CN111588387A

CN111588387A - Percutaneous sensor application device

Info

Publication number: CN111588387A
Application number: CN202010510302.9A
Authority: CN
Inventors: 施广平; 李宁
Original assignee: Tianjin Jiu'an Medical Electronics Co ltd
Current assignee: Tianjin Jiu'an Medical Electronics Co ltd
Priority date: 2020-06-08
Filing date: 2020-06-08
Publication date: 2020-08-28

Abstract

The present invention provides a transcutaneous sensor application device, comprising: the sensor comprises a base, a handle, a guide needle and a sensor unit, wherein the sensor unit comprises a sensor body and a sensor shell, and the sensor shell is provided with a through hole for the guide needle to pass through; the support frame is detachably and fixedly arranged in the handle; a sensor holder coupled to the support frame for supporting the sensor unit; a shuttle for supporting an introducer needle extending through the through bore; a drive assembly for driving the shuttle to move to a proximal position; when the handle is moved from a first position to a second position, the support frame, sensor carriage and shuttle as a whole move from a proximal position to a distal-most position, and the sensor carriage releases the sensor unit when the distal-most position is reached; the guide needle can be automatically inserted and pulled out, and the device is simple to operate, comfortable to use, compact in structure, safe and reliable and beneficial to popularization.

Description

Percutaneous sensor application device

Technical Field

The present invention relates to a medical device for monitoring an analyte in vivo, and in particular to an apparatus for inserting an analyte sensor into the skin of a subject.

Background

Diabetes is a disease caused by the abnormal condition of pancreas in a patient and the failure to produce sufficient insulin. More severe patients may be accompanied later by a series of complications, such as renal failure, skin ulcers. At the current medical level, no method for radically treating the disease is found, and only blood sugar can be controlled by diet or insulin and the like.

In most cases, diabetes mellitus uses a conventional glucose meter and glucose strip to monitor blood glucose values by measuring the amount of blood glucose by measuring the current produced by the reaction of glucose in the blood and glucose oxidase in the strip. Since the above-mentioned blood sugar test mostly uses finger tip blood, a diabetic needs to measure his or her glucose level every day at a time period designated by a medical staff. Besides the pain caused by the repeated use of the acupuncture blood sampling, the detection mode is also easily influenced by external factors (diet, emotion, exercise and the like), and the change trend of the blood sugar in the body of a patient cannot be effectively monitored.

With the development of blood sugar calibration and measurement technology, products for monitoring dynamic blood sugar in real time appear on the market, and the change of the blood sugar of a human body is monitored in real time through a glucose sensor probe implanted into subcutaneous tissues of the human body. The sensor probe is matched with external equipment, can dynamically monitor the change of the blood sugar value in the body of the diabetic patient within 24 hours, and provides reliable data information for professional medical personnel, so that the diabetic patient can be better treated.

However, the continuous blood glucose sensor applicator devices currently available on the market still lack convenience and comfort. The insertion and extraction of the introducer needle of the device as disclosed in patent EP2327362a1, although fulfilling the function of applying the transcutaneous sensor to the skin of the subject, is entirely performed manually by the patient. Not only is the operation inconvenient, but also can bring psychological fear to the patient. As the analyte sensor mounting apparatus disclosed in patent CN 106137214 a, although the insertion and extraction of the introducer needle are realized by 2 springs, there is an impact during the application process, which easily causes the vibration of the introducer needle in the skin, and aggravates the pain of the user; moreover, this equipment uses 2 release buttons, and the user uses the improper degree of pressure to cause easily and does not trigger or trigger by mistake, and unexpected injury risk is higher. The applicator for applying the on-skin sensor assembly to the skin of a subject, as disclosed in patent CN 206777328U, advantageously allows for automatic insertion and extraction of the introducer needle, the user having to press only 1 key to complete the operation. However, the applicator is complex, requires high precision in the positioning of the sensor probe, introducer needle and seal, and is highly associated with the sensor assembly structure, making it difficult to use with sensors from outside manufacturers. Resulting in high cost of the applicator, which is not favorable for popularization and civilization of the product.

Disclosure of Invention

The technical problem to be solved by the invention is to overcome the defects in the prior art, and provide a percutaneous sensor application device, which realizes automatic penetration and extraction of a guide needle, has simple operation, comfortable use, compact structure, safety and reliability, and is beneficial to popularization.

The invention is realized by the following technical scheme, and the percutaneous sensor application device provided by the invention comprises:

a base having a surface for placement on the skin of a subject;

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 shell, and the sensor shell is provided with a through hole for the guide needle to pass through;

the support frame is detachably and fixedly arranged in the handle;

a sensor holder coupled to the support frame for supporting the sensor unit;

a shuttle for supporting an introducer needle extending through the through bore;

a drive assembly for driving the shuttle to move to a proximal position;

the device is configured such that when the handle is moved from a first position to a second position, the support frame, sensor carriage and shuttle as a whole move from a proximal position to a distal-most position, and when the distal-most position is reached the sensor carriage releases the sensor unit;

when the handle is moved from the second position to the third position, the drive assembly drives the shuttle to move to the proximal position, thereby withdrawing the introducer needle from the sensor unit and the skin of the subject.

The invention can be further realized by adopting the following technical scheme:

in the percutaneous sensor application device, first sliding grooves are formed in two sides of the support frame, and a first sliding block is connected in the first sliding grooves in a sliding manner through a first elastic piece; first finger-shaped pins lower than the top end surface of the base are formed on two sides of the base and are used for being matched with the first sliding block and the first elastic piece to form a first trigger part; in an initial configuration, the first finger pin is engaged with the first slider block and the support bracket is locked relative to the base.

In the percutaneous sensor application device, the sensor holder includes a bracket, and a through groove is formed in a side wall of the bracket; second sliding grooves are formed in two sides of the shuttle and are connected with second sliding blocks in a sliding mode through second elastic pieces; in an initial configuration, the second slider upper surface engages the through slot and the shuttle is locked relative to the sensor mount. The inner wall of the base extends to form a convex rib for being matched with the second sliding block and the second elastic piece to form a second trigger part.

Preferably, in the transdermal sensor application device, a third sliding groove is further formed above the first sliding groove, and a third sliding block is slidably connected to the third sliding groove through a third elastic member; a limiting rib is formed on the inner wall of the handle; in an initial configuration, the upper end surface of the third sliding block is engaged with the limiting rib, and the handle is locked relative to the supporting frame; the second finger-shaped pin is used for being matched with the third sliding block, the third elastic piece and the limiting rib to form a third triggering part.

Preferably, in the transdermal sensor application device, the third slider is composed of a main body part and a protrusion part formed by extending from the middle of the front end surface of the main body part, and the front ends of both sides of the main body part are provided with working slopes matched with the second finger pins.

The percutaneous sensor application device comprises a drive assembly, a first vertical rack and a second vertical rack, wherein the drive assembly comprises a one-way transmission assembly consisting of a first gear and a second gear which are coaxially matched in end face, the first vertical rack is arranged on the inner wall of the handle, the second vertical rack is arranged on the back of the shuttle, the first gear is used for being meshed with the first vertical rack, and the second gear is used for being meshed with the second vertical rack;

optionally, in the transdermal sensor application device, a plurality of grooves are formed in the end surface of the inner side of the first gear, a plurality of corresponding protrusions are formed in the end surface of the inner side of the second gear, and mutually matched inclined surfaces are formed on the inner wall of each groove and the surface of each protrusion;

optionally, the percutaneous sensor application device may further comprise a second gear, wherein the second gear has a concave part on the inner end surface, the side wall of the concave part is formed with a plurality of elastic arms, the bottom of the concave part is formed with a plurality of notches, and the notches provide deformation spaces for the elastic arms; and the end surface of the inner side of the second gear is provided with a ratchet corresponding to the elastic arm.

The transcutaneous sensor application device as described above, wherein said handle is disposed at least partially around said base.

The percutaneous sensor application device described above, wherein the sensor holder further comprises a base, a bottom surface of which is formed with a receiving portion for receiving a sensor unit for releasably holding the sensor unit; the base is also provided with a through hole for the guide needle to pass through.

In the transdermal sensor application device, an elastic buckle is arranged at the front end of the shuttle, and in the initial position, one end of the guide needle is matched with the elastic buckle through a clamping part, and the other end of the guide needle sequentially passes through the through holes in the base and the sensor shell and does not exceed the end surface of the bottom of the base.

The transcutaneous sensor application device as described above, wherein the introducer needle is a slotted needle.

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

(1) according to the invention, the application device and the sensor are set as one device, so that a user can finish the application of the sensor without additional assembly, the operation steps are simplified, and meanwhile, misoperation in the assembly process can be avoided.

(2) The application device realizes automatic penetration and extraction of the guide needle by utilizing the one-way transmission assembly consisting of the first gear and the second gear without manual operation; the whole process is stable and smooth, and no impact vibration exists; the user operation is simple, and the travelling comfort is good.

(3) The driving assembly can well ensure the engagement of the handle and the first gear, and simultaneously avoids the influence of the movement of the handle on the position of the shuttle in the assembling process.

(4) The application device is compact in structure, safe, reliable and beneficial to popularization.

Drawings

FIG. 1 is an overall assembly schematic of the present invention;

FIG. 2 is a schematic view of a sensor assembly;

FIG. 3 is a schematic view of a sensor unit assembly;

FIG. 4 is a schematic view of the application device of the present invention in use;

FIG. 5 is a partial cross-sectional view of the housing of the handle;

FIG. 6(a) is a schematic top view of the upper cover of the handle;

FIG. 6(b) is a schematic bottom view of the upper cover of the handle;

FIG. 7 is a schematic view of the supporting frame;

FIG. 8 is a schematic view of a base;

FIG. 9 is a schematic view of a sensor holder;

FIG. 10(a) is a schematic shuttle;

FIG. 10(b) is a schematic view of another shuttle angle;

FIG. 11 is a schematic view of the shuttle initially mounted to the sensor mount;

FIG. 12(a) is an assembled view of the unidirectional actuator assembly;

FIG. 12(b) is a schematic view of the assembly of the unidirectional actuator assembly at another angle;

FIG. 13 is a partial cross-sectional view illustrating the drive assembly;

FIG. 14(a) is a schematic view of an alternative one-way transmission assembly;

FIG. 14(b) is an assembly schematic of an alternative one-way transmission assembly;

FIG. 14(c) is an alternate angular assembly view of the one-way transmission assembly alternative;

FIG. 15 is a schematic view of the handle and the base in an initial state;

FIG. 16 is a schematic view of the support frame and the base in an initial state;

FIG. 17 is a partial cross-sectional view taken along line A-A of FIG. 15, illustrating a pre-activation state of the first activation portion;

FIG. 18 is a partial cross-sectional view taken along line A-A of FIG. 15, illustrating a post-activation state of the first activation portion;

FIG. 19 is a cross-sectional view of an alternative first trigger portion;

FIG. 20 is a partial cross-sectional view taken along line B-B of FIG. 15, illustrating a pre-activation state of the second activation portion;

FIG. 21 is a partial cross-sectional view taken along line B-B of FIG. 15, illustrating a post-activation state of the second activation portion;

FIG. 22 is a cross-sectional view of an alternative second trigger portion;

FIG. 23 is a schematic view of a third slider structure;

FIG. 24 is a partial cross-sectional view taken along line A-A of FIG. 15, illustrating a pre-activation state of the third activation portion;

FIG. 25 is a partial cross-sectional view taken along line A-A of FIG. 15, illustrating a first state after activation of the third activation portion;

FIG. 26 is a partial cross-sectional view taken along line A-A of FIG. 15, illustrating a second condition of the third trigger portion after actuation;

FIG. 27 is a cross-sectional view of an alternative third trigger portion;

fig. 28 is a schematic view showing the final state of the applicator of the present invention.

Detailed Description

The structure, features and effects of the present invention are described in detail below with reference to the accompanying drawings and preferred embodiments:

as shown in fig. 1 to 3, the present invention provides a transcutaneous sensor application device comprising:

a base 1 having a surface for placement on the skin of a subject;

a handle 2 movable relative to the base between a proximal position and a distal position;

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 shell 42, and the sensor shell 42 is provided with a through hole 421 for the guide needle to pass through;

a support frame 5 detachably and fixedly arranged in the handle;

a sensor holder 6 coupled to the support frame for supporting the sensor unit 4;

a shuttle 7 for supporting the introducer needle 3 extending through the through hole 421;

a drive assembly for driving the shuttle to move to a proximal position;

the transcutaneous sensor application device further comprises a protective cover 10, which protective cover 10 in combination with the open end of the handle 2 may provide a sterile, contamination free environment for the sensor assembly. For example, the connection and fixation can be performed by means of screw threads or hooks. The protective cover is provided with a drying agent therein and is provided with one or more holes at the bottom thereof to allow the entry of sterilizing gas. Preferably, the outer part of the protective cover is covered with a shading sealing aluminum foil film.

The base 1 has a surface for placement on the skin of a subject; the handle 2 is disposed at least partially around the base 1 and is advanceable relative to the base to advance at least a portion of the sensor body 41 into the skin of a recipient.

One embodiment of the sensor unit 4 is shown in fig. 3, said sensor unit 4 further comprising an electronic unit 43 and a battery assembly 44. The electronic unit may comprise, for example, an analog interface for connecting the sensor body 41, a processor, a communication unit, etc. The sensor housing 42 includes an upper case 422 and a lower case 423. The sensor body 41 further has an insertion portion 411 for insertion into the skin of a subject. The end face of the lower shell is provided with an adhesive layer 4231 for adhering the sensor unit to the skin of a subject.

Fig. 4 shows the use of the applicator device of the invention, with the protective cover 10 first removed, exposing the base 1; then place the applicator on the subject' S skin surface S, press down on the handle 2 until the handle is moved to the most distal position, remove the applicator; eventually the sensor unit 4 remains on the skin surface S with the introducer needle retracted inside the applicator. As will be described in more detail below.

Further, as shown in fig. 5, fig. 6(a), and fig. 6(b), the handle 2 includes a housing 21 and an upper cover 22 fixedly mounted on the top of the housing, for example, the handle may be fixed by forming a ring-shaped slot 211 on the top of the inner wall of the housing 21, and configuring a corresponding ring-shaped buckle 221 on the bottom side wall of the upper cover 22, alternatively, the handle may be connected by ultrasonic pressing or buckling.

The inner wall of the housing 21 is further provided with guide grooves 212 along the vertical direction, the lower ends of the guide grooves are closed, and preferably, the number of the guide grooves is two or more.

As shown in fig. 7, a receiving portion for receiving the sensor holder 6 and the shuttle 7 is formed inside the support frame 5; the outer side of the support frame 5 is provided with guide ribs 51, the positions of the guide ribs 51 correspond to the guide grooves 212, and the number of the guide ribs 51 is consistent with that of the guide grooves; adopt above-mentioned structure to make support frame and handle position keep fixed, guarantee simultaneously that the handle motion process steady, smooth, and then guarantee that the guide needle pierces in-process movement track and shell axis and be parallel, reduce the amount of wandering at the needle point end, reduce user's sense of pain. The top of the support frame 5 is coupled to the bottom of the upper cover 22 of the handle, for example, by providing a snap 222 at the bottom of the upper cover 22 (as shown in fig. 6 (b)) and a corresponding slot 52 at the top of the support frame 5. The coupling can ensure that the handle reliably wraps other parts after the application is finished, and prevent the structural part from displacing and causing unnecessary injury.

The lower end of the guide rib 51 extends to form an extension part 53, and the width of the guide rib 51 is greater than that of the extension part 53;

two sides of the supporting frame 5 are provided with first sliding grooves 54, and first sliding blocks 542 are connected in the first sliding grooves in a sliding manner through first elastic pieces 541; preferably, the first elastic element 541 is a spring. Preferably, a third sliding chute 55 is further disposed above the first sliding chute, and a third sliding block 552 is slidably connected in the third sliding chute 55 through a third elastic member 551; preferably, the third elastic member 551 is a spring.

As shown in fig. 8, the base 1 has a substantially flat surface at the bottom for placement on the skin of a subject; a longitudinal gap 11 is formed in the top of the base 1 and used for providing a certain movable space for the extension part 53, and the position and the number of the longitudinal gap 11 correspond to those of the extension part 53; a first finger-shaped pin 12 lower than the top end surface of the base 1 is formed on two sides of the base 1 and is used for being matched with the first slider 542 and the first elastic piece 541 to form a first trigger part; preferably, second finger pins 13 higher than the top end surface of the base 1 are formed on two sides of the base;

as shown in fig. 9, the sensor holder 6 includes a bracket 61 and a base 62, a through groove 611 is provided on a side wall of the bracket 61, and a receiving portion for receiving the sensor unit 4 is formed on a bottom surface of the base 62; furthermore, the accommodating portions are 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, and the elastic arms 621 cooperate with the convex rib 14 to clamp the sensor unit. Preferably, the inner side of the resilient arm is further provided with a protrusion 6211, and the protrusion 6211 engages with a correspondingly provided recess 424 (shown in fig. 2) of the sensor housing 42 to further clamp the sensor unit 4. The base 62 is also provided with a through hole 622 through which the guide pin passes.

As shown in fig. 10(a) and 10(b), the front end of the shuttle 7 is provided with an elastic buckle 71 for fixing the clamping part of the guide needle; a second sliding groove 72 is arranged on two sides of the shuttle, and a second sliding block 722 is connected in the second sliding groove 72 in a sliding manner through a second elastic element 721; preferably, the second elastic element 721 is a spring.

As shown in fig. 11, in the initial configuration, the upper surface of the second slider 722 engages the through slot 611 and the shuttle 7 is locked with respect to the sensor holder 6. As shown in fig. 8, a flange 15 is further formed on the inner wall of the base 1 for cooperating with the second slider 722 and the second elastic element 721 to form a second trigger portion.

In the initial configuration, one end of the guide pin 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 sequence and does not exceed the bottom end surface of the base 1.

As shown in fig. 12(a), 12(b) and 13, the driving assembly includes a one-way transmission assembly composed of a first gear 8 and a second gear 9, a first vertical rack 213 (shown in fig. 5) disposed on the inner wall of the housing 21, and a second vertical rack 73 (shown in fig. 10 (a)) disposed at the back of the shuttle 7; the first gear 8 and the second gear 9 are coaxially mounted on a gear mounting arm 56 (shown in fig. 7) of the support frame 5; the first gear 8 is used for meshing with the first vertical rack 213, and the second gear 9 is used for meshing with the second vertical rack 73; a plurality of grooves 81 are formed in the end surface of the inner side of the first gear 8, a plurality of corresponding protrusions 91 are formed in the end surface of the inner side of the second gear 9, and inclined surfaces 811 and 911 which are matched with each other are respectively formed on the inner wall of each groove 81 and the surface of each protrusion 91; a ring groove 82 is formed in the outer end face of the first gear 8, a compression spring 83 is sleeved in the ring groove 82, and the other end of the compression spring 83 abuts against the gear mounting arm 56; the first gear and the second gear are always kept in close contact by arranging the compression spring; by adopting the structure, when the handle moves towards the far end, the protrusion 91 is meshed 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 towards the near end by being meshed with the second vertical rack; when the handles are moved proximally, the inclined surfaces 811, 911 cooperate, particularly if the shuttle 7 is stopped, so that the second gear wheel 9 remains stationary and the first gear wheel 8 is free to move in an idle motion and in a reciprocating axial motion on the shaft. The transmission ratio of the first gear and the second gear is more than or equal to 1, and can be a fixed value such as 2, 3 and the like. Preferably, the number of the protrusions 91 and the grooves 81 is 5; preferably, the protrusions and the grooves are uniformly distributed. Adopt the whole needle process of returning steady, smooth of above-mentioned structure to can guarantee the needle return route and pierce the coincidence of route, can effectively reduce the spring drive and feel because of the sense of pain that the shake brought, can avoid adopting button mode drive spring's impact force to cause the device that applies ointment or plaster vibrations to cause the psychological panic for the user simultaneously. By adopting the one-way transmission assembly, unnecessary movement between parts during assembly can be avoided, thereby ensuring smooth assembly.

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

Preferably, a boss 95 is disposed on an end face of the outer side of the second gear 9, a fool-proof rib 561 (as shown in fig. 7) is disposed on an inner wall of one side of the gear mounting arm 56, and the boss 95 interferes with the fool-proof rib 561 to form a fool-proof structure. The error of the installation direction of the second gear can be prevented by arranging the fool-proof structure; furthermore, the diameter of the circumscribed circle of the fool-proof rib 561 is slightly smaller than the inner diameter of the pressing spring 83, so that the pressing spring can be well limited. Optionally, the fool-proof rib can be replaced by a round table, a square table or a ring rib.

Preferably, a protrusion 215 (as shown in fig. 5) is disposed on the top of the inner wall of the housing 21, and the protrusion 215 corresponds to the first gear 8 and the second gear 9, so as to prevent the transmission mechanism from moving due to the wrong mounting direction of the housing during the assembly process. As shown in fig. 14(a) to 14(c), alternatively, the above-mentioned first gear and second gear may be replaced by a one-way transmission method in which the ratchet and the elastic arm are engaged with each other; for example, the inner end surface of the first gear 8 is provided with an inner concave part, the side wall of the inner concave part is provided with a plurality of elastic arms 82, the bottom of the inner concave part is provided with a plurality of notches 83, and the notches 83 provide deformation spaces for the elastic arms 82; the inner end surface of the second gear 9 is provided with a ratchet 96 corresponding to the elastic arm. When the first gear 8 rotates clockwise, the elastic arm 82 thereon comes into contact with the ratchet 96, and the elastic arm is elastically deformed to make a sliding contact, so that no motion is transmitted to the second vertical rack 73. When the first gear wheel 8 is rotated anticlockwise the resilient arm 82 thereon engages the ratchet 96 so that the first gear wheel can transmit motion to the second vertical rack 73 via the second gear wheel. The notch 83 can ensure that the deformation amount of each position of the elastic arm parallel to the axis is consistent. Optionally, the elastic arm can also be arranged on the second gear, and the ratchet is arranged on the first gear; alternatively, the number of ratchet teeth may be greater than, equal to, or less than the number of resilient arms.

In the initial configuration of the applicator device, the handle 2 is disposed in a proximal position (first position) relative to the base 1, as shown in figures 15 to 18. In this configuration, the first finger pin 12 engages the first slider 542, forming a first trigger; at the moment, the support frame 5 and the base 1 are in a locking relation; when the user applies a manual force (≦ 10N) to the handle, the working bevel 121 (shown in FIG. 8) of the first finger pin 12 contacts and slides against the working bevel 5421 (shown in FIG. 7) of the first slider 542 during its distal movement (downward), causing the first slider to move backward, the first resilient member 541 to be compressed, causing the support 5 to decouple from the base 1; where the manual force required by the user is ≦ 10N. The handle 2, the support 5, the sensor holder 6 and the shuttle 7 move distally as a unit; the first sliding blocks on the two sides of the supporting frame are always in contact with the inner wall of the base under the action of the first elastic piece, friction force is generated, and discomfort caused by sudden change of the application device towards the far end after the first trigger part triggers is avoided due to the continuous existence of the friction force. Alternatively, the working slope 121 may be a plane or a circular arc.

Alternatively, as shown in fig. 19, the first trigger part may adopt a mode that first elastic buckles 16 lower than the top end surfaces of the base 1 are formed at both sides of the base 1 to abut against the bottom ends of the side walls of the support frame 5, wherein the first elastic buckles 16 are composed of elastic arms 161 and buckles 162; adopt this alternative structure can reduce the complexity of part injection molding in-process mould, reduce the quantity of part simultaneously, and then reduce assembly man-hour. The friction force between the first elastic buckle and the support frame can be adjusted through the thickness, the width and the height of the elastic arm and the deformation of the buckle. Specifically, the thickness of the elastic arm 161 may be 1.0mm, 1.2mm, not more than 2.0 mm; the width of the resilient arm 161 may be 3.0mm, 3.2mm, not more than 5.0 mm; the height of the elastic arm 161 may be 3.0mm, 4.0mm, not more than 20mm, and the engaging amount of the latch 162 may be 0.4mm, 0.6mm, not more than 2.0 mm.

As shown in fig. 20 and 21, as the introducer needle 3 is advanced distally, it carries the insertion portion 411 of the sensor body 41 into the recipient's skin and into contact with interstitial fluid. As the handle is moved to the second position, the sensor holder 6 is shown to reach the most distal position, the resilient arms 621 are released from the restraint of the ribs 14, releasing the sensor housing and securing the sensor unit 4 to the skin surface of the subject by the adhesive layer on the distal surface of the sensor housing 42.

Meanwhile, as the guide needle is pushed distally, the second slider 722 is engaged with the flange 15 extending from the inner wall of the base 1 to form a second trigger part; the side wall of the bracket 61 is further provided with a long groove 612 (as shown in fig. 9) for the extension part of the flange 15 to move; subsequently, the working inclined surface 7221 of the second slider 722 contacts and slides against the working inclined surface 151 of the flange 15, so that the second slider 722 moves backward, the second elastic element 721 is compressed, and the upper end surface of the second slider 722 is separated from the limit of the through groove 611 until the sensor holder 6 reaches the most distal position, so that the shuttle 7 is decoupled from the sensor holder 6.

Alternatively, as shown in fig. 22, the second trigger part may be provided with a second elastic catch 74 on both sides of the shuttle to engage with the flange 15, and the structure and principle of the second elastic catch are the same as those of the first elastic catch, which will not be described herein.

Preferably, the applicator device shown in FIGS. 23 to 28 further comprises a third trigger part formed by the third slider 552, the third elastic member 551, the second finger pin 13 and the limiting rib 214 (shown in FIG. 5) formed by the inner wall of the housing 21; in the initial position, the upper end surface of the third slider 552 is engaged with the limit rib 214; at the moment, 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 formed by extending from the middle of the front end surface of the main body, as the guiding needle advances distally, the working slopes 55211 of the front ends of the two sides of the main body contact with the working slopes 131 of the second finger pin 13 and slide, so that the third slider 552 moves backwards, the third elastic member 551 is compressed, and until the sensor support 6 reaches the farthest position, that is, at the same time or at a later time when the second trigger triggers, the limiting rib 214 is separated from the limiting of the upper end surface of the third slider 552, so that the handle is decoupled from the supporting frame. The third trigger part is arranged, so that interference on decoupling of the shuttle and the sensor support caused by the movement trend of the shell can be avoided, and the shuttle and the sensor support can be guaranteed to complete decoupling instantly. Preferably, in order to ensure smooth movement of the third slider 553, two third elastic members 551 may be provided.

Alternatively, as shown in fig. 19 and 27, a third elastic buckle 57 may be disposed on two sides of the supporting frame 5 instead of the third slider and the third elastic member, and the structure and principle of the third elastic buckle 57 may be the same as those of the first elastic buckle, which is not described herein again.

As the sensor holder reaches the most distal position, the first gear 8 meshes with the first vertical rack 212 and the second gear 9 meshes with the second vertical rack 73; when the handle continues to move towards the far end, 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, the second gear drives the shuttle to move towards the near end through meshing with the second vertical rack, and when the handle moves to the far end position (third position), the guide needle 3 retracts to the inside of the application device.

As shown in fig. 6(a), preferably, the top of the upper cover 22 is further provided with a sensor mark 223 and an introducer needle mark 224, the sensor mark 223 is used for marking the projection position of the sensor on the upper cover, and the introducer needle mark 224 is used for marking the projection position of the introducer needle or the sensor body on the upper cover, so as to help the user to identify the orientation and help the identification of the application direction. Preferably, a rib 216 (as shown in fig. 5) is disposed on the top of the inner wall of the housing 21, and a notch 225 matched with the rib 216 is disposed on the bottom side wall of the upper cover 22, so as to prevent the assembling direction of the upper cover from being wrong, so that the direction of the mark on the upper cover is wrong.

In conclusion, the percutaneous sensor application device disclosed by the invention realizes automatic penetration and extraction of the guide needle, is simple to operate, comfortable to use, compact in structure, safe and reliable, and is beneficial to popularization.

The above description is only a preferred embodiment of the present invention, and any simple modifications and equivalent changes to the above embodiment according to the technical solution of the present invention are within the protection scope of the present invention.

Claims

1. A transcutaneous sensor application device comprising:

a base having a surface for placement on the skin of a subject;

the support frame is detachably and fixedly arranged in the handle;

a sensor holder coupled to the support frame for supporting the sensor unit;

a drive assembly for driving the shuttle to move to a proximal position;

2. The percutaneous sensor application device according to claim 1, wherein first sliding grooves are formed in two sides of the support frame, and first sliding blocks are slidably connected in the first sliding grooves through first elastic pieces; first finger-shaped pins lower than the top end surface of the base are formed on two sides of the base and are used for being matched with the first sliding block and the first elastic piece to form a first trigger part; in an initial configuration, the first finger pin is engaged with the first slider block and the support bracket is locked relative to the base.

3. The transcutaneous sensor application device of claim 2, wherein the sensor mount comprises a bracket having a through slot in a side wall thereof; second sliding grooves are formed in two sides of the shuttle and are connected with second sliding blocks in a sliding mode through second elastic pieces; in an initial configuration, the upper surface of the second sliding block is engaged with the through groove, the shuttle is locked relative to the sensor bracket, and a convex rib is formed on the inner wall of the base in an extending mode and used for forming a second trigger part in cooperation with the second sliding block and the second elastic piece.

4. The transdermal sensor application device of claim 3, wherein a third sliding groove is further provided above the first sliding groove, and a third sliding block is slidably connected to the third sliding groove through a third elastic member; a limiting rib is formed on the inner wall of the handle; in an initial configuration, the upper end surface of the third sliding block is engaged with the limiting rib, and the handle is locked relative to the supporting frame; the second finger-shaped pin is used for being matched with the third sliding block, the third elastic piece and the limiting rib to form a third triggering part.

5. The percutaneous sensor application device according to claim 4, wherein the third slider is composed of a main body portion and a projecting portion formed extending from the middle of the front end surface of the main body portion, and the front ends of both sides of the main body portion are formed with working slopes to be fitted with the second finger pins.

6. The percutaneous sensor application device according to claim 1, wherein the drive assembly comprises a one-way transmission assembly consisting of a first gear and a second gear which are coaxially end-fitted, a first vertical rack provided on the inner wall of the handle, and a second vertical rack provided on the back of the shuttle, the first gear being for meshing with the first vertical rack, and the second gear being for meshing with the second vertical rack.

7. The transdermal sensor application device according to claim 6, wherein the inner side end surface of the first gear is formed with a plurality of grooves, the inner side end surface of the second gear is formed with a corresponding plurality of protrusions, and the inner walls of the grooves and the surfaces of the protrusions are respectively formed with mutually matching slopes.

8. The percutaneous sensor application device according to claim 6, wherein the inner end face of the first gear has a concave portion, the side wall of the concave portion is formed with a plurality of elastic arms, the bottom of the concave portion is formed with a plurality of notches, and the notches provide deformation spaces for the elastic arms; and the end surface of the inner side of the second gear is provided with a ratchet corresponding to the elastic arm.

9. The transcutaneous sensor applicator device of claim 1, wherein the handle is disposed at least partially around the base.

10. The transdermal sensor application device of claim 1, wherein the sensor holder further comprises a base, the base having a bottom surface formed with a receiving portion for receiving a sensor unit for releasably holding the sensor unit; the base is also provided with a through hole for the guide needle to pass through.

11. The percutaneous sensor application device according to claim 10, wherein the shuttle is provided at a front end thereof with an elastic clip, and in an initial position, one end of the introducer needle is engaged with the elastic clip through the clamping portion, and the other end thereof passes through the through holes of the base and the sensor housing in sequence and does not exceed the end surface of the base bottom.

12. The transcutaneous sensor application device of claim 1, wherein the introducer needle is a slotted needle.