Implanting device for intervening analyte sensor into subcutaneous tissue

Abstract

The implantation device comprises a shell, the shell is provided with a first end and a second end which are oppositely arranged in the first direction, a mounting opening is formed in the first end, and a mounting channel extending in the first direction is formed in the shell; the sealing unit is arranged in the mounting channel, and the sealing unit is provided with a sealing cavity isolated from the mounting channel; the monitoring unit is arranged in the sealing cavity; and the bottom shell is detachably connected with the outer shell, and when the bottom shell is separated from the outer shell, the sealing cavity is communicated with the mounting channel. The bottom shell is detachably connected with the outer shell, when the bottom shell is separated from the outer shell, the sealing cavity is communicated with the mounting channel, the bottom shell can be removed only through one-step operation, sealing is relieved at the same time, the steps needing to be operated by a user are reduced, and the user experience is improved; the situation that a user forgets to release sealing and then starts implantation can be effectively avoided, and the probability of implantation failure is reduced.

Description

Technical Field

[0001] The present application belongs to the technical field, and in particular relates to an implantation device for inserting an analyte sensor into subcutaneous tissue. Background Art

[0002] Detecting various analytes in an individual is essential for monitoring their health status. Deviations from normal analyte levels can often indicate underlying physiological conditions, such as metabolic conditions, diseases, etc. Regular ex vivo analyte monitoring using extracted body fluids is sufficient to observe the physiological conditions of many individuals. However, due to the limited number of test values, ex vivo analyte monitoring may cause irreversible harm to patients by missing the best treatment opportunity due to the lack of key measurement data. In addition, for individuals with severe analyte disorders and / or rapid fluctuations in analyte levels, body fluids need to be drawn more frequently for monitoring, which will cause inconvenience and pain to patients.

[0003] In many cases, subcutaneous, interstitial or skin analyte sensors can provide sufficient measurement accuracy while minimizing user discomfort. Continuous analyte monitoring using an implanted analyte monitoring sensor is an ideal monitoring method. Typically, an implant device is used to implant the analyte monitoring sensor into an individual. The sensor reacts with the body fluid of the implanted person to generate an electrical signal. The processing unit converts the electrical signal into data that can characterize the analyte concentration and transmits it to a display device for display, thereby achieving continuous monitoring of the analyte concentration.

[0004] Each time a new sensor is used, the user implants a portion of the sensor under the skin. Usually, the sensor is inserted into the user's body using an implantation device. The puncture needle in the implantation device engages with the sensor and brings the sensor under the user's skin. After the sensor is implanted in place, the puncture needle is removed from the user's body while the sensor remains in the user's body. Before use, the user needs to unpack and remove parts that are not related to the implantation process. The numerous steps will reduce the user experience and increase the probability of sensor implantation failure due to improper user operation. Summary of the invention

[0005] The present application provides an implantation device for inserting an analyte sensor into subcutaneous tissue, which can improve user experience and reduce the probability of implantation failure, and includes:

[0006] The housing has a first end and a second end that are arranged opposite to each other along a first direction, the first end is provided with a mounting opening, and the housing has a mounting channel extending along the first direction;

[0007] A sealing unit is disposed in the installation channel, and the sealing unit has a sealing cavity isolated from the installation channel;

[0008] A monitoring unit is disposed in the sealed cavity; and

[0009] The bottom shell is detachably connected to the outer shell, and when the bottom shell is separated from the outer shell, the sealing cavity is communicated with the installation channel.

[0010] In a possible implementation, the sealing unit includes a container and a sealing member detachably connected to the container, the container and the sealing member form the sealed cavity, the container is provided with connecting openings at both ends of the first direction, and the sealing member covers the connecting openings.

[0011] In a possible implementation manner, the sealing member is connected to the bottom shell, so that when the bottom shell is separated from the outer shell, the sealing member is detached from the receiving member.

[0012] In a possible implementation, the communication port includes a first communication port and a second communication port, the sealing member includes a first sealing portion and a second sealing portion, the first sealing portion covers the first communication port, and the second sealing portion covers the second communication port.

[0013] In a possible embodiment, the sealing member also includes a first folding portion and a second folding portion respectively extending from the first sealing portion and the second sealing portion, and a first operating portion and a second operating portion respectively extending from the first folding portion and the second folding portion, the first folding portion and the second folding portion are respectively stacked with the first sealing portion and the second sealing portion on a side away from the sealing cavity, the outer shell is provided with a withdrawal port, the first operating portion and the second operating portion extend out of the outer shell from the withdrawal port and are fixed to the bottom shell.

[0014] In a possible embodiment, the implant device also includes a driving unit and a puncture unit. In an initial position, the driving unit and the puncture unit are both arranged in the installation channel and outside the sealed cavity. The driving unit can drive the puncture unit to move along the first direction so that the puncture unit and the monitoring unit are assembled and the puncture unit and the monitoring unit at least partially penetrate the subcutaneous tissue.

[0015] In a possible embodiment, the implantation device further includes a driving unit and a puncture unit, the puncture unit includes a needle seat and a puncture needle connected to the needle seat, the driving unit includes a driving member and a connecting member connected between the driving member and the needle seat, and in an initial position, the needle seat is located in the sealed cavity and is fixedly connected to the monitoring unit, and the connecting member is located outside the sealed cavity.

[0016] In a possible implementation, the connecting member is provided with a snap-fit ​​structure, the needle seat is provided with a matching structure, and the connecting member can move along the first direction to connect the snap-fit ​​structure with the matching structure.

[0017] In a possible embodiment, the driving unit is provided with a stop structure, and the puncture unit has a mating portion, the mating portion cooperates with the stop structure to prevent the puncture unit from moving relative to the driving unit, and an unlocking structure is provided in the mounting channel, and the unlocking structure can apply force to the mating portion or the stop structure to disengage the two.

[0018] In a possible embodiment, a fixing member is further provided inside the housing, the fixing member is located between the sealing unit and the second end, the sealing unit is connected to the fixing member, the fixing member has an opening for the driving unit to pass through, and the driving unit is provided between the fixing member and the second end.

[0019] In a possible embodiment, the puncture unit is connected to the drive unit, and an unlocking structure is provided at the edge of the opening, and the unlocking structure can abut and cooperate with the puncture unit to unlock the puncture unit, so that the puncture unit moves in a second direction relative to the drive unit, and the second direction is opposite to the first direction.

[0020] In a possible embodiment, the monitoring unit includes a shell, an electronic module and a monitoring module, the shell is detachably arranged at the first end, the electronic module is arranged inside the shell, and the monitoring module is arranged in the sealed cavity. The monitoring module can move along the first direction under the drive of the driving unit so that the monitoring module is assembled to the shell and the monitoring module is partially implanted into the host's subcutaneous tissue.

[0021] In a possible implementation, the monitoring unit includes a shell, an attachment arranged on the bottom surface of the shell, and an isolation membrane detachable from the attachment, and when the bottom shell is separated from the outer shell, the isolation membrane is separated from the attachment.

[0022] The bottom shell of the present application is detachably connected to the outer shell. When the bottom shell is separated from the outer shell, the sealing cavity is connected to the installation channel. The bottom shell can be removed and the seal can be released in one step, which reduces the number of steps the user needs to operate and improves the user experience. In addition, it can effectively prevent the user from forgetting to release the seal before starting the implant, thereby reducing the probability of implantation failure. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings described herein are used to provide a further understanding of the present application and form a part of the present application. The schematic embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation of the present application. In the drawings:

[0024] Figure 1 is a schematic structural diagram of an implant device under an embodiment of the present application;

[0025] Figure 2 is Figure 1 a cross-sectional view of the implant device in ;

[0026] Figure 3 is a schematic structural diagram of a housing under an embodiment of the present application;

[0027] Figure 4 is a cross-sectional view of the implant device under an embodiment of the present application, where the bottom shell is not shown;

[0028] Figure 5 is a cross-sectional view of the implant device under an embodiment of the present application from another perspective;

[0029] Figure 6 is a cross-sectional view of the implant device in the initial state under an embodiment of the present application;

[0030] Figure 7 is Figure 6 a cross-sectional view of the implant device in the implanted completed state in ;

[0031] Figure 8 is a schematic structural diagram of a partial structure of the implant device under an embodiment of the present application;

[0032] Figure 9 is a schematic structural diagram of a partial structure of the implant device from another perspective under an embodiment of the present application;

[0033] Figure 10 is a cross-sectional view of a sealing unit under an embodiment of the present application;

[0034] Figure 11 is Figure 10 a schematic structural diagram of the sealing unit in ;

[0035] Figure 12 is a schematic structural diagram of a monitoring module under an embodiment of the present application;

[0036] Figure 13 is a schematic structural diagram of a bottom shell under an embodiment of the present application;

[0037] Figure 14 is a schematic structural diagram of a fixing ring under an embodiment of the present application;

[0038] Figure 15 This is a schematic structural diagram of a housing under an implementation manner of the present application.

[0039] Among them:

[0040] 1. Outer shell; 11. Installation channel; 111. Stopper; 12. Accommodating groove; 121. Avoidance groove; 13. Fitting end; 14. Limiting groove; 15. Guide rib; 16. Abutting section; 17. Fixed ring; 171. Positioning rib; 172. Trigger ring; 1721. Guide post; 173. Fitting inclined surface; 174. Elastic arm; 175. Contact part; 18. Installation opening; 19. Clamping groove;

[0041] 2. Bottom shell; 21. Connection section; 22. Support section; 23. Notch; 24. Clamping rib; 25. Clearance groove;

[0042] 3. Unlocking part; 31. Manipulation part; 32. Trigger part; 321. Installation groove; 33. Connection rib;

[0043] 4. Driving unit; 41. Boosting spring; 42. Driving part; 421. Elastic rib position; 422. Stopping part; 423. Guide inclined surface; 424. Guide groove; 43. Transmission part; 431. Stopping structure; 432. Needle retraction channel; 433. Slide groove;

[0044] 5. Puncturing unit; 51. Pulling spring; 52. Needle holder; 521. Fitting structure; 53. Connecting part; 531. Fitting part; 532. Clamping structure;

[0045] 6. Monitoring unit; 61. Housing; 611. Installation position; 612. Positioning hole; 613. Limiting rib; 62. Attachment; 63. Monitoring module; 631. First clamping part; 64. Electronic module;

[0046] 7. Sealing part; 71. First sealing part; 711. First folding part; 712. First operating part; 72. Second sealing part; 721. Second folding part; 722. Second operating part;

[0047] 8. Sealing unit; 81. Sealing cavity; 82. Accommodating part; 821. Protruding part; 83. First through hole; 84. Second through hole;

[0048] 9. Fixing part; 91. Opening. Specific implementation manner

[0049] In order to more clearly illustrate the overall concept of the present application, the following will be described in detail by way of examples in conjunction with the accompanying drawings of the specification.

[0050] In the following description, many specific details are set forth in order to provide a thorough understanding of the present application. However, the present application may be implemented in other ways different from those described herein. Therefore, the scope of protection of the present application is not limited by the specific embodiments disclosed below.

[0051] In addition, in the description of the present application, it should be understood that the orientation or positional relationship indicated by terms such as "top", "bottom", "inner", "outer", "axial direction", "radial direction", "circumferential direction", etc. is based on the orientation or positional relationship shown in the drawings. These are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on the present invention.

[0052] In the present application, unless otherwise clearly specified and defined, terms such as "install", "connect", "connection", "fix", etc. should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection, an electrical connection, or a communication connection; it can be directly connected, or indirectly connected through an intermediate medium, and can be the communication inside two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0053] In the present application, unless otherwise clearly specified and defined, the first feature being "on" or "under" the second feature can 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 terms such as "embodiment", "example", "a kind of embodiment", "example" or "specific example", etc. means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In this specification, the schematic expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in a suitable manner in any one or more embodiments or examples.

[0054] As Figure 5 , Figure 6 , Figure 7 shown, an implantation device for inserting an analyte sensor into subcutaneous tissue includes a housing 1 having a first end and a second end oppositely arranged in a first direction. The first end is provided with an installation opening 18, and the housing 1 internally has an installation channel 11 extending in the first direction; a sealing unit 8 disposed in the installation channel 11, the sealing unit 8 having a sealing cavity 81 isolated from the installation channel 11; a monitoring unit 6 disposed in the sealing cavity 81; and a bottom case 2 detachably connected to the housing 1. When the bottom case 2 is separated from the housing 1, the sealing cavity 81 communicates with the installation channel 11.

[0055] The bottom shell 2 of the present application is detachably connected to the outer shell 1. When the bottom shell 2 is separated from the outer shell 1, the sealing cavity 81 is connected to the installation channel 11. The bottom shell 2 can be removed and the seal can be released in one step, which reduces the number of steps the user needs to operate and improves the user experience. In addition, it can effectively prevent the user from forgetting to release the seal before starting the implant, thereby reducing the probability of implantation failure.

[0056] It should be noted that, in the initial state, the monitoring unit 6 may be completely located in the sealed cavity 81, or may be partially located in the sealed cavity 81. Preferably, as shown in the figure, the sealing unit 8 forms a sealed cavity 81 in the installation channel 11 that is isolated from the installation channel 11. In the initial state, the monitoring module 63 is arranged in the sealed cavity 81, and the housing 61 is arranged outside the sealed cavity 81. The monitoring module 63 is isolated from the external environment to ensure the cleanliness of the monitoring module 63.

[0057] As a preferred embodiment of the present application, Figure 5 , Figure 6 , Figure 7 As shown, the monitoring unit 6 further includes a monitoring module 63 and an electronic module 64. The electronic module 64 is disposed inside the housing 61, and the monitoring module 63 and the housing 61 are spaced apart along the first direction.

[0058] The monitoring module 63 includes a sensor, and the electronic module 64 includes a transmitter. In the initial state, the monitoring module 63 is fixed inside the shell 1, and the electronic module 64 is fixed inside the shell 61. The shell 61 is separated from the shell 1, so two different sterilization methods can be used to sterilize the two modules respectively. For example, after the monitoring module 63 is fixed inside the shell 1 (the shell 61 is not installed to the shell 1 at this time), the components inside the shell 1 are sterilized by radiation, and the sterilization of the monitoring module 63 and other components inside the shell 1 is completed, while the shell 61 and the electronic unit inside it can be sterilized by gas separately. The two different methods of sterilization are completed before the shell 1 and the shell 61 are assembled (that is, the monitoring module 63 and the electronic module 64 are separated), so it can avoid a certain sterilization method from causing damage to other components. After the sterilization is completed, the shell 61 is assembled to the shell 1 to complete the assembly, and the subsequent packaging and shipment are carried out. Since the assembly is completed before leaving the factory, when the user receives the product, it is already sterilized and the entire product has been assembled, so the user does not need to assemble it by himself, which reduces the difficulty of use and improves the convenience of use. In addition, the battery used to power the electronic module 64 can also be set on the monitoring module 63, so that before the implantation is triggered, the battery and the electronic module 64 are also in a separated state, and the battery and the electronic module 64 are not electrically connected. This can reduce the discharge of the battery before the user uses it, and also increase the storage time, ensuring the battery power storage. After the user implants it, it can have a longer battery life and improve the user experience.

[0059] Of course, in other embodiments, the monitoring module 63 and the electronic module 64 may also be assembled together before leaving the factory and disposed in the sealed cavity 81, which is not limited herein.

[0060] Furthermore, as Figure 7 , Figure 15 shown, the housing 61 has a mounting position 611 for accommodating the monitoring module 63. Triggering the trigger member causes the monitoring module 63 to be installed in the mounting position 611 and the puncturing unit 5 to penetrate into the subcutaneous tissue.

[0061] After a user's single triggering operation, the driving unit 4 drives the puncturing unit 5 and the monitoring module 63 to move in the first direction to perform the implantation action. During this process, the monitoring module 63 is installed in the mounting position 611 of the housing 61, completing the assembly of the monitoring module 63 and the electronic module 64 in the monitoring unit 6, and the puncturing assembly carries the detection module to penetrate into the user's subcutaneous tissue to complete the implantation. The entire process only requires a single triggering operation by the user without the need for a separate assembly operation of the detection unit, which not only simplifies the operation steps and improves the usability but also avoids damaging the sealed environment of the monitoring module 63 and the electronic module 64 during the user's self-assembly process, resulting in contamination.

[0062] Specifically, as Figure 15 shown, the shape of the mounting position 611 is adapted to the shape of the monitoring module 63.

[0063] This application does not limit the assembly method of the monitoring module 63 and the housing 61. Preferably, as Figure 12 , Figure 15 shown, the monitoring module 63 is provided with a first clamping portion 631, and a second clamping portion is provided in the mounting position 611. The first clamping portion 631 and the second clamping portion are clamped and fixed.

[0064] The connection between the two is made simpler and more convenient by the clamping and fixing method. Under the driving force of the driving unit 4 in the first direction, the first clamping portion 631 and the second clamping portion can automatically complete the clamping without additional operations.

[0065] Specifically, one of the first clamping portion 631 and the second clamping portion can be a clamping hook, and the other can be a clamping groove, so that the clamping hook and the clamping groove form a clamping fit. Alternatively, both the first clamping portion 631 and the second clamping portion can be set as clamping hooks, which can also complete the clamping fit. Preferably, a bevel or arc surface structure is provided on the opposite sides of the first clamping portion 631 and the second clamping portion, so that the two can complete the clamping when subjected to a relative acting force along the axial direction of the housing 1.

[0066] Furthermore, the installation position 611 has a first electrical connection part inside, and the monitoring module 63 is provided with a second electrical connection part. When the monitoring module 63 is installed in the installation position 611, the first electrical connection part is electrically connected to the second electrical connection part.

[0067] While the monitoring module 63 completes the structural connection with the housing 61, the first electrical connection part and the second electrical connection part are also coupled to achieve electrical connection. Therefore, the battery used to supply power to the electronic module 64 can also be arranged on the monitoring module 63, so that before the trigger implantation, the battery and the electronic module 64 are also in a separated state and not electrically connected. After the trigger implantation, the battery is electrically connected to the electronic module 64 to supply power to the electronic module 64.

[0068] Specifically, the first electrical connection part is a spring piece, and the second electrical connection part is an electrode. When the monitoring module 63 enters the installation position 611, the spring piece connects both sides of the electrode to complete the electrical connection.

[0069] Preferably, as Figure 15 shown, a limiting rib 613 protrudes from the outer peripheral side of the installation position 611 to limit the monitoring module 63 after it is installed in place and prevent the monitoring module 63 from detaching from the installation position 611. As Figure 15 shown, a plurality of positioning holes 612 are also spaced apart on the outer periphery of the installation position 611. The monitoring module 63 is provided with a plurality of positioning ribs corresponding to the positioning holes 612 for plugging and cooperating with the positioning holes 612 for positioning. The positioning holes 612 surround the outside of the limiting rib 613. At the same time, a sealing strip is also arranged at the edge of the installation position 611 for sealing the gap between the monitoring module 63 and the installation position 611.

[0070] Among them, in one embodiment, initially, the puncture unit 5 is located outside the sealing cavity 81. When the implantation device is triggered, the puncture unit 5 moves along the first direction into the sealing cavity 81 and drives the monitoring module 63 to move so as to complete the assembly with the housing 61 and be implanted under the user's skin.

[0071] In another embodiment, as Figures 6 to 9 shown, the puncture unit 5 includes a needle seat 52 having a puncture needle and a connecting member 53. Among them, initially, the needle seat 52 is located in the sealing cavity 81 and fixed to the monitoring module 63, and the connecting rib 33 is located outside the sealing cavity 81, and the two are in a separated state.

[0072] When the implantation device is triggered, the driving unit 4 drives the connecting member 53 to move along the first direction into the sealing cavity 81 to complete the assembly with the needle seat 52, and drives the monitoring module 63 to move along the first direction to be assembled with the housing 61 and complete the implantation. At this time, the connecting member 53 and the needle seat 52 have been assembled into one body. After the implantation is completed, the two move together along the second direction to perform the needle withdrawal action.

[0073] Specifically, as Figures 7 to 9 shown, the driving unit 4 includes a driving member 42 and a transmission member 43 connected to each other. The transmission member 43 has a needle retraction channel 432 inside. The connecting member 53 is locked to the transmission member 43. A tension spring 51 is arranged in the needle retraction channel 432. In the initial state, the tension spring 51 is in a stretched state. An unlocking structure is arranged in the installation channel 11. When the connecting member 53 moves to the end of the stroke along the first direction, the unlocking structure triggers the connecting member 53, causing it to move along the second direction in the needle retraction channel 432 under the action of the tension spring 51.

[0074] Specifically, as Figure 6 , Figure 9 shown, the connecting member 53 is provided with a clamping structure 532, and the needle seat 52 is provided with a matching structure 521. When the connecting member 53 moves along the first direction, the clamping structure 532 and the matching structure 521 are matched to complete the assembly of the connecting member 53 and the needle seat 52. Specifically, as Figure 6 , Figure 9 shown, the clamping structure 532 is a clamping groove, and the matching structure 521 is a clamping hook. Of course, the structures of the two can also be interchanged, or both are clamping hooks, which is not limited herein.

[0075] As Figure 6 , Figure 9 shown, the transmission member 43 is further provided with a stop structure 431, and the connecting member 53 is provided with a matching portion 531. The matching portion 531 is matched with the stop structure 431 to prevent the connecting member 53 from moving relative to the transmission member 43. An unlocking structure is arranged in the installation channel 11, and the unlocking structure can apply a force to the matching portion 531 or the stop structure 431 to disengage them from each other.

[0076] In a specific embodiment, as Figure 6 , Figure 7 , Figure 8 , Figure 9 shown, the connecting member 53 has a stressed portion located in the needle retraction channel 432. The matching portion 531 and the clamping structure 532 are both located outside the needle retraction channel 432. One end of the tension spring 51 is connected to the stressed portion. A stop bump is arranged on the outer surface of the transmission member 43 to form the stop structure 431. The matching portion 531 is an elastic rib connected to the clamping structure 532 at one end, and the elastic rib is matched with the stop bump to lock the connecting member 53.

[0077] When the transmission member 43 drives the connecting member 53 to move to the end of the stroke along the first direction, the unlocking structure squeezes the elastic rib to cause it to move, so that it is misaligned with the stop bump in the first direction to complete unlocking.

[0078] Specifically, as Figure 8 , Figure 9As shown, the first end is the end provided with the mounting opening 18, the second end is the mating end 13 opposite to the first end, a fixing member 9 is provided between the mating end 13 of the sealing unit 8 and the housing 1. The fixing member 9 is in a plate-like structure and has an opening 91 for the transmission member 43 and the connecting member 53 to enter the sealing cavity 81. The edge of the opening 91 constitutes an unlocking structure. When the connecting member 53 passes through the opening 91, the edge of the opening 91 squeezes the elastic rib to cause it to move.

[0079] Preferably, as Figure 9 shown, the outer surface of the transmission member 43 is provided with a chute 433 extending in the first direction. Stopping structures 431 are provided on both sides of the chute 433, and the connecting part correspondingly provides two mating parts 531 to mate with the stopping structures 431 on both sides one by one.

[0080] As Figure 10 、 Figure 11 shown, the sealing unit 8 includes a receiving member 82 and a sealing member 7 detachably connected to the receiving member 82. The receiving member 82 encloses a sealing cavity 81, and the upper end is fixedly connected to the fixing member 9, and the lower end abuts against the housing 61 of the monitoring unit 6. The receiving member 82 is provided with communication ports at both ends in the first direction, and the sealing member 7 covers the communication ports to seal the sealing cavity 81. The communication ports include a first through port 83 located at the top end of the receiving member 82 and a second through port 84 located at the bottom end of the receiving member 82. The transmission member 43 and the connecting member 53 can enter the sealing cavity 81 through the opening 91 and the first through port 83.

[0081] As Figure 10 、 Figure 11 shown, the receiving member 82 further has a convex portion 821 protruding laterally to form a cavity for placing a drying member in the sealing cavity 81.

[0082] Specifically, as Figure 9 shown, the top end of the receiving member 82 is provided with a hook, and the hook is fixedly connected in a mating and clamping manner with the edge of the opening 91 of the fixing member 9.

[0083] As Figure 10 、 Figure 11 shown, the sealing member 7 further includes a first folding portion 711 and a second folding portion 721 respectively extending from the first sealing portion 71 and the second sealing portion 72, and a first operating portion 712 and a second operating portion 722 respectively extending from the first folding portion 711 and the second folding portion 721. The first folding portion 711 and the second folding portion 721 are respectively stacked with the first sealing portion 71 and the second sealing portion 72 on the side facing away from the sealing cavity 81. The housing 1 is provided with a pulling-out opening, and the first operating portion 712 and the second operating portion 722 extend out of the housing 1 from the pulling-out opening.

[0084] Preferably, as Figure 10As shown, both the first sealing portion 71 and the second sealing portion 72 are film structures. The first through-port 83 and the second through-port 84 are sealed by the first folding portion 711 and the second folding portion 721. Taking the first sealing portion 71 as an example, the first operating portion 712 is located outside the housing 1 in the third direction, and the third direction is perpendicular to the first direction. The first sealing portion 71 covers the first through-port 83 and is folded downward at one end away from the first operating portion 712 to form the first folding portion 711. The lowermost layer of the first folding portion 711 abuts against the top wall of the accommodating member 82 to seal the first through-port 83. When the first operating portion 712 is pulled, the upper layer of the first folding portion 711 is driven by the first operating portion 712 to move first in the third direction, and the first folding portion 711 is gradually unfolded, so that the first sealing portion 71 is separated from the accommodating member 82, and the first through-port 83 is opened.

[0085] It should be noted that the present application does not limit the pulling direction of the first operating portion 712 and the second operating portion 722. It can move in the third direction perpendicular to the first direction to remove the first sealing portion 71 and the second sealing portion 72, or it can move in the first direction or the second direction, and both can realize the removal of the first sealing portion 71 and the second sealing portion 72, which is not limited here.

[0086] As a preferred embodiment of the present application, as Figure 1 , Figure 6 , Figure 13 shown, the implanting device further includes a bottom case 2 detachably fixed to the mounting port 18. The bottom case 2 closes the mounting port 18. The bottom case 2 has a supporting portion protruding in the second direction, and the supporting portion abuts against the attaching member 62 to support the monitoring unit 6.

[0087] In the state where the bottom case 2 is not disassembled, the supporting portion can support the monitoring unit 6, ensure the stable connection between the monitoring unit 6 and the housing 1, and prevent the monitoring unit 6 from falling off. Preferably, a notch 23 is provided in the adhesive layer on the bottom surface of the adhesive member corresponding to the supporting portion to prevent the supporting portion from kneading the colloid on the adhesive layer and causing the adhesive member to wrinkle.

[0088] The bottom case 2 can jointly form a relatively sealed space with the housing 1, playing a role in dust prevention and sealing during storage and transportation. Before use by the user, the bottom case 2 is first removed to expose the mounting port 18, and then one end of the housing 1 is abutted against the skin surface for implantation.

[0089] Preferably, the first operating portion 712 and the second operating portion 722 are fixed to the bottom case 2. So that when the user disassembles the bottom case 2, the seal 7 can be removed synchronously, and the sealed cavity 81 is communicated with the installation passage 11. Thus, the operation of removing the seal 7 additionally is omitted, the user operation steps are simplified, and the use convenience is improved. Of course, the seal 7 can also be removed by other means. For example, the user first removes the bottom case 2 and then pulls the seal 7 to release the seal, which is not limited herein.

[0090] Preferably, as Figure 1 , Figure 13 shown, the bottom case 2 includes a connecting section 21 connected to the outer shell 1 and a supporting section 22 extending radially outward from the connecting section 21, and the outer contour of the supporting section 22 is arc-shaped.

[0091] Before implantation, the housing 61 of the monitoring unit 6 is located inside the installation opening 18, and the attachment 62 is located outside the installation opening 18 and protrudes from one end of the outer shell 1. In the axial direction of the outer shell 1, the end surface of the supporting portion can support the attachment 62, so that the attachment 62 remains flat without wrinkles, thereby keeping the surface colloid intact and uniform, and maintaining the sticking effect and stability with the user's skin surface. In addition, since the outer shell 1 has a slender structure, when the outer shell 1 is placed upright during storage and transportation, the contact area between the end surface of the outer shell 1 and the tabletop is small, the placement is unstable, and it is easy to fall over. When the outer shell 1 is placed horizontally, the outer peripheral surface of the outer shell 1 is similar to an arc surface and is easy to roll. By providing an outwardly expanding supporting portion at the end of the outer shell 1, the diameter of the end of the outer shell 1 can be increased, and further, when the outer shell 1 is placed upright, the contact area between the end surface and the tabletop can be increased, making the placement of the outer shell 1 more stable.

[0092] At the same time, the arc-shaped contour of the outer surface of the supporting section 22 makes the transition between the connecting section 21 and the supporting section 22 smoother, which can improve the hand feeling when the user grasps it and avoid forming a large step on the outer surface that is uncomfortable to hold.

[0093] Preferably, the bottom case 2 is sleeved outside the outer shell 1. The present application does not limit the assembly method of the bottom case 2 and the outer shell 1. Preferably, as Figure 3 , Figure 13 shown, one of the outer wall of the outer shell 1 and the inner wall of the connecting section 21 is provided with a clamping rib 24, and the other is provided with a clamping groove 19, and the clamping rib 24 and the clamping groove 19 cooperate to fix the bottom case 2 to the outer shell 1.

[0094] In a specific example, as Figure 3 , Figure 13As shown, a plurality of clamping grooves 19 are circumferentially and spacedly arranged on the outer peripheral surface of the outer shell 1, and the connecting section 21 is provided with clamping ribs 24 protruding towards the outer shell 1 corresponding to the clamping grooves 19 in the circumferential direction. Avoidance grooves 25 are arranged on both sides of the clamping ribs 24 so that the clamping ribs 24 can move in the radial direction of the outer shell 1, facilitating the installation and disassembly of the bottom shell 2.

[0095] In this example, the user can apply a force to the bottom shell 2 in the first direction to pull out the bottom shell 2 from one end of the outer shell 1. Of course, in other examples, the bottom shell 2 and the outer shell 1 can also be connected in other ways and disassembled using other methods. For example, threaded sections can be respectively arranged on the outer wall of the outer shell 1 and the inner wall of the bottom shell 2, and the bottom shell 2 and the outer shell 1 are connected by threads. Then, when disassembling the bottom shell 2, the disassembly is completed by rotating the bottom shell 2.

[0096] As Figure 13 shown, the bottom shell 2 is further provided with a notch 23 extending in the first direction to jointly form a sliding groove with the outer shell 1 for the unlocking member 3 to move in the first direction.

[0097] As Figure 1 、 Figure 2 shown, the inner part of the outer shell 1 has an installation channel 11 extending in the first direction. The installation channel 11 is provided with an installation opening 18 located at the end of the outer shell 1 in the first direction; a puncturing unit 5, the puncturing unit 5 is arranged in the installation channel 11 and can move in the installation channel 11; a driving unit 4, the driving unit 4 is arranged in the installation channel 11, and the driving unit 4 is configured to be able to drive the puncturing unit 5 to move in the first direction and the second direction, and the second direction is opposite to the first direction; an unlocking member 3, the unlocking member 3 is configured as a sliding button arranged on one side of the outer peripheral surface of the outer shell 1; and a monitoring unit 6, the monitoring unit 6 includes a housing 61 and a data processing component and / or a sensor arranged in the housing 61, and the housing 61 is arranged at the installation opening 18.

[0098] The unlocking member 3 is a sliding button with a small volume and is located on one side of the outer shell 1. It can not only effectively reduce the radial size of the outer shell 1, thereby realizing a miniaturized design, but also enable the user to complete the triggering in a more comfortable posture. For example, the user can rotate the outer shell 1 to adjust the orientation of the control part 31, and then complete the triggering with a more habitual finger and a more comfortable angle, improving the use experience.

[0099] In addition, the control part 31 with a small volume can also effectively prevent the user from accidentally triggering, avoiding the scrapping of the implant device due to the user's incorrect operation.

[0100] It should be noted that the first direction is the axial direction of the outer shell 1 and the direction towards the installation opening 18.

[0101] In the prior art, most of the product's outer shapes are short and thick structures, and the trigger button for triggering the implant device is arranged on the outer peripheral surface of the housing 1. When in use, the user needs to hold the housing 1 with a hand ring and then press the trigger button to complete the triggering operation. However, due to the relatively thick outer diameter of the housing 1, it is inconvenient for the user to grasp it with one hand, and it may not be possible to trigger the trigger button while maintaining the stability of the housing 1, that is, the operation cannot be completed with one hand, resulting in poor usability of the product.

[0102] In addition, the outer diameter of the part of the housing 1 that fits the human skin is relatively large, and the opening 91 for the monitoring module 63 to extend out at the end of the housing 1 is also relatively large. Therefore, when the user is using it, a greater sense of fear will be generated, resulting in a poor user experience. Moreover, the relatively large diameter of the housing 1 also makes it easier for the monitoring module 63 and the boosting components inside the housing 1 to shake during movement, which will further exacerbate the pain of the user during the implantation process.

[0103] As Figure 2 、 Figure 4 shown, the monitoring unit 6 further includes an attachment 62 arranged on the bottom surface of the housing 61. The outer diameter D2 of the housing 61 is smaller than the inner diameter D1 of the installation opening 18, and the inner diameter D1 of the installation opening 18 is smaller than or equal to the outer diameter D3 of the attachment 62.

[0104] In this application, the implant device has an initial state, a trigger state, and a recovery state. In the initial state, part of the driving unit 4, the puncture unit 5, and the monitoring unit 6 are locked inside the installation channel 11. After the user triggers the unlocking member 3, the implant device switches to the trigger state. At this time, the driving unit 4 is unlocked, and the driving puncture unit 5 moves along the first direction towards the installation opening 18 to perform the needle insertion action. The needle of the puncture unit 5 carries the sensor needle of the monitoring unit 6 to pierce the user's skin, implant the sensor into the user's subcutaneous tissue, and the attachment 62 of the monitoring unit 6 is adhesively fixed to the user's skin surface. When the puncture unit 5 moves to the end of the stroke along the first direction, the puncture unit 5 is triggered to unlock, causing the implant device to switch to the recovery state. In this state, the puncture unit 5 moves relative to the driving unit 4 along the second direction to perform the needle withdrawal action, and the needle withdraws and retracts into the housing 1 along the second direction to complete the recovery.

[0105] Preferably, as Figure 3 shown, the housing 1 is a structure similar to a cylinder, that is, its outer peripheral surface is an arc surface and its cross-section is circular. Of course, the cross-section of the housing 1 can also be square, oval or other shapes. At this time, the diameters of the housing 1 and the installation opening 18 are the equivalent circle diameters corresponding to the minimum side or the minor axis.

[0106] In this application, the monitoring unit 6 includes a housing 61 and an attachment 62 disposed on the bottom surface of the housing 61. Inside the housing 61, a monitoring module 63, an electronic module 64, a battery, etc. are accommodated. The bottom surface of the attachment 62 has an adhesive layer for adhesively fixing to the skin surface of the user. After the monitoring module 63 is implanted under the skin of the user, the monitoring unit 6 can be fixed to the skin surface of the user to achieve wearable on the body. During use, the end where the installation opening 18 is located is used to abut against the skin surface of the user, so that the user's skin seals the installation opening 18. Furthermore, during the implantation process, a force in the first direction is applied to the monitoring unit 6 by the driving unit 4 to make it move in the first direction and complete the adhesive fixation with the user's skin.

[0107] Wherein, the outer diameter of the housing 61 is smaller than the inner diameter of the installation opening 18, so that before implantation, the housing 61 can be accommodated inside the installation opening 18, that is, inside the outer shell 1, thereby preventing the housing 61 from protruding from the outer shell 1, protecting the housing 61 from being knocked and falling off, and at the same time reducing the overall volume. Also, the outer diameter of the housing 61 being smaller than the inner diameter of the installation opening 18 enables the housing 61 to move in the installation opening 18 in the first direction without interfering with the outer shell 1, thus ensuring the smooth progress of the implantation action.

[0108] The inner diameter of the installation opening 18 is smaller than or equal to the outer diameter of the attachment 62. On the one hand, this makes the diameter of the outer shell 1 smaller, so that the overall shape of the outer shell 1 is slender. Then, when the user uses it, it is more convenient to grasp the outer shell 1, and the user can completely hold the outer shell 1 in a ring. For example, the user can stably grasp the outer shell 1 with only a few fingers, so more fingers can be liberated to operate the trigger member located on the outer surface of the outer shell 1 to complete the triggering. Furthermore, it is easier to complete single-handed triggering without the need to rely on other tools or the help of others, making the use of the implantation device simpler and more convenient. On the other hand, the smaller inner diameter of the installation opening 18 makes the opening hole at the end of the outer shell 1 smaller, which can greatly reduce the user's sense of fear. During the implantation process, the smaller diameter of the installation opening 18 reduces the radial space of the monitoring unit 6, as well as the driving unit 4 and the puncturing unit 5, which can play a role in limiting movement. When each moving part moves in the first direction to perform the implantation action, the probability of shaking and the amplitude of shaking are smaller, thereby improving the movement reliability and reducing the pain caused by the needle shaking to the user.

[0109] In addition, due to the dimensional design of the inner diameter of the installation opening 18, before implantation, the housing 61 of the monitoring unit 6 is located inside the installation opening 18, and the attachment 62 is located outside the installation opening 18, protruding from one end of the outer shell 1. Therefore, in the axial direction of the outer shell 1, the end face of one end of the outer shell 1, that is, the end face where the installation opening 18 is located, can support the attachment 62, keeping the attachment 62 flat without wrinkles, thereby maintaining the integrity and uniformity of the colloid on its surface and maintaining the sticking effect and stability with the user's skin surface.

[0110] In one embodiment, the outer shell 1 has an abutting section 16 located at the end of the outer shell 1 along the first direction, and the inner wall of the abutting section 16 encloses the installation opening 18. In another embodiment, the inner wall of the abutting section 16 is provided with a rib protruding towards the inside of the installation channel 11, and the rib encloses the installation opening 18, so that the diameter of the installation opening 18 is smaller than the inner diameter of the abutting section 16.

[0111] It should be noted that, in one embodiment, as Figure 4 shown, the inner diameter of the installation opening 18 is smaller than the outer diameter of the attachment 62 to be able to form axial support for the attachment 62. Preferably, the outer diameter of the attachment 62 is the same as or smaller than the outer diameter of the end of the outer shell 1 where the installation opening 18 is located. Of course, it is also possible to make the inner diameter of the installation opening 18 the same as the outer diameter of the attachment 62, which is not limited herein.

[0112] Preferably, the ratio of the outer diameter of the outer shell 1 to the length of the outer shell 1 along the first direction is 1:3 to 1:6.

[0113] By designing the ratio of the outer diameter and the length of the outer shell 1, the outer shape structure of the outer shell 1 is defined, making the outer shell 1 as a slender structure as a whole, so as to facilitate the user's grasping and use and enable the user to obtain a better use experience.

[0114] Furthermore, the ratio of the outer diameter of the outer shell 1 to the length of the outer shell 1 along the first direction is 1:3.5 to 1:4.5. As a preference, the ratio of the outer diameter of the outer shell 1 to the length of the outer shell 1 along the first direction is 1:3.5. Preferably, the outer diameter of the outer shell 1 is 28 - 35 mm. The length of the outer shell 1 is 100 - 120 mm.

[0115] In a specific embodiment, the outer diameter of the outer shell 1 is 28 mm (about 1.1 inches), and the length of the outer shell 1 along the first direction is 98 mm (about 3.85 inches). Preferably, the implanting device further includes a bottom shell 2 detachably fixed to the end where the installation opening 18 is located. When the bottom shell 2 is installed on the outer shell 1, the overall length of the implanting device in the first direction is 103 mm (about 4 inches).

[0116] Preferably, as Figure 3As shown in the figure, the outer shell 1 has an abutting section 16 located at the end of the outer shell 1 along the first direction. The mounting opening 18 is located at the abutting section 16. The abutting section 16 is used to abut against the host skin, and the outer diameter of the abutting section 16 is 28 - 35 mm.

[0117] The size design of the abutting section 16 can directly affect the caliber of the mounting opening 18 and the size of the part of the outer shell 1 that directly contacts the user's skin. With the above size range, on the basis of ensuring the abutting stability and comfort between the abutting section 16 and the user's skin, the inner diameter of the mounting opening 18 is reduced as much as possible, so as to improve the guiding and limiting effect on the housing 61, reduce the shaking of the monitoring unit 6, and reduce the user's sense of fear and pain.

[0118] Preferably, as Figure 3 shown in the figure, the outer diameter of the outer shell 1 remains unchanged along the first direction, that is, the outer diameter of the abutting section 16 is the outer diameter of the outer shell 1. Of course, the outer shell 1 can also be a variable-diameter structure along the first direction, so that the outer diameter of the abutting section 16 is larger or smaller than the outer diameter of other parts of the outer shell 1.

[0119] This application does not limit the driving method of the driving unit 4, that is, the implantation method of the implant device. It can be automatic implantation or manual implantation. Specifically, in one embodiment, the implant device adopts a manual implantation method, that is, the implant device further includes an operating member. Part of the operating member is located inside the installation channel 11, and part is located outside the outer shell 1. The user can control the operating member along the first direction from outside the outer shell 1, so that it drives the driving unit 4 to move along the first direction to perform the implantation action, that is, the power of the driving unit 4 is provided by the user, and the speed of the entire implantation process is manually operated by the user. That is, when the user stops pushing the operating member, the driving unit 4 also stops moving.

[0120] As a preferred embodiment of this application, the implant device adopts an automatic implantation method. As Figure 2 、 Figure 4 shown in the figure, the driving unit 4 includes a driving member 42. The installation channel 11 has a mating end 13 facing away from the mounting opening 18 along the first direction. A boosting spring 41 is arranged between the mating end 13 and the driving member 42. The mating end 13 and / or the driving member 42 is provided with a limiting groove 14, and the end of the boosting spring 41 is placed in the limiting groove 14.

[0121] The power of the driving unit 4 is provided by the boosting spring 41. In the initial state, the driving member 42 is locked inside the installation channel 11, and at this time, the boosting spring 41 is in a compressed state. When the user unlocks the driving unit 4, the boosting spring 41 pushes the driving member 42 under its own elastic force, causing the driving member 42 to move in the first direction to perform the implantation action. This method not only realizes automatic implantation, but also uses the boosting spring 41 to drive, and can better control the movement speed of the driving member 42, making it more uniform, and the movement direction is more stable, avoiding jamming during the movement, thereby reducing shaking and alleviating the pain of the user during implantation.

[0122] The limiting groove 14 can limit the end of the boosting spring 41, so that the boosting spring 41 always deforms along its own axis and provides a stable force in the first direction to the driving member 42. Specifically, as Figure 2 、 Figure 4 shown, a limiting groove 14 is provided on one side of the driving member 42 facing the mating end 13. At the same time, the inner wall of the mating end 13 also has a limiting groove 14, so that both ends of the boosting spring 41 are located in the limiting groove 14. As Figure 2 、 Figure 4 shown, a surrounding wall protruding towards the mating end 13 is also provided on the periphery of the driving member 42 to limit the boosting spring 41 when the middle of the boosting spring 41 deviates from the axis. Preferably, as Figure 4 shown, the axis of the boosting spring 41 coincides with the axis of the housing 1.

[0123] As Figure 2 、 Figure 8 shown, a guiding rib 15 is provided on the inner wall of the housing 1. The guiding rib 15 extends in the first direction. A guiding groove 424 cooperating with the guiding rib 15 is provided on the outer peripheral side of the driving unit 4 to play a role in guiding the movement of the driving unit 4 and making its movement more stable. The guiding ribs 15 are arranged at intervals along the circumferential direction of the housing 1.

[0124] Of course, a guiding groove 424 can also be provided on the inner wall of the housing 1. Correspondingly, a guiding rib 15 is provided on the outer wall of the driving unit 4, which is not limited here.

[0125] As Figure 1 、 Figure 3 、 Figure 5 shown, the implantation device further includes an unlocking member 3. The unlocking member 3 is a sliding button and is arranged on one side of the outer peripheral surface of the housing 1, and can move in the first direction or the second direction to unlock the driving unit 4.

[0126] It can be understood that the housing 1 is a cylindrical structure extending in the first direction. The two ends of the housing 1 in the first direction are the end faces of the housing 1, and the wall surface surrounding the first direction is the outer peripheral surface of the housing 1.

[0127] The trigger moves in the first direction or the second direction to unlock the drive unit 4. Compared with the way of pressing the trigger button radially inward along the outer shell 1, when the user holds the outer shell 1 by hand, the force application direction of the finger is radially inward along the outer shell 1, while the force application direction of the trigger unlocking member 3 is along the axis of the outer shell 1. The force application directions of the two actions are perpendicular to each other. Therefore, the probability that the user accidentally touches the trigger when grasping the outer shell 1 is greatly reduced, the risk that the implant device is accidentally triggered is reduced, it is ensured that the implant device can be effectively triggered and the implantation can be completed, and the user experience is improved.

[0128] Further, as Figure 3 , Figure 5 , Figure 8 , Figure 9 shown, the unlocking member 3 includes a manipulation part 31 located outside the outer shell 1, a trigger part 32 located in the installation channel 11, and a connecting rib 33 connecting the trigger part 32 and the manipulation part 31. The outer shell 1 is provided with an avoidance groove 121 for the connecting rib 33 to pass through, and the avoidance groove 121 extends in the first direction.

[0129] The manipulation part 31 of the unlocking member 3 is located outside the outer shell 1 for the user to operate, the trigger part 32 is located inside the installation channel 11 for performing an unlocking action on the drive unit 4, and the outer peripheral surface of the outer shell 1 is provided with an avoidance groove 121 for the connecting rib 33 to pass through. It can not only limit the connecting rib 33, thereby limiting the unlocking member 3 as a whole, so that it can only extend in the first direction or the second direction, but also the length of the avoidance groove 121 constitutes the movement stroke of the unlocking member 3. When the unlocking member 3 moves until the connecting rib 33 abuts against the end of the avoidance groove 121, the unlocking member 3 can no longer move in the same direction, so that the movement of the unlocking member 3 is more reliable and the unlocking member 3 is prevented from falling off the outer shell 1.

[0130] Preferably, as Figure 1 , Figure 3 shown, the manipulation part 31 is a sliding button arranged on one side of the outer peripheral surface of the outer shell 1, and the outer surface of the outer shell 1 is provided with a receiving groove 12 extending in the first direction, and the sliding button is located in the receiving groove 12.

[0131] The control part 31 is a small-sized sliding button located on one side of the housing 1. This not only enables the user to complete the triggering in a more comfortable posture. For example, the user can rotate the housing 1 to adjust the orientation of the control part 31, and then complete the triggering with a more habitual finger and a more comfortable angle, improving the user experience. Moreover, the small-sized control part 31 can effectively prevent the user from accidentally triggering, avoiding the scrapping of the implant device due to the user's misoperation. In addition, a receiving groove 12 extending in the first direction is provided on the surface of the housing 1, and the control part 31 is received in the receiving groove 12. The receiving groove 12 can not only guide the movement of the control part 31, making its movement smoother and reducing jamming during the movement, thereby reducing the pain during the implantation process. Moreover, the control part 31 is located in the receiving groove 12, so that its outer surface will not protrude too much from the surface of the housing 1, and can even be flush with the outer peripheral surface of the housing 1 or recessed relative to the outer peripheral surface of the housing 1, thereby further improving the anti-misoperation effect.

[0132] In a preferred embodiment, as Figure 5 shown, the driving unit 4 includes a stop part 422, and the housing 1 includes a stop member 111 that cooperates with the stop part 422. The stop part 422 and the stop member 111 cooperate to prevent the driving unit 4 from moving relative to the housing 1. The triggering part 32 can extend from the avoidance groove 121 into the installation channel 11 and abut against the stop part 422 or the stop member 111 to disengage the two from cooperation.

[0133] In a specific example, a groove structure is provided on the inner side wall of the installation channel 11 to form the stop member 111. The stop part 422 is a rib protruding laterally outward from the outer peripheral side of the driving unit 4, and the rib is located in the groove structure to achieve the stop cooperation. The triggering part 32 can squeeze the stop part 422 inward to cause it to deform inward or move so that the rib is disengaged from the groove structure, thereby unlocking the driving unit 4.

[0134] Of course, a convex structure can also be provided on the inner wall of the installation channel 11 to form the stop member 111, which can also complete the stop locking with the stop part 422. Similarly, the triggering part 32 can also squeeze the stop member 111 to cause it to deform or move, thereby disengaging from the stop part 422.

[0135] Specifically, the stop part 422 is an elastic rib position 421. The structure of the stop part 422 is not limited in this embodiment. The stop part 422 can extend in the first direction or the second direction, and a laterally protruding rib is provided on its outer side for cooperation with the stop member 111. In another example, as Figure 5 , Figure 8 , Figure 9 shown, the stop part 422 is an elastically extending rib position 421 that extends obliquely, and there is a gap between its end and the driving unit 4 to provide a movement space for the stop part 422. When the triggering part 32 squeezes the stop part 422, it swings inward.

[0136] Further, as shown in Figure 5 , Figure 8 , Figure 9 , the trigger part 32 has a mounting groove 321, the stop part 422 passes through the mounting groove 321 to abut and cooperate with the stop member 111, and a guiding inclined surface 423 is provided on the mounting groove 321 and / or the stop part 422. The trigger part 32 drives the stop part 422 through the guiding inclined surface 423 so that the stop part 422 disengages from the stop member 111.

[0137] The stop part 422 of the driving unit 4 passes outward through the mounting groove 321 of the trigger part 32 and cooperates with the stop member 111 on the inner wall of the housing 1 to form a stop, thereby locking the driving unit 4 and preventing the driving unit 4 from moving relative to the housing 1. When the user drives the unlocking member 3 to move in the first direction or the second direction, the mounting groove 321 and the stop part 422 contact through the guiding inclined surface 423. The guiding inclined surface 423 converts part of the vertical acting force of the trigger part 32 into a lateral acting force, and then forms a squeezing force perpendicular to the first direction on the stop part 422, causing the stop part 422 to move and then disengage from the stop member 111. The driving unit 4 is unlocked and starts to perform the implantation action.

[0138] In one embodiment, as shown in Figure 5 , the stop part 422 is an elastically extending rib position 421 with an inclined extension, and thus the guiding inclined surface 423 is naturally formed on its surface. Of course, the guiding inclined surface 423 can also be provided in the mounting groove 321, which is not limited herein.

[0139] As shown in Figure 5 , Figure 8 , Figure 9 , when the unlocking member 3 moves in the first direction to trigger the driving unit 4, the stop part 422 extends obliquely downward to form a guiding inclined surface 423 on its upper surface. When the trigger part 32 moves downward in the first direction, the lower end of the stop part 422 is squeezed and swings inward. Similarly, when the unlocking member 3 is designed to move in the second direction to trigger the driving unit 4, the stop part 422 can be correspondingly arranged as a structure extending obliquely upward to form a guiding inclined surface 423 on its lower surface.

[0140] As a preferred embodiment of the present application, as shown in Figure 4 , the driving unit 4 includes a driving member 42 and a transmission member 43. A boosting spring 41 is provided between the driving member 42 and the housing 1. The transmission member 43 is located on one side of the driving member 42 along the first direction and is close to the mounting opening 18. The transmission member 43 is fixed to the driving member 42 by a buckle or other means to be able to move synchronously with the driving member 42.

[0141] As a preferred embodiment of the present application, the outer shell 1 is provided with an elastic arm 174 extending into the installation opening 18 and a fixing portion provided at the end of the elastic arm 174, and the fixing portion abuts against the outer peripheral surface of the housing 61.

[0142] The elastic arm 174 clamps the housing 61 from the outer peripheral side of the housing 61 to fix the housing 61. It should be noted that the present application does not limit the installation position of the elastic arm 174. In one embodiment, the elastic arm 174 is provided on the inner wall of the installation channel 11, that is, the elastic arm 174 and the outer shell 1 are of an integral structure. In another embodiment, as Figure 4 , Figure 7 , Figure 8 , Figure 9 , Figure 14 shown, the implant device further includes a fixing ring 17 at one end of the outer shell 1. The inner diameter of the fixing ring 17 is the same as the inner diameter of the abutting section 16 of the outer shell 1, and the elastic arm 174 is provided on the fixing ring 17.

[0143] Specifically, as Figure 14 shown, one end of the elastic arm 174 is fixed to the fixing ring 17, and the other end extends along the circumferential direction of the housing 61 and has a deformation gap with the fixing ring 17. This end contacts the housing 61 and forms a clamp on the housing 61, so that the elastic arm 174 has better elastic deformation ability.

[0144] Preferably, as Figure 14 shown, a contact member 175 is provided on the side of the fixing portion facing the housing 61. The contact member 175 is made of a flexible material and elastically abuts against the housing 61.

[0145] The fixing portion clamps the housing 61 through the contact member 175. The contact member 175 is made of a flexible material. On the one hand, it can make the contact between the fixing portion and the housing 61 softer, avoiding rigid contact between the fixing portion and the housing 61 and causing wear. On the other hand, under the action of the extrusion force, the contact member 175 will undergo elastic deformation, thereby increasing the friction force between it and the housing 61 and improving the fixing stability.

[0146] Preferably, the contact member 175 is made of silicone material. Of course, it can also be made of other flexible materials, such as felt, cotton, etc.

[0147] Preferably, as Figure 4 , Figure 9 , Figure 14 shown, the fixing ring 17 is located at the end of the outer shell 1. The fixing ring 17 is provided with a positioning rib 171 protruding towards the outer shell 1. The positioning rib 171 extends in the second direction. The outer shell 1 has a plug-in groove cooperating with the positioning rib 171 to plug and position the fixing ring 17 and the outer shell 1.

[0148] As a preferred embodiment of the present application, as Figure 9As shown, a trigger ring 172 is further disposed inside the outer shell 1. At least one of the trigger ring 172 and the elastic arm 174 is provided with a mating inclined surface 173, so that the trigger ring 172 and the elastic arm 174 contact along the first direction through the mating inclined surface 173. The trigger ring 172 can be driven by the driving unit 4 to move along the first direction. Further, the driving force generates a component force perpendicular to the first direction through the mating inclined surface 173, and pushes the elastic arm 174 to expand outwards to release the housing 61, thereby completing the release of the monitoring unit 6.

[0149] As Figure 9 shown, the trigger ring 172 further has a guiding column 1721 extending along the first direction. There is a fixing member 9 between the mating end 13 of the sealing unit 8 and the housing 61. The fixing member 9 has a through opening for the guiding column 1721 to pass through, so as to form a movement guide for the trigger ring 172 along the first direction.

[0150] What is not described in this application can be realized by adopting or referring to the prior art.

[0151] Each embodiment in this specification is described in a progressive manner. The same or similar parts among the embodiments can be referred to each other, and the differences between each embodiment and other embodiments are emphasized.

[0152] The above are only the embodiments of the present application and are not used to limit the present application. For those skilled in the art, various changes and modifications can be made to the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included within the scope of the claims of the present application.

Claims

1. An implantation device for inserting an analyte sensor into subcutaneous tissue, characterized in that: include: The housing has a first end and a second end that are arranged opposite to each other along a first direction, the first end is provided with a mounting opening, and the housing has a mounting channel extending along the first direction; A sealing unit is disposed in the installation channel, and the sealing unit has a sealing cavity isolated from the installation channel; A monitoring unit is disposed in the sealed cavity; and The bottom shell is detachably connected to the outer shell, and when the bottom shell is separated from the outer shell, the sealing cavity is communicated with the installation channel.

2. The implant device according to claim 1, characterized in that The sealing unit includes a container and a sealing member detachably connected to the container, the container and the sealing member enclose the sealing cavity, the container is provided with communication ports at both ends in the first direction, and the sealing member covers the communication ports.

3. The implant device according to claim 2, characterized in that The sealing member is connected to the bottom shell, so that when the bottom shell is separated from the outer shell, the sealing member is separated from the receiving member.

4. The implant device according to claim 3, characterized in that The communication port includes a first communication port and a second communication port, and the seal includes a first sealing portion and a second sealing portion, wherein the first sealing portion covers the first communication port and the second sealing portion covers the second communication port.

5. The implant device according to claim 4, characterized in that The sealing member also includes a first folding portion and a second folding portion extending from the first sealing portion and the second sealing portion respectively, and a first operating portion and a second operating portion extending from the first folding portion and the second folding portion respectively, the first folding portion and the second folding portion are stacked with the first sealing portion and the second sealing portion respectively on a side away from the sealing cavity, the outer shell is provided with a withdrawal port, the first operating portion and the second operating portion extend out of the outer shell from the withdrawal port and are fixed to the bottom shell.

6. The implant device according to claim 1, characterized in that The implant device also includes a driving unit and a puncture unit. In an initial position, the driving unit and the puncture unit are both arranged in the installation channel and outside the sealed cavity. The driving unit can drive the puncture unit to move along the first direction so that the puncture unit and the monitoring unit are assembled and the puncture unit and the monitoring unit at least partially penetrate the subcutaneous tissue.

7. The implant device according to claim 1, characterized in that The implantation device also includes a driving unit and a puncture unit, the puncture unit includes a needle seat and a puncture needle connected to the needle seat, the driving unit includes a driving member and a connecting member connected between the driving member and the needle seat, in an initial position, the needle seat is located in the sealed cavity and is fixedly connected to the monitoring unit, and the connecting member is located outside the sealed cavity.

8. The implant device according to claim 7, characterized in that The connecting piece is provided with a clamping structure, and the needle seat is provided with a matching structure. The connecting piece can move along the first direction to connect the clamping structure with the matching structure.

9. The implant device according to claim 6 or 7, characterized in that: The driving unit is provided with a stop structure, and the puncture unit has a matching portion, which cooperates with the stop structure to prevent the puncture unit from moving relative to the driving unit. An unlocking structure is provided in the installation channel, and the unlocking structure can apply force to the matching portion or the stop structure to disengage the two.

10. The implant device according to claim 6 or 7, characterized in that: A fixing piece is also provided inside the housing, the fixing piece is located between the sealing unit and the second end, the sealing unit is connected to the fixing piece, the fixing piece has an opening for the driving unit to pass through, and the driving unit is provided between the fixing piece and the second end.

11. The implant device according to claim 10, characterized in that The puncture unit is connected to the drive unit, and an unlocking structure is provided at the edge of the opening, and the unlocking structure can abut and cooperate with the puncture unit to unlock the puncture unit, so that the puncture unit moves relative to the drive unit in a second direction, and the second direction is opposite to the first direction.

12. The implant device according to claim 1, characterized in that The monitoring unit includes a shell, an electronic module and a monitoring module. The shell is detachably arranged at the first end, the electronic module is arranged inside the shell, and the monitoring module is arranged in the sealed cavity. The monitoring module can move along the first direction under the drive of the driving unit so that the monitoring module is assembled to the shell and the monitoring module is partially implanted into the host's subcutaneous tissue.

13. The implant device according to claim 1, characterized in that The monitoring unit comprises a shell, an attachment arranged on the bottom surface of the shell, and an isolation membrane which is detachable from the attachment. When the bottom shell is separated from the outer shell, the isolation membrane is separated from the attachment.

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