Analyte sensor implanting device and needle assisting device thereof

Abstract

The invention relates to the technical field of medical equipment, in particular to an analyte sensor implanting device and a needle assisting device thereof. Due to the fact that the guide needle frame is movably installed in the needle assisting device shell, after the guide needle frame drives the guide needle to complete implantation of the analyte sensor, the guide needle rebounds under the action of the needle returning elastic piece, and the needle returning removing structure of the needle assisting device shell can remove the stopping effect of the installation piece stopping structure on the guide needle frame. The needle frame matching part can cross the installation piece stopping structure, the retraction amount of the guide needle is increased, the hand of a user is not prone to being pricked after needle assisting is completed, and the problem that after needle assisting is completed, an operator is prone to being pricked when the user presses a needle assisting device is solved.

Description

Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular to an analyte sensor implantation device and a needle aid thereof. Background Art

[0002] The traditional blood glucose measurement method is cumbersome to use, causes deep wounds, is painful, and can only measure a single value. Diabetic patients cannot understand their glucose levels in real time. In order to understand their glucose levels in real time, some patients choose to wear analyte sensors. The analyte sensor needs to use a sharp object (introducer needle) of the implant device to insert the analyte sensor into the human body so that the analyte sensor contacts the body fluid. After the existing needle assist device is completed, the guide needle retracts a small amount, and the user is more likely to be pricked by the guide needle when pressing the needle assist device after the needle assist is completed. Summary of the invention

[0003] The present application provides a needle-assisting device for an analyte sensor implantation device, which is used to improve the problem that after the current needle-assisting device is used, the guide needle retracts a small amount, and the user is easily injured by pressing the needle-assisting device after the needle-assisting device is used.

[0004] In addition, the present application also aims to provide an analyte sensor implantation device using the above-mentioned needle aid.

[0005] In a first aspect, an embodiment provides a needle aid for an analyte sensor implantation device, comprising:

[0006] A needle-assisting device shell, wherein the proximal end of the needle-assisting device shell is an operating end for pressing operation;

[0007] A mounting member, at least a portion of which is mounted in the needle assisting device housing;

[0008] An introducer needle, the introducer needle is used to implant the analyte sensor into a human body;

[0009] A guide needle holder, the guide needle holder is movably mounted in the needle assisting device shell, and the guide needle is mounted on the guide needle holder; after the needle assisting device shell is pressed, the guide needle holder can drive the guide needle to be implanted into the human body;

[0010] and a needle return elastic member, which is used to apply a needle return elastic force to the guide needle holder after the guide needle is implanted;

[0011] The mounting piece has a mounting piece stop structure, the guide needle holder includes a needle holder matching part, and the mounting piece stop structure is used to cooperate with the needle holder matching part to prevent the guide needle holder from moving toward the operating end before pressing the needle assisting device shell;

[0012] The needle-assisting device shell has a needle-return releasing structure, which is used to apply force to the mounting component stop structure after pressing the needle-assisting device shell, thereby releasing the stopping effect between the mounting component stop structure and the matching part of the needle holder, so that the matching part of the needle holder can pass over the position of the mounting component stop structure under the action of the needle-return elastic member.

[0013] Furthermore, in one embodiment, the mounting member stop structure is an elastic structure, and the return needle releasing structure releases the stopping effect of the mounting member stop structure after applying force to the mounting member stop structure to elastically deform the mounting member stop structure.

[0014] Furthermore, in one embodiment, the needle holder mating part includes a needle holder spring arm, and the mounting piece stopping structure includes a mounting piece spring arm; the proximal end of the needle holder spring arm and the proximal end of the mounting piece spring arm are both movable free ends; the proximal end of the mounting piece spring arm and the proximal end of the needle holder spring arm stop to prevent the guide needle holder from moving toward the operating end; the needle return release structure is used to apply a force to the proximal end of the mounting piece spring arm to elastically deform the mounting piece spring arm to release the stopping relationship between the needle holder spring arm and the mounting piece spring arm.

[0015] Furthermore, in one embodiment, the mounting piece spring arm and the needle holder spring arm are arranged inside and outside, the needle holder spring arm is on the inner side of the mounting piece spring arm, the proximal end of the needle holder spring arm has a needle holder protrusion protruding outward, the proximal end of the mounting piece spring arm has an inner protrusion protruding inward and an outer protrusion protruding outward, the inner protrusion cooperates with the needle holder protrusion stopper, and the outer protrusion is used for the needle return release structure to press the proximal end of the mounting piece spring arm to elastically deform outward, so as to release the stopping effect on the needle holder spring arm.

[0016] Furthermore, in one embodiment, the needle assisting device further includes an implantation frame and an implantation elastic member;

[0017] The implantation frame can be movably mounted in the needle-assisting device shell; the implantation frame includes a locking structure for locking the mounting member with the implantation frame; the needle-assisting device shell includes an unlocking portion, the unlocking portion is used to contact the locking structure to unlock;

[0018] The implantation elastic member is used to apply an implantation elastic force to the implantation frame, and the implantation elastic force is used to drive the implantation frame to move in a direction close to the human body after the locking structure is unlocked;

[0019] The implantation frame further comprises a stop structure, which stops the guide needle frame in a direction away from the human body, so that the implantation frame can drive the guide needle frame to move in a direction close to the human body;

[0020] The mounting member includes a releasing structure; when the implantation frame moves to the guide needle to implant the analyte sensor into the human body, the releasing structure releases the stop structure from stopping the guide needle frame;

[0021] After the stopping effect of the stopping structure on the guide needle holder is released, the needle return elastic member drives the guide needle holder to withdraw the guide needle.

[0022] Furthermore, in one embodiment, the implant frame is a monitor frame for installing a monitor.

[0023] Furthermore, in one embodiment, the release structure is used to apply a force to the stop structure to release the stop structure from stopping the guide needle holder; at least a portion of the stop structure is an elastic structure, which is used to elastically deform under the force applied by the release structure to release the stop on the guide needle holder.

[0024] Furthermore, in one embodiment, the stop structure includes a bracket elastic arm and a stop portion on the bracket elastic arm, the stop portion is used to stop with the guide needle holder; the implant frame includes a frame body, one end of the bracket elastic arm is a free end that can move when the bracket elastic arm is deformed, and the other end is a connecting end connected to the frame body; the release structure applies a force to the bracket elastic arm to deform the elastic arm, so as to release the stopping relationship between the stop portion and the guide needle holder.

[0025] Furthermore, in one embodiment, before the releasing structure releases the stopping effect of the stopping structure, the return needle releasing structure releases the stopping effect of the mounting member stopping structure.

[0026] In a second aspect, an embodiment provides an analyte sensor implantation device, comprising a monitor and a needle assisting device as described in any embodiment of the first aspect, wherein the monitor comprises an analyte sensor.

[0027] According to the needle-assisting device of the analyte sensor implantation device of the above embodiment, since the guide needle holder is movably installed in the needle-assisting device shell, after the guide needle holder drives the guide needle to complete the implantation of the analyte sensor, the guide needle rebounds under the action of the needle-returning elastic member, and the needle-returning releasing structure of the needle-assisting device shell can release the stopping effect of the mounting part stop structure on the guide needle holder, so that the matching part of the needle holder can pass over the mounting part stop structure, thereby increasing the retraction amount of the guide needle. The user is not likely to be pricked by the hand after the needle-assisting operation is completed, thereby improving the problem that the user may be easily pricked by pressing the needle-assisting device after the needle-assisting operation is completed. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a schematic structural diagram of an analyte sensor implant device in an embodiment;

[0029] Figure 2 is a cross-sectional view of an analyte sensor implant device in one embodiment;

[0030] Figure 3 A cross-sectional view of an analyte sensor implant device from another perspective in one embodiment;

[0031] Figure 4 A schematic diagram of the structure of a guide needle holder and an implantation holder in an analyte sensor implantation device in an embodiment;

[0032] Figure 5 A schematic diagram of the structure of an implantation frame in an analyte sensor implantation device in an embodiment;

[0033] Figure 6 A schematic diagram of the structure of a mounting member in an analyte sensor implant device in an embodiment;

[0034] Figure 7 This is a state diagram of the guide needle after the guide needle is driven back by the guide needle support in the analyte sensor implantation device in one embodiment.

[0035] List of feature names corresponding to the reference numerals in the figure: 1. monitor; 11. analyte sensor; 12. adhesive sheet; 13. battery; 2. needle aid; 21. needle aid shell; 211. operating end; 213. unlocking part; 2131. unlocking arm; 214. retaining release structure; 215. retaining release arm; 2151. retaining release arm slope; 216. needle return release structure; 22. mounting piece; 221. release structure; 2211. release protrusion; 2212. protrusion slope; 2213. protrusion guide slope; 222. mounting piece stop structure; 2221. mounting piece elastic arm; 22211. inner protrusion; 22212. outer protrusion; 22213. stop surface; 23. implant Frame; 231, locking structure; 2311, locking arm; 2312, hook; 2313, hook slope; 232, stopping structure; 2321, bracket elastic arm; 23211, bracket elastic arm slope; 23213, contact part; 23214, contact slope; 23215, protrusion; 2322, stopping part; 233, frame; 24, implant elastic member; 25, guide needle frame; 251, claw; 252, needle frame matching part; 2521, needle frame elastic arm; 25211, needle frame protrusion; 25212, activity space; 26, guide needle; 261, needle handle; 27, unlocking shell holding structure; 28, return needle elastic member; 29, protective cover; 210, sensor cap; 3, skin.

[0036] Explanation on the reference numerals in brackets in the drawings: In the reference numerals in brackets in the drawings, the features referred to by the reference numerals are both the features represented by the numbers in the brackets and the features represented by the numbers outside the brackets. DETAILED DESCRIPTION

[0037] The present application is further described in detail below by specific embodiments in conjunction with the accompanying drawings. Wherein similar elements in different embodiments adopt associated similar element numbers. In the following embodiments, many detailed descriptions are intended to enable the present application to be better understood. However, those skilled in the art can easily recognize that some of the features can be omitted in different situations, or can be replaced by other elements, materials, and methods. In some cases, some operations related to the present application are not shown or described in the specification, in order to avoid the core part of the present application being overwhelmed by too much description, and for those skilled in the art, it is not necessary to describe these related operations in detail, and they can fully understand the related operations based on the description in the specification and the general technical knowledge in the art.

[0038] In addition, the features, operations or characteristics described in the specification can be combined in any appropriate manner to form various implementations. At the same time, the steps or actions in the method description can also be interchanged or adjusted in a manner that is obvious to those skilled in the art. Therefore, the various sequences in the specification and the drawings are only for the purpose of clearly describing a certain embodiment and are not meant to be a required sequence, unless otherwise specified that a certain sequence must be followed.

[0039] The serial numbers assigned to the components herein, such as "first", "second", etc., are only used to distinguish the objects described and do not have any order or technical meaning. The "connection" and "coupling" mentioned in this application, unless otherwise specified, include direct connection, indirect connection and contact connection (coupling), etc.

[0040] It should be noted that "proximal" and "distal" are conventional terms in the medical field. For an analyte sensor implant device, the proximal end is the end where the analyte sensor needs to be implanted in the human body, and the distal end is the end close to the human body where the analyte sensor needs to be implanted.

[0041] In one embodiment, please refer to Figures 1 to 7 The analyte sensor implantation device comprises a monitor 1 and a needle aid 2, wherein the monitor 1 comprises an analyte sensor 11. The monitor 1 may be an instrument for monitoring physiological parameters of a human body.

[0042] The analyte sensor implantation device is used to insert the analyte sensor 11 of the monitor 1 into the human body, and the analyte sensor 11 usually needs to be implanted into the human body with the help of an introducer needle 26. The monitor 1 and the analyte sensor 11 can adopt any feasible existing structure, for example, the analyte sensor 11 can be a sensor for detecting human blood sugar, and the monitor 1 can be an instrument for monitoring human blood sugar.

[0043] In one embodiment, please refer to Figures 1 to 7 The needle-assisting device 2 of the analyte sensor implantation device includes a needle-assisting device shell 21, a mounting member 22, a guide needle 26, a guide needle holder 25 and a needle return elastic member 28, and the proximal end of the needle-assisting device shell 21 is an operating end 211 for pressing operation.

[0044] Furthermore, in one embodiment, the distal end of the needle assisting device is a human body contact end for contacting a human body. It should be noted that the distal end and the proximal end in this application are described based on the operator's operating position, wherein the proximal end is the end close to the operator's hand, and the distal end is the end away from the operator's hand.

[0045] Please refer to Figures 1 to 7 At least part of the mounting member 22 is mounted in the needle-assisting device housing 21, the guide needle 26 is used to implant the analyte sensor 11 into the human body, the guide needle holder 25 is movably mounted in the needle-assisting device housing 21, and the guide needle 26 is mounted on the guide needle holder 25. After the needle-assisting device housing 21 is pressed, the guide needle holder 25 can drive the guide needle 26 to be implanted into the human body.

[0046] The needle return elastic member 28 is used to apply a needle return elastic force to the guide needle holder 25 after the guide needle 26 is implanted. The mounting member 22 has a mounting member stop structure 222, and the guide needle holder 25 includes a needle holder matching portion 252 that matches the mounting member stop structure 222. The mounting member stop structure 222 is used to match with the needle holder matching portion 252 before pressing the needle assisting device housing 21, so as to prevent the guide needle holder 25 from moving toward the operating end 211.

[0047] The needle assisting device shell 21 has a needle return releasing structure 216, which is used to apply force to the mounting part stop structure 222 after pressing the needle assisting device shell 21, thereby releasing the stopping effect of the mounting part stop structure 222, so that the needle holder mating part 252 can pass the position of the mounting part stop structure 222 under the action of the needle return elastic part 28.

[0048] Since the guide needle holder 25 is movably installed in the needle assisting device shell 21, after the guide needle holder 25 drives the guide needle 26 to complete the implantation of the analyte sensor 11, the guide needle 26 retracts under the action of the needle return elastic member 28, and the needle return release structure 216 of the needle assisting device shell 21 can release the stopping effect of the mounting part stop structure 222 on the guide needle holder 25, so that the needle holder matching part 252 can pass over the mounting part stop structure 222, thereby increasing the retraction amount of the guide needle 26. The user is not likely to be pricked by the hand after the needle assisting is completed, thereby improving the problem that the user may easily be pricked by pressing the needle assisting device after the needle assisting is completed.

[0049] In one embodiment, please refer to Figure 7 After the analyte sensor 11 is implanted, the guide needle holder 25 rebounds under the action of the needle return elastic member 28 until it contacts the inner wall of the needle assisting device housing 21 .

[0050] Further, in one embodiment, please refer to Figures 2 to 4 The mounting member stop structure 222 is an elastic structure. After the return needle release structure 216 applies force to the mounting member stop structure 222 to elastically deform the mounting member stop structure 222, the stop function of the mounting member stop structure 222 is released. In some other embodiments, in addition to the elastic structure, the mounting member stop structure 222 can also be a disposable structure. After the return needle contact structure applies force to the mounting member stop structure 222, the mounting member stop structure 222 is destroyed, such as separated from the mounting member 22, thereby releasing the stopping function of the mounting member stop structure 222 on the guide needle holder 25.

[0051] Further, in one embodiment, please refer to Figures 2 to 4 , the needle holder matching part 252 includes a needle holder elastic arm 2521, and the mounting member stop structure 222 includes a mounting member elastic arm 2221. The proximal end of the needle holder elastic arm 2521 and the proximal end of the mounting member elastic arm 2221 are both free ends that can move, and the distal end of the needle holder elastic arm 2521 and the distal end of the mounting member elastic arm 2221 are both fixed ends. Among them, the free end that can move refers to the free end that is elastically deformed after being subjected to an external force. Specifically, the distal end of the needle holder elastic arm 2521 is fixed, and the proximal end can be elastically deformed after being subjected to an external force, thereby moving in a direction perpendicular to the extension of the needle holder elastic arm 2521. The distal end of the mounting member elastic arm 2221 is fixed, and the proximal end can be elastically deformed after being subjected to an external force, thereby moving in a direction perpendicular to the extension of the mounting member elastic arm 2221.

[0052] The proximal end of the mounting member elastic arm 2221 blocks the proximal end of the needle holder elastic arm 2521 to prevent the guide needle holder 25 from moving toward the operating end 211. The needle return release structure 216 is used to apply a force to the proximal end of the mounting member elastic arm 2221 to elastically deform the mounting member elastic arm 2221 so as to release the blocking relationship between the needle holder elastic arm 2521 and the mounting member elastic arm 2221.

[0053] In some other embodiments, in addition to the elastic arm, the mounting member stop structure 222 may also be in the form of an elastic structure such as a spring sheet or a spring block. Similarly, the mounting member elastic arm 2221 may also be in the form of an elastic structure such as a spring sheet or a spring block. In some other embodiments, a movable lock may also be used, such as using an movable lock to stop the needle holder mating part, and when the stop relationship needs to be released, the needle return release structure 216 is used to unlock it.

[0054] Further, in one embodiment, please refer to Figure 2 and Figure 4The mounting piece spring arm 2221 and the needle holder spring arm 2521 are arranged inside and outside, the needle holder spring arm 2521 is on the inner side of the mounting piece spring arm 2221, the proximal end of the needle holder spring arm 2521 has a needle holder protrusion 25211 protruding outward, the proximal end of the mounting piece spring arm 2221 has an inner protrusion 22211 protruding inward and an outer protrusion 22212 protruding outward, the inner protrusion 22211 cooperates with the needle holder protrusion 25211 to stop, and the outer protrusion 22212 is pressed by the needle return release structure 216 to make the proximal end of the mounting piece spring arm 2221 elastically deform outward to release the stopping effect on the needle holder spring arm 2521.

[0055] The extension direction of the mounting piece spring arm 2221 is consistent with the extension direction of the needle holder spring arm 2521, and an activity space 25212 is formed on the side of the needle holder protrusion 25211 toward the distal end of the needle holder spring arm 2521. The activity space 25212 can accommodate the inner protrusion 22211 on the mounting piece spring arm 2221, so that after the needle holder mating part 252 passes over the mounting piece stop structure 222, the inner protrusion 22211 can enter the activity space 25212.

[0056] Specifically, in one embodiment, please refer to Figure 2 , Figure 4 and Figure 7 When the needle return release structure 216 releases the stopping effect of the mounting member elastic arm 2221, the stopping surface 22213 of the inner protrusion 22211 changes from a fitted state to an inclined state, in which the inner protrusion 22211 is fitted with the needle holder protrusion 25211, and the force of the needle return elastic member 28 is approximately perpendicular to the stopping surface 22213. After the stopping surface 22213 changes to an inclined state, the needle holder protrusion 25211 is no longer fitted with the stopping surface 22213. At this time, under the guidance of the stopping surface 22213 and the elastic force of the needle return elastic member 28, the needle holder The elastic arm 2521 deforms inwardly and moves toward the operating end 211 until the needle holder protrusion 25211 of the needle holder elastic arm 2521 is out of contact with the inner protrusion 22211, and the stopping effect of the mounting part stop structure 222 is released. The inner protrusion 22211 enters the activity space 25212, reducing the deformation of the needle holder elastic arm 2521 and the mounting part elastic arm 2221. At this time, the inner protrusion 22211 and the needle holder protrusion 25211 are arranged in the extension direction of the needle holder elastic arm 2521, and the needle holder elastic arm 2521 can move smoothly toward the operating end 211.

[0057] In one embodiment, please refer to Figure 2 , Figure 4 and Figure 7 The needle return release structure 216 is a needle return release arm, and the extension direction of the needle return release arm is consistent with the extension direction of the guide needle. After applying pressure to the needle assisting device shell 21, the needle return release arm presses the outer protrusion 22212.

[0058] Further, in one embodiment, please refer to Figure 2 and Figure 3 The needle aid also includes an implantation frame 23 and an implantation elastic member 24. The implantation frame 23 can be movably installed in the needle aid shell 21. The implantation frame 23 includes a locking structure 231 for locking the mounting member 22 with the implantation frame 23. Before using the analyte sensor implantation device, the relative positions of the implantation frame 23 and the mounting member 22 are locked and cannot move relative to each other. When the analyte sensor 11 needs to be implanted into the human body, the locking structure 231 needs to be unlocked. The implantation elastic member 24 is used to apply an implantation elastic force to the implantation frame 23, and the implantation elastic force is used to drive the implantation frame 23 after the locking structure 231 is unlocked, so that the implantation frame 23 drives the guide needle frame 25 to move toward the human body.

[0059] The needle assisting device housing 21 includes an unlocking portion 213, which is used to contact the locking structure 231 to release the locking effect on the implantation frame 23. The unlocking portion 213 is used to contact the locking structure 231 to release the locking effect of the locking structure 231 on the implantation frame 23, so that the implantation frame 23 moves toward the distal end under the elastic force of the implantation elastic member 24, that is, moves toward the human body relative to the mounting member 22.

[0060] The implantation frame 23 has an initial position and an implantation position in its movable stroke. In the initial position, the implantation frame 23 is locked by the locking structure 231. In the implantation position, the guide needle 26 can implant the analyte sensor 11 into the human body. The implantation elastic member 24 is used to apply an implantation elastic force to the implantation frame 23, and the implantation elastic force is used to drive the implantation frame 23 to move toward the implantation position after the locking structure 231 is released.

[0061] The implantation frame 23 further includes a stop structure 232, which stops the guide needle frame 25 in a direction away from the human body, so that the implantation frame 23 can drive the guide needle frame 25 to move in a direction close to the human body.

[0062] The mounting member 22 includes a release structure 221. When the implantation frame 23 moves to the implantation position, the guide needle 26 implants the analyte sensor 11 into the human body, and the release structure 221 releases the stop structure 232 from stopping the guide needle frame 25. After the stop structure 232 stops stopping the guide needle frame 25, the return needle elastic member 28 drives the guide needle frame 25 to move toward the operating end 211 to extract the guide needle 26.

[0063] The needle-assisting device uses a locking structure 231 to lock the implantation frame 23 and the mounting member 22. After the locking structure 231 is unlocked by the unlocking part 213, the implantation frame 23 moves toward the direction close to the human body under the elastic force of the implantation elastic member 24. Under the action of the stop structure 232, the implantation frame 23 can drive the guide needle frame 25 to move, and the guide needle 26 can penetrate the human body to achieve the implantation of the analyte sensor 11. Compared with relying on manual pressing force to control the penetration depth of the guide needle 26 of the implantation device, the penetration of the guide needle 26 is completed by applying elastic force through the implantation elastic member 24, which reduces the requirements for manual operation strength. After the guide needle 26 is inserted into the human body and is in place, the releasing structure 221 on the mounting part 22 can exert a force on the stopping structure 232, thereby releasing the stopping effect of the stopping structure 232 on the guide needle holder 25. In this way, the guide needle holder 25 can move away from the human body under the action of the return needle elastic force of the return needle elastic part 28, thereby pulling the guide needle 26 out of the human body. Under the action of the implanting elastic part 24, the guide needle 26 can be inserted into place, and the releasing structure 221 can stably complete the releasing effect on the stopping structure 232, thereby reducing the operating difficulty for the operator.

[0064] In some other embodiments, in addition to implanting the analyte sensor 11 into the human body by means of the implantation frame 23 and the implantation elastic member 24, the analyte sensor 11 can also be implanted by manually applying pressure to the needle-assisting device shell 21 to insert the guide needle 26 into the human body.

[0065] Further, in one embodiment, please refer to Figure 2 and Figure 3 The implantation frame 23 is a monitor frame for installing the monitor 1. In some other embodiments, the implantation frame 23 may not be installed with the monitor 1, and the monitor 1 may be installed on the installation member 22.

[0066] In one embodiment, please refer to Figure 2 and Figure 3 The mounting member 22 guides the guide needle holder 25 and the implantation holder 23 , so that the guide needle holder 25 and the implantation holder 23 move linearly along the extension direction of the guide needle 26 , while preventing the guide needle holder 25 and the implantation holder 23 from rotating relative to the mounting member 22 .

[0067] In one embodiment, please refer to Figure 2 and Figure 3 , the return needle elastic member 28 is between the guide needle frame 25 and the implantation frame 23 and is always in a compressed state. In one embodiment, the implantation elastic member 24 is between the mounting member 22 and the implantation frame 23 and is always in a compressed state. In one embodiment, the return needle elastic member 28 and the implantation elastic member 24 are both coil springs. The coil spring has a simple structure and is easy to install.

[0068] In one embodiment, please refer to Figure 2 and Figure 3 The release structure 221 releases the stop structure 232 from stopping the guide needle holder 25 by applying a force to the stop structure 232. At least part of the stop structure 232 is an elastic structure, and the elastic structure is elastically deformed after the release structure 221 applies a force, thereby releasing the stop on the guide needle holder 25. The stop structure 232 is an elastic structure, which makes it easier for the release structure 221 to release the stop structure 232 from stopping the guide needle holder 25.

[0069] In some other embodiments, the release structure 221 can also limit the stopping structure 232. When the restriction is released, the stopping structure 232 can automatically release the stop by relying on its own elastic force or under the force of other components.

[0070] Regarding the form of the stop structure 232, in one embodiment, please refer to Figure 2 and Figure 3 The stop structure 232 includes a support spring arm 2321 and a stop portion 2322 on the support spring arm 2321, and the stop portion 2322 is used to stop the guide needle holder 25. The implantation frame 23 includes a frame body, one end of the support spring arm 2321 is a free end that can move when the support spring arm 2321 is deformed, and the other end is a connection end connected to the frame body. The release structure 221 applies a force to the support spring arm 2321 to deform the support spring arm 2321, so as to release the stop relationship between the stop portion 2322 and the guide needle holder 25.

[0071] In some other embodiments, in addition to using the bracket elastic arm 2321, the stop structure 232 may also include a rigid bracket and an elastic sheet fixed on the rigid bracket, the elastic sheet and the guide needle holder 25 are stopped, and the stop structure 232 releases the stopping effect of the elastic sheet by deforming the elastic sheet. In some other embodiments, the stop structure 232 may also be other forms other than the elastic structure, and the stop structure 232 may include a movable locking tongue, which stops the guide needle holder 25, and after the locking tongue is retracted by the release structure 221, the stopping relationship between the locking tongue and the guide needle holder 25 is released.

[0072] Further, in one embodiment, please refer to Figure 2 and Figure 3 Before the release structure 221 releases the stopping function of the stopping structure 232, the return needle release structure 216 releases the stopping function of the installation member stopping structure 222. In some other embodiments, the return needle release structure 216 can also release the stopping function of the installation member stopping structure 222 at the same time or after the release structure 221 releases the stopping function of the stopping structure 232.

[0073] Further, in one embodiment, please refer to Figures 2 to 6, the direction in which the guide needle 26 penetrates the human body is the first direction, the support elastic arm 2321 extends along the first direction, the support elastic arm 2321 includes a contact portion 23213, the contact portion 23213 has a contact slope 23214 for contacting the release structure 221, and the release structure 221 deforms the support elastic arm 2321 by abutting against the contact slope 23214. Specifically, in one embodiment, the support elastic arm 2321 includes a straight arm and a protrusion 23215 on the straight arm, the straight arm extends along the first direction, the protrusion 23215 is on one side of the straight arm, and the contact slope 23214 is on the protrusion 23215. In some other embodiments, in addition to using a straight arm, the support elastic arm 2321 may also use any other type of any form, such as the support elastic arm 2321 is a curved elastic arm or an inclined elastic arm.

[0074] Regarding the release structure 221, in one embodiment, please refer to Figures 3 to 5 The release structure 221 includes a release protrusion 2211 on the mounting member 22 , and the release protrusion 2211 has a protruding slope 2212 , and the protruding slope 2212 is used to cooperate with the contact slope 23214 to make the bracket elastic arm 2321 elastically deform in a direction away from the release protrusion 2211 .

[0075] In one embodiment, please refer to Figures 3 to 5 The proximal end of the bracket elastic arm 2321 is a free end, and the distal end of the bracket elastic arm 2321 is a connecting end. The stopper 2322 is close to the contact portion 23213 and away from the connecting end. When the bracket elastic arm 2321 is deformed, the stopper 2322 is away from the connecting end, which can make the stopper 2322 have a larger range of motion and more easily release the stop on the guide needle holder 25. In some other embodiments, the stopper 2322 can also be composed of the contact portion 23213.

[0076] Specifically, in one embodiment, please refer to Figures 3 to 5 In order to facilitate the design of the structure, the bracket elastic arm 2321 has a set width, and the contact portion 23213 and the stop portion 2322 are arranged or connected at intervals along the circumference of the implant frame 23. In some other embodiments, the contact portion 23213 and the stop portion 2322 can also be arranged side by side only along the circumference of the implant frame 23, and in the extension direction of the bracket elastic arm 2321, the contact portion 23213 and the stop portion 2322 are at the same position.

[0077] In one embodiment, please refer to Figure 2 , Figure 3 and Figure 7 The distal end of the needle assisting device shell 21 has an opening for facing the human body. The mounting member 22 and the implantation frame 23 are both movably assembled in the needle assisting device shell 21. The unlocking portion 213 is on the needle assisting device shell 21, and the release structure 221 is on the mounting member 22.

[0078] In one embodiment, please refer to Figure 2 , Figure 3 and Figure 7 The mounting member 22 is movably mounted in the needle assisting device shell 21. The implanting frame 23 is movably mounted on the mounting member 22. The implanting frame 23 is provided with an unlocking shell holding structure 27, which is used to apply a holding force to the needle assisting device shell 21 to maintain the position of the needle assisting device shell 21.

[0079] The needle assisting device shell 21 has a holding release structure 221, which contacts the unlocking shell holding structure 27 after the needle assisting device shell 21 is pressed, so as to overcome the holding force and release the holding effect of the unlocking shell holding structure 27 on the needle assisting device shell 21, so that the unlocking part 213 can unlock the locking structure 231. The magnitude of the holding force is selected within a reasonable range according to the force of pressing the needle assisting device shell 21. The unlocking shell holding structure 27 releases the holding of the needle assisting device shell 21 after the needle assisting device shell 21 is pressed and the holding force is overcome, so as to prevent accidental touch.

[0080] In one embodiment, please refer to Figure 2 , Figure 3 and Figure 7 , the unlocking shell holding structure 27 is at the proximal end of the implantation frame 23. This facilitates the interaction between the unlocking shell holding structure 27 and the needle assisting device shell 21. In some other embodiments, the unlocking shell holding structure 27 can also be arranged at the distal end of the needle assisting device shell 21.

[0081] The stop structure 232 includes a support spring arm 2321 and a stop portion 2322 on the support spring arm 2321, and the stop portion 2322 is used to stop the guide needle holder 25. The implantation frame 23 includes a frame body 233, one end of the support spring arm 2321 is a free end that can move when the support spring arm 2321 is deformed, and the other end is a connection end connected to the frame body 233.

[0082] The release structure 221 applies a force to the support elastic arm 2321 to deform the support elastic arm 2321, so as to release the blocking relationship between the stopper 2322 and the guide needle holder 25. The support elastic arm 2321 forms at least a part of the unlocking shell holding structure 27. The support elastic arm 2321 extends from the distal end to the proximal end of the implanting frame 23. The support elastic arm 2321 maintains the position of the needle assisting shell 21 by abutting against the needle assisting shell 21. The needle assisting shell 21 is deformed by pressing the support elastic arm 2321, and the abutting relationship between the support elastic arm 2321 and the needle assisting shell 21 is released.

[0083] In one embodiment, please refer to Figures 2 to 5 The support spring arm 2321 extends from the distal end to the proximal end of the implant frame 23 , and the support spring arm 2321 maintains the position of the needle assisting device shell 21 by abutting against the needle assisting device shell 21 .

[0084] Further, in one embodiment, please refer to Figures 2 to 5 The release structure 214 includes a release arm 215, which is located in the needle assisting device shell 21. The release arm 215 extends from the proximal end of the needle assisting device shell 21 to the distal end of the needle assisting device shell 21. The distal end of the release arm 215 abuts against the proximal end of the support elastic arm 2321. The distal end of the release arm 215 and the proximal end of the support elastic arm 2321 both have slopes. The slope of the distal end of the release arm 215 is the release arm slope 2151, and the slope of the proximal end of the support elastic arm 2321 is the support elastic arm slope 23211. The release arm slope 2151 and the support elastic arm slope 23211 are both used to guide the support elastic arm 2321 to deform after the needle assisting device shell 21 is pressed, and the release arm 215 and the support elastic arm 2321 are released. The release function of the unlocking shell holding structure 27. In one embodiment, the release arm 215 is a rigid arm. In some other embodiments, the bracket elastic arm 2321 and the retaining release arm 215 are both elastic arms.

[0085] In some other embodiments, only the distal end of the holding release arm 215 may have the holding release arm slope 2151, and the proximal end of the support elastic arm 2321 may have a plane in contact with the holding release arm slope 2151, and the plane may be perpendicular to the direction of movement of the implant frame 23. In some other embodiments, only the proximal end of the support elastic arm 2321 may have the support elastic arm slope 23211. It should be noted that the slope in the present application refers to a surface with a certain slope in the direction of movement of the implant frame 23, and the slope may be an inclined surface, an outer convex surface, or an inner concave surface.

[0086] In one embodiment, please refer to Figures 2 to 5 When the support spring arm 2321 releases the abutting relationship with the needle assisting device shell 21, it bends and deforms toward the first side of the support spring arm 2321, and when the stopping relationship with the guide needle frame 25 is released, it bends and deforms toward the second side of the support spring arm 2321. The first side and the second side are two opposite sides of the support spring arm 2321.

[0087] In one embodiment, please refer to Figures 2 to 5 In order to facilitate unlocking of the implantation frame 23, the minimum force required for the unlocking structure 214 to unlock the unlocking shell holding structure 27 from holding the needle assisting device shell 21 is the first force, and the minimum force required for the unlocking part 213 to unlock the locking structure 231 from locking the implantation frame 23 is the second force, and the first force is greater than the second force. This can not only improve the effect of preventing accidental touch, but also unlock the implantation frame 23 more smoothly, and the overall operation is smoother.

[0088] In some other embodiments, according to actual needs, the first force may also be less than or equal to the second force.

[0089] Specifically, in one embodiment, please refer to Figures 2 to 5 The number of the release arms 215 is more than two, the unlocking portion 213 is an unlocking arm 2131, the unlocking arm 2131 extends from the proximal end of the self-needle device shell 21 to the distal end of the auxiliary needle device shell 21, the number of the unlocking arms 2131 is more than two, and the unlocking arms 2131 and the release arms 215 are alternately arranged along the circumference of the auxiliary needle device shell 21.

[0090] Further, in one embodiment, please refer to Figures 2 to 5 The locking structure 231 includes a locking arm 2311, which extends from the distal end to the proximal end of the implant frame 23. A hook 2312 is provided at the proximal end of the locking arm 2311. The hook 2312 is clamped on the mounting member 22 to lock the implant frame 23 and the mounting member 22. The unlocking portion 213 deforms the locking arm 2311 by abutting against the hook 2312, so as to separate the hook 2312 from the mounting member 22.

[0091] For details, please refer to Figures 2 to 5 In order to facilitate the unlocking of the hook 2312, a hook slope 2313 is provided on the hook 2312, and an unlocking arm slope is provided at the end of the unlocking arm 2131. Through the cooperation between the unlocking arm slope and the hook slope 2313, a force can be applied to the hook 2312 to separate the hook 2312 from the mounting member 22.

[0092] Further, in one embodiment, please refer to Figures 2 to 6 The mounting member 22 is sleeve-shaped, and the implantation frame 23 is mounted in the mounting member 22. The mounting member 22 can guide the implantation frame 23 to move in a straight line. This can prevent the implantation frame 23 from rotating, and the implantation frame 23 moves more smoothly. In one embodiment, the mounting member elastic arm 2221 is located on the side wall of the mounting member 22.

[0093] In one embodiment, please refer to Figures 2 to 6 The mounting piece 22 is sleeve-shaped. Under the action of the return needle elastic piece 28, the guide needle frame 25 and the implantation frame 23 can be pre-assembled to form a preassembled body. The preassembled body is inserted into the mounting piece 22 from the distal end of the mounting piece 22, and the implantation elastic piece 24 is pressed between the implantation frame 23 and the mounting piece 22.

[0094] In order to further facilitate the installation of the implantation frame 23, in one embodiment, please refer to Figures 2 to 5 In addition to the raised slope 2212, the release protrusion 2211 also has a raised guide slope 2213, and the raised guide slope 2213 is arranged opposite to the raised slope 2212, so that when the implant frame 23 is installed into the mounting member 22, the raised guide slope 2213 can guide the bracket elastic arm 2321 to be inserted into the mounting member 22.

[0095] Specifically, in one embodiment, please refer to Figures 2 to 7After the lock between the implantation frame 23 and the mounting member 22 is released, the implantation frame 23 moves toward the human body. At this time, the stop structure 232 does not contact the guide needle frame 25. After the implantation frame 23 moves a first distance, the stop structure 232 stops the guide needle frame 25, driving the guide needle frame 25 to move toward the distal end. This movement situation can be applicable to the situation where the needle handle 261 of the guide needle 26 is relatively long. After the needle handle 261 passes through the monitor 1, it still extends out of the monitor 1 for a section. The side of the monitor 1 facing the human body is provided with an adhesive sheet 12. After the guide needle 26 implants the analyte sensor 11 into the human body, the adhesive sheet 12 contacts the human skin 3 and fixes the monitor 1 on the human skin 3. When the guide needle 26 pierces the human body, if the needle handle 261 of the guide needle 26 protrudes from the side of the monitor 1 facing the human body, the needle handle 261 of the guide needle 26 will conflict with the human skin 3, affecting the adhesion of the monitor 1 to the human body. In order to make the monitor 1 stick better to the human skin 3, in one embodiment, the length of the first distance is equal to the length of the needle handle 261 extending from the monitor 1, or the first distance is greater than the length of the needle handle 261 extending from the monitor 1, so that when the guide needle 26 is inserted into the human body, the needle handle 261 is flush with the side of the monitor 1 facing the human body or retracted a certain distance into the monitor 1.

[0096] Further, in one embodiment, please refer to Figure 2 When the implantation frame 23 is in the initial position, although the stop structure 232 of the implantation frame 23 does not stop the guide needle frame 25, the return needle elastic member 28 is still in a compressed state and is between the guide needle frame 25 and the implantation frame 23, so that the guide needle frame 25 is not easy to shake and has better stability. Relying on the stopping effect of the mounting member stop structure 222, the guide needle frame 25 and the stop structure 232 of the implantation frame 23 are kept in a state of being spaced apart and not in contact.

[0097] Specifically, in one embodiment, please refer to Figure 2 The mounting member stop structure 222 cooperates with the guide needle holder 25 to stop the return needle elastic member 28 so that the return needle elastic member 28 is still in a compressed state.

[0098] In one embodiment, please refer to Figure 2 and Figure 3 The needle handle 261 passes through the monitor 1 to install the sensor cap 210, and the sensor cap 210 can be installed on the needle handle 261 by any feasible method such as screwing, snapping, magnetic attraction, etc. The sensor cap 210 can protect the monitor 1 and the analyte sensor 11.

[0099] The needle assisting device 2 includes a protective cover 29, a sensor cap 210 is mounted on the portion of the guide needle holder 25 passing through the monitor 1, and the protective cover 29 is fixed on the needle assisting device shell 21. The needle assisting device shell 21 has an opening, and the protective cover 29 is mounted at the opening.

[0100] In one embodiment, the anti-accidental touch function can be realized by unlocking the shell holding structure 27, and the user does not need to remove the anti-accidental touch parts, which is more convenient for users to use. The needle-assisting device shell 21 of the needle-assisting device acts as a button, and there is no need to add a button part separately, which reduces the manufacturing cost. At the same time, the area of ​​the needle-assisting device shell 21 is larger than that of a separate button, which is more convenient for users to use.

[0101] In one embodiment, please refer to Figure 2 and Figure 3 The guide needle holder 25 has a claw 251 , and the claw 251 holds the needle handle 261 of the guide needle 26 .

[0102] In one embodiment, please refer to Figure 7 The implantation frame 23 is provided with a magnet (not shown in the figure), and the monitor 1 includes a battery 13. The monitor 1 is fixed to the implantation frame 23 by adsorbing the battery 13 shell of the battery 13 with the magnet. After the adhesive sheet 12 is adhered to the human body, the adhesive force of the adhesive sheet 12 is greater than the magnetic attraction force. When the biosensor needle aid is pulled out, the monitor 1 is separated from the implantation frame 23.

[0103] In one embodiment, please refer to Figures 1 to 7 , please refer to the figure. The implantation process of the analyte sensor implant device is as follows:

[0104] When it is necessary to implant the analyte sensor 11 into the human body, the protective cover 29 is opened and the sensor cap 210 is removed, so that the opening of the needle-assistant shell 21 is facing the position where the sensor needs to be implanted in the human body, and pressure is applied to the operating end 211 of the needle-assistant shell 21, so that the retaining release structure 214 of the needle-assistant shell 21 contacts the unlocking shell retaining structure 27, thereby overcoming the retaining force of the unlocking shell retaining structure 27 on the needle-assistant shell 21, releasing the retaining effect of the unlocking shell retaining structure 27 on the needle-assistant shell 21, and enabling the unlocking portion 213 to unlock the locking structure 231.

[0105] After the implantation frame 23 is unlocked, it moves toward the human body under the action of the implantation elastic member 24, and the stop structure 232 stops the guide needle frame 25 in the direction away from the human body, so that when the implantation frame 23 moves toward the implantation position, it can drive the guide needle frame 25 and the guide needle 26 to move in the direction close to the human body, and then drive the guide needle 26 to move in the direction of piercing the human body, so that the guide needle 26 implants the analyte sensor 11 into the human body. The release structure 221 applies a force to the stop structure 232, releases the stop of the stop structure 232 on the guide needle frame 25, and the guide needle frame 25 and the implantation frame 23 can move relative to each other. Under the action of the needle return elastic member 28, the guide needle 26 is pulled out of the human body. After the implantation of the analyte sensor 11 is completed, the needle aid 2 is removed by operating the needle aid shell 21, and the monitor 1 is separated from the implantation frame 23 under the action of the adhesive sheet 12. The monitor 1 is attached to the surface of the human body and can monitor the parameters of the human body in real time.

[0106] In an embodiment of a needle assisting device for an analyte sensor implantation device, the structure of the needle assisting device for the analyte sensor implantation device is the same as the structure of the needle assisting device in any of the above embodiments, and will not be described in detail.

[0107] The above specific examples are used to illustrate the present application, which is only used to help understand the present application and is not intended to limit the present application. For technicians in the technical field to which the present application belongs, they can also make some simple deductions, deformations or substitutions based on the ideas of the present application.

Claims

1. A needle aid for an analyte sensor implantation device, characterized in that: include: A needle-assisting device shell, wherein the proximal end of the needle-assisting device shell is an operating end for pressing operation; A mounting member, at least a portion of which is mounted in the needle assisting device housing; An introducer needle, the introducer needle is used to implant the analyte sensor into a human body; A guide needle holder, the guide needle holder is movably mounted in the needle assisting device shell, and the guide needle is mounted on the guide needle holder; after the needle assisting device shell is pressed, the guide needle holder can drive the guide needle to be implanted into the human body; and a needle return elastic member, which is used to apply a needle return elastic force to the guide needle holder after the guide needle is implanted; The mounting piece has a mounting piece stop structure, the guide needle holder includes a needle holder matching part, and the mounting piece stop structure is used to cooperate with the needle holder matching part to prevent the guide needle holder from moving toward the operating end before pressing the needle assisting device shell; The needle-assisting device shell has a needle-return releasing structure, which is used to apply force to the mounting component stop structure after pressing the needle-assisting device shell, thereby releasing the stopping effect between the mounting component stop structure and the matching part of the needle holder, so that the matching part of the needle holder can pass over the position of the mounting component stop structure under the action of the needle-return elastic member.

2. The needle-aiding device for the analyte sensor implantation device according to claim 1, characterized in that: The mounting member stop structure is an elastic structure. After the return needle releasing structure applies force to the mounting member stop structure to elastically deform the mounting member stop structure, the stopping effect of the mounting member stop structure is released.

3. The needle-aiding device for the analyte sensor implantation device according to claim 2, characterized in that: The needle holder mating part includes a needle holder spring arm, and the mounting piece stopping structure includes a mounting piece spring arm; the proximal ends of the needle holder spring arm and the mounting piece spring arm are both movable free ends; the proximal ends of the mounting piece spring arm and the proximal ends of the needle holder spring arm are stopped to prevent the guide needle holder from moving toward the operating end; the needle return release structure is used to apply a force to the proximal end of the mounting piece spring arm to elastically deform the mounting piece spring arm to release the stopping relationship between the needle holder spring arm and the mounting piece spring arm.

4. The needle-aiding device for the analyte sensor implantation device according to claim 3, characterized in that: The mounting piece spring arm and the needle holder spring arm are arranged inside and outside, the needle holder spring arm is on the inner side of the mounting piece spring arm, the proximal end of the needle holder spring arm has a needle holder protrusion protruding outward, the proximal end of the mounting piece spring arm has an inner protrusion protruding inward and an outer protrusion protruding outward, the inner protrusion cooperates with the needle holder protrusion stopper, and the outer protrusion is pressed by the needle return release structure to make the proximal end of the mounting piece spring arm elastically deform outward to release the stopping effect on the needle holder spring arm.

5. The needle aid of the analyte sensor implantation device according to any one of claims 1 to 4, characterized in that: The needle assisting device also includes an implantation frame and an implantation elastic member; The implantation frame can be movably mounted in the needle-assisting device shell; the implantation frame includes a locking structure for locking the mounting member with the implantation frame; the needle-assisting device shell includes an unlocking portion, the unlocking portion is used to contact the locking structure to unlock; The implantation elastic member is used to apply an implantation elastic force to the implantation frame, and the implantation elastic force is used to drive the implantation frame to move in a direction close to the human body after the locking structure is unlocked; The implantation frame further comprises a stop structure, which stops the guide needle frame in a direction away from the human body, so that the implantation frame can drive the guide needle frame to move in a direction close to the human body; The mounting member includes a releasing structure; when the implantation frame moves to the guide needle to implant the analyte sensor into the human body, the releasing structure releases the stop structure from stopping the guide needle frame; After the stopping effect of the stopping structure on the guide needle holder is released, the needle return elastic member drives the guide needle holder to withdraw the guide needle.

6. The needle-aiding device for the analyte sensor implantation device according to claim 5, characterized in that: The implantation frame is a monitor frame for installing a monitor.

7. The needle-aiding device for the analyte sensor implantation device according to claim 5, characterized in that: The release structure is used to apply a force to the stop structure to release the stop structure from stopping the guide needle holder; at least a portion of the stop structure is an elastic structure, which is used to elastically deform under the force applied by the release structure to release the stop on the guide needle holder.

8. The needle-aiding device for the analyte sensor implantation device according to claim 7, characterized in that: The stop structure includes a support spring arm and a stop portion on the support spring arm, and the stop portion is used to stop with the guide needle holder; the implantation frame includes a frame body, one end of the support spring arm is a free end that can move when the support spring arm is deformed, and the other end is a connection end connected to the frame body; The releasing structure applies a force to the elastic arm of the bracket to deform the elastic arm, so as to release the stopping relationship between the stopping part and the guide needle holder.

9. The needle-aiding device for the analyte sensor implantation device according to claim 5, characterized in that: Before the releasing structure releases the stopping effect of the stopping structure, the return needle releasing structure releases the stopping effect of the mounting part stopping structure.

10. An analyte sensor implant device, characterized in that: The invention comprises a monitoring instrument and a needle assisting device as claimed in any one of claims 1 to 9, wherein the monitoring instrument comprises an analyte sensor.

Images