CN114831633A

CN114831633A - Sensor implantation device

Info

Publication number: CN114831633A
Application number: CN202210468353.9A
Authority: CN
Inventors: 毛帅; 李宁
Original assignee: Andon Health Co Ltd
Current assignee: Andon Health Co Ltd
Priority date: 2022-04-29
Filing date: 2022-04-29
Publication date: 2022-08-02

Abstract

The invention provides a sensor implantation device, which comprises a needle seat, a needle seat and a driving mechanism, wherein the needle seat is used for pushing a bracket to move towards a far end; a guide pin for guiding the transdermal analyte sensor into the skin of the recipient; an elastic member providing kinetic energy to the implant device; the needle pulling device is used for unlocking under the action of the elastic piece when the guide needle is inserted in place, so that needle pulling is completed; the sliding cylinder sequentially unlocks the framework, the shell and the multiple limit of the needle puller according to a specified sequence to complete the application process; the shell moves from the near end to the far end, the framework releases the limit of the sliding barrel, the needle seat, the support, the guide needle and the sensor base assembly move towards the far end together, and the needle seat and the support stop moving when the sensor base assembly is applied to the skin of a receptor. The sensor implanting device provided by the invention can realize automatic penetration and extraction of the guide needle, and compared with the prior art, the sensor implanting device is more accurate in insertion depth, simple in operation in the using process, reliable in use, capable of avoiding false triggering and wider in applicable population.

Description

Sensor implantation device

Technical Field

The invention belongs to the field of receptor analyte measurement, and particularly relates to a sensor implantation device which is suitable for inserting a transdermal analyte sensor into the skin of a receptor.

Background

Diabetes is a disease in which the pancreas develops an abnormal condition in the patient's body, resulting in the pancreas not producing insulin or producing sufficient insulin. At present, the existing treatment scheme takes blood sugar value as reference, and controls the blood sugar value within a target range by means of taking hypoglycemic drugs, injecting insulin and the like.

Currently, the most common blood glucose monitoring method is that a patient uses a finger blood glucose meter to monitor blood glucose of a capillary vessel, and blood glucose value at a certain time point can be measured. However, this method requires the patient to measure several times a day, and the pain is great. The patient needs to carry with a complete set of tools such as a blood taking needle, a glucometer, a test strip and the like, and the measurement process is complicated. The method can only reflect the blood sugar value (namely instantaneous blood sugar) of a patient at several time points in one day, has one-sidedness and inaccuracy, the instantaneous blood sugar value is influenced by a plurality of factors such as exercise, diet, medicines, emotion and the like, the obtained information is limited, the change trend of the blood sugar is not known, the injection amount of insulin is difficult to determine, the blood sugar level is effectively managed, and asymptomatic hyperglycemia and hypoglycemia are difficult to find.

With the development of the technology, a dynamic blood glucose monitoring system (CGMS) is available in the market, a transdermal analyte sensor with the size of hair is delivered to interstitial fluid of human skin through an insertion device, and reactive enzyme on the sensor reacts with certain substances in the interstitial fluid and transmits a signal to a receiver end through a transmitter, so that the blood glucose of the human body can be dynamically monitored.

However, the transdermal analyte sensor implant devices currently available on the market still lack convenience and comfort. The insertion device as disclosed in patent EP2327362a1 guides the penetration and extraction of the needle to be done completely manually by the patient. Not only the operation is inconvenient, but also the psychological fear is brought to the patient. A device for inserting a transcutaneous analyte sensor into the skin as disclosed in patent CN206777328U, the transcutaneous analyte sensor and the sensor mount not being in contact prior to use; the transdermal analyte sensor is coupled to the sensor base only in the use process, and the transdermal analyte sensor and the sensor base need to be electrically connected, so that the requirements on the size and the position of parts are high; the cost of the inserting device is high, and the product is not beneficial to popularization and civilization. For example, patent CN110664415A discloses an application device, which has a structure that the needle is pulled out too early, and the device cannot be well adapted to situations with different skin bulges, and cannot ensure that the sensor is inserted into a sufficient depth.

Disclosure of Invention

In view of this, the present invention is directed to a sensor implanting device suitable for skin with different protrusion degrees, and the device has the advantages of simple structure, convenient operation for users, comfortable use, safety, reliability, avoidance of false triggering, and wider application range.

In order to achieve the purpose, the technical scheme of the invention is realized as follows:

a sensor implantation device for inserting a transcutaneous analyte sensor into a skin of a subject and for automatically extracting the transcutaneous analyte sensor therefrom, comprising:

the touch back assembly comprises a trigger assembly and an insertion assembly arranged in the trigger assembly;

the brake mechanism comprises a shell, the touch back component is arranged in the shell and can move between a far end and a near end relative to the touch back component, and the brake mechanism is triggered by external force and provides a heavy driving force for the device;

the driving mechanism is arranged on the touch-back component and is triggered by the braking mechanism to provide dual driving force for the device;

the shell is pressed to move towards the far end, a heavy driving force is provided for the device, the driving mechanism is triggered to provide a heavy driving force for the device, and the touch back component completes reciprocating motion between the far end and the near end.

Further, the trigger component includes:

the framework is accommodated in the opening end of the shell, one end of the framework is in contact with the skin of a receptor, and the shell slides along the framework;

the bracket is slidably mounted inside the framework and used for fixing the sensor base assembly;

the sliding cylinder is slidably arranged in the framework and can push the bracket to move towards the far end;

the needle extractor is sleeved on the sliding cylinder and is connected with the shell in a sliding manner;

the peripheral side of the sliding barrel extends to the periphery to form a bearing platform, and the driving mechanism is arranged between the bearing platform and the needle extractor.

Further, the insert assembly includes:

the needle seat is slidably arranged in the sliding barrel and can push the bracket to move towards the far end, and the top of the needle seat extends towards two sides to form an extension arm arranged above the needle extractor;

and the guide needle is coupled with the bottom of the needle seat and can fix the position of the bracket.

Furthermore, be equipped with first elasticity buckle on the skeleton, the inside first spacing muscle that corresponds with it that is equipped with of shell, first spacing muscle restriction the skeleton with relative slip between the shell.

Furthermore, a third limiting rib is arranged on the inner side wall of the shell, a fifth elastic buckle connected with the needle pulling device in a clamped mode is arranged on the needle pulling device, a fourth elastic buckle in contact with the fifth elastic buckle is arranged on the sliding barrel, and the third limiting rib and the fourth elastic buckle limit the relative movement between the needle pulling device and the shell.

Furthermore, a second groove is formed in the sliding cylinder, a second elastic buckle clamped in the second groove is arranged on the framework, and the sliding cylinder is limited to move in the vertical direction;

the shell moves towards the far end, a first groove formed in the inner side wall of the shell is arranged on one side of the second elastic buckle, and the limit of the second elastic buckle on the sliding barrel is relieved.

Furthermore, a fourth groove is formed in the upper portion of the needle seat, the fourth elastic buckle moves to the fourth groove, and the limitation of the fifth elastic buckle in the horizontal direction is relieved.

Furthermore, a fifth groove is formed in the lower portion of the needle seat, a third limiting buckle embedded in the fifth groove is arranged on the sliding cylinder, a limiting block arranged on one side of the third limiting buckle is arranged on the framework, the opening and closing of the third limiting buckle are limited, and the position relation between the sliding cylinder and the needle seat is locked;

and a third groove is arranged below the limiting block, the third limiting buckle moves to the third groove, the limiting of the third limiting buckle is released, and the locking position relation between the sliding barrel and the needle seat is released.

Furthermore, a sixth elastic buckle and a push plate are arranged at the bottom of the needle seat, and the push plate is abutted against the top of the support;

the top of the guide needle is provided with a clamping protrusion which is clamped in the sixth elastic buckle and can drive the guide needle to move between the near end and the far end.

Furthermore, the top of the support is provided with third elastic buckles which extend upwards and are in a mirror image, a guide pin groove penetrating through the support is formed between the third elastic buckles, the guide pin is arranged in the guide pin groove, and the guide pin is provided with an inclined surface contacting with the inner top wall of the third elastic buckle.

Furthermore, the top of the third elastic buckle is provided with a limiting column extending towards two sides, and the sliding cylinder is provided with a second limiting rib in contact with the sliding cylinder to limit the movement of the limiting column in the horizontal direction;

the sliding cylinder moves towards the far end, the second limiting rib relieves the limitation of the limiting column in the horizontal direction, and the third elastic buckle can deflect towards an opening formed in the second limiting rib.

Furthermore, a guide needle head and a stabilizing plate arranged on one side of the guide needle head are arranged at the bottom of the guide needle;

the sensor base assembly is provided with a through hole for the guide needle to pass through, and the stabilizer plate is inserted into a positioning groove formed in the sensor base assembly.

Furthermore, 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.

Further, the shell further comprises an end cover, and the end cover is connected with the shell.

Further, the driving mechanism includes an elastic member.

Compared with the prior art, the sensor implantation device has the following advantages:

(1) when the device is used, multiple mechanisms are continuously unlocked and are mutually matched to ensure that the guide needle head is always in a stable state in the insertion and extraction processes, so that the condition that the guide needle head is stuck in the skin of a receptor and is inclined or even broken off is prevented;

(2) due to the arrangement of the elastic piece, two processes of inserting the needle and pulling the needle can be completed only by applying pressure to the device once, the use is convenient, the comfort of user operation is improved, and the fear of the user to pull the needle can be reduced;

(3) the elastic part is in a semi-compression state in the initial state, so that the risk of part deformation caused by the elasticity of the elastic part in the storage process of the implantation device can be effectively reduced, the elasticity of the elastic part in the semi-compression state can balance the acting force among the internal elements of the device, and each part in the device is ensured to be in the initial state when leaving the factory before use;

(4) the sensor base assembly can pull out the needle only when being adhered to the skin of a receptor, so that the remaining part of the sensor base can be ensured to be inserted in place, and various problems caused by the fact that the sensor base assembly is not inserted in place are prevented;

(5) the device is reliable, avoids mistaken touch, is suitable for the condition that the skin protrusion degrees of different positions of a receptor are different, and ensures the insertion depth.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention, illustrate embodiments of the invention and together with the description serve to explain the invention and do not constitute a limitation of the invention. In the drawings:

FIG. 1 is an exploded view of an embodiment of the present invention;

FIG. 2 is a schematic sectional view of an outer shell according to an embodiment of the present invention;

FIG. 3 is a schematic view of a needle holder structure according to an embodiment of the present invention;

FIG. 4 is a schematic view of a stent structure according to an embodiment of the present invention;

FIG. 5 is a schematic view of an introducer needle configuration in accordance with an embodiment of the present invention;

FIG. 6a is a cross-sectional structural schematic view of a frame according to an embodiment of the present invention;

FIG. 6b is a schematic diagram of the front structure of the skeleton according to the embodiment of the present invention;

FIG. 7a is a schematic cross-sectional view of a shuttle according to an embodiment of the present invention;

FIG. 7b is a schematic front view of a slide cartridge according to an embodiment of the present invention;

FIG. 8a is a schematic cross-sectional view of a needle extractor according to an embodiment of the present invention;

FIG. 8b is a schematic view of the front structure of the needle extractor according to the embodiment of the present invention;

FIG. 9 is a sectional view of the structure of an initial state of the embodiment of the present invention;

FIG. 10 is a sectional view of a third exemplary embodiment of a third limiting rib in a limiting state;

FIG. 11 is an enlarged view of a second elastic buckle in a position-limiting state according to an embodiment of the present invention;

FIG. 12 is a sectional view of the structure of the embodiment of the present invention after the outer case is moved;

FIG. 13 is a cross-sectional view of a structure of an embodiment of the present invention before a needle is guided to a recipient's skin;

FIG. 14 is a sectional view of a limiting state structure of a limiting block according to an embodiment of the present invention;

FIG. 15 is an enlarged view of a limiting state structure of a limiting block in the embodiment of the present invention;

FIG. 16 is a sectional view of a structure after an introducer needle has been advanced into a recipient's skin in accordance with an embodiment of the present invention;

FIG. 17 is a schematic view of a sensor mount assembly of an embodiment of the present invention shown after stopping movement;

FIG. 18 is a sectional view of the structure of the embodiment of the present invention before needle withdrawal;

FIG. 19 is a sectional view of the structure of the needle pulling process according to the embodiment of the present invention;

FIG. 20 is an enlarged view of a portion of the needle pulling process according to an embodiment of the present invention;

FIG. 21 is a cross-sectional view of an introducer needle bevel structure release stop according to an embodiment of the present invention;

FIG. 22 is a schematic view of a sensor mount assembly according to an embodiment of the present invention;

FIG. 23 is a schematic view of another side view of a stent according to an embodiment of the present invention;

FIG. 24 is a schematic view of a skeleton structure according to another embodiment of the present invention;

FIG. 25 is a schematic view of an outer shell structure according to another embodiment of the present invention;

FIG. 26 is a schematic view of a stent according to another embodiment of the present invention;

FIG. 27 is a schematic view of a structure of a first resilient latch and a fourth limiting rib according to another embodiment of the present invention;

fig. 28 is a schematic view of a seventh elastic buckle and a limiting plate according to another embodiment of the present invention.

Description of reference numerals:

1-a shell, 101-a third limiting rib, 102-a first groove, 103-a first guide groove, 104-a first limiting rib and 105-a fourth limiting rib;

2-a needle seat, 201-a push plate, 202-a sixth elastic buckle, 203-a fourth guide rib, 204-a fourth groove, 205-a fifth groove and 206-an extension arm;

3-bracket, 301-guide pin groove, 302-limit column, 303-third elastic buckle, 304-convex rib, 305-third guide rib, 306-elastic arm and 307-limit plate;

4-guide needle, 401-clamping bulge, 402-inclined plane, 403-guide needle head and 404-dimensional stabilizing plate;

5-sensor base assembly, 501-through hole, 502-positioning groove, 503-clamping groove, 504-connecting clamping hook, 505-sensor base;

6-end cover;

7-framework, 701-second elastic buckle, 702-third guide groove, 703-limiting block, 704-second guide groove, 705-first elastic buckle, 706-first guide rib, 707-third groove, 7011-second elastic buckle is convex, 7012-second elastic buckle is convex, 708-seventh elastic buckle;

8-sliding cylinder, 801-fourth elastic buckle, 802-second groove, 803-third limiting buckle, 804-second limiting rib, 805-fourth guide groove, 806-second guide rib, 807-bearing platform and 8041-opening;

9-an elastic member;

10-needle pulling device, 1001-fifth elastic buckle, 1002-fifth guide rib, 10011-fifth elastic buckle is convex outward, and 10012 fifth elastic buckle is convex inward.

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 28, the present invention provides a sensor implanting device, comprising: the touch back component, the brake mechanism and the driving mechanism.

the braking mechanism is a shell 1, an initial limiting structure I and an initial limiting structure II are arranged in the shell 1, the trigger assembly is arranged in the shell 1 and can move between a far end and a near end relative to the trigger assembly, and the braking mechanism is triggered by external force to provide a heavy driving force for the device;

and the driving mechanism is an elastic part 9 and is arranged on the touch back component, and the driving mechanism is triggered by the braking mechanism to provide double driving force for the device.

In the initial state, the touch back component and the shell 1 are relatively static;

in the insertion state, the shell 1 is pressed, the shell 1 moves towards the far end, a heavy driving force is provided for the device, the driving mechanism is triggered, namely the elastic piece 9 is compressed, the double driving force is provided for the device, the touch back component is partially unlocked, and the device moves towards the far end;

needle pulling state: the touch back component is unlocked completely, the driving mechanism continues to provide double driving force, and the touch back component moves towards the near end.

The trigger assembly includes: the framework 7, the bracket 3, the sliding barrel 8 and the needle extractor 10 are described below.

The shell is accommodated in a framework 7 at the opening end of the shell 1, a first guide groove 103 is arranged in the shell 1, a first guide rib 706 matched with the framework 7 is arranged on the framework 7, the shell 1 can slide between a near end position and a far end position relative to the framework 7, and one end of the framework 7 is in contact with the skin surface of a receptor.

A sliding barrel 8 and a bracket 3 which are connected with the framework 7 in a sliding way are arranged in the framework 7, and the bracket 3 is positioned below the sliding barrel 8. A bearing platform 807 is formed by the protrusion of the outer peripheral side of the sliding cylinder 8, a second guide rib 806 is arranged on the outer side wall of the sliding cylinder 8 and can move along a second guide groove 704 arranged on the inner side of the framework 7, an initial limiting structure IV is arranged at the bottom of the sliding cylinder 8, and the limiting support 3 moves in the vertical direction;

the outer side wall of the bracket 3 is provided with a third guide rib 305, the inner side wall of the framework 7 is correspondingly provided with a third guide groove 702 so as to facilitate the bracket 3 to slide in the framework 7, the top of the bracket 3 is provided with third elastic buckles 303 which are symmetrical and extend upwards, and a guide pin groove 301 which penetrates through the top wall of the bracket 3 is formed between the two third elastic buckles 303;

the elastic part 9 and the needle puller 10 are sleeved on the outer side of the sliding barrel 8, and the elastic part 9 is arranged between the needle puller 10 and the supporting platform 807 and used for enabling the device to realize the actions of inserting needles and pulling needles;

the side wall of the needle puller 10 is provided with a fifth guide rib 1002 which can move along the first guide groove 103 inside the housing 1, so that the needle puller 10 is always kept in a stable state in the moving process.

The insertion assembly comprises a needle hub 2 and an introducer needle 4, which are described below:

the needle base 2 is arranged in the sliding barrel 8, the side wall of the needle base 2 is provided with a fourth guide rib 203 which can slide along a fourth guide groove 805 on the inner side wall of the sliding barrel 8, the bottom of the needle base 2 is provided with a push plate 201, the push plate 201 is contacted with the bracket 3 in an initial state, the bracket 3 can be pushed towards a receptor in the needle inserting process, the top of the needle base 2 extends towards two sides to form an extension arm 206, and the needle extractor 10 can push the extension arm 206 towards the direction far away from the receptor in the needle extracting state, so that the needle base 2 is driven to move towards the direction far away from the receptor;

the guide needle 4 is arranged in the guide needle groove 301, can fix the position of the bracket 3, extends upwards at the upper part and is coupled with the bottom of the needle seat 2. Specifically, guide needle 4 top is equipped with the protruding 401 of joint that extends to both sides, and with it complex, 2 bottoms of needle file are equipped with the sixth elastic buckle 202 of symmetry and downwardly extending, and the protruding 401 of joint is arranged in between two elastic buckle 202, can spacing guide needle 4 the ascending motion of vertical direction. Two sides of the guide needle 4 disposed inside the guide needle slot 301 form a slope 402 extending downward, and the slope 402 contacts with the inner top wall of the third elastic catch 303. The section of the top of the third elastic buckle 303 is

In shape, the inclined plane 402 limits the movement of the bracket 3 in the vertical direction, and the bottom of the guide needle 4 is provided with a guide needle head 403.

The bracket 3 is internally coupled with a sensor base component 5, the sensor base component 5 comprises a sensor base 505, a through hole 501 for the guide needle 4 to pass through is arranged on the sensor base 505, and the guide needle head 403 is used for inserting the indwelling part of the sensor base 505 into the skin of a subject.

The needle 403 is configured to be fully open on one side, and the sensor retaining portion is wrapped in the needle 403.

The device is configured such that when the housing 1 is moved from the first position to the second position, i.e. from the proximal end to the distal end, the backbone 7 clears the slide cartridge 8, the hub 2, the carrier 3, the introducer needle 4, the sensor mount assembly 5 move distally together, and when the sensor mount assembly 5 is applied to the skin of a subject, the hub 2 and the carrier 3 stop moving.

The sliding barrel 8 continues to move towards the far end, and the needle extractor 10 moves towards the third position, namely the near end position under the action of the elastic piece 9, so that the needle extractor 10 drives the needle seat 2 to extract the guide needle 4 from the skin of a subject.

It should be noted that, in the present invention, "distal" refers to a direction close to the skin, and "proximal" refers to a direction away from the skin; the first position is the initial position of the device, the second position is the complete insertion position of the guiding needle of the device, and the third position is the complete needle pulling position.

As shown in FIG. 1, the transdermal sensor applicator device further comprises an end cap 6, wherein the end cap 6, in combination with the open end of the housing 1, provides a sterile, contamination-free environment for the sensor base assembly 5. In this embodiment, the end cap 6 is connected to the housing 1 by a hook, and in other embodiments, the end cap may be connected by interference fit or threads. A drying bag is fixedly arranged in the end cover 6 to keep the storage environment in the end cover 6 dry. In order to prevent the factors such as illumination from influencing the sensor base component 5 and leading to the reduction of measurement accuracy, the end cover 6 is of a full light-shading structure. Of course, in other embodiments, the end cap 6 may be covered with a light-shielding sealing aluminum foil film.

The end cover 6 not only protects the sensor base assembly 5, but also prevents the device from triggering before use. After the end cover 6 is taken down, the initial limit structure I and the initial limit structure II on the shell 1 and the initial limit structure III on the framework 7 ensure that the device is still in a locking state, and the locking state of the device can be released only by pressing the shell 1 after the device is pressurized. The false touch is avoided to a great extent so as to avoid the damage of the device.

As shown in fig. 9, the elastic member 9 includes, but is not limited to, a cylindrical coil spring. When the device is located the first position, elastic component 9 is in half compression state, can effectively reduce implantation device storage in-process because the risk that the part warp is aroused to elastic component 9 elasticity.

As shown in fig. 2-11, when the device is in an initial state (first position), the first initial limit structure and the second initial limit structure limit the movement of the frame 7 and the needle extractor 10, respectively, the third initial limit structure limits the movement of the slide cylinder 8, the fourth initial limit structure on the slide cylinder 8 limits the movement of the needle base 2, the fifth initial limit structure limit bracket 3, and the sixth initial limit structure limit sensor base assembly 5 disposed on the bracket 3.

The first initial limiting structure is a first limiting rib 104 arranged on the inner side wall of the shell 1, the first initial limiting structure is a limiting framework 7, and the framework 7 cannot move towards the far end under the pre-elastic action of the elastic part 9.

Specifically, for guaranteeing the balance of device, the setting of first spacing muscle 104 symmetry is equipped with the first elastic buckle 705 that corresponds with it on the relative two inside walls of casing 1 on the skeleton 7, its and first spacing muscle 104 butt, the relative slip between spacing skeleton 7 and the shell 1.

The third initial limiting structure is a second elastic buckle 701 arranged on the framework 7, the second elastic buckle 701 comprises 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 is abutted with the outer side wall of the sliding cylinder 8, the second elastic buckle outer protrusion 7011 is abutted with the inner side wall of the shell 1, the second elastic buckle 701 is locked in the horizontal direction, the framework 7 keeps static under the action of the first limiting rib 104, the second elastic buckle inner protrusion 7012 is abutted with a second groove 802 arranged on the side wall of the sliding cylinder 8, and the limiting sliding cylinder 8 slides towards the far end (the second position).

The second initial limiting structure is a third limiting rib 101 arranged on the inner side wall of the shell 1, the needle puller 10 is limited by the third limiting rib 101, and the needle puller cannot move towards the near end under the pre-elastic force action of the elastic part 9. The surface of the third limiting rib 101 is perpendicular to the surface of the first limiting rib, and the third limiting rib and the connecting line between the two first limiting ribs 104 form a space perpendicular. Specifically, a fifth elastic buckle 1001 is arranged on the needle withdrawing device 10, 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 inner protrusion 10012 of the fifth elastic buckle abuts against the fourth elastic buckle 801 on the sliding barrel 8, the fourth elastic buckle 801 abuts against the side wall of the needle seat 2, the outer side wall of the fifth elastic buckle 1001 abuts against the inner side wall of the housing 1, the fifth elastic buckle 1001 is locked in the horizontal direction, the outer protrusion 10011 of the fifth elastic buckle abuts against and is matched with the third limiting rib 101, and the needle extractor 10 is limited to move in the vertical direction.

Further, in order to facilitate the device to move from the first position to the second position and to realize the insertion of the device, the contact surfaces of the third limiting rib 101 and the fifth elastic buckle protrusion 10011 are both inclined surfaces, and the contact surfaces of the second elastic buckle protrusion 7011 and the second groove 802 are also inclined surfaces.

The fourth initial limiting structure is a third limiting buckle 803, a fifth groove 205 corresponding to the third limiting buckle 803 is arranged on the needle base 2, and the third limiting buckle 803 contacts with the upper top surface in the fifth groove 205 to limit the downward movement track of the needle base 2 under the action of gravity.

The initial limiting structure five is a second limiting rib 804 symmetrically arranged at the bottom of the sliding barrel 8, an opening 8041 is formed in the second limiting rib 804, in an initial state, the limiting column 302 extending from the top of the third elastic buckle 303 to the width direction of the third elastic buckle is located between the two second limiting ribs 804, locking of the third elastic buckle 303 in the horizontal direction is achieved, and the guide needle 4 is limited on the vertical direction of the support 3.

The side wall of the bracket 3 is provided with an elastic arm 306, the initial limiting structure six is a convex rib 304 arranged on the inner side of the elastic arm 306, and a clamping groove 503 arranged on the sensor base 505 is clamped with the convex rib 304 to limit the movement of the sensor base assembly 5, so that the sensor base assembly 5 is not influenced by the movement of any part before unlocking, and no displacement occurs. Further, through-hole 501 week side is equipped with constant head tank 502, is equipped with the steady board 404 of dimension of joint in constant head tank 502 on the guide needle 4, reduces and pierces rocking of in-process at guide needle 4.

As shown in fig. 12-18, the device is moved from the first position to the second position, i.e., an insertion motion is performed. The framework 7 is used for being placed at one end of the surface of the skin of a receptor and is in contact with the skin of the receptor, the shell 1 is pressed towards the far end, the shell 1 moves downwards, the third limiting rib 101 is matched with the fifth elastic buckle 1001 to drive the needle extractor 10 to move downwards, and the elastic piece 9 continues to be compressed. The bottom of the shell 1 is contacted with the skin of a receptor, the framework 7 is completely wrapped in the shell 1 at the moment, the first groove 102 moves to one side of the second elastic buckle 701, and the side wall of the shell 1 releases the limit of the second elastic buckle 701 in the horizontal direction.

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

Further, the second elastic buckle 701 is contacted with the limit in the horizontal direction, and can be elastically deformed to release the limit of the sliding cylinder 8 in the vertical direction, and the third limit rib 101 still keeps the limit of the fifth elastic buckle 1001 in the vertical direction. The elastic part 9 is compressed and then returns to the original shape, the needle extractor 10 is still limited by the third limiting rib 101, the position is unchanged, the elastic part 9 applies downward elastic force to the supporting platform 807 to drive the sliding cylinder 8 and the needle seat 2 to move downwards, and the push plate 201 on the needle seat 2 pushes the support 3 to move downwards to drive the guide needle 4 and the sensor base assembly 5 to move downwards.

Specifically, as shown in fig. 14, the limitation of the upper limiting block 703 of the framework 7 on the third limiting buckle 803 of the sliding barrel 8 ensures that the needle base 2 and the sliding barrel 8 are locked relatively when the needle point pierces the skin; as shown in FIG. 15, the limitation of the second limiting rib 804 of the sliding tube 8 on the limiting column 302 of the bracket 3 ensures that the guide needle 4 and the bracket 3 are relatively locked when the needle point pierces the skin, thereby smoothly completing the application and puncturing actions.

After the guide needle 4 punctures the skin, the sliding cylinder 8 continues to move downwards under the action of the elastic force, the third limiting buckle 803 moves to the lower side of the limiting block 703 along with the sliding cylinder 8, the limiting block 703 relieves the limitation of the third limiting buckle 803 in the horizontal direction, the third limiting buckle 803 moves to one side of a third groove 707 arranged below the limiting block 703, the movement space of the third limiting buckle 803 is released, the limitation of the third limiting buckle 803 in the horizontal direction is completely relieved, the third limiting buckle 803 continues to move downwards along with the sliding cylinder 8, the third limiting buckle 803 generates elastic deformation and opens towards two sides, and the third limiting buckle 803 and the fifth groove 205 are initially separated.

The holder 3 is moved to the most distal end to stop the movement, the sensor mount 505 is applied to the skin of the subject by the application of the adhesive on the bottom thereof, and the sensor-indwelling portion is inserted into the skin of the subject together with the guide needle 403. At this time, the third stopper catch 803 is not completely disengaged from the fifth groove 205.

It should be noted that the bottom of the sensor base 505 is at the same level as the bottom of the frame 3, and the adhesive on the bottom of the sensor base 505 is disposed below the bottom of the frame 3, so as to ensure that the sensor is more firmly applied to the skin of the subject. As shown in fig. 18-21, during the process of moving from the second position to the third position, i.e. during the needle pulling process, the support 3 stops moving, the sliding barrel 8 continues to move downward under the action of the elastic force of the elastic element 9 until the bottom of the sliding barrel 8 contacts with the top of the support 3, and at this time, the third limiting buckle 803 completely peels off the fifth groove 205. The second limiting rib 804 relieves the limitation of the limiting column 302 in the horizontal direction, the third elastic buckle 303 is positioned at the opening 8041 on the second limiting rib 804, and the limiting column 302 can be opened towards two sides.

In the process, the sliding barrel 8 moves downwards, the needle seat 2 stops moving, the fourth elastic catch 801 moves into the fourth groove 204, and the restriction of the fifth elastic catch 1001 in the horizontal direction is released.

As shown in fig. 19-20, after the sliding barrel 8 stops moving, the elastic element 9 continues to rebound under the most elastic force, the elastic element 9 pushes the needle remover 10 to move towards the proximal end, the fifth elastic buckle 1001 is elastically deformed to disengage from the limitation of the third limiting rib 101, the needle remover 10 realizes the movement towards the proximal end, and the extension arm 206 at the top of the needle base 2 is pushed to drive the needle base 2 to move towards the proximal end as a whole.

Specifically, the fourth elastic buckle 801 is elastically deformed by the extrusion of the inner protrusion 10012 of the fifth elastic buckle, and is deflected into the fourth groove 204, the needle extractor 10 moves upward, and the fifth elastic buckle 1001 is elastically deformed to be separated from the limitation of the third limiting rib 101.

As shown in fig. 21, the needle holder 2 drives the guiding needle 4 to move upwards, the top of the third elastic buckle 303 is elastically deformed to shift towards the opening 8041, the inclined surface 402 is separated from the guiding needle groove 301, the guiding needle 403 moves towards the proximal direction, and is separated from the skin of the recipient and retracted into the device, so that the sensor indwelling part is retained in the skin of the recipient.

It should be noted that the elastic member 9 is restored to its original length only when the needle pulling operation is completed.

After the needle pulling action is completed, the device is removed, and the application work is completed. It should be noted that the sensor base assembly 5 further includes an emitting portion, which is mounted to the sensor base 505 by the user after the sensor base assembly 5 is applied to the skin of the subject and is fixed by the connection hook 504. Of course, in other embodiments, the sensor base 505 and the transmitting portion may be a unitary structure, and the transmitting portion does not need to be mounted additionally.

It should be noted that, when the device is removed, the holder 3 remains on the skin of the subject together with the sensor base 505, and the user needs to manually take the holder 3, so that the engaging groove 503 is disengaged from the rib 304, and the holder 3 is separated from the sensor base 505.

The structure and movement principle of the embodiment are briefly described as follows:

(1) initial state of implant device

As shown in fig. 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, so as to ensure that the framework 7 cannot move towards the skin side of the recipient. As shown in fig. 10, the third limiting rib 101 of the housing limits the fifth elastic buckle 1001 of the needle remover 10, so as to ensure that the needle remover 10 cannot move in the direction away from the skin side; as shown in fig. 11, the second elastic fastener 701 of the frame 7 limits the second groove 802 on the slide cartridge 8, so as to ensure that the slide cartridge 8 cannot move towards the skin side of the recipient.

(2) Implant device triggering

Firstly, removing the end cover 6 to expose the framework 7; then the implantation device is placed on the skin of a subject, as shown in fig. 12, the housing 1 is pressed downwards, the elastic element 9 continues to be compressed, the first groove 102 on the housing 1 releases the horizontal limit of the second elastic buckle 701 of the framework 7, as shown in fig. 13, under the elastic action of the elastic element 9, the second elastic buckle 701 of the framework 7 generates elastic deformation, and the sliding cylinder 8, the needle seat 2, the guide needle 4, the bracket 3 and the sensor base assembly 5 move towards the skin of the subject together to carry out application and puncture actions. As shown in fig. 14, the limitation of the third limiting buckle 803 of the sliding barrel 8 by the upper limiting block 703 of the framework 7 ensures that the needle seat 2 and the sliding barrel 8 are relatively locked before the needle point punctures the skin; as shown in FIG. 15, the limitation of the second limiting rib 804 of the sliding tube 8 on the limiting column 302 of the bracket 3 ensures that the guide needle 4 and the bracket 3 are relatively locked when the needle point pierces the skin, thereby smoothly completing the application and puncturing actions. As shown in fig. 16, after the guide needle 4 penetrates the skin, the stopper 703 releases the stopper of the third stopper 803.

(3) Needle for pulling (returning) implantation device

After the sensor base assembly 5 and the guide pin 4 are in place, the movement of the bracket 3 is stopped, as shown in fig. 17, the sliding cylinder 8 continues to move towards the skin side of the receptor until the sliding cylinder is contacted with the bracket 3, and therefore the second limiting rib 804 of the sliding cylinder 8 relieves the limitation on the limiting column 302 of the bracket 3. The sliding barrel 8 is limited by the bracket 3 to stop moving, as shown in fig. 18, the fourth groove 204 of the needle holder 2 releases the horizontal limitation of the fourth elastic buckle 801 of the sliding barrel 8, and the needle extractor 10 moves towards the direction far away from the skin under the action of the elastic part 9, as shown in fig. 19 and 20, the fourth elastic buckle 801 is extruded by the fifth elastic buckle 1001 to generate elastic deformation, so that the third limiting rib 101 of the shell 1 releases the limitation of the fifth elastic buckle 1001 of the needle extractor 10, and the needle extracting (returning) action is started. Referring to fig. 21, the needle extractor 10 drives the needle hub 2 to move towards the side far away from the skin, the upper end of the guiding needle 4 is provided with a bevel 402, the bevel 402 is separated from the bracket guiding needle groove 301, and the guiding needle 4 moves towards the side far away from the skin and retracts into the implanting device.

(4) Implant device removal

The application of the sensor base assembly 5 is completed by removing the implant device by hand. After the sensor base assembly 5 is applied in place, the sliding barrel 8 continues to move under the action of the elastic component 9, and then the needle pulling action is triggered, so that the needle pulling action is guaranteed to be carried out after the application is in place, and the situation that the sensor is not inserted in place due to the early needle pulling is avoided.

As shown in fig. 24-28, in other embodiments:

a fourth limiting rib 105 is arranged above the first limiting rib 104 arranged on the shell 1, and the fourth limiting rib are positioned on the same vertical line. When the shell 1 is pressed, the shell 1 moves from the first position to the second position, the first limiting rib 104 is separated from the first elastic buckle 705, the fourth limiting rib 105 is arranged below the first elastic buckle 705, and the upper top surface of the fourth limiting rib is in contact with the first elastic buckle 705. The movement locus of the skeleton 7 in the vertical direction is restricted, and after the application is completed, the process of removing the device can lock the position between the skeleton 7 and the case 1.

Further, the distance between the first limiting rib 104 and the fourth limiting rib 107 is the farthest distance for the casing 1 to travel along the framework 7. In other embodiments, the distance between the two is not greater than the maximum distance that the housing 1 travels along the framework 7.

Limiting plates 307 extending outwards are arranged on two sides of the top of the support 3, seventh elastic buckles 707 extending inwards are correspondingly arranged on the framework 7, when the support 3 moves to the far end, the sensor base 505 is pasted on the skin of a receptor through applying glue, the limiting plates 307 are in contact with the seventh limiting buckles 708, the seventh limiting buckles 709 limit the movement track of the support 3 in the vertical direction, and the support 3 is prevented from falling after being locked in contact. The direct removing device is characterized in that the bracket 3 is kept relatively still with the framework 7 under the action of the limiting plate 307 and the buckle 708, the clamping groove 503 is stripped from the convex rib 304, and the bracket 3 is removed together with the framework 7 without manual stripping.

In conclusion, compared with the prior art, the invention uses the elastic piece secondary loading mechanism to reduce the risk of part deformation in the storage process; the sensor insertion depth is more accurate, and the use easy operation, use are reliable, avoid the false triggering, and applicable crowd is wider.

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.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships that the products of the present invention usually place when in use, and are used for simplifying the description of the present invention, but do not indicate or imply that the devices or elements indicated must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as implying or implying relative importance.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. A sensor implantation device for inserting a transcutaneous analyte sensor into a skin of a subject and for automatically extracting the sensor therefrom, comprising: comprises the following steps of;

the braking mechanism comprises a shell (1), the touch-back component is arranged in the shell (1) and can move between a far end and a near end relative to the touch-back component, and the braking mechanism is triggered by external force and provides a heavy driving force for the device;

the shell (1) is pressed, the shell (1) moves towards the far end, a heavy driving force is provided for the device, the driving mechanism is triggered to provide a heavy driving force for the device, and the touch-back component completes reciprocating motion between the far end and the near end.

2. A sensor implantation device according to claim 1, wherein: the trigger assembly includes:

the framework (7) is accommodated in the opening end of the shell (1), one end of the framework is in contact with the skin of a receptor, and the shell (1) slides along the framework (7);

the bracket (3) is slidably mounted inside the framework (7) and is used for fixing the sensor base assembly (5);

the sliding barrel (8) is slidably mounted in the framework (7) and can push the bracket (3) to move towards the far end;

the needle extractor (10) is sleeved on the sliding cylinder (8) and is connected with the shell (1) in a sliding manner;

the peripheral side of the sliding barrel (8) extends to the periphery to form a supporting platform (807), and the driving mechanism is arranged between the supporting platform (807) and the needle extractor (10).

3. A sensor implant apparatus according to claim 2, wherein: the insertion assembly includes:

the needle seat (2) is slidably arranged in the sliding barrel (8) and can push the bracket (3) to move towards the far end, and the top of the needle seat extends towards two sides to form an extension arm (206) arranged above the needle extractor (10);

and the guide needle (4) is coupled with the bottom of the needle seat (2) and can fix the position of the bracket (3).

4. A sensor implantation device according to claim 2, wherein: be equipped with first elasticity buckle (705) on skeleton (7), shell (1) inside is equipped with first spacing muscle (104) that correspond with it, first spacing muscle (104) restriction skeleton (7) with relative slip between shell (1).

5. A sensor implantation device according to claim 3, wherein: the needle extractor is characterized in that a third limiting rib (101) is arranged on the inner side wall of the shell (1), a fifth elastic buckle (1001) clamped with the needle extractor (10) is arranged on the needle extractor (10), a fourth elastic buckle (801) contacted with the fifth elastic buckle (1001) is arranged on the sliding barrel (8), and the third limiting rib (101) and the fourth elastic buckle (801) are limited to pull out the needle extractor (10) and move relatively between the shells (1).

6. The sensor implant device of any one of claims 2-5, wherein: a second groove (802) is formed in the sliding barrel (8), a second elastic buckle (701) clamped in the second groove (802) is arranged on the framework (7), and the sliding barrel (8) is limited to move in the vertical direction;

the shell (1) moves towards the far end, a first groove (102) formed in the inner side wall of the shell (1) is arranged on one side of the second elastic buckle (701), and the second elastic buckle (701) is released from limiting the sliding cylinder (8).

7. The sensor implant device of claim 5, wherein: a fourth groove (204) is formed in the upper portion of the needle base (2), the fourth elastic buckle (801) moves to the fourth groove (204), and the limiting of the fifth elastic buckle (1001) in the horizontal direction is relieved.

8. A sensor implantation device according to claim 3, wherein: a fifth groove (205) is formed in the lower portion of the needle seat (2), a third limiting buckle (803) embedded in the fifth groove (205) is arranged on the sliding cylinder (8), a limiting block (703) arranged on one side of the third limiting buckle (803) is arranged on the framework (7), the opening and closing of the third limiting buckle (803) are limited, and the position relation between the sliding cylinder (8) and the needle seat (2) is locked;

a third groove (707) is arranged below the limiting block (703), the third limiting buckle (803) moves to the third groove (707), the limiting of the third limiting buckle (803) is released, and the locking position relation between the sliding cylinder (8) and the needle seat (2) is released.

9. A sensor implantation device according to claim 3, wherein: a sixth elastic buckle (202) and a push plate (201) are arranged at the bottom of the needle seat (2), and the push plate (201) is abutted against the top of the bracket (3);

the top of the guide needle (4) is provided with a clamping bulge (401) in the sixth elastic clamp (202), and the guide needle (4) can be driven to move between the near end and the far end.

10. A sensor implantation device according to claim 3, wherein: support (3) top is equipped with upwards extends and becomes mirrored third elasticity buckle (303), two form between third elasticity buckle (303) and link up guide pin groove (301) of support (3), guide needle (4) are arranged in guide pin groove (301), be equipped with on guide needle (4) with third elasticity buckle (303) interior roof contact inclined plane (402).

11. The sensor implant device of claim 10, wherein: the top of the third elastic buckle (303) is provided with a limiting column (302) extending towards two sides, and the sliding cylinder (8) is provided with a second limiting rib (804) contacting with the sliding cylinder to limit the movement of the limiting column (302) in the horizontal direction;

the sliding barrel (8) moves towards the far end, the second limiting rib (804) relieves the limitation of the limiting column (302) in the horizontal direction, and the third elastic buckle (303) can deviate towards an opening (8041) formed in the second limiting rib (804).

12. A sensor implantation device according to claim 3, wherein: the bottom of the guide needle (4) is provided with a guide needle head (403) and a maintenance plate (404) arranged on one side of the guide needle head (403);

the sensor base assembly (5) is provided with a through hole (501) for a guide needle (403) to pass through, and the stabilizing plate (404) is inserted into a positioning groove (502) formed in the sensor base assembly (5).

13. A sensor implantation device according to claim 3, wherein: the sensor base is characterized in that an elastic arm (306) is arranged at the lower part of the support (3), a clamping groove (503) is formed in the inner side of the elastic arm (306), and a convex rib (304) clamped in the clamping groove (503) is arranged at the lower part of the sensor base component (5).

14. The sensor implant device of any one of claims 1-5, 7-13, wherein: the end cover (6) is further included, and the end cover (6) is connected with the opening end of the shell (1).

15. The sensor implant device of claim 14, wherein: the drive mechanism comprises an elastic member (9).