Airtight applicator

Abstract

Disclosed in the present application is an airtight applicator, which helps prevent gas from directly entering the applicator and thus affecting a probe of a medical instrument, and reduces gas permeation through the applicator housing material into the interior of the applicator, thereby helping to extend the shelf life of the medical instrument. The airtight applicator is used for applying an implantable medical instrument to a human body and comprises a housing component, an exposed movable component, and a detachable component. The housing component has an upper opening and a lower opening. The exposed movable component is arranged at the upper opening. During the application operation, there is relative movement between the exposed movable component and the housing component. The detachable component is detachably arranged at the lower opening. An upper sealing structure is provided between the housing component and the exposed movable component to seal the upper opening, and a lower sealing structure is provided between the housing component and the detachable component to seal the lower opening.

Description

Air-tight applicator TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an air-tight applicator. BACKGROUND

[0002] Body fluid detection is a common medical detection method. Many medical devices for detecting body fluid need to be implanted into the skin using an applicator, and the probe of the medical device is in contact with the body fluid to perform detection and transmit signals. For example, the medical device used in continuous glucose monitoring (CGM) needs to be implanted into the subcutaneous tissue with the help of a guide needle, and then the guide needle is removed, and the probe is left in the subcutaneous tissue to detect blood glucose. The implantation process needs the assistance of an applicator of a medical device.

[0003] The whole or part of the medical device is usually installed inside the applicator before leaving the factory, that is, the medical device is fixed inside the applicator, and is provided to the user together. When the user uses it, the medical device is pushed to the skin of the user by applying a pushing force to the applicator or triggering the trigger switch of the applicator. During this process, the guide needle of the medical device pierces the skin and enters the subcutaneous tissue with the probe. When the medical device is tightly attached to the skin and the probe reaches the corresponding position, the applicator stops pushing and releases the medical device. The internal structure of the applicator removes the guide needle from the skin and separates from the medical device, thereby completing the implantation process.

[0004] FIG. 1A is a schematic diagram of the structure of a medical device for body fluid detection in the prior art; and FIG. 1B is a schematic diagram of the exploded state of the medical device shown in FIG. 1A. As shown in FIGS. 1A and 1B, the medical device 2 mainly consists of three parts: an integrated guide needle 21, a device body 22, and a probe 23. The integrated guide needle 21 passes through the device body to cover the probe 23. In the implantation process, the guide needle 21 implants the probe 23 into the subcutaneous tissue, and then the guide needle 21 itself is withdrawn, leaving the probe 23 in the subcutaneous tissue.

[0005] Fig. 2A to Fig. 2C are schematic diagrams of the structure of an applicator in the prior art (in which the sealing structure in the embodiments of the present application is also shown). Generally, the applicator usually has built-in fixed components, built-in moving components, and a driver, wherein the built-in fixed components are connected with the built-in moving components before the applicator is triggered, the built-in moving components are used to move the medical device from the inside of the applicator to the skin, and the driver is used to provide the driving force for the movement of the built-in moving components. For the needle withdrawal action, after the moving seat with the medical device reaches the skin in the later stage of the implantation process, the elastic arm 150 (see Fig. 9A) on the moving seat is not blocked by the inner shell retainer 130 (see Fig. 8C), and is opened under the elastic force of the needle withdrawal spring, the needle withdrawal seat is separated upward due to the force of the needle withdrawal spring, and the guide needle is taken away; then the applicator can be removed, leaving the medical device on the skin. The above is the basic action principle of the applicator in the prior art.

[0006] In the prior art, air can flow to the medical device during storage; however, for some probes, if in contact with air for a long time, the substances used for detection on the probe will change in physical properties, thereby causing poor or ineffective functions, such as oxygen or water vapor will gradually change the enzymes or membranes on the probe, resulting in poor or lost detection effect. Therefore, a new applicator is needed. SUMMARY

[0007] Therefore, the present application proposes an air-tight applicator, which helps to prevent air from directly entering the applicator and affecting the medical device probe, and reduces the penetration of air into the inside of the applicator through the shell material of the applicator, thereby helping to improve the shelf life of the medical device.

[0008] The present application provides the following technical solutions:

[0009] An air-tight applicator for applying an implantable medical device to a human body, the applicator comprising a shell component, an exposed moving component, and a detachable component, wherein the shell component has an upper opening and a lower opening, the exposed moving component is arranged at the upper opening and has relative movement with respect to the shell component during the application operation, and the detachable component is arranged at the lower opening in a detachable manner, the upper opening is sealed by an upper sealing structure between the shell component and the exposed moving component, and the lower opening is sealed by a lower sealing structure between the shell component and the detachable component.

[0010] Optionally, the upper sealing structure comprises an upper annular sealing groove and an upper sealing ring; the shell component has a sealing side wall which encloses an upper opening of the shell component; an outer circumferential surface or an inner circumferential surface of the exposed movable component is in contact with the sealing side wall; the upper annular sealing groove is arranged on the sealing side wall or on the outer circumferential surface or the inner circumferential surface of the exposed movable component; the upper sealing ring is arranged in the upper annular sealing groove and is pressed when the two are in contact, thereby forming a seal for the upper opening between the shell component and the exposed movable component.

[0011] Optionally, the exposed movable component is a button which is used to trigger the application operation when pressed by an external force.

[0012] Optionally, the lower sealing structure comprises a lower annular sealing groove and a lower sealing ring; an outer circumferential surface of the detachable component is in contact with an inner wall at the lower opening of the shell component, and one of them is provided with the lower annular sealing groove, or an inner circumferential surface of the detachable component is in contact with an outer wall at the lower opening of the shell component, and one of them is provided with the lower annular sealing groove; the lower sealing ring is arranged in the lower annular sealing groove and is pressed when the two are in contact, thereby forming a seal for the lower opening between the shell component and the detachable component.

[0013] Optionally, the detachable component and the shell component are connected by threads.

[0014] Optionally, the detachable component is a bottom cover which is used to cover the lower opening.

[0015] Optionally, the cross section of the upper sealing ring and the lower sealing ring is circular, and the material is EPDM.

[0016] Optionally, the shell component, the exposed movable component, and the detachable component are made of plastic.

[0017] Optionally, the plastic is polypropylene.

[0018] Optionally, the shell component is the outer shell of the applicator.

[0019] Optionally, the side surface of the shell component and the side surface of the bottom cover are pasted with a tamper-evident label which can increase the connection force between the outer shell and the bottom cover; a weak part is arranged in the middle of the tamper-evident label, and when the outer shell and the bottom cover are subjected to opposite torques, the tamper-evident label is torn at the weak part, so that the part originally pasted on the side surface of the outer shell remains on the side surface of the outer shell, and the part originally pasted on the side surface of the bottom cover remains on the side surface of the bottom cover.

[0020] Optionally, the device further comprises an internal fixed component, an internal moving component and a driver, wherein: the internal fixed component is connected with the internal moving component before the applicator is triggered; the internal moving component is used to move the medical device from inside the applicator to the skin; and the driver is used to provide driving force for the internal moving component.

[0021] Optionally, the internal fixed component is an inner shell; the internal moving component is a moving seat; the driver is a driving spring; the inner shell has at least one cantilever with a buckle position for hooking the moving seat before the applicator is triggered; the moving seat has at least two rotating arms for clamping the medical device; and the driving spring is located between the inner shell and the moving seat.

[0022] Optionally, the button is provided with a pressing surface, and the pressing surface is exposed outside the applicator; the button is further provided with at least one trigger rib below; after the bottom cover is removed, when the pressing surface is pressed by external force, the trigger rib goes down and can contact the cantilever of the inner shell; the button continues to go down and forces the cantilever to open laterally, so that the buckle position of the cantilever no longer hooks the moving seat, and the moving seat is pushed downward by the driving spring.

[0023] Optionally, the pressing surface is provided with a pressing mark for the user to identify the pressing position and provide the external force.

[0024] Optionally, the bottom cover is provided with at least one anti-touch rib; the trigger rib is provided with a lower support arm below; the periphery of the arm of the inner shell is provided with an outer support rib; in the state that the bottom cover is connected with the outer shell, the inner side of the anti-touch rib blocks the outer support rib, so as to prevent the cantilever of the inner shell from opening, and the upper end of the anti-touch rib blocks the lower support arm, so as to prevent the trigger rib from going down and triggering.

[0025] Optionally, the bottom cover is provided with a gas absorption component.

[0026] According to the technical scheme of the present application, the periphery of the applicator is composed of an outer shell component, an exposed movable component and an exposed detachable component; a movable sealing structure is arranged between the outer shell component and the exposed movable component and between the outer shell component and the exposed detachable component, so as to form overall gas tightness of the periphery. The outer shell component is an outer shell, the exposed movable component is a button, and the exposed detachable component is a bottom cover. The upper sealing structure between the outer shell and the button and the lower sealing structure between the outer shell and the bottom cover together form overall sealing of the periphery, so as to prevent gas from directly entering the applicator and affecting the medical device. In addition, the present application provides an anti-mis-triggering structure, which can prevent the applicator from being unnecessarily triggered due to vibration impact and mis-touching of the button as long as the bottom cover is not opened. BRIEF DESCRIPTION OF DRAWINGS

[0027] For the purpose of illustration and not limitation, the present application will now be described according to the preferred embodiments thereof, with particular reference to the figures, wherein:

[0028] Fig. 1A is a schematic diagram of the structure of a medical device for body fluid detection in the prior art;

[0029] Fig. 1B is a schematic diagram of the exploded state of the medical device shown in Fig. 1A;

[0030] Figs. 2A to 2C are schematic diagrams of the structure of an applicator in the prior art;

[0031] Fig. 3A is a schematic diagram of the main structure of an applicator in the embodiments of the present application;

[0032] Fig. 3B is a schematic diagram of the exploded state of the main components of the applicator in the embodiments of the present application;

[0033] Fig. 4A is a schematic diagram of a first sealing mode in the embodiments of the present application;

[0034] Figs. 4B and 4C are schematic diagrams of the upper sealing structure and the lower sealing structure, respectively, of the first sealing mode in the embodiments of the present application;

[0035] Fig. 5A is a schematic diagram of a second sealing mode in the embodiments of the present application;

[0036] Figs. 5B and 5C are schematic diagrams of the upper sealing structure and the lower sealing structure, respectively, of the second sealing mode in the embodiments of the present application;

[0037] Fig. 6A is a schematic diagram of the outer shape of the applicator in the embodiments of the present application;

[0038] Fig. 6B is a schematic diagram of the state of the outer shell and the bottom cover of the applicator in the embodiments of the present application being separated;

[0039] Fig. 7 is a schematic diagram of the structure of a button in the embodiments of the present application;

[0040] Figs. 8A to 8C are schematic diagrams of the inner shell structure of the applicator in the embodiments of the present application;

[0041] Figs. 9A and 9B are schematic diagrams of the structure of the moving seat of the applicator in the embodiments of the present application;

[0042] Figs. 10A to 10C are schematic diagrams of the implantation process of the applicator in the embodiments of the present application;

[0043] Figs. 11A to 11C are schematic diagrams of the anti-misfire structure of the applicator in the embodiments of the present application.

[0044] Fig. 1: 1, applicator; 10, label; 11, outer shell; 111, upper opening; 112, lower opening; 113, outer shell elastic side wall; 114, outer shell airtight side wall; 115, outer shell sealing side wall; 116, outer shell rubber ring groove; 12, button; 121, button pressing surface; 122, pressing mark; 123, trigger rib; 1231, trigger slope; 124, button lower support arm; 125, button rubber ring groove; 126, button sealing side wall; 13, inner shell; 130, inner shell retaining ring; 131, inner shell cantilever; 1311, deformation slope; 1312, inner shell cantilever buckle; 132, inner shell outer support rib; 14, needle removal seat; 15, movement seat; 150, elastic arm; 151, movement seat hanging buckle surface; 152, movement seat rotating arm; 1521, rotating arm rotating hook; 16, bottom cover; 161, bottom cover anti-touch rib; 1611, bottom cover inner blocking surface; 1612, bottom cover upper blocking surface; 162, bottom cover elastic side wall; 163, bottom cover sealing side wall; 171, upper sealing ring; 172, lower sealing ring; 181, pushing spring; 182, needle removal spring; 19, gas absorber; 2, medical device; 21, guide needle; 22, device main body; 23, probe. DETAILED DESCRIPTION

[0045] The embodiments of the present application will be described in detail below with reference to the accompanying drawings. Fig. 3A is a schematic diagram of the main structure of the applicator in the embodiments of the present application. As shown in Fig. 3A, the applicator 1 is in an assembled state, and a medical device 2 is arranged inside the applicator 1. Fig. 3B is a schematic diagram of the disassembled state of the main components of the applicator in the embodiments of the present application, from which the shapes of the various parts can be seen.

[0046] The applicator 1 has airtightness, and the outer peripheral components, which mainly include the shell component, the exposed movable component, and the detachable component, specifically the outer shell 11, the button 12, and the bottom cover 16 in Figs. 3A and 3B, play a sealing role. Due to the functional requirements of the applicator 1, the button 12 is arranged at the upper opening 111 of the outer shell 11, the lower opening 112 of the outer shell 11 is used to place the medical device 2, and the bottom cover 16 covers the lower opening 112. The outer peripheral components further include an upper sealing structure between the outer shell 11 and the button 12, and a lower sealing structure between the outer shell 11 and the bottom cover 16.

[0047] In addition, in order to perform the basic function of the applicator 1, i.e., to apply the medical device 2 to the skin, the inner shell 13, which plays a positioning role, the movement seat 15, which is used to drive the medical device 2 to the skin and then release it, the needle removal seat 14, which is used to take away the guide needle after implantation is completed, and the pushing spring 181 and the needle removal spring 182, which are respectively used to provide implantation power and needle removal power, are also required. In addition, the bottom cover 16 can further be provided with a gas absorber component, and the gas absorber component is provided with a gas absorber 19, which plays a role in absorbing water vapor or oxygen in the interior of the applicator 1.

[0048] Figure 4A is a schematic diagram of a first sealing mode of the present application. Figures 4B and 4C are schematic diagrams of the upper sealing structure and the lower sealing structure of the first sealing mode of the present application, respectively. In the first sealing mode, the sealing structure is an elastic tapered side wall sealing structure on the component itself, which will be described in detail below.

[0049] The upper sealing structure includes an entire circle of elastic side walls on the shell 11, the shell elastic side walls 113 have a certain taper, and the button 12 also has a corresponding entire circle of button sealing side walls 126, which also have a taper. The shell 11 and the button 12 are assembled in the positions shown in the figure and form an interference fit, and after the two are pressed against each other, the shell elastic side walls 113 will deform and open, but tightly compress the button sealing side walls 126, thereby achieving sealing.

[0050] The entire circle of elastic side walls of the lower sealing structure is on the bottom cover 16, such as the bottom cover elastic side walls 162 in Figure 3, which also have a taper. The shell 11 has a corresponding entire circle of tapered shell air-tight side walls 114. The bottom cover elastic side walls 162 and the shell air-tight side walls 114 form an interference fit, and after the two are pressed against each other, the bottom cover elastic side walls 162 deform and tightly adhere to the shell air-tight side walls 114 to achieve sealing.

[0051] Figure 5A is a schematic diagram of a second sealing mode of the present application. Figures 5B and 5C are schematic diagrams of the upper sealing structure and the lower sealing structure of the second sealing mode of the present application, respectively.

[0052] In the upper sealing structure, the button 12 has an entire circle of button rubber ring grooves 125, and the upper sealing ring 171 is placed inside. The shell 11 has a corresponding entire circle of shell sealing side walls 115. The upper sealing ring 171 is an elastic rubber O-ring, which is compressed by the button 12 and the shell 11 to achieve sealing. In the lower sealing structure, the shell 11 has an entire circle of shell rubber ring grooves 116, and the lower sealing ring 172 is placed inside. The bottom cover 16 has a corresponding entire circle of bottom cover sealing side walls 163. The lower sealing ring 172 is an elastic rubber O-ring, which is compressed by the shell 11 and the bottom cover 16 to achieve sealing.

[0053] The material selection of the applicator is described below. Although it is a complete peripheral sealing structure, first of all, gas molecules such as water vapor have very small molecular volumes. The peripheral components are plastic parts formed by injection molding, and although the plastic is macroscopically sealed, the intermolecular gap at the microscopic level is relatively large, and gas molecules will slowly penetrate. The air permeability of different plastics for various gases differs greatly, such as water vapor and oxygen. The air permeability of different plastic materials is as follows. In the application scenario of the present application, the most influential factor on medical devices is water vapor, and materials with low moisture vapor transmission rate need to be selected, and mechanical properties and process performance are also considered. Therefore, in the present application, the preferred material for the applicator is polypropylene PP.

[0054] In addition, in the micro-level rubber ring sealing structure, there are gaps between the molecules of the rubber ring itself, between the rubber ring and the plastic interface, through which gas molecules can penetrate, so the material of the rubber ring also relates to the air permeability of the sealing structure; low air permeability and low friction are required, so the preferred rubber ring material is ethylene-propylene-diene rubber.

[0055] By selecting appropriate plastic materials and rubber ring materials, the air permeability can be significantly reduced; however, if the shelf life requirement is relatively long, the accumulated air permeation amount is still considerable and can affect the medical instrument probe, in which case an air adsorber needs to be placed inside the applicator 1. In the embodiments of the present application, the main source of influence on the probe is moisture, so an air adsorber 19 is placed, and the preferred desiccant filled therein is molecular sieve polymer.

[0056] The applicator can only be triggered when in use, and cannot be mistakenly triggered in other cases. The applicator 1 in the embodiments of the present application has measures to prevent mistaken triggering, one of which is to use a label with a weak part, which functions like a seal to remind the user that the product has been opened and there is a possibility of mistaken triggering; the other of which is to use a structure to prevent mistaken triggering, which will be described below.

[0057] FIG. 6A is a schematic diagram of the shape of the applicator in the embodiments of the present application, and FIG. 6B is a schematic diagram of the shell and bottom cover of the applicator in the embodiments of the present application in a separated state. In the embodiments of the present application, the shell 11 and the bottom cover 16 of the applicator 1 are screwed together, and a label 10 for preventing disassembly is attached to the outside of the shell 11 and the bottom cover 16, half on the side of the shell 11 and half on the side of the bottom cover 16, and is bonded to the shell 11 and the bottom cover 16. The label 10 is also designed with a tearable opening as a weak part, for example, similar to a row of holes on a stamp, so that when the shell 11 and the bottom cover 16 move relative to each other, the label 10 is more likely to break in the middle. Due to the friction between the threads of the shell 11 and the bottom cover 16 and the bonding force of the label 10, the shell 11 and the bottom cover 16 are prevented from coming loose during transportation and storage or when the user handles them.

[0058] When in use, the user needs to apply a certain amount of force to unscrew the bottom cover 16 from the shell 11; at this time, the label 10 also breaks in the middle due to the design of the tearable opening, with one half remaining on the side of the shell 11 and the other half remaining on the side of the bottom cover 16. The label 10 for preventing disassembly also gives a strong indication to the user; if the label 10 is intact and has not broken, it indicates that the product is new and has not been opened; if the label 10 has broken or is misaligned, it indicates that the applicator product has already been used or the seal has been compromised, and therefore cannot be used again.

[0059] More importantly, in terms of preventing false triggering, the exposed button 12 is the trigger component of the applicator 1, and it is necessary to prevent false triggering when the user does not open the bottom cover 16 but does not intend to use it, or when the button 12 is displaced due to vibration and impact during transportation. Therefore, the double-pre-triggering structure is designed in the embodiment of the present application. In order to facilitate understanding, the trigger mechanism of the applicator is first described.

[0060] The trigger of the applicator is realized by the button 12, the inner shell 13, and the movement seat 15. FIG. 7 is a schematic diagram of the structure of the button in the embodiment of the present application. FIGS. 8A to 8C are schematic diagrams of the structure of the inner shell of the applicator in the embodiment of the present application, wherein FIG. 8A shows a perspective view of the top view state of the inner shell 13, FIG. 8B shows a longitudinal sectional view of the inner shell 13, and FIG. 8C shows the internal structure of the inner shell 13. FIGS. 9A and 9B are schematic diagrams of the structure of the movement seat of the applicator in the embodiment of the present application, wherein FIG. 9A shows a perspective view of the top view state of the movement seat 15, and FIG. 9B shows the structure of the bottom of the movement seat 15, which is the structure visible from the bottom view state of FIG. 9A.

[0061] The starting surface of the button 12 trigger is the button pressing surface 121, which is also the surface exposed outside the outer shell 11. In order to facilitate user identification, the button pressing surface 121 also has a pressing mark 122. The force and action of pressing the button pressing surface 121 will be transmitted to the trigger ribs 123 on both sides of the button 12, and the end of each trigger rib 123 has a trigger inclined surface 1231. The trigger inclined surface 1231 is kept at a distance from the inner shell 13 when the button 12 is not pressed down, and will contact the deformation inclined surface 1311 on the inner shell cantilever 131 when the button 12 is pressed down. If the button 12 is continuously pressed down, the inner shell cantilever 131 will rotate outward around the edge root as the axis, so that the inner shell cantilever buckle 1312 below the inner shell cantilever 131 also opens outward (horizontally in the figure).

[0062] FIGS. 10A to 10C are schematic diagrams of the implantation process of the applicator in the embodiment of the present application, and the black arrows in the figures show the movement direction of each component. In the normal use, i.e., implantation, the bottom cover 16 needs to be opened first. Next, the user will experience the states shown in FIGS. 10A to 10C in sequence. FIG. 10A is the initial state, the user starts to press the button 12, reaches the state shown in FIG. 10B, i.e., the button 12 goes down and rotates to open the inner shell cantilever 131, and then reaches the state shown in FIG. 10C, i.e., the movement seat 15 is released, the spring 181 pushes the movement seat 15, and the medical device 2 is implanted. The black arrows in the figures represent the movement direction of the components. The specific structure will be described below.

[0063] In the initial state, the moving seat 15 with the medical instrument 2 is hooked by the inner shell cantilever 131, and the moving seat hanging buckle surface 151 on both sides is just hooked by the inner shell cantilever buckle 1312; and the pushing spring 181 is between the inner shell 13 and the moving seat 15, and in the initial state, the moving seat 15 is forced to stay in the fixed position due to the blocking of the inner shell cantilever 131. When triggered, the inner shell cantilever 131 is opened, the inner shell cantilever buckle 1312 is separated from the moving seat hanging buckle surface 151, the moving seat 15 is triggered and released under the pushing force of the pushing spring 181, and the implantation movement is made to the skin, and the guide needle 21 of the medical instrument 2 with the probe 23 is implanted subcutaneously.

[0064] The above is the normal triggering and implantation process, which is based on the premise of opening the bottom cover 16. Before the bottom cover 16 is opened, the safety structure must be designed to ensure that the moving seat is in the initial position; under normal circumstances, neither vibration impact nor pressing the button 12 should cause triggering, that is, the moving seat 15 should not be separated from the hooking of the inner shell cantilever 131. Therefore, in the bottom cover 16, the present application embodiment proposes to set two bottom cover anti-triggering ribs 161, which have two effects: first, to prevent vibration and impact from causing accidental triggering, which is achieved by the bottom cover inner blocking surface 1611 of the bottom cover anti-triggering rib 161; second, to prevent accidental pressing of the button 12 from causing accidental triggering, which is achieved by the bottom cover upper blocking surface 1612 of the bottom cover anti-triggering rib 161. The following will be described in combination with FIGS. 11A and 11B.

[0065] FIGS. 11A to 11C are schematic diagrams of the anti-accidental triggering structure of the applicator of the present application embodiment. FIG. 11A shows the internal structure of the bottom cover. FIG. 11B shows the state in which the inner shell outer support rib 132 of the inner shell cooperates with the bottom cover inner blocking surface 1611, and FIG. 11C shows the state in which the button lower support arm 124 cooperates with the bottom cover upper blocking surface 1612. As shown in FIG. 11B, when the bottom cover 16 is not opened, the bottom cover inner blocking surface 1611 on the bottom cover anti-triggering rib 161 blocks the inner shell outer support rib 132 on the inner shell cantilever 131, so that the inner shell cantilever 131 cannot be opened outwardly, thereby preventing vibration and impact from causing the inner shell cantilever 131 to open and release the moving seat 15. As shown in FIG. 11C, the button lower support arm 124 is blocked by the bottom cover upper blocking surface 1612 of the bottom cover anti-triggering rib 161, so that the button 12 cannot be pressed at this time, and the triggering cannot be performed. Only after the bottom cover 16 is opened, the state in which the bottom cover inner blocking surface 1611 blocks the inner shell outer support rib 132 and the state in which the bottom cover upper blocking surface 1612 blocks the button lower support arm 124 are released, and the applicator 1 can be normally triggered and used.

[0066] According to the technical scheme of the embodiment of the present application, the outer periphery of the applicator is composed of a shell part, an exposed movable part and an exposed detachable part; a movable sealing structure is arranged between the shell part and the exposed movable part and between the shell part and the exposed detachable part, thereby forming overall air tightness of the outer periphery. The shell part is a shell, the exposed movable part is a button, and the exposed detachable part is a bottom cover. The upper sealing structure between the shell and the button and the lower sealing structure between the shell and the bottom cover together form overall sealing of the outer periphery, so as to prevent gas from directly entering the applicator and affecting the medical instrument. The upper sealing structure and the lower sealing structure can have two movable air tightness modes, i.e., an elastic taper sidewall sealing structure or an elastic sealing ring structure, and the elastic sealing ring structure is preferred.

[0067] The applicator in the embodiment of the present application also reduces the gas permeation rate under the premise of sealing. For the shell, the button and the bottom cover, a plastic material with low gas permeation rate must be selected, and if the moisture permeation rate is to be reduced, PP material is preferred. For the upper and lower sealing structures, the sealing ring is preferably an O-ring, and the material is preferably EPDM. In addition, the applicator is provided with an anti-advance triggering structure, and the anti-touching rib is arranged on the bottom cover. When the bottom cover is not opened, the anti-touching rib can block the cantilever of the inner shell from being opened, thereby avoiding accidental triggering due to vibration and impact, and can also block the button from being pressed in advance, thereby avoiding triggering of the applicator due to accidental pressing of the button.

[0068] The above specific embodiments do not constitute a limitation on the protection scope of the present application. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions can occur depending on design requirements and other factors. Any modification, equivalent replacement and improvement made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. An airtight applicator (1) for applying an implantable medical device (2) to a human body, the applicator comprising a shell component (11), an exposed movable component (12), and a detachable component (16), wherein: The shell component (11) has an upper opening (111) and a lower opening (112), the exposed movable component (12) is exposed at the upper opening (111), the exposed movable component (12) moves relative to the shell component (11) during the application operation, and the detachable component (16) is attached to the lower opening (112) in a detachable manner, wherein: The upper sealing structure is used to seal the upper opening (111) between the shell component (11) and the exposed movable component (12), and the lower sealing structure is used to seal the lower opening (112) between the shell component (11) and the detachable component (16).

2. The applicator of claim 1, wherein: The upper sealing structure comprises an upper annular sealing groove (125) and an upper sealing ring (171); The shell component (11) has sealing side walls (113, 115), and the sealing side walls (113, 115) surround an upper opening (111) of the shell component (11); The outer circumference or inner circumference of the exposed movable part (12) is in contact with the sealing side wall (113, 115); The upper annular sealing groove (125) is provided on the sealing side wall (113, 115), or is provided on the outer peripheral surface or the inner peripheral surface of the exposed movable part (12); The upper sealing ring (171) is arranged in the upper annular sealing groove (125), and when the upper sealing ring (171) is fitted together, the upper sealing ring (171) is squeezed to form a seal for the upper opening (111) between the shell component (11) and the exposed movable component (12).

3. An applicator according to claim 1 or 2, wherein The exposed movable part (12) is a button, which is used to trigger the applying operation when pressed by an external force.

4. The applicator of claim 1, wherein: The lower sealing structure comprises a lower annular sealing groove (115, 163) and a lower sealing ring (172); The outer circumferential surface of the detachable component (16) and the inner wall of the lower opening (112) of the shell component (11) are fitted together, and one of them is provided with the lower annular sealing groove (115, 163); or the inner circumferential surface of the detachable component (16) or the outer wall of the lower opening (112) of the shell component (11) are fitted together, and one of them is provided with the lower annular sealing groove (115, 163); The lower sealing ring (172) is arranged in the lower annular sealing groove (115, 163), and when the two parts are fitted together, the lower sealing ring (172) is squeezed to form a seal for the lower opening (112) between the shell part (11) and the detachable part (16).

5. The applicator according to claim 1 or 4, wherein The detachable component (16) and the shell component (11) are connected by threads.

6. The applicator of claim 3, wherein: The detachable component (16) is a bottom cover, used for covering the lower opening (112).

7. The applicator of claim 1, 2 or 4, wherein: The cross-sections of the upper sealing ring (171) and the lower sealing ring (172) are circular, and the material is EPDM rubber.

8. The applicator of claim 1, 2 or 4, wherein: The shell component (11), the exposed movable component (12), and the detachable component (16) are made of plastic.

9. The applicator of claim 8, wherein: The plastic is polypropylene.

10. The applicator of claim 6, wherein: The shell component (11) is the outer shell of the applicator (1).

11. The applicator of claim 10, wherein: Anti-tamper labels (10) are attached to the side surfaces of the shell component (11) and the bottom cover (16), and the anti-tamper labels (10) can increase the connection force between the shell and the bottom cover; A weak portion is provided in the middle of the anti-tampering label (10). When the outer shell and the bottom cover are subjected to opposite torques, the anti-tampering label (10) is torn off at the weak portion, so that the portion originally pasted on the side of the outer shell continues to remain on the side of the outer shell; and the portion originally pasted on the side of the bottom cover continues to remain on the side of the bottom cover.

12. The applicator of claim 10, wherein: It also includes a built-in fixed component (13), a built-in moving component (15), and a driver (181), wherein: The built-in fixed component (13) is connected to the built-in moving component (15) before the applicator (1) is triggered; The built-in moving part (15) is used to move the medical device (2) from the inside of the applicator (1) to the skin, and the driver (181) is used to provide a driving force for moving the built-in moving part (15).

13. The applicator of claim 12, wherein: The built-in fixing component (13) is an inner shell; The built-in moving component (15) is a moving seat; The driver (181) is a driving spring; The inner shell has at least one cantilever with a buckle, which is used to hook the moving seat by the buckle before the applicator is triggered; the moving seat has at least two rotary arms for clamping the medical device (2); and the driving spring is located between the inner shell and the moving seat.

14. The applicator of claim 13, wherein: The button is provided with a pressing surface, which is exposed to the applicator (1); At least one trigger rib is also provided below the button; After the bottom cover is removed, when the pressing surface is pressed down by external force, the trigger rib moves downward and is able to contact the cantilever of the inner shell; the button continues to move downward, applying force to force the cantilever to open horizontally, and when the cantilever buckle no longer hooks the moving seat, the moving seat is pushed downward by the driving spring.

15. The applicator of claim 14, wherein: The pressing surface is provided with a pressing mark for the user to identify the pressing position so as to provide the external force.

16. The applicator of claim 15, wherein: The bottom cover is provided with at least one anti-touch rib; A lower support arm is provided below the trigger rib; The outer periphery of the arm of the inner shell is provided with an external supporting rib; When the bottom cover is connected to the outer shell, the inner side of the anti-touch rib blocks the outer support rib, thereby preventing the cantilever of the inner shell from opening, and the upper end of the anti-touch rib blocks the lower support arm, thereby preventing the trigger rib from triggering downward.

17. The applicator of claim 6, wherein: A gas absorbing component is arranged in the bottom cover.

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