Analyte sensor needle aid and analyte sensor implantation device

Abstract

This application relates to the field of medical device technology, specifically to an analytical sensor needle applicator and an analytical sensor implantation device. The analytical sensor implantation device employs a locking structure to lock the monitor frame and housing assembly. After unlocking the locking structure via an unlocking mechanism, the monitor frame moves towards the human body under the elastic force of the implanted elastic element. Under the action of the stopping structure, the monitor frame can drive the guide needle frame to move, allowing the guide needle to pierce the human body, thus achieving the implantation of the analytical sensor. This application uses the elastic force of the implanted elastic element to complete the insertion of the guide needle, reducing the required manual force. Under the return elastic force of the return needle elastic element, the guide needle frame can move away from the human body, thereby withdrawing the guide needle from the body. Under the action of the implanted elastic element, the guide needle can be inserted into place. The release structure can stably release the stopping structure, reducing the difficulty of operation for the operator.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to an analytical sensor needle aid and an analytical sensor implantation device. Background Technology

[0002] Traditional blood glucose measurement methods are cumbersome, involve deep incisions, cause significant pain, and can only measure a single value, preventing diabetic patients from understanding their glucose levels in real time. To gain real-time access to glucose levels, some patients choose to wear analyte sensors. These sensors require a sharp implantable device (guide needle) to insert into the body, allowing the sensor to come into contact with bodily fluids.

[0003] However, most existing implantable devices consist of two components: a needle guide and a monitoring device. Users need to assemble these two parts, which increases the difficulty of use. Current implantable devices rely on user pressure to insert the guide needle, which is then withdrawn after the pressure is released. During insertion, it's difficult for users to determine if the sharp part of the injection device has been properly inserted, potentially leading to premature retraction of the sharp part before the sensor is implanted. Therefore, current implantable devices present a problem of inconvenience in operation. Summary of the Invention

[0004] This application provides an analytical sensor needle aid to improve the inconvenience of operation of current analytical sensor implantation devices.

[0005] In addition, the purpose of this application is to provide an analyte sensor implantation device using the above-mentioned analyte sensor needle aid.

[0006] In a first aspect, one embodiment provides an analyte sensor assist device, comprising:

[0007] Shell assembly;

[0008] A monitoring device frame for mounting a monitoring device; the monitoring device frame is movably mounted in a housing assembly; the monitoring device frame includes a locking structure for locking the housing assembly to the monitoring device frame; the housing assembly includes an unlocking part for contacting the locking structure to release the lock;

[0009] An implantable elastic element is used to apply an implantable elastic force to the monitoring frame, and the implantable elastic force is used to drive the monitoring frame to move toward the human body after the locking structure is unlocked;

[0010] A guide needle holder, wherein the guide needle holder is mounted on the monitor frame;

[0011] A guide pin, which is mounted on the guide pin holder;

[0012] The monitoring device frame also includes a blocking structure, which blocks the guide needle frame in a direction away from the human body, so that the monitoring device frame can drive the guide needle frame to move in a direction closer to the human body;

[0013] The housing assembly includes a release structure; when the monitor frame moves to the point where the guide needle implants the analyte sensor into the human body, the release structure releases the blocking structure from blocking the guide needle frame;

[0014] And a return needle elastic element, which is used to apply a return needle elastic force to the guide needle frame. After the blocking effect of the blocking structure on the guide needle frame is released, the return needle elastic force drives the guide needle frame to pull out the guide needle.

[0015] In a further embodiment, the release structure is used to apply a force to the stop structure to release the stop structure from blocking the guide needle holder. At least a portion of the stop structure is an elastic structure, which elastically deforms after the release structure applies a force, thereby releasing the blockage on the guide needle holder.

[0016] Furthermore, in one embodiment, the blocking structure includes a support spring arm and a blocking portion located on the support spring arm, the blocking portion being used to block the guide needle frame; the monitoring 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 connecting end connected to the frame body; the release structure releases the blocking relationship between the blocking portion and the guide needle frame by applying a force to the support spring arm to deform the spring arm.

[0017] In a further embodiment, the support spring arm extends along the direction in which the guide needle pierces the human body, the support spring arm includes a contact portion having a contact slope for contacting the release structure, and the release structure deforms the support spring arm by abutting against the contact slope.

[0018] In a further embodiment, the proximal end of the analyte needle is the operating end, the distal end is the human contact end for contacting the human body, the proximal end of the support arm is the free end, the distal end of the support arm is the connecting end, and the stop portion is close to the contact portion and far from the connecting end.

[0019] In a further embodiment, the proximal end of the analyte needle assist device is the operating end, and the distal end is the human body contact end for contacting the human body. The shell assembly has a shell stop structure for stopping the guide needle holder, thereby limiting the maximum stroke of the guide needle holder toward the operating end.

[0020] In a further embodiment, the shell assembly includes a mounting member and a press-to-unlock shell, the mounting member being installed in the press-to-unlock shell, the proximal end of the press-to-unlock shell being a press end for pressing operation; the unlocking part is located on the press-to-unlock shell, and the release structure is located on the mounting member and / or the press-to-unlock shell.

[0021] Furthermore, in one embodiment, the mounting component is movably assembled in the press-to-unlock housing; the monitoring device frame is movably assembled on the mounting component;

[0022] The mounting component and / or the monitoring device frame are provided with an unlocking shell retaining structure, which is used to apply a retaining force to the pressed unlocking shell to keep the position of the pressed unlocking shell.

[0023] The press-to-unlock shell has a retaining-release structure. After the press-to-unlock shell is pressed, the retaining-release structure contacts the retaining structure of the unlock shell to overcome the retaining force and release the retaining effect of the retaining structure of the unlock shell on the press-to-unlock shell, so that the unlocking part can unlock the locking structure.

[0024] In a further embodiment, the blocking structure includes a support spring arm and a blocking portion on the support spring arm, the blocking portion being used to block the guide needle holder; the monitoring 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 connecting end connected to the frame body; the release structure releases the blocking relationship between the blocking portion and the guide needle holder by applying a force to the support spring arm to deform the support spring arm; the support spring arm forms at least a part of the unlocking shell retaining structure, the support spring arm extends from the distal end to the proximal end of the monitoring frame, and the support spring arm retains the position of the press-to-unlock shell by abutting against the press-to-unlock shell; the press-to-unlock shell releases the abutting relationship between the support spring arm and the press-to-unlock shell by pressing and deforming the support spring arm.

[0025] Furthermore, in one embodiment, the support spring arm bends and deforms to a first side when it releases its abutment relationship with the press-to-unlock shell, and bends and deforms to a second side when it releases its blocking relationship with the guide pin holder. The first side and the second side are opposite sides of the support spring arm.

[0026] In a further embodiment, the mounting component is sleeve-shaped, and under the action of the return needle elastic element, the guide needle frame and the monitoring instrument frame can be pre-assembled to form a pre-mounted body. The pre-mounted body is inserted into the mounting component from the distal end of the mounting component, and the implantation elastic element is pressed between the monitoring instrument frame and the mounting component.

[0027] In a second aspect, one embodiment provides an analyte sensor implantation device, including a monitor and an analyte sensor needle aid, wherein the monitor includes an analyte sensor;

[0028] The analyte sensor aid includes:

[0029] Shell assembly;

[0030] A monitoring device frame for mounting a monitoring device; the monitoring device frame is movably mounted in a housing assembly; the monitoring device frame includes a locking structure for locking the housing assembly to the monitoring device frame; the housing assembly includes an unlocking part for contacting the locking structure to release the lock;

[0031] An implantable elastic element is used to apply an implantable elastic force to the monitoring frame, and the implantable elastic force is used to drive the monitoring frame to move toward the human body after the locking structure is unlocked;

[0032] A guide needle holder, wherein the guide needle holder is mounted on the monitor frame;

[0033] A guide pin, which is mounted on the guide pin holder;

[0034] The monitoring device frame also includes a blocking structure, which blocks the guide needle frame in a direction away from the human body, so that the monitoring device frame can drive the guide needle frame to move in a direction closer to the human body;

[0035] The housing assembly includes a release structure; when the monitor frame moves to the point where the guide needle implants the analyte sensor into the human body, the release structure releases the blocking structure from blocking the guide needle frame;

[0036] And a return needle elastic element, which is used to apply a return needle elastic force to the guide needle frame. After the blocking effect of the blocking structure on the guide needle frame is released, the return needle elastic force drives the guide needle frame to pull out the guide needle.

[0037] In a further embodiment, the release structure is used to apply a force to the stop structure to release the stop structure from blocking the guide needle holder. At least a portion of the stop structure is an elastic structure, which elastically deforms after the release structure applies a force, thereby releasing the blockage on the guide needle holder.

[0038] Furthermore, in one embodiment, the blocking structure includes a support spring arm and a blocking portion located on the support spring arm, the blocking portion being used to block the guide needle frame; the monitoring 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 connecting end connected to the frame body; the release structure releases the blocking relationship between the blocking portion and the guide needle frame by applying a force to the support spring arm to deform the spring arm.

[0039] In a further embodiment, the support spring arm extends along the direction in which the guide needle pierces the human body, the support spring arm includes a contact portion having a contact slope for contacting the release structure, and the release structure deforms the support spring arm by abutting against the contact slope.

[0040] In a further embodiment, the proximal end of the analyte needle is the operating end, the distal end is the human contact end for contacting the human body, the proximal end of the support arm is the free end, the distal end of the support arm is the connecting end, and the stop portion is close to the contact portion and far from the connecting end.

[0041] In a further embodiment, the proximal end of the analyte needle assist device is the operating end, and the distal end is the human body contact end for contacting the human body. The shell assembly has a shell stop structure for stopping the guide needle holder, thereby limiting the maximum stroke of the guide needle holder toward the operating end.

[0042] In a further embodiment, the shell assembly includes a mounting member and a press-to-unlock shell, the mounting member being installed in the press-to-unlock shell, the proximal end of the press-to-unlock shell being a press end for pressing operation; the unlocking part is located on the press-to-unlock shell, and the release structure is located on the mounting member and / or the press-to-unlock shell.

[0043] Furthermore, in one embodiment, the mounting component is movably assembled in the press-to-unlock housing; the monitoring device frame is movably assembled on the mounting component;

[0044] The mounting component and / or the monitoring device frame are provided with an unlocking shell retaining structure, which is used to apply a retaining force to the pressed unlocking shell to keep the position of the pressed unlocking shell.

[0045] The press-to-unlock shell has a retaining-release structure. After the press-to-unlock shell is pressed, the retaining-release structure contacts the retaining structure of the unlock shell to overcome the retaining force and release the retaining effect of the retaining structure of the unlock shell on the press-to-unlock shell, so that the unlocking part can unlock the locking structure.

[0046] In a further embodiment, the blocking structure includes a support spring arm and a blocking portion on the support spring arm, the blocking portion being used to block the guide needle holder; the monitoring 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 connecting end connected to the frame body; the release structure releases the blocking relationship between the blocking portion and the guide needle holder by applying a force to the support spring arm to deform the support spring arm; the support spring arm forms at least a part of the unlocking shell retaining structure, the support spring arm extends from the distal end to the proximal end of the monitoring frame, and the support spring arm retains the position of the press-to-unlock shell by abutting against the press-to-unlock shell; the press-to-unlock shell releases the abutting relationship between the support spring arm and the press-to-unlock shell by pressing and deforming the support spring arm.

[0047] Furthermore, in one embodiment, the support spring arm bends and deforms to a first side when it releases its abutment relationship with the press-to-unlock shell, and bends and deforms to a second side when it releases its blocking relationship with the guide pin holder. The first side and the second side are opposite sides of the support spring arm.

[0048] In a further embodiment, the mounting component is sleeve-shaped, and under the action of the return needle elastic element, the guide needle frame and the monitoring instrument frame can be pre-assembled to form a pre-mounted body. The pre-mounted body is inserted into the mounting component from the distal end of the mounting component, and the implantation elastic element is pressed between the monitoring instrument frame and the mounting component.

[0049] According to the analytical sensor implantation device of the above embodiment, the analytical sensor implantation device adopts a locking structure that can lock the monitor frame and the housing assembly. After the locking structure is unlocked by the unlocking part, the monitor frame moves towards the human body under the elastic force of the implantation elastic element. Under the action of the blocking structure, the monitor frame can drive the guide needle frame to move, and the guide needle can be inserted into the human body, realizing the implantation of the analytical sensor into the human body. Compared with the current method of controlling the insertion depth of the guide needle by manual pressing force, this application completes the insertion of the guide needle by applying elastic force through the implantation elastic element, reducing the requirements for manual operation force. After the guide needle is inserted into the human body, the release structure on the housing assembly can apply force to the blocking structure, releasing the blocking effect of the blocking structure on the guide needle frame. In this way, under the action of the return elastic force of the return needle elastic element, the guide needle frame can move away from the human body, thereby pulling the guide needle out of the human body. Under the action of the implantation elastic element, the guide needle can be inserted into place. The release structure can stably complete the release action of the blocking structure, reducing the operation difficulty for operators. Attached Figure Description

[0050] Figure 1This is a schematic diagram of the structure of an analyte sensor implantation device in one embodiment;

[0051] Figure 2 For along Figure 1 Sectional view of AA;

[0052] Figure 3 This is a schematic diagram of the structure of the analyzer sensor implantation device after removing the protective cover and sensor cap in one embodiment.

[0053] Figure 4 This is a schematic diagram of the structure of the analyte sensor implantation device after the shell is hidden by pressing and unlocking in one embodiment;

[0054] Figure 5 This is a schematic diagram of the assembly structure of the monitoring instrument frame and the guide needle frame in one embodiment;

[0055] Figure 6 This is another cross-sectional view of the analyte sensor implantation device in one embodiment;

[0056] Figure 7 This is a state diagram of the analyzer sensor implantation device after the monitor and the needle assist device are separated in one embodiment.

[0057] List of feature names corresponding to the reference numerals in the figure: 1. Monitor; 11. Analyte sensor; 12. Adhesive sheet; 13. Battery; 2. Analyte sensor needle aid; 20. Housing assembly; 21. Press-to-unlock housing; 211. Press end; 212. Opening; 213. Unlocking part; 2131. Unlocking arm; 214. Retaining release structure; 215. Retaining release arm; 2151. Retaining release arm slope; 22. Mounting component; 221. Release structure; 2211. Release protrusion; 2212. Protrusion slope; 2213. Protrusion guide slope; 222. Needle holder stop structure; 23. Monitor frame; 2 31. Locking structure; 2311. Locking arm; 2312. Hook; 2313. Hook slope; 232. Stopping structure; 2321. Support spring arm; 23211. Support spring arm slope; 23212. Inclined section; 23213. Contact part; 23214. Contact slope; 23215. Protrusion; 2322. Stopping part; 233. Frame; 234. Magnet; 24. Implanted elastic element; 25. Guide needle holder; 251. Claw; 26. Guide needle; 261. Needle handle; 27. Unlocking shell retaining structure; 28. Return needle elastic element; 29. ​​Protective cover; 210. Sensor cap; 3. Skin.

[0058] Explanation of reference numerals in parentheses in the accompanying drawings: The feature referred to by the reference numerals in parentheses in the accompanying drawings is the feature represented by both the number inside the parentheses and the number outside the parentheses. Detailed Implementation

[0059] The present application will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by related similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the present application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present application are not shown or described in the specification. This is to avoid obscuring the core parts of the present application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0060] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0061] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the objects being described and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include direct connection, indirect connection, and contact connection (linkage).

[0062] In one embodiment, please refer to Figures 1 to 6 The analyte sensor implantation device includes a monitor 1 and an analyte sensor needle applicator 2. The monitor 1 includes an analyte sensor 11. The monitor 1 can be an instrument used to monitor human physiological parameters.

[0063] The analyte sensor implantation device is used to insert the analyte sensor 11 of the monitor 1 into the human body. The analyte sensor 11 is typically implanted into the human body with the aid of a guide 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 glucose, and the monitor 1 can be an instrument for monitoring human blood glucose.

[0064] In one embodiment, please refer to Figures 1 to 6 The analyte sensor needle aid includes a housing assembly 20, a monitor frame 23, an implantation elastic element 24, a guide needle holder 25 mounted on the monitor frame 23, and a guide needle 26 mounted on the guide needle holder 25. The monitor frame 23 is used to mount the monitor 1, and the guide needle 26 is used to implant the analyte sensor 11 of the monitor 1 into the human body.

[0065] The monitor holder 23 is movably mounted within the housing assembly 20. The monitor holder 23 includes a locking structure 231 for locking the housing assembly 20 to the monitor holder 23. Before the analyte sensor 11 is implanted, the relative positions of the monitor holder 23 and the housing assembly 20 are locked, preventing relative movement. When the analyte sensor 11 needs to be implanted into the human body, the locking structure 231 needs to be unlocked.

[0066] The housing assembly 20 includes an unlocking part 213, which is used to contact the locking structure 231 to release the locking effect on the monitoring device frame 23. The unlocking part 213 contacts the locking structure 231 to release the locking effect of the locking structure 231 on the monitoring device frame 23, allowing the monitoring device frame 23 to move distally under the elastic force of the implanted elastic member 24, that is, to move relative to the mounting member 22 towards the human body.

[0067] The monitor holder 23 has an initial position and an implantation position during its travel. In the initial position, the monitor holder 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 monitor holder 23, which drives the monitor holder 23 to move towards the implantation position after the locking structure 231 is released.

[0068] The monitor frame 23 also includes a blocking structure 232, which blocks the guide needle holder 25 in a direction away from the human body, so that when the monitor frame 23 moves toward the implantation position, it can drive the guide needle holder 25 to move toward the human body, thereby driving the guide needle to move toward the direction of needle insertion into the human body.

[0069] The housing assembly 20 also includes a release structure 221, which releases the blocking structure 232 from the guide needle holder 25 when the monitor holder 23 moves to the implantation position and the guide needle 26 implants the analyzer sensor 11 into the human body.

[0070] The analyzer sensor needle aid also includes a return needle elastic element 28, which is used to apply a return needle elastic force to the guide needle holder 25. After the blocking effect of the stop structure 232 on the guide needle holder 25 is released, the return needle elastic force drives the guide needle holder 25 to pull out the guide needle 26.

[0071] The analyte sensor implanter employs a locking structure 231 to lock the monitor frame 23 to the housing assembly 20. After the locking structure 231 is unlocked by the unlocking part 213, the monitor frame 23 moves towards the human body under the elastic force of the implanted elastic element 24. Under the action of the blocking structure 232, the monitor frame 23 can drive the guide needle holder 25 to move, allowing the guide needle 26 to pierce the human body, thus realizing the implantation of the analyte sensor 11. Compared with the current method of relying on manual pressure to control the insertion depth of the guide needle 26 of the implantation device, this application completes the insertion of the guide needle 26 by applying elastic force through the implanted elastic element 24, reducing the requirements for manual operation force. After the guide needle 26 is inserted into the human body, the release structure 221 on the shell assembly 20 can apply force to the stop structure 232, releasing the stop structure 232 from blocking the guide needle holder 25. In this way, under the action of the return elastic force of the return needle elastic member 28, the guide needle holder 25 can move away from the human body, thereby pulling the guide needle 26 out of the human body. Under the action of the implantation elastic member 24, the guide needle 26 can be inserted into place. The release structure 221 can stably complete the release action of the stop structure 232, reducing the difficulty of operation for the operator.

[0072] In one embodiment, please refer to Figures 2 to 4 The return needle elastic element 28 is located between the guide needle holder 25 and the monitor holder 23 and is always in a compressed state. In one embodiment, the implantation elastic element 24 is located between the mounting element and the monitor holder 23 and is always in a compressed state. In one embodiment, both the return needle elastic element 28 and the implantation elastic element 24 are helical springs. Helical springs have a simple structure and are easy to install.

[0073] In one embodiment, the release structure 221 releases the stop structure 232 from blocking the guide needle holder 25 by applying a force to the stop structure 232. In some other embodiments, the release structure 221 may also restrict the stop structure 232, and when the restriction is released, the stop structure 232 may automatically release from the stop by its own elasticity or by the force of other components.

[0074] Furthermore, in one embodiment, please refer to Figures 2 to 5 At least a portion of the stopping structure 232 is an elastic structure. This elastic structure deforms elastically after the force is applied by the release structure 221, thus releasing the obstruction of the guide needle holder 25. The elasticity of the stopping structure 232 facilitates the release of the obstruction effect of the stopping structure 232 on the guide needle holder 25.

[0075] Regarding the form of the blocking structure 232, in one embodiment, please refer to... Figure 5 The blocking structure 232 includes a support spring arm 2321 and a blocking part 2322 located on the support spring arm 2321. The blocking part 2322 is used to block the guide needle holder 25.

[0076] In one embodiment, please refer to Figure 5 The monitoring device frame 23 includes a frame 233, one end of the support arm 2321 is a free end that can move when the support arm 2321 is deformed, and the other end is a connecting end connected to the frame 233.

[0077] In one embodiment, please refer to Figures 2 to 5 The release structure 221 applies a force to the support spring arm 2321, causing it to deform and thus releasing the blocking relationship between the stop portion 2322 and the guide needle holder 25. In some other embodiments, besides using the support spring arm 2321, the stop structure 232 may also include a rigid support and a spring piece fixed to the rigid support. The spring piece blocks the guide needle holder 25, and the stop structure 232 releases the blocking effect of the spring piece by deforming it. In other embodiments, the stop structure 232 may also be in a form other than an elastic structure. The stop structure 232 may include a movable locking tongue that blocks the guide needle holder 25. After the release structure 221 retracts the locking tongue, the blocking relationship between the locking tongue and the guide needle holder 25 is released.

[0078] Furthermore, in one embodiment, please refer to Figures 3 to 5 The guide needle 26 is inserted into the human body in a first direction. The support spring arm 2321 extends along the first direction and includes a contact portion 23213. The contact portion 23213 has a contact slope 23214 for contacting the release structure 221. The release structure 221 deforms the support spring arm 2321 by abutting against the contact slope 23214. Specifically, in one embodiment, the support spring 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 located on one side of the straight arm, and the contact slope 23214 is located on the protrusion 23215. In some other embodiments, the support spring arm 2321 can be any other type besides a straight arm, such as a curved spring arm or an inclined spring arm.

[0079] Regarding the release structure 221, in one embodiment, please refer to... Figure 2 and Figure 3 The release structure 221 includes a release protrusion 2211 on the housing assembly 20. The release protrusion 2211 has a raised slope 2212 for engaging with a contact slope 23214 to elastically deform the support arm 2321 away from the release protrusion 2211.

[0080] Furthermore, in one embodiment, the proximal end of the analyte sensor needle aid 2 is the operating end, and the distal end is the human contact end for contacting the human body. It should be noted that in this application, the distal and proximal ends are described based on the operator's operating position, where the proximal end is the end closer to the operator, and the distal end is the end farther away from the operator.

[0081] In one embodiment, please refer to Figures 2 to 5 The proximal end of the support arm 2321 is the free end, and the distal end is the connecting end. The stop portion 2322 is close to the contact portion 23213 and away from the connecting end. When the support arm 2321 deforms, the stop portion 2322 being away from the connecting end allows for a larger range of motion, making it easier to release the stop on the guide needle holder 25. In some other embodiments, the stop portion 2322 may also be composed of the contact portion 23213.

[0082] Specifically, in one embodiment, please refer to Figure 5 To facilitate structural design, the support arm 2321 has a predetermined width, and the contact portion 23213 and the stop portion 2322 are arranged at intervals or connected along the circumference of the monitoring frame 23. In some other embodiments, the contact portion 23213 and the stop portion 2322 may also be arranged side by side along the circumference of the monitoring frame 23, and the contact portion 23213 and the stop portion 2322 are in the same position in the extending direction of the support arm 2321.

[0083] In one embodiment, please refer to Figure 2 The housing assembly 20 includes a mounting member 22 and a press-to-unlock housing 21. The proximal end of the press-to-unlock housing 21 is a press end 211 for pressing operation, and the distal end has an opening 212 for facing the human body. The mounting member 22 and the monitor frame 23 are both movably mounted in the press-to-unlock housing 21. The unlocking part 213 is located on the press-to-unlock housing 21, and the release structure 221 is located on the mounting member 22 and / or the press-to-unlock housing 21.

[0084] In one embodiment, please refer to Figures 2 to 5 The mounting component 22 is movably mounted in the press-to-unlock housing 21. The monitoring device frame 23 is movably mounted on the mounting component 22, and the monitoring device frame 23 is provided with an unlock housing retaining structure 27, which is used to apply a retaining force to the press-to-unlock housing 21 to maintain its position. In some other embodiments, the unlock housing retaining structure 27 may also be located on the mounting component 22, and in some other embodiments, there may be two or more unlock housing retaining structures 27, some of which are located on the mounting component 22 and some of which are located on the monitoring device frame 23.

[0085] The press-to-unlock shell 21 has a retaining-release structure 221. After the press-to-unlock shell 21 is pressed, the retaining-release structure 221 contacts the unlock shell retaining structure 27 to overcome the retaining force and release the retaining structure 27 from the press-to-unlock shell 21, allowing the unlocking part 213 to unlock the locking structure 231. The magnitude of the retaining force is selected within a reasonable range based on the pressure applied to the press-to-unlock shell 21. The unlock shell retaining structure 27 releases its hold on the press-to-unlock shell 21 after the press-to-unlock shell 21 is pressed and the retaining force is overcome, thus preventing accidental activation.

[0086] In one embodiment, please refer to Figure 2 The unlocking shell retaining structure 27 is located at the proximal end of the monitoring device frame 23. This facilitates the interaction between the unlocking shell retaining structure 27 and the press-to-unlock shell 21. In some other embodiments, the unlocking shell retaining structure 27 may also be located at the distal end of the press-to-unlock shell 21.

[0087] The blocking structure 232 includes a support spring arm 2321 and a blocking part 2322 located on the support spring arm 2321. The blocking part 2322 is used to block the guide needle holder 25. The monitoring instrument 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 connecting end connected to the frame body 233.

[0088] Release structure 221 applies force to support spring arm 2321, causing it to deform and thus releasing the blocking relationship between stop 2322 and guide needle holder 25. Support spring arm 2321 forms at least a part of unlocking shell retaining structure 27, extending from the distal end to the proximal end of monitor holder 23. Support spring arm 2321 holds the position of press-on unlocking shell 21 by pressing against it. Press-on unlocking shell 21 releases the abutting relationship between support spring arm 2321 and press-on unlocking shell 21 by deforming support spring arm 2321.

[0089] 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 monitoring device frame 23, and the support spring arm 2321 holds the unlocking shell 21 in position by pressing against it. In some other embodiments, the unlocking shell holding structure 27 may also use a spring sheet in addition to the support spring arm 2321.

[0090] Furthermore, in one embodiment, please refer to Figure 2The retaining release structure 214 includes a retaining release arm 215, which is located within the press-to-unlock shell 21. The retaining release arm 215 extends from the proximal end to the distal end of the press-to-unlock shell 21, with the distal end of the retaining release arm 215 abutting against the proximal end of the support spring arm 2321. Both the distal end of the retaining release arm 215 and the proximal end of the support spring arm 2321 have slopes. The slope of the distal end of the retaining release arm 215 is called the retaining release arm slope 2151, and the slope of the proximal end of the support spring arm 2321 is called the support spring arm slope 23211. Both the retaining release arm slope 2151 and the support spring arm slope 23211 are used to guide the support spring arm 2321 to deform after the press-to-unlock shell 21 is pressed, thereby releasing the abutting relationship between the retaining release arm 215 and the support spring arm 2321, and thus releasing the retaining function of the unlock shell retaining structure 27. In one embodiment, the retaining release arm 215 is a rigid arm. In some other embodiments, both the support spring arm 2321 and the retention release arm 215 are spring arms.

[0091] In some other embodiments, only the distal end of the holding release arm 215 may have a holding release arm slope 2151, while the proximal end of the support spring arm 2321 may have a plane that contacts the holding release arm slope 2151, the plane being perpendicular to the direction of movement of the monitoring frame 23. In some other embodiments, only the proximal end of the support spring arm 2321 may have a support spring arm slope 23211. It should be noted that, in this application, a slope refers to a surface with a certain gradient in the direction of movement of the monitoring frame 23; the slope can be an inclined surface, a convex surface, or a concave surface.

[0092] In one embodiment, please refer to Figures 2 to 5 When the support spring arm 2321 is released from its abutting relationship with the pressing unlock shell 21, it bends and deforms to the first side of the support spring arm 2321. When the blocking relationship with the guide pin frame 25 is released, it bends and deforms to the second side of the support spring arm 2321. The first side and the second side are the two opposite sides of the support spring arm 2321.

[0093] Specifically, in one embodiment, please refer to Figures 2 to 5 The support spring arm 2321 includes an inclined section 23212, one end face of which is the support spring arm slope 23211. The support spring arm slope 23211 is used to abut against the retaining release structure 221 after the unlocking shell 21 is pressed, causing the support spring arm 2321 to deform.

[0094] In one embodiment, please refer to Figure 2In the direction from the distal end to the proximal end of the support spring arm 2321, the inclined section 23212 gradually tilts towards the distal end of the holding release arm 215. Thus, when pressure is applied to the pressing unlock shell 21 to make the holding release arm 215 abut against the slope surface 23211 of the support spring arm on the inclined section 23212, a larger force is required to cause the support spring arm 2321 to elastically deform, thereby releasing the holding effect of the support spring arm 2321 on the pressing unlock shell 21.

[0095] In one embodiment, please refer to Figure 2 To facilitate the unlocking of the monitor holder 23, the minimum force required for the unlocking structure 214 to release the unlocking shell retaining structure 27 to hold the unlocking shell 21 is a first force, and the minimum force required for the unlocking part 213 to release the locking structure 231 to lock the monitor holder 23 is a second force. The first force is greater than the second force. This improves the anti-accidental touch effect and allows for smoother unlocking of the monitor holder 23, resulting in a more fluid overall operation.

[0096] In some other embodiments, the first force may be less than or equal to the second force, depending on actual needs.

[0097] In one embodiment, please refer to Figure 2 and Figure 5 The number of unlocking shell retaining structures 27 is at least two, the number of retaining release structures 214 is at least two, and the number of unlocking parts 213 is at least two. The retaining release structures 214 and unlocking parts 213 are arranged alternately in the circumferential direction of the pressed unlocking shell 21. Specifically, in one embodiment, the number of retaining release arms 215 is two or more, and the unlocking part 213 is an unlocking arm 2131. The unlocking arm 2131 extends from the proximal end of the pressed unlocking shell 21 to the distal end of the pressed unlocking shell 21. The number of unlocking arms 2131 is two or more, and the unlocking arm 2131 and retaining release arms 215 are arranged alternately in the circumferential direction of the pressed unlocking shell 21.

[0098] Furthermore, in one embodiment, please refer to Figure 2 The unlocking arm 2131 extends from the proximal end of the press-unlock housing 21 to the distal end of the press-unlock housing 21. The unlocking arm 2131 unlocks by abutting against the locking structure 231, and the length of the unlocking arm 2131 is not less than the length of the holding release arm 215. This ensures that the abutting relationship between the holding release arm 215 and the bracket spring arm 2321 is released before the unlocking arm 2131 unlocks the locking structure 231.

[0099] Furthermore, in one embodiment, please refer to Figure 2 and Figure 5The locking structure 231 includes a locking arm 2311, which extends from the distal end to the proximal end of the monitoring unit 23. A hook 2312 is provided at the proximal end of the locking arm 2311. The hook 2312 engages with the mounting member 22, thereby locking the monitoring unit 23 to the mounting member 22. The unlocking part 213 deforms the locking arm 2311 by abutting against the hook 2312, thus separating the hook 2312 from the mounting member 22.

[0100] For details, please refer to Figure 2 In order to facilitate the unlocking of the hook 2312, the hook 2312 is provided with a hook slope 2313, and the end of the unlocking arm 2131 is provided with an unlocking arm slope. By the cooperation of 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 part 22.

[0101] Furthermore, in one embodiment, please refer to Figures 2 to 4 The mounting component 22 is sleeve-shaped, and the monitoring device frame 23 is installed inside the mounting component 22. The mounting component 22 can guide the monitoring device frame 23 to move in a straight line. This can prevent the monitoring device frame 23 from rotating and make the movement of the monitoring device frame 23 smoother.

[0102] In one embodiment, please refer to Figures 2 to 4 The mounting component 22 is sleeve-shaped. Under the action of the return needle elastic element 28, the guide needle frame 25 and the monitor frame 23 can be pre-assembled to form a pre-assembled body. The pre-assembled body is inserted into the mounting component 22 from the far end of the mounting component 22, and the implanted elastic element 24 is pressed between the monitor frame 23 and the mounting component 22.

[0103] Furthermore, in one embodiment, please refer to Figure 5 There are at least two support arms 2321. In the direction from the distal end to the proximal end of the support arm 2321, the inclined section 23212 gradually tilts towards the center line of the guide pin 26. This facilitates the insertion of the support arm 2321 into the mounting member 22.

[0104] To further facilitate the installation of the monitoring device mount 23, in one embodiment, please refer to... Figure 2 In addition to the raised slope 2212, the raised protrusion 2211 also has a raised guide slope 2213. The raised guide slope 2213 is arranged opposite to the raised slope 2212. In this way, when the monitoring frame 23 is installed into the mounting part 22, the raised guide slope 2213 can guide the bracket spring arm 2321 to be inserted into the mounting part 22.

[0105] Furthermore, in one embodiment, please refer to Figure 2 and Figure 5The housing assembly 20 has a needle carriage stop structure 222, which stops the guide needle carriage 25 to limit the maximum stroke of the guide needle carriage 25 toward the operating end. This allows the range of motion of the guide needle carriage 25 to be limited as needed.

[0106] Specifically, in one embodiment, after the locking between the monitor frame 23 and the housing assembly 20 is released, the monitor frame 23 moves towards the human body. At this time, the blocking structure 232 does not contact the guide needle holder 25 until the monitor frame 23 has moved a first distance, at which point the blocking structure 232 stops the guide needle holder 25, causing the guide needle holder 25 to move towards the distal end. This movement can be applied to cases where the needle handle 261 of the guide needle 26 is relatively long, extending beyond the monitor 1 after passing through it. An adhesive sheet 12 is provided on the side of the monitor 1 facing the human body. After the guide needle 26 implants the analyte sensor 11 into the human body, the adhesive sheet 12 contacts the human skin 3, fixing the monitor 1 to the 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 will come into contact with the human skin 3, affecting the adhesion of the monitor 1 to the human body. In order to make the monitor 1 adhere 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 out of the monitor 1, or the first distance is greater than the length of the needle handle 261 extending out of the monitor 1. In this way, 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 in the monitor 1.

[0107] Furthermore, in one embodiment, please refer to Figure 5 and Figure 6 When the monitoring frame 23 is in its initial position, although the blocking structure 232 of the monitoring frame 23 does not block the guide needle holder 25, the return needle elastic element 28 is still in a compressed state and positioned between the guide needle holder 25 and the monitoring frame 23. This makes the guide needle holder 25 less prone to shaking and improves stability. Relying on the blocking effect of the needle holder blocking structure 222, the guide needle holder 25 and the blocking structure 232 of the monitoring frame 23 maintain a state of distance and non-contact.

[0108] Specifically, in one embodiment, please refer to Figure 5 and Figure 6 The needle holder stop structure 222 engages with the guide needle holder 25 to keep the return needle elastic element 28 in a compressed state. In one embodiment, the needle holder stop structure 222 is a stop block. In some other embodiments, the needle holder stop structure 222 can also be a stop step or a stop groove, etc.

[0109] In one embodiment, please refer to Figures 2 to 6The needle handle 261 passes through the monitor 1 to mount the sensor cap 210. The sensor cap 210 can be mounted on the needle handle 261 by any feasible method such as screwing, snapping, or magnetic attraction. The sensor cap 210 protects the monitor 1 and the analyte sensor 11.

[0110] The housing assembly 20 includes a protective cover 29, a sensor cap 210 mounted on the portion of the guide pin holder 25 that passes through the monitor 1, and the protective cover 29 fixed to the press-to-unlock housing 21. The press-to-unlock housing 21 has an opening 212, and the protective cover 29 is mounted at the opening 212.

[0111] In one embodiment, the anti-accidental touch function is achieved through the unlocking shell retaining structure 27, eliminating the need for the user to disassemble the anti-accidental touch component, thus making it more convenient for the user. The press-to-unlock shell 21 of the needle aid functions as a button, eliminating the need for a separate button component, reducing manufacturing costs. At the same time, the press-to-unlock shell 21 has a larger area than a separate button, making it more convenient for the user to use.

[0112] In one embodiment, please refer to Figure 2 The guide needle holder 25 has a claw 251, which holds the needle handle 261 of the guide needle 26.

[0113] In one embodiment, please refer to Figure 6 and Figure 7 The monitor holder 23 is equipped with a magnet 234. The monitor 1 includes a battery 13. The battery casing of the battery 13 is attracted to the magnet 234, thus fixing the monitor 1 to the monitor holder 23. After the adhesive sheet 12 is attached to the human body, the adhesive force of the adhesive sheet 12 is greater than the magnetic attraction force. When the biosensor needle is removed, the monitor 1 separates from the monitor holder 23.

[0114] In one embodiment, please refer to Figures 1 to 6 The implantation process of the analyzer sensor 11 implantation device is as follows:

[0115] When it is necessary to implant the analyzer sensor 11 into the human body, open the protective cover 29 of the analyzer sensor 11 implantation device, remove the sensor cap 210, and make the opening 212 of the press-to-unlock shell 21 face the position of the human body where the sensor needs to be implanted. Apply pressure to the press end 211 of the press-to-unlock shell 21 to make the holding release structure 214 of the press-to-unlock shell 21 contact the unlock shell holding structure 27, overcome the holding force of the unlock shell holding structure 27 on the press-to-unlock shell 21, release the holding effect of the unlock shell holding structure 27 on the press-to-unlock shell 21, and enable the unlocking part 213 to unlock the locking structure 231.

[0116] After the monitor frame 23 is unlocked, it moves toward the human body under the action of the implanted elastic element 24. The blocking structure 232 blocks the guide needle frame 25 in a direction away from the human body, so that when the monitor frame 23 moves toward the implantation position, it can drive the guide needle frame 25 and the guide needle 26 to move toward the human body, and then drive the guide needle to move toward the direction of needle insertion into the human body, so that the guide needle 26 implants the analyzer sensor 11 into the human body. After the analyzer sensor 11 is implanted into the human body, the release structure 221 applies a force to the blocking structure 232, releasing the blocking structure 232 from the guide needle frame 25. The guide needle frame 25 and the monitor frame 23 can move relative to each other. Under the action of the return needle elastic element 28, the guide needle 26 is withdrawn from the human body. After the analyte sensor 11 is implanted, the analyte sensor needle 2 is removed by pressing the unlocking shell 21. Under the action of the adhesive sheet 12, the monitor 1 is separated from the monitor frame 23. The monitor 1 is attached to the human body surface and can monitor the human body parameters in real time.

[0117] In one embodiment of an analyte sensor needle aid, the structure of the analyte sensor needle aid is the same as that of any of the above embodiments, and will not be described again.

[0118] The above examples illustrate this application only to aid understanding and are not intended to limit its scope. Those skilled in the art to which this application pertains can make various simple deductions, modifications, or substitutions based on the ideas presented.

Claims

1. An analytical analyte sensor probe, characterized in that, include: Shell assembly; A monitoring device frame for mounting a monitoring device; the monitoring device frame is movably mounted within the housing assembly. The monitoring device frame includes a locking structure for locking the housing assembly to the monitoring device frame; the housing assembly includes an unlocking part for contacting the locking structure to release the lock; An implantable elastic element is used to apply an implantable elastic force to the monitoring frame, and the implantable elastic force is used to drive the monitoring frame to move toward the human body after the locking structure is unlocked; A guide needle holder, wherein the guide needle holder is mounted on the monitor frame; A guide pin, which is mounted on the guide pin holder; The monitoring device frame also includes a blocking structure, which blocks the guide needle frame in a direction away from the human body, so that the monitoring device frame can drive the guide needle frame to move in a direction closer to the human body; The housing assembly includes a release structure; when the monitor frame moves to the point where the guide needle implants the analyte sensor into the human body, the release structure releases the blocking structure from blocking the guide needle frame; And a return needle elastic element, which is used to apply a return needle elastic force to the guide needle frame. After the blocking effect of the blocking structure on the guide needle frame is released, the return needle elastic force drives the guide needle frame to pull out the guide needle. The release structure is used to apply force to the stop structure to release the stop structure from blocking the guide needle holder. At least a portion of the stop structure is an elastic structure. The elastic structure deforms elastically after the release structure applies force, thereby releasing the blockage on the guide needle holder.

2. The analyte sensor needle aid as described in claim 1, characterized in that, The blocking structure includes a support spring arm and a blocking part located on the support spring arm. The blocking part is used to block the guide needle frame. The monitoring instrument 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 connecting end connected to the frame body. The release structure applies a force to the support arm to deform the arm, thereby releasing the blocking relationship between the stop and the guide needle holder.

3. The analyte sensor needle aid as described in claim 2, characterized in that, The support spring arm extends along the direction in which the guide needle pierces the human body. The support spring arm includes a contact portion with a contact slope for contacting the release structure. The release structure deforms the support spring arm by abutting against the contact slope.

4. The analyte sensor needle aid as described in claim 3, characterized in that, The proximal end of the analyte needle is the operating end, and the distal end is the human contact end for contacting the human body. The proximal end of the support arm is the free end, and the distal end of the support arm is the connecting end. The stop portion is close to the contact portion and far from the connecting end.

5. The analyte sensor needle aid as described in claim 1, characterized in that, The proximal end of the analyte needle assist device is the operating end, and the distal end is the human contact end for contacting the human body. The shell assembly has a shell stop structure, which is used to stop the guide needle frame to limit the maximum stroke of the guide needle frame toward the operating end.

6. The analyte sensor needle aid as described in claim 1, characterized in that, The shell assembly includes a mounting member and a press-to-unlock shell, the mounting member being installed in the press-to-unlock shell, the proximal end of the press-to-unlock shell being a press end for pressing operation; the unlocking part is located on the press-to-unlock shell, and the release structure is located on the mounting member and / or the press-to-unlock shell.

7. The analyte sensor probe as described in claim 6, characterized in that, The mounting component is movably assembled in the press-to-unlock housing; the monitoring device frame is movably assembled on the mounting component; The mounting component and / or the monitoring device frame are provided with an unlocking shell retaining structure, which is used to apply a retaining force to the pressed unlocking shell to keep the position of the pressed unlocking shell. The press-to-unlock shell has a retaining-release structure. After the press-to-unlock shell is pressed, the retaining-release structure contacts the retaining structure of the unlock shell to overcome the retaining force and release the retaining effect of the retaining structure of the unlock shell on the press-to-unlock shell, so that the unlocking part can unlock the locking structure.

8. The analyte sensor needle aid as described in claim 7, characterized in that, The blocking structure includes a support spring arm and a blocking part located on the support spring arm, the blocking part being used to block the guide needle frame; the monitoring instrument 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 connecting end connected to the frame body; the release structure applies a force to the support spring arm to deform the support spring arm, thereby releasing the blocking relationship between the blocking part and the guide needle frame; The support spring arm forms at least a part of the unlocking shell retaining structure. The support spring arm extends from the distal end to the proximal end of the monitoring device frame. The support spring arm holds the position of the press-to-unlock shell by abutting against it. The press-to-unlock shell releases the abutting relationship between the support spring arm and the press-to-unlock shell by pressing and deforming the support spring arm.

9. The analyte sensor needle aid as described in claim 8, characterized in that, When the support spring arm is released from its abutting relationship with the press-to-unlock shell, it bends and deforms to the first side of the support spring arm; when the blocking relationship with the guide pin frame is released, it bends and deforms to the second side of the support spring arm. The first side and the second side are the two opposite sides of the support spring arm.

10. The analyte sensor probe as described in claim 6, characterized in that, The mounting component is sleeve-shaped. Under the action of the return needle elastic element, the guide needle frame and the monitoring instrument frame can be pre-assembled to form a pre-mounted body. The pre-mounted body is inserted into the mounting component from the far end of the mounting component, and the implantation elastic element is pressed between the monitoring instrument frame and the mounting component.

11. An analyte sensor implantation device, characterized in that, It includes a monitor and an analyte sensor aid as described in any one of claims 1-10, wherein the monitor includes an analyte sensor.

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