CN115868974A - Medical equipment and medical auxiliary device - Google Patents

Abstract

The invention relates to a medical auxiliary device and medical equipment, wherein the medical equipment comprises a medical device and the medical auxiliary device, the medical device comprises a base and an object, an insertion part of the medical auxiliary device is used for loading the base and at least partially inserting the object into a preset object, the medical auxiliary device comprises a shell assembly, an energy storage part and an insertion part, the shell assembly comprises an inner shell and an outer shell, the inner shell and the outer shell can move relatively, the energy storage part is arranged in the inner shell and connected with the outer shell, the energy storage part is used for storing elastic potential energy in an initial position, the insertion part is arranged on the energy storage part, the outer shell is used for driving the insertion part and the energy storage part to move from the initial position to the far end along the near end so as to insert the insertion part into the preset object at least partially, and when the insertion part and the energy storage part move to the preset position along the near end, the energy storage part releases the elastic potential energy to drive the insertion part to move along the near end, thereby simplifying the structure and the use steps of the medical auxiliary tool.

Description

Medical equipment and medical aids

technical field

The invention relates to the technical field of medical devices, in particular to a medical device and a medical auxiliary device.

Background technique

For diabetic users, measuring blood sugar is an essential thing every day. At present, the more common measurement method on the market is to collect fingertip blood and use a finger blood glucose meter to measure the blood sugar level. But this test method has great limitations, because it can only measure the blood sugar level of the user at a single point, and cannot continuously monitor the blood sugar level. In response to this defect, CGM (Continuous Glucose Monitoring, that is, continuous blood glucose monitoring) came into being. The principle of CGM is to monitor the glucose concentration in the subcutaneous interstitial fluid through the glucose sensor, and a monitoring technology that indirectly reflects the blood sugar level, which can continuously provide blood sugar information throughout the day, understand the trend of blood sugar fluctuations, and provide doctors with information on users. Provides a very effective basis for diagnosis and treatment.

Because the pins of the glucose sensor need to be implanted under the skin of the human body, and maintain the entire monitoring period (usually 7 to 14 days). In order to minimize the pain and discomfort of the implanted part for the user, the sensor pins need to be made small in size and made of a soft material (usually plastic). Therefore, in order to make the sensor pin penetrate the user's epidermis and implant it under the user's skin, an auxiliary tool is needed: a needle aid. The structure of the existing CGM products is quite complex, the cost is high, and the user’s use steps are cumbersome, which is not friendly to the user. Once the use steps are wrong, the entire CGM product will be scrapped. good.

Contents of the invention

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 to reduce the manufacturing cost.

To achieve the above object, the present invention provides a medical auxiliary device, comprising:

a shell assembly, including an outer shell and an inner shell, the inner shell and the outer shell can move relative to each other;

an energy storage component 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; and,

an insertion part, arranged on the energy storage part;

The housing is configured to move the insertion member and the energy storage member from the initial position in a proximal-to-distal direction to at least partially insert the insertion member into a predetermined object;

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

Optionally, the medical aids also include:

a locking component, including a first locking structure, the first locking structure is arranged on the housing;

The first locking structure is used to lock the energy storage component at the initial position, and when the insertion component and the energy storage component move to the predetermined position along the direction from the proximal end to the distal end, the The first locking structure unlocks the energy storage component, so that the energy storage component releases elastic potential energy.

Optionally, the locking component further includes a second locking structure, and the second locking structure is arranged on the inner shell;

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

When the insertion part and the energy storage part move from the proximal end to the distal end to the predetermined position, the second locking structure is disconnected or abutted against the first locking structure, so that all The first locking structure unlocks the energy storage component.

Optionally, the first locking structure includes at least two elastic claws, the at least two elastic claws are uniformly arranged and used to clamp and fix the insertion part, so that the insertion part is pressed against the storage energy components, and the deformation force of each elastic claw is smaller than the compression resilience of the energy storage components.

Optionally, the number of the elastic claws is three, and the three elastic claws are evenly arranged along the circumferential direction of the insertion part.

Optionally, the second locking structure includes a plurality of resisting portions arranged at intervals, and the plurality of resisting portions are used to respectively abut against a corresponding one of the elastic claws, or, the second locking structure includes An annular resisting portion, the annular resisting portion is arranged on the top end of the inner shell and extends downward to form an annular side wall, the inner ring surface of the annular side wall is used to abut against all the elastic claws simultaneously.

Optionally, the medical aids also include:

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

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

Optionally, a connection structure is provided on the bottom of the housing, and the connection structure is used for detachable connection with a medical device.

Optionally, the connection structure includes a plurality of evenly arranged elastic clamping arms.

Optionally, the insertion part includes a needle, and the needle is a solid structure or a hollow structure.

Optionally, the medical aids also include:

a protective cover for limiting a medical device to prevent the medical device from falling;

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

Optionally, the medical device includes a base, the base is detachably connected to the housing, and the protective cover is provided with a convex portion, and the convex portion is used for against the base.

Optionally, the protrusion is a rib structure extending outward along the edge of the protective cover.

To achieve the above object, the present invention also provides a medical device, including a medical device and any one of the medical auxiliary devices; the medical device includes a base and a target set in the base; the medical aid The insertion part of the device is used to load the base and at least partially insert the target into the intended object.

Optionally, the target includes 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 protrudes from the base;

The base is used for detachable connection with the housing, and the insertion part is used for loading the insertion part and inserting the insertion part at least partially into the predetermined object.

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

Optionally, the release paper includes a first half structure and a second half structure divided in half 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 the diagonal line of the base.

Optionally, the release paper has a flange extending outward relative to the fixing sticker;

The medical device further includes a protective cover, the protective cover includes lugs, and the lugs are configured to pass through the flange and be detachably connected to the housing.

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

The hanging lug has a variable radial size, the hanging lug is configured to pass through the groove structure and snap-connected with the housing when radially contracted, and the hanging lug is configured to be connected to the After the shell is separated, it extends radially and abuts against the groove structure.

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

Optionally, the medical device further comprises electronic components configured to communicate with 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 packaged in the space formed by the upper cover and the lower cover;

An ultrasonic welding structure is provided at the seam surface where the upper cover and the lower cover are connected, or the upper cover is sealed and connected with the lower cover through an injection molding process.

Optionally, the analyte sensor has an upper end surface and a lower end surface, the upper end surface is sealingly connected to the sealing surface of the circuit board, the lower end surface is sealingly connected to the sealing surface of the base, and the upper end surface and the lower end surface are both flat, the sealing surface of the circuit board and the sealing surface of the base are both flat, and a filler is arranged between the upper end surface and the sealing surface of the circuit board to form a first plane In the sealing structure, a filler is provided between the lower end surface and the sealing surface of the base to form a second plane sealing structure.

Optionally, the filler includes a silicone piece.

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

Optionally, the medical device further includes a sterilization box for accommodating the medical device and the medical auxiliary device.

Through the relative movement of the inner shell and the outer shell, the above-mentioned medical equipment and medical auxiliary device complete the operation of loading the target object into the object by the insertion part, and instantly rebound the insertion part, while at least part of the target object remains in the object, which simplifies the structure. Simultaneously, it also simplifies the convenience of operation, thereby reducing the steps for the user to use, reducing the risk of user error, and also reducing the manufacturing cost.

The above-mentioned medical equipment and medical auxiliary device are provided with a groove structure on the release paper of the fixed adhesive of the base, and by means of the engagement of the groove structure and the hanging ear on the protective cover, the user can remove the protective cover while Quickly peel off the release paper, which further reduces the steps of user operation and is more convenient to use.

The above-mentioned medical equipment and medical auxiliary device protect the medical device during storage and transportation through the protective cover to prevent the medical device from falling off from the medical auxiliary device due to shaking during storage and transportation, and at the same time prevent the user from triggering the structure by mistake, avoiding the The problem of product damage due to premature movement of the outer shell and the inner shell.

The above-mentioned medical equipment and medical auxiliary device are equipped with an ultrasonic welding structure at the joint surface of the upper cover and the lower cover of the electronic component, which improves the sealing performance and reduces the risk of water leakage. In addition, the upper end surface and the lower end surface of the analyte sensor are respectively sealed with the circuit board and the base using a flat sealing structure, which has a good sealing effect, effectively reduces the risk of water leakage, and also reduces the difficulty of installation.

Description of drawings

Those of ordinary skill in the art will understand that the provided drawings are for better understanding of the present invention, but do not constitute any limitation to the scope of the present invention. In the attached picture:

Fig. 1 is a schematic diagram of a three-dimensional structure of a medical device in a preferred embodiment of the present invention;

Fig. 2 is the axial sectional view of the medical equipment in the preferred embodiment of the present invention;

Fig. 3 is a three-dimensional structural schematic diagram of a medical device in a preferred embodiment of the present invention;

Fig. 4 is a schematic diagram of the internal structure of the housing assembly in the preferred embodiment of the present invention;

Fig. 5 is a schematic structural view of the medical auxiliary device in the initial position in the preferred embodiment of the present invention;

Fig. 6 is a structural schematic diagram cut along the line C-C of the medical auxiliary device in Fig. 8;

Fig. 7 is a structural schematic diagram cut along the line F-F of the medical auxiliary device in Fig. 8;

Fig. 8 is a top view of the medical aid device in the preferred embodiment of the present invention;

Fig. 9 is a schematic diagram of the structure of the medical auxiliary device in the preferred embodiment of the present invention, which is clamped to the base of the medical device through the elastic clamping arm;

Fig. 10 is a structural schematic view of a symmetrical elastic clamping arm arranged at the bottom of the medical aid device in a preferred embodiment of the present invention;

Fig. 11 is a schematic perspective view of the three-dimensional structure of the medical device in a preferred embodiment of the present invention, wherein the electronic components are not installed on the base;

Fig. 12 is a schematic structural view of an insertion part in a preferred embodiment of the present invention;

Fig. 13 is a schematic structural view of the insertion part where the needle of the insertion part is loaded with an analyte sensor in a preferred embodiment of the present invention;

Fig. 14 is a structural schematic diagram of a half-parted release paper provided on the fixing adhesive of the base in a preferred embodiment of the present invention;

Fig. 15 is a structural schematic diagram of the cooperation between the groove structure on the flange of the release paper on the base and the hanging ear on the protective cover in the preferred embodiment of the present invention;

Fig. 16 is a schematic structural view of a protective cover in a preferred embodiment of the present invention;

Fig. 17 is a schematic structural view of an electronic component in a preferred embodiment of the present invention;

Fig. 18 is a schematic diagram of the structure of the electronic component in the preferred embodiment of the present invention, through the cooperation of the first hook structure and the second hook structure on the base;

Fig. 19 is a schematic structural view of electronic components prone to water ingress in a preferred embodiment of the present invention;

Fig. 20 shows the sterilization box and the medical aids installed in the sterilization box in the preferred embodiment of the present invention.

Wherein the reference signs are explained as follows:

Medical auxiliary device 100; outer shell 1; elastic claw 11; hook 12; elastic clamping arm 13; inner shell 2; inner shell proximal end 21; tight ring structure 22; inner shell distal end 23; Part 3; base part 31; needle part 32; energy storage part 4; protective cover 6; hanging ear 61; rib structure 62;

Medical device 200; base 5; concave clamping part 51; release paper 52; first half structure 5211; second half structure 5212; groove structure 5213; flange 5214; Second hook 55; electronic component 7; upper cover 71; circuit board 72; battery 73; lower cover 74; first hook 741; 83;

Sterilization box 910.

Detailed ways

In order to make the content of the present invention clearer and easier to understand, the present invention will be further described below in conjunction with the accompanying drawings. Of course, the present invention is not limited to this specific embodiment, and general replacements known to those skilled in the art are also covered within the protection scope of the present invention. In the case of no conflict, the following embodiments and the features in the embodiments may complement each other or be combined with each other.

The terminology used in this application is for the purpose of describing particular embodiments only, and is not intended to limit the application. As used in this application, the singular forms "a", "the", and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It should be understood that words such as "a" or "one" do not mean a limitation of quantity, but mean that there is at least one; "a plurality" means two or more than two. "Includes" or "comprises" and similar terms mean that the elements or items listed before "comprises" or "comprises" include the elements or items listed after "comprises" or "comprises" 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 describing the examples of the present invention in detail, and should not be used as a limitation of the present invention. As used herein, "proximal end" refers to the end close to the operator during the operation; "distal end" refers to the end opposite to the "proximal end", that is, the end close to the predetermined object.

The present invention mainly relates to medical aids, medical devices and medical equipment including medical aids and medical devices.

The medical equipment disclosed in the present invention includes a medical auxiliary device and a medical device. The medical device is used to engage with the medical auxiliary device, so that the medical auxiliary device is loaded with a target object in the medical device, and the target object is at least partially implanted into a predetermined object. In some embodiments, in use, the medical device is secured to the intended object by the medical aid.

The medical auxiliary device disclosed in the present invention relates to a base for loading a medical device, and at least partially implants a target in the medical device into the user's skin. The medical aid device disclosed in the present invention is configured to at least partially insert various targets into the body of the intended subject, that is, including but not limited to inserting an analyte sensor into the body of the intended subject, and may also be other devices, such as a cannula, Infusion set. A medical aid may place a medical device on, under, or through the skin of a subject, or place a medical device on the surface of the skin.

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, an infusion device, etc., and the target object is used to be at least partially implanted in human skin. In some embodiments of the present disclosure, directed to medical devices that detect at least one analyte, such as glucose, in blood or other bodily fluids, the embodiments include an analyte sensor configured such that the analyte sensor At least a portion is positioned within the body of the user to obtain information about at least one analyte of the body, for example positioned transcutaneously in the body of the user. In certain embodiments, the analyte sensor is interfaced with electronic components held on the user's body to process and/or transmit information obtained from the analyte sensor. The medical device may include a fixation structure to hold the medical device in place relative to the skin after insertion, the fixation structure may include, for example, a fixation sticker having an adhesive material on both sides.

In some embodiments, a medical device includes a base, an analyte sensor, and electronics that together provide a body-wearable assembly. In some embodiments, the base, analyte sensor, and electronics are fully integrated (fixed connection during manufacture), while in other embodiments, the analyte sensor and electronics are separate but connectable after manufacture, e.g. Before, during or after the analyte sensor is inserted into the body, generally, after the analyte sensor is inserted into the skin, the electronic components are bonded to the analyte sensor (bonding includes electrical connection and mechanical connection).

For the sake of convenience, the embodiments disclosed in the present invention are mainly described for the medical device, medical auxiliary device, medical equipment and method for glucose monitoring, and the following description is not intended to limit the scope of the present invention. The analyte sensor may be inserted into a vein, artery, or other part of the body that contains the analyte. In certain embodiments, an analyte sensor may be positioned in contact with blood or other fluid to detect analyte levels, wherein the detected analyte levels may be used to infer glucose levels in the user's blood or interstitial tissue.

FIG. 1 shows a medical auxiliary device 100 of a preferred embodiment and a medical device 200 engaged with the medical auxiliary device 100 , and FIG. 2 shows an axial cross-sectional view of the medical auxiliary device 100 engaged with the medical device 200 .

As shown in FIG. 1 and FIG. 2 , a preferred embodiment of the present invention provides a medical device, including a medical auxiliary device 100 and a medical device 200 . The medical auxiliary device 100 includes a housing assembly, the housing assembly includes an outer shell 1 and an inner shell 2 , and the medical auxiliary device 100 also includes an insertion part 3 and an energy storage part 4 . The inner shell 2 and the outer shell 1 can move relatively, and the energy storage component 4 is arranged in the inner shell 2 and connected with the outer shell 1 . The energy storage component 4 is used to store elastic potential energy at the initial position, that is, the energy storage component 4 is compressed at the initial position to store elastic potential energy. It should be understood that the base part of the outer shell 1 is set outside the inner shell 2, for example, the part of the outer shell 1 for the user to hold is set outside the inner shell 2, and the other part is set inside the inner shell 2 so as to be connected with the energy storage component 4 , but with the relative movement of the inner shell 2 and the outer shell 1, the positional relationship between the two will change, so that the inner shell 2 will also partially protrude from the outer shell 1 or be completely accommodated in the outer shell 1, so it is not absolutely limited The inner shell 2 is completely inside the outer shell 1 .

A preferred embodiment of a medical device 200 is shown in FIGS. 3 and 11 . The medical device 200 includes a base 5 , electronic components 7 and an analyte sensor 8 . Among them, the medical device 200 needs to be fixed on the human skin, usually bonded to the human skin. The analyte sensor 8 is preferably fixedly disposed on the base 5 in a detachable manner, the base 5 may be configured as a structure having 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 snap-connected or otherwise connected. The analyte sensor 8 includes an insertion part 81, which can be understood as a sensor pin. The insertion portion 81 is used to enter the skin of the intended subject to establish fluid contact. The electronic component 7 is mainly detachably fixed on the base 5 and communicated with the analyte sensor 8 , and the electronic component 7 is a reusable component. In some embodiments, the electronic component 7 is configured as a component for wireless transmission of data collected by the analyte sensor 8 . In some embodiments, electronic component 7 wirelessly transmits analyte-related data upon receipt of an external command. In certain embodiments, the electronic component 7 may include control logic or a microprocessor that may process information obtained from the analyte sensor 8 to obtain relevant analysis results.

In view of the high cost of the electronic component 7, for this reason, the electronic component 7 is configured as a recyclable component; while the cost of the medical auxiliary device 100 and the base 5 is low, and the insertion part 3 and the insertion part 81 of the analyte sensor 8 It needs to puncture human skin, so it needs to be sterilized. As shown in FIG. 20 , the medical equipment may further include a sterilization box 910 , which may be used to accommodate the medical auxiliary device 100 and the medical equipment 200 and provide a sterilized storage environment. In one embodiment, the medical auxiliary device 100 and the base 5 can be assembled after being sterilized, and then placed in the sterilization box 910. When percutaneous injection is required, the sterilization box 910 is opened, taken out and installed directly. Ordinary users do not have the conditions to sterilize them, therefore, the medical aid device 100 , the base 5 and the analyte sensor 8 are all disposable and disposable components. It can also be understood that some parts can be recycled and reused, and some parts are disposable products, so that the medical device 200 of the present invention is a semi-reusable medical device, and the medical auxiliary device 100 is a single-use device. Of course, those skilled in the art should understand that the medical auxiliary device 100 of the present invention can also directly carry the assembled electronic components 7 and base 5, that is, after percutaneous injection, the medical device 200 as a whole is directly installed on the subject's skin. on, under, or through, or place the medical device 200 on the surface of the skin.

4 and 5 show that the insertion part 3 is arranged on the energy storage part 4 , and the energy storage part 4 is arranged in the inner shell 2 and connected with the outer shell 1 . Specifically, in FIG. 5 , the energy storage component 4 is fixed at an initial position, and at the initial position, the energy storage component 4 is compressed to store elastic potential energy. As shown in FIG. 2 and FIG. 5 , during 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 protrudes downwards from the far end of the outer shell 1. During specific operations, it is only necessary to remove the protective cover, and then place the distal end 23 of the inner shell 2 against the Leaning against the epidermis, the user manually or an external mechanism presses down the shell 1, the insertion part 3 can be triggered through the shell 1, and the insertion part 3 and the energy storage part 4 are driven down from the initial position (that is, along the proximal direction) The direction of the distal end) moves, and the inner shell 2 cannot move because the distal end 23 has been pressed against the skin of the human body and is relatively fixed. The insertion part 3 finally punctures the skin of the human body, and when the housing 1, the insertion part 3 and the energy storage part 4 move down to a predetermined position, the energy storage part 4 releases the elastic potential energy, thereby driving the insertion part 3 to move upwards (i.e. end to the proximal direction), as shown in FIG.

A preferred embodiment of the insert part 3 is further shown in FIG. 12 . The insertion part 3 may include a base part 31 and a needle part 32 , the base part 31 is connected with the energy storage part 4 , and the needle part 32 is connected with the base part 31 . In some embodiments, needle portion 32 is a solid needle, for example, with needle portion 32 inserted into a cannula. In some embodiments, as shown in Figure 12, the needle portion 32 is a hollow needle provided with a substantially cylindrical structure defining an inner bore. 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 fabricated from sheet metal and bent into a "V" or "U" or "C" shape in cross-section to define a longitudinal gap or longitudinal opening, the longitudinal gap Or the longitudinal opening is used to accommodate the insertion portion 81 of the analyte sensor 8 . Further, the energy storage component 4 is a spring, and the spring is sheathed 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 .

The position of the insertion part 81 of the analyte sensor 8 and the insertion part 3 is shown in FIG. 13 . The needle part 32 of the insertion part 3 has a longitudinal opening or a longitudinal gap, which can partially cover the insertion part 81 of the analyte sensor 8, so that during the downward movement of the insertion part 3, the insertion part 81 is loaded by the needle part 32 and the insertion part 81 is at least partially implanted under the skin of the human body, and when the energy storage component 4 rebounds, the insertion component 3 moves upwards driven by the energy storage component 4, so that the needle part 32 leaves the skin of the human body, and the insertion part 81 is left in the human body Under the skin, this process is instantaneous so that the user feels no significant pain.

When the energy storage component 4 rebounds to the equilibrium position, the medical auxiliary device 100 is separated from the base 5 of the medical device 200, and the base 5 is pasted and fixed on the human skin. In this embodiment, the base 5 is detachably connected to the housing 1 in advance, and the detachable connection method is not limited. In some embodiments, after the base 5 is fixed on the human skin, the electronic component 7 is assembled on the base 5, so that the collection of the glucose concentration data of the subcutaneous interstitial fluid can be started, and the electronic component 7 can use the wireless Communication technology, sending data to terminal devices, such as mobile APP or other handheld devices, for data conversion and display.

Therefore, the medical auxiliary device 100 of the present invention completes the delivery of the insertion part 81 of the analyte sensor 8 under the skin of the human body through the relative movement of the inner shell and instantly rebounds the insertion part 3, while the insertion part 81 remains under the skin of the human body to This method realizes the implantation of the target object, which not only has a simple structure and low manufacturing cost, but also is easy to operate, and the user is not easy to make mistakes when using it, which reduces the risk of operation errors and also reduces the risk of product scrapping.

The medical auxiliary device 100 may further include a locking component, the locking component includes a first locking structure, and the first locking structure is arranged on the housing 1 . The first locking structure is used to lock the energy storage component 4 at the initial position, and when the insertion component 3 and the energy storage component 4 move down to a predetermined position, the first locking structure can release the energy storage component. 4, so that the energy storage component 4 releases the elastic potential energy.

Fig. 4 to Fig. 6 and Fig. 8 show a first locking structure of a preferred embodiment. The first locking structure includes at least two elastic claws 11 , and the at least two elastic claws 11 are symmetrically arranged on the outer side of the insertion part 3 . At least two elastic claws 11 hold or clamp the insertion part 3 at the same time, so that the energy storage part 4 is pressed by the insertion part 3, so that the energy storage part 4 is compressed and fixed at 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 circumferential direction of the insertion part 3 , which can fix the insertion part 3 more reliably. Preferably, the deformation force of the elastic claw 11 is smaller than the compression resilience of the energy storage part 4, so that the energy storage part 4 can automatically overcome the deformation force of the elastic claw 11 and release the elastic potential energy, so that the structure can be further simplified and simplified. Steps. Of course, the present application is not limited to fixing the initial position of the energy storage component 4 by means of the elastic claw 11 , and this purpose can also be achieved by other mechanical, electrical or magnetic means. 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 resilience of the energy storage component 4. At this time, the automatic opening and closing of the elastic claw 11 can be realized by certain control means. The fixing and unlocking of the energy storage component 4 can also be achieved.

Further, the locking component may also include a second locking structure, and the second locking structure is arranged on the inner shell 2 . When the insertion part 3 and the energy storage part 4 move down to a predetermined position, the second locking structure is used to cooperate with the first locking structure, so that the first locking structure will lock the energy storage part 4 is always locked at the initial position, so as to ensure that the energy storage part 4 will not release the elastic potential energy during this process; and when the insertion part 3 and the energy storage part 4 move down to the predetermined position, the second locking structure and the The above-mentioned first locking structure is released from the connection, thereby also causing the first locking structure to release the locking of the energy storage component 4, so that the energy storage component 4 can release the elastic potential energy.

In some embodiments, the second locking structure includes a resisting portion, and the resisting portion is used to abut against the elastic claw 11 to prevent the elastic claw 11 from being deformed when the deformation force is smaller than the compression resilience of the energy storage component 4 . Curved outward.

Referring to Fig. 5 and Fig. 6, in some embodiments, the resisting portion is configured to hold the 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 annular The inner ring surface of the side wall can abut against all the elastic claws 11 at the same time, the structure is simple and the operation is more convenient. During the downward movement of the insertion part 3 and the energy storage part 4 , the inner ring surface of the holding ring structure 22 always bears against the elastic claw 11 . As shown in FIG. 5 , in the initial position, the elastic claw 11 is surrounded by the holding ring structure 22 , and as the insertion part 3 and the energy storage part 4 move down until the elastic claw 11 breaks away from the holding ring structure 22 , Since the compression resilience of the energy storage component 4 is greater than the deformation force of the three elastic claws 11, the three elastic claws 11 are automatically bent and deformed outwards without the constraint of the ring structure 22, and the insertion part 3 is released, so that The insertion part 3 can be retracted into the inner shell 2 , as shown in FIG. 6 , so as to avoid the sharp insertion part 3 accidentally injuring the user or other personnel.

In this embodiment, the elastic claw 11 is integrally formed with the outer shell 1 , and the holding ring structure 22 is integrally formed with the inner shell 2 . Preferably, the three elastic claws 11 protruding from the shell 1 hold the insertion part 3 tightly, which has a simple structure and is easy to operate. Further, the ring structure 22 that grows from the inner shell 2 tightly hugs the elastic claws 11 from the outside, so that the three elastic claws 11 cannot be bent and deformed outward, so that the downward force of the elastic claws 11 on the insertion part 3 Balanced with the compression resilience of the energy storage component 4, it is convenient for the user to fix the insertion component 3 at the initial position before use, further simplifying the structure and simplifying the operation.

Of course, this application is not limited to prevent the elastic claw 1 from bending and deforming by holding the ring structure 22. The ring structure 22 is only a schematic example. It should be known that it can also be realized by other structures. The outer side of the elastic claw 11 bears against the elastic claw 11 to prevent the elastic claw 11 from bending and deforming outwardly under the force of the elastic force of the spring compression. For example, in other embodiments, the second locking structure may include at least three independently spaced resisting portions, the number of resisting portions is the same as or different from the number of elastic claws 11 , and the outer side of each elastic claw 11 The abutment is at least via one abutment.

In order to prevent the user from disassembling the inner shell and exposing the insertion part 3, the medical auxiliary device 100 preferably further includes a limiting device, which is used to limit the extreme position of the relative movement of the outer shell 1 and the inner shell 2, in this way The risk of accidentally injuring the needle portion 32 of the insertion part 3 is reduced.

Further preferably, the limiting device includes a hook and a slot, one of the inner shell 2 and the outer shell 1 is provided with a hook, and the other is provided with a slot; through the cooperation of the hook and the slot, the inner shell 2 and the outer shell 1 Definition of the extreme positions of the housings 1 during mutual movement. However, the present application does not impose special limitations on the structure of the limiting device, and the hook and the slot are only one preferred embodiment. In a preferred embodiment, as shown in FIG. 7 and FIG. 8 , the inner shell 2 is provided with a locking groove 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 locking The slot 24 and the hook 12 can be locked with each other, the structure is simple, and the position-limiting effect is good. Of course, in other embodiments, the limit position when the outer shell 1 moves upward relative to the inner shell 2 can also be restricted through the cooperation of the locking groove 24 and the hook 12 .

The medical auxiliary device 100 is detachably connected with the medical device 200 when in use, specifically, the housing 1 and the base 5 are detachably connected. In some embodiments, the shell 1 and the base 5 are connected by means of friction fit, snap fit, snap fit, adhesive, and the like. In this embodiment, the bottom (ie, the distal end) of the housing 1 is provided with a connection structure for detachable connection with the base 5 of the medical device 200 .

9 to 10 show a connection structure of a preferred embodiment. The connection structure includes a plurality of elastic clamping arms 13 uniformly arranged, and the elastic clamping arms 13 are preferably integrally formed with the housing 1 . As shown in FIG. 11 , the base 5 is correspondingly provided with concave engaging portions 51 , and the concave engaging portions 51 are symmetrically arranged on the outer wall of the base 5 . The base 5 is detachably connected to the bottom of the medical auxiliary device 100 through the engagement of the elastic clamping arm 13 and the concave clamping portion 51 , as shown in FIG. 2 . In addition, as shown in FIG. 14 , the base 5 is provided with a through hole 54 allowing the insertion part 3 to pass through.

Before the medical auxiliary device 100 and the medical device 200 are used, the base 5 carrying the analyte sensor 8 is generally assembled with the medical auxiliary device 100 for storage and transportation. In order to prevent the base 5 from falling off from the medical auxiliary device 100 when the product falls, preferably the medical device 200 further includes a protective cover 6 .

Please refer to FIG. 1 and FIG. 2 , the base 5 is disposed between the protective cover 6 and the shell 1 , and the protective cover 6 is detachably connected to the shell 1 and the base 5 respectively. The protective cover 6 is used to further limit the medical device 200 and prevent the medical device 200 from falling. Therefore, before use, the base 5 is protected by the protective cover 6, and then the protective cover 6 can be removed during use.

In some embodiments, as shown in FIG. 15 and FIG. 16 , the protective cover 6 is detachably connected to the housing 1 through two evenly arranged hanging ears 61 . The hanging ear 61 is configured to have a variable radial size, so as to be able to expand and contract in the radial direction, for example, the hanging ear 61 has two evenly arranged barbs, and a gap is formed between the two barbs to provide elastic deformation, so that it can be clipped and fixed on the shell 1 by means of elastic deformation, the structure is simple, and the assembly and disassembly are convenient. In other embodiments, the protective cover 6 can be detachably connected to the housing 1 in other ways, so the present application is not limited to the way of the hanging ear 61 to realize the connection with the housing 1 .

Preferably, the protective cover 6 is provided with a convex portion, and the convex portion resists the base 5 on the side of the base 5 away from the housing 1 to prevent the base 5 from falling. Further, as shown in FIG. 16 , the protrusion can be a rib structure 62 extending outward along the edge of the protective cover 6 . The rib structure 62 can also prevent the user from triggering the structure by mistake, preventing the outer shell 1 and the inner shell 2 from moving up and down in advance, and reducing the risk of product damage.

Next, referring to FIG. 11 , in some embodiments, a fixing sticker 53 is connected to the bottom of the base 5 for firmly pasting the base 5 on the human skin. When the shell 1 of the medical auxiliary device drives the base 5 to move downwards, until the fixing sticker 53 of the base 5 sticks to the human skin. When removing the medical auxiliary device 100, because the sticking force of the fixing sticker 53 to the skin is greater than the holding force of the elastic clamping arm 13 to the base 5, therefore, during this process, the base 5 is separated from the medical auxiliary device 100 and retained on human skin and for one monitoring period. Usually, the bottom of the fixing sticker 53 is attached with a release paper 52, which is used to prevent the fixing sticker 53 from being polluted by dust, sundries, etc. Weaken or even lose stickiness.

Preferably, as shown in FIG. 14 , 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 uniform with respect to the dividing line. Arrangement, or, the dividing line coincides with the diagonal line of the base 5; such configuration is convenient for the user to remove the release paper 52, and avoid the release paper 52 from being hung on the needle portion 32, resulting in difficulty in removing the release paper 52. The half-point mode of the release paper 52 can be diagonally half-point or positively half-point. Dividing in half refers to dividing along the axis of symmetry of the release paper 52 . In addition, diagonal half-pointing means that 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 other positions, so that the gap between the two halves of the structure It is easier to separate, and the release paper 52 can be taken away more easily.

In order to further simplify the operation, the release paper 52 preferably has a flange 5214 extending outward relative to the fixed sticker 53 (see FIG. 14 ). Preferably, the flanges 5214 are evenly arranged. (See FIG. 14 ) at least partly is not pasted with the fixing sticker 53. Further, the hanging ear 61 can pass through the flange 5214 and be detachably connected with the housing 1 . Further, the flange 5214 is provided with a cut-through groove structure 5213 . After the lug 61 on the protective cover 6 passes through the groove structure 5213 on the release paper 52, the lug 61 can also abut against the groove structure 5213, so that when the user removes the protective cover 6, the release paper will be attached. 52 together, reducing one operation step for the user. The shape of the groove structure 5213 only needs to match the shape of the barb on the hanging 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 hanging ear 61 passes through the groove structure 5213 of the release paper 52 and is clamped with the housing 1, it can be clamped with the housing 1 through the radial contraction of the hanging ear 61, and when the hanging ear 61 is separated from the housing 1 , the hanging lug 61 automatically extends radially and abuts against the groove structure 5213 of the release paper 52 , and drives the release paper 52 to separate from the fixing sticker 5 . With such a structure, it is convenient to install the protective cover 6 by shrinking the hanging ears, and the release paper 52 will not be torn, and when the hanging ears are separated from the shell 1, the release paper 52 can be automatically torn off by the protective cover 6, making the operation easier. For convenience.

17 to 19 show an electronic component 7 of a preferred embodiment. The electronic component 7 has a waterproof function, which is beneficial to the daily life of the user, such as showering and the like. 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 all packaged in the space formed by the upper cover 71 and the lower cover 74; the battery 73 is used to supply power to the circuit board 72, and the battery 73 is a storage battery or a disposable battery; the battery 73 can be arranged on the circuit board 72 On or not set on the circuit board 72, 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. Analyte sensor 8 is electrically connected to circuit board 72 .

In a specific operation, after the medical auxiliary device 100 sticks and fixes the base 5 on the human skin, and after the medical auxiliary device 100 is removed, the electronic component 7 is installed on the base 5 . In a preferred solution, the electronic component 7 is snap-connected with the base 5 . In some embodiments, as shown in FIG. 18 , the lower cover 74 is provided with a first hook 741 , the base 5 is provided with a second hook 55 , and the first hook 741 and the second hook 55 are engaged with each other. A mutual fixing effect is achieved, so that the electronic component 7 is fixed on the base 5 and detachably connected with the base 5 .

As shown in Figure 19, there are two possible water 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 analyte The upper end surface 82 and the lower end surface 83 of the sensor 8 , the upper end surface 82 is in sealing connection with the circuit board 72 , and the lower end surface 83 is in sealing connection with the base 5 .

For the seam surface 711 , it is preferable to connect the upper cover 71 and the lower cover 74 by ultrasonic welding or low-pressure injection molding. If the ultrasonic welding process is adopted, an ultrasonic welding structure is added on 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 adopted, after the circuit board 72, the battery 73, and the lower cover 74 are assembled, they are put into the corresponding mold, and the upper cover 71 is injected into the mold with a low-pressure injection molding material to complete the product packaging, so that the upper cover 71 is connected with the lower cover through the low-pressure injection molding process. The cover 74 is hermetically connected. Compared with the traditional glue sealing waterproof or sealing ring waterproof, ultrasonic welding or low-pressure injection molding process can be more effective sealing, good sealing effect, improved waterproof performance.

For the upper end surface 82 and the lower end surface 83, the upper end surface 82 is sealingly connected with the sealing surface of the circuit board 75, the lower end surface 83 is sealingly connected with the sealing surface of the base 5, and the upper end surface 82 and the lower end surface 83 are both plane, the sealing surface of the circuit board 72 and the sealing surface of the base 5 are both plane, and a filler is arranged between the upper end surface 82 and the sealing surface of the circuit board 72 to form a first plane sealing structure, the Fillers are provided between the lower end surface 83 and the sealing surface of the base 5 to form a second planar sealing structure. The filler is specifically soft silicone or rubber. The flat sealing method is adopted, and the circuit board and the filler are crimped and sealed. The flat sealing has a large contact area, which is easy to install and easy to ensure the sealing.

It should be understood that the above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any form and in essence, and although the innovation of the present invention comes from glucose detection, those skilled in the art can understand that the present invention The invention can also be applied to the detection of other analytes, the present invention is not limited to this, and although the innovation of the present invention originates from the analyte sensor, those skilled in the art can understand that the medical aid device of the present invention can also be applied to other The implantation of the target object is not limited in the present invention.

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 those of ordinary skill in the field of the present invention based on the above disclosures belong to the protection scope of the present invention.

Claims (26)

1. A medical assistance device, comprising:

a housing assembly including an outer housing and an inner housing, the inner housing and the outer housing being relatively movable;

the energy storage component is arranged in the inner shell and connected with the outer shell, and is used for storing elastic potential energy at an initial position; and the number of the first and second groups,

an insertion member provided on the energy storage member;

the housing is used for driving the insertion component and the energy storage component to move from the initial position along the proximal end to the distal end direction so as to at least partially insert the insertion component into a predetermined object;

when the insertion component and the energy storage component move to a preset position along the proximal-to-distal direction, the energy storage component releases elastic potential energy to drive the insertion component to move along the distal-to-proximal direction.

2. The medical assist device of claim 1, further comprising:

a locking member including a first locking structure disposed on the housing;

the first locking structure is used for locking the energy storage component at the initial position, and when the insertion component and the energy storage component move to the preset position along the proximal end to the distal end direction, the first locking structure unlocks the energy storage component so that the energy storage component releases elastic potential energy.

3. The medical accessory of claim 2, wherein the locking member further comprises a second locking structure disposed on the inner housing;

the second locking structure is used for connecting or abutting with the first locking structure in the process that the insertion component and the energy storage component move to the preset position in the proximal-to-distal direction, so that the first locking structure locks the energy storage component at the initial position;

when the insertion component and the energy storage component move to the preset position along the proximal end to the distal end, the second locking structure is disconnected or abutted with the first locking structure, so that the first locking structure releases the locking of the energy storage component.

4. The medical assist device of claim 3, wherein the first locking structure comprises at least two elastic claws which are uniformly arranged and used for clamping and fixing the insertion member so that the insertion member is pressed against the energy storage member, and the deformation force of each elastic claw is smaller than the compression resilience force of the energy storage member.

5. Medical aid according to claim 4, wherein the number of resilient jaws is three, three of which are evenly arranged in the circumferential direction of the insertion part.

6. Medical assistance device according to claim 4 or 5,

the second locking structure comprises a plurality of abutting parts arranged at intervals, the abutting parts are used for abutting against one or more corresponding elastic clamping jaws respectively, or the second locking structure comprises an annular abutting part which is arranged at the top end of the inner shell and extends downwards to form an annular side wall, and the inner ring surface of the annular side wall is used for abutting against all the elastic clamping jaws simultaneously.

7. The medical assist device of claim 1, further comprising:

and the limiting device is used for limiting the limiting position when the outer shell and the inner shell move relatively.

8. The medical aid of claim 7, wherein the limiting means comprises a hook and a slot, one of the inner shell and the outer shell being provided with the hook and the other being provided with the slot.

9. The medical assist device of claim 1, wherein the bottom of the housing is provided with an attachment structure for detachable connection to a medical device.

10. A medical accessory device as claimed in claim 9, wherein the coupling arrangement comprises a plurality of resilient gripping arms arranged evenly.

11. The medical aid of claim 1, wherein the insertion member includes a needle portion, the needle portion being of a solid or hollow construction.

12. The medical assist device of claim 1, further comprising:

a protective cover for restraining a medical device to prevent the medical device from falling;

the protective cover is detachably connected with the housing and the medical device respectively.

13. A medical aid according to claim 12, wherein the medical device comprises a base which is detachably connected to the housing, and wherein the protective cover is provided with a projection for abutting against the base on a side of the base facing away from the housing.

14. The medical assist device of claim 13, wherein the protrusion is a ridge structure extending outwardly along an edge of the protective cover.

15. A medical apparatus comprising a medical device and a medical aid of any one of claims 1-14; the medical device comprises a base and a target disposed within the base; the insertion member of the medical aid is used to load the base and to insert the object at least partially into a predetermined subject.

16. The medical device of claim 15, wherein the target includes an analyte sensor fixedly disposed within the base, the analyte sensor having an insertion portion extending at least partially out of the base;

the base is adapted to be removably coupled to the housing, and the insertion member is adapted to load the insertion portion and to at least partially insert the insertion portion into the predetermined object.

17. The medical device of claim 15, wherein a fixing sticker is attached to the bottom of the base, and a release paper is attached to the bottom of the fixing sticker.

18. The medical device of claim 17, wherein the release paper includes a first half structure and a second half structure bisected along a parting line;

the first half structure and the second half structure are uniformly arranged relative to the dividing line, or the dividing line is superposed with the diagonal line of the base.

19. The medical device of claim 17, wherein said release paper has an outwardly extending flange opposite said fastening sticker;

the medical device also includes a protective cover including a tab configured to pass through the flange and removably connect with the housing.

20. The medical device of claim 19, wherein said flange is provided with a cut-through groove structure;

the hanger has variable radial dimension, can pass when being configured as radial shrink the groove structure and with the shell joint is connected, and the hanger is configured with radial extension and with the groove structure butt after the shell separation.

21. The medical device of claim 20, wherein the groove structure is a cross-shaped structure or a rectangular structure.

22. The medical apparatus of claim 16, wherein the medical device further comprises electronics for communicatively coupling with the analyte sensor;

the electronic component comprises an upper cover, a circuit board, a battery and a lower cover; the circuit board and the battery are packaged in a space formed by the upper cover and the lower cover in a surrounding manner;

and an ultrasonic welding structure is arranged at the joint surface where the upper cover and the lower cover are connected, or the upper cover is connected with the lower cover in a sealing manner through an injection molding process.

23. The medical device of claim 22, wherein the analyte sensor has an upper end surface and a lower end surface, the upper end surface is sealingly connected to the sealing surface of the circuit board, the lower end surface is sealingly connected to the sealing surface of the base, and the upper end surface and the lower end surface are both planar, the sealing surface of the circuit board and the sealing surface of the base are both planar, a filler is disposed between the upper end surface and the sealing surface of the circuit board to form a first planar sealing structure, and a filler is disposed between the lower end surface and the sealing surface of the base to form a second planar sealing structure.

24. The medical device of claim 23, wherein the filler comprises a silicone element.

25. The medical device of claim 22, wherein the bottom cover has a first hook and the base has a second hook, the first hook and the second hook being snap-fit together.

26. The medical apparatus of claim 15, further comprising a sterilization case for housing the medical device and the medical accessory device.

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