Implanting device for intervening micro biosensor into subcutaneous tissue and using method

Abstract

The invention relates to an implantation device for intervening a micro biosensor into subcutaneous tissue and a using method, the implantation device comprises a fixed seat, a driving unit, a monitoring unit and a mounting seat, the driving unit is slidably mounted in the fixed seat, the monitoring unit is detachably mounted on the driving unit, and the mounting seat is mounted on the mounting seat. The driving unit can move relative to the fixing base in the first direction and drive the monitoring unit to move from the first position to the second position. The mounting base is used for accommodating the monitoring unit. The fixing seat is provided with at least two first limiting parts, the mounting seat is provided with first matching parts, and the first matching parts are used for being matched with the first limiting parts. At the first position, the first limiting part is matched with the first matching part to limit the mounting seat to move relative to the fixed seat, and before the monitoring unit reaches the second position, the first limiting part can prevent the mounting seat from moving relative to the fixed seat. Therefore, the possibility of relative displacement between the mounting seat and the fixing seat when the monitoring unit is mounted is reduced, and the success rate of implantation of the monitoring unit is improved.

Description

[0001] This application claims priority to Chinese Patent Application No. 202411391591.X, filed on September 30, 2024, entitled "An Online Blood Glucose Monitoring Device and Method of Use", the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical device technology, and more specifically to an implantation device and method for inserting a micro biosensor into subcutaneous tissue. Background Technology

[0003] Detecting various analytes within an individual is crucial for monitoring their health, and deviations from normal analyte levels can often indicate underlying physiological conditions, such as metabolic status or disease. Regular in vitro analyte monitoring using extracted bodily fluids is sufficient to observe the physiological status of many individuals. However, in vitro analyte monitoring has a limited number of values ​​that can be measured, potentially leading to missed opportunities for optimal treatment and irreversible harm to the patient due to missing key measurements. Furthermore, for individuals with severe analyte imbalances and / or rapidly fluctuating analyte levels, more frequent bodily fluid extractions are required for monitoring, which can be inconvenient and painful for the patient.

[0004] In many cases, subcutaneous, interstitial, or skin analyte sensors can provide sufficient measurement accuracy while minimizing user discomfort. Continuous analyte monitoring using implanted analyte monitoring sensors is a preferred method. Typically, an implantable device is used to insert the analyte monitoring sensor into the individual's body. The sensor reacts with the recipient's bodily fluids to generate an electrical signal. A processing unit converts this signal into data characterizing the analyte concentration, which is then transmitted to a display device for display, thus enabling continuous monitoring of the analyte concentration.

[0005] Each time a new sensor is used, the user implants a portion of the sensor under their skin. Typically, an implantation device is used to insert the sensor into the user's body. A puncture needle within the implantation device engages with the sensor and guides it under the user's skin. Once implanted, the puncture needle is removed from the user's body, while the sensor remains inside. Existing implantation devices, such as those disclosed in US9931065B2 and CN113827230B, have technical issues regarding the difficulty in guaranteeing implantation success rates. Summary of the Invention

[0006] In view of this, this application provides an implantation device and method for inserting a micro biosensor into subcutaneous tissue to improve the success rate of monitoring unit implantation.

[0007] In a first aspect, embodiments of this application provide an implantation device for inserting a micro biosensor into subcutaneous tissue, the implantation device comprising:

[0008] The fixing base is provided with at least two first limiting parts;

[0009] A drive unit is slidably mounted in the fixed base and is capable of moving relative to the fixed base in a first direction;

[0010] A monitoring unit, detachably connected to the driving unit, the driving unit being configured to move along the first direction to drive the monitoring unit from a first position to a second position; and

[0011] The mounting base is attached to the host skin and is configured to accommodate the monitoring unit. The mounting base is provided with a first mating part that mates with the first limiting part.

[0012] In the second position, the monitoring unit is installed on the mounting base. Before the monitoring unit reaches the second position, the first limiting part is configured to prevent the mounting base from moving relative to the fixed base.

[0013] In one possible implementation, in the second position, the force between the first limiting portion and the first mating portion is less than the adhesive force between the mounting base and the skin.

[0014] In one possible implementation, in the second position, at least a portion of the first limiting portion is disengaged from the first mating portion, and the fixing seat is movable relative to the mounting seat.

[0015] In one possible implementation, the first limiting part includes a first limiting segment and a second limiting segment connected together, and the included angle between the first limiting segment and the second limiting segment is an obtuse angle. When the monitoring unit has not reached the second position, the first limiting segment engages with the first mating part for limiting engagement. When the monitoring unit reaches the second position, the second limiting segment engages with the first mating part for limiting engagement.

[0016] In one possible implementation, the first limiting segment includes a first abutting surface, the second limiting segment includes a second abutting surface, the included angle between the first abutting surface and the second abutting surface is an acute angle, and the first mating part includes a third abutting surface. When the monitoring unit is in the first position, the first abutting surface abuts against the third abutting surface, and when the monitoring unit is in the second position, the second abutting surface abuts against the third abutting surface.

[0017] In one possible implementation, the first limiting segment includes a first abutting surface, the second limiting segment includes a second abutting surface, the included angle between the first abutting surface and the second abutting surface is an acute angle, and the first mating part includes a third abutting surface and a fourth abutting surface;

[0018] When the monitoring unit is in the first position, the first contact surface abuts against the third contact surface; when the monitoring unit is in the second position, the second contact surface abuts against the fourth contact surface.

[0019] In one possible implementation, the mounting base further includes a mounting wall and a connecting arm connecting the mounting wall and the first limiting portion, wherein the angle between the extending direction of the connecting arm and the first direction is an acute angle.

[0020] In one possible implementation, the angle between the connecting arm and the first direction is 15° to 45°.

[0021] In one possible implementation, the drive unit includes an abutment portion. In the first position, the abutment portion is spaced apart from the connecting arm. When the drive unit moves along the first direction, the abutment portion can abut against the connected arm to drive the connecting arm to move or deform in a direction gradually away from the first mating portion.

[0022] In one possible implementation, the drive unit includes a needle-assist assembly and a first drive member. The needle-assist assembly includes at least one second limiting portion, and the fixing base includes at least one second mating portion. The second limiting portion cooperates with the second mating portion to restrict the movement of the needle-assist assembly relative to the fixing base. The second limiting portion is configured to be movable or deformable relative to the fixing base to allow the drive unit to move relative to the fixing base.

[0023] In one possible implementation, the driving unit includes a puncture assembly and a second driving member, the needle assist assembly includes a third limiting portion, and the puncture assembly includes a third mating portion. The third limiting portion and the third mating portion cooperate to restrict the movement of the puncture assembly relative to the needle assist assembly in a second direction, wherein the first direction and the second direction are opposite.

[0024] In one possible implementation, the fixed base further includes a fourth mating part, which abuts against the third limiting part during the movement of the driving unit along the first direction, thereby preventing the third limiting part from disengaging from the third mating part.

[0025] In one possible implementation, the needle-assisting assembly includes a fourth limiting portion that protrudes in a direction close to the fixing base, and a fourth mating portion that protrudes in a direction close to the needle-assisting assembly. The fourth limiting portion is used to cooperate with the fourth mating portion to limit the movement distance of the driving unit in the first direction.

[0026] In one possible implementation, the implantation device further includes a trigger, and the fixation base is provided with a clearance space. The trigger passes through the clearance space and presses against the second limiting part, causing the second limiting part to move or deform relative to the fixation base to release the cooperation relationship between the second limiting part and the second mating part.

[0027] The trigger does not drive the first limiting part to move relative to the first mating part.

[0028] In one possible implementation, the implantation device includes a locking member for limiting the trigger member from pressing against the second limiting portion.

[0029] In one possible implementation, the mounting base includes a main body and a fifth limiting part, the fifth limiting part being swayable relative to the main body, and the monitoring unit includes a fifth mating part, the fifth limiting part cooperating with the fifth mating part to restrict the monitoring unit from detaching from the mounting base.

[0030] In one possible implementation, the monitoring unit and the mounting base do not include at least one of the battery module, data processing module, and data transmission module.

[0031] This application also provides a method of using an implantation device for inserting a micro biosensor into subcutaneous tissue. The implantation device includes a fixation base, a driving unit, a monitoring unit, and a mounting base. The method of use includes:

[0032] The driving unit drives the monitoring unit to move relative to the fixed base from a first position along a first direction. In the first position, the first limiting part of the fixed base cooperates with the first mating part of the mounting base to prevent the mounting base from moving relative to the fixed base.

[0033] The driving unit drives the first limiting part, causing the first limiting part to gradually move or deform in a direction away from the first mating part;

[0034] When the drive unit reaches the second position, the monitoring unit is installed on the mounting base. In the second position, the first limiting part and the first mating part are at least partially disengaged.

[0035] In one possible implementation, the driving unit reaches the second position, the monitoring unit is mounted to the mounting base, and in the second position, the step of at least partially disengaging the first limiting portion from the first mating portion includes:

[0036] In the second position, the first limiting part and the first mating part are completely disengaged.

[0037] In one possible implementation, the implantation device further includes a trigger, the drive unit includes a second limiting portion, the fixing base includes a clearance space and a second mating portion disposed within the clearance space, and the method of use includes:

[0038] The trigger drives the second limiting part to move or deform, so that the second limiting part is disengaged from the second mating part, and the driving unit drives the monitoring unit to move along the first direction.

[0039] In one possible implementation, the mounting base includes a fifth limiting part, the monitoring unit includes a fifth mating part, and the method of use further includes:

[0040] During the process of the driving unit driving the monitoring unit to move along the first direction, the fifth mating part drives the fifth limiting part to move or deform; when the monitoring unit reaches the second position, the fifth limiting part resets and engages with the fifth mating part to limit the monitoring unit from detaching from the mounting base.

[0041] In one possible implementation, the implantable device includes an electronic unit, which includes at least one of a battery module, a data processing module, and a data transmission module. The method of use further includes: removing the drive unit and installing the electronic unit onto the mounting base.

[0042] This application provides an implantation device and method for inserting a micro biosensor into subcutaneous tissue. The limiting unit of the implantation device can prevent the fixed seat from moving relative to the housing during the installation of the monitoring unit to the mounting seat. This limits the relative position between the fixed seat and the mounting seat before the monitoring unit is installed in place, thereby reducing the possibility of displacement between the fixed seat and the mounting seat, and thus reducing the possibility of monitoring unit implantation failure, which is beneficial to improving the success rate of monitoring unit implantation.

[0043] It should be understood that the above general description and the following detailed description are merely exemplary and do not limit this application. Attached Figure Description

[0044] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0045] Figure 1 This is a schematic diagram of the implantable device provided in this application;

[0046] Figure 2 This is an internal schematic diagram of the implantable device provided in this application;

[0047] Figure 3 for Figure 2 A magnified view of position I, where the driving unit is in the first position;

[0048] Figure 4 for Figure 2 A partial enlarged view of position I, wherein the first mating part has a third abutting surface, and the driving unit is located between the first position and the second position;

[0049] Figure 5 for Figure 2 A partial enlarged view of position I, wherein the first mating part has a third abutment surface, and the driving unit is in the second position;

[0050] Figure 6 for Figure 2 A partial enlarged view of position I, wherein the first mating part has a third abutting surface and a fourth abutting surface, and the driving unit is located between the first position and the second position;

[0051] Figure 7 for Figure 2 A partial enlarged view of position I, wherein the first mating part has a third abutting surface and a fourth abutting surface, and the driving unit is in the second position;

[0052] Figure 8 A front view of the drive unit provided in this application in the first position, with the second limiting part and the second mating part not disengaged;

[0053] Figure 9 A front view of the drive unit provided in this application in the first position, with the second limiting part and the second mating part disengaged;

[0054] Figure 10 A schematic diagram showing the drive unit provided in this application located between the first position and the second position;

[0055] Figure 11 A side view of the drive unit provided in this application when it is in the first position;

[0056] Figure 12 A side view of the drive unit provided in this application located in the second position;

[0057] Figure 13 A side view of the monitoring unit provided in this application reaching the second position and the puncture component retracting;

[0058] Figure 14 A schematic diagram of the locking element provided in this application;

[0059] Figure 15 An internal schematic diagram of the implantable device with locking mechanism provided in this application;

[0060] Figure 16 This is a cross-sectional view of the implantable device provided in this application;

[0061] Figure 17 A cross-sectional view showing the engagement of the mounting base and the drive unit in the first embodiment provided in this application;

[0062] Figure 18 A perspective view of the fixing base in the first embodiment provided in this application;

[0063] Figure 19 A perspective view of the driving unit in the first embodiment provided in this application;

[0064] Figure 20 A top view showing the engagement of the mounting base and the drive unit in the second embodiment provided in this application;

[0065] Figure 21 A partial schematic diagram of the fixing base in the second embodiment provided in this application;

[0066] Figure 22 A top view showing the engagement of the needle-assist component and the puncture component in the second embodiment provided in this application.

[0067] Figure label:

[0068] 1-Fixed base; 11-First limiting part; 111-First limiting section; 111a-First abutting surface; 112-Second limiting section; 112a-Second abutting surface; 113-Connecting arm; 12-Second mating part; 13-Fourth mating part; 14-First guide part; 15-Second guide part; 16-Third guide part; 2-Drive unit; 21-Auxiliary needle assembly; 211-Abutting part; 212-Second limiting part; 213-Third limiting part; 214-Fourth limiting part; 215-Third guide part; 215a-Protrusion; 216 - Fourth guide section; 217-Sixth guide section; 22-Piercing assembly; 221-Third mating section; 222-Fifth guide section; 23-Second driving member; 3-Monitoring unit; 31-Fifth mating section; 4-Mounting base; 41-First mating section; 411-Third abutting surface; 412-Fourth abutting surface; 42-Main body; 43-Fifth limiting section; 5-First driving member; 6-Locking member; 61-Main body; 62-First extension; 621-Limiting groove; 63-Second extension; 7-Trigger member; 8-Housing; 9-Guide section. Detailed Implementation

[0069] To better understand the technical solution of this application, the embodiments of this application will be described in detail below with reference to the accompanying drawings.

[0070] It should be understood that the described embodiments are merely some, not all, of the embodiments in this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

[0071] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise.

[0072] It should be understood that the term "and / or" used in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, the character " / " in this article generally indicates that the preceding and following related objects have an "or" relationship.

[0073] like Figure 1-22 As shown, this application provides an implantation device for inserting a micro biosensor into subcutaneous tissue, enabling the sensor to be implanted in the body to monitor the blood glucose level of the implanted subject. Figure 2As shown, the implantable device includes a fixation base 1, a drive unit 2, a monitoring unit 3, a mounting base 4, and a housing 8. The fixation base 1 can be disposed within the housing 8 of the online blood glucose monitoring device. The drive unit 2 is slidably mounted within the fixation base 1, and the monitoring unit 3 is detachably mounted within the drive unit 2. The drive unit 2 can move relative to the fixation base 1 along a first direction, simultaneously driving the monitoring unit 3 to move from a first position to a second position along the first direction. The mounting base 4 is used to accommodate the monitoring unit 3. Figure 3 As shown, the fixed base 1 is provided with at least two first limiting parts 11, and the mounting base 4 is provided with a first mating part 41. The first mating part 41 is used to form a limiting unit with the first limiting parts 11. The limiting unit is configured to prevent the mounting base 4 from moving relative to the housing 8 during the installation of the monitoring unit 3 onto the mounting base 4. Specifically, in the first position, the first limiting part 11 and the first mating part 41 cooperate to limit the movement of the mounting base 4 relative to the fixed base 1. In the second position, the monitoring unit 3 is installed onto the mounting base 4. Before the monitoring unit 3 reaches the second position, the first limiting part 11 can prevent the mounting base 4 from moving relative to the fixed base 1. That is, before the monitoring unit 3 is installed onto the mounting base 4, the first limiting part 11 can be in a cooperating state with the first mating part 41, thereby limiting the relative movement between the mounting base 4 and the fixed base 1.

[0074] In the solution provided in this application embodiment, the limiting cooperation between the first limiting part 11 and the first mating part 41 can limit the relative position between the mounting base 4 and the fixed base 1 during the installation of the monitoring unit 3 to the mounting base 4. This can reduce the possibility of displacement of the mounting base 4 relative to the fixed base 1 during the installation of the monitoring unit 3, and prevent the fixed base 1 and the mounting base 4 from moving relative to each other before the monitoring unit 3 is installed in place, which would cause the installation of the monitoring unit 3 to fail. This is beneficial to improving the success rate of implantation of the monitoring unit 3.

[0075] Since the monitoring unit 3 needs to be implanted into the body, it will puncture the skin during the implantation process. Therefore, if the mounting base 4 shakes during implantation, it will cause the monitoring unit 3 to shake as well, which can easily lead to a larger wound area, increased pain and bleeding, and a reduced user experience. The solution provided in this application ensures that the first limiting part 11 and the first mating part 41 are always in a mating state before the monitoring unit 3 is installed on the mounting base 4, thereby limiting the mounting base 4 and reducing the possibility of shaking. This reduces the likelihood of shaking during implantation, which helps to reduce the wound area, decrease pain and bleeding during implantation, improve the user experience, and better meet actual usage needs.

[0076] The mounting base 4 can be attached to the skin surface and fixed relative to the skin by means of adhesive bonding, thereby preventing the mounting base 4 and the monitoring unit 3 installed on the mounting base 4 from falling off the body. In the second position, the monitoring unit 3 has been installed on the mounting base 4, and the implantation process is complete. After implantation, it is necessary to separate the fixing base 1 from the mounting base 4. At this time, the first limiting part 11 can be in a state of complete disengagement from the mounting base 4 or in a state of partial disengagement. When the first limiting part 11 is completely disengaged from the mounting base 4, it can be considered that the force between the first limiting part 11 and the mounting base 4 is zero, and there is an adhesive force between the mounting base 4 and the skin. Therefore, when separating the fixing base 1 and the mounting base 4, only the fixing base 1 can be removed, leaving the mounting base 4 and the monitoring unit 3 installed on the mounting base 4 in the body. When the first limiting part 11 is partially disengaged from the mounting base 4, a certain force still exists between the first limiting part 11 and the mounting base 4 to restrict the separation of the fixing base 1 and the mounting base 4. The user needs to apply external force to the fixing base 1 to overcome the force between the fixing base 1 and the mounting base 4 and remove the fixing base 1. In the second position, the force between the fixing base 1 and the mounting base 4 in the solution provided by this application embodiment is less than the adhesive force between the mounting base 4 and the skin, which can reduce the possibility of the mounting base 4 detaching from the skin during the removal of the fixing base 1.

[0077] In one possible implementation, in the second position, at least a portion of the first limiting part 11 is disengaged from the first mating part 41 so that after the monitoring unit 3 is installed in place, the structure such as the fixing seat 1 can be removed, leaving the mounting seat 4 and the monitoring unit 3 in the human body.

[0078] In the second position, the first limiting part 11 can be completely disengaged from the first mating part 41 to facilitate the separation of the fixed base 1 and the mounting base 4, making it convenient for user operation. The first limiting part 11 can also be partially disengaged while partially mating with the first mating part 41, maintaining a certain limiting relationship between the fixed base 1 and the mounting base 4. This reduces the possibility of relative movement between the fixed base 1 and the mounting base 4 before the user removes the fixed base 1. When the user deems it necessary to remove the fixed base 1, external force is applied to separate the fixed base 1 from the mounting base 4. Furthermore, since a certain degree of engagement still exists between the first limiting part 11 and the first mating part 41 after the monitoring unit 3 is installed, the stability of the mounting base 4 is further improved, reducing the possibility of shaking or displacement of the mounting base 4 before the monitoring unit 3 is installed.

[0079] like Figure 3As shown, in one possible implementation, the first limiting part 11 includes a first limiting segment 111 and a second limiting segment 112 connected to each other. The included angle between the first limiting segment 111 and the second limiting segment 112 is an obtuse angle. When the monitoring unit 3 has not reached the second position, the first limiting segment 111 is engaged with the first limiting part 11 for limiting. When the monitoring unit 3 reaches the second position, the second limiting segment 112 is engaged with the first limiting part 11 for limiting.

[0080] The first limiting segment 111 and the second limiting segment 112 can cooperate with the first limiting part 11 at different stages, thereby changing the cooperation state between the first limiting part 11 and the first mating part 41. The included angle between the first limiting segment 111 and the second limiting segment 112 can make the cooperation state between the first limiting segment 111 and the first mating part 41 different from that between the second limiting segment 112 and the first mating part 41, including but not limited to different contact areas (resulting in different magnitudes of pressure). By changing the cooperation state between the first limiting part 11 and the first mating part 41, the fixing seat 1 can limit the mounting seat 4 to different degrees. Before the monitoring unit 3 is installed on the mounting seat 4, the first limiting part 11 imposes a greater restriction on the mounting seat 4 to prevent the mounting seat 4 from shaking or vibrating during the installation of the monitoring unit 3, which could cause displacement of the mounting seat 4 and affect the implantation success rate of the monitoring unit 3. After the monitoring unit 3 is installed on the mounting base 4, the first limiting part 11 releases part of the restriction on the mounting base 4, reducing the difficulty for the user to remove the fixing base 1 after implantation, making it easier and less strenuous to operate.

[0081] like Figure 4 As shown, in one possible implementation, the first limiting segment 111 includes a first abutting surface 111a, and the second limiting segment 112 includes a second abutting surface 112a. The included angle between the first abutting surface 111a and the second abutting surface 112a is an acute angle, and the included angle between the first abutting surface 111a and the second abutting surface 112a is α, where 0° < α < 90°, meaning the first abutting surface 111a and the second abutting surface 112a are not parallel or perpendicular to each other. Along a direction away from the first abutting surface 111a, the second abutting surface 112a can be tilted away from the driving unit 2. The first mating part 41 includes a third abutting surface 411. Figure 4 As shown, when the monitoring unit 3 is in the first position, the first contact surface 111a and the third contact surface 411 abut against each other; as Figure 5 As shown, when the monitoring unit 3 is in the second position, the second contact surface 112a and the third contact surface 411 are in contact.

[0082] Because the angles of the first abutment surface 111a and the second abutment surface 112a are different, the contact area when the first abutment surface 111a and the third abutment surface 411 mate is different from the contact area when the second abutment surface 112a and the third abutment surface 411 mate. This results in different mating states between the first limiting part 11 and the first mating part 41. When the mating states of the first limiting part 11 and the second limiting part 212 are different, the restriction of the first limiting part 11 on the mounting base 4 is different. Before the monitoring unit 3 is installed, the first limiting part 11 imposes a greater restriction on the mounting base 4 to limit relative movement between the mounting base 4 and the fixing base 1, thereby improving the success rate of the monitoring unit 3 implantation. After the monitoring unit 3 is installed, the restriction of the first limiting part 11 on the mounting base 4 is less, making it easier for the user to separate the fixing base 1 from the mounting base 4, making the operation simpler and less strenuous.

[0083] like Figure 6 and Figure 7As shown, in one possible implementation, when the monitoring unit 3 is in the first position, the first limiting part 11 abuts against the first abutting surface 111a and the third abutting surface 411. At this time, the first abutting surface 111a and the third abutting surface 411 are parallel, and the contact area between them is large. An angle may exist between the first abutting surface 111a and the third abutting surface 411 and the first direction. This angle is related to the implantation angle of the implantation device. Typically, the angle between the first abutting surface 111a and the third abutting surface 411 and the first direction can be the same as the implantation angle, or it can fluctuate within a certain range relative to the implantation angle. Typically, the first abutting surface 111a and the third abutting surface 411 can be parallel to the top surface of the mounting base 4, which is the surface of the mounting base 4 away from the human body. This design restricts the movement of the fixing seat 1 relative to the mounting seat 4 away from the human body when the first abutting surface 111a and the third abutting surface 411 are engaged. This prevents the fixing seat 1 from moving relative to the mounting seat 4 before the monitoring unit 3 is installed in place. It also prevents the fixing seat 1 from detaching from the mounting seat 4. When the monitoring unit 3 is in the second position, the first limiting part 11 contacts the third abutting surface 411 through the second abutting surface 112a. At this time, the second abutting surface 112a and the third abutting surface 411 are not parallel. The second abutting surface 112a is inclined relative to the third abutting surface 411. The contact area between the second abutting surface 112a and the third abutting surface 411 is small. In one possible embodiment, along the first direction, the second abutting surface 112a gradually tilts towards the interior of the fixing seat 1. The second abutment surface 112a can be used to form an inclined guide surface. When the second abutment surface 112a engages with the first mating part 41, the first mating part 41 can slide along the second abutment surface 112a relative to the first limiting part 11, so that the first limiting part 11 and the first mating part 41 are disengaged. Since the contact area between the first limiting part 11 and the third abutment surface 411 is different when the monitoring unit 3 is in different positions, the restriction of the first limiting part 11 on the mounting base 4 is also different. Before the monitoring unit 3 is installed on the mounting base 4, the contact area between the first limiting part 11 and the mounting base 4 can be greater than the contact area between the first limiting part 11 and the mounting base 4 after the monitoring unit 3 is installed on the mounting base 4. This can reduce the shaking between the mounting base 4 and the fixed base 1 before the monitoring unit 3 is installed in place, thereby improving the success rate of the implantation of the monitoring unit 3, reducing the wound area, reducing pain, and improving the user experience.

[0084] In one possible implementation, the first limiting segment 111 includes a first abutting surface 111a, the second limiting segment 112 includes a second abutting surface 112a, and the first mating part 41 includes a third abutting surface 411 and a fourth abutting surface 412. When the monitoring unit 3 is in the first position, the first abutting surface 111a abuts against the third abutting surface 411, and the first abutting surface 111a can be parallel to the third abutting surface 411. When the monitoring unit 3 is in the second position, the second abutting surface 112a and the fourth abutting surface 412a... 2. The second abutting surface 112a can be parallel to the fourth abutting surface 412. In order to facilitate the separation of the fixing seat 1 and the mounting seat 4 after the monitoring unit 3 is installed, the second abutting surface 112a and the fourth abutting surface 412 can be used to form a guide surface. The second abutting surface 112a and the fourth abutting surface 412 can be inclined relative to the direction of movement when the fixing seat 1 is removed. When the fixing seat 1 is removed, the second abutting surface 112a and the fourth abutting surface 412 can slide relative to each other to facilitate the separation of the fixing seat 1 and the mounting seat 4.

[0085] like Figure 2 As shown, in one possible implementation, the fixing base 1 further includes a mounting wall and a connecting arm 113 connected to the mounting wall and the first limiting part 11. The mounting wall may be the inner wall of the fixing base 1, and the angle between the extension direction of the connecting arm 113 and the first direction is an acute angle.

[0086] The connecting arm 113 can be a flexible arm or similar structure. By providing a flexible arm, the position of the first limiting part 11 can be easily adjusted. By changing the structure of the connecting arm 113 and its angle with the first direction, the position of the first limiting part 11 can be adjusted, making its placement more flexible. This is beneficial for optimizing the internal structure of the implantation device and making the overall structure more compact. Simultaneously, driving the connecting arm 113 can move the first limiting part 11 relative to the first mating part 41, which helps reduce the volume of the first limiting part 11 and facilitates its movement.

[0087] In one possible implementation, the angle between the connecting arm 113 and the first direction is 15° to 45°. The angle between the connecting arm 113 and the first direction can be set according to actual needs, including but not limited to 15°, 17°, 19°, 21°, 23°, 25°, 27°, 29°, 31°, 33°, 35°, 37°, 39°, 41°, 43°, 45°, etc.

[0088] When the angle between the connecting arm 113 and the first direction is too large, it is difficult to drive the connecting arm 113 to disengage the first limiting part 11 from the first mating part 41. When the angle between the connecting arm 113 and the first direction is too small, it is easy to reduce the stability of the engagement between the first limiting part 11 and the first mating part 41, resulting in accidental activation during use and premature disengagement of the first limiting part 11 and the first mating part 41. This can lead to situations where the mounting base 4 and the fixing base 1 disengage before the monitoring unit 3 reaches the second position, resulting in relative positional changes and implantation failure. Therefore, the angle between the connecting arm 113 and the first direction can be set to 15° to 45°. Considering the structure and size of the implantation device, the angle between the connecting arm 113 and the first direction can be set to 15° to 23°. This allows the first limiting part 11 to stably engage with the first mating part 41 while also facilitating the movement of the connecting arm 113 relative to the first mating part 41 to disengage the limiting part. This design not only makes operation easier and more convenient, but also allows for a more compact structure of the implanted device, which is conducive to miniaturization.

[0089] like Figure 8 As shown, in one possible implementation, the drive unit 2 includes an abutment portion 211. In the first position, the abutment portion 211 is spaced apart from the connecting arm 113, and a gap is provided between the abutment portion 211 and the connecting arm 113 along a first direction. When the drive unit 2 moves along the first direction, the abutment portion 211 can move to abut against the connecting arm 113, thereby driving the connecting arm 113 to move or deform in a direction that gradually moves away from the first mating portion 41, thereby causing the first limiting portion 11 to gradually disengage from the first mating portion 41.

[0090] By spacing the abutment part 211 and the connecting arm 113, the driving unit 2 can move a certain distance relative to the fixed base 1 before contacting the connecting arm 113 and driving the connecting arm 113 to move the first limiting part 11. This allows for delayed driving of the connecting arm 113 through a mechanical structure; that is, the first limiting part 11 gradually disengages from the first mating part 41 some time after the implantation action begins. This design ensures that the implantation action and the disengagement of the first limiting part 11 and the first mating part 41 do not start synchronously. By delaying the disengagement of the first limiting part 11 and the first mating part 41, the possibility of disengagement between the fixed base 1 and the mounting base 4 before the monitoring unit 3 is installed in place can be reduced. This reduces the risk of the mounting base 4 shaking or shifting due to premature disengagement, thereby improving the implantation success rate of the monitoring unit 3, reducing the wound area, pain, and bleeding, and enhancing the user experience.

[0091] like Figure 8As shown, in one possible implementation, the driving unit 2 includes a needle-assist assembly 21 and a first driving member 5. The needle-assist assembly 21 includes at least one second limiting portion 212, and the fixing base 1 includes at least one second engaging portion 12. The engagement of the second limiting portion 212 with the second engaging portion 12 can be used to restrict the movement of the needle-assist assembly 21 relative to the fixing base 1. The second limiting portion 212 can move or deform relative to the fixing base 1 to disengage from the second engaging portion 12, thereby allowing the needle-assist assembly 21 to move relative to the fixing base 1, thereby allowing the driving unit 2 to move relative to the fixing base 1 and perform the implantation action.

[0092] By setting the second limiting part 212 and the second cooperating part 12, the movement of the driving unit 2 can be controlled, thereby controlling the implantation action. When the implantation action needs to be performed, the limiting of the driving unit 2 can be released by releasing the cooperation between the second limiting part 212 and the second cooperating part 12, so that the driving unit 2 can move along the first direction and perform the implantation action.

[0093] In one possible implementation, the first driving member 5 may be an elastic member such as a spring. Before the second limiting part 212 and the second mating part 12 are disengaged, the first driving member 5 may be in a deformed state. After the first limiting part 11 and the second mating part 12 are disengaged, the restoring force of the first driving member 5 acts on the driving unit 2 to drive the driving unit 2 to move along the first direction.

[0094] The drive unit 2 and the fixed base 1 are limited by the cooperation between the second limiting part 212 and the second mating part 12. The cooperation between the fixed base 1 and the mounting base 4 is limited by the cooperation between the first limiting part 11 and the first mating part 41. When an implantation action is required, the cooperation between the second limiting part 212 and the second mating part 12 is released to allow the drive unit 2 to move in the first direction to perform the implantation action. After the drive unit 2 moves to the point where the abutment part 211 contacts the connecting arm 113, the drive unit 2 continues to move in the first direction, thereby driving the connecting arm 113 to swing and causing the first limiting part 11 to move away from the first mating part 41. That is, in the solution provided in this application embodiment, the limiting of the drive unit 2 and the limiting of the mounting base 4 are not released simultaneously. When disengaging the second limiting part 212 and the second mating part 12, the first limiting part 11 and the first mating part 41 will not be disengaged simultaneously or directly. The drive unit 2 needs to move until the abutting part 211 contacts the connecting arm 113 before disengaging the first limiting part 11 and the first mating part 41.

[0095] This design avoids releasing the limit of the mounting base 4 at the same time as releasing the limit of the drive unit 2. Therefore, during the implantation process, the relative position between the mounting base 4 and the fixed base 1 can still be limited by the cooperation of the first limiting part 11 and the first mating part 41, thereby reducing the possibility of the mounting base 4 shaking during the implantation process, which is conducive to improving the success rate of implantation and is more in line with actual use needs.

[0096] The state after the second limiting part 212 and the second mating part 12 are unlocked is as follows: Figure 9 As shown, when the drive unit 2 moves the monitoring unit 3 to the second position, the state of the implanted device is as follows: Figure 10 As shown.

[0097] like Figure 11 , Figure 12 and Figure 13 As shown, in one possible implementation, the drive unit 2 further includes a puncture assembly 22 and a second drive member 23. The puncture assembly 22 can be a half-wall needle assembly, etc. The needle assist assembly 21 includes a third limiting portion 213, and the puncture assembly 22 includes a third mating portion 221. The third limiting portion 213 and the third mating portion 221 cooperate to restrict the movement of the puncture assembly 22 relative to the needle assist assembly 21 along a second direction. The first direction and the second direction are opposite; typically, the first direction is the direction closer to the human body, and the second direction is the direction farther away from the human body.

[0098] During the implantation process, the third limiting part 213 and the third engaging part 221 cooperate to restrict relative movement between the puncture component 22 and the assist needle component 21, allowing the puncture component 22 to move along the first direction with the assist needle component 21 for implantation. The puncture component 22 is used to puncture the skin, allowing the electrode of the monitoring unit 3 to be implanted into the human body. After the monitoring unit 3 reaches the second position, i.e., after the monitoring unit 3 is installed, the third limiting part 213 can disengage from the third engaging part 221, allowing the second driving member 23 to drive the puncture component 22 to move along the second direction opposite to the first direction. That is, after implantation, the puncture component 22 is withdrawn away from the human body.

[0099] like Figure 11 , Figure 12 and Figure 13 As shown, in one possible implementation, the fixed base 1 includes a fourth mating part 13. During the movement of the drive unit 2 in the first direction, the fourth mating part 13 abuts against the third limiting part 213 to prevent the third limiting part 213 from disengaging from the third mating part 221.

[0100] The fourth mating part 13 can be located on the side of the third limiting part 213 away from the third mating part 221, and is used to restrict the movement of the third limiting part 213 away from the third mating part 221, thereby restricting the third limiting part 213 from disengaging from the third mating part 221. During the process of the monitoring unit 3 being in the first position and moving from the first position to the second position, the fourth mating part 13 abuts against the third limiting part 213. When the monitoring unit 3 is in the second position, the monitoring unit 3 is installed. The implantation component moves until the fourth mating part 13 disengages from the third limiting part 213, and the third limiting part 213 disengages from the third mating part 221, so that the puncture component 22 can move relative to the needle assist component 21 in the second direction to realize the needle withdrawal action.

[0101] This design utilizes the positional relationship between the components and controls the implantation and needle withdrawal actions through a mechanical structure, achieving automatic needle withdrawal. In use, it is simple to operate, has low difficulty, and is more convenient for users.

[0102] The second driving member 23 can be an elastic element such as a spring. One end of the second driving member 23 is connected to the needle assist assembly 21, and the other end is connected to the puncture assembly 22. The third limiting part 213 can be a structure such as an elastic arm. Before the third limiting part 213 and the third mating part 221 are disengaged, the third limiting part 213 can be deformed to make the third limiting part 213 and the third mating part 221 engage, and at the same time, the second driving member 23 can be in a deformed state. The puncture component 22 can move along the first direction with the needle assist component 21, thereby puncturing the skin and allowing the electrode of the monitoring unit 3 to be implanted into the human body. After the monitoring unit 3 is installed, the fourth mating part 13 and the third limiting part 213 are released from contact. At this time, the third limiting part 213 can restore its deformation and release the limiting of the third mating part 221, thereby releasing the limiting between the needle assist component 21 and the puncture component 22. The restoring force of the second driving member 23 can act on the puncture component 22 to drive the puncture component 22 to move relative to the needle assist component 21 along the second direction, thereby realizing the needle withdrawal action.

[0103] like Figure 11 , Figure 12 and Figure 13 As shown, in one possible implementation, the needle-assisting assembly 21 includes a fourth limiting portion 214, which protrudes along the direction close to the fixed base 1, and a fourth mating portion 13 protrudes along the direction close to the needle-assisting assembly 21. The fourth limiting portion 214 is used to cooperate with the fourth limiting mating portion to limit the movement distance of the drive unit 2 along the first direction.

[0104] When the monitoring unit 3 is in the first position, there is a gap between the fourth limiting part 214 and the fourth mating part 13 along the first direction. As the driving unit 2 moves along the first direction, the gap between the fourth limiting part 214 and the fourth mating part 13 gradually decreases. When the monitoring unit 3 is in the second position, the fourth limiting part 214 abuts against the fourth mating part 13 along the first direction to limit the driving unit 2 from continuing to move along the first direction. This allows control over the movement distance of the driving unit 2 during implantation, enabling the driving unit 2 to move the monitoring unit 3 within a predetermined range of motion. This prevents the driving unit 2 from moving too far along the first direction, which could lead to installation failure of the monitoring unit 3. It also controls the distance at which the puncture component 22 penetrates the body, preventing excessive penetration that could increase pain and affect the user experience.

[0105] like Figure 8 , Figure 9 and Figure 10 As shown, in one possible implementation, the implantation device further includes a trigger 7, and the fixing base 1 is also provided with a clearance space. The trigger 7 passes through the clearance space and presses against the second limiting part 212 to drive the second limiting part 212 to move or deform relative to the fixing base 1, so as to release the cooperation relationship between the second limiting part 212 and the second mating part 12. During the movement of the trigger 7, the trigger 7 does not drive the first limiting part 11 to move relative to the first mating part 41, that is, the trigger 7 is not used to control the first limiting part 11 and the first mating part 41.

[0106] This design ensures that when the limit of the drive unit 2 is released, the limit of the mounting base 4 is not simultaneously unlocked. This reduces the possibility of relative movement between the mounting base 4 and the fixed base 1 during the implantation process, which could lead to implantation failure of the monitoring unit 3, and is more in line with actual usage needs.

[0107] like Figure 2 As shown, in one possible implementation, the implantation device includes a locking member 6, which restricts the trigger member 7 from pressing against the second limiting portion 212. When the locking member 6 is in the locked state, the trigger member 7 cannot drive the second limiting portion 212 to disengage from the second mating portion 12. When the locking member 6 is in the unlocked state, the trigger member 7 can press against the second limiting portion 212, driving the second limiting portion 212 to disengage from the second mating portion 12.

[0108] In one possible implementation, the implantable device includes a puncture component 22 for piercing the skin. The puncture component 22 is relatively sharp and poses a certain risk. By setting a locking element 6, the possibility of accidental activation of the online blood glucose device can be reduced. It needs to be unlocked before use, which can reduce the possibility of the puncture component 22 popping out due to misoperation. This helps to improve the safety of the implantable device and better meet the actual use needs.

[0109] like Figure 14 As shown, in one possible embodiment, the locking member 6 includes a body portion 61, a first extension portion 62, and a second extension portion 63. The first extension portion 62 and the second extension portion 63 are respectively connected to the body portion 61, and the second extension portion 63 is capable of moving or deforming relative to the body portion 61. When the locking member 6 is in the locked state, the first extension portion 62 is located between the trigger member 7 and the second limiting portion 212. At this time, pressing the trigger member 7 will cause the trigger member 7 to abut against the first extension portion 62, preventing the second limiting portion 212 from disengaging from the second mating portion 12. The first extension portion 62 may include a limiting groove 621, such as... Figure 15 As shown, when the locking member 6 is in the locked state, at least a portion of the trigger member 7 is located in the limiting groove 621. The limiting groove 621 improves the fitting accuracy between the first extension 62 and the trigger member 7. When the locking member 6 is in the unlocked state, the second extension 63 is located between the trigger member 7 and the second limiting part 212. Pressing the trigger member 7 causes it to abut against the second extension 63, driving it to move or deform closer to the second limiting part 212. This allows the second extension 63 to drive the second limiting part 212, disengaging it from the second mating part 12 and releasing the restriction on the drive unit 2, thus initiating the implantation action. This design allows the second extension 63 to drive the second limiting part 212, transmitting motion through the second extension 63, thereby reducing the movement distance and size of the trigger member 7.

[0110] like Figure 11 As shown, in one possible implementation, the mounting base 4 includes a main body 42 and a fifth limiting part 43, the fifth limiting part 43 being able to swing relative to the main body 42, and the monitoring unit 3 including a fifth mating part 31, the fifth limiting part 43 and the fifth mating part 31 cooperating to restrict the monitoring unit 3 from detaching from the mounting base 4.

[0111] During the installation of the monitoring unit 3 on the mounting base 4, as the monitoring unit 3 moves along the first direction, the fifth mating part 31 can abut against the fifth mating part 31 and drive the fifth limiting part 43 to swing, so that the fifth limiting part 43 avoids the monitoring unit 3 during the installation process, allowing the monitoring unit 3 to pass over the fifth fiber cloth. After the monitoring unit 3 is installed, the fifth limiting part 43 can be reset to cooperate with the fifth mating part 31 to restrict the monitoring unit 3 from detaching from the mounting base 4, thereby improving the stability of the installation of the monitoring unit 3.

[0112] In one possible implementation, the monitoring unit 3 may include electrodes, but not at least one of the battery module, data processing module, and data transmission module. After the monitoring unit 3 is implanted in the body, a needle withdrawal action is performed. After the needle is withdrawn, the fixing base 1 can be removed, leaving the mounting base 4 and the monitoring unit 3 in the body. At this time, the electronic unit with the battery module and data processing module is then installed in the mounting base 4.

[0113] By setting up a separate electronic unit, the volume of the monitoring unit 3 and the mounting base 4 can be reduced, thereby reducing the overall volume of the implantation device.

[0114] Based on the implantation devices provided in the above embodiments, this application also provides a method for using the implantation device, which can be applied to the implantation devices involved in any of the above embodiments. The method of use includes:

[0115] The drive unit 2 drives the monitoring unit 3 to move relative to the fixed seat 1 from the first position along the first direction. In the first position, the first limiting part 11 of the fixed seat 1 cooperates with the first mating part 41 of the mounting seat 4 to prevent the mounting seat 4 from moving relative to the fixed seat 1.

[0116] The driving unit 2 drives the first limiting part 11, causing the first limiting part 11 to gradually move or deform in a direction away from the first mating part 41;

[0117] When the drive unit 2 reaches the second position, the monitoring unit 3 is installed on the mounting base 4. In the second position, the first limiting part 11 and the first mating part 41 are at least partially disengaged.

[0118] The driving unit 2 drives the monitoring unit 3 to move relative to the fixing base 1 in a first direction for implantation. The puncture component 22 of the driving unit 2 is used to puncture the human body so that the electrode of the monitoring unit 3 can enter the body through the incision, thereby enabling blood glucose monitoring. During the movement of the driving unit 2, the driving unit 2 drives the first limiting part 11 to move or deform, thereby releasing the engagement relationship between the first limiting part 11 and the first mating part 41. When the driving unit 2 reaches the second position, the implantation of the monitoring unit 3 is completed. At this time, the monitoring unit 3 is installed on the mounting base 4, and the engagement relationship between the first limiting part 11 and the first mating part 41 is at least partially released. Since the monitoring unit 3 has been implanted, the restriction on the relative position between the mounting base 4 and the fixing base 1 can be released, thereby facilitating the separation of the fixing base 1 and the mounting base 4 and making it convenient to use.

[0119] In one possible implementation, when the drive unit 2 reaches the second position, the monitoring unit 3 is installed onto the mounting base 4, and in the second position, the step of at least partially disengaging the first limiting part 11 from the first mating part 41 includes:

[0120] In the second position, the first limiting part 11 and the first mating part 41 are completely disengaged.

[0121] In the second position, the monitoring unit 3 has been installed on the mounting base 4. At this time, the drive unit 2, the fixing base 1 and other structures used for implantation can be removed. By completely disengaging the first limiting part 11 and the first mating part 41, the resistance when removing the drive unit 2, the fixing base 1 and other structures can be reduced, thus facilitating use.

[0122] In one possible implementation, the method further includes:

[0123] The trigger 7 drives the second limiting part 212 to move or deform, causing the second limiting part 212 and the mating part to disengage, and the driving unit 2 drives the monitoring unit 3 to move along the first direction.

[0124] The second limiting part 212 located in the drive unit 2 and the second mating part 12 located in the clearance space of the fixed base 1 are used to restrict the relative movement between the drive unit 2 and the fixed base 1. The trigger 7 is used to drive the second limiting part 212 and the second mating part 12 to disengage, so as to release the restriction on the drive unit 2 and perform the implantation action.

[0125] During the movement of the monitoring unit 3 along the first direction driven by the drive unit 2, the fifth mating part 31 drives the fifth limiting part 43 to move or deform. When the monitoring unit 3 reaches the second position, the fifth limiting part 43 resets and cooperates with the fifth mating part 31 to prevent the monitoring unit 3 from detaching from the mounting base 4.

[0126] The cooperation between the fifth limiting part 43 and the fifth mating part 31 is used to improve the stability of the monitoring unit 3 installation and reduce the possibility of the monitoring unit 3 detaching from the mounting base 4.

[0127] In one possible implementation, the method of use further includes: removing the implanted device and installing the electronic unit in the mounting base 4.

[0128] In one possible implementation, a continuous analyte monitoring device is provided, comprising the aforementioned implantable device and an electronic unit. The electronic unit may include at least one of a battery module, a data processing module, and a data transmission module, and can be used in conjunction with the monitoring unit 3. In the monitoring unit 3 and the electronic unit, the battery module, data processing module, and data transmission module may not be redundant; that is, the monitoring unit 3 and the electronic unit together include one battery module, one data processing module, and one data transmission module to reduce the overall number of components, thereby facilitating miniaturization. The battery module may include one or more batteries. After the monitoring unit 3 is implanted, the drive unit 2 is removed, and the monitoring unit 3, used to monitor user indicators, is placed on the human body along with the mounting base 4. The electronic unit can provide power and simultaneously collect and / or process the data collected by the monitoring unit 3, transmitting the data to electronic devices such as mobile phones and tablets via Bluetooth, WiFi, etc., allowing users to understand their health status in a timely manner, better meeting practical usage needs.

[0129] In use, the implantation device is placed at the predetermined implantation position, so that one side of the mounting base 4 is in contact with the skin. The locking member 6 is unlocked, and then the trigger member 7 is driven to move. The trigger member 7 drives the second extension 63 of the locking member 6 to move towards the second limiting part 212, thereby disengaging the second limiting part 212 from the second mating part 12. Before the second limiting part 212 disengages from the second mating part 12, the first driving member 5 can be in a deformed state. After the second limiting part 212 disengages from the second mating part 12, the restoring force of the first driving member 5 can act on the needle assist assembly 21, thereby driving the needle assist assembly 21 to move the puncture assembly 22 and the monitoring unit 3 along the first direction. When the driving unit 2 moves along the first direction until the abutment part 211 abuts against the connecting arm 113, the driving unit 2 continues to move along the first direction. During the movement, the driving unit 2 drives the connecting arm 113 to move the first limiting part 11 away from the first mating part 41, thereby disengaging the first limiting part 111 from the first mating part 41. During the movement of the drive unit 2 along the first direction, the puncture component 22 can extend relative to the implantation device to puncture the skin, and the electrode of the monitoring unit 3 can be inserted into the user's body along with the puncture component 22. When the drive unit 2 moves to the point where the fourth limiting part 214 and the fourth mating part 13 abut against each other along the first direction, the drive unit 2 drives the monitoring unit 3 to move to the second position, at which time the monitoring unit 3 is installed on the mounting base 4. The third limiting part 213 of the needle assist component 21 disengages from the fourth mating part 13, and the third limiting part 213 can move away from the third mating part 221 of the puncture component 22 to disengage from the third mating part 221, thereby releasing the limitation between the needle assist component 21 and the puncture component 22. Before the limiting mechanism between the needle assist assembly 21 and the puncture assembly 22 is released, the second driving member 23 can be in a deformed state. After the limiting mechanism between the needle assist assembly 21 and the puncture assembly 22 is released, the restoring force of the second driving member 23 can act on the puncture assembly 22 to drive the puncture assembly 22 to move in the second direction and withdraw the needle, leaving the electrode of the monitoring unit 3 in the user's body. After the needle withdrawal is completed, the user can remove the driving unit 2, the fixing base 1, and other structures, and then install the electronic unit on the mounting base 4 to transmit the data collected by the monitoring device, allowing the user to understand their physical condition in real time.

[0130] During implantation, the stability of the drive unit 2's movement is one of the factors affecting the success rate of the monitoring device implantation and the size of the incision, such as... Figure 16As shown, in one possible embodiment, the implantation device includes a fixation base 1 and a drive unit 2. The drive unit 2 is slidably mounted within the fixation base 1 and is movable relative to the fixation base 1 along a first direction to perform an implantation action. The fixation base 1 is provided with a first guide portion 14 extending along the first direction. The drive unit 2 includes a second guide portion 15 extending along the first direction and a second limiting portion 212 capable of elastically abutting against the inner wall of the fixation base 1. During the movement of the drive unit 2 relative to the fixation base 1, the first guide portion 14 and the second guide portion 15 cooperate to guide the relative movement between the fixation base 1 and the drive unit 2. Simultaneously, during the movement of the drive unit 2 relative to the fixation base 1, the second limiting portion 212 elastically abuts against the inner wall of the fixation base 1, thereby guiding the movement of the drive unit 2 relative to the fixation base 1.

[0131] By providing the first guide portion 14 and the second guide portion 15, the stability of the drive unit 2's movement relative to the fixed base 1 can be improved. The second limiting portion 212 can be a structure capable of elastic deformation, such as an elastic arm, used to abut against the inner wall of the fixed base 1 during movement. Because the second limiting portion 212 elastically abuts against the inner wall of the fixed base 1, when the drive unit 2 shakes during movement, the second limiting portion 212 will deform, thereby changing the interaction force between the second limiting portion 212 and the fixed base 1. This allows the drive unit 2 to move in the opposite direction to the shaking direction, thus helping to maintain the stability of the drive unit 2. This design improves the stability of the drive unit 2's movement relative to the fixed base 1, reduces the possibility of the drive unit 2 shaking relative to the fixed base 1, helps to reduce the wound area, thereby reducing bleeding and pain, and improving the user experience.

[0132] During implantation, if the drive unit 2 has poor motion stability and shakes, it will cause the wound area in the human body to increase, resulting in increased pain and bleeding, which will affect the user's experience.

[0133] like Figure 8 , Figure 9 and Figure 10 As shown, the second limiting part 212 includes a locked position and an unlocked position. In the locked position, the second limiting part 212 engages with the second mating part 12 of the fixed base 1 to prevent the drive unit 2 from moving relative to the fixed base 1. When the second limiting part 212 moves or deforms away from the second mating part 12, the second limiting part 212 can switch from the locked position to the unlocked position. In the unlocked position, the drive unit 2 can move relative to the fixed base 1.

[0134] This design allows the second limiting part 212 to both limit and guide the drive unit 2. Before the implantation process begins, the second limiting part 212 locks the drive unit 2; after the implantation process begins, it guides the drive unit 2. The second limiting part 212 integrates both limiting and guiding functions, which helps reduce the number of components in the implantation device, making the overall structure more compact and facilitating miniaturization.

[0135] like Figure 17 and Figure 18 As shown, in one possible implementation, the first guide portion 14 and the second guide portion 15 are respectively a guide protrusion and a guide recess, with at least a portion of the guide protrusion extending into the guide recess.

[0136] This design allows for the formation of a guide rail and guide groove structure, which helps improve the stability of the drive unit 2's movement relative to the fixed base 1, making it more in line with actual usage requirements.

[0137] like Figure 18 As shown, in one possible embodiment, at least one inner sidewall of the guide recess is provided with at least two protrusions 215a, which protrude toward the direction of the guide protrusion. When the guide protrusion and the guide recess are engaged, the protrusions 215a are used to abut against the guide protrusion.

[0138] This design reduces the contact area between the guide protrusion and the guide recess, thereby reducing the friction between the first guide portion 14 and the second guide portion 15, and reducing the impact of friction on the relative movement between the drive unit 2 and the fixed base 1.

[0139] like Figure 18 As shown, in one possible implementation, the inner walls of the guide recess located on both sides of the guide protrusion are provided with protrusions 215a.

[0140] like Figure 19 As shown, in one possible implementation, the first guide portion 14 protrudes along the direction close to the drive unit 2, and the second guide portion 15 protrudes along the direction close to the fixed base 1. The first guide portion 14 abuts against the drive unit 2 and / or the second guide portion 15 abuts against the fixed base 1. The first guide portion 14 and the second guide portion 15 can be staggered, and both are guide protrusions. This design can reduce the volume of the guide portions and reduce the contact area between the first guide portion 14 and the second guide portion 15, thereby helping to reduce friction.

[0141] Both the first guide portion 14 and the second guide portion 15 can be protruding structures. This design can help reduce the volume of the guide portion, thereby optimizing the structure of the fixed base 1 and the drive unit 2, and helping to reduce the volume of the online monitoring device.

[0142] In one possible implementation, the surfaces of the first guide portion 14 and the second guide portion 15 that come into contact with each other are either flat or curved.

[0143] This design allows for a line contact between the first guide portion 14 and the second guide portion 15. While providing guidance, it also helps to reduce the contact area between the first guide portion 14 and the second guide portion 15, thereby reducing the friction between them and making the relative movement between the drive unit 2 and the fixed base 1 smoother, thus improving the stability of the movement.

[0144] like Figure 16 As shown, in one possible implementation, one of the fixed base 1 and the drive unit 2 is provided with a third guide portion 215, which extends along a first direction and protrudes along a direction close to the other for contact with the other.

[0145] This design helps to further enhance the guiding effect, thereby improving the stability of the relative movement between the drive unit 2 and the fixed base 1, which is more in line with actual usage requirements.

[0146] like Figure 16 As shown, in one possible implementation, the first guide portion 14 and the third guide portion 215 can be disposed on the fixed base 1, and the second guide portion 15 can be disposed on the drive unit 2. The first guide portion 14 and the third guide portion 215 can be guide protrusions, and the second guide portion 15 can be a guide groove. The first guide portion 14 and the third guide portion 215 can be disposed on the same side or on different sides. The drive unit 2 can include at least two second limiting portions 212, which are disposed on opposite sides of the drive unit 2, and the second limiting portions 212 on both sides can be symmetrically disposed. The first guide portion 14 and the third guide portion 215 can be located on opposite sides of the drive unit 2, and the first guide portion 14, the third guide portion 215, and the second guide portion 15 are on different sides.

[0147] This design allows the drive unit 2 to be guided from different directions, thereby improving the stability of the drive unit 2's movement.

[0148] like Figure 16As shown, in one possible embodiment, the first guide portion 14 and the third guide portion 215 are guide protrusions, and each of the first guide portion 14 and the third guide portion 215 includes at least two guide segments 9. The guide segments 9 included in the first guide portion 14 and the third guide portion 215 are respectively spaced apart along a first direction. The structure of the third guide portion 215 is as follows. Figure 20 As shown, the structure of the first guide section 14 can be similar to that of the third guide section 215, and it also includes multiple guide segments 9 spaced apart.

[0149] The first guide portion 14 and the third guide portion 215 may each include multiple protruding structures. This design can reduce the volume of the guide protrusions, thereby reducing the contact area between the drive unit 2 and the fixed base 1, reducing the friction between them, and improving the stability of the movement.

[0150] like Figure 21 As shown, in one possible implementation, the needle-assist assembly 21 includes a fourth guide portion 216 extending along the second direction, and the puncture assembly 22 includes a fifth guide portion 222 extending along the second direction. The fourth guide portion 216 and the fifth guide portion 222 cooperate to guide the movement of the puncture assembly 22.

[0151] This design improves the stability of the puncture component 22 relative to the needle assist component 21 during needle withdrawal, thereby reducing the possibility of the puncture component 22 shaking during the needle withdrawal process, which can reduce the wound area and reduce bleeding.

[0152] One of the fourth guide portion 216 and the fifth guide portion 222 is a guide protrusion and the other is a guide recess, with at least a portion of the guide protrusion extending into the guide recess.

[0153] This design enables the guide rail and guide groove to work together, which helps to improve the stability of the movement of the puncture component 22 relative to the needle assist component 21.

[0154] In one possible implementation, in the first direction, the size of the fixing seat 1 is c, the movement distance of the puncture assembly 22 in the second direction is d, and the size of the fourth guide portion 216 and the fifth guide portion 222 is e, wherein e satisfies: e≥40%c, and / or, e≥2d.

[0155] This design allows the guide distance for the puncture component 22 to exceed 40% of the size of the fixing seat 1, and can exceed twice the movement distance during needle withdrawal, which helps to improve the stability of the movement during needle withdrawal.

[0156] like Figure 21As shown, in one possible implementation, one of the needle-assist assembly 21 and the puncture assembly 22 is provided with a sixth guide portion 217, which extends along a second direction and protrudes toward the other and abuts against the other.

[0157] This design guides the movement between the needle-assist component 21 and the puncture component 22, thereby improving the stability of the movement of the puncture component 22 during needle withdrawal and reducing the possibility of shaking during needle withdrawal, which could lead to an increase in the wound area.

[0158] The sixth guide part 217 can be provided in the needle assist assembly 21. The fourth guide part 216 and the sixth guide part 217 can be located on different sides of the needle assist assembly 21, so that they can cooperate with the puncture assembly 22 from different directions, which is conducive to improving the stability of the movement of the puncture assembly 22 and is more in line with the actual use requirements.

[0159] In one possible implementation, the fourth guide portion 216 and the sixth guide portion 217 can be guide protrusions. The fourth guide portion 216 can include at least two guide segments 9, which are spaced apart along a second direction. The sixth guide portion 217 can also include at least two guide segments 9, which are spaced apart along a second direction. The structure of the fourth guide portion 216 and the sixth guide portion 217 can be similar to that of the third guide portion 215, and each of the fourth guide portion 216 and the sixth guide portion 217 can be provided with multiple spaced protrusion structures.

[0160] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. An implant device for interposing a micro-biosensor into subcutaneous tissue, characterized by, The implant device comprises: a housing; a mount adapted to be attached to a skin of a host; a fixing seat arranged in the housing and detachably coupled with the mount; a driving unit movably arranged in the fixing seat; a monitoring unit detachably coupled with the driving unit, the driving unit being movable relative to the fixing seat to drive the monitoring unit to be mounted to the mount; and a limiting unit configured to prevent the fixing seat from moving relative to the housing during the mounting of the monitoring unit to the mount. The limiting unit comprises a first limiting portion and a first coupling portion, the fixing seat is provided with the first limiting portion, the mount is provided with the first coupling portion which is coupled with the first limiting portion, and the driving unit is slidably mounted to the fixing seat in a first direction.

2. The implant device of claim 1, wherein, The driving unit is configured to move in the first direction to drive the monitoring unit to move from a first position to a second position, in which the monitoring unit is mounted to the mount, and before the monitoring unit reaches the second position, the first limiting portion is configured to be coupled with the first coupling portion to limit the relative position of the fixing seat and the mount.

3. The implant device of claim 2, wherein, In the second position, the force between the first limiting portion and the first coupling portion is less than the adhesive force between the mount and the skin.

4. The implant device of claim 3, wherein, In the second position, at least part of the first limiting portion is uncoupled with the first coupling portion to enable the fixing seat to move relative to the mount.

5. The implant device of claim 3, wherein, The first limiting portion comprises a first limiting segment and a second limiting segment connected with each other, the first limiting segment is coupled with the first coupling portion to limit the movement when the monitoring unit does not reach the second position, and the second limiting segment is coupled with the first coupling portion to limit the movement when the monitoring unit reaches the second position.

6. The implant device of claim 3, wherein, The first limiting segment comprises a first abutting surface, the second limiting segment comprises a second abutting surface, the included angle between the first abutting surface and the second abutting surface is obtuse, the first coupling portion comprises a third abutting surface, the first abutting surface abuts against the third abutting surface when the monitoring unit is in the first position, and the second abutting surface abuts against the third abutting surface when the monitoring unit is in the second position.

7. The implant device of claim 6, wherein, The first limiting segment comprises a first abutting surface, the second limiting segment comprises a second abutting surface, the included angle between the first abutting surface and the second abutting surface is obtuse, the first coupling portion comprises a third abutting surface and a fourth abutting surface; 8. The implant device of claim 6, wherein, The first abutting surface abuts against the third abutting surface when the monitoring unit is in the first position, and the second abutting surface abuts against the fourth abutting surface when the monitoring unit is in the second position. ​ 9. The implant device of claim 3, wherein, The fixed seat further comprises a mounting wall and a connecting arm connected between the mounting wall and the first limiting portion, the driving unit comprises an abutting portion, in the first position, the abutting portion is spaced apart from the connecting arm, when the driving unit moves along the first direction, the abutting portion can abut against the connecting arm to drive the connecting arm to move or deform in a direction gradually away from the first cooperating portion.

10. The implant device of claim 9, wherein, The included angle between the extension direction of the connecting arm and the first direction is an acute angle.

11. The implant device of claim 10, wherein, The included angle between the connecting arm and the first direction is 15° to 45°.

12. The implant device of claim 2, wherein, The driving unit comprises a needle assisting assembly and a first driving member, the needle assisting assembly comprises at least one second limiting portion, the fixed seat comprises at least one second cooperating portion, the second limiting portion and the second cooperating portion cooperate to limit the movement of the needle assisting assembly relative to the fixed seat, and the second limiting portion is configured to move or deform relative to the fixed seat to allow the driving unit to move relative to the fixed seat along the first direction.

13. The implant device of claim 12, wherein, The driving unit comprises a puncture assembly and a second driving member, the needle assisting assembly comprises a third limiting portion, the puncture assembly comprises a third cooperating portion, the third limiting portion and the third cooperating portion cooperate to limit the movement of the puncture assembly relative to the needle assisting assembly along a second direction, and the first direction and the second direction are opposite.

14. The implant device of claim 13, wherein, The fixed seat further comprises a fourth cooperating portion, during the movement of the driving unit along the first direction, the fourth cooperating portion abuts against the third limiting portion to make the third limiting portion and the third cooperating portion cooperate.

15. The implant device of claim 14, wherein, The needle assisting assembly comprises a fourth limiting portion, the fourth limiting portion protrudes towards the fixed seat, the fourth cooperating portion protrudes towards the needle assisting assembly, and the fourth limiting portion is used to cooperate with the fourth cooperating portion to limit the movement distance of the driving unit along the first direction.

16. The implant device of claim 12, wherein, The implanting device further comprises a trigger movably arranged on the fixed seat, the trigger is adapted to press against the second limiting portion to make the second limiting portion move or deform relative to the fixed seat to release the cooperation between the second limiting portion and the second cooperating portion.

17. The implant device of claim 16, wherein, The implanting device comprises a locking member movably arranged on the fixed seat, and the locking member is used to limit the pressing of the trigger against the second limiting portion.

18. The implant device of any one of claims 1 to 17, wherein, The mounting seat comprises a main body portion and a fifth limiting portion, the fifth limiting portion can swing relative to the main body portion, the monitoring unit comprises a fifth cooperating portion, and the fifth limiting portion cooperates with the fifth cooperating portion to limit the disengagement of the monitoring unit from the mounting seat.

19. A method of using an implant device for interposing a micro-biosensor into subcutaneous tissue, the method comprising: The implanting device comprises a fixed seat, a driving unit, a monitoring unit and a mounting seat, and the use method comprises: The driving unit drives the monitoring unit to move relative to the fixed seat along a first direction from a first position, in the first position, a first limiting portion of the fixed seat cooperates with a first cooperating portion of the mounting seat to prevent the mounting seat from moving relative to the fixed seat; The driving unit drives the first limiting portion to gradually move or deform in a direction away from the first cooperating portion; The driving unit reaches a second position, the monitoring unit is mounted to the mounting seat, and in the second position, the first limiting part and the first matching part are at least partially out of matching relationship.

20. The method of using an implant device of claim 19, wherein, The driving unit reaches a second position, the monitoring unit is mounted to the mounting seat, and in the second position, the first limiting part and the first matching part are at least partially out of matching relationship. In the second position, the first limiting part and the first matching part are completely out of matching relationship.

21. The method of using an implant device of claim 20, wherein, The implant device further comprises a trigger, the driving unit comprises a second limiting part, the fixing seat comprises a avoiding space and a second matching part arranged in the avoiding space, and the use method comprises: The trigger drives the second limiting part to move or deform, so that the second limiting part is out of matching relationship with the second matching part, and the driving unit drives the monitoring unit to move in the first direction.

22. The method of using a blood glucose monitoring device of claim 21, wherein, The mounting seat comprises a fifth limiting part, the monitoring unit comprises a fifth matching part, and the use method further comprises: In the process that the driving unit drives the monitoring unit to move in the first direction, the fifth matching part drives the fifth limiting part to move or deform; when the monitoring unit reaches the second position, the fifth limiting part resets and is in limiting matching relationship with the fifth matching part to prevent the monitoring unit from being separated from the mounting seat.

23. The method of using an implant device of any of claims 19-22, wherein, The implant device comprises an electronic unit, the electronic unit at least comprises one of a battery module, a data processing module and a data transmission module, and the use method further comprises: removing the driving unit and mounting the electronic unit to the mounting seat.

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