In-vivo blood glucose monitoring device

Abstract

The in-vivo blood glucose monitoring device comprises a shell, an in-vivo monitoring unit and a needle assisting unit, the shell is provided with a first end and a second end which are oppositely arranged in the first direction, and the second end is provided with an implanting opening; the in-vivo monitoring unit comprises a first electronic unit and a second electronic unit which are arranged at an interval, the first electronic unit comprises a sensor and a power supply part, and the second electronic unit comprises a signal processing module; the needle assisting unit can drive the first electronic unit to move in the first direction so that the sensor part can be implanted into the host skin, and meanwhile the first electronic unit and the second electronic unit can be electrically connected. A first electronic unit and a second electronic unit of the in-vivo monitoring unit are arranged in a shell at an interval and are always in a mutually separated state before a user triggers a needle assisting unit, and a power supply part and a signal processing module are not electrically connected, so that the discharge of the power supply part before the user uses the device can be reduced, and meanwhile, the storage time is prolonged; and electric quantity storage of the power supply part is ensured.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical equipment, and in particular relates to an in-body blood sugar monitoring device. Background Art

[0002] Diabetic patients measure their blood sugar concentration by drawing blood from their fingertips. Since blood sugar concentration is constantly changing, this measurement method requires patients to perform regular tests to continuously track blood sugar indicators. Fingerstick blood measurement cannot help patients accurately track blood sugar concentration in real time to improve their health quality.

[0003] CGM (Continuous Glucose Monitoring) stands for continuous glucose monitoring system, which is a medical device used to continuously monitor the blood glucose levels of diabetic patients. Compared with traditional blood glucose monitoring methods, CGM provides continuous and detailed blood glucose level data, which can help users better manage their blood glucose status.

[0004] When in use, the user needs to place the shell of the CGM product 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 enzyme on the sensor and the subcutaneous tissue fluid produce an electrochemical reaction, which is converted into an electrical signal and provided to the user by converting it into a blood sugar value. The sensor used to obtain the blood sugar value in the host in real time and the electronic components that send signals to the display device are generally integrated in the in-body monitoring unit. After the implantation is completed, the in-body monitoring unit is attached to the surface of the host's skin for continuous monitoring.

[0005] The on-body monitoring unit is usually assembled before leaving the factory, and is equipped with a signal transmitter and a battery for powering the signal transmitter. The battery is electrically connected to the signal transmitter before leaving the factory. However, CGM products often go through a long period of transportation and storage before they are used by users. During this period, the battery is always electrically connected to the signal processing module, resulting in power loss. When the user uses it, the battery power is low, resulting in a shorter battery life of the product. Utility Model Content

[0006] The utility model provides an in-body blood glucose monitoring device to solve the problems of battery discharge, reduced continuous monitoring endurance and reduced storage time in an in-body monitoring unit during storage and transportation.

[0007] The technical solution adopted by the utility model is:

[0008] An in vivo blood glucose monitoring device comprises a shell, the shell having a first end and a second end arranged opposite to each other along a first direction, the second end being provided with an implantation port; an in vivo monitoring unit, the in vivo monitoring unit comprising a first electronic unit and a second electronic unit arranged at intervals, the first electronic unit comprising a sensor and a power supply, the second electronic unit comprising a signal processing module, the first electronic unit and the second electronic unit being both arranged inside the shell; and an auxiliary needle unit, the auxiliary needle unit being arranged inside the shell, the auxiliary needle unit being capable of driving the first electronic unit to move along a first direction so as to implant the sensor portion into the host's skin, while electrically connecting the first electronic unit and the second electronic unit.

[0009] In the utility model, before the product leaves the factory, the first electronic unit and the second electronic unit of the body monitoring unit are spaced apart inside the housing, the first electronic unit includes a power supply for supplying power to the signal processing module, and the second electronic unit includes a signal processing module. Until the user triggers the auxiliary needle unit to perform the implantation action, the first electronic unit and the second electronic unit are always in a state of being separated from each other, and the power supply and the signal processing module are not electrically connected. In addition, the power supply is not electrically connected to any electrical appliance, which can reduce the discharge of the power supply before the user uses it, and also increase the storage time, ensuring the power storage of the power supply. After the user implants it, it can have a longer battery life and improve the user experience.

[0010] When the user triggers the auxiliary needle unit, the auxiliary needle unit moves in the first direction. During the movement, not only the sensor is implanted under the host's skin, but also the first electronic unit and the second electronic unit are electrically connected, and the power supply and the signal processing module are electrically connected. In this way, a trigger operation is achieved, and the electrical connection between the first electronic unit and the second electronic unit and the implantation of the sensor are completed at the same time. This greatly simplifies the operation steps of the user's implantation process, reduces the difficulty of product operation, and reduces the user's learning cost. At the same time, it also shortens the time of the entire implantation stage, which helps to reduce the fear of users while waiting for implantation.

[0011] Preferably, the first electronic unit further comprises an upper shell having a through hole for the puncture needle to pass through, the sensor comprises a contact pin extending into the puncture needle, and a substrate arranged outside the through hole, and the power supply is arranged opposite to the substrate along the radial direction of the through hole.

[0012] In this solution, the substrate and the power supply are arranged on both sides of the through hole in a radial direction of the through hole. On the one hand, the space inside the upper shell is reasonably utilized to avoid the problem that the components are concentrated on one side of the upper shell and the space on the other side of the upper shell cannot be better utilized. In addition, the counterweights on the two sides of the through hole can be adjusted to make the weights on both sides of the upper shell closer, avoiding the upper shell from tilting due to the large weight difference on both sides. On the other hand, the substrate and the power supply are arranged on both sides of the through hole relatively far apart, thereby reducing the heat transferred from the power supply to the substrate, keeping a lower temperature at the substrate, reducing the interference of heat on the sensor, and ensuring the service life of the sensor and the accuracy of the monitoring data.

[0013] Preferably, the housing comprises a cover shell and a bottom shell, the needle-assisting unit and the first electronic unit are arranged inside the cover shell, and the second electronic unit is arranged inside the bottom shell.

[0014] In this solution, the outer shell is a split structure, the needle-assisting unit and the first electronic unit are fixed in the cover shell, and the second electronic unit is fixed in the bottom shell, so that the in vivo blood glucose monitoring device is divided into two modules, among which the puncture unit, sensor and other components with high sterilization requirements are concentrated in one module (inside the cover shell). Therefore, before leaving the factory, the cover shell and the bottom shell modules can be sterilized with different processes or levels respectively. After the sterilization is completed, the cover shell and the bottom shell are assembled into one. Avoid the problem of sensor or electronic component failure during the sterilization process. In addition, when leaving the factory, the bottom shell and the cover shell have been fixed. The user does not need to fix the bottom shell and the cover shell before use. He only needs to directly perform the trigger operation, which reduces the operation steps and improves the user experience.

[0015] Preferably, the bottom shell is provided with a fixing structure, the second electronic unit is interference fit with the fixing structure, and the second electronic unit can be separated from the bottom shell under the push of the needle-assisting unit or when the shell is separated from the host skin.

[0016] In this solution, before the user triggers the device, the second electronic unit is fixed to the bottom shell by interference fit, and the fixing structure fixes the second electronic unit, ensuring a relatively stable connection while having a relatively small fixing force. When the second electronic unit is pushed by the auxiliary needle unit or by the adhesive force with the host's skin, it easily falls off the fixing structure and is separated from the bottom shell.

[0017] Preferably, a fixing buckle is provided inside the housing, and the fixing buckle is used to clamp and fix the first electronic unit, and the fixing buckle can be deformed or moved to be disengaged from the first electronic unit.

[0018] In this solution, the cover is fixed to the first electronic unit by means of a fixing buckle, which makes the connection between the first electronic unit and the housing more secure and reduces the risk of premature detachment. In addition, the fixing buckle can cooperate with the first electronic unit to form a rotation limit for the first electronic unit, preventing the first electronic unit from rotating relative to the housing, ensuring that the posture of the first electronic unit is unique and improving reliability.

[0019] Preferably, the implantation port is arranged on the bottom shell, and a mating port is arranged on one end of the cover shell facing the bottom shell. The in vivo blood glucose monitoring device also includes a sealing component, which is located between the first electronic unit and the second electronic unit to seal the mating port; the sealing component can move along the second direction to release the seal of the mating port so that the mating port is connected with the implantation port, and the second direction is perpendicular to the first direction.

[0020] In this solution, before leaving the factory, the first electronic unit inside the cover shell and the second electronic unit inside the bottom shell can be sterilized in different ways. After sterilization, the sealing component is set between the cover shell and the bottom shell to seal and isolate the internal spaces of the cover shell and the bottom shell respectively, thereby reducing the risk of external bacteria entering the cover shell and the bottom shell. Before use, the sealing component is pulled out from one side of the in-vivo blood glucose monitoring device so that the internal chamber of the cover shell and the internal chamber of the bottom shell are connected, and the first electronic unit and the second electronic unit can be assembled and electrically connected. The setting of the sealing component can isolate the inside of the shell from the outside world before the user uses it, thereby ensuring a sterile environment inside the shell.

[0021] Preferably, the in vivo blood glucose monitoring device further comprises a bottom cover, which is detachably connected to the second end and is used to cover the implantation port.

[0022] In this solution, the bottom cover is detachably connected to the outer shell. When leaving the factory, the bottom cover is fixed to the outer shell and cooperates with the outer shell to form a relatively sealed environment to prevent external dust and bacteria from entering the interior during storage and transportation, and to ensure the cleanliness of the internal components. Before the user implants the device, the bottom cover needs to be removed from the outer shell and the implantation port opened so that the internal sensor can penetrate the body through the implantation port.

[0023] Preferably, the first electronic unit also includes an upper shell, the sensor and the power supply are arranged in the upper shell, the second electronic unit also includes a lower shell, the signal processing module is arranged in the lower shell, one of the upper shell and the lower shell is provided with a sealing rib, and the other of the two is provided with a sealing groove, a sealing member is arranged in the sealing groove, and the sealing rib can extend into the sealing groove and abut against the sealing member to form an installation cavity between the upper shell and the lower shell.

[0024] In this solution, the sealing rib and the sealing member in the sealing groove are arranged correspondingly. When the upper shell contacts the lower shell along the first direction, the sealing rib extends into the sealing groove, abuts against the sealing member and squeezes the sealing member to deform, thereby achieving sealing between the upper and lower shells.

[0025] Preferably, the first electronic unit further includes an upper shell, the sensor and the power supply are arranged in the upper shell, the second electronic unit further includes a lower shell, the signal processing module is arranged in the lower shell, and the upper shell and the lower shell can be matched and fixed along the first direction.

[0026] In this solution, after the needle-assisting unit is triggered, it moves along the first direction toward the implantation port, and pushes the first electronic unit and the second electronic unit to move along the first direction to the implantation port, and contact with the patient's skin to complete bonding. The implantation direction of the needle-assisting unit and the movement direction of the first electronic unit and the second electronic unit are the same, which not only makes the arrangement of the needle-assisting structure inside the shell simpler and more compact, but also makes the movement of each component more reliable, and helps to ensure the stability of the puncture unit during movement, avoiding shaking of the puncture unit during implantation and increasing the user's pain.

[0027] Preferably, the in vivo blood glucose monitoring device also includes a puncture unit, a pushing member and a reset member arranged inside the shell, the pushing member is used to drive the auxiliary needle unit to carry the puncture unit to move along a first direction, and the reset member is used to drive the puncture unit to move along a third direction, which is opposite to the first direction; in the first direction, the pushing member and the reset member at least partially overlap.

[0028] In this solution, in the axial direction of the shell, the reset member and the push member at least partially overlap, which can improve the compactness of the structural arrangement, help reduce the overall axial size of the in-body blood glucose monitoring device, and achieve miniaturization.

[0029] Due to the adoption of the above technical solution, the beneficial effects achieved by the utility model are as follows:

[0030] Before the product leaves the factory, the first electronic unit and the second electronic unit of the in-body monitoring unit are spaced apart inside the housing, the first electronic unit includes a power supply for supplying power to the signal processing module, and the second electronic unit includes a signal processing module. Until the user triggers the auxiliary needle unit to perform the implantation action, the first electronic unit and the second electronic unit are always separated from each other, and the power supply and the signal processing module are not electrically connected. Therefore, the power supply is not electrically connected to any electrical appliance, which can reduce the discharge of the power supply before the user uses it, and also increase the storage time, ensuring the power storage of the power supply. After the user implants it, it can have a longer battery life and improve the user experience.

[0031] And the user can complete the electrical connection between the first electronic unit and the second electronic unit and the implantation of the sensor at the same time by performing a trigger operation. This greatly simplifies the operation steps of the user during the implantation process, reduces the difficulty of product operation, and reduces the user's learning cost. It also shortens the time of the entire implantation stage, which helps to reduce the fear of users while waiting for implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The drawings described herein are used to provide a further understanding of the present invention and constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation on the present invention. In the drawings:

[0033] Figure 1 This is a schematic structural diagram of a first electronic unit in one embodiment of the utility model;

[0034] Figure 2 for Figure 1 A cross-sectional view of a first electronic unit;

[0035] Figure 3 is a cross-sectional view of a second electronic unit in one embodiment of the utility model;

[0036] Figure 4 It is a structural schematic diagram of an on-body monitoring unit in an embodiment of the utility model when the first electronic unit and the second electronic unit are separated;

[0037] Figure 5 A cross-sectional view of an on-body monitoring unit according to an embodiment of the present invention;

[0038] Figure 6 This is a cross-sectional view of an in-body blood glucose monitoring device according to an embodiment of the present invention;

[0039] Figure 7 It is a cross-sectional view of a part of the in-body blood glucose monitoring device according to an embodiment of the utility model, wherein the needle-assisting unit is in an untriggered state;

[0040] Figure 8 for Figure 7 A cross-sectional view of the in vivo blood glucose monitoring device during implantation when the first electronic unit and the second electronic unit are assembled;

[0041] Fig. 9 for Figure 7 A cross-sectional view of the in-vivo blood glucose monitoring device when the auxiliary needle unit moves into position along the first direction;

[0042] Fig.10 It is a cross-sectional view of a partial area of ​​an in-body blood glucose monitoring device according to another embodiment of the utility model, wherein the auxiliary needle unit is in an untriggered state;

[0043] Fig.11 for Fig.10 A cross-sectional view of the in-vivo blood glucose monitoring device when the auxiliary needle unit moves into position along the first direction;

[0044] Fig.12A cross-sectional view of a partial area of ​​an in-body blood glucose monitoring unit according to another embodiment of the present invention;

[0045] Fig.13 A cross-sectional view of a bottom shell and a bottom cover in one embodiment of the utility model;

[0046] Fig.14 for Fig.13 Schematic diagram of the structure of the mid-bottom shell and bottom cover.

[0047] in:

[0048] 1 housing; 11 cover; 111 matching opening; 112 unlocking structure; 113 snap-on buckle; 12 bottom housing; 121 slot; 122 avoidance opening; 123 implantation opening; 124 through opening; 125 elastic rib position;

[0049] 2 on-body monitoring unit; 21 first electronic unit; 211 upper shell; 212 fixing groove; 213 sensor; 2131 substrate; 2132 contact pin; 214 power supply; 215 conductive silicone; 216 sealing silicone; 217 sealing rib; 218 buckle; 219 through hole; 22 second electronic unit; 221 lower shell; 222 adhesive layer; 223 bayonet; 224 retaining rib; 225 signal processing module; 226 sealing groove; 227 sealing member;

[0050] 3 auxiliary needle unit; 31 first mounting groove; 32 second mounting groove; 33 stopper; 34 fixing buckle; 35 clamping part;

[0051] 4 puncture units;

[0052] 5 bottom cover; 51 support column;

[0053] 6 pusher;

[0054] 7. Reset member;

[0055] 8. Sealing assembly;

[0056] 9 Limiting sleeve. DETAILED DESCRIPTION

[0057] In order to more clearly illustrate the overall concept of the present invention, a detailed description is given below in the form of examples in conjunction with the accompanying drawings.

[0058] In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention may also be implemented in other ways different from those described herein. Therefore, the protection scope of the present invention is not limited to the specific embodiments disclosed below.

[0059] In addition, in the description of the present invention, 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 invention 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.

[0060] In the present invention, unless otherwise clearly specified and limited, the terms "install", "connect", "connect", "fix" 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.

[0061] In the present utility model, 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 utility model. 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.

[0062] like Figure 1 , Figure 2 , Figure 3 , Figure 5 , Figures 6 to 9 As shown, an in vivo blood glucose monitoring device includes a shell 1, the shell 1 has a first end and a second end arranged opposite to each other along a first direction, and the second end is provided with an implantation port 123; an in vivo monitoring unit 2, the in vivo monitoring unit 2 includes a first electronic unit 21 and a second electronic unit 22 arranged at intervals, the first electronic unit 21 includes a sensor 213 and a power supply 214, the second electronic unit 22 includes a signal processing module 225, and the first electronic unit 21 and the second electronic unit 22 are both arranged inside the shell 1; and an auxiliary needle unit 3, the auxiliary needle unit 3 is arranged inside the shell 1, and the auxiliary needle unit 3 can drive the first electronic unit 21 to move along the first direction to implant the sensor 213 partially into the host skin, and at the same time electrically connect the first electronic unit 21 and the second electronic unit 22.

[0063] It can be understood that the first direction is along the axial direction of the shell 1 toward the implantation port 123 .

[0064] Preferably, if Figure 3 , Figure 4 , Figure 5 As shown, an adhesive layer 222 is provided on one side of the second electronic unit 22 facing the implantation port 123 for bonding and fixing with the host skin surface, so that the in-body monitoring unit 2 is fixed to the host skin surface to achieve continuous blood glucose monitoring.

[0065] In the utility model, before the product leaves the factory, the first electronic unit 21 and the second electronic unit 22 of the body monitoring unit 2 are spaced apart inside the housing 1, and the first electronic unit 21 includes a power supply 214 for supplying power to the signal processing module 225, and the second electronic unit 22 includes a signal processing module 225. Until the user triggers the auxiliary needle unit 3 to perform the implantation action, the first electronic unit 21 and the second electronic unit 22 are always in a state of being separated from each other, and the power supply 214 and the signal processing module 225 are not electrically connected. In addition, the power supply 214 is not electrically connected to any electrical appliance, which can reduce the discharge of the power supply 214 before the user uses it, and also increase the storage time, ensuring the power storage of the power supply 214. After the user implants it, it can have a longer battery life and improve the user experience.

[0066] Preferably, the first electronic unit 21 and the second electronic unit 22 are spaced apart along the first direction, so that when the user triggers the auxiliary needle unit 3, the auxiliary needle unit 3 moves along the first direction. During the movement, not only the sensor 213 is implanted under the host's skin, but also the first electronic unit 21 and the second electronic unit 22 are electrically connected, and the power supply 214 and the signal processing module 225 are electrically connected. In this way, a trigger operation is achieved, and the electrical connection of the first electronic unit 21 and the second electronic unit 22, as well as the implantation of the sensor 213 are completed at the same time. The operation steps of the user's implantation process are greatly simplified, the difficulty of product operation is reduced, and the user's learning cost is reduced. At the same time, the time of the entire implantation stage is shortened, which helps to reduce the fear of the user while waiting for implantation.

[0067] In addition, the first electronic unit 21 also includes a sensor 213, which is also separated from the signal processing module 225 of the second electronic unit 22 before implantation. This helps to sterilize the sensor 213 and the signal processing module 225 separately, thereby avoiding the problem of failure of the sensor 213 or electronic components due to different sterilization methods during the sterilization process.

[0068] It should be noted that the present invention does not limit the time sequence of the electrical connection between the first electronic unit 21 and the second electronic unit 22 and the insertion of the sensor 213 into the host body. Figures 6 to 9 As shown, in the process of the auxiliary needle unit 3 and the first electronic unit 21 moving together along the first direction, the first electronic unit 21 and the second electronic unit 22 may complete the electrical connection first, and the auxiliary needle unit 3 has not yet moved into place. As the movement continues, the puncture unit 4 carries the sensor 213 and penetrates into the host body to complete the implantation. That is to say, the electrical connection between the first electronic unit 21 and the second electronic unit 22 occurs before the puncture unit 4 penetrates into the host body. For another example, in the process of the auxiliary needle unit 3 and the first electronic unit 21 moving together along the first direction, the puncture unit 4 carries the sensor 213 and penetrates into the host body first. At this time, the auxiliary needle unit 3 and the puncture unit 4 have not yet moved into place. As the movement continues, the first electronic unit 21 and the second electronic unit 22 complete the electrical connection. That is to say, the puncture unit 4 penetrates into the host body before the electrical connection between the first electronic unit 21 and the second electronic unit 22 occurs. In addition, the above two steps may also occur simultaneously.

[0069] However, no matter which of the above examples is used, the user only needs to perform a single trigger operation and does not need to perform additional operations. Therefore, the situations in the above examples are all within the protection scope of the present utility model.

[0070] As a preferred embodiment of the present invention, Figure 2 As shown, the first electronic unit 21 also includes an upper shell 211, which is provided with a through hole 219 for the puncture needle to pass through. The sensor 213 includes a contact pin 2132 extending into the puncture needle, and a base 2131 arranged outside the through hole 219, and the power supply 214 is arranged opposite to the base 2131 along the radial direction of the through hole 219.

[0071] The base 2131 and the power supply 214 are arranged on both sides of the through hole 219 in a radial direction of the through hole 219. On the one hand, the space inside the upper shell 211 is reasonably utilized to avoid the problem that the components are concentrated on one side of the upper shell 211 and the space on the other side of the upper shell 211 cannot be better utilized. In addition, the counterweights on the two sides of the through hole 219 can be adjusted to make the weights on both sides of the upper shell 211 closer, avoiding the upper shell 211 from tilting due to the large weight difference on both sides. On the other hand, the base 2131 and the power supply 214 are arranged on both sides of the through hole 219 in a relative manner, so that the distance between them is relatively far, thereby reducing the heat transferred from the power supply 214 to the base 2131, maintaining a lower temperature at the base 2131, reducing the interference of heat on the sensor 213, and ensuring the service life of the sensor 213 and the accuracy of the monitoring data.

[0072] Preferably, if Figure 6 , Figure 7 , Fig.10 , Fig.13 As shown, the housing 1 includes a cover shell 11 and a bottom shell 12 , the needle assisting unit 3 and the first electronic unit 21 are arranged inside the cover shell 11 , and the second electronic unit 22 is arranged inside the bottom shell 12 .

[0073] The housing 1 is a split structure, the needle-assisting unit 3 and the first electronic unit 21 are fixed in the cover shell 11, and the second electronic unit 22 is fixed in the bottom shell 12, so that the in vivo blood glucose monitoring device is divided into two modules, wherein the puncture unit 4, the sensor 213 and other components with high sterilization requirements are concentrated in one module (inside the cover shell 11), so before leaving the factory, the cover shell 11 and the bottom shell 12 modules can be sterilized with different processes or levels respectively. After the sterilization is completed, the cover shell 11 and the bottom shell 12 are assembled into one. Avoid the problem of failure of the sensor 213 or electronic components during the sterilization process. And when leaving the factory, the bottom shell 12 and the cover shell 11 have been fixed, and the user does not need to perform the fixing operation of the bottom shell 12 and the cover shell 11 before use, but only needs to directly perform the trigger operation, which reduces the operation steps and improves the user experience.

[0074] Of course, in other embodiments, the cover shell 11 and the bottom shell 12 may be combined into one, that is, the outer shell 1 is a complete shell, and the first electronic unit 21 and the second electronic unit 22 are arranged inside the outer shell 1 at intervals.

[0075] like Figure 7 , Fig. 9 , Fig.12 , Fig.13 As shown, in one embodiment, the side wall of the bottom shell 12 is provided with a slot 121, and the side wall of the cover shell 11 is provided with a snap-fit ​​buckle 113, so that the two are snap-fitted and fixed. The snap-fit ​​buckle 113 can be provided on the inner wall of the cover shell 11, so that the side wall of the bottom shell 12 extends into the cover shell 11 and is fixed to the cover shell 11, and the snap-fit ​​buckle 113 can also be provided on the outer wall of the cover shell 11, so that the cover shell 11 extends into the bottom shell 12 and is fixed.

[0076] The cover shell 11 and the bottom shell 12 may also be fixed by other means, such as threaded connection, etc., which is not limited here.

[0077] Furthermore, if Fig.13 , Fig.14 As shown, the bottom shell 12 is provided with a fixing structure, and the second electronic unit 22 is interference fit with the fixing structure. The second electronic unit 22 can be separated from the bottom shell 12 under the push of the needle-assisting unit 3 or when the shell 1 is separated from the host's skin.

[0078] Specifically, Fig.13 , Fig.14As shown, the bottom shell 12 has a through opening 124, and a plurality of elastic ribs 125 are arranged at intervals along the edge of the through opening 124. The elastic ribs 125 surround the installation position for fixing the second electronic unit 22. After the second electronic unit 22 is installed, the elastic ribs 125 are pressed outwardly, and the elastic ribs 125 are pressed inwardly and clamped and fixed by their own elastic force. When the second electronic unit 22 is pushed by the first electronic unit 21 in the first direction, or after the adhesive layer 222 of the second electronic unit 22 is bonded to the host skin, the second electronic unit 22 can be released from the clamping of the elastic ribs 125 and fall off from the bottom shell 12.

[0079] That is to say, the utility model does not limit the timing of the separation of the bottom shell 12 and the second electronic unit 22. In one embodiment, the second electronic unit 22 is fixed at the implantation port 123. When the user presses the implantation port 123 against the skin surface, the adhesive layer 222 of the second electronic unit 22 adheres to the skin. After the implantation is completed and the first electronic unit 21 and the second electronic unit 22 are assembled, the user removes the outer shell 1. At this time, the on-body monitoring unit 2 falls off from the bottom shell 12 under the action of the adhesive force.

[0080] In another embodiment, if Figures 6 to 9 As shown, the second electronic unit 22 is arranged at a certain distance from the implantation port 123. When the first electronic unit 21 moves to the second electronic unit 22, the two are assembled and electrically connected. Then, the second electronic unit 22 is separated from the bottom shell 12 under the push of the first electronic unit 21, and the in-body monitoring unit 2 continues to move along the first direction as a whole until the adhesive layer 222 of the second electronic unit 22 is fixed to the host skin.

[0081] like Figure 1 , Figures 6 to 11 As shown, a fixing buckle 34 is provided inside the housing 11, and a fixing groove 212 is provided on the peripheral side of the first electronic unit 21. The fixing buckle 34 is fixedly engaged with the fixing groove 212, so that the first electronic unit 21 is fixed inside the housing 1 and can move with the auxiliary needle unit 3. The groove walls on both sides of the fixing groove 212 can stop and limit with the fixing buckle 34, so as to limit the rotation of the first electronic unit 21 relative to the auxiliary needle unit 3.

[0082] At the same time, if Fig.13 , Fig.14 As shown, an escape opening 122 is provided on the outside of the passage 124 on the bottom shell 12, and a trigger rib is provided on the side of the escape opening 122 close to the center of the bottom shell 12. When the auxiliary needle unit 3 carries the first electronic unit 21 to move to the bottom shell 12, the trigger rib squeezes the fixing buckle 34, causing the fixing buckle 34 to expand and deform outward, loosen from the fixing groove 212, release the first electronic unit 21, and at the same time, the fixing buckle 34 enters the escape opening 122.

[0083] Preferably, the fixing buckle 34 is provided on the auxiliary needle unit 3 so that the first electronic unit 21 can move with the auxiliary needle unit 3. Of course, the fixing buckle 34 can also be provided on other components, or separately provided inside the housing 1, as long as the first electronic unit 21 can be fixed by clamping and can move with the auxiliary needle unit 3.

[0084] In a preferred embodiment, Fig.12 As shown, the implantation port 123 is provided on the bottom shell 12, and a mating port 111 is provided on one end of the cover shell 11 facing the bottom shell 12. The in vivo blood glucose monitoring device also includes a sealing component 8, which is located between the first electronic unit 21 and the second electronic unit 22 to seal the mating port 111; the sealing component 8 can move along the second direction to release the seal of the mating port 111 so that the mating port 111 is connected with the implantation port 123, and the second direction is perpendicular to the first direction.

[0085] It can be understood that the first direction is along the axial direction of the housing 1 toward the implantation port 123, and the second direction can be along the radial direction of the housing 1, or can be a direction that does not pass through the axis of the housing 1, as long as it is perpendicular to the first direction. Fig.12 As shown, when the housing 1 is placed vertically, the first direction is the vertical direction, and the second direction only needs to be along the horizontal direction.

[0086] Before leaving the factory, the first electronic unit 21 inside the cover shell 11 and the second electronic unit 22 inside the bottom shell 12 can be sterilized in different ways. After sterilization, the sealing component 8 is set between the cover shell 11 and the bottom shell 12 to seal and isolate the internal spaces of the cover shell 11 and the bottom shell 12, respectively, to reduce the risk of external bacteria entering the cover shell 11 and the bottom shell 12. Before use, the sealing component 8 is pulled out from one side of the in-vivo blood glucose monitoring device to connect the internal chamber of the cover shell 11 and the internal chamber of the bottom shell 12, so that the first electronic unit 21 and the second electronic unit 22 can be assembled and electrically connected. The setting of the sealing component 8 can isolate the inside of the housing 1 from the outside world before the user uses it, thereby ensuring a sterile environment inside the housing 1.

[0087] As a preferred embodiment of the present invention, Figure 6 , Fig.13 , Fig.14 As shown, the in vivo blood glucose monitoring device further includes a bottom cover 5 , which is detachably connected to the second end and is used to cover the implantation port 123 .

[0088] The bottom cover 5 is detachably connected to the outer shell 1. When leaving the factory, the bottom cover 5 is fixed to the outer shell 1 and cooperates with the outer shell 1 to form a relatively sealed environment to prevent external dust and bacteria from entering the interior during storage and transportation, thereby ensuring the cleanliness of the internal components. Before the user implants, the bottom cover 5 needs to be removed from the outer shell 1 and the implantation port 123 is opened so that the internal sensor 213 can penetrate into the body through the implantation port 123.

[0089] Preferably, if Fig.13 As shown, the bottom cover 5 is provided with a supporting column 51 extending toward the housing 1 , and the supporting column 51 contacts the second electronic unit 22 to support the second electronic unit 22 .

[0090] like Fig.13 As shown, before the user removes the bottom cover 5 , the support column 51 supports the second electronic unit 22 to ensure that the second electronic unit 22 is stably fixed in the housing 1 to avoid falling off.

[0091] Specifically, in one embodiment, Figure 7 As shown, before use, the user first removes the bottom cover 5 and then pulls out the sealing assembly 8. After the user presses the trigger unit, the auxiliary needle unit 3 loses its movement limit and carries the first electronic unit 21 to move along the first direction. During the movement, Figure 8 As shown, the first electronic unit 21 and the second electronic unit 22 are in contact and are fixedly electrically connected. At the same time, the fixing buckle 34 is squeezed by the trigger ribs on the bottom shell 12 to loosen the first electronic unit 21, and the second electronic unit 22 is pushed away from the clamping of the elastic ribs 125 by the first electronic unit 21. At this time, the first electronic unit 21 and the second electronic unit 22 are electrically connected. Fig. 9 As shown, at this time, the auxiliary needle unit 3 carries the on-body monitoring unit 2 and continues to move along the first direction as a whole until the puncture unit 4 pierces the host body and the adhesive layer 222 contacts and adheres to the host skin surface.

[0092] Specifically, Fig.13 , Fig.14 As shown, the bottom cover 5 and the housing 1 are fixed by a snap connection. Of course, the bottom cover 5 can also be fixed to the housing 1 by threaded connection, interference fit, plug-in connection, etc., which is not limited here.

[0093] As a preferred embodiment, Figure 2 , Figure 3 , Figure 5As shown, the first electronic unit 21 also includes an upper shell 211, the sensor 213 and the power supply 214 are arranged in the upper shell 211, the second electronic unit 22 also includes a lower shell 221, the signal processing module 225 is arranged in the lower shell 221, one of the upper shell 211 and the lower shell 221 is provided with a sealing rib 217, and the other of the upper shell 211 and the lower shell 221 is provided with a sealing groove 226, and a sealing member 227 is arranged in the sealing groove 226, and the sealing rib 217 can extend into the sealing groove 226 and abut against the sealing member 227 to form an installation cavity between the upper shell 211 and the lower shell 221.

[0094] The sealing rib 217 and the sealing member 227 in the sealing groove 226 are arranged correspondingly. When the upper shell 211 contacts the lower shell 221 along the first direction, the sealing rib 217 extends into the sealing groove 226, abuts against the sealing member 227 and squeezes the sealing member 227 to deform, thereby achieving sealing between the upper and lower shells 221.

[0095] Specifically, Figure 2 , Figure 3 As shown, the sealing rib 217 is provided on the upper shell 211, the sealing groove 226 is provided on the lower shell 221, and the sealing member 227 is an O-ring and is placed in the sealing groove 226. The positions of the sealing rib 217 and the sealing groove 226 can also be interchanged, that is, the sealing rib 217 is provided on the lower shell 221, and the sealing groove 226 is correspondingly provided on the upper shell 211, which is not limited here. Preferably, as Figure 3 As shown, the groove walls on both sides of the sealing groove 226 extend obliquely so that the width of the groove opening is greater than the width of the groove bottom, thereby guiding the insertion of the sealing rib 217, making the plugging of the sealing rib 217 and the sealing groove 226 smoother and reducing the jamming feeling generated during the plugging process.

[0096] Furthermore, if Figure 2 As shown, the sensor 213 includes a sheet-like substrate 2131 and a contact pin 2132 extending downward and integrating multiple electrodes, which is used to be inserted into the human epidermis and analyze the concentration index of glucose and other analytes of the individual through the electrochemical reaction in the tissue fluid inside the epidermis. A conductive silicone 215 is provided on the lower side of the substrate 2131, which is used to transmit the electrical signal of the electrochemical reaction of the sensor 213 to the signal processing module 225. A sealing silicone 216 is also provided on the lower side of the conductive silicone 215, which is mainly used for waterproof sealing of the electrode contacts of the sensor 213, and cooperates with the conductive silicone 215 to achieve electrical connection with the signal processing module 225 while completing the sealing.

[0097] Preferably, the upper shell 211 and the lower shell 221 are fixed by snapping to reduce the difficulty of fixing the two, and no manual connection is required, and the fixing can be completed only by relying on the power of the auxiliary needle unit 3. Figure 2 , Figure 3 , Figure 4 , Figure 5 As shown, the upper shell 211 is provided with a buckle 218, and the lower shell 221 is provided with a bayonet 223. When the upper shell 211 moves along the first direction with the auxiliary needle unit 3, it collides with the lower shell 221. Under the action of the impact force, the buckle 218 slides into the bayonet 223, so that the upper shell 211 and the lower shell 221 are fixed together.

[0098] Of course, the buckle 218 may be provided on the lower shell 221 , and correspondingly, the bayonet 223 may be provided on the upper shell 211 , so that the two can be fixed together by a snap connection.

[0099] Specifically, Figure 2 , Figure 3 As shown, the buckle 218 is provided with a guide surface on the side facing the bayonet 223, and the bayonet 223 is provided with a retaining rib 224 on the side close to the buckle 218. The buckle 218 first contacts the retaining rib 224, and expands toward the outer shape under the pressure of the retaining rib 224. When the buckle 218 continues to move to the bayonet 223, it loses the pressure of the retaining rib 224, shrinks and deforms under the action of its own elasticity, and is snapped into the bayonet 223.

[0100] In a preferred embodiment, Figure 4 , Figure 6 As shown, the first electronic unit 21 also includes an upper shell 211, a sensor 213 and a power supply 214 are arranged on the upper shell 211, and the second electronic unit 22 also includes a lower shell 221, a signal processing module 225 is arranged on the lower shell 221, and the upper shell 211 and the lower shell 221 can be matched and fixed along the first direction.

[0101] After being triggered, the needle-assisting unit 3 moves along the first direction toward the implantation port 123, and pushes the first electronic unit 21 and the second electronic unit 22 to move along the first direction to the implantation port 123, and contact and bond with the patient's skin. The implantation direction of the needle-assisting unit 3 and the movement direction of the first electronic unit 21 and the second electronic unit 22 are the same, which not only makes the arrangement of the needle-assisting structure inside the housing 1 simpler and more compact, but also makes the movement of each component more reliable, and helps to ensure the stability of the puncture unit 4 during movement, avoiding shaking of the puncture unit 4 during implantation and increasing the user's pain.

[0102] Preferably, if Figure 6 , Fig.10 As shown, the in vivo blood glucose monitoring device also includes a puncture unit 4, a pushing member 6 and a resetting member 7 arranged inside the shell 1, the pushing member 6 is used to drive the auxiliary needle unit 3 to carry the puncture unit 4 to move along a first direction, and the resetting member 7 is used to drive the puncture unit 4 to move along a third direction, which is opposite to the first direction; in the first direction, the pushing member 6 and the resetting member 7 at least partially overlap.

[0103] In the axial direction of the housing 1, the reset member 7 and the push member 6 at least partially overlap, which can improve the compactness of the structural arrangement, help reduce the overall axial size of the in-body blood glucose monitoring device, and achieve miniaturization.

[0104] Preferably, both the pusher 6 and the reset member 7 are springs, wherein in the initial state, the pusher 6 is in a compressed state, and a thrust is applied to the auxiliary needle unit 3 along a first direction. The reset member 7 is not deformed in the initial state, and during the movement of the auxiliary needle unit 3 and the puncture unit 4 along the first direction, the reset member 7 is gradually stretched, and a pulling force is applied to the puncture unit 4 along a third direction. This ensures that the puncture unit 4 will not be withdrawn prematurely before the end of the implantation process, resulting in implantation failure, thereby improving the implantation success rate, and at the same time, it can prevent the reset member 7 from being in a deformed state for a long time and causing fatigue, thereby improving the needle withdrawal effect. Alternatively, the reset member 7 can also be designed to be stretched in the initial state to increase the driving force of the reset member 7 on the puncture unit 4.

[0105] Furthermore, if Figures 6 to 11 As shown, the push member 6 is sleeved on the outer circumference of the reset member 7, which helps to reduce the overall radial and axial dimensions of the housing 1, making the internal structure more compact. While reducing the product size, it also improves the guiding role of the reset member 7 and the push member 6, ensuring that the puncture unit 4 will not tilt along the axial movement.

[0106] It should be noted that the present invention does not limit the driving and limiting structure of the needle-assisting unit 3 on the puncture unit 4, which includes but is not limited to the situations listed in the following embodiments:

[0107] Implementation method 1: In this implementation method, Figures 6 to 9 As shown, the auxiliary needle unit 3 is provided with a stopper 33, and the stopper 33 abuts against one end of the puncture unit 4 toward the second end to limit the puncture unit 4 along the third direction. At the same time, when the auxiliary needle unit 3 is triggered, the stopper 33 can also apply a thrust along the first direction to the puncture unit 4, so that the puncture unit 4 follows the auxiliary needle unit 3 to move along the first direction to perform the implantation operation. An unlocking structure 112 is provided on the movement path of the stopper 33. When the auxiliary needle unit 3 carries the puncture unit 4 and moves to the position along the first direction, the unlocking structure 112 can squeeze the stopper 33 to make it move or deform to release the restriction on the puncture unit 4, thereby automatically triggering the unlocking of the puncture unit 4, and the puncture unit 4 is withdrawn along the third direction without the user having to perform an additional needle withdrawal operation. A single triggering operation automatically completes the implantation and needle withdrawal steps in succession, which simplifies the user's operation steps, reduces the operation difficulty, and greatly improves the user experience.

[0108] Furthermore, if Figure 6As shown, the auxiliary needle unit 3 is a tubular structure and has an inner wall and an outer wall. The inner wall forms a first mounting groove 31 for placing the puncture unit 4 and the reset member 7 in the central area of ​​the auxiliary needle unit 3, and a second mounting groove 32 for placing the push member 6 is formed between the inner wall and the outer wall.

[0109] This helps to reduce the space occupied by the reset member 7 and the push member 6 in the axial direction, and reduce the size of the housing 1 in both the axial and radial directions, making the size of the in-body blood glucose monitoring device more compact and lightweight, and more convenient to use and store. At the same time, the movement guiding effect of the push member 6 and the reset member 7 is also improved, so that the two can move in the first direction and the third direction, making the movement of the puncture unit 4 more stable and reducing shaking.

[0110] Implementation method 2: In this implementation method, Fig.10 , Fig.11 As shown, a limiting sleeve 9 is also provided in the housing 1, and the limiting sleeve 9 is provided with a limiting channel extending along the first direction; the needle-assisting unit 3 includes at least two clamping parts 35, the clamping part 35 is located on the outside of the puncture unit 4 to limit the movement of the puncture unit 4 relative to the clamping part 35, and the clamping part 35 is located in the limiting channel and can move along the first direction in the limiting channel; when the clamping part 35 moves to a release position relative to the limiting channel, the clamping part 35 releases the puncture unit 4, so that the puncture unit 4 moves along a third direction relative to the clamping part 35, and the third direction is opposite to the first direction.

[0111] The clamping part 35 limits the puncture unit 4 by clamping and fixing in the limiting channel. Under the abutment of the inner wall of the outer limiting channel, the clamping part 35 tightly clamps the puncture unit 4, so that the relative position of the puncture unit 4 and the auxiliary needle unit 3 remains unchanged. The clamping force can not only drive the trigger unit to drive the puncture unit 4 when the auxiliary needle unit 3 is triggered, and carry the puncture unit 4 to move along the first direction, but also firmly fix the puncture unit 4 to limit the puncture unit 4, prevent the puncture unit 4 from being released in advance and withdrawing the needle, and ensure that the whole implantation process is carried out reliably and orderly. As the clamping part 35 moves in the first direction, at least part of the clamping part 35 slides out of the limiting channel, thereby losing the squeezing of the inner wall of the limiting channel, and the clamping force of the clamping part 35 on the puncture unit 4 is weakened, so that the puncture unit 4 loses the restriction of the auxiliary needle unit 3 and is released, and then moves along the third direction to complete the withdrawal of the needle.

[0112] By clamping and releasing the puncture unit 4 from the outside through the clamping portion 35, the driving of the puncture unit 4 and the restriction and triggering of the needle withdrawal movement are realized, so that the structural design of the needle-assisting unit 3 and the puncture unit 4 is simpler, and there is no need to set a complex stop structure on the two. The position requirements of each component are reduced, and the processing accuracy and assembly accuracy requirements are reduced, thereby reducing the production difficulty and improving the production efficiency. In addition, on the path of the puncture unit 4 moving along the first direction to insert the needle and moving along the third direction to withdraw the needle, there will be no structure perpendicular to the first direction to interfere with its movement, thereby improving the stability and smoothness of the puncture unit 4 during the movement, so that the puncture unit 4 moves smoothly, and the switching process of inserting and withdrawing the needle is also more streamlined, and there will be no jamming feeling. In addition, the shaking generated when the puncture unit 4 moves is also reduced, so that the puncture unit 4 moves more smoothly along the axial direction of the housing 1, reducing the pain of the user during use.

[0113] The parts not described in the present invention can be realized by adopting or drawing on the existing technology.

[0114] 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.

[0115] The above description is only an embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention shall be included in the scope of the claims of the present invention.

Claims

1. An in vivo blood glucose monitoring device, characterized in that: include: A shell, the shell having a first end and a second end disposed opposite to each other along a first direction, the second end being provided with an implantation port; An on-body monitoring unit, the on-body monitoring unit comprising a first electronic unit and a second electronic unit arranged at intervals, the first electronic unit comprising a sensor and a power supply, the second electronic unit comprising a signal processing module, and the first electronic unit and the second electronic unit are both arranged inside the housing; as well as An auxiliary needle unit is arranged inside the shell, and the auxiliary needle unit can drive the first electronic unit to move along the first direction to implant the sensor part into the host skin, and at the same time electrically connect the first electronic unit and the second electronic unit.

2. The in vivo blood glucose monitoring device according to claim 1, characterized in that: The first electronic unit also includes an upper shell, which is provided with a through hole for the puncture needle to pass through. The sensor includes a contact needle extending into the puncture needle and a substrate arranged outside the through hole. The power supply is arranged opposite to the substrate along the radial direction of the through hole.

3. The in vivo blood glucose monitoring device according to claim 1, characterized in that: The housing includes a cover shell and a bottom shell. The needle-assisting unit and the first electronic unit are arranged inside the cover shell, and the second electronic unit is arranged inside the bottom shell.

4. The in vivo blood glucose monitoring device according to claim 3, characterized in that: The bottom shell is provided with a fixing structure, and the second electronic unit is interference-fitted with the fixing structure. The second electronic unit can be separated from the bottom shell under the push of the needle-assisting unit or when the shell is separated from the host's skin.

5. The in vivo blood glucose monitoring device according to claim 3, characterized in that: A fixing buckle is disposed inside the cover shell, and the fixing buckle is used to clamp and fix the first electronic unit. The fixing buckle can be deformed or moved to be disengaged from the first electronic unit.

6. The in vivo blood glucose monitoring device according to claim 3, characterized in that: The implantation port is arranged on the bottom shell, and a mating port is arranged on one end of the cover shell facing the bottom shell. The in vivo blood glucose monitoring device also includes a sealing component, and the sealing component is located between the first electronic unit and the second electronic unit to seal the mating port; the sealing component can move along a second direction to release the seal of the mating port so that the mating port is connected with the implantation port, and the second direction is perpendicular to the first direction.

7. The in vivo blood glucose monitoring device according to claim 1, characterized in that: The in-vivo blood glucose monitoring device further comprises a bottom cover, which is detachably connected to the second end and is used to cover the implantation port.

8. The in vivo blood glucose monitoring device according to claim 1, characterized in that: The first electronic unit also includes an upper shell, the sensor and the power supply are arranged in the upper shell, the second electronic unit also includes a lower shell, the signal processing module is arranged in the lower shell, one of the upper shell and the lower shell is provided with a sealing rib, and the other of the upper shell and the lower shell is provided with a sealing groove, a sealing member is arranged in the sealing groove, and the sealing rib can extend into the sealing groove and abut against the sealing member to form an installation cavity between the upper shell and the lower shell.

9. The in-vivo blood glucose monitoring device according to claim 1, characterized in that: The first electronic unit further includes an upper shell, the sensor and the power supply are arranged in the upper shell, the second electronic unit further includes a lower shell, the signal processing module is arranged in the lower shell, and the upper shell and the lower shell can be matched and fixed along the first direction.

10. The in-vivo blood glucose monitoring device according to claim 1, characterized in that: The in-vivo blood glucose monitoring device further comprises a puncture unit, a pusher and a resetter arranged inside the housing, wherein the pusher is used to drive the needle-assisting unit to carry the puncture unit to move along the first direction, and the resetter is used to drive the puncture unit to move along a third direction, which is opposite to the first direction; In the first direction, the pushing member and the restoring member at least partially overlap.

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