Integrated pre-packaged glucose monitoring implant device

Abstract

This invention discloses an integrated pre-installed glucose monitoring implantable device, belonging to the field of medical device technology. Specifically, it includes an upper shell, a lower shell, a fixed base, a drive button, a sliding base, a needle-carrying component, a locking component, a guide needle, a transmitter, and an elastic element. The fixed base is fixedly installed inside the upper shell, and the lower shell is detachably connected to the upper shell and forms a rigid limit with the fixed base. The drive button is assembled between the upper shell and the fixed base. The sliding base is slidably fitted inside the fixed base. The locking component is fixed inside the fixed base and constrains the elastic arm of the sliding base. The needle-carrying component is connected to the guide needle and pre-pressed inside the sliding base by the elastic element. The transmitter is assembled at the lower end of the sliding base. Pre-installation, triggering, automatic needle retraction, and accidental triggering are achieved through a triple structure of inclined wedge angle engagement, locking, and an anti-accidental trigger base, without relying on the force applied to the transmitter and guide needle throughout the entire process.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to implantable medical devices, specifically to an integrated pre-installed glucose monitoring implantable device. Background Technology

[0002] A continuous glucose monitor (CGM) is a monitoring system that continuously monitors blood glucose levels using biosensors and transmits the data to a mobile phone or dedicated terminal device via Bluetooth Low Energy (BLE) technology. The sensor is partially inserted into the skin (percutaneously), contacting the interstitial fluid beneath the skin surface to measure blood glucose levels. The sensor is battery-powered and communicates wirelessly with the monitoring unit, which receives the blood glucose data, processes and / or analyzes it, and provides the data to the user / patient.

[0003] The sensor is coupled with sensor electronics to form an integrated component (also called a transmitter) capable of emission, and is housed within the implantable device. The implantable device includes a housing, an inserter (guide needle), a biasing mechanism (elastic element), and a cap. The cap provides a closure or seal for the opening of the implantable device; the inserter (guide needle) can pierce the user's skin surface and position the glucose sensor of the integrated component (transmitter) in contact with the user's interstitial fluid; the biasing mechanism (elastic element) is used to retract the inserter (guide needle) from the insertion position to the retracted position, in which the inserter (guide needle) is completely retained within the housing, thereby ensuring that the integrated component inside the implantable device moves towards the user's skin surface in a direction substantially perpendicular to the skin surface within the housing.

[0004] Descriptions of the structure and assembly of the implantable device can be found in patent documents CN102307517B, CN102307518B, CN104287744B, and EP3960072B1. The implantable device disclosed by Abbott uses a manually operated handle to pierce the user's skin with the guide needle. When the guide needle reaches a predetermined position, a biasing mechanism (elastic element) is triggered, retracting the guide needle from the insertion position into the implantable device. It is well known that the shorter the skin piercing time, the less pain the patient / user experiences. Therefore, the intensity of pain from traditional manual skin piercing depends on the operator's skill level. Since this implantable device is disposable and cannot be reused after an operational error, the operator needs to carefully read the operating instructions before use. Furthermore, the handle and cap are secured by threads, hooks, or tape. If the cap falls off, it can easily cause the handle to be accidentally triggered, rendering the implantable device malfunctioning.

[0005] Furthermore, the implantation device's internal guide needle or moving parts (shuttle) are fixed by barbs (wing-shaped parts or finger pins), which increases the chance of false triggering. Since the barb position cannot withstand great force, structural failure is prone to occur, causing problems such as airtightness and structural damage at the guide needle position.

[0006] Patent document CN119924831A discloses a method using a launch spring as the launch drive element, replacing the manual launch method of the implantable device disclosed by Abbott Laboratories. By constructing a bracket clip that engages with a locking hole, reset without disassembly is achieved, making the implantable device reusable. However, this structure also suffers from the technical problem of the cap detaching and causing accidental triggering of the control handle. Furthermore, the clip structure design and the barbed structure also present risks of airtightness and structural damage.

[0007] Analysis revealed that the common flaw of the aforementioned implantable devices lies in relying on weak structures or additional components to prevent accidental activation, which violates the "fail-safe" design principle of medical devices. Summary of the Invention

[0008] This invention abandons the external insurance approach and proposes "the structure itself is insurance"—by utilizing the geometric limiting relationship of the component structure, the prevention of accidental contact is transformed into a rigid constraint problem, fundamentally eliminating weak links.

[0009] The main objective of this invention is to provide an integrated pre-installed glucose monitoring implantation device that does not rely on the force of the transmitter guide needle throughout the entire process. Through the triple structure of inclined wedge angle cooperation, snap-locking, and anti-false triggering base, it achieves mass-producible pre-installation, reliable triggering, automatic needle retraction, and prevention of false triggering.

[0010] To achieve the above objectives, the present invention provides an integrated pre-assembled glucose monitoring implantation device, comprising: an upper shell, a bottom shell, a fixing base, a drive button, a sliding base, a needle-carrying component, a locking component, a guide needle, a transmitter, and an elastic element.

[0011] The fixed base is fixedly installed inside the upper shell, and the bottom shell is detachably connected to the upper shell and forms a rigid limit with the fixed base; the drive button is assembled between the upper shell and the fixed base, the sliding base is slidably sleeved on the inner side of the fixed base, the locking member is fixed on the inner side of the fixed base and constrains the elastic arm of the sliding base, the pin-bearing member is connected to the guide pin and pre-pressed in the sliding base by an elastic element, and the transmitter is assembled at the lower end of the sliding base;

[0012] The implantation device achieves pre-installation, triggering, automatic needle retraction, and prevention of accidental contact through a triple structure of inclined wedge angle cooperation, buckling and locking, and anti-accidental triggering base, without relying on the force of the transmitter and the guide needle throughout the process.

[0013] Preferably, the inner wall of the upper shell is provided with a first rib portion and a first locking protrusion; the upper side of the fixing seat is provided with a first groove that cooperates with the first rib portion, and the middle part of the fixing seat is provided with a first flange that engages with the first locking protrusion, so that the fixing seat and the upper shell are rigidly fixed.

[0014] Preferably, the inner side of the bottom shell is provided with a limiting baffle, a limiting protrusion and a limiting platform; the outer side of the fixing seat is provided with an inverted "L"-shaped first guide groove and a locking structure; the limiting protrusion slides and engages with the first guide groove and is locked in the locking structure; the limiting baffle extends into the gap space between the upper shell and the fixing seat, forming a radial rigid limit on the first locking structure of the fixing seat.

[0015] Preferably, the side wall of the fixed seat is provided with a first latching structure, the free end of the first latching structure is provided with a locking part and an arc-shaped protrusion; the outer side of the sliding seat is provided with a locking engagement part that cooperates with the locking part, and a second guide groove that adapts to the arc-shaped protrusion; the drive button is provided with a drive leg, when pressed, the drive leg squeezes the arc-shaped protrusion to cause the first latching structure to release radially, thereby releasing the locking of the sliding seat.

[0016] Preferably, the sliding seat includes a sliding seat body, a first elastic arm, and a second elastic arm; the first elastic arm is provided with a third fastening structure, and the inner side of the fixed seat is provided with a first buckle. After triggering, the third fastening structure is engaged with the first buckle to restrict the sliding seat from disengaging; the second elastic arm is provided with a fourth fastening structure with a first inclined surface, and the pin member is provided with a second inclined surface. The first inclined surface and the second inclined surface form a wedge fit, and the wedge angle α satisfies 15°≤α≤45°.

[0017] Preferably, the locking member has an annular segment, which constrains the first elastic arm and the second elastic arm; the length of the second elastic arm is less than that of the first elastic arm, and when the sliding seat moves to a preset stroke, the second elastic arm disengages from the constraint of the locking member, and the needle-carrying member automatically retracts with the guide needle under the action of the elastic element.

[0018] Preferably, the retraction of the needle element is triggered at 70% to 85% of the total stroke of the sliding seat.

[0019] Preferably, the upper end of the locking member is provided with a second buckle, which is fastened and fixed to the hook of the fixed seat; the inner side of the locking member is provided with a second guide flange, which cooperates with the second guide groove of the sliding seat to restrict the circumferential rotation of the sliding seat.

[0020] Preferably, the lower end of the sliding seat is provided with an eccentric second slot and a second latching structure for engaging the transmitter; after triggering, the transmitter is substantially flush with the end face of the fixed seat and disengages from the sliding seat.

[0021] Preferably, the elastic element comprises:

[0022] The first spring between the drive button and the fixed base is used to provide the button reset force;

[0023] The second spring between the fixed seat and the sliding seat is used to provide the sliding seat trigger driving force;

[0024] The third spring between the needle-carrying component and the sliding seat is used to provide a retraction force between the needle-carrying component and the guide needle.

[0025] Preferably, the upper shell, fixed base, drive button, sliding base, locking component, pin component, and elastic element are pre-integrated into a single structure, which can be mass-produced, pre-installed, and triggered for use in one go.

[0026] Preferably, before the bottom shell detaches, the limiting baffle always constrains the first fastening structure, forming a failure protection mechanism to prevent accidental activation of the structure itself, without any additional weak safety components.

[0027] This application adopts a pre-assembled unit that integrates an upper shell, a fixed base, a drive button, a sliding base, a locking component, a needle-carrying component, and a spring. It does not rely on the force of the transmitter guide pin throughout the process. Through the triple structure of inclined wedge angle cooperation, snap-locking, and anti-mistake triggering base, it realizes an integrated implantation device that can be mass-produced and pre-assembled, reliably triggered, automatically withdraws the needle, and prevents accidental touch. Attached Figure Description

[0028] Figure 1 This is a cross-sectional view of the implantation device (untriggered state) involved in the embodiment of the present invention.

[0029] Figure 2a This is a perspective view of the upper shell involved in the embodiment of the present invention.

[0030] Figure 2b This is a cross-sectional view of the upper shell involved in the embodiment of the present invention.

[0031] Figure 3a This is a perspective view of the bottom shell involved in the embodiment of the present invention.

[0032] Figure 3b This is a cross-sectional view of the assembly state of the upper shell and the bottom shell involved in the embodiment of the present invention.

[0033] Figure 3c yes Figure 3b Enlarged view of part A in the image.

[0034] Figure 4a This is a perspective view (a) of the fixing base involved in the embodiment of the present invention.

[0035] Figure 4b This is a perspective view (II) of the fixing base involved in the embodiment of the present invention.

[0036] Figure 4c This is a cross-sectional view of the assembly state of the upper shell, fixing base, and drive button involved in the embodiment of the present invention.

[0037] Figure 4d This is a cross-sectional view of the fixing base involved in the embodiment of the present invention.

[0038] Figure 5a This is a perspective view (a) of the driving button involved in the embodiment of the present invention.

[0039] Figure 5b This is a perspective view (II) of the driving button involved in the embodiment of the present invention.

[0040] Figure 5c This is a perspective view of the assembly state of the drive button and the fixing base involved in the embodiment of the present invention.

[0041] Figure 6a This is a perspective view (a) of the sliding seat involved in the embodiment of the present invention.

[0042] Figure 6b This is a perspective view (II) of the sliding seat involved in the embodiment of the present invention.

[0043] Figure 7 This is a cross-sectional view of the assembly state of the fixed base and the second spring involved in the embodiment of the present invention.

[0044] Figure 8 This is a cross-sectional view of the assembly state (not triggered) of the fixed seat and sliding seat involved in the embodiment of the present invention.

[0045] Figure 9 This is a cross-sectional view of the assembly state (trigger) of the fixed seat, sliding seat, pin-bearing component, locking component, and guide pin involved in the embodiment of the present invention.

[0046] Figure 10a This is a perspective view of the needle-bearing component involved in the embodiment of the present invention.

[0047] Figure 10b This is a cross-sectional view of the assembly of the needle-bearing component and the guide needle involved in the embodiment of the present invention.

[0048] Figure 11a This is a perspective view of the assembly of the locking component and the sliding seat involved in the embodiment of the present invention.

[0049] Figure 11b This is a perspective view of the locking component involved in the embodiment of the present invention.

[0050] Attached icon numbers and names:

[0051] 100. Gap space;

[0052] 200. Activity space;

[0053] 10. Implantable device;

[0054] 11. Upper shell; 111. Arc-shaped surface; 112. Recessed area; 113. Opening; 114. Inner edge; 115. First rib portion; 115a. First stepped surface; 116. First locking protrusion;

[0055] 12. Bottom shell; 121. Edge portion; 122. Limiting baffle; 123. Limiting protrusion; 124. Limiting platform;

[0056] 13. Fixing base; 131. End face; 131a. Flange; 132. First groove; 133. Top edge position; 134. First flange; 135. First slot; 136. First locking structure; 136a. Free end; 136a1. Protrusion; 136a2. Engaging part; 136a3. Arc-shaped protrusion; 137. First guide groove; 137a. Locking structure; 138. Hole; 139. First buckle; 139a. Hook;

[0057] 14. Drive button; 141. Button part; 142. Limiting groove; 143. Drive leg; 143a. Drive protrusion; 144. First spring;

[0058] 15. Sliding seat; 151. Sliding seat body; 152. Engaging part; 153. Second guide groove; 154. Second slot; 154a. Second latching structure; 155. First elastic arm; 155a. Third latching structure; 155b. Second limiting protrusion; 156. Second elastic arm; 156a. Fourth latching structure; 156a1. First inclined surface; 157. Second spring; 158. First groove; 159. Second guide groove;

[0059] 16. Needle-mounted component; 161. Third spring; 162. Second inclined surface; 163. Guide flange; 163a. ​​Second groove;

[0060] 17. Locking element; 171. Annular segment; 171a. Second protrusion; 171a1. Second retaining ring; 171b. Third groove; 1711. Second guide flange;

[0061] 18. Guide needle;

[0062] 20. Transmitter.

[0063] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0064] To make the objectives, technical solutions, and advantages of the embodiments of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. Based on the described embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0065] Currently, implantable devices in continuous glucose monitoring systems on the market have the following characteristics:

[0066] 1. Fixing the needle component in the implantable device is a technical challenge. Most products are assembled with the needle component by the barbs of the guide pin on the transmitter, and the guide pin of the transmitter is under stress.

[0067] 2. The problem of accidental button presses is difficult to solve. Adding accessories or directly fixing the button results in insufficient button force, making it easy to trigger the button accidentally.

[0068] 3. The overall user experience of the product is poor.

[0069] This invention provides an implantable device for implanting a medical device, such as a glucose sensor and / or electronic components (collectively referred to as transmitter 20), into a subject, specifically, referring to... Figure 1 The implantable device 10 includes an upper shell 11 and a lower shell 12. The lower shell 12 is detachably fixed to the upper shell 11 and provides a sterile and sealed environment for the components housed therein. It also limits the position of the components housed therein, forming a rigid constraint. The implantable device 10 also includes a retainer 13 for triggering the components housed therein and mounting the medical device (also referred to as the transmitter 20) onto the subject's skin. Therefore, the retainer 13 has an end face 131 that can contact the subject's skin. The implantable device 10 also includes an actuation button 14 for cooperating in triggering the components housed in the retainer 13, which will be described in detail herein.

[0070] The components of the implantable device 10 are shown below. Figures 2a-11b .

[0071] like Figure 2a , 2b As shown, the upper shell 11 includes an arcuate surface 111 that varies circumferentially along the body of the shell 11, forming a recessed area 112 for handheld fixation and easy operation of the drive button 14. An inner edge 114 is formed on the sidewall of the opening 113 of the upper shell 11, which engages with the edge portion 121 of the bottom shell 12. Figure 3cIn some embodiments, the edge portion 121 of the bottom shell 12 is inserted into the inner edge 114, allowing the bottom shell 12 and the upper shell 11 to rotate relative to each other. Restricting baffles 122 are symmetrically arranged on the inner sidewall of the bottom shell 12, and the restricting baffles 122 can extend a certain distance along the inner sidewall of the shell 11. Figure 3c ).

[0072] See Figure 4a , 4b 4c and 4d, the fixing seat 13 is fixed inside the upper shell 11. Specifically, the fixing seat 13 has a first groove 132 circumferentially spaced on its upper side. The first groove 132 extends axially from the upper end of the fixing seat 13. Correspondingly, the inner wall of the upper shell 11 has a first rib portion 115 that corresponds to and cooperates with the first groove 132. The first rib portion 115 guides the fixing seat 13 to move longitudinally. The upper side of the first rib portion 115 has a first stepped surface 115a that can abut against the top edge position 133 of the fixing seat 13. Figure 2b ).

[0073] See also Figure 4b and Figure 2b The fixing seat 13 has a first flange 134 circumferentially oriented in the middle. Correspondingly, the inner wall of the upper shell 11 has a first locking protrusion 116 that can engage with the first flange 134. Figure 4c As shown, when the first stepped surface 115a of the first rib portion 115 abuts against the top edge position 133 of the fixing seat 13, the first latching protrusion 116 of the upper shell 11 engages with the first flange 134. With this assembly, the fixing seat 13 is fixedly positioned inside the upper shell 11, forming a rigid constraint. In some embodiments, a first latching groove 135 is constructed below the first flange 134 of the fixing seat 13, corresponding to the position of the first latching protrusion 116.

[0074] return Figure 4a and 4d The middle sidewall of the fixed seat 13 is circumferentially symmetrically constructed with a first latching structure 136, which is used to form a releasable radial latch with the engaging part 152 of the sliding seat 15. The outer side of the free end 136a of the first latching structure 136 is flush with the surrounding sidewall. In some embodiments, the outer side of the free end 136a of the first latching structure 136 is constructed with a protrusion 136a1, which is flush with the sidewall of the surrounding fixed seat 13. Since the middle of the fixed seat 13 is circumferentially constructed with a first flange 134, the upper shell 11 and the lower part of the fixed seat 13 form a gap space 100. The gap space 100 satisfies the radial offset of the free end 136a of the first latching structure 136, ensuring that the first latching structure 136 can be released. Figure 4c and Figure 1 ).

[0075] See also Figure 4dThe free end 136a of the first latching structure 136 has an inner engaging portion 136a2 for engaging with the sliding seat 15. In some embodiments, the contact surface of the engaging portion 136a2 may be a plane, an inclined plane, or a curved surface. The free end of the first latching structure 136 has an inner arcuate protrusion 136a3, which cooperates with the drive button 14 for triggering operation.

[0076] return Figure 4c The portion of the lower sidewall of the fixing base 13 extending beyond the upper shell 11 forms an end face 131 that contacts the subject's skin. A first guide groove 137 is constructed on the outer side of the extended portion, and it engages with a limiting protrusion 123 constructed on the inner sidewall of the bottom shell 12. In some embodiments, the first guide groove 137 is inverted "L" shape, and the limiting protrusion 123 can slide longitudinally into it and rotate relative to it, engaging with the locking structure 137a at the end of the first guide groove 137. Figure 4b In some embodiments, the inner wall of the bottom shell 12 is circumferentially spaced with limiting platforms 124. When the fixing seat 13 is connected to the bottom shell 12, and the limiting protrusion 123 slides into the guide groove 137, the limiting platforms 124 prevent the fixing seat 13 from moving longitudinally.

[0077] like Figure 1 and Figure 4c As shown, the fixing seat 13 is limited and fixed inside the upper shell 11, and the bottom shell 12 is locked and fixed to the fixing seat 13. At the same time, the limiting baffle 122 on the bottom shell 12 extends into the gap space 100 formed by the lower part of the upper shell 11 and the fixing seat 13, and is located between the side wall of the upper shell 11 and the free end 136a of the first fastening structure 136, which radially limits the first fastening structure 136, forming a rigid constraint through the geometric limiting relationship. Figure 1 ).

[0078] See Figure 5a , 5b Like 5c, the drive button 14 includes a button portion 141, which is disposed within the upper housing 11 and has a structure, such as a limiting groove 142, that mates with the first rib portion 115, allowing it to slide longitudinally. The drive button 14 also includes a drive leg 143, which is disposed within the hole 138 of the fixing seat 13, and together with the first latching structure 136, defines the radial offset of the free end 136a for triggering operation. Figure 5c In some embodiments, a drive protrusion 143a is constructed on the outer side of the drive leg 143, which increases the radial offset of the free end 136a when pressed. In some embodiments, an elastic element, such as a first spring 144, is provided between the drive button 14 and the fixed base 13 to provide a restoring force after pressing, returning the button to its state before pressing. Figure 1 ).

[0079] See Figure 6a , Figure 7and Figure 8 The sliding seat 15 is slidably fitted inside the fixed seat 13. The outer side of the sliding seat body 151 of the sliding seat 15 has a locking engagement portion 152 that mates with the locking portion 136a2 of the first locking structure 136. In some embodiments, the locking engagement portion 152 and the locking portion 136a2 have complementary structures, such as a protrusion and a groove. The second guide groove 153 on the locking engagement portion 152 is adapted to the arcuate protrusion 136a3 of the first locking structure 136, providing a smooth adjustment environment. For example, when the drive button 14 is pressed, the drive leg 143 of the drive button 14 squeezes or releases the arcuate protrusion 136a3 of the first locking structure 136. The free end 136a of the first locking structure 136 (including the arcuate protrusion 136a3) has a relatively large elastic space in the radial direction, also included in the assembly and release operations.

[0080] See Figure 6b The lower end of the sliding seat body 151 is eccentrically provided with a second slot 154 for engaging the transmitter 20. The second slot 154 has a continuous semi-circular sidewall, and elastic second locking structures 154a are constructed at both ends of the semi-circular sidewall to engage the transmitter 20 placed in the second slot 154. In some embodiments, the sidewall of the second slot 154 is a discontinuous sidewall to ensure that the transmitter can be smoothly disengaged from the second slot 154 after a triggering operation.

[0081] return Figure 6a The upper end of the sliding seat body 151 is provided with three first elastic arms 155 and three second elastic arms 156 spaced apart in sequence. The three first elastic arms 155 and three second elastic arms 156 enclose the movable space 200 of the pin member 16. The outer side of the movable space 200, together with the sliding seat body 151, forms a first groove 158 that defines the second spring 157. Figure 8 (As shown).

[0082] The first elastic arm 155 has a third locking structure 155a configured in the direction of the outer side of the movable space 200, which is used to form an axial limiting engagement with the first locking ring 139 in the fixed seat 13. Figure 9 As shown, after the release operation is completed, the third locking structure 155a engages with the first locking ring 139, and the limiting sliding seat 15 disengages from the fixed seat 13. In some embodiments, a flange 131a is formed on the inner side of the end face 131 of the fixed seat 13. Figure 9 The sliding seat 15 is further limited, and the two limiting structures work simultaneously to ensure that the sliding seat 15 remains in the fixed seat 13 after the release operation is completed. Specifically, the transmitter 20 in the second slot 154 at the lower end of the sliding seat 15 is basically flush with the end face 131 of the fixed seat 13 to avoid the elastic force of the second spring 157 causing instantaneous pressure on the subject's skin after the sliding seat 15 is released.

[0083] like Figure 7 As shown, the second spring 157 is located between the side wall of the fixed seat 13 and the first buckle 139. Its top abuts against the inner top of the fixed seat 13, and its bottom is limited in the first groove 158 of the sliding seat 15. The third buckling structure 155a of the first elastic arm 155 moves longitudinally along the first buckle 139 under the action of the second spring 157.

[0084] The second elastic arm 156 is provided with a fourth fastening structure 156a in the direction of the inner side of the movable space 200. The fourth fastening structure 156a has a first inclined surface 156a1, which forms a wedge-shaped fit with the second inclined surface 162 of the pin 16. Figure 9 and Figure 1 ).

[0085] like Figure 9 , 10a As shown in Figure 10b, a guide pin 18 is mounted on the front end of the needle-bearing component 16, which is pre-compressed within the sliding seat 15 by a third spring 161 (moving space 200) (as shown in Figure 10b). Figure 1 (As shown). In some embodiments, the wedge angle α between the first inclined surface 156a1 of the second elastic arm 156 and the second inclined surface 162 of the pin-shaped component 16 satisfies: 15°≤α≤45°, ensuring smooth assembly and stable guidance, while avoiding excessive force on the second elastic arm 156 and its failure.

[0086] See also Figure 10a , 10b The outer side of the needle member 16 has a guide flange 163, and a second groove 163a is formed between adjacent guide flanges 163. The second limiting protrusion 155b, which is vertically arranged along the first elastic arm 155 toward the inner side of the movable space 200, slides. Figure 6a ).

[0087] See Figure 11a The locking member 17 is sleeved on the outside of the elastic arms (the first elastic arm and the second elastic arm). The locking member 17 has an annular segment 171 that matches the elastic arms. The annular segment 171 constrains the first elastic arm 155 and the second elastic arm 156, for example, as... Figure 1 As shown, the needle-type member 16 and the second elastic arm 156 form a wedge-shaped fit. The locking member 17 constrains the second elastic arm 156. The length of the second elastic arm 156 is less than the length of the first elastic arm 155. The second elastic arm 156 and the locking member 17 move relative to each other. That is, when the sliding seat 15 moves to the preset position, the locking member 17 releases the constraint on the second elastic arm 156.

[0088] Specifically, the upper end of the annular segment 171 has three second protrusions 171a, regularly distributed along the circumferential direction, thus forming an alternating pattern of second protrusions 171a and third grooves 171b when viewed in the circumferential direction. A second buckle 171a1 is constructed on the top of the second protrusion 171a, and the second buckle 171a1 is fastened and fixed to the hook 139a of the fixing seat 13. At the same time, the third groove 171b matches the first buckle 139 of the fixing seat 13, so that the first buckle 139 does not undergo plastic deformation.

[0089] Combination Figure 1 and Figure 9 The locking member 17 is fastened and fixed by the hook 139a of the fixing seat 13. When a release operation is performed (pressing the drive button 14), the sliding seat 15 is released and driven by the second spring 157. The needle-carrying member 16, which is pre-compressed inside the sliding seat 15, moves together with the sliding seat 15. At the same time, the second elastic arm 156 is constrained by the locking member 17. When the sliding seat 15 moves to the preset position (i.e., the operation of installing the transmitter on the subject's skin is completed), the second elastic arm 156 is released from the constraint of the locking member 17 and is released by the third spring 161. The needle-carrying member 16, carrying the guide needle 18, is withdrawn from the subject's skin and returned to the inside of the fixing seat 13 (upper shell 11). In some embodiments, the retraction action of the needle-carrying member 16 is precisely triggered at 70% to 85% of the stroke of the sliding seat 15.

[0090] See also Figure 11a and 11b The inner side of the annular segment 171 is axially constructed with a second guide flange 1711, which matches the second guide groove 159 on the outer side of the first elastic arm 155 of the sliding seat 15, thus constraining the rotation of the sliding seat 15 in the circumferential direction.

[0091] The front end of the guide needle 18 is a sharp blade, used to pierce the subject's skin to insert the sensor into a predetermined position, and its rear end is fixed / coupled to the needle-attached part 16.

[0092] The transmitter involved in this application, i.e., a medical device, includes a glucose sensor and / or electronic components, also referred to as a sensor assembly, comprising a sensor and a housing for securing the sensor. The sensor is configured such that one part is inserted into the skin and the other part is outside the skin; that is, the sensor includes an insertion portion and a connection portion. The insertion portion is provided with an enzyme electrode capable of contacting interstitial fluid and monitoring blood glucose. The electrode wire is connected to the sensor electronic component (sensor control unit) via the connection portion. The sensor electronic component receives the voltage / current signal from the sensor, converts it into a corresponding blood glucose concentration data signal, and transmits it to a display unit such as a remote terminal. The sensor electronic component includes at least a control circuit, electrical components such as capacitors, inductors, antennas, and a battery.

[0093] The transmitter or sensor assembly has been disclosed in Chinese patent application 202522808916.6. It should be noted that the sensor in the transmitter or sensor assembly involved in this application is arranged in an off-center configuration, which is advantageous for arranging the sensor electronic components. It is understood that for commonly available sensor assemblies (body units) with centrally located sensors, the second slot 154 of the sliding seat 15 can be adapted accordingly.

[0094] The pre-installation process for the integrated pre-assembled glucose monitoring implantation device is as follows:

[0095] The locking member 17 is fastened and fixed to the hook 139a of the fixing base 13 by the second buckle 171a1;

[0096] The third spring 161 is installed into the movable space 200 of the sliding seat 15, and then the needle-carrying part 16 and the guide needle 18 are pressed into the movable space 200, so that the second inclined surface 162 and the first inclined surface 156a1 of the second elastic arm 156 are wedged together, thus completing the pre-pressing of the needle-carrying part.

[0097] The second spring 157 is installed inside the fixed seat 13, and then the assembled sliding seat 15 is pressed into the fixed seat 13 so that the first snap-fit ​​structure 136 and the snap-fit ​​part 152 are snap-locked.

[0098] Insert the drive button 14 and the first spring 144 between the upper shell 11 and the fixed base 13 to complete the pre-installation of the drive assembly.

[0099] The fixing seat 13 and the upper shell 11 are rigidly engaged by the first flange 134 and the first locking protrusion 116;

[0100] The transmitter 20 is inserted into the second slot 154 of the sliding seat 15 and locked in place by the second locking structure 154a.

[0101] Rotate the bottom shell 12 to engage with the fixed base 13, so that the limiting baffle 122 extends into the gap space (100), and complete the final pre-installation and sealing.

[0102] The implantable device includes a non-triggered, triggered, automatic needle withdrawal, and locking process. Specifically, the bottom shell 12 is in the installed state, with the limiting baffle 122 pressing against the free end 136a of the first locking structure 136, preventing it from opening radially and achieving rigid anti-accidental activation; the second spring 157 and the third spring 161 are both in a pre-compressed state. Rotating to remove the bottom shell 12, the limiting baffle 122 exits the gap space 100, and the first locking structure 136 returns to a radially releaseable state. Pressing the drive button 14, the drive leg 143 squeezes the arc-shaped protrusion 136a3, causing the first locking structure 136 to open radially, and the locking of the sliding seat 15 is released. The sliding seat 15 moves downward under the push of the second spring 157, and the needle-carrying component 16 and the guide needle 18 move downward synchronously. The guide needle 18 pierces the skin and delivers the sensor of the transmitter 20 into the interstitial fluid. When the sliding seat 15 descends to 70%–85% of its total stroke, the second elastic arm 156 disengages from the annular segment 171 of the locking member 17. Under the thrust of the third spring 161, the needle-carrying member 16 drives the guide needle 18 to retract upwards, completely returning it to the inside of the housing. When the sliding seat 15 descends to its end point, the third locking structure 155a of the first elastic arm 155 engages with the first locking ring 139 of the fixed seat 13, and the sliding seat 15 is limited. The transmitter 20 becomes flush with the end face 131 of the fixed seat 13 and disengages from the sliding seat 15, completing the implantation.

[0103] In the implantable device, with the bottom shell 12 in the installed state, the limiting baffle 122 radially and rigidly restricts the first locking structure 136, preventing the button from being triggered and completely eliminating accidental touches; the entire process does not rely on the guide pin 18 for force, avoiding damage to the sensor due to force; the multi-level locking and the inclined wedge angle cooperation ensure uniform force distribution and are not easy to break, meeting the "fail-safe" design principle of medical devices.

Claims

1. An integrated pre-assembled glucose monitoring implantation device (10), characterized in that, It includes an upper shell (11), a bottom shell (12), a fixed base (13), a drive button (14), a sliding base (15), a pin assembly (16), a locking assembly (17), a guide pin (18), a transmitter (20), and an elastic element; The fixed base (13) is fixedly installed inside the upper shell (11), the bottom shell (12) is detachably connected to the upper shell (11) and forms a rigid limit with the fixed base (13); the drive button (14) is assembled between the upper shell (11) and the fixed base (13), the sliding base (15) is slidably sleeved on the inner side of the fixed base (13), the locking member (17) is fixed on the inner side of the fixed base (13) and constrains the elastic arm of the sliding base (15), the needle member (16) is connected to the guide needle (18) and pre-pressed in the sliding base (15) through the elastic element, and the transmitter (20) is assembled at the lower end of the sliding base (15); The implantation device (10) achieves pre-installation, triggering, automatic needle withdrawal and anti-misoperation through a triple structure of inclined wedge angle cooperation, buckling and locking and anti-misoperation base, without relying on the force of the transmitter (20) and the guide needle (18) throughout the process.

2. The implantation device (10) according to claim 1, characterized in that, The inner wall of the upper shell (11) is provided with a first rib portion (115) and a first locking protrusion (116); the upper side of the fixing seat (13) is provided with a first groove (132) that cooperates with the first rib portion (115), and the middle part of the fixing seat (13) is provided with a first flange (134) that engages with the first locking protrusion (116), so that the fixing seat (13) and the upper shell (11) are rigidly fixed.

3. The implantation device (10) according to claim 1, characterized in that, The inner side of the bottom shell (12) is provided with a limiting baffle (122), a limiting protrusion (123) and a limiting platform (124); the outer side of the fixed seat (13) is provided with an inverted "L"-shaped first guide groove (137) and a locking structure (137a); the limiting protrusion (123) slides and engages with the first guide groove (137) and is locked in the locking structure (137a); the limiting baffle (122) extends into the gap space (100) between the upper shell (11) and the fixed seat (13), forming a radial rigid limit on the first fastening structure (136) of the fixed seat (13).

4. The implantation device (10) according to claim 1, characterized in that, The fixed seat (13) has a first latching structure (136) on its side wall. The free end (136a) of the first latching structure (136) has a locking part (136a2) and an arc-shaped protrusion (136a3). The sliding seat (15) has a locking engagement part (152) that cooperates with the locking part (136a2) and a second guide groove (153) that adapts to the arc-shaped protrusion (136a3) on its outer side. The drive button (14) has a drive leg (143). When pressed, the drive leg (143) squeezes the arc-shaped protrusion (136a3) to release the first latching structure (136) radially and release the locking of the sliding seat (15).

5. The implantation device (10) according to claim 1, characterized in that, The sliding seat (15) includes a sliding seat body (151), a first elastic arm (155), and a second elastic arm (156). The first elastic arm (155) is provided with a third fastening structure (155a), and the inner side of the fixed seat (13) is provided with a first buckle (139). After the trigger is completed, the third fastening structure (155a) is engaged with the first buckle (139) to restrict the sliding seat (15) from coming out. The second elastic arm (156) is provided with a fourth fastening structure (156a) with a first inclined surface (156a1), and the pin-type part (16) is provided with a second inclined surface (162). The first inclined surface (156a1) and the second inclined surface (162) form a wedge fit, and the wedge angle α satisfies 15°≤α≤45°.

6. The implantation device (10) according to claim 5, characterized in that, The locking member (17) has an annular segment (171) that constrains the first elastic arm (155) and the second elastic arm (156). The second elastic arm (156) is shorter than the first elastic arm (155). When the sliding seat (15) moves to a preset stroke, the second elastic arm (156) is released from the constraint of the locking member (17), and the needle-carrying member (16) automatically retracts the guide needle (18) under the action of the elastic element.

7. The implantation device (10) according to claim 6, characterized in that, The retraction of the needle element (16) is triggered at 70% to 85% of the total stroke of the slide seat (15).

8. The implantation device (10) according to claim 1, characterized in that, The upper end of the locking member (17) is provided with a second buckle (171a1), which is fastened and fixed with the hook (139a) of the fixed seat (13); the inner side of the locking member (17) is provided with a second guide flange (1711), which cooperates with the second guide groove (159) of the sliding seat (15) to restrict the circumferential rotation of the sliding seat (15).

9. The implantation device (10) according to claim 1, characterized in that, The lower end of the sliding seat (15) is provided with an eccentric second slot (154) and a second latching structure (154a) for engaging the transmitter (20); after the triggering is completed, the end face (131) of the transmitter (20) and the fixed seat (13) are basically flush and disengage from the sliding seat (15).

10. The implantation device (10) according to claim 1, characterized in that, The elastic element includes: The first spring (144) between the drive button (14) and the fixed base (13) is used to provide button reset force; The second spring (157) between the fixed seat (13) and the sliding seat (15) is used to provide the sliding seat trigger driving force; The third spring (161) between the needle-carrying member (16) and the sliding seat (15) is used to provide the retraction force between the needle-carrying member and the guide needle.

11. The implantation device (10) according to claim 1, characterized in that, The upper shell (11), fixed seat (13), drive button (14), sliding seat (15), locking member (17), pin member (16) and elastic element are pre-integrated into one structure, which can be mass-produced, pre-installed and triggered at one time.

12. The implantation device (10) according to claim 1, characterized in that, Before the bottom shell (12) falls off, the limiting baffle (122) always constrains the first fastening structure (136), forming a failure protection mechanism to prevent accidental contact of the structure body as a safety device, without any additional weak safety components.

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