sets a trigger cover 4 at one end of the auxiliary needle assembly 2. The trigger cover 4 can serve as an anti-accidental touch component of the implant device to prevent the auxiliary needle assembly 2 from being accidentally touched. After being accidentally triggered, the auxiliary needle assembly 2 can be reset through simple operations without affecting the next implantation operation.

[0062] If the user does not press the top of the trigger cover 4 against the skin, it means that the user has not operated the implant device according to the correct method of use, which can be understood as an erroneous triggering operation. Since the trigger cover 4 is connected to the auxiliary needle assembly 2, when the trigger cover 4 is not stopped, the auxiliary needle assembly 2 can move toward the opening together with the trigger cover 4. Although the implantation action is completed at this time, the needle withdrawal action of the piercing member 23 inside the auxiliary needle assembly 2 will not be triggered, so the implant device will not be scrapped. The user can push the auxiliary needle assembly 2 and the trigger cover 4 back to their original position without affecting the next use of the implant device.

[0063] When the user puts the opening against the skin surface, the top portion 41 of the trigger cover 4 contacts the skin and is stopped by the skin, which indicates that the user is using it in the correct way. At this time, after triggering the implantation device, the trigger cover 4 cannot move with the auxiliary needle assembly 2, and the auxiliary needle assembly 2 moves to the first proximal position alone. The trigger cover 4 can trigger the needle withdrawal movement of the puncture member 23 to complete the complete implantation and needle withdrawal action.

[0064] Through the above design, a recovery measure is provided after the implant device is triggered by mistake. Before the implant device is correctly triggered and implanted with the correct operation method, the user is given more opportunities for trial and error, thereby avoiding the problem of the entire product being scrapped due to a single erroneous operation, reducing the cost of use and improving the user experience.

[0065] As a preferred embodiment of the present application, Figure 2 , Figure 3 As shown, the trigger cover 4 is disposed inside the housing 1 , the housing is provided with a limiting portion 14 , and the trigger cover 4 is provided with a stopper 46 , which abuts against the limiting portion 14 .

[0066] like Figure 2 As shown, the limiting part 14 cooperates with the stopper 46 to limit the trigger cover 4. When the user triggers the trigger cover 4 by mistake, the trigger cover 4 moves toward the opening together with the auxiliary needle assembly 2. At this time, a part of the trigger cover 4 extends out from the opening. At this time, the user can intuitively see the position of the trigger cover 4 and know the status of the trigger cover 4 and the auxiliary needle assembly 2. Then, the user can directly push the trigger cover 4 upward from the bottom to push the trigger cover 4 and the auxiliary needle assembly 2 back to reset. After the trigger cover 4 is reset, the stopper 46 cooperates with the limiting part 14 to stop. At this time, the trigger cover 4 cannot continue to move upward, so as to give the user a prompt of reset through force feedback.

[0067] Preferably, Figure 3As shown, the housing 1 is folded outward at the opening to form a limiting groove, the groove wall of the limiting groove constitutes the limiting portion 14, and the bottom end of the trigger cover 4 is also folded outward to form an outer flange, which is located in the limiting groove, and the upper end surface of the outer flange constitutes a stopper 46, and the lower end surface constitutes a stopper 41. At the same time, the flange structure also increases the contact area between the stopper 41 and the skin, improves the user's touch, and improves the comfort of use.

[0068] Furthermore, if Figure 2 , Figure 3 As shown, one end of the trigger cover 4 and one end of the housing 1 are located on the same end surface.

[0069] In the initial state, the shell 1 surrounds the trigger cover 4, realizing a hidden design of the trigger cover 4, making the appearance of the implant device more simple, and when the user misoperates and causes the trigger cover 4 to extend from the opening, the user can clearly see the state of the trigger cover 4.

[0070] It should be noted that the present application does not specifically limit the connection method between the trigger cover 4 and the auxiliary needle assembly 2. In a preferred embodiment, Figure 8 , Fig. 9 As shown, the trigger cover 4 has a first clamping structure 44, and the needle-assisting assembly 2 has a second clamping structure 223, and the first clamping structure 44 and the second clamping structure 223 are clamped and matched.

[0071] Specifically, Figure 8 , Fig. 9 As shown, the first clamping structure 44 is a clamping protrusion arranged on the trigger cover 4, and the second clamping structure 223 is a clamping groove arranged on the auxiliary needle assembly 2. The clamping protrusion is located in the clamping groove, and the groove wall on the upper side of the clamping groove has a guide surface 2231, so that when the trigger cover 4 is stopped, the clamping protrusion can slide out of the clamping groove along the guide surface 2231 above the clamping groove, so that the trigger cover 4 and the auxiliary needle assembly 2 are disconnected.

[0072] Of course, the first clamping structure 44 can also be a clamping groove, and the second clamping structure 223 can be a clamping protrusion. In this case, the groove wall on the lower side of the clamping groove is provided with a guide surface to facilitate the second clamping structure 223 to escape from the clamping groove from the lower side. Alternatively, the first clamping structure 44 and the second clamping structure 223 are both clamping protrusions, and the guide surface is provided on the opposite side of the two, which is not specifically limited here.

[0073] As a preferred embodiment of the present application, Fig. 9 As shown, one of the outer wall of the trigger cover 4 and the inner wall of the housing 1 is provided with a guide rib, and the other is provided with a guide groove 45 matched with the guide rib, and the guide groove 45 and the guide rib extend toward the opening.

[0074] The guide ribs and the guide grooves 45 cooperate to limit the movement of the trigger cover 4 so that the trigger cover 4 can only move along the axial direction of the housing 1 and will not rotate, thereby improving the movement reliability of the trigger cover 4.

[0075] like Fig. 9 As shown, in one embodiment, the guide rib is arranged on the inner wall of the housing 1, and the guide groove 45 is arranged on the outer wall of the trigger cover 4. Of course, the guide rib can also be arranged on the outer wall of the trigger cover 4, and correspondingly, the guide rib is arranged on the inner wall of the housing 1. Furthermore, the movement amount of the trigger cover 4 can be limited by setting the length of the guide groove 45.

[0076] In a preferred embodiment, Figure 2 As shown, the needle-assisting assembly 2 includes a pushing member 22 and a piercing member 23. The piercing member 23 can move relative to the pushing member 22 to have a second proximal position and a second distal position. The pushing member 22 is provided with a limiting structure for limiting the piercing member 23 at the second proximal position. The trigger cover 4 is provided with an unlocking structure. When the needle-assisting assembly 2 moves to the first proximal position, the unlocking structure can release the limiting structure to allow the piercing member 23 to move to the second distal position.

[0077] When the user triggers the implantation operation, the push member 22 and the puncture member 23 move synchronously, moving from the first distal position to the first proximal position together. At this time, the puncture member 23 penetrates the patient's skin and implants the sensor needle inside the skin fixing seat 5 under the patient's skin. The limiting structure limits the puncture member 23 so that it keeps moving synchronously with the push member 22. When the implantation is completed, the puncture member 23 is located at the first proximal position. At this time, the puncture member 23 is triggered by the unlocking structure, thereby releasing the restriction of the limiting structure, so that the puncture member 23 can move relative to the push member 22. At this time, the push member 22 still stays at the first proximal position, while the puncture member 23 retracts to the second distal position alone, completing the needle withdrawal operation.

[0078] The unlocking structure is located at the first proximal position and on the movement path of the puncture member 23. Therefore, when the pushing member 22 carries the puncture member 23 to the first proximal position, the unlocking structure can automatically trigger and unlock the puncture member 23 without the user having to perform additional needle withdrawal operations. The implantation and needle withdrawal steps are automatically completed in one step, which simplifies the user's operating steps, reduces the operating difficulty, and greatly improves the user experience.

[0079] Furthermore, if Figure 2 , Figures 13 to 15As shown, the piercing member 23 includes a needle body 231 and a needle seat 232, and the implantation device also includes a tension spring 6, one end of the tension spring 6 is connected to the needle seat 232, and the other end is connected to the needle-assisting assembly 2. The tension spring 6 provides the piercing member 23 with the power required for the needle withdrawal movement. When the unlocking structure unlocks the limiting structure, the piercing member 23 moves to the second distal position under the pull of the tension spring 6 to complete the needle withdrawal.

[0080] This embodiment does not specifically limit the specific structure of the limiting structure. In a preferred embodiment, Figure 8 As shown, the pushing member 22 has a guide portion 221, and the guide portion 221 has a guide channel 2211. The piercing member 23 is placed in the guide channel 2211. The limiting structure includes an abutment wing 2212 arranged on the guide portion 221, and the abutment wing 2212 has a stop protrusion 2213 protruding toward the inside of the guide channel 2211. The stop protrusion 2213 and the piercing member 23 are stopped and limited to limit the movement of the piercing member 23 to the second distal position.

[0081] like Figure 8 As shown, the guide portion 221 is provided with an abutting wing 2212 extending from the outside of the guide channel 2211 , and the abutting wing 2212 has a stop protrusion 2213 inside, and the stop protrusion 2213 stops the piercing member 23 to form a limit for the piercing member 23 .

[0082] like Figure 8 As described above, the abutting wing 2212 extends obliquely toward the outside of the guide channel 2211 to have a fixed end and a free end, the stop protrusion 2213 is arranged at the free end, and the unlocking structure can abut against the free end, so that the abutting wing 2212 switches the limiting state of the piercing member 23 in a deformed manner.

[0083] In addition, if Figure 8 As shown, the abutting wing 2212 is further provided with a reinforcing rib 2214 to increase the strength of the abutting wing 2212 and prevent the abutting wing 2212 from being greatly deformed and broken when being squeezed.

[0084] Furthermore, if Fig.15 As shown, the piercing member 23 has a matching plane 2321 , and the stop protrusion 2213 abuts against the matching plane 2321 .

[0085] The stop protrusion 2213 stops the matching plane 2321, which increases the contact area between the two, making the stop protrusion 2213 stop the piercing member 23 more stable and firm, improving stability and preventing the piercing member 23 from being triggered by mistake.

[0086] Preferably, Fig.13 , Fig.15As shown, the piercing member 23 includes a needle body 231 and a needle seat 232 . The needle seat 232 serves as a carrier of the needle body 231 , and a matching plane 2321 is disposed on the needle seat 232 .

[0087] Furthermore, if Figure 8 , Fig.15 As shown, one of the inner wall of the guide channel 2211 and the outer wall of the piercing member 23 is provided with a guide slide bar 2215, and the other is provided with a guide slot 2322 that cooperates with the guide slide bar 2215, and the two cooperate to form a limit for the piercing member 23, so that the piercing member 23 can move axially along the housing 1, and prevent the piercing member 23 from deflecting itself during the needle withdrawal process.

[0088] like Fig. 9 As shown, the unlocking structure includes an unlocking rib 43 disposed on the trigger cover 4 , and the unlocking rib 43 can abut against the abutting wing 2212 to move the stop protrusion 2213 and disengage from the piercing member 23 .

[0089] When the pushing member 22 and the piercing member 23 move to the first proximal position together, the unlocking rib 43 squeezes the abutting wing 2212, causing the abutting wing 2212 to deform and open toward the outside of the guide channel 2211, and the stop protrusion 2213 on the inner side opens outward synchronously, thereby losing the stop on the piercing member 23. At this time, the piercing member 23 can move upward under the action of the tension spring 6 to complete the needle withdrawal.

[0090] Furthermore, if Fig. 9 As shown, the trigger cover 4 is provided with a slideway 42 , the abutting wing 2212 is located in the slideway 42 and moves along the slideway 42 , and the unlocking rib 43 is located at one end of the slideway 42 .

[0091] The cooperation between the slide 42 and the abutment wing 2212 can further guide the movement of the push member 22. At the same time, the unlocking rib 43 is located at one end of the slide 42, which can ensure that the unlocking structure effectively triggers the abutment wing 2212, reduce the probability of failure of the unlocking structure due to assembly errors, and improve the reliability of the cooperation between the two.

[0092] Preferably, Figure 8 , Fig. 9 As shown, there are two abutment wings 2212 symmetrically arranged on both sides of the guide channel 2211 , and there are also two corresponding slideways 42 distributed on both sides of the guide portion 221 , so that the abutment wings 2212 on both sides are located in the slideway 42 and move along the slideway 42 .

[0093] In a preferred embodiment, Figure 1 , Figure 2As shown, the implant device also includes a trigger member 3, which has a connecting end 32 and an operating end 33. The connecting end 32 is hinged to the housing 1. The trigger member 3 also has a pushing end 31, which can push the auxiliary needle assembly 2 to move the auxiliary needle assembly 2 toward the opening.

[0094] The connection end 32 of the trigger member 3 of the present application is hinged to the housing 1, so that the trigger member 3 can rotate relative to the housing 1 to switch between the initial position and the auxiliary needle position, that is, the trigger member 3 triggers the implant device by rotating. Compared with the method of pressing a button, the transmission by means of a hinge shaft not only improves the operating feel, but also the distance between the operating end 33 and the connection end 32 is longer, so the lever arm length is longer, making it easier and more labor-saving for the user to operate the trigger member 3.

[0095] In addition, the trigger member 3 is hingedly connected to the shell 1, which can make the trigger member 3 obtain a more significant visual effect. When the user holds the shell 1, the user can consciously avoid the trigger member 3 with his fingers, thereby reducing the probability of false triggering caused by accidentally touching the trigger member 3 when holding the implant device.

[0096] Moreover, during the rotation of the trigger member 3, the user and medical staff can see the status of the trigger member 3 in real time, thereby knowing the implantation status of the internal auxiliary needle assembly 2, which is convenient for precise control of the implantation process and improves the user experience.

[0097] like Figure 4 , Figure 5 As shown, in a specific embodiment, the connection end 32 of the trigger member 3 is provided with an articulated arm 321, and the housing 1 is provided with an articulated seat 13. The side wall of the articulated arm 321 protrudes to form an articulated shaft 322, and the articulated shaft 322 extends into the hole of the articulated seat 13 to complete the articulation. Of course, the articulated shaft can also be fixed to the articulated seat 13, and a hole is correspondingly provided in the articulated arm 321 for the articulated shaft to pass through. For another example, both the articulated arm 321 and the articulated seat 13 are provided with openings, and the articulated shaft is an independent structure. The articulated shaft is passed through the openings of the articulated arm 321 and the articulated seat 13 to achieve articulation.

[0098] It should be noted that the present application does not specifically limit the manner in which the trigger member 3 triggers the auxiliary needle assembly 2. In one embodiment, the housing is provided with a stop structure for limiting the auxiliary needle assembly 2, so as to limit the auxiliary needle assembly 2 to the first distal position. When the user operates the trigger member 3, the trigger member 3 pushes the auxiliary needle assembly 2, so that it is disengaged from the cooperation with the stop structure and automatically moves toward the first proximal position to complete the implantation action. For example, a spring or other structure may be provided in the housing to provide a thrust for the auxiliary needle assembly 2 to move toward the first proximal position.

[0099] In another embodiment, the auxiliary needle assembly 2 is a manually implanted structure, that is, when the user operates the trigger member 3, the user needs to keep pressing the trigger member 3 so that the trigger member 3 continuously forms a pushing force on the auxiliary needle assembly 2, and then continuously pushes the auxiliary needle assembly 2 to the first proximal position. The implantation process requires the user to keep pressing the trigger member 3, and the thrust of the trigger member 3 on the auxiliary needle assembly 2 and the movement speed of the auxiliary needle assembly 2 are completely controlled by the user.

[0100] Specifically, Figure 5 As shown, the top wall of the housing 1 is provided with a through opening 11, and the push portion 31 extends from the through opening 11 into the housing 1 to cooperate with the auxiliary needle assembly 2. When the trigger member 3 is in the auxiliary needle position, the trigger member 3 covers the through opening 11.

[0101] Preferably, the angle between the initial position of the trigger member 3 and the implantation position is 30-60°.

[0102] The rotational movement of the trigger member 3 is converted into a driving force on the auxiliary needle assembly 2 along the axial direction of the shell 1. The trigger member 3 only needs to rotate a small angle to enable the auxiliary needle assembly 2 to complete the implantation action. At the same time, it is more convenient for the user to operate, and the trigger member 3 can be pressed with one hand.

[0103] Furthermore, if Figure 1 , Figure 6 As shown, the needle-assisting assembly 2 includes a pushing member 22 and a transmission member 21 disposed in the housing 1, the transmission member 21 is fixedly connected to the pushing member 22, the pushing top portion 31 has a positioning column 311, the transmission member 21 is provided with a positioning slide 211, the positioning column 311 is arranged in the positioning slide 211, and when the operating end 33 rotates around the connecting end 32, the positioning column 311 can slide in the positioning slide 211.

[0104] The positioning slide 211 can limit the positioning column 311 and restrict its movement to the inside of the positioning slide 211. When the trigger member 3 rotates around the hinge axis, the positioning column 311 not only forms a pushing force toward the opening on the auxiliary needle assembly 2 to move the auxiliary needle assembly 2, but also slides laterally along the positioning slide 211, making the movement of the trigger member 3 more reliable, enabling it to move along a preset path, and making the user's operating feel more stable.

[0105] Furthermore, if Figure 6 As shown, the positioning slide 211 extends transversely to have an initial end 216 and a trigger end 217 , and a limiting rib 213 is also provided in the positioning slide 211 , and the limiting rib 213 can cooperate with the positioning column 311 to limit the positioning column 311 to the initial end 216 .

[0106] The limiting rib 213 limits the positioning column 311 at the initial end 216 and cooperates with the stopper of the positioning column 311. Therefore, when the user presses the trigger member 3, it will not easily trigger the trigger member 3 to rotate. Instead, a greater force needs to be applied to make the positioning column 311 pass over the limiting rib 213 before it can slide in the positioning slide 211. This appropriately increases the operating difficulty of the trigger member 3 and further improves the anti-accidental touch effect of the trigger member 3.

[0107] Preferably, Figure 4 , Figure 6 As shown, the positioning column 311 is a cylindrical structure, and the surface of the limiting rib 213 is also provided with a transition arc surface, so that the positioning column 311 can pass over the limiting rib 213 more smoothly, reduce the sticking feeling of the positioning column 311 when moving, and improve the operating feel.

[0108] by Figure 2 , Figure 6 For example, the left end of the positioning slide 211 is the initial end 216, and the right end is the trigger end 217. When the operating end 33 of the trigger member 3 rotates downward, under the restriction of the positioning slide 211, the end of the push-top part 31, that is, the positioning column 311 will slide to the right. When the trigger member 3 rotates to the auxiliary needle position, the positioning column 311 moves to the trigger end 217.

[0109] The present embodiment does not specifically limit the assembly method of the transmission member 21 and the pushing member 22. In a preferred embodiment, Figure 7 , Figure 8 As shown, the transmission member 21 has a first clamping portion 218, and the push member 22 has a second clamping portion 222 that cooperates with the first clamping portion 218, so that the transmission member 21 is clamped and fixed with the push member 22. Of course, the transmission member 21 and the push member 22 can be fixedly connected by other means, such as magnetic fixation, screw connection, etc.

[0110] In another embodiment, the transmission member 21 and the pushing member 22 are integrally formed to simplify the structure of the needle-assisting assembly 2, save assembly steps, and improve assembly efficiency.

[0111] Furthermore, if Figure 6 As shown, a positioning rib 212 is provided at the top of the transmission member 21. The positioning rib 212 cooperates with the surface of the pushing member 22 to form a positioning slide 211. The positioning rib 212 is provided with an avoidance notch 214 so that the positioning column 311 can enter the positioning slide 211 from the avoidance notch 214.

[0112] Specifically, Figure 7 , Figure 8As shown, the pushing member 22 is provided with at least two channels, and a second clamping portion 222 is provided on the channel wall of each channel. The transmission member 21 is provided with a first clamping portion 218 corresponding to the second clamping portion 222, so that the transmission member 21 and the pushing member 22 are clamped at multiple positions, thereby improving the connection strength, ensuring that the two are coaxial, and avoiding tilting.

[0113] Preferably, Figure 5 , Figure 6 As shown, one of the outer wall of the transmission member 21 and the inner wall of the housing 1 is provided with a guide groove 215 extending toward the opening, and the other is provided with a guide protrusion 12 cooperating with the guide groove 215 .

[0114] The guide groove 215 cooperates with the guide protrusion 12 to limit the transmission member 21 and the pushing member 22 so that they can only move along the axial direction of the housing 1, thereby improving the movement reliability of the needle-assisting assembly 2.

[0115] Preferably, Figure 6 As shown, a plurality of guide grooves 215 are provided and are evenly spaced along the circumference of the transmission member 21 , and the guide protrusions 12 are provided in one-to-one correspondence with the guide grooves 215 .

[0116] like Figure 1 , Fig.10 As shown, the present application also discloses a monitor, including the above-mentioned implant device, and also includes a skin fixing base 5 fixed to the auxiliary needle assembly 2 toward the opening end, the skin fixing base 5 includes a base 51, a sensor 52 and a sensor electronic unit 53, the sensor 52 is fixed to the base 51, and the sensor electronic unit 53 is detachably connected to the base 51.

[0117] like Fig.10 As shown, the contact needle of the sensor 52 extends out of the skin fixing base 5 , the puncture member 23 penetrates the skin fixing base 5 , and the contact needle of the sensor 52 is accommodated inside the puncture member 23 .

[0118] An adhesive sheet is provided on one side of the skin fixing seat 5, and when it contacts the patient's skin, it can stick to the patient's skin surface, so that after the implantation is completed, the internal sensor 52 probe extends into the patient's subcutaneous tissue, while the skin fixing seat 5 is fixed on the patient's skin surface.

[0119] When the monitor of the present application is in use, when the user triggers the implantation operation, the needle-assisting assembly 2 and the skin fixing seat 5 move synchronously, moving together from a first distal position to a first proximal position. At this time, the puncture member 23 pierces the patient's skin and implants the sensor 52 contact needle under the patient's skin.

[0120] When the implantation is completed, the unlocking structure releases the restriction of the limiting structure, so that the piercing member 23 retracts to the second distal position alone, completing the needle withdrawal operation. Finally, the user removes the housing assembly, and the skin fixing seat 5 remains on the patient's skin surface.

[0121] It should be noted that the present application does not specifically limit the assembly method of the sensor electronic unit 53 and the base 51, which can be one of the following embodiments:

[0122] Embodiment 1: In this embodiment, the sensor electronic unit 53 and the base 51 are detachably connected before leaving the factory, so that the sensor electronic unit 53 and the sensor 52 can be installed on the base 51 in steps, thereby realizing step-by-step sterilization. For example, the sensor 52 is first fixed to the base 51, and the sensor 52 is sterilized by radiation. Then, the sensor electronic unit 53 is installed on the base 51 and gas sterilized, thereby avoiding cross-sterilization causing different degrees of damage to the sensor 52 and the sensor electronic unit 53.

[0123] When the monitor leaves the factory, the sensor electronic unit 53 and the base 51 have been fixed. After the user completes the implantation, there is no need to manually install the sensor electronic unit 53, which saves the user operation steps and improves the user experience.

[0124] Example 2: In this example, the sensor electronic unit 53 and the base 51 are detachable structures when leaving the factory. Therefore, when the skin fixing seat 53 is fixed on the auxiliary needle assembly 2, it does not contain the sensor electronic unit 53. After the user completes the implantation, the sensor electronic unit 53 needs to be manually installed on the base 51. At this time, the skin fixing seat 5 can realize the blood glucose monitoring function.

[0125] Furthermore, if Fig.11 , Fig.12 As shown, the base 51 is provided with a first clamping rib 512 along its circumference, and the sensor electronic unit 53 is correspondingly provided with a second clamping rib 531 . The base 51 has a mounting position 511 for mounting the sensor 52 , and the sensor electronic unit 53 has a positioning structure 532 that is adapted to the shape of the mounting position 511 .

[0126] The clamping fixing method makes the assembly simpler and more convenient, and is easy to install and disassemble. Of course, the base 51 and the sensor electronic unit 53 can also be fixed in other ways, such as thread fixing, magnetic fixing, etc., which are not specifically limited here.

[0127] By providing a positioning structure 532 on the sensor electronic unit 53 corresponding to the shape of the mounting position 511, the sensor electronic unit 53 is installed and positioned. Fig.11 , Fig.12As shown, the installation position 511 has a positioning ring protruding upward, and the sensor electronic unit 53 is correspondingly provided with a positioning groove to form a positioning structure 532. The two are plugged in and positioned to reduce the difficulty of positioning the sensor electronic unit 53 and further improve assembly efficiency.

[0128] Anything not described in this application can be achieved by adopting or drawing on existing technologies.

[0129] The various embodiments in this specification are described in a progressive manner, and the same or similar parts between the various embodiments can be referenced to each other, and each embodiment focuses on the differences from other embodiments.

[0130] The above is only an embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.

Claims

1. A biological monitoring sensor implant device, comprising a housing and an auxiliary needle assembly disposed in the housing, wherein one end of the housing is provided with an opening, characterized in that: The implant device also includes a trigger cover arranged at one end of the auxiliary needle assembly, the trigger cover is placed inside the shell, and the trigger cover has an abutment top portion for contacting the skin. When the abutment top portion is not stopped, the auxiliary needle assembly can move toward the opening synchronously with the trigger cover, so that a partial area of ​​the trigger cover extends from the opening, but will not trigger the needle withdrawal action of the puncture member, so that the position of the trigger cover can be seen, and the status of the trigger cover and the auxiliary needle assembly can be known; pushing the auxiliary needle assembly and the trigger cover back to their original positions will not affect the next use of the implant device; when the abutment top portion is stopped, the auxiliary needle assembly can move relative to the trigger cover to have a first proximal position and a first distal position, the first distal position being the initial position of the auxiliary needle assembly, and when the auxiliary needle assembly performs an implantation action, it moves toward the opening to the position where the puncture needle pierces the patient's skin, and at this time the auxiliary needle assembly reaches the first proximal position.

2. The biological monitoring sensor implant device according to claim 1, characterized in that: The housing is provided with a limiting portion, and the trigger cover is provided with a stopping portion, and the stopping portion abuts against the limiting portion.

3. The biological monitoring sensor implantation device according to claim 2, characterized in that: One end of the trigger cover and one end of the shell are located on the same end surface.

4. The biological monitoring sensor implant device according to claim 1, characterized in that: The trigger cover has a first clamping structure, and the auxiliary needle assembly has a second clamping structure, and the first clamping structure and the second clamping structure are clamped and matched.

5. The biological monitoring sensor implant device according to claim 1, characterized in that: One of the outer wall of the trigger cover and the inner wall of the shell is provided with a guide rib, and the other is provided with a guide groove matched with the guide rib, and the guide groove and the guide rib extend toward the opening.

6. The biological monitoring sensor implant device according to claim 1, characterized in that: The auxiliary needle assembly includes a pushing member and a piercing member, the piercing member can move relative to the pushing member to have a second proximal position and a second distal position, the pushing member is provided with a limiting structure for limiting the piercing member at the second proximal position, and the trigger cover is provided with an unlocking structure, when the auxiliary needle assembly moves to the first proximal position, the unlocking structure can release the limiting structure to allow the piercing member to move to the second distal position.

7. The biological monitoring sensor implant device according to claim 6, characterized in that: The pushing member has a guide portion, a guide channel is provided in the guide portion, the puncture member is placed in the guide channel, the limiting structure includes an abutment wing arranged on the guide portion, the abutment wing has a stop protrusion protruding toward the inside of the guide channel, the stop protrusion and the puncture member are stopped and limited to limit the movement of the puncture member to the distal position.

8. The biological monitoring sensor implant device according to claim 7, characterized in that: The piercing member has a matching plane, and the stop protrusion is in abutment with the matching plane.

9. The biological monitoring sensor implantation device according to claim 7, characterized in that: The unlocking structure comprises an unlocking rib disposed on the trigger cover, and the unlocking rib can abut against the abutting wing to move the stop protrusion and disengage from the piercing member.

10. The biological monitoring sensor implantation device according to claim 9, characterized in that: The trigger cover is provided with a slideway, the abutment wing is located in the slideway and moves along the slideway, and the unlocking rib is located at one end of the slideway.

11. The biological monitoring sensor implant device according to claim 7, characterized in that: The abutting wing extends obliquely toward the outside of the guide channel to have a fixed end and a free end, the stopping protrusion is arranged at the free end, and the unlocking structure can abut against the free end.

12. The biological monitoring sensor implant device according to claim 7, characterized in that: One of the inner wall of the guide channel and the outer wall of the piercing member is provided with a guide slide bar, and the other is provided with a guide slide groove matched with the guide slide bar.

13. The biological monitoring sensor implant device according to claim 6, characterized in that: The puncture member includes a needle body and a needle seat, and the implantation device also includes a tension spring, one end of the tension spring is connected to the needle seat, and the other end is connected to the pushing member.

14. The biological monitoring sensor implant device according to claim 1, characterized in that: The implant device also includes a trigger member, which has a connecting end and an operating end, the connecting end is hinged to the shell, and the trigger member also has a pushing top portion, which can push the auxiliary needle assembly to move the auxiliary needle assembly toward the opening.

15. The biological monitoring sensor implant device according to claim 14, characterized in that: The needle-assisting assembly includes a pushing member and a transmission member disposed in the shell, the transmission member is fixedly connected to the pushing member, the pushing top portion has a positioning column, the transmission member is provided with a positioning slide, the positioning column is disposed in the positioning slide, and when the operating end rotates around the connecting end, the positioning column can slide in the positioning slide.

16. A continuous blood glucose monitor, characterized in that: A bio-monitoring sensor implant device comprising any one of claims 1 to 15; The monitor also includes a skin mount fixed to one end of the needle-assisting assembly facing the opening, the skin mount including a base, a sensor and a sensor electronic unit, the sensor is fixed to the base, and the sensor electronic unit is detachably connected to the base.

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