Medical equipment and medical assistive devices

Abstract

The present invention relates to a medical auxiliary device and medical equipment. The medical equipment includes a medical device and a medical auxiliary device. The medical device includes a base and a target object. The insertion component of the medical auxiliary device is used to load the base and insert the target object at least partially into a predetermined object. The medical auxiliary device includes a shell assembly, an energy storage component and an insertion component. The shell assembly includes an inner shell and an outer shell. The inner shell and the outer shell can move relative to each other. The energy storage component is arranged in the inner shell and connected to the outer shell. The energy storage component is used to store elastic potential energy at an initial position. The insertion component is arranged on the energy storage component. The outer shell is used to drive the insertion component and the energy storage component to move from the initial position along the proximal end to the distal end to insert the insertion component at least partially into the predetermined object. When the insertion component and the energy storage component move along the proximal end to the distal end to the predetermined position, the energy storage component releases the elastic potential energy to drive the insertion component to move along the distal end to the proximal end, thereby simplifying the structure and use steps of the medical auxiliary tool.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical device and a medical auxiliary device. Background Art

[0002] For diabetic users, measuring blood sugar levels is an essential daily task. Currently, the more common measurement method on the market is to collect blood from the fingertips and use a finger blood glucose meter to measure blood sugar levels. However, this testing method has great limitations because it can only measure the user's blood sugar level at a single point in time and cannot continuously monitor blood sugar levels. To address this shortcoming, CGM (Continuous Glucose Monitoring) came into being. The principle of CGM is to monitor the glucose concentration in the interstitial fluid of the subcutaneous tissue through a glucose sensor, which is a monitoring technology that indirectly reflects blood sugar levels. It can continuously provide blood sugar information throughout the day, understand the trend of blood sugar fluctuations, and provide doctors with a very effective judgment basis for diagnosing and treating users.

[0003] Because the pins of the glucose sensor need to be implanted under the human skin and maintained for the entire monitoring period (usually 7 to 14 days). In order to minimize the pain and discomfort the user feels on the implanted part, the sensor pins need to be made very small and made of a relatively soft material (usually plastic). Therefore, in order for the sensor pins to penetrate the user's epidermis and implant under the user's skin, an auxiliary tool is required: a needle aid. Existing CGM products have a rather complex structure, high cost, and cumbersome user procedures. They are not user-friendly. Once the usage steps are wrong, the entire CGM product will be scrapped. The user's operation requirements are high and the user experience is not good. Summary of the Invention

[0004] The object of the present invention is to provide a medical device and a medical auxiliary device to simplify the structure and operation steps of the device for inserting a target object and reduce the manufacturing cost.

[0005] To achieve the above objectives, the present invention provides a medical assisting device, comprising:

[0006] A housing assembly comprising an outer shell and an inner shell, wherein the inner shell and the outer shell are capable of relative movement;

[0007] an energy storage component, disposed in the inner shell and connected to the outer shell, the energy storage component being configured to store elastic potential energy at an initial position; and

[0008] an inserting component, disposed on the energy storage component;

[0009] The housing is used to drive the insertion component and the energy storage component to move from the initial position in a proximal to distal direction so as to at least partially insert the insertion component into a predetermined object;

[0010] When the insertion component and the energy storage component move from the proximal end to the distal end to a predetermined position, the energy storage component releases elastic potential energy to drive the insertion component to move from the distal end to the proximal end.

[0011] Optionally, the medical assisting device further includes:

[0012] A locking component, comprising a first locking structure, wherein the first locking structure is provided on the housing;

[0013] The first locking structure is used to lock the energy storage component in the initial position, and when the insertion component and the energy storage component move from the proximal end to the distal end to the predetermined position, the first locking structure releases the lock on the energy storage component to allow the energy storage component to release elastic potential energy.

[0014] Optionally, the locking component further includes a second locking structure, and the second locking structure is provided on the inner shell;

[0015] During the process of the insertion component and the energy storage component moving from the proximal end to the distal end to the predetermined position, the second locking structure is used to connect with or abut against the first locking structure, so that the first locking structure locks the energy storage component at the initial position;

[0016] When the insertion component and the energy storage component move from the proximal end to the distal end to the predetermined position, the second locking structure is disconnected from or abuts against the first locking structure, so that the first locking structure releases the lock on the energy storage component.

[0017] Optionally, the first locking structure includes at least two elastic claws, which are evenly arranged and used to clamp and fix the insertion component so that the insertion component is pressed against the energy storage component, and the deformation force of each elastic claw is less than the compression rebound force of the energy storage component.

[0018] Optionally, the number of the elastic claws is three, and the three elastic claws are evenly arranged along the circumference of the insertion component.

[0019] Optionally, the second locking structure includes a plurality of spaced-apart retaining portions, each of which is used to abut against a corresponding elastic claw. Alternatively, the second locking structure includes an annular retaining portion, which is arranged at the top of the inner shell and extends downward to form an annular side wall, and the inner annular surface of the annular side wall is used to abut against all the elastic claws at the same time.

[0020] Optionally, the medical assisting device further includes:

[0021] The limiting device is used to limit the extreme position of the relative movement between the outer shell and the inner shell.

[0022] Optionally, the limiting device includes a hook and a slot, and one of the inner shell and the outer shell is provided with the hook, and the other is provided with the slot.

[0023] Optionally, a connecting structure is provided at the bottom of the housing, and the connecting structure is used for detachable connection with a medical device.

[0024] Optionally, the connecting structure includes a plurality of elastic clamping arms that are evenly arranged.

[0025] Optionally, the insertion component includes a needle portion, and the needle portion is a solid structure or a hollow structure.

[0026] Optionally, the medical assisting device further includes:

[0027] A protective cover, used to limit the position of a medical device to prevent the medical device from falling;

[0028] The protective cover is detachably connected to the housing and the medical device respectively.

[0029] Optionally, the medical device includes a base, which is detachably connected to the shell, and the protective cover is provided with a protrusion, which is used to resist the base on a side of the base facing away from the shell.

[0030] Optionally, the protrusion is a ridge structure extending outward along the edge of the protective cover.

[0031] To achieve the above-mentioned objectives, the present invention also provides a medical device, comprising a medical device and any one of the medical auxiliary devices described above; the medical device comprises a base and a target object arranged in the base; the insertion component of the medical auxiliary device is used to load the base and at least partially insert the target object into a predetermined object.

[0032] Optionally, the target object comprises an analyte sensor, the analyte sensor is fixedly disposed in the base, the analyte sensor has an insertion portion, and the insertion portion at least partially extends out of the base;

[0033] The base is used for detachably connecting with the housing, and the insertion component is used for loading the insertion part and inserting the insertion part at least partially into the predetermined object.

[0034] Optionally, a fixing adhesive sticker is connected to the bottom of the base, and a release paper is attached to the bottom of the fixing adhesive sticker.

[0035] Optionally, the release paper includes a first half structure and a second half structure divided into two halves along a dividing line;

[0036] The first half structure and the second half structure are evenly arranged relative to the dividing line, or the dividing line coincides with a diagonal line of the base.

[0037] Optionally, the release paper has a flange extending outward relative to the fixing adhesive tape;

[0038] The medical device further includes a protective cover including a hanging ear configured to pass through the flange and be detachably connected to the housing.

[0039] Optionally, the flange is provided with a through-cut groove structure;

[0040] The hanging ear has a variable radial size. The hanging ear is configured to pass through the groove structure and be snap-connected with the shell when radially contracted, and the hanging ear is configured to radially extend and abut against the groove structure after being separated from the shell.

[0041] Optionally, the groove structure is a cross-shaped structure or a rectangular structure.

[0042] Optionally, the medical device further comprises an electronic component, wherein the electronic component is configured to be communicatively connected with the analyte sensor;

[0043] The electronic components include an upper cover, a circuit board, a battery and a lower cover; the circuit board and the battery are both enclosed in a space enclosed by the upper cover and the lower cover;

[0044] An ultrasonic welding structure is provided at the joint surface where the upper cover and the lower cover are connected, or the upper cover is sealed and connected to the lower cover through an injection molding process.

[0045] Optionally, the analyte sensor has an upper end face and a lower end face, the upper end face is sealedly connected to the sealing surface of the circuit board, and the lower end face is sealedly connected to the sealing surface of the base, and the upper end face and the lower end face are both planes, the sealing surface of the circuit board and the sealing surface of the base are both planes, a filler is provided between the upper end face and the sealing surface of the circuit board to form a first planar sealing structure, and a filler is provided between the lower end face and the sealing surface of the base to form a second planar sealing structure.

[0046] Optionally, the filler includes a silicone member.

[0047] Optionally, the lower cover has a first hook, the base has a second hook, and the first hook is engaged with the second hook.

[0048] Optionally, the medical equipment further comprises a sterilization box for accommodating the medical device and the medical auxiliary device.

[0049] The above-mentioned medical equipment and medical auxiliary device complete the operation of inserting the target object into the object through the relative movement of the inner shell and the outer shell, and instantly rebound the inserted component, while the target object is at least partially retained in the object, which simplifies the structure and also simplifies the operation convenience, thereby reducing the steps for users to use, reducing the risk of user errors, and also reducing manufacturing costs.

[0050] The above-mentioned medical equipment and medical auxiliary device are provided with a groove structure on the release paper of the fixed adhesive sticker of the base, and with the help of the engagement of the groove structure with the hanging ear on the protective cover, the user can quickly peel off the release paper while removing the protective cover, further reducing the user's operation steps and making it more convenient to use.

[0051] The above-mentioned medical equipment and medical auxiliary devices protect the medical devices during storage and transportation through protective covers to prevent the medical devices from falling off the medical auxiliary devices due to shaking during storage and transportation. At the same time, it can prevent users from accidentally triggering the structure, avoiding the problem of premature movement of the outer shell and inner shell causing damage to the product.

[0052] The medical device and medical assistive device utilize ultrasonic welding at the joints between the upper and lower covers of the electronic components, improving sealing performance and reducing the risk of leakage. Furthermore, the upper and lower surfaces of the analyte sensor are sealed to the circuit board and base, respectively, using flat sealing structures. This provides excellent sealing, effectively reducing the risk of leakage and simplifying installation. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0054] Figure 1 is a schematic diagram of the three-dimensional structure of a medical device in a preferred embodiment of the present invention;

[0055] Figure 2 is an axial cross-sectional view of a medical device in a preferred embodiment of the present invention;

[0056] Figure 3 is a schematic diagram of the three-dimensional structure of a medical device in a preferred embodiment of the present invention;

[0057] Figure 4is a schematic diagram of the internal structure of the housing assembly in a preferred embodiment of the present invention;

[0058] Figure 5 is a schematic structural diagram of the medical assisting device in the preferred embodiment of the present invention in the initial position;

[0059] Figure 6 It is along Figure 8 Schematic diagram of the structure of the traditional Chinese medicine auxiliary device cut along the CC line;

[0060] Figure 7 It is along Figure 8 Schematic diagram of the structure of the FF line section of the traditional Chinese medical auxiliary device;

[0061] Figure 8 is a top view of a medical assisting device in a preferred embodiment of the present invention;

[0062] Figure 9 This is a structural diagram of a medical auxiliary device in a preferred embodiment of the present invention being clamped to a base of a medical device via an elastic clamping arm;

[0063] Figure 10 2 is a schematic structural diagram of a medical assisting device in a preferred embodiment of the present invention, in which symmetrical elastic clamping arms are provided at the bottom;

[0064] Figure 11 is a schematic diagram of the three-dimensional structure of a medical device in a preferred embodiment of the present invention, wherein the electronic components are not mounted on the base;

[0065] Figure 12 is a schematic structural diagram of an inserting component in a preferred embodiment of the present invention;

[0066] Figure 13 1 is a schematic structural diagram of an insertion portion of an insertion component loaded with an analyte sensor in a preferred embodiment of the present invention;

[0067] Figure 14 This is a schematic structural diagram of a base having a fixed adhesive sticker provided thereon with a release paper split in half in a preferred embodiment of the present invention;

[0068] Figure 15 This is a schematic diagram of the structure in which the groove structure on the flange of the release paper on the base cooperates with the hanging ear on the protective cover in a preferred embodiment of the present invention;

[0069] Figure 16 It is a schematic structural diagram of a protective cover in a preferred embodiment of the present invention;

[0070] Figure 17 is a schematic structural diagram of an electronic component in a preferred embodiment of the present invention;

[0071] Figure 18This is a structural diagram of an electronic component in a preferred embodiment of the present invention being engaged with a second hook structure on a base through a first hook structure;

[0072] Figure 19 This is a schematic diagram of the structure of the electronic components in the preferred embodiment of the present invention that are susceptible to water ingress;

[0073] Figure 20 The present invention relates to a sterilization box and a medical auxiliary device arranged in the sterilization box in a preferred embodiment of the present invention.

[0074] The accompanying drawings are described as follows:

[0075] Medical assistive device 100; outer shell 1; elastic claw 11; hook 12; elastic clamping arm 13; inner shell 2; inner shell proximal end 21; clamping annular structure 22; inner shell distal end 23; clamping slot 24; insertion component 3; base 31; needle 32; energy storage component 4; protective cover 6; hanging ear 61; ridge structure 62;

[0076] Medical device 200; base 5; concave engaging portion 51; release paper 52; first half structure 5211; second half structure 5212; groove structure 5213; flange 5214; fixing adhesive 53; through hole 54; second hook 55; electronic component 7; upper cover 71; circuit board 72; battery 73; lower cover 74; first hook 741; joint surface 711; analyte sensor 8; insertion portion 81; upper end surface 82; lower end surface 83;

[0077] Sterilization box 910. DETAILED DESCRIPTION

[0078] To make the present invention more clearly understood, the present invention is further described below with reference to the accompanying drawings. Of course, the present invention is not limited to this specific embodiment; general substitutions known to those skilled in the art are also encompassed within the scope of protection of the present invention. The following embodiments and features thereof may complement or be combined with each other, unless they conflict.

[0079] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms "a", "said" and "the" used in this application are also intended to include the plural forms, unless the context clearly indicates otherwise. It should be understood that "a" or "an" and similar words do not indicate a quantity limitation, but rather indicate the presence of at least one; "plurality" indicates a quantity of two or more. "Include" or "comprising" and similar words mean that the elements or objects appearing before "include" or "comprising" include the elements or objects listed after "include" or "comprising" and their equivalents, and do not exclude other elements or objects. Secondly, the present invention is described in detail using schematic diagrams, but these schematic diagrams are only for the convenience of detailing examples of the present invention and should not be used as limitations of the present invention. For example, in this article, "proximal end" refers to the end close to the operator during surgery; "distal end" is the end opposite to the "proximal end", that is, the end close to the predetermined object.

[0080] The present invention generally relates to a medical assisting device, a medical device, and a medical apparatus comprising the medical assisting device and the medical device.

[0081] The medical device disclosed herein includes a medical assisting device and a medical device. The medical device is configured to engage with the medical assisting device to load a target object into the medical device through the medical assisting device and at least partially implant the target object into a predetermined object. In some embodiments, during use, the medical assisting device secures the medical device to the predetermined object.

[0082] The medical assistance device disclosed herein relates to a base for loading a medical device and at least partially implanting a target object within the medical device into the skin of a user. The medical assistance device disclosed herein is configured to at least partially insert various targets into a predetermined subject's body, including, but not limited to, inserting an analyte sensor into a predetermined subject's body, or other devices such as a cannula or infusion device. The medical assistance device can be mounted on, beneath, or through a subject's skin, or placed on the skin's surface.

[0083] The medical device disclosed in the present invention relates to a target object, which may be an analyte sensor, or other devices such as a cannula and an infusion device, and the target object is used to be at least partially implanted in human skin. In some embodiments disclosed in the present invention, it relates to a medical device for detecting at least one analyte (such as glucose) in blood or other body fluids. Therefore, the embodiment includes an analyte sensor, which is constructed so that at least a portion of the analyte sensor is positioned in the user's body to obtain information about at least one analyte of the body, such as being positioned percutaneously in the user's body. In certain embodiments, the analyte sensor is coupled to an electronic component maintained on the user's body to process and / or send out information obtained from the analyte sensor. The medical device may include a fixing structure to hold the medical device in place relative to the skin after insertion, and the fixing structure may include, for example, a fixing adhesive patch having adhesive material on both sides.

[0084] In some embodiments, the medical device includes a base, an analyte sensor, and electronics, which together provide a body-worn assembly. In some embodiments, the base, analyte sensor, and electronics are fully integrated (fixedly connected during manufacturing), while in other embodiments, the analyte sensor and electronics are separate but connectable after manufacturing, such as before, during, or after insertion of the analyte sensor into the body. Typically, the electronics are connected to the analyte sensor after the analyte sensor is inserted into the skin (including electrical and mechanical connection).

[0085] For convenience, the following description of the embodiments disclosed herein is primarily directed to medical devices, medical assistive devices, and medical equipment and methods for glucose monitoring, and the following description is not intended to limit the scope of the present invention. The analyte sensor can be inserted into a vein, artery, or other part of the body containing an analyte. In certain embodiments, the analyte sensor can be positioned to contact blood or other fluids to detect analyte levels, wherein the detected analyte levels can be used to infer glucose levels in the user's blood or interstitial tissue.

[0086] Figure 1 FIG. 1 shows a medical assisting device 100 and a medical device 200 coupled to the medical assisting device 100 according to a preferred embodiment. Figure 2 , an axial cross-sectional view of the medical assisting device 100 when coupled to the medical device 200 is shown.

[0087] like Figure 1 and Figure 2As shown, a preferred embodiment of the present invention provides a medical device comprising a medical assistive device 100 and a medical device 200. The medical assistive device 100 includes a housing assembly comprising an outer shell 1 and an inner shell 2. The medical assistive device 100 also includes an insert component 3 and an energy storage component 4. The inner shell 2 and outer shell 1 are capable of relative movement, and the energy storage component 4 is disposed within the inner shell 2 and connected to the outer shell 1. The energy storage component 4 is used to store elastic potential energy in an initial position, i.e., in the initial position, the energy storage component 4 is compressed to store elastic potential energy. It should be understood that the base portion of the outer shell 1 is disposed outside the inner shell 2, such as the portion of the outer shell 1 for user gripping that is positioned outside the inner shell 2, while the other portion is disposed within the inner shell 2 to connect to the energy storage component 4. However, as the inner shell 2 and outer shell 1 move relative to each other, the positional relationship between the two will change, causing the inner shell 2 to partially extend from the outer shell 1 or be completely contained within the outer shell 1. Therefore, it is not absolutely necessary for the inner shell 2 to be entirely within the outer shell 1.

[0088] Figure 3 and Figure 11 A medical device 200 of a preferred embodiment is shown in FIG. The medical device 200 includes a base 5, an electronic component 7 and an analyte sensor 8. The medical device 200 needs to be fixed on the human skin, usually adhered to the human skin. The analyte sensor 8 is preferably fixedly arranged on the base 5 in a detachable manner. The base 5 can be constructed as a structure with a cavity, and the analyte sensor 8 is accommodated in the cavity of the base 5. In some embodiments, the base 5 and the analyte sensor 8 are connected by snap-fit ​​connection or other means. The analyte sensor 8 includes an insertion portion 81, which can be understood as a sensor pin. The insertion portion 81 is used to enter the skin of a predetermined object to establish fluid contact. The electronic component 7 is mainly fixedly arranged on the base 5 in a detachable manner and is in communication connection with the analyte sensor 8, and the electronic component 7 is a reusable component. In some embodiments, the electronic component 7 is constructed as a component for wirelessly transmitting data collected by the analyte sensor 8. In some embodiments, the electronic component 7 wirelessly transmits analyte-related data after receiving an external command. In certain embodiments, the electronic component 7 may include control logic or a microprocessor that processes information obtained from the analyte sensor 8 to obtain relevant analysis results.

[0089] In view of the high cost of the electronic component 7, the electronic component 7 is constructed as a recyclable component; while the cost of the medical assistive device 100 and the base 5 is relatively low, and the insertion component 3 and the insertion portion 81 of the analyte sensor 8 need to pierce the human skin, so they need to be sterilized. Figure 20As shown, the medical device may also include a sterilization box 910, which can be used to store the medical assistive device 100 and the medical device 200 and provide a sterilized storage environment. In one embodiment, the medical assistive device 100 and the base 5 can be assembled after sterilization and then placed in the sterilization box 910. When transcutaneous injection is required, the sterilization box 910 is opened, removed, and directly installed. Since ordinary users do not have the conditions to sterilize these components, the medical assistive device 100, the base 5, and the analyte sensor 8 are all disposable, single-use components. Alternatively, some components can be recycled and reused, while others are disposable, making the medical assistive device 200 of the present invention a semi-reusable medical device and the medical assistive device 100 a disposable device. Of course, those skilled in the art will appreciate that the medical assistive device 100 of the present invention can also directly carry the assembled electronic components 7 and base 5. That is, after transcutaneous injection, the entire medical device 200 can be directly installed on, beneath, or through the subject's skin, or placed on the skin surface.

[0090] Figure 4 and Figure 5 It is shown that the inserting component 3 is arranged on the energy storage component 4, and the energy storage component 4 is arranged in the inner shell 2 and connected to the outer shell 1. Figure 5 In the embodiment, the energy storage component 4 is fixed in the initial position, in which the energy storage component 4 is compressed to store elastic potential energy. Figure 2 and Figure 5 As shown, when in use, the outer shell 1 and the inner shell 2 can move relative to each other. Specifically, in the initial state determined by the initial position, the distal end 23 of the inner shell 2 extends downward from the distal end of the outer shell 1. During specific operation, it is only necessary to remove the protective cover, and then place the distal end 23 of the inner shell 2 against the epidermis. After that, the user manually or an external mechanism presses down the outer shell 1, and the insertion component 3 can be triggered through the outer shell 1 to drive the insertion component 3 and the energy storage component 4 to move downward from the initial position (i.e., from the proximal end to the distal end). The inner shell 2 cannot move because the distal end 23 is relatively fixed against the human skin. The insertion component 3 eventually pierces the human skin, and when the outer shell 1, the insertion component 3 and the energy storage component 4 move downward to the predetermined position, the energy storage component 4 releases elastic potential energy, thereby driving the insertion component 3 to move upward (i.e., from the distal end to the proximal end). Figure 6 As shown, the insert part 3 is retracted back into the inner housing 2 .

[0091] Figure 12 FIG further shows an insertion component 3 of a preferred embodiment. The insertion component 3 may include a base 31 and a needle 32, wherein the base 31 is connected to the energy storage component 4 and the needle 32 is connected to the base 31. In some embodiments, the needle 32 is a solid needle, for example, the needle 32 is inserted into the cannula. In some embodiments, as Figure 12 As shown, the needle portion 32 is a hollow needle provided with a substantially cylindrical structure defining an inner hole. The needle portion 32 may also be provided with an elongated longitudinal opening or longitudinal gap in the wall. In certain embodiments, the needle portion 32 is made of sheet metal and bent into a structure having a "V" shape, a "U" shape, or a "C" shape in cross section to define a longitudinal gap or longitudinal opening, which is used to accommodate the insertion portion 81 of the analyte sensor 8. Furthermore, the energy storage component 4 is a spring, which is sleeved on the base 31, wherein one end of the spring is embedded in the base 31 and the other end of the spring is connected to the housing 1.

[0092] Figure 13 Figure 3 shows the positions of the insertion portion 81 of the analyte sensor 8 and the insertion component 3. The needle portion 32 of the insertion component 3 has a longitudinal opening or gap that partially covers the insertion portion 81 of the analyte sensor 8. Thus, during the downward movement of the insertion component 3, the insertion portion 81 is loaded by the needle portion 32 and at least partially implanted under the human skin. When the energy storage component 4 rebounds, the insertion component 3 moves upward under the force of the energy storage component 4, causing the needle portion 32 to leave the human skin and leaving the insertion portion 81 under the human skin. This process is instantaneous, so the user does not experience significant pain.

[0093] When the energy storage component 4 rebounds to the equilibrium position, the medical assistive device 100 is separated from the base 5 of the medical device 200, and the base 5 is adhered and fixed to the human skin. In this embodiment, the base 5 is pre-detachably connected to the housing 1, and the detachable connection method is not limited. In some embodiments, after the base 5 is fixed to the human skin, the electronic component 7 is assembled to the base 5, thereby starting to collect glucose concentration data of the subcutaneous interstitial fluid, and the electronic component 7 uses wireless communication technology to send the data to a terminal device, such as a mobile phone app or other handheld device, for data conversion and display.

[0094] Therefore, the medical assistive device 100 of the present invention completes the delivery of the insertion portion 81 of the analyte sensor 8 under the human skin and instantly rebounds the insertion component 3 through the relative movement of the inner and outer shells, while the insertion portion 81 remains under the human skin. In this way, the implantation of the target object is achieved. It not only has a simple structure and low manufacturing cost, but also is easy to operate. Users are less likely to make mistakes when using it, which reduces the risk of operational errors and also reduces the risk of product scrapping.

[0095] The medical assistive device 100 may further include a locking component, which includes a first locking structure, disposed on the housing 1. The first locking structure is configured to lock the energy storage component 4 in an initial position, and when the insertion component 3 and the energy storage component 4 move downward to a predetermined position, the first locking structure releases the lock on the energy storage component 4, allowing the energy storage component 4 to release its elastic potential energy.

[0096] Figures 4 to 6 ,and Figure 8 The first locking structure of a preferred embodiment is shown. The first locking structure includes at least two elastic claws 11, and the at least two elastic claws 11 are symmetrically arranged on the outside of the insertion component 3. At least two elastic claws 11 simultaneously clamp or hold the insertion component 3, thereby applying pressure to the energy storage component 4 through the insertion component 3, so that the energy storage component 4 is compressed and fixed in the initial position. In this embodiment, the number of elastic claws 11 is preferably three, and the three elastic claws 11 are evenly arranged along the circumference of the insertion component 3. This method can more reliably fix the insertion component 3. Preferably, the deformation force of the elastic claws 11 is less than the compression rebound force of the energy storage component 4, so that the energy storage component 4 can automatically overcome the deformation force of the elastic claws 11 and release elastic potential energy. This structure can further simplify the structure and simplify the operating steps. Of course, the present application is not limited to fixing the initial position of the energy storage component 4 in the form of elastic claws 11, and this purpose can also be achieved by other mechanical, electrical or magnetic methods. Moreover, when the elastic claw 11 is used for clamping, the deformation force of the elastic claw 11 can also be greater than the compression rebound force of the energy storage component 4. At this time, the automatic opening and closing of the elastic claw 11 can be achieved through certain control means, and the energy storage component 4 can also be fixed and unlocked.

[0097] Furthermore, the locking component may also include a second locking structure, which is provided on the inner shell 2. During the downward movement of the insertion component 3 and the energy storage component 4 to a predetermined position, the second locking structure is configured to cooperate with the first locking structure so that the first locking structure always locks the energy storage component 4 in the initial position, thereby ensuring that the energy storage component 4 does not release its elastic potential energy during this process. When the insertion component 3 and the energy storage component 4 move downward to the predetermined position, the second locking structure is disconnected from the first locking structure, thereby also releasing the lock of the energy storage component 4 by the first locking structure, allowing the energy storage component 4 to release its elastic potential energy.

[0098] In some embodiments, the second locking structure includes a resisting portion, which is used to resist the elastic claw 11 to prevent the elastic claw 11 from bending outward when the deformation force is less than the compression rebound force of the energy storage component 4.

[0099] refer to Figure 5 and Figure 6In some embodiments, the resisting portion is constructed as a clamping annular structure 22, which is arranged at the proximal end 21 of the inner shell 2 and extends downward to form an annular side wall. The inner annular surface of the annular side wall can simultaneously abut all elastic claws 11, which has a simple structure and is more convenient to operate. During the downward movement of the insertion component 3 and the energy storage component 4, the inner annular surface of the clamping annular structure 22 always abuts the elastic claws 11. Figure 5 As shown, in the initial position, the elastic claws 11 are surrounded by the clamping annular structure 22. As the insertion component 3 and the energy storage component 4 move downward until the elastic claws 11 are separated from the clamping annular structure 22, since the compression rebound force of the energy storage component 4 is greater than the deformation force of the three elastic claws 11, in the absence of the constraint of the clamping annular structure 22, the three elastic claws 11 automatically bend outward and release the insertion component 3, so that the insertion component 3 can be retracted into the inner shell 2, that is, Figure 6 As shown, the sharp insertion component 3 is prevented from accidentally injuring the user or other personnel.

[0100] In this embodiment, the elastic claws 11 are integrally formed with the outer shell 1, and the clamping annular structure 22 is integrally formed with the inner shell 2. Preferably, the three elastic claws 11 growing from the outer shell 1 clamp the insert component 3, which has a simple structure and is easy to operate. Furthermore, a circle of clamping annular structures 22 growing from the inner shell 2 clamps the elastic claws 11 from the outside, so that the three elastic claws 11 cannot bend and deform outward, thereby achieving a balance between the downward pressure of the elastic claws 11 on the insert component 3 and the compression and rebound force of the energy storage component 4, making it easier for the user to fix the insert component 3 in its initial position before use, further simplifying the structure and simplifying the operation.

[0101] Of course, the present application is not limited to preventing the elastic claw 11 from bending outward by means of the clamping annular structure 22. The clamping annular structure 22 is merely an illustrative example. It should be understood that other structures can also be used to achieve this, as long as they can support the elastic claw 11 on the outside of the elastic claw 11 to prevent the elastic claw 11 from bending outward under the action of the spring compression and rebound force. For example, in other embodiments, the second locking structure may include at least three independently spaced apart retaining portions, the number of retaining portions being the same as or different from the number of elastic claws 11, and the outer side of each elastic claw 11 being abutted by at least one retaining portion.

[0102] In order to prevent the user from disassembling the inner and outer shells to expose the insertion component 3, the medical auxiliary device 100 preferably also includes a limiting device for limiting the extreme position of the relative movement of the outer shell 1 and the inner shell 2, thereby reducing the risk of accidental injury to the needle portion 32 of the insertion component 3.

[0103] Further preferably, the limiting device includes a hook and a slot, and one of the inner shell 2 and the outer shell 1 is provided with a hook, and the other is provided with a slot; the inner shell 2 and the outer shell 1 are limited to their limit positions when they move relative to each other by the cooperation of the hook and the slot. However, the present application does not impose any particular limitation on the structure of the limiting device, and the hook and the slot are only one preferred embodiment. In a preferred embodiment, as Figure 7 and Figure 8 As shown, the inner shell 2 is provided with a slot 24, and the outer shell 1 is provided with a hook 12. When the outer shell 1 moves downward relative to the inner shell 2 to the limit position, the slot 24 and the hook 12 can interlock with each other. This structure is simple and has a good limiting effect. Of course, in other embodiments, the slot 24 and the hook 12 can also cooperate to limit the limit position of the outer shell 1 when it moves upward relative to the inner shell 2.

[0104] During use, the medical assistive device 100 is detachably connected to the medical device 200, specifically, the housing 1 is detachably connected to the base 5. In some embodiments, the housing 1 and base 5 are connected using a friction fit, snap fit, snap fit, adhesive, or other means. In this embodiment, a connection structure is provided at the bottom (i.e., distal end) of the housing 1 for detachable connection to the base 5 of the medical device 200.

[0105] Figures 9 and 10 FIG. 1 shows a connection structure of a preferred embodiment. The connection structure includes a plurality of elastic clamping arms 13 arranged evenly, and the elastic clamping arms 13 are preferably integrally formed with the housing 1. Figure 11 As shown, the base 5 is provided with a corresponding concave clamping portion 51, which is symmetrically arranged on the outer wall of the base 5. By the engagement of the elastic clamping arm 13 with the concave clamping portion 51, the base 5 is detachably connected to the bottom of the medical assistive device 100, that is, Figure 2 In addition, Figure 14 As shown, the base 5 is provided with a through hole 54 allowing the insertion component 3 to pass through.

[0106] Before use, the medical assisting device 100 and the medical device 200 are typically assembled with the base 5 carrying the analyte sensor 8 for storage and transportation. To prevent the base 5 from falling off the medical assisting device 100 in the event of a product drop, the medical device 200 preferably further includes a protective cover 6.

[0107] Please refer to Figure 1 and Figure 2The base 5 is disposed between the protective cover 6 and the housing 1. The protective cover 6 is detachably connected to the housing 1 and the base 5. The protective cover 6 further limits the position of the medical device 200 and prevents it from falling. Therefore, before use, the base 5 is protected by the protective cover 6, and when in use, the protective cover 6 can be removed.

[0108] In some embodiments, as Figure 15 and Figure 16 As shown, the protective cover 6 is detachably connected to the housing 1 via two evenly spaced lugs 61. The lugs 61 are configured to have variable radial dimensions to enable radial expansion and contraction. For example, the lugs 61 may have two evenly spaced barbs with a gap formed between them to provide elastic deformation in the radial direction. This allows the protective cover 6 to be securely fastened to the housing 1 via elastic deformation, resulting in a simple structure and easy assembly and disassembly. In other embodiments, the protective cover 6 may be detachably connected to the housing 1 via other means. Therefore, this application is not limited to the lugs 61 as the means for achieving connection to the housing 1.

[0109] Preferably, the protective cover 6 is provided with a convex portion, which blocks the base 5 on the side of the base 5 away from the housing 1 to prevent the base 5 from falling. Figure 16 As shown, the convex portion can be a ridge structure 62 extending outward along the edge of the protective cover 6. The ridge structure 62 can also prevent the user from accidentally triggering the structure, avoiding the outer shell 1 and the inner shell 2 from moving up or down in advance, reducing the risk of product damage.

[0110] Next reference Figure 11 In some embodiments, a fixing adhesive patch 53 is connected to the bottom of the base 5 to firmly adhere the base 5 to the human skin. When the housing 1 of the medical assistive device drives the base 5 to move downward, the fixing adhesive patch 53 of the base 5 adheres to the human skin. When the medical assistive device 100 is removed, because the adhesion force of the fixing adhesive patch 53 on the skin is greater than the holding force of the elastic clamping arm 13 on the base 5, the base 5 is separated from the medical assistive device 100 and remains on the human skin for one monitoring cycle. Usually, a release paper 52 is attached to the bottom of the fixing adhesive patch 53 to prevent the fixing adhesive patch 53 from being contaminated by dust, debris, etc. during the processing process and before the user uses it, so as to avoid the adhesiveness of the fixing adhesive patch 53 being weakened or even losing its adhesiveness.

[0111] Preferably, Figure 14As shown, the release paper 52 includes a first half structure 5211 and a second half structure 5212 divided in half along a dividing line, and the first half structure 5211 and the second half structure 5212 are evenly arranged relative to the dividing line, or the dividing line coincides with the diagonal line of the base 5; such a configuration makes it convenient for the user to remove the release paper 52 and avoids the release paper 52 from getting caught on the needle portion 32, which makes it difficult to remove the release paper 52. The release paper 52 can be divided in half diagonally or in half squarely. Squarely divided in half means dividing along the axis of symmetry of the release paper 52. In addition, diagonally divided in half means when the dividing line coincides with the diagonal line of the base 5. It can be understood that the length of the diagonal dividing line is longer than that of the dividing line in other positions, making it easier to separate the two halves of the structure and making it easier to remove the release paper 52.

[0112] In order to further simplify the operation, the release paper 52 preferably has a flange 5214 extending outward relative to the fixed adhesive tape 53 (see Figure 14 ), preferably the flanges 5214 are evenly arranged. It can be understood that the flanges 5214 of the release paper 52 (see Figure 14 ) is at least partially not attached to the fixing adhesive tape 53. Furthermore, the ear 61 can pass through the flange 5214 and be detachably connected to the housing 1. Furthermore, a through-cut groove structure 5213 is provided on the flange 5214. After the ear 61 on the protective cover 6 passes through the groove structure 5213 on the release paper 52, the ear 61 can also abut against the groove structure 5213, so that when the user removes the protective cover 6, the release paper 52 will be torn off together, reducing one operation step for the user. The shape of the groove structure 5213 can match the shape of the barb on the ear 61. In this embodiment, the groove structure 5213 is preferably a cross-shaped structure. Of course, the groove structure 5213 can also be a groove of other shapes, such as a rectangle. Therefore, when the lug 61 passes through the groove structure 5213 of the release paper 52 and is connected to the housing 1, it can be clamped to the housing 1 by radial contraction of the lug 61. When the lug 61 is separated from the housing 1, the lug 61 automatically extends radially and abuts against the groove structure 5213 of the release paper 52, thereby driving the release paper 52 to separate from the fixing adhesive 53. This structure facilitates the installation of the protective cover 6 by utilizing the contraction of the lug without tearing the release paper 52. When the lug is separated from the housing 1, the release paper 52 can be automatically torn off by the protective cover 6, making operation more convenient.

[0113] Figures 17 to 19An electronic component 7 of a preferred embodiment is shown. The electronic component 7 has a waterproof function, which is beneficial to the user's daily life, such as showering. The electronic component 7 includes an upper cover 71, a circuit board 72, a battery 73 and a lower cover 74. The circuit board 72 and the battery 73 are both encapsulated in the space formed by the upper cover 71 and the lower cover 74; the battery 73 is used to power the circuit board 72, and the battery 73 is a storage battery or a disposable battery; the battery 73 can be set on the circuit board 72 or not. In this embodiment, the circuit board and the battery are set independently. The circuit board 72 is integrated with relevant electronic devices, such as communication devices, processors, etc., which are mainly used for wireless communication with the outside. The analyte sensor 8 is electrically connected to the circuit board 72.

[0114] In a specific operation, after the medical assisting device 100 is attached to the base 5 on the human skin, and after the medical assisting device 100 is removed, the electronic component 7 is installed on the base 5. In a preferred embodiment, the electronic component 7 is connected to the base 5 by snap-fitting. In some embodiments, Figure 18 As shown, a first hook 741 is provided on the lower cover 74, and a second hook 55 is provided on the base 5. The first hook 741 and the second hook 55 are engaged with each other to achieve a mutual fixing effect, thereby fixing the electronic component 7 on the base 5 and connecting it to the base 5 in a detachable manner.

[0115] like Figure 19 As shown, there are two possible leakage points in the structure and installation method of the electronic component 7, one of which is the joint surface 711 where the upper cover 71 and the lower cover 74 are connected, and the other is the upper end surface 82 and the lower end surface 83 of the analyte sensor 8, the upper end surface 82 is sealed to the circuit board 72, and the lower end surface 83 is sealed to the base 5.

[0116] For the joint surface 711, ultrasonic welding or low-pressure injection molding is preferably used to connect the upper cover 71 and the lower cover 74. If the ultrasonic welding process is used, an ultrasonic welding structure is added to the upper cover 71 and the lower cover 74 at the joint surface 711, that is, the packaging of the upper cover 71, the lower cover 74, the circuit board 72, and the battery 73 is completed by the ultrasonic welding process. If the low-pressure injection molding process is used, after the circuit board 72, the battery 73, and the lower cover 74 are assembled, they are placed in the corresponding mold, and the upper cover 71 is injected into the mold with low-pressure injection molding material to complete the product packaging, so that the upper cover 71 is sealed with the lower cover 74 through the low-pressure injection molding process. Compared with traditional glue sealing or sealing ring waterproofing, ultrasonic welding or low-pressure injection molding processes can achieve more effective sealing, good sealing effect, and improved waterproof performance.

[0117] With respect to the upper end face 82 and the lower end face 83, the upper end face 82 is sealedly connected to the sealing surface of the circuit board 75, and the lower end face 83 is sealedly connected to the sealing surface of the base 5, and both the upper end face 82 and the lower end face 83 are planes, and the sealing surface of the circuit board 72 and the sealing surface of the base 5 are planes. A filler is provided between the upper end face 82 and the sealing surface of the circuit board 72 to form a first plane sealing structure, and a filler is provided between the lower end face 83 and the sealing surface of the base 5 to form a second plane sealing structure. The filler is specifically a relatively soft silicone or rubber part. A plane sealing method is adopted, and a crimping seal is used between the circuit board and the filler. The plane sealing has a large contact area, is easy to install, and is easy to ensure sealing.

[0118] It should be understood that the above description is merely a preferred embodiment of the present invention and does not constitute any formal or substantial limitation to the present invention. Moreover, although the innovation of the present invention originates from glucose detection, those skilled in the art will appreciate that the present invention can also be applied to the detection of other analytes, and the present invention does not impose any limitation thereto. Moreover, although the innovation of the present invention originates from an analyte sensor, those skilled in the art will appreciate that the medical assistive device of the present invention can also be applied to the implantation of other target objects, and the present invention does not impose any limitation thereto.

[0119] The above description is only a description of the preferred embodiments of the present invention and does not limit the scope of the present invention. Any changes and modifications made by ordinary technicians in the field of the present invention based on the above disclosure are within the scope of protection of the present invention.

Claims

1. A medical assisting device, characterized in that: include: A housing assembly comprising an outer shell and an inner shell, wherein the inner shell and the outer shell are capable of relative movement; An energy storage component is disposed in the inner shell and connected to the outer shell, the energy storage component is used to store elastic potential energy at an initial position, and the energy storage component is a spring; an insertion component disposed on the energy storage component, the insertion component comprising a base and a needle portion connected to each other, the spring being sleeved on the base and connected to the housing, the housing being used to trigger the insertion component, driving the insertion component and the energy storage component to move along with the housing from an initial position in a proximal to distal direction, so as to at least partially insert the insertion component into a predetermined object; and A locking component, comprising a first locking structure provided on the outer shell and a second locking structure provided on the inner shell, wherein the first locking structure comprises three elastic claws, each of which has a deformation force less than a compression rebound force of the energy storage component, and the second locking structure comprises a resisting portion, wherein the resisting portion is configured as a clamping annular structure, the clamping annular structure being provided at a proximal end of the inner shell and extending downward to form an annular sidewall; In the initial position, the three elastic claws hold the insertion component tightly, and the holding annular structure holds the elastic claws tightly from the outside, so that the three elastic claws cannot bend and deform outward, thereby achieving a balance between the downward pressure of the elastic claws on the insertion component and the compression and rebound force of the energy storage component; When the insertion component and the energy storage component move along with the housing from the proximal end to the distal end to a predetermined position, the elastic claw disengages from the clamping annular structure, so that the energy storage component can release elastic potential energy; after releasing the elastic potential energy, the energy storage component drives the insertion component to move from the distal end to the proximal end.

2. The medical assisting device according to claim 1, wherein: Also includes: The limiting device is used to limit the extreme position of the relative movement between the outer shell and the inner shell.

3. The medical assisting device according to claim 2, wherein: The limiting device includes a hook and a slot. The hook is provided on one of the inner shell and the outer shell, and the slot is provided on the other.

4. The medical assisting device according to claim 1, wherein: The bottom of the shell is provided with a connection structure, and the connection structure is used for detachable connection with a medical device.

5. The medical assisting device according to claim 4, wherein: The connecting structure includes a plurality of elastic clamping arms that are evenly arranged.

6. The medical assisting device according to claim 1, wherein: The insertion component includes a needle portion, and the needle portion is a solid structure or a hollow structure.

7. The medical assisting device according to claim 1, wherein: Also includes: A protective cover, used to limit the position of a medical device to prevent the medical device from falling; The protective cover is detachably connected to the housing and the medical device respectively.

8. The medical assisting device according to claim 7, wherein: The medical device comprises a base, which is detachably connected to the shell. The protective cover is provided with a convex portion, which is used to abut the base on a side of the base facing away from the shell.

9. The medical assisting device according to claim 8, wherein: The convex portion is a ridge structure extending outward along the edge of the protective cover.

10. A medical device, characterized in that: A medical device and a medical assisting device according to any one of claims 1 to 9; the medical device comprising a base and a target object disposed within the base; an insertion component of the medical assisting device being configured to load the base and at least partially insert the target object into a predetermined subject; the target object comprising an analyte sensor, the analyte sensor being fixedly disposed within the base, the analyte sensor having an insertion portion that at least partially extends beyond the base; The base is used for detachably connecting with the housing, and the insertion component is used for loading the insertion part and inserting the insertion part at least partially into the predetermined object.

11. The medical device according to claim 10, wherein The bottom of the base is connected with a fixing adhesive sticker, and the bottom of the fixing adhesive sticker is attached with release paper.

12. The medical device according to claim 11, wherein The release paper comprises a first half structure and a second half structure divided into two halves along a dividing line; The first half structure and the second half structure are evenly arranged relative to the dividing line, or the dividing line coincides with a diagonal line of the base.

13. The medical device according to claim 11, wherein The release paper has a flange extending outward relative to the fixing adhesive tape; The medical device further includes a protective cover including a hanging ear configured to pass through the flange and be detachably connected to the housing.

14. The medical device according to claim 13, wherein The flange is provided with a through-cut groove structure; The hanging ear has a variable radial size. The hanging ear is configured to pass through the groove structure and be snap-connected with the shell when radially contracted, and the hanging ear is configured to radially extend and abut against the groove structure after being separated from the shell.

15. The medical device according to claim 14, wherein The groove structure is a cross-shaped structure or a rectangular structure.

16. The medical device according to claim 10, wherein The medical device further includes an electronic component configured to be communicatively coupled to the analyte sensor; The electronic components include an upper cover, a circuit board, a battery and a lower cover; the circuit board and the battery are both enclosed in a space enclosed by the upper cover and the lower cover; An ultrasonic welding structure is provided at the joint surface where the upper cover and the lower cover are connected, or the upper cover is sealed and connected to the lower cover through an injection molding process.

17. The medical device according to claim 16, wherein The analyte sensor has an upper end surface and a lower end surface, the upper end surface is sealedly connected to the sealing surface of the circuit board, and the lower end surface is sealedly connected to the sealing surface of the base, and the upper end surface and the lower end surface are both planes, the sealing surface of the circuit board and the sealing surface of the base are both planes, a filler is provided between the upper end surface and the sealing surface of the circuit board to form a first planar sealing structure, and a filler is provided between the lower end surface and the sealing surface of the base to form a second planar sealing structure.

18. The medical device according to claim 17, wherein The filler includes a silicone member.

19. The medical device according to claim 16, wherein The lower cover has a first hook, the base has a second hook, and the first hook is engaged with the second hook.

20. The medical device according to claim 10, wherein Also included is a sterilization box for accommodating the medical device and the medical auxiliary device.

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