A sensor implantation device

Abstract

The present invention provides a sensor implantation device, comprising a needle holder for pushing a stent to move distally; a guiding needle for guiding a percutaneous analyte sensor into the skin of a recipient; an elastic member for providing kinetic energy to the implantation device; a needle extractor which is unlocked by the elastic member when the guiding needle is inserted in place to complete needle extraction; a sliding cylinder for unlocking the multiple limit positions of the skeleton, the outer shell and the needle extractor in a specified order to complete the application process; the outer shell moves from the proximal end to the distal end, the skeleton releases the limit on the sliding cylinder, and the needle holder, the stent, the guiding needle and the sensor base assembly move distally together. When the sensor base assembly is applied to the skin of the recipient, the needle holder and the stent stop moving. The sensor implantation device of the present invention realizes automatic insertion and extraction of the guiding needle. Compared with the prior art, the insertion depth of the sensor is more accurate, the operation in the use process is simple, the use is reliable, mis-triggering is avoided, and the applicable population is wider.

Description

Technical Field

[0001] The present invention belongs to the field of receptor analyte measurement, and in particular relates to a sensor implantation device suitable for inserting a transcutaneous analyte sensor into the skin of a receptor. Background Art

[0002] Diabetes is a disease caused by abnormal conditions in the pancreas of a patient, resulting in the pancreas not producing insulin or not producing enough insulin. At present, it cannot be effectively cured. The existing treatment plans take the blood glucose value as a reference and control the blood glucose value within the target range by means such as taking hypoglycemic drugs and injecting insulin.

[0003] Currently, the most common blood glucose monitoring method is for patients to use a finger blood glucose meter to monitor the blood glucose in capillaries, which can measure the blood glucose value at a certain point in time. However, this method requires patients to measure multiple times a day, causing greater pain. Patients need to carry a complete set of tools such as a blood collection needle, a blood glucose meter, and test strips with them, and the measurement process is also relatively cumbersome. This method can only reflect the blood glucose values at several time points in a day (i.e., instantaneous blood glucose), which is one-sided and inaccurate. The instantaneous blood glucose value is affected by many factors such as exercise, diet, drugs, and emotions, and the information obtained is limited. It is impossible to know the trend of blood glucose changes, it is difficult to determine the insulin injection amount, and thus effectively manage the blood glucose level. It is also difficult to detect asymptomatic hyperglycemia and hypoglycemia.

[0004] With the development of technology, a continuous glucose monitoring system (CGMS) has emerged on the market. A transcutaneous analyte sensor as thin as a hair is sent into the interstitial fluid of the human skin through an insertion device. The reaction enzyme on the sensor reacts with certain substances in the interstitial fluid and transmits the signal to the receiver end through a transmitter, so as to continuously monitor the blood glucose of the human body.

[0005] However, the existing transcutaneous analyte sensor implantation devices on the market still lack convenience and comfort. For example, in the insertion device disclosed in patent EP2327362A1, the insertion and extraction of the guiding needle are completely completed manually by the patient. It is not only inconvenient to operate but also brings psychological fear to the patient. For example, in the device for inserting a transcutaneous analyte sensor into the skin disclosed in patent CN206777328U, the transcutaneous analyte sensor and the sensor base do not contact before use; during use, the transcutaneous analyte sensor is only coupled to the sensor base, and an electrical connection needs to be achieved between the two, which requires high requirements for the size and position of the components; resulting in a high cost of the insertion device, which is not conducive to the promotion and popularization of the product. For example, in the application disclosed in patent CN110664415A, there is a situation of premature needle extraction in the structure of the patch device, which cannot well adapt to different skin protrusion degrees and cannot ensure the sufficient depth of sensor insertion. Summary of the Invention

[0006] In view of this, the present invention aims to provide a sensor implantation device that can be applied to skins with different degrees of protrusion. The structure of the present invention is simple, user operation is convenient, use is comfortable, safe and reliable, mis-triggering is avoided, and the applicable population is wider.

[0007] To achieve the above object, the technical solution of the present invention is realized as follows:

[0008] A sensor implantation device that inserts a transcutaneous analyte sensor into the recipient skin and can be automatically withdrawn, characterized in that it includes:

[0009] A touch-back component, including a trigger component and an insertion component placed inside the trigger component;

[0010] A braking mechanism, including a housing, the touch-back component is arranged inside the housing and can move between the distal end and the proximal end relative to the touch-back component. The braking mechanism is triggered by an external force to provide a primary driving force for the device;

[0011] A driving mechanism, installed on the touch-back component, is triggered by the braking mechanism to provide a secondary driving force for the device;

[0012] Press the housing, the housing moves towards the distal end, providing a primary driving force for the device, triggering the driving mechanism to provide a secondary driving force for the device, and the touch-back component completes a reciprocating motion between the distal end and the proximal end.

[0013] Further, the trigger component includes:

[0014] A skeleton, received at the open end of the housing, and one end of it contacts the recipient skin, and the housing slides along the skeleton;

[0015] A bracket, slidably installed inside the skeleton, for fixing the sensor base assembly;

[0016] A sliding cylinder, slidably installed inside the skeleton, can push the bracket towards the distal end;

[0017] A needle extractor, sleeved on the sliding cylinder, and slidably connected to the housing;

[0018] A supporting platform extends radially around the sliding cylinder, and the driving mechanism is placed between the supporting platform and the needle extractor.

[0019] Further, the insertion component includes:

[0020] A needle seat, slidably installed inside the sliding cylinder, can push the bracket towards the distal end, and its top extends to both sides to form an extension arm placed above the needle extractor;

[0021] A guide needle, coupled to the bottom of the needle seat, can fix the position of the bracket.

[0022] Further, a first elastic buckle is provided on the skeleton, and a corresponding first limiting rib is provided inside the outer shell. The first limiting rib restricts the relative sliding between the skeleton and the outer shell.

[0023] Further, a third limiting rib is provided on the inner side wall of the outer shell, a fifth elastic buckle is provided on the needle extractor and is snap-connected thereto, a fourth elastic buckle is provided on the sliding cylinder and contacts the fifth elastic buckle. The third limiting rib and the fourth elastic buckle limit the relative movement between the needle extractor and the outer shell.

[0024] Further, a second groove is provided on the sliding cylinder, and a second elastic buckle is provided on the skeleton and is snap-connected into the second groove to limit the movement of the sliding cylinder in the vertical direction;

[0025] When the outer shell moves distally, the first groove provided on the inner side wall of the outer shell is placed on one side of the second elastic buckle, and the limitation of the second elastic buckle on the sliding cylinder is released.

[0026] Further, a fourth groove is provided on the upper part of the needle seat. When the fourth elastic buckle moves to the fourth groove, the limitation of the fifth elastic buckle in the horizontal direction is released.

[0027] Further, a fifth groove is provided on the lower part of the needle seat. A third limiting buckle is provided on the sliding cylinder and is embedded in the fifth groove. A limiting block is provided on the skeleton and is placed on one side of the third limiting buckle to limit the opening and closing of the third limiting buckle and lock the positional relationship between the sliding cylinder and the needle seat;

[0028] A third groove is provided below the limiting block. When the third limiting buckle moves to the third groove, the limitation of the third limiting buckle is released, and the locked positional relationship between the sliding cylinder and the needle seat is released.

[0029] Further, a sixth elastic buckle and a push plate are provided at the bottom of the needle seat, and the push plate abuts against the top of the bracket;

[0030] A clamping protrusion is provided at the top of the guiding needle and is clamped in the sixth elastic buckle, which can drive the movement of the guiding needle between the proximal end and the distal end.

[0031] Further, third elastic buckles extending upward and in mirror image are provided at the top of the bracket. A guiding needle groove penetrating the bracket is formed between the two third elastic buckles. The guiding needle is placed in the guiding needle groove, and an inclined surface contacting the inner top wall of the third elastic buckle is provided on the guiding needle.

[0032] Further, the top of the third elastic buckle is provided with limiting posts extending to both sides, and the sliding cylinder is provided with second limiting ribs in contact with the limiting posts to restrict the movement of the limiting posts in the horizontal direction;

[0033] When the sliding cylinder moves towards the distal end, the second limiting rib releases the limitation on the horizontal movement of the limiting post, and the third elastic buckle can shift towards the opening provided on the second limiting rib.

[0034] Further, the bottom of the guiding needle is provided with a guiding needle tip and a stability plate arranged on one side of the guiding needle tip;

[0035] The sensor base assembly is provided with a through hole for the guiding needle to pass through, and the stability plate is inserted into a positioning groove arranged on the sensor base assembly.

[0036] Further, the lower part of the bracket is provided with an elastic arm, the inner side of the elastic arm is provided with a clamping groove, and the lower part of the sensor base assembly is provided with a convex rib clamped in the clamping groove.

[0037] Further, it further includes an end cap, and the end cap is connected to the housing.

[0038] Further, the driving mechanism includes an elastic member.

[0039] Compared with the prior art, the sensor implantation device of the present invention has the following advantages:

[0040] (1) During the use of the device, multiple mechanisms are continuously unlocked and cooperate with each other to ensure that the guiding needle is always in a stable state during the insertion and extraction processes, preventing the situation that the guiding needle pierces obliquely or even breaks in the recipient's skin;

[0041] (2) With the arrangement of the elastic member, only one pressure needs to be applied to the device to complete both the needle insertion and extraction processes, which is convenient to use, improves the comfort of the user's operation, and can also reduce the user's fear of needle extraction;

[0042] (3) In the initial state, the elastic member is in a semi-compressed state, which can effectively reduce the risk of part deformation caused by the elastic force of the elastic member during the storage of the implantation device, and the elastic force of the semi-compressed elastic member can balance the acting forces between the internal components of the device, ensuring that all components in the device are in the initial state when leaving the factory before use;

[0043] (4) The sensor base assembly will extract the needle only when it is pasted on the recipient's skin, which can ensure that the retained part of the sensor base is inserted in place and prevent various problems caused by its incomplete insertion;

[0044] (5) This device is reliable, avoids accidental touch, is suitable for situations where the skin bulges at different positions of the recipient are different, and the insertion depth is more guaranteed. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] The drawings forming a part of the present invention are used to provide a further understanding of the present invention. The schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0046] Figure 1 is an exploded view of an embodiment of the present invention;

[0047] Figure 2 is a schematic cross-sectional view of the housing of an embodiment of the present invention;

[0048] Figure 3 is a schematic view of the needle seat structure of an embodiment of the present invention;

[0049] Figure 4 is a schematic view of the bracket structure of an embodiment of the present invention;

[0050] Figure 5 is a schematic view of the guide needle structure of an embodiment of the present invention;

[0051] Figure 6a is a schematic cross-sectional view of the skeleton of an embodiment of the present invention;

[0052] Figure 6b is a schematic front view of the skeleton of an embodiment of the present invention;

[0053] Figure 7a is a schematic cross-sectional view of the sliding cylinder of an embodiment of the present invention;

[0054] Figure 7b is a schematic front view of the sliding cylinder of an embodiment of the present invention;

[0055] Figure 8a is a schematic cross-sectional view of the needle extractor of an embodiment of the present invention;

[0056] Figure 8b is a schematic front view of the needle extractor of an embodiment of the present invention;

[0057] Figure 9 is a schematic cross-sectional view of the initial state structure of an embodiment of the present invention;

[0058] Figure 10 is a schematic cross-sectional view of the limiting state structure of the third limiting rib of an embodiment of the present invention;

[0059] Figure 11 is an enlarged view of the limiting state structure of the second elastic buckle of an embodiment of the present invention;

[0060] Figure 12 is a schematic cross-sectional view of the structure after the housing of an embodiment of the present invention moves;

[0061] Figure 13 Cross-sectional view of the structure before the guiding needle of an embodiment of the present invention reaches the recipient's skin;

[0062] Figure 14 Cross-sectional view of the structure of the limiting block in the limiting state of an embodiment of the present invention;

[0063] Figure 15 Enlarged view of the structure of the limiting block in the limiting state of an embodiment of the present invention;

[0064] Figure 16 Cross-sectional view of the structure after the guiding needle of an embodiment of the present invention reaches the recipient's skin;

[0065] Figure 17 Schematic diagram of the structure of the sensor base assembly after stopping moving in an embodiment of the present invention;

[0066] Figure 18 Cross-sectional view of the structure before needle extraction in an embodiment of the present invention;

[0067] Figure 19 Cross-sectional view of the structure during needle extraction in an embodiment of the present invention;

[0068] Figure 20 Enlarged view of the partial structure during needle extraction in an embodiment of the present invention;

[0069] Figure 21 Cross-sectional view of the structure for releasing the limit of the inclined surface structure of the guiding needle in an embodiment of the present invention;

[0070] Figure 22 Schematic diagram of the structure of the sensor base assembly in an embodiment of the present invention;

[0071] Figure 23 Schematic diagram of the structure of the other side of the bracket in an embodiment of the present invention;

[0072] Figure 24 Schematic diagram of the skeleton structure of another embodiment of the present invention;

[0073] Figure 25 Schematic diagram of the outer shell structure of another embodiment of the present invention;

[0074] Figure 26 Schematic diagram of the bracket structure of another embodiment of the present invention;

[0075] Figure 27 Schematic diagram of the structure of the cooperation between the first elastic buckle and the fourth limiting rib of another embodiment of the present invention;

[0076] Figure 28 Schematic diagram of the structure of the cooperation between the seventh elastic buckle and the limiting plate of another embodiment of the present invention.

[0077] Description of the reference numerals:

[0078] 1 - Outer shell, 101 - Third limiting rib, 102 - First groove, 103 - First guiding groove, 104 - First limiting rib, 105 - Fourth limiting rib;

[0079] 2 - Needle holder, 201 - Pushing plate, 202 - Sixth elastic buckle, 203 - Fourth guiding rib, 204 - Fourth groove, 205 - Fifth groove, 206 - Extension arm;

[0080] 3 - Bracket, 301 - Needle guiding groove, 302 - Limiting post, 303 - Third elastic buckle, 304 - Rib, 305 - Third guiding rib, 306 - Elastic arm, 307 - Limiting plate;

[0081] 4 - Guiding needle, 401 - Clamping protrusion, 402 - Inclined surface, 403 - Guiding needle tip, 404 - Stabilizing plate;

[0082] 5 - Sensor base assembly, 501 - Through hole, 502 - Positioning groove, 503 - Card slot, 504 - Connecting hook, 505 - Sensor base;

[0083] 6 - End cap;

[0084] 7 - Skeleton, 701 - Second elastic buckle, 702 - Third guiding groove, 703 - Limiting block, 704 - Second guiding groove, 705 - First elastic buckle, 706 - First guiding rib, 707 - Third groove, 7011 - Outer protrusion of second elastic buckle, 7012 - Inner protrusion of second elastic buckle, 708 - Seventh elastic buckle;

[0085] 8 - Slide cylinder, 801 - Fourth elastic buckle, 802 - Second groove, 803 - Third limiting buckle, 804 - Second limiting rib, 805 - Fourth guiding groove, 806 - Second guiding rib, 807 - Supporting platform, 8041 - Opening;

[0086] 9 - Elastic member;

[0087] 10 - Needle extractor, 1001 - Fifth elastic buckle, 1002 - Fifth guiding rib, 10011 - Outer protrusion of fifth elastic buckle, 10012 - Inner protrusion of fifth elastic buckle. Detailed implementation mode

[0088] The structure, features and effects of the present invention are described in detail as follows in combination with the accompanying drawings and preferred embodiments:

[0089] As Figures 1-28 shown, a sensor implantation device provided by the present invention includes: a touch - back assembly, a braking mechanism and a driving mechanism.

[0090] The touch - back assembly includes a triggering assembly and an insertion assembly placed inside the triggering assembly;

[0091] The braking mechanism is the housing 1. Inside the housing 1, there are an initial limiting structure one and an initial limiting structure two. The triggering component is installed inside the housing 1 and can move between the distal end and the proximal end relative to the triggering component. The braking mechanism is triggered by an external force to provide a primary driving force for the device.

[0092] The driving mechanism is an elastic member 9, which is installed on the touch-return component and is triggered by the braking mechanism to provide a secondary driving force for the device.

[0093] In the initial state, the touch-return component is relatively stationary with respect to the housing 1.

[0094] In the insertion state, when the housing 1 is pressed, the housing 1 moves towards the distal end to provide a primary driving force for the device, trigger the driving mechanism, that is, compress the elastic member 9 to provide a secondary driving force for the device, and the touch-return component is partially unlocked and moves towards the distal end.

[0095] In the needle-pulling state: the touch-return component is fully unlocked, the driving mechanism continues to provide a secondary driving force, and the touch-return component moves towards the proximal end.

[0096] The triggering component includes: a skeleton 7, a bracket 3, a sliding cylinder 8, and a needle puller 10, which are introduced below.

[0097] The skeleton 7 is received at the open end of the housing 1. Inside the housing 1, there is a first guiding groove 103, and on the skeleton 7, there is a first guiding rib 706 that cooperates with it. The housing 1 can slide between the proximal end and the distal end positions relative to the skeleton 7, and one end of the skeleton 7 contacts the surface of the recipient's skin.

[0098] Inside the skeleton 7, there is a sliding cylinder 8 and a bracket 3 that are slidably connected to it. The bracket 3 is located below the sliding cylinder 8. A supporting platform 807 protrudes from the outer peripheral side of the sliding cylinder 8. On the outer side wall of the sliding cylinder 8, there is a second guiding rib 806 that can move along the second guiding groove 704 provided on the inner side of the skeleton 7. At the bottom of the sliding cylinder 8, there is an initial limiting structure four to limit the movement of the bracket 3 in the vertical direction.

[0099] On the outer side wall of the bracket 3, there is a third guiding rib 305, and correspondingly, on the inner side wall of the skeleton 7, there is a third guiding groove 702 to facilitate the sliding of the bracket 3 inside the skeleton 7. At the top of the bracket 3, there are symmetrically arranged and upwardly extending third elastic buckles 303, and a needle guiding groove 301 that penetrates the top wall of the bracket 3 is formed between the two third elastic buckles 303.

[0100] Both the elastic member 9 and the needle puller 10 are sleeved on the outside of the sliding cylinder 8. The elastic member 9 is placed between the needle puller 10 and the supporting platform 807 to empower the device to perform the needle insertion and needle pulling actions.

[0101] On the side wall of the needle puller 10, there is a fifth guiding rib 1002 that can move along the first guiding groove 103 inside the housing 1 to ensure that the needle puller 10 always maintains a stable state during the movement.

[0102] The insertion component includes a needle base 2 and a guide needle 4, which are introduced as follows:

[0103] The needle base 2 is placed inside the sliding cylinder 8. A fourth guiding rib 203 is provided on the side wall of the needle base 2, which can slide along the fourth guiding groove 805 on the inner side wall of the sliding cylinder 8. A push plate 201 is provided at the bottom of the needle base 2. In the initial state, the push plate 201 contacts the bracket 3 and can push the bracket 3 towards the receptor during the needle insertion process. The top of the needle base 2 extends towards both sides to form an extension arm 206. In the state of pulling out the needle, the needle puller 10 can push the extension arm 206 away from the receptor, thereby driving the needle base 2 to move away from the receptor.

[0104] The guide needle 4 is placed in the guide needle groove 301 and can fix the position of the bracket 3. Its upper part extends upwards and is coupled to the bottom of the needle base 2. Specifically, a clamping protrusion 401 extending towards both sides is provided at the top of the guide needle 4. Correspondingly, symmetric and downward-extending sixth elastic buckles 202 are provided at the bottom of the needle base 2. The clamping protrusion 401 is placed between the two elastic buckles 202, which can limit the movement of the guide needle 4 in the vertical direction. Slanting surfaces 402 extending downwards are formed on both sides of the guide needle 4 placed inside the guide needle groove 301, and the slanting surfaces 402 contact the inner top wall of the third elastic buckle 303. The top cross-section of the third elastic buckle 303 is in a [specific shape], and the slanting surfaces 402 limit the movement of the bracket 3 in the vertical direction. A guide needle tip 403 is provided at the bottom of the guide needle 4.

[0105] A sensor base component 5 is coupled inside the bracket 3. The sensor base component 5 includes a sensor base 505. A through hole 501 for the guide needle 4 to pass through is provided on the sensor base 505. The guide needle tip 403 is used to insert the retained part of the sensor base 505 into the skin of the receptor.

[0106] It should be noted that the guide needle tip 403 has a structure with a fully open side on one side, and the retained part of the sensor is wrapped inside the guide needle tip 403.

[0107] The device is configured such that when the housing 1 moves from the first position to the second position, that is, from the proximal end to the distal end, the frame 7 releases the limit on the sliding cylinder 8, and the needle base 2, the bracket 3, the guide needle 4, and the sensor base component 5 move towards the distal end together. And when the sensor base component 5 is applied to the skin of the receptor, the needle base 2 and the bracket 3 stop moving.

[0108] The sliding cylinder 8 continues to move towards the distal end, and the needle puller 10 moves towards the third position, that is, towards the proximal position, under the action of the elastic member 9. Thus, the needle puller 10 drives the needle base 2 to pull out the guide needle 4 from the skin of the receptor.

[0109] It should be noted that in the present invention, the "distal end" refers to the direction close to the skin, and the "proximal end" refers to the direction away from the skin; the first position is the initial position of the device, the second position is the position where the guiding needle of the device is fully inserted, and the third position is the position where the needle is fully withdrawn.

[0110] As Figure 1 shown, the transcutaneous sensor patch device further includes an end cap 6, and the end cap 6 is combined with the open end of the housing 1, which can provide a sterile and pollution-free environment for the sensor base assembly 5. In this embodiment, the end cap 6 is connected to the housing 1 by means of a hook. In other embodiments, it can also be connected by means of interference fit or thread, etc. A drying pack is fixedly placed inside the end cap 6 to keep the storage environment inside the end cap 6 dry. To prevent factors such as light from affecting the sensor base assembly 5 and resulting in a reduction in measurement accuracy, the end cap 6 is a fully light-shielding structure. Of course, in other embodiments, the end cap 6 can also be covered with a light-shielding and sealing aluminum foil film on the outside.

[0111] The setting of the end cap 6 not only plays a protective role for the sensor base assembly 5, but also can prevent the device from being triggered before use. After removing the end cap 6, the initial limit structure one and the initial limit structure two on the housing 1 and the initial limit structure three on the skeleton 7 ensure that the device remains in the locked state, and the locked state of the device will be released only after pressing the housing 1, that is, applying pressure to the device. This greatly avoids accidental touch and prevents damage to the device.

[0112] As Figure 9 shown, the elastic member 9 includes but is not limited to a cylindrical helical spring. When the device is in the first position, the elastic member 9 is in a semi-compressed state, which can effectively reduce the risk of part deformation caused by the elastic force of the elastic member 9 during the storage of the implant device.

[0113] As Figures 2-11 shown, when the device is in the initial state (at the first position), the initial limit structure one and the initial limit structure two respectively limit the movement of the skeleton 7 and the needle extractor 10, the initial limit structure three limits the movement of the sliding cylinder 8, the initial limit structure four on the sliding cylinder 8 limits the movement of the needle seat 2, the initial limit structure five limits the movement of the bracket 3, and the initial limit structure six provided on the bracket 3 limits the sensor base assembly 5.

[0114] The initial limit structure one is the first limit rib 104 disposed on the inner side wall of the housing 1, and the initial limit structure one limits the skeleton 7. Under the pre-tension of the elastic member 9, the skeleton 7 cannot move distally.

[0115] Specifically, to ensure the balance of the device, the first limit ribs 104 are symmetrically arranged on the two opposite inner side walls of the housing 1, and the first elastic buckle 705 corresponding thereto is provided on the skeleton 7, which abuts against the first limit rib 104 to limit the relative sliding between the skeleton 7 and the housing 1.

[0116] The initial limiting structure three is the second elastic buckle 701 arranged on the framework 7. The second elastic buckle 701 includes a second elastic buckle outer protrusion 7011 and a second elastic buckle inner protrusion 7012. The inner side wall of the second elastic buckle 701 abuts against the outer side wall of the sliding cylinder 8, and the second elastic buckle outer protrusion 7011 abuts against the inner side wall of the outer shell 1, so that the second elastic buckle 701 is locked in the horizontal direction, and the framework 7 remains stationary under the action of the first limiting rib 104. The second elastic buckle inner protrusion 7012 abuts against the second groove 802 arranged on the side wall of the sliding cylinder 8, limiting the sliding of the sliding cylinder 8 towards the distal end (the second position).

[0117] The initial limiting structure two is the third limiting rib 101 arranged on the inner side wall of the outer shell 1. The third limiting rib 101 limits the needle extractor 10 and cannot move towards the proximal end under the pre-tension of the elastic member 9. After drawing a perpendicular line from the third limiting rib 101 to its plane, the connection line between it and the two first limiting ribs 104 forms a spatial perpendicular. Specifically, the needle extractor 10 is provided with a fifth elastic buckle 1001, and the fifth elastic buckle 1001 is composed of a fifth elastic buckle outer protrusion 10011 and a fifth elastic buckle inner protrusion 10012. Further, the fifth elastic buckle inner protrusion 10012 abuts against the fourth elastic buckle 801 on the sliding cylinder 8, the fourth elastic buckle 801 abuts against the side wall of the needle seat 2, and the outer side wall of the fifth elastic buckle 1001 abuts against the inner side wall of the outer shell 1. The three form the locking of the fifth elastic buckle 1001 in the horizontal direction, and the fifth elastic buckle outer protrusion 10011 abuts and cooperates with the third limiting rib 101 to limit the movement of the needle extractor 10 in the vertical direction.

[0118] Further, for facilitating the movement of the device from the first position to the second position and realizing the insertion action of the device, the contact surfaces of the third limiting rib 101 and the fifth elastic buckle outer protrusion 10011 are both inclined surfaces, and the contact surface of the second elastic buckle inner protrusion 7011 and the second groove 802 is also an inclined surface.

[0119] The initial limiting structure four is the third limiting buckle 803. The needle seat 2 is provided with a corresponding fifth groove 205. The third limiting buckle 803 contacts the upper top surface in the fifth groove 205, restricting the downward movement trajectory of the needle seat 2 under the action of gravity.

[0120] The initial limiting structure five is the second limiting ribs 804 symmetrically arranged at the bottom of the sliding cylinder 8. The second limiting ribs 804 are provided with openings 8041. In the initial state, the limiting posts 302 extending in the width direction at the top of the third elastic buckle 303 are located between the two second limiting ribs 804, realizing the locking of the third elastic buckle 303 in the horizontal direction and guiding the needle 4 to limit the bracket 3 in the vertical direction.

[0121] An elastic arm 306 is provided on the side wall of the bracket 3, and the initial limiting structure 6 is a convex rib 304 provided on the inner side of the elastic arm 306. The card slot 503 provided on the sensor base 505 is engaged with the convex rib 304 to limit the movement of the sensor base assembly 5, ensuring that the sensor base assembly 5 is not affected by the movement of any parts before unlocking, and no displacement occurs. Further, a positioning groove 502 is provided around the through hole 501, and a stabilizing plate 404 engaged in the positioning groove 502 is provided on the guide needle 4 to reduce the shaking during the insertion of the guide needle 4.

[0122] like Figures 12-18 As shown, the device moves from the first position to the second position, i.e., performs an insertion action. The skeleton 7 is used to be placed on one end of the surface of the recipient's skin to contact the recipient's skin, press the shell 1 toward the distal end, the shell 1 moves downward, the third limiting rib 101 cooperates with the fifth elastic buckle 1001 to drive the needle remover 10 to move downward, and the elastic member 9 continues to compress. The bottom of the shell 1 contacts the recipient's skin, at which time the skeleton 7 is completely wrapped in the shell 1, the first groove 102 moves to the side of the second elastic buckle 701, and the side wall of the shell 1 releases the horizontal limit on the second elastic buckle 701.

[0123] Specifically, the third limiting rib 101 and the first groove 102 are located on the same vertical line, and the length of the first groove 102 is greater than the length of the second elastic buckle protrusion 7011 , and the depth of the first groove 102 is greater than the depth of the second elastic buckle protrusion 7012 .

[0124] Furthermore, the second elastic buckle 701 is contacted in the horizontal limit and can be elastically deformed, releasing the limit on the slide 8 in the vertical direction, and the third limit rib 101 still keeps the limit on the fifth elastic buckle 1001 in the vertical direction. The elastic member 9 returns to its original state after being compressed, and the needle puller 10 is still limited by the third limit rib 101, and the position remains unchanged. The elastic member 9 applies a downward elastic force to the support platform 807, driving the slide 8 and the needle seat 2 to move downward, and the push plate 201 on the needle seat 2 pushes the bracket 3 to move downward, driving the guide needle 4 and the sensor base assembly 5 to move downward.

[0125] Specifically, Figure 14 The upper limit block 703 on the frame 7 limits the third limit buckle 803 of the slide 8 to ensure that the needle seat 2 and the slide 8 are relatively locked when the needle tip pierces the skin; Figure 15 The second limiting rib 804 of the slide tube 8 limits the limiting column 302 of the bracket 3 to ensure that the guide needle 4 and the bracket 3 are relatively locked when the needle tip pierces the skin, thereby successfully completing the application insertion action.

[0126] After the guiding needle 4 pierces the skin, the sliding cylinder 8 continues to move downward under the action of elastic force. The third limit buckle 803 moves with the sliding cylinder 8 to below the limit block 703. The limit block 703 releases the restriction on the third limit buckle 803 in the horizontal direction. The third limit buckle 803 moves to one side of the third groove 707 provided below the limit block 703, releasing the movement space of the third limit buckle 803. The restriction on the movement of the third limit buckle 803 in the horizontal direction is completely released. As the sliding cylinder 8 continues to move downward, the third limit buckle 803 undergoes elastic deformation and opens to both sides, and the third limit buckle 803 is preliminarily separated from the fifth groove 205.

[0127] The bracket 3 moves to the farthest end and stops moving. The sensor base 505 is affixed to the skin of the recipient through the adhesive patch on its bottom. The sensor indwelling part is inserted into the skin of the recipient together with the guiding needle head 403. At this time, the third limit buckle 803 and the fifth groove 205 are not completely separated.

[0128] It should be noted that the bottom of the sensor base 505 and the bottom of the bracket 3 are located on the same horizontal plane. The adhesive patch at the bottom of the sensor base 505 is placed below the bottom of the bracket 3, which can ensure that the sensor is more firmly affixed to the skin of the recipient. As Figures 18-21 shown, during the movement from the second position to the third position, that is, the needle-pulling process, the bracket 3 stops moving, and the sliding cylinder 8 continues to move downward under the action of the elastic force of the elastic member 9 until the bottom of the sliding cylinder 8 contacts the top of the bracket 3. At this time, the third limit buckle 803 is completely peeled off from the fifth groove 205. The second limit rib 804 releases the restriction on the limit post 302 in the horizontal direction. The third elastic buckle 303 is located at the opening 8041 on the second limit rib 804, and the limit post 302 can open to both sides.

[0129] During this process, the sliding cylinder 8 moves downward, while the needle base 2 stops moving. The fourth elastic buckle 801 moves into the fourth groove 204, releasing the restriction on the fifth elastic buckle 1001 in the horizontal direction.

[0130] As Figures 19-20 shown, after the sliding cylinder 8 stops moving, the elastic member 9 continues to rebound under the action of the elastic force. The elastic member 9 pushes the needle puller 10 to move proximally. The fifth elastic buckle 1001 undergoes elastic deformation and breaks away from the restriction of the third limit rib 101. The needle puller 10 realizes the proximal movement and pushes the extension arm 206 at the top of the needle base 2 to drive the entire needle base 2 to move proximally.

[0131] Specifically, the fourth elastic buckle 801 is squeezed by the inner protrusion 10012 of the fifth elastic buckle to produce elastic deformation and shift into the fourth groove 204. The needle puller 10 moves upward, and the fifth elastic buckle 1001 undergoes elastic deformation and breaks away from the restriction of the third limit rib 101.

[0132] As Figure 21 shown, the needle seat 2 drives the guiding needle 4 to move upward, the top of the third elastic buckle 303 undergoes elastic deformation and deflects towards the opening 8041, the inclined surface 402 disengages from the needle guide groove 301, the guiding needle tip 403 moves towards the proximal direction, disengages from the recipient's skin and retracts into the device, leaving the sensor indwelling part in the recipient's skin.

[0133] It should be noted that the elastic member 9 only resumes its original length when the needle extraction operation is completed.

[0134] After the needle extraction operation is completed, the device is removed, and the application work is completed. It should be noted that the sensor base assembly 5 further includes a transmitting part. After the sensor base assembly 5 is applied to the recipient's skin, the user installs the transmitting part onto the sensor base 505 and fixes it through the connecting hook 504. Of course, in other embodiments, the sensor base 505 and the transmitting part may also be an integral structure, and the transmitting part does not require additional installation.

[0135] It should be noted that when the device is removed, the bracket 3 remains on the recipient's skin together with the sensor base 505. The user needs to manually pick up the bracket 3 to separate the card slot 503 from the rib 304, and the bracket 3 is separated from the sensor base 505.

[0136] The structure and movement principle of the embodiment are briefly described below:

[0137] (1) Initial state of the implantation device

[0138] As Figure 9 , in the initial state, the elastic member 9 is in a semi-compressed state, and the first limiting rib 104 limits the first elastic buckle 705 to ensure that the skeleton 7 cannot move towards the recipient's skin side. As Figure 10 , the third limiting rib 101 of the outer shell limits the fifth elastic buckle 1001 of the needle extractor 10 to ensure that the needle extractor 10 cannot move towards the side away from the skin; as Figure 11 , the second elastic buckle 701 of the skeleton 7 limits the second groove 802 on the sliding cylinder 8 to ensure that the sliding cylinder 8 cannot move towards the recipient's skin side.

[0139] (2) Triggering of the implantation device

[0140] First, remove the end cap 6 to expose the skeleton 7; then place the implantation device on the subject's skin. As Figure 12 , press down the outer shell 1, the elastic member 9 continues to be compressed, and the first groove 102 on the outer shell 1 releases the horizontal limit on the second elastic buckle 701 of the skeleton 7. As Figure 13, under the elastic force of the elastic member 9, the second elastic buckle 701 of the skeleton 7 undergoes elastic deformation, and then the sliding cylinder 8, the needle holder 2, the guiding needle 4, the bracket 3, and the sensor base assembly 5 move together toward the recipient's skin side to perform the application and piercing action. As Figure 14 , the limit of the third limit buckle 803 of the sliding cylinder 8 by the limit block 703 on the skeleton 7 ensures the relative locking of the needle holder 2 and the sliding cylinder 8 before the tip of the needle pierces the skin; as Figure 15 , the limit of the limiting post 302 of the bracket 3 by the second limiting rib 804 of the sliding cylinder 8 ensures the relative locking of the guiding needle 4 and the bracket 3 when the tip of the needle pierces the skin, and then the application and piercing action is successfully completed. As Figure 16 , after the guiding needle 4 pierces the skin, the limit block 703 releases the limit on the third limit buckle 803.

[0141] (3) Withdrawal (retraction) of the implantation device

[0142] After the sensor base assembly 5 and the guiding needle 4 are in place, the bracket 3 stops moving, as Figure 17 , the sliding cylinder 8 continues to move toward the recipient's skin side until it contacts the bracket 3, so that the second limiting rib 804 of the sliding cylinder 8 releases the limit on the limiting post 302 of the bracket 3. The sliding cylinder 8 stops moving under the limit of the bracket 3, as Figure 18 , the fourth groove 204 of the needle holder 2 releases the horizontal limit on the fourth elastic buckle 801 of the sliding cylinder 8. Under the action of the elastic member 9, the needle extractor 10 moves in the direction away from the skin side, as Figure 19 、 20 , the fourth elastic buckle 801 undergoes elastic deformation under the extrusion of the fifth elastic buckle 1001, so that the third limiting rib 101 of the housing 1 releases the limit on the fifth elastic buckle 1001 of the needle extractor 10, and the withdrawal (retraction) needle action begins. As Figure 21 , the needle extractor 10 drives the needle holder 2 to move in the direction away from the skin side. The upper end of the guiding needle 4 is provided with an inclined surface 402, and the inclined surface 402 disengages from the guiding needle groove 301 of the bracket 3. The guiding needle 4 moves in the direction away from the skin side and retracts into the implantation device.

[0143] (4) Removal of the implantation device

[0144] Removing the implantation device by hand completes the application process of the sensor base assembly 5. After the sensor base assembly 5 is applied in place, the sliding cylinder 8 continues to move under the action of the elastic member 9, and then triggers the needle withdrawal action, ensuring that the needle withdrawal action is carried out after the application is in place, and avoiding the situation that the sensor is not inserted in place caused by premature needle withdrawal.

[0145] As Figures 24-28 shown, in other embodiments:

[0146] Above the first limiting rib 104 provided on the housing 1, there is a fourth limiting rib 105, and the two are located on the same vertical line. When pressing the housing 1, the housing 1 moves from position one to position two, the first limiting rib 104 is separated from the first elastic buckle 705, and the fourth limiting rib 105 is placed below the first elastic buckle 705, and its upper surface contacts the first elastic buckle 705. The movement trajectory of the skeleton 7 in the vertical direction is restricted, and after the application is completed, the position between the skeleton 7 and the housing 1 can be locked during the process of removing the device.

[0147] Furthermore, the distance between the first limiting rib 104 and the fourth limiting rib 107 is the maximum distance that the housing 1 runs along the skeleton 7. In other embodiments, the distance between the two only needs to be not greater than the maximum distance that the housing 1 runs along the skeleton 7.

[0148] On both sides of the top of the bracket 3, there are limiting plates 307 extending outwards. Correspondingly, on the skeleton 7, there are seventh elastic buckles 707 extending inwards. When the bracket 3 moves to the farthest end, the sensor base 505 is applied to the receptor skin through the application glue, the limiting plate 307 contacts the seventh limiting buckle 708, and the seventh limiting buckle 709 restricts the movement trajectory of the bracket 3 in the vertical direction to prevent the bracket 3 from falling after contact locking. When directly removing the device, under the action of the limiting plate 307 and the buckle 708, the bracket 3 remains relatively stationary with the skeleton 7, the card slot 503 is peeled off from the rib 304, and the bracket 3 is removed together with the skeleton 7 without manual peeling.

[0149] In summary, compared with the prior art, the present invention uses an elastic member secondary loading mechanism, reducing the risk of part deformation during storage; the insertion depth of the sensor is more accurate, the operation during use is simple, the use is reliable, false triggering is avoided, and the applicable population is wider.

[0150] The above are only the preferred embodiments of the present invention. Any simple modifications and equivalent transformations made to the above embodiments based on the technical solutions of the present invention all belong to the scope of protection of the present invention.

[0151] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present invention is usually placed during use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first", "second", "third", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0152] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A sensor implantation device that inserts a transcutaneous analyte sensor into the skin of a recipient and can automatically withdraw it, characterized in that: Comprising; A touch-back component, including a triggering component and an insertion component disposed within the triggering component, the triggering component including a bracket (3) and a sliding cylinder (8) that are movably connected; A braking mechanism, including a housing (1), the touch-back component being disposed inside the housing (1) and being movable relative to the touch-back component between a distal end and a proximal end, the braking mechanism being triggered by an external force to provide a primary driving force for the device; A driving mechanism, mounted on the touch-back component, which is triggered by the braking mechanism to provide a secondary driving force for the device, the driving mechanism including an elastic member; Pressing the housing (1), the housing (1) moves towards the distal end to provide a primary driving force for the device, triggering the driving mechanism to be further compressed to provide a secondary driving force for the device, partially unlocking the touch-back component, the triggering component pushing the insertion component towards the distal end to complete the patch piercing action. After the insertion component is in place, the bracket (3) stops moving, and the sliding cylinder (8) continues to move towards the receptor skin side until it contacts the bracket (3). The touch-back component changes from partial unlocking to full unlocking, the driving mechanism continues to provide a secondary driving force, and the touch-back component moves towards the proximal end.

2. The sensor implantation device according to claim 1, wherein: The triggering component includes: A skeleton (7), received at the open end of the housing (1), and one end thereof contacts the receptor skin, and the housing (1) slides along the skeleton (7); A bracket (3), slidably mounted inside the skeleton (7) for fixing the sensor base assembly (5); A sliding cylinder (8), slidably mounted inside the skeleton (7) and capable of pushing the bracket (3) towards the distal end; A needle extractor (10), sleeved on the sliding cylinder (8) and slidably connected to the housing (1); A supporting platform (807) extends radially around the sliding cylinder (8), and the driving mechanism is disposed between the supporting platform (807) and the needle extractor (10).

3. The sensor implantation device according to claim 2, characterized in that: The insertion component includes: A needle seat (2), slidably mounted inside the sliding cylinder (8) and capable of pushing the bracket (3) towards the distal end, and its top extends towards both sides to form an extension arm (206) disposed above the needle extractor (10); A guiding needle (4), coupled to the bottom of the needle seat (2) and capable of fixing the position of the bracket (3).

4. A sensor implantation device according to claim 2, characterized in that: A first elastic buckle (705) is provided on the skeleton (7), and a corresponding first limiting rib (104) is provided inside the housing (1), and the first limiting rib (104) restricts the relative sliding between the skeleton (7) and the housing (1).

5. The sensor implantation device according to claim 3, characterized in that: A third limiting rib (101) is provided on the inner side wall of the housing (1), a fifth elastic buckle (1001) that is snap-connected thereto is provided on the needle extractor (10), a fourth elastic buckle (801) that contacts the fifth elastic buckle (1001) is provided on the sliding cylinder (8), and the third limiting rib (101) and the fourth elastic buckle (801) limit the relative movement between the needle extractor (10) and the housing (1).

6. A sensor implantation device according to any one of claims 2-5, characterized in that: The sliding cylinder (8) is provided with a second groove (802), and the framework (7) is provided with a second elastic buckle (701) clamped in the second groove (802) to limit the movement of the sliding cylinder (8) in the vertical direction; When the outer shell (1) moves towards the distal end, the first groove (102) provided on the inner side wall of the outer shell (1) is placed on one side of the second elastic buckle (701) to release the limit of the second elastic buckle (701) on the sliding cylinder (8).

7. The sensor implantation device according to claim 5, characterized in that: The upper part of the needle holder (2) is provided with a fourth groove (204), and when the fourth elastic buckle (801) moves to the fourth groove (204), the limit on the fifth elastic buckle (1001) in the horizontal direction is released.

8. The sensor implantation device according to claim 3, characterized in that: The lower part of the needle holder (2) is provided with a fifth groove (205), the sliding cylinder (8) is provided with a third limiting buckle (803) embedded in the fifth groove (205), and the framework (7) is provided with a limiting block (703) placed on one side of the third limiting buckle (803) to limit the opening and closing of the third limiting buckle (803) and lock the positional relationship between the sliding cylinder (8) and the needle holder (2); Below the limiting block (703) is provided with a third groove (707), and when the third limiting buckle (803) moves to the third groove (707), the limit of the third limiting buckle (803) is released, and the locked positional relationship between the sliding cylinder (8) and the needle holder (2) is released.

9. The sensor implantation device according to claim 3, characterized in that: The bottom of the needle holder (2) is provided with a sixth elastic buckle (202) and a push plate (201), and the push plate (201) abuts against the top of the bracket (3); The top of the guiding needle (4) is provided with a clamping protrusion (401) clamped in the sixth elastic buckle (202), which can drive the guiding needle (4) to move between the proximal end and the distal end.

10. The sensor implantation device according to claim 3, wherein: The top of the bracket (3) is provided with third elastic buckles (303) extending upward and in mirror image, and a needle guiding groove (301) penetrating through the bracket (3) is formed between the two third elastic buckles (303). The guiding needle (4) is placed in the needle guiding groove (301), and the guiding needle (4) is provided with an inclined surface (402) in contact with the inner top wall of the third elastic buckle (303).

11. A sensor implantation device according to claim 10, characterized in that: The top of the third elastic buckle (303) is provided with limiting columns (302) extending to both sides, and the sliding cylinder (8) is provided with second limiting ribs (804) in contact with them to limit the movement of the limiting columns (302) in the horizontal direction; When the sliding cylinder (8) moves towards the distal end, the second limiting ribs (804) release the limit on the limiting columns (302) in the horizontal direction, and the third elastic buckle (303) can shift towards the opening (8041) provided on the second limiting ribs (804).

12. The sensor implantation device according to claim 3, characterized in that: The bottom of the guiding needle (4) is provided with a guiding needle head (403) and a stabilizing plate (404) arranged on one side of the guiding needle head (403); A through hole (501) for guiding the needle (403) to pass through is provided on the sensor base assembly (5), and the stability plate (404) is inserted into a positioning groove (502) provided on the sensor base assembly (5).

13. The sensor implantation device according to claim 3, characterized in that: An elastic arm (306) is provided at the lower part of the bracket (3), a clamping groove (503) is provided on the inner side of the elastic arm (306), and a rib (304) is provided at the lower part of the sensor base assembly (5) and is clamped in the clamping groove (503).

14. A sensor implantation device according to any one of claims 1-5, 7-13, characterized in that: It further includes an end cap (6), and the end cap (6) is connected to the open end of the housing (1).

15. A sensor implantation device according to claim 14, characterized in that: The driving mechanism includes an elastic member (9).

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