Transcutaneous sensor patch device

Abstract

The present invention provides a transcutaneous sensor application device, comprising: a base, a handle, a guide needle and a sensor unit, the sensor unit comprising a sensor body and a sensor housing, the sensor housing being provided with a through hole for the guide needle to pass through; a support frame detachably fixed inside the handle; a sensor bracket coupled to the support frame, for supporting the sensor unit; a shuttle, for supporting the guide needle extending through the through hole; a driving assembly, for driving the shuttle to move toward a proximal position; when the handle moves from a first position to a second position, the support frame, the sensor bracket and the shuttle move as a whole from the proximal position to the distal position, and when the distal position is reached, the sensor bracket releases the sensor unit; the guide needle can be automatically inserted and removed, and the device is simple to operate, comfortable to use, compact in structure, safe and reliable, and conducive to promotion.

Description

Technical Field

[0001] The present invention relates to a medical device for monitoring an analyte in a living body, and more particularly to a device for inserting an analyte sensor into the skin of a recipient. Background Art

[0002] Diabetes is a disease caused by abnormalities in the pancreas that prevent the patient from producing enough insulin. Severe cases may develop a series of complications in the later stages, such as kidney failure and skin ulcers. The current medical level has not yet found a cure for the disease, and blood sugar can only be controlled through diet or insulin.

[0003] In most cases, diabetes patients use traditional blood glucose meters and blood glucose test strips to monitor blood glucose levels. The principle is to measure blood glucose by measuring the amount of current generated by the reaction between glucose in the blood and glucose oxidase in the test strip. Since the above blood glucose tests mostly use fingertip blood, diabetic patients need to measure their glucose levels every day at the time period specified by medical staff. In addition to the pain caused by repeated use of needles to draw blood, this detection method is also easily affected by external factors (diet, mood, exercise, etc.), and cannot effectively monitor the changing trend of blood glucose in patients.

[0004] With the development of blood sugar calibration technology, products for real-time dynamic blood sugar monitoring have appeared on the market. By implanting glucose sensor probes in the subcutaneous tissue of the human body, the changes in human blood sugar can be monitored in real time. The sensor probe, in conjunction with external equipment, can dynamically monitor the changes in blood sugar values ​​in diabetic patients 24 hours a day, providing professional medical staff with reliable data information, so as to better treat diabetic patients.

[0005] However, the continuous blood glucose sensor application devices currently available on the market still lack convenience and comfort. For example, the application device disclosed in patent EP2327362A1, although it meets the function of applying the transcutaneous sensor to the recipient's skin, the insertion and removal of the guide needle of the device are completely completed manually by the patient. Not only is the operation inconvenient, but it also brings psychological fear to the patient himself. For example, the analyte sensor installation device disclosed in patent CN 106137214 A, although the insertion and removal of the guide needle are achieved with the help of two springs, there is impact during the application process, which is easy to cause the vibration of the guide needle in the skin, aggravating the user's pain; furthermore, the device uses two release buttons, and improper pressure during the user's use process is easy to cause non-triggering or mis-triggering, and the risk of accidental injury is high. For example, the applicator for applying the sensor assembly on the skin to the recipient's skin disclosed in patent CN 206777328 U realizes the automatic insertion and removal of the guide needle very well, and the user only needs to press one button to complete the operation. However, the applicator has a complex structure, and the position accuracy of the sensor probe, guide needle and seal is very high. In addition, the applicator and the sensor component structure are highly correlated, making it difficult to use with sensors from external manufacturers. This results in high cost of the applicator, which is not conducive to the promotion and popularization of the product. Summary of the invention

[0006] The technical problem to be solved by the present invention is to overcome the above-mentioned defects of the known technology and provide a transcutaneous sensor application device, which can realize automatic insertion and removal of the guide needle, and has simple operation, comfortable use, compact structure, safety and reliability, and is conducive to promotion.

[0007] The present invention is implemented by the following technical solutions. The transcutaneous sensor application device provided by the present invention comprises:

[0008] a base having a surface for placement on the skin of a recipient;

[0009] a handle movable relative to the base between a proximal position and a distal position;

[0010] The sensor assembly comprises a guide needle and a sensor unit, wherein the sensor unit comprises a sensor body and a sensor housing, and the sensor housing is provided with a through hole for the guide needle to pass through;

[0011] A support frame detachably fixed inside the handle;

[0012] a sensor bracket coupled to the support frame, for supporting the sensor unit;

[0013] a shuttle member for supporting a guide needle extending through the through hole;

[0014] A driving assembly, used for driving the shuttle to move toward a proximal position;

[0015] The device is configured such that when the handle moves from the first position to the second position, the support frame, the sensor holder and the shuttle move as a whole from the proximal position to the distal position, and the sensor holder releases the sensor unit when reaching the distal position;

[0016] When the handle moves from the second position to the third position, the drive assembly drives the shuttle toward the proximal position, thereby withdrawing the introducer needle from the sensor unit and the recipient's skin.

[0017] The present invention can also be further implemented by taking the following technical solutions:

[0018] The aforementioned transcutaneous sensor applicator, wherein a first slide groove is provided on both sides of the support frame, and a first slider is slidably connected in the first slide groove through a first elastic member; first finger pins are formed on both sides of the base below its top end surface, which are used to cooperate with the first slider and the first elastic member to form a first triggering part; in the initial structure, the first finger pin is engaged with the first slider, and the support frame is locked relative to the base.

[0019] The aforementioned transcutaneous sensor patch device, wherein the sensor bracket includes a bracket, a through groove is provided on the side wall of the bracket; second slide grooves are provided on both sides of the shuttle, and a second slider is slidably connected in the second slide groove through a second elastic member; in the initial structure, the upper surface of the second slider is engaged with the through groove, and the shuttle is locked relative to the sensor bracket. The inner wall of the base extends to form a convex rib, which is used to cooperate with the second slider and the second elastic member to form a second triggering part.

[0020] Preferably, the aforementioned transcutaneous sensor applicator device, wherein a third slide groove is further provided above the first slide groove, and a third slider is slidably connected in the third slide groove through a third elastic member; a limiting rib is formed on the inner wall of the handle; in the initial structure, the upper end surface of the third slider is engaged with the limiting rib, and the handle is locked relative to the support frame; the second finger pin is used to cooperate with the third slider, the third elastic member and the limiting rib to form a third trigger part.

[0021] Preferably, in the aforementioned transcutaneous sensor applicator, the third slider is composed of a main body and a protrusion extending from the middle of the front end surface of the main body, and working inclined surfaces cooperating with the second finger pin are formed at the front ends of both sides of the main body.

[0022] The aforementioned transcutaneous sensor patch device, wherein the driving assembly comprises a one-way transmission assembly consisting of a first gear and a second gear matched with coaxial end faces, a first vertical rack disposed on the inner wall of the handle, and a second vertical rack disposed on the back of the shuttle, the first gear being used to mesh with the first vertical rack, and the second gear being used to mesh with the second vertical rack;

[0023] Optionally, in the aforementioned transcutaneous sensor patch device, the inner end surface of the first gear is provided with a plurality of grooves, the inner end surface of the second gear is provided with a plurality of corresponding protrusions, and the inner walls of the grooves and the surfaces of the protrusions are respectively formed with mutually matching inclined surfaces;

[0024] Optionally, the aforementioned transcutaneous sensor applicator device, wherein the inner end face of the first gear has a recessed portion, a plurality of elastic arms are formed on the side walls of the recessed portion, a plurality of notches are formed on the bottom of the recessed portion, and the notches provide deformation space for the elastic arms; and the inner end face of the second gear is provided with ratchet teeth corresponding to the elastic arms.

[0025] The aforementioned transcutaneous sensor patch device, wherein the handle is at least partially disposed around the base.

[0026] The aforementioned transcutaneous sensor patch device, wherein the sensor bracket further comprises a base, the bottom surface of the base is formed with a receiving portion for accommodating the sensor unit, for releasably clamping the sensor unit; the base is also provided with a through hole for the guide needle to pass through.

[0027] The aforementioned transcutaneous sensor applicator, wherein the front end of the shuttle is provided with an elastic buckle. In the initial position, one end of the guide needle cooperates with the elastic buckle through the clamping portion, and the other end passes through the through holes on the base and the sensor housing in turn, and does not exceed the bottom end surface of the base.

[0028] The aforementioned transcutaneous sensor patch device, wherein the guide needle is a slotted needle.

[0029] In summary, compared with the prior art, the present invention has at least the following beneficial effects:

[0030] (1) The present invention configures the application device and the sensor as one device, so that the user can complete the application of the sensor without additional assembly, thereby simplifying the operation steps and avoiding misoperation during the assembly process.

[0031] (2) The patch application device of the present invention utilizes a one-way transmission assembly composed of a first gear and a second gear to achieve automatic insertion and removal of the guide needle without manual operation; and the entire process is smooth and free of impact and vibration; the user operation is simple and comfortable.

[0032] (3) The drive assembly of the present invention can well ensure the meshing of the handle and the first gear, while avoiding the influence of the movement of the handle on the position of the shuttle during the assembly process.

[0033] (4) The patch application device of the present invention has a compact structure, is safe and reliable, and is easy to promote. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic diagram of the overall assembly of the present invention;

[0035] Figure 2 Provide a schematic diagram for assembling the sensor assembly;

[0036] Figure 3 Assemble the schematic diagram of the sensor unit;

[0037] Figure 4 It is a schematic diagram of the use process of the patch application device of the present invention;

[0038] Figure 5 A partial cross-sectional view of the housing of the handle;

[0039] FIG6 (a) is a schematic top view of the upper cover of the handle;

[0040] FIG6 (b) is a bottom view of the upper cover of the handle;

[0041] Figure 7 is a schematic diagram of the support frame;

[0042] Figure 8 is a schematic diagram of the base;

[0043] Fig. 9 This is a schematic diagram of the sensor bracket;

[0044] Figure 10(a) is a schematic diagram of a shuttle;

[0045] FIG10( b ) is a schematic diagram of the shuttle from another angle;

[0046] Fig.11 is a schematic diagram of the initial installation of the shuttle on the sensor bracket;

[0047] FIG12( a ) is a schematic diagram of the assembly of a one-way transmission assembly;

[0048] FIG12( b ) is a schematic diagram of the assembly of the one-way transmission assembly from another angle;

[0049] Fig.13 A partial cross-sectional view illustrating a drive assembly;

[0050] FIG14( a ) is a schematic diagram of an alternative solution for a one-way transmission assembly;

[0051] FIG14( b ) is a schematic diagram of the assembly of an alternative solution for a one-way transmission assembly;

[0052] FIG14( c ) is a schematic diagram of assembling an alternative solution of a one-way transmission assembly from another angle;

[0053] Fig.15 This is a schematic diagram of the handle and the base being combined in the initial state;

[0054] Fig.16 This is a schematic diagram of the initial state of the support frame and the base being combined;

[0055] Fig.17 for Fig.15 A partial cross-sectional view taken along the AA line, illustrating the state of the first triggering unit before triggering;

[0056] Fig.18 for Fig.15 A partial cross-sectional view along the AA line, illustrating the state of the first triggering unit after being triggered;

[0057] Fig.19 It is a cross-sectional view of a first trigger part replacement scheme;

[0058] Fig. 20 for Fig.15 A partial cross-sectional view taken along line BB, illustrating the state of the second triggering portion before triggering;

[0059] Fig.21 for Fig.15 A partial cross-sectional view along the line BB, illustrating the state of the second triggering unit after being triggered;

[0060] Fig. 22 A cross-sectional view of a second trigger portion replacement scheme;

[0061] Fig.23 is a schematic diagram of the structure of the third slider;

[0062] Fig.24 for Fig.15 A partial cross-sectional view taken along the line AA, illustrating a state before the third triggering unit is triggered;

[0063] Fig.25 for Fig.15 A partial cross-sectional view taken along the line AA, illustrating a first state after the third triggering unit is triggered;

[0064] Fig.26 for Fig.15 A partial cross-sectional view taken along the line AA, illustrating the second state after the third triggering unit is triggered;

[0065] Fig. 27 It is a cross-sectional view of a third trigger portion replacement scheme;

[0066] Fig.28 It is a schematic diagram of the final state of the patch application device of the present invention. DETAILED DESCRIPTION

[0067] The structure, features and effects of the present invention are described in detail below in conjunction with the accompanying drawings and preferred embodiments:

[0068] like Figures 1 to 3 As shown, the present invention provides a transcutaneous sensor patch device, comprising:

[0069] a base 1 having a surface for placement on the skin of a recipient;

[0070] A handle 2, movable relative to the base between a proximal position and a distal position;

[0071] The sensor assembly comprises a guide needle 3 and a sensor unit 4, wherein the sensor unit 4 comprises a sensor body 41 and a sensor housing 42, wherein the sensor housing 42 is provided with a through hole 421 for the guide needle to pass through;

[0072] A support frame 5 detachably fixed inside the handle;

[0073] a sensor bracket 6 coupled to the support frame, for supporting the sensor unit 4;

[0074] A shuttle 7, used for supporting the guide needle 3 extending through the through hole 421;

[0075] A driving assembly, used for driving the shuttle to move toward a proximal position;

[0076] The transcutaneous sensor patch device also includes a protective cover 10, which is combined with the open end of the handle 2 to provide a sterile and pollution-free environment for the sensor assembly. For example, it can be connected and fixed by means of threads or hooks. A desiccant is arranged in the protective cover, and one or more holes are opened at the bottom to allow sterilizing gas to enter. Preferably, the outside of the protective cover is covered with a light-shielding sealing aluminum foil film.

[0077] The base 1 has a surface for being placed on the recipient's skin; the handle 2 is at least partially arranged around the base 1 and can be pushed relative to the base to push at least a portion of the sensor body 41 into the recipient's skin.

[0078] An embodiment of the sensor unit 4 is shown in Figure 3In the embodiment, the sensor unit 4 further includes an electronic unit 43 and a battery assembly 44. The electronic unit may include, for example, an analog interface, a processor, a communication unit, etc. for connecting to the sensor body 41. The sensor housing 42 includes an upper shell 422 and a lower shell 423. The sensor body 41 further has an insertion portion 411 for inserting into the skin of a subject. The end surface of the lower shell is provided with an adhesive layer 4231 for attaching the sensor unit to the skin of the subject.

[0079] Figure 4 The process of using the patch device of the present invention is shown, firstly, the protective cover 10 is removed to expose the base 1; then the patch device is placed on the skin surface S of the subject, the handle 2 is pressed down until the handle moves to the farthest position, and the patch device is removed; finally, the sensor unit 4 remains on the skin surface S, and the guide needle is retracted into the patch device. This will be described in more detail below.

[0080] Further, such as Figure 5 As shown in Figures 6(a) and 6(b), the handle 2 includes a shell 21 and an upper cover 22 fixed on the top of the shell. For example, the handle 2 can be fixed by providing an annular groove 211 on the top of the inner wall of the shell 21 and configuring a corresponding annular buckle 221 on the bottom side wall of the upper cover 22. Alternatively, the handle 2 can be connected by ultrasonic pressing or buckling.

[0081] A guide groove 212 is further provided on the inner wall of the housing 21 in the vertical direction, and the lower end of the guide groove is closed. Preferably, the number of the guide grooves is two or more.

[0082] like Figure 7 As shown, the inner side of the support frame 5 forms a receiving portion for accommodating the sensor bracket 6 and the shuttle 7; the outer side of the support frame 5 is provided with a guide rib 51, the position of the guide rib 51 corresponds to the guide groove 212, and the number is consistent with the number of guide grooves; the above structure is adopted to keep the support frame and the handle in a fixed position, while ensuring the stability and smoothness of the handle movement process, thereby ensuring that the movement trajectory of the guide needle is parallel to the axis of the shell during the insertion process, reducing the movement of the needle tip and reducing the user's pain. The top of the support frame 5 is coupled with the bottom of the upper cover 22 of the handle, for example: it can be connected by setting a buckle 222 at the bottom of the upper cover 22 (as shown in Figure 6 (b)) and a corresponding card slot 52 at the top of the support frame 5. Through the above coupling, it can be ensured that the handle reliably wraps the remaining components after the application is completed, preventing the structural parts from being displaced and causing unnecessary injuries.

[0083] The lower end of the guide rib 51 extends to form an extension portion 53, and the width of the guide rib 51 is greater than the width of the extension portion 53;

[0084] The support frame 5 is provided with first slide grooves 54 on both sides, and a first slider 542 is slidably connected to the first slide grooves via a first elastic member 541; preferably, the first elastic member 541 is a spring. Preferably, a third slide groove 55 is further provided above the first slide groove, and a third slider 552 is slidably connected to the third slide groove 55 via a third elastic member 551; preferably, the third elastic member 551 is a spring.

[0085] like Figure 8 As shown, the bottom of the base 1 has a substantially flat surface for being placed on the skin of a recipient; a longitudinal notch 11 is provided from the top of the base 1 to provide a certain movable space for the extension 53, and the position and number of the longitudinal notch 11 correspond to the extension 53; first finger pins 12 are formed on both sides of the base 1 and are lower than the top end surface thereof, and are used to cooperate with the first slider 542 and the first elastic member 541 to form a first triggering portion; preferably, second finger pins 13 are also formed on both sides of the base 1 and are higher than the top end surface thereof;

[0086] like Fig. 9 As shown, the sensor bracket 6 includes a bracket 61 and a base 62. The side wall of the bracket 61 is provided with a through groove 611. The bottom surface of the base 62 is formed with a receiving portion for accommodating the sensor unit 4. Further, the receiving portion is symmetrically provided with elastic arms 621. The bottom end of the inner wall of the base 1 is correspondingly provided with a convex rib 14. The elastic arms 621 cooperate with the convex rib 14 to clamp the sensor unit. Preferably, the inner side of the elastic arm is also provided with a protrusion 6211. The protrusion 6211 is in contact with the groove 424 (as shown in FIG. 4 ) correspondingly provided on the sensor housing 42. Figure 2 The base 62 is engaged with the sensor unit 4 to further clamp the sensor unit 4. The base 62 is also provided with a through hole 622 for the guide needle to pass through.

[0087] As shown in Figures 10(a) and 10(b), the front end of the shuttle 7 is provided with an elastic buckle 71 for fixing the clamping portion of the guide needle; second slide grooves 72 are provided on both sides of the shuttle, and a second slider 722 is slidably connected in the second slide groove 72 via a second elastic member 721; preferably, the second elastic member 721 is a spring.

[0088] like Fig.11 As shown, in the initial configuration, the upper surface of the second slider 722 engages with the through slot 611, and the shuttle 7 is locked relative to the sensor bracket 6. Figure 8 As shown, the inner wall of the base 1 is further extended to form a flange 15 for cooperating with the second slider 722 and the second elastic member 721 to form a second triggering portion.

[0089] In the initial structure, one end of the guide needle 3 is fixed on the shuttle 7 by the cooperation of the clamping part and the elastic buckle 71, and the other end passes through the through holes 622 and 421 on the base 62 and the sensor housing 42 in turn, and does not exceed the bottom end surface of the base 1.

[0090] As shown in Figure 12 (a), Figure 12 (b), Fig.13 As shown, the driving assembly includes a one-way transmission assembly consisting of a first gear 8 and a second gear 9, a first vertical rack 213 (as shown in FIG. Figure 5 10 (a) and a second vertical rack 73 arranged on the back of the shuttle 7 (as shown in FIG. 10 (a)); the first gear 8 and the second gear 9 are coaxially mounted on the gear mounting arm 56 of the support frame 5 (as shown in FIG. Figure 7 The first gear 8 is used to mesh with the first vertical rack 213, and the second gear 9 is used to mesh with the second vertical rack 73; the inner end surface of the first gear 8 is provided with a plurality of grooves 81, and the inner end surface of the second gear 9 is provided with a plurality of corresponding protrusions 91, and the inner wall of the groove 81 and the surface of the protrusion 91 are respectively formed with mutually matching inclined surfaces 811 and 911; the outer end surface of the first gear 8 is provided with an annular groove 82, and a compression spring 83 is sleeved in the annular groove 82, and the other end of the compression spring 83 is against the gear mounting arm 56; By setting a compression spring, the first gear and the second gear always keep in close contact; by adopting the above structure, when the handle moves toward the distal end, the protrusion 91 meshes with the groove 81, the first vertical rack drives the first gear to rotate, the first gear transmits the motion to the second gear and rotates at the same speed, and the second gear drives the shuttle to move toward the proximal end by meshing with the second vertical rack; when the handle moves toward the proximal end, the inclined surfaces 811 and 911 cooperate, especially when the shuttle 7 is limited, so that the second gear 9 remains stationary, the first gear 8 performs idling motion and performs reciprocating axial motion on the shaft. The transmission ratio of the first gear and the second gear is ≥1, such as 2, 3, etc. Preferably, the number of the protrusions 91 and the grooves 81 is 5; preferably, the protrusions and grooves are evenly distributed. The above structure ensures that the entire needle return process is smooth and stable, and ensures that the needle return path coincides with the insertion path, which can effectively reduce the pain caused by the vibration of the spring drive, and at the same time avoid the psychological panic caused by the vibration of the application device caused by the impact force of the spring driven by the key. By adopting a one-way transmission component, unnecessary movement between components during assembly can be avoided, thereby ensuring smooth assembly.

[0091] Preferably, the end of the axle 94 outside the second gear 9 has a bevel 941, which is used for guiding during the assembly process.

[0092] Preferably, the outer end surface of the second gear 9 is provided with a boss 95, and the inner wall of one side of the gear mounting arm 56 is provided with an anti-fouling rib 561 (such as Figure 7 As shown in FIG. 1 ), the boss 95 interferes with the foolproof rib 561 to form a foolproof structure. The foolproof structure can prevent the second gear from being installed in the wrong direction; further, the circumscribed circle diameter of the foolproof rib 561 is slightly smaller than the inner diameter of the clamping spring 83, thereby limiting the position of the clamping spring. Optionally, the foolproof rib can be replaced by a round table, a square table or a ring rib.

[0093] Preferably, the top of the inner wall of the housing 21 is provided with a protrusion 215 (such as Figure 5 As shown in FIG. 1 ), the protrusion 215 corresponds to the first gear 8 and the second gear 9 to prevent the housing from being installed in the wrong direction during assembly, causing the transmission mechanism to not move. Figure 14(a) to Figure 14(c) As shown, alternatively, the above-mentioned transmission mode of the first gear and the second gear through the groove and the protrusion can be replaced by a one-way transmission mode of the ratchet and the elastic arm; for example: the inner end surface of the first gear 8 has an inner concave portion, the side wall of the inner concave portion is formed with a plurality of elastic arms 82, and the bottom of the inner concave portion is formed with a plurality of notches 83, and the notches 83 provide deformation space for the elastic arms 82; the inner end surface of the second gear 9 is provided with ratchet teeth 96 corresponding to the elastic arms. When the first gear 8 rotates clockwise, the elastic arms 82 thereon contact with the ratchet teeth 96, and the elastic arms are elastically deformed to form a sliding contact, and no movement can be transmitted to the second vertical rack 73. When the first gear 8 rotates counterclockwise, the elastic arms 82 thereon engage with the ratchet teeth 96, so the first gear can transmit the movement to the second vertical rack 73 through the second gear. By setting the notches 83, it can be ensured that the deformation amount of each position of the elastic arm parallel to the axis is consistent. Optionally, the elastic arm may also be arranged on the second gear, and the ratchet teeth may be arranged on the first gear; optionally, the number of the ratchet teeth may be greater than, equal to or less than the number of the elastic arms.

[0094] like Figures 15 to 18 As shown, in the initial configuration of the patch device, the handle 2 is set at the proximal position (first position) relative to the base 1. In this configuration, the first finger pin 12 is engaged with the first slider 542 to form a first trigger portion; at this time, the support frame 5 and the base 1 are in a locking relationship; when the user applies manual force (≤10N) to the handle, the working inclined surface 121 (such as the first finger pin 12) of the first finger pin 12 is in the process of moving toward the distal end (downward). Figure 8 ) and the working inclined surface 5421 of the first sliding block 542 (as shown Figure 7As shown in the figure, the first slider contacts and slides, causing the first slider to move backward, and the first elastic member 541 is compressed, so that the support frame 5 is decoupled from the base 1; the manual force required by the user here is ≤10N. The handle 2, the support frame 5, the sensor bracket 6 and the shuttle 7 move distally as a unit; the first sliders on both sides of the support frame are always in contact with the inner wall of the base under the action of the first elastic member, and generate friction. Due to the continuous existence of friction, the discomfort caused to the user by the sudden movement of the application device to the distal end after the first trigger part is triggered is avoided. Optionally, the working inclined surface 121 can be a plane or an arc surface.

[0095] Alternatives, such as Fig.19 As shown, the first trigger part can be formed on both sides of the base 1 with a first elastic buckle 16 lower than the top end surface thereof to abut against the bottom end of the side wall of the support frame 5. The first elastic buckle 16 is composed of an elastic arm 161 and a buckle 162. The use of this alternative structure can reduce the complexity of the mold during the injection molding process of the parts, while reducing the number of parts, thereby reducing the assembly time. The friction between the first elastic buckle and the support frame can be adjusted by the thickness, width, height and deformation of the elastic arm. Specifically, the thickness of the elastic arm 161 can be 1.0mm, 1.2mm, not exceeding 2.0mm; the width of the elastic arm 161 can be 3.0mm, 3.2mm, not exceeding 5.0mm; the height of the elastic arm 161 can be 3.0mm, 4.0mm, not exceeding 20mm, and the bite amount of the buckle 162 can be 0.4mm, 0.6mm, not exceeding 2.0mm.

[0096] like Fig. 20 , Fig.21 As shown, as the guide needle 3 is pushed toward the distal end, it carries the insertion portion 411 of the sensor body 41 into the recipient's skin and contacts the tissue fluid. As the handle moves to the second position, the sensor bracket 6 reaches the most distal position, the elastic arm 621 is freed from the restriction of the rib 14, the sensor housing is released, and the sensor unit 4 is fixed on the recipient's skin surface through the adhesive layer on the distal surface of the sensor housing 42.

[0097] At the same time, as the guide needle is pushed toward the distal end, the second slider 722 engages with the flange 15 extending from the inner wall of the base 1 to form a second triggering portion; the side wall of the bracket 61 is also provided with a long groove 612 (such as Fig. 9 As shown); subsequently, the working inclined surface 7221 of the second slider 722 contacts and slides with the working inclined surface 151 of the flange 15, so that the second slider 722 moves backward and the second elastic member 721 is compressed. Until the sensor bracket 6 reaches the farthest position, the upper end surface of the second slider 722 is separated from the limit of the through groove 611, so that the shuttle 7 is decoupled from the sensor bracket 6.

[0098] Alternatives, such as Fig. 22 As shown, the second triggering part can be provided with second elastic buckles 74 on both sides of the shuttle to engage with the flange 15. The structure and principle of the second elastic buckle are the same as those of the first elastic buckle, which will not be repeated here.

[0099] Better, such as Figure 23 to Figure 28 The application device further includes a third triggering portion, which is formed by the third slider 552, the third elastic member 551, the second finger pin 13 and the limiting rib 214 (such as Figure 5 As shown in the figure, in the initial position, the upper end surface of the third slider 552 is engaged with the limiting rib 214; at this time, the handle 2 and the support frame 5 are in a locking relationship; further, the third slider 552 is composed of a main body 5521 and a protrusion 5522 extending from the middle of the front end surface of the main body. As the guide needle is pushed toward the distal end, the working inclined surfaces 55211 at the front ends of both sides of the main body contact and slide with the working inclined surfaces 131 of the second finger pin 13, so that the third slider 552 moves backward, and the third elastic member 551 is compressed until the sensor bracket 6 reaches the farthest position, that is, at the same time or later when the second triggering part is triggered, the limiting rib 214 is separated from the limiting of the upper end surface of the third slider 552, so that the handle and the support frame are decoupled. By setting the third triggering part, the movement trend of the housing can be prevented from interfering with the decoupling of the shuttle and the sensor bracket, thereby ensuring that the shuttle and the sensor bracket can be decoupled instantly. Preferably, in order to ensure the smooth movement of the third slider 553, two third elastic members 551 can be provided.

[0100] Alternatives, such as Fig.19 , Fig. 27 As shown, a third elastic buckle 57 may be provided on both sides of the support frame 5 to replace the third slider and the third elastic member. The structure and principle of the third elastic buckle 57 may be the same as the first elastic buckle, which will not be described in detail.

[0101] As the sensor bracket reaches the farthest position, the first gear 8 engages with the first vertical rack 212, and the second gear 9 engages with the second vertical rack 73; when the handle continues to move toward the farthest end, the first vertical rack drives the first gear to rotate, and the first gear transmits the motion to the second gear and rotates at the same speed, and the second gear drives the shuttle to move toward the proximal end by engaging with the second vertical rack. When the handle moves to the farthest position (the third position), the guide needle 3 retracts to the inside of the application device.

[0102] Continuing with FIG. 6 (a), preferably, the top of the upper cover 22 is also provided with a sensor mark 223 and a guide needle mark 224, wherein the sensor mark 223 is used to identify the projection position of the sensor on the upper cover, and the guide needle mark 224 is used to identify the projection position of the guide needle or the sensor body on the upper cover, so as to help the user identify the orientation and the direction of application. Preferably, the top of the inner wall of the shell 21 is provided with a convex rib 216 (such as Figure 5 As shown in FIG. 1 ), the bottom side wall of the upper cover 22 is provided with a notch 225 that cooperates with the convex rib 216 to prevent the upper cover from being assembled in the wrong direction, which would cause the mark on the upper cover to be in the wrong direction.

[0103] In summary, the transcutaneous sensor application device of the present invention realizes automatic insertion and removal of the guide needle, and is simple to operate, comfortable to use, compact in structure, safe and reliable, and is conducive to promotion.

[0104] The above are only preferred embodiments of the present invention. Any simple modification and equivalent transformation of the above embodiments according to the technical solution of the present invention shall fall within the protection scope of the present invention.

Claims

1. A transcutaneous sensor patch device, comprising: a base having a surface for placement on the skin of a recipient; a handle movable relative to the base between a proximal position and a distal position; The sensor assembly comprises a guide needle and a sensor unit, wherein the sensor unit comprises a sensor body and a sensor housing, and the sensor housing is provided with a through hole for the guide needle to pass through; A support frame detachably fixed inside the handle; The support frame is provided with first slide grooves on both sides, and a first slider is slidably connected in the first slide grooves through a first elastic member; first finger pins are formed on both sides of the base and are lower than the top end surface thereof, and in the initial configuration, the first finger pins are engaged with the first slider, and the support frame is locked relative to the base; A sensor bracket coupled to the support frame, used to support the sensor unit; the sensor bracket includes a bracket, and a through groove is provided on the side wall of the bracket; a second slide groove is provided on both sides of the shuttle, and a second slider is slidably connected in the second slide groove through a second elastic member; in the initial configuration, the upper surface of the second slider is engaged with the through groove, and the shuttle is locked relative to the sensor bracket; a shuttle member for supporting a guide needle extending through the through hole; A driving assembly, used for driving the shuttle to move toward a proximal position; The driving assembly includes a one-way transmission assembly consisting of a first gear and a second gear matched with coaxial end faces, a first vertical rack arranged on the inner wall of the handle, and a second vertical rack arranged on the back of the shuttle, the first gear is used to mesh with the first vertical rack, and the second gear is used to mesh with the second vertical rack; The device is configured such that when the handle moves from the first position to the second position, the support frame, the sensor holder and the shuttle move as a whole from the proximal position to the distal position, and the sensor holder releases the sensor unit when reaching the distal position; When the handle moves from the second position to the third position, the drive assembly drives the shuttle toward the proximal position, thereby withdrawing the introducer needle from the sensor unit and the recipient's skin.

2. The transcutaneous sensor patch device according to claim 1, characterized in that: The first finger pin is used to cooperate with the first sliding block and the first elastic member to form a first triggering portion.

3. The transcutaneous sensor patch device according to claim 2, characterized in that: The inner wall of the base is extended to form a convex rib for cooperating with the second sliding block and the second elastic member to form a second triggering portion.

4. The transcutaneous sensor patch device according to claim 3, characterized in that: A third slide groove is also provided above the first slide groove, and a third slider is slidably connected in the third slide groove through a third elastic member; a limiting rib is formed on the inner wall of the handle; in the initial structure, the upper end surface of the third slider is engaged with the limiting rib, and the handle is locked relative to the support frame; second finger-shaped pins higher than the top end surface are also formed on both sides of the base, and the second finger-shaped pins are used to cooperate with the third slider, the third elastic member and the limiting rib to form a third trigger part.

5. The transcutaneous sensor patch device according to claim 4, characterized in that: The third sliding block is composed of a main body and a protruding portion extending from the middle of the front end surface of the main body. The front ends of both sides of the main body are formed with working inclined surfaces that match the second finger pins.

6. The transcutaneous sensor patch device according to claim 1, characterized in that: The inner end surface of the first gear is provided with a plurality of grooves, the inner end surface of the second gear is provided with a plurality of corresponding protrusions, and the inner walls of the grooves and the surfaces of the protrusions are respectively formed with mutually matching inclined surfaces.

7. The transcutaneous sensor patch device according to claim 1, characterized in that: The inner end surface of the first gear has an inner recess, the side wall of the inner recess is formed with a plurality of elastic arms, the bottom of the inner recess is formed with a plurality of notches, and the notches provide deformation space for the elastic arms; the inner end surface of the second gear is provided with ratchet teeth corresponding to the elastic arms.

8. The transcutaneous sensor patch device according to claim 1, characterized in that: The handle is disposed at least partially around the base.

9. The transcutaneous sensor patch device according to claim 1, characterized in that: The sensor bracket also includes a base, and a receiving portion for accommodating the sensor unit is formed on the bottom surface of the base, which is used to releasably clamp the sensor unit; the base is also provided with a through hole for the guide needle to pass through.

10. The transcutaneous sensor patch device according to claim 9, characterized in that: An elastic buckle is arranged at the front end of the shuttle. In the initial position, one end of the guide needle cooperates with the elastic buckle through the clamping part, and the other end passes through the through holes on the base and the sensor housing in sequence and does not exceed the bottom end surface of the base.

11. The transcutaneous sensor patch device according to claim 1, characterized in that: The introducer needle is a slotted needle.

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