Insertion device assembly for inserting analyte monitoring device

By designing an integrated insertion device component, using a dual sealing structure and electron beam disinfection method, the existing blood sugar monitoring device is solved in the process of use, and the maintenance of sterile state and the reliability and safety of the equipment are improved.

CN119744143APending Publication Date: 2025-04-01SD BIOSENSOR INC
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Patent Information

Application Number
CN202380060581.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-06-01
Filing Date
2023-08-21
Publication Date
2025-04-01

AI Technical Summary

Technical Problem

The existing blood sugar monitoring devices are suffering, fear and infection risks during use, and are difficult to maintain aseptic condition, affecting the reliability and safety of the equipment.

Method used

An insertion device assembly is designed in which the applicator and emitter are manufactured in one piece, with a dual sealing structure remaining aseptic and without failure under the electron beam disinfection method, which can identify defects in the manufacturing process and simplify the sealing process to reduce manufacturing costs.

Benefits of technology

It realizes simplified preparation operations during use, improves the retention ability of sterile state, reduces the risk of infection, and improves the reliability and safety of the equipment.

✦ Generated by Eureka AI based on patent content.

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Abstract

In accordance with an embodiment of the present invention, there is provided an interposer assembly comprising: a transmitter; and an applicator comprising an emitter mounted therein, where the emitter comprises: an upper housing; a lower housing coupled to the upper housing to form an accommodation space therein; the sensor is arranged on the lower shell; a hollow holder disposed at the center of the lower housing and disposed on the sensor; the applicator includes: an upper housing having an opening formed at a lower portion thereof and having a button on an outer periphery thereof; a cover configured to be mounted on or separated from the upper case; a lower case disposed inside the cover and coupled to an opening at the open lower portion of the upper case to form an internal space with the upper case; a needle assembly disposed at an upper portion of the emitter in the internal space and configured to have at least a portion inserted into the holder; a needle carrier disposed in the internal space and configured to linearly move the needle assembly; and a driving unit configured to provide power to the needle carrier.
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Description

Technical Field

[0001] The present invention relates to an insertion device assembly, and more particularly to an insertion device assembly for inserting a device for monitoring an analyte in a human body. Background Art

[0002] The content described in this section merely provides background information for the present disclosure and does not constitute general technology.

[0003] As the preference for processed foods has increased recently, people are easily exposed to simple sugars. Due to this environment, diabetes is also increasing rapidly. Diabetic patients may go into shock and in rare cases even die when their blood sugar levels drop or rise rapidly. Therefore, diabetic patients need to monitor their blood sugar levels continuously.

[0004] In the case of a conventional blood sugar measuring device, an incision is made at a fingertip using a lancet, and the blood of a diabetic patient flowing through the incision is inserted into a blood sugar analyzing device to calculate the blood sugar level.

[0005] This blood sugar measuring device can bring pain and fear to the user. In addition, it is actually difficult to cut a finger once an hour and let it bleed.

[0006] In order to solve these problems, a continuous glucose monitoring (CGM) system has been developed. When a sensor with a very small thickness and an electronic device (hereinafter referred to as a "transmitter") for analyzing an analyte measured by the sensor (hereinafter referred to as "blood sugar") is attached to the skin of a diabetic patient, blood sugar can be measured continuously for one to ten days.

[0007] The sensor of the transmitter is too thin to directly pierce the skin. Therefore, a structure (hereinafter referred to as an "applicator") is required to insert a needle into the skin, insert a sensor into the gap therein, and remove the needle.

[0008] Meanwhile, according to document US2021-0038131 A1, the user must insert the sensor introducer 106 into the sensor inserter 500. In this case, the sensor introducer must be aligned and inserted into the sensor inserter, and during this process, the risk of the user feeling fatigue is high. Therefore, it is desirable that the insertion device assembly is configured so that the applicator and the transmitter are integrated with each other from the time of manufacturing.

[0009] Furthermore, according to document US 2022-0322975 A1, the on-skin component 102 is assembled within the applicator 100 without any sealing structure between the insertion component 118 and the sealing element 110, and thus there is a risk of exposure to contamination in the future.

[0010] In addition, according to document US2021-0361197 A1, although the needle unit 550 including the sensor unit 520 is positioned to pass through the upper and lower parts of the body attachment unit 20, after the body attachment unit 20 is attached to the user's body and the needle unit 550 is detached, the passed part remains open, and thus there is a risk of infection, etc. due to the influx of water or foreign substances.

[0011] In addition, since the sensor probe 521 as one side of the sensor unit 520 exposed to the outside of the body attachment unit 20 and the sensor main body unit 522 as the other side of the sensor unit positioned inside the body attachment unit 20 are positioned to be bent at a right angle, there is a risk that the sensor unit 520 composed of a flexible film may be damaged.

[0012] Furthermore, in the case of sterilizing the applicator using sterilizing gas, it takes a long time and there is a concern that residues may remain. Therefore, electron beams are sometimes used to sterilize medical devices, but in this case, there is a concern that it may affect the electronic device.

[0013] Furthermore, with a general applicator, it is difficult to inspect the inside of the applicator during the assembly process. Therefore, there is a concern that a defective product may not be properly inspected.

[0014] In addition, after the insertion device components are sterilized, it is important to maintain sterility. In this case, due to double or triple packaging to maintain sterility, there are problems of increased manufacturing costs and increased waste. Summary of the invention

[0015]

Technical issues

[0016] Therefore, the present invention is directed to an insertion device assembly in which the applicator and emitter are integrally manufactured and are simple to prepare for use.

[0017] Furthermore, the present invention is directed to providing an insertion device assembly capable of maintaining a sterile state by applying a double sealing structure between an applicator and a transmitter.

[0018] Furthermore, the present invention is directed to providing an insertion device assembly that does not malfunction even when sterilized using an electron beam method.

[0019] Furthermore, the present disclosure is directed to providing an insertion device assembly capable of identifying defects during the manufacturing process.

[0020] Furthermore, the present invention aims to provide an insertion device assembly that is easy to manufacture due to a simplified sealing process for maintaining sterility.

[0021] Furthermore, the present invention is directed to providing an insertion device assembly capable of sealing a portion through which a needle has passed after the needle is separated from a transmitter.

[0022] Furthermore, the present disclosure is directed to providing an insertion device assembly that prevents damage to a sensor unit, which is one of important components inserted into a user's body to analyze the concentration of an analyte in the body.

[0023] Problems to be solved by the present invention are not limited to the above-mentioned problems, and other problems not mentioned will be clearly understood by those skilled in the art through the following description.

[0024]

Technical solution

[0025] According to an embodiment of the present invention, an insertion device assembly is provided, which includes: a transmitter; and an applicator, which includes the transmitter installed therein, wherein the transmitter includes: an upper shell; a lower shell, which is coupled to the upper shell to form a accommodating space therein; a sensor, which is arranged on the lower shell; a hollow retainer, which is arranged at the center of the lower shell and arranged on the sensor; and wherein the applicator includes: an upper shell, which has an opening formed in the lower part thereof and has a button on its periphery; a cover, which is configured to be mounted on the upper shell or separated from the upper shell; a lower shell, which is arranged inside the cover and coupled to the opening at the open lower part of the upper shell to form an internal space with the upper shell; a needle assembly, which is arranged at the upper part of the transmitter in the internal space and is configured to have at least a portion inserted into the retainer; a needle carrier, which is arranged in the internal space and configured to cause the needle assembly to move linearly; and a drive unit, which is configured to provide power to the needle carrier.

[0026] Preferably, the needle assembly includes a needle configured to pierce the skin of a user, a gripping portion coupled to one end of a needle carrier, and a needle injection molded portion disposed between the needle and the gripping portion and configured to be frictionally coupled to a retainer.

[0027] Furthermore, preferably, the needle molded part is coupled to the holder when the insertion device assembly is assembled, and the needle molded part is decoupled from the holder when the insertion device assembly is used.

[0028] Furthermore, preferably, the cover includes: an opening formed on a lower surface thereof; a plurality of ribs, at least some of which are disposed in the lower shell and extend radially inward from an inner periphery of the cover; and a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle.

[0029] Furthermore, preferably, the needle assembly further comprises a cover molding portion having a shape corresponding to the shape of the upper surface of the needle accommodating portion and disposed on the upper surface of the needle accommodating portion, and the cover molding portion contacts the lower surface of the lower housing.

[0030] Furthermore, preferably, the plurality of ribs are two or more and are symmetrically arranged with respect to the center of the needle accommodating portion, the transmitter further includes an adhesive tape attached to the lower surface of the lower housing in a number equal to the number of the plurality of ribs, and the adhesive tape is inserted through the opening.

[0031] Furthermore, preferably, the transmitter further includes a PCB (Printed Circuit Board) accommodated in the accommodation space between the upper housing and the lower housing, and a dummy PCB connecting the sensor and the PCB.

[0032] Furthermore, preferably, the transmitter further includes a packaging portion located on the holder and made of an elastic material.

[0033] Furthermore, preferably, the transmitter includes: a lower opening in the lower housing, the lower opening being provided with a holder therein; and an inclined rail having an inclined surface formed to be inclined downward from one side of the lower opening, a part of the sensor being placed on the inclined surface.

[0034] Furthermore, preferably, the insertion portion of the sensor is located in the needle passing through the holder, and two bent portions are formed between one end and the other end of the sensor by the inclined surface and the needle, and the two bent portions form an obtuse angle.

[0035] According to an embodiment of the present invention, an insertion device assembly is provided, which includes: a transmitter; and an applicator configured to install the transmitter therein, wherein the insertion device assembly is divided into first to fourth assemblies according to an assembly order, and the first assembly includes: a cover including an open upper portion and an open lower portion; a lower shell disposed in the cover; a lower shell of the transmitter, the lower shell being disposed on at least a portion of the lower shell; a sensor disposed on the lower shell; a hollow retainer disposed at the center of the lower shell and on the sensor; and a needle assembly disposed on the transmitter and configured to allow at least a portion thereof to be inserted into the retainer.

[0036] Preferably, the second component further includes, on the first component sterilized by the electron beam: a PCB disposed on the lower housing; and an upper housing coupled to the lower housing to form a receiving space therein.

[0037] Furthermore, preferably, the third component further comprises on the second component: a needle carrier configured to linearly move the needle assembly; and a driving unit configured to provide power to the needle carrier.

[0038] Furthermore, preferably, the fourth component further includes, on the third component: an adhesive tape attached to a lower surface of the lower housing; and a sealing portion configured to seal an open lower portion of the cover.

[0039] Furthermore, preferably, the needle assembly includes a needle configured to pierce the skin of a user; a grip portion coupled to one end of a needle carrier; and a needle injection portion disposed between the needle and the grip portion and configured to be frictionally coupled to a retainer.

[0040] In addition, preferably, the cover includes: a plurality of ribs, at least some of which are arranged in the lower shell body and extend radially inward from the inner periphery of the cover; a needle accommodating portion, which is supported by the plurality of ribs and configured to surround at least a portion of the needle; and a cover injection molding portion, which has a shape corresponding to the shape of the upper surface of the needle accommodating portion and is arranged on the upper surface of the needle accommodating portion, and the cover injection molding portion contacts the lower surface of the lower shell body.

[0041] In addition, preferably, the plurality of ribs are two or more and are symmetrically arranged with respect to the center of the needle accommodating portion, the transmitter further includes a tape attached to the lower surface of the lower housing, the number of which is equal to the number of the plurality of ribs, and the tape is inserted through the open lower portion of the cover.

[0042] According to an embodiment of the present invention, an insertion device assembly is provided, which includes: a transmitter; and an applicator, which includes the transmitter installed therein, wherein the applicator includes an upper shell having an opening formed in a lower portion thereof and a button on an outer periphery thereof; a cover, which is configured to be mounted on or separated from the upper shell, and the upper and lower portions of the cover are open; a lower shell, which is disposed inside the cover and coupled to the opening at the open lower portion of the upper shell to form an internal space with the upper shell; and a needle assembly, which includes a needle configured to pass through the transmitter, wherein the cover includes a plurality of ribs, at least some of which are disposed in the lower shell and extend radially inward from the inner periphery of the cover; a needle accommodating portion, which is supported by the plurality of ribs and is configured to surround at least a portion of the needle; and a cover injection molding portion, which has a shape corresponding to the shape of the upper surface of the needle accommodating portion, is disposed on the upper surface of the needle accommodating portion and contacts the lower surface of the transmitter.

[0043] In addition, the plurality of ribs are two or more and are symmetrically arranged with respect to the center of the needle accommodating portion, the transmitter further includes a tape attached to the lower surface of the transmitter, the number of which is equal to the number of the plurality of ribs, and the tape is inserted through the open lower portion of the cover.

[0044]

Beneficial effects

[0045] As described above, according to the embodiments of the present disclosure, the applicator and the transmitter can be manufactured integrally, and when the applicator is used, the needle protection configuration can be immediately separated by simply removing the cover, thereby providing convenience to the user.

[0046] Furthermore, the needle and the interior of the applicator can be kept sterile by the double seal structure of the insertion device assembly.

[0047] Furthermore, according to an embodiment of the present disclosure, when assembling the interposer assembly, the PCB is assembled after being sterilized by an electron beam, so there is no need to worry about the electronic devices mounted on the PCB being damaged.

[0048] In addition, since the cover is made of a transparent material, it is possible to visually confirm whether a seal is formed between the injection-molded part of the cover and the emitter, so there is an advantage that defective products can be easily inspected.

[0049] Furthermore, since only the sealing portion needs to be attached to the lower portion of the cover after the assembly of the insert device assembly is completed, the sealing method is simple and easy to manufacture.

[0050] Furthermore, the elastic packing portion is located at the portion of the transmitter through which the needle is penetrated and placed, so after the needle is separated, the penetrated portion is sealed, thereby preventing the inflow of water or foreign matter and the infection caused by it.

[0051] Furthermore, the sensor is mounted using a rail structure forming the inside of the housing of the transmitter, and thus a bent portion of the sensor is smoothly formed, thereby preventing damage to the sensor. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] 1 is a front perspective view of an insertion device assembly according to an embodiment of the present disclosure.

[0053] Figure 2 is an exploded perspective view of an insertion device assembly according to an embodiment of the present disclosure.

[0054] Figure 3 are complete and exploded perspective views of a transmitter according to an embodiment of the present disclosure.

[0055] Figure 4 The interior of a cover according to an embodiment of the present disclosure is shown.

[0056] Figure 5 is a front perspective view of a lower housing according to an embodiment of the present disclosure;

[0057] Figure 6 is a flow chart of a method of assembling an insertion device assembly according to an embodiment of the present disclosure.

[0058] Figure 7 The assembly sequence of an insertion device assembly according to an embodiment of the present disclosure is shown.

[0059] Figures 8 to 11 A state during the assembly of the insertion device assembly according to an embodiment of the present disclosure is explained.

[0060] Fig.12 1 is an overall stereoscopic view of a connection structure of a PCB, a sensor, and a dummy PCB located inside a transmitter according to an embodiment of the present disclosure, viewed from below.

[0061] Fig.13 is an exploded perspective view of a connection structure of a PCB, a sensor, and a dummy PCB located inside a transmitter according to an embodiment of the present disclosure, viewed from below.

[0062] Fig.14 and Fig.15 2 are perspective views respectively illustrating a rail structure of a lower housing and a sensor installed therein according to an embodiment of the present disclosure.

[0063] Fig.16 and Fig.17 2 are longitudinal cross-sectional views respectively showing a shape of a sensor when a needle assembly is not coupled to a transmitter and a shape of the sensor when the needle assembly is coupled to the transmitter according to an embodiment of the present disclosure.

[0064] Fig.18 The coupling of the needle assembly and the transmitter according to another embodiment of the present disclosure is explained. DETAILED DESCRIPTION

[0065] Hereinafter, some embodiments of the present disclosure will be described in detail through illustrative drawings. When adding reference numerals to the components of each figure, it should be noted that the same reference numerals should be given to the same components as much as possible even if they are shown on different figures. In addition, in the description of the present disclosure, when it is determined that the detailed description of the relevant known configuration or function may obscure the key points of the present disclosure, its detailed description will be omitted.

[0066] In the description of components according to the embodiments of the present disclosure, symbols such as first, second, i), ii), a), b), etc. may be used. These symbols are only used to distinguish one component from other components, and the nature, order or sequence of the components are not limited by these symbols. When a part of the specification is referred to as "including" or "comprising" a component, it means that it may include other components rather than excluding them, unless otherwise explicitly stated.

[0067] In this disclosure, an "insertion device assembly" refers to the assembly in which the applicator and emitter are assembled.

[0068] In addition, in the present disclosure, "distal position" refers to a position relatively farther from the skin than "proximal position". At the same time, the proximal position and the distal position are concepts of relative positions, and it can be understood that a certain element is close to one element and also far away from another element.

[0069] Furthermore, in the present disclosure, "firing" refers to the action of a user activating an applicator, causing a needle to be inserted into the user's skin.

[0070] Furthermore, in the present disclosure, "retraction" is a process in which a pointer returns to its original position after being inserted into the user's skin.

[0071] Furthermore, in the present disclosure, “upward” refers to a direction from a proximal position to a distal position.

[0072] Furthermore, in the present disclosure, “downward” refers to a direction from a distal position to a proximal position.

[0073] Furthermore, in the present disclosure, "horizontal" refers to a plane that contacts the applicator when the applicator is used, and refers to the skin surface. In the present disclosure, the curvature of the skin surface is not considered, and the explanation is given assuming that the skin surface of the user is flat.

[0074] 1. Applicator Instructions

[0075] 1.1 Structure of the applicator

[0076] 1 is a front perspective view of an insertion device assembly according to an embodiment of the present disclosure.

[0077] Specifically, Figure 1a The cover 130 is shown in the installed state, and Figure 1b A state in which the cover 130 is separated is shown.

[0078] The applicator 100 according to the embodiment of the present disclosure includes an upper housing 110, a button 120 configured to be inserted and pressed into the outer periphery of the upper housing 110, and a cover 130 (see FIG. 1 ) which can be detached from the upper housing 110. Figure 1a ).

[0079] When the cover 130 of the applicator 100 is separated from the upper housing 110, a portion of the lower housing 140 is exposed (see Figure 1b ). When the cover 130 is separated, the insertion device assembly is ready for use by the user.

[0080] Figure 2 is an exploded perspective view of an insertion device assembly according to an embodiment of the present disclosure.

[0081] refer to Figure 2 In addition to the upper shell 110, the button 120, the cover 130 and the lower shell 140, the applicator 100 according to an embodiment of the present disclosure may also include all or part of the following: a drive unit 150, a needle carrier 160, a needle assembly 170, a transmitter holder 180, a desiccant 190 and a sealing unit 191.

[0082] The upper housing 110 is configured to be gripped by a user, and preferably has a substantially cylindrical shape. Meanwhile, the lower portion of the upper housing (110) is open.

[0083] The button 120 is placed and disposed on the outer circumference of the upper housing 110 , and is configured to be pressed toward the inside of the upper housing 110 .

[0084] The cover 130 is configured to be mounted on or separated from the upper housing 110, and can protect the interior of the applicator 100 from external contaminants or impacts. Preferably, the cover 130 has a substantially cylindrical shape.

[0085] The lower housing 140 is disposed inside the cover 130. The lower housing 140 is configured to form a space inside by being coupled with a lower portion of the upper housing 110. When the applicator 100 is used, the lower housing 140 is configured to directly contact the skin of the user.

[0086] The drive unit 150 is disposed in an internal space formed by the upper housing 110 and the lower housing 140. The drive unit 150 is configured to linearly move the transmitter 200 and the needle assembly 170 along the length direction of the applicator 100. To this end, the drive unit 150 includes all or part of the spring 151, the wheel 152, and the locking member 153.

[0087] The spring 151 is a power source that provides power to the needle carrier 160 so that the needle carrier 160 can move in a straight line. For this purpose, it is preferred that the spring 151 is a reel spring. The spring 151 is assembled in a compressed state in the initial state. At the same time, when the compressed fastener that fixes the spring 151 is released by the pressure of the button 120, the spring 151 can be opened to return to its original state. Therefore, one end of the spring 151 rotates. That is, it can be a scotch yoke or double slider crank mechanism principle, in which the rotational motion of the spring 151 is converted into the linear motion of the needle carrier 160 and the needle assembly 170.

[0088] One side of the wheel 152 is connected to one end of the spring 151, and thus is configured to rotate along with the rotation of the spring 151. A groove for coupling with the locking member 153 may be formed on the outer circumference of the wheel 152.

[0089] The locking member 153 is configured such that one end thereof is coupled to the button 120 and the other end thereof is connected to the wheel 152. In this case, a groove is formed at the other end of the locking member 153 so that it can engage with the groove of the wheel 152. Therefore, the rotation of the wheel 152 is prevented, and the expansion of the spring 151 is also prevented.

[0090] When the button 120 moves toward the inside of the applicator 100, the locking member 153 also moves with the button 120. Therefore, the engagement between the other end of the locking member 153 and the groove of the cover 130 is released, and due to the expansion and rotation of the spring 151, the wheel 152 can rotate together.

[0091] The needle carrier 160 is configured to move linearly within the upper housing 110 and the lower housing 140. In this case, the linear movement of the needle carrier 160 can be caused by the rotational movement of the drive unit 150. For this purpose, it is preferred that the needle carrier 160 has an overall T-shape. The needle carrier 160 can be coupled to the other side of the wheel 152 to undergo the rotational movement of the drive unit 150.

[0092] The needle assembly 170 is placed in the inner space formed by the upper housing 110 and the lower housing 140. The needle assembly 170 is coupled to the lower end of the needle carrier 160 and thus is configured to move linearly together with the linear movement of the needle carrier 160.

[0093] The needle assembly 170 includes all or part of a needle 171 , a grip portion 172 , and a needle injection-molded portion 173 .

[0094] Needle 171 is configured to pierce the skin of a user.

[0095] The gripping portion 172 is configured to be coupled to a lower portion of the needle carrier 160. The needle 171 and the gripping portion 172 may be configured as an integral whole, and are preferably made entirely of a metal material, but the present disclosure is not necessarily limited thereto.

[0096] The needle injection molded part 173 is disposed between the needle 171 and the gripping part 172. The needle injection molded part 173 is made of a material different from that of the needle 171 and the gripping part 172, and may preferably be made of rubber. For this purpose, it is preferred that the needle injection molded part 173 is double-molded when the needle assembly 170 is manufactured.

[0097] Meanwhile, when manufacturing the insertion device assembly, the needle injection molded portion 173 is inserted into the interior of the transmitter 200. In this case, since the needle injection molded portion 173 is made of rubber, a sealing structure can be formed with the transmitter 200. In this regard, reference will be made to Figure 7 and Figure 8 Describe in detail.

[0098] According to an embodiment of the present disclosure, when coupled with the transmitter 200 through the needle injection-molded portion 173 , the needle assembly 170 may be prevented from rotating.

[0099] Meanwhile, according to another embodiment of the present disclosure, instead of providing the needle assembly 170' having a separate needle injection molded portion, at least a portion of the upper surface of the transmitter 200' is formed as an elastic portion, so that when the needle 171' is coupled to the upper housing 210' of the transmitter 200', a sealing structure is formed while preventing the needle 171' from rotating (refer to Fig.18 ). In this regard, reference will be made to Fig.18 Describe in detail.

[0100] The transmitter holder 180 is disposed in the internal space formed by the upper housing 110 and the lower housing 140. The transmitter holder 180 is coupled to the transmitter and is thus configured to linearly move the transmitter 200 from the distal position to the proximal position. The transmitter holder 180 is pressed from the distal position to the proximal position by the needle carrier 160. Meanwhile, the transmitter holder 180 does not move from the proximal position to the distal position, but can only move from the distal position to the proximal position.

[0101] The desiccant 190 is inserted into the interior of the cover 130 through the bottom surface of the cover 130 , and is configured to dehumidify the interior of the applicator 100 .

[0102] The sealing portion 191 is attached to the open bottom surface of the cover 130 and is configured to provide a barrier between the interior and exterior of the applicator 100 .

[0103] Figure 3 are a complete perspective view and an exploded perspective view of a transmitter according to an embodiment of the present disclosure.

[0104] The transmitter 200 according to an embodiment of the present disclosure is configured to attach to the user's skin, analyze the concentration of an analyte in the user's body, and transmit information about the concentration to an external device. The transmitter 200 can be manufactured by being inserted into the inside of the applicator 100 during the production process of the insertion device assembly.

[0105] refer to Figure 3 , the transmitter 200 includes all or part of the following: an upper housing 210, a PCB 220, a holder 230, a sensor 240, a dummy PCB 245, a lower housing 250, and a tape 260. The detailed construction will be referred to Figures 12 to 17 Give a description.

[0106] Figure 4 The interior of a cover according to an embodiment of the present disclosure is shown.

[0107] refer to Figure 4 The cover 130 according to the embodiment of the present disclosure may be composed of one or more materials of ABS (acrylonitrile butadiene styrene copolymer) resin, PC (polycarbonate) resin, and PE (polyethylene) resin, but any material commonly used in medical devices (such as applicators, etc.) may be applied without limitation. For example, PC resin and ABS resin may be used in combination, but this may be appropriately changed according to the designer's choice.

[0108] The cover 130 includes all or part of the opening 131 , the ribs 132 a and 132 b , the needle accommodating portion 133 , the cover injection molding portion 134 , and the coupling protrusions 135 a , 135 b , 135 c , and 135 d .

[0109] An opening 131 is formed on the bottom surface of the cover 130 .

[0110] The ribs 132a and 132b are formed to extend radially inward from the inner circumference of the cover 130. According to an embodiment of the present invention, the two ribs 132a and 132b are symmetrically formed, but the present invention is not necessarily limited thereto, and the number and shape thereof may be appropriately changed according to the designer's choice.

[0111] Since the ribs 132a and 132b are arranged along the diameter of the cover 130, the cover 130 may have a bisected shape when viewed from the bottom or top thereof. That is, the cover 130 may have an approximately θ shape.

[0112] The needle accommodating portion 133 is formed at the center of the diameter of the cover 130, and is formed to accommodate the needle 171. To this end, the needle accommodating portion 133 may have a cylindrical shape including an accommodating space therein and having an open upper surface.

[0113] The needle accommodating portion 133 is supported by one rib 132a and the other rib 132b.

[0114] Since the needle receiving portion 133 is integrally formed with the cover 130, the needle protection configuration can be immediately separated by simply separating the cover 130 when using the applicator 100, which provides a convenient advantage to the user.

[0115] The cover injection molding part 134 is formed on the upper surface of the needle accommodating part 133 and contacts the lower surface of the lower housing 250 of the transmitter 200. Meanwhile, during the manufacturing process of the cover 130, the cover injection molding part 134 may be formed by double injection molding on the needle accommodating part 133, but the present invention is not necessarily limited thereto.

[0116] Meanwhile, when manufacturing the insert device assembly, the cover injection molding part 134 contacts the bottom surface of the transmitter 200. In this case, the cover injection molding part 134 is made of rubber so that a sealing structure can be formed with the transmitter 200. In this regard, reference will be made to Figure 7 and Figure 8 Describe in detail.

[0117] One or more coupling protrusions 135a, 135b, 135c, and 135d are formed to protrude radially inward from the inner circumference of the cover 130. The one or more coupling protrusions 135a, 135b, 135c, and 135d are configured to be coupled to the outer circumference of the lower case 140. In this regard, reference will be made to Figure 5 Describe in detail.

[0118] Figure 5 is a front perspective view of a lower housing according to one embodiment of the present disclosure.

[0119] refer to Figure 5 , the lower case 140 according to an embodiment of the present disclosure includes one or more coupling grooves 141 a and 141 b formed on an outer circumference thereof.

[0120] The coupling grooves 141a and 141b are formed to be recessed radially inward from the outer periphery of the lower housing 140, and the coupling protrusions 135a, 135b, 135c, and 135d can be placed and coupled. In this case, the number of coupling grooves 141a and 141b is formed to be equal to the number of coupling protrusions 135a, 135b, 135c, and 135d. Meanwhile, although it is shown in the present disclosure that two coupling grooves 141a and 141b are formed, it should be noted that two more coupling grooves are formed on the invisible side.

[0121] Guide grooves 142a and 142b may be further formed on one side of the coupling grooves 141a and 141b. The guide grooves 142a and 142b are formed to be recessed radially inward from the outer periphery of the lower shell 140, but extend along the height direction of the lower shell 140. Meanwhile, preferably, the width of the coupling grooves 141a and 141b is formed to be greater than the width of the coupling protrusions 135a, 135b, 135c, and 135d. Therefore, the coupling protrusions 135a, 135b, 135c, and 135d can move up and down in the coupling grooves 141a and 141b.

[0122] For example, the guide grooves 142a and 142b may be continuously formed on the left side of the coupling grooves 141a and 141b. In this case, the coupling protrusions 135a, 135b, 135c, and 135d are coupled to the coupling grooves 141a and 141b, move to the left along the width of the coupling grooves 141a, 141b and the guide grooves 142a, 142b, and then move downward along the height direction of the guide grooves 142a, 142b, so that the coupling protrusions 135b, 135 and 135d can be separated toward the outside of the lower shell 140. That is, the user can release the coupling between the cover 130 and the lower shell 140 by rotating the cover 130 to the right along the outer circumference of the lower shell 140 and then moving the cover 130 downward along the height direction of the lower shell 140.

[0123] Meanwhile, according to an embodiment of the present disclosure, it is described that the lower housing 140 and the cover 130 can be coupled or decoupled by the coupling protrusions 135a, 135b, 135c and 135d and the coupling grooves 141a and 141b, but the present disclosure is not necessarily limited thereto. For example, the lower housing (140) and the cover (130) can be coupled by hook coupling, thread coupling, etc. Alternatively, the two can be coupled by a combination of an opening and closing method of a wing member (not shown) provided on one of the cover 130 and the lower housing 140 and a hook (not shown) provided on the other of the cover 130 and the lower housing 140.

[0124] 1.2. Assembly method of the applicator

[0125] Figure 6 is a flow chart of a method of assembling an insertion device assembly according to an embodiment of the present disclosure. Figure 7 The assembly sequence of an insertion device assembly according to an embodiment of the present disclosure is shown. Figures 8 to 11 A state during the assembly of the insertion device assembly according to an embodiment of the present disclosure is explained.

[0126] Reference Figures 6 to 11 Methods of assembling and sterilizing insertion device assemblies according to embodiments of the present disclosure are described.

[0127] First, the cover 130, the lower housing 250, the sensor 240, the retainer 230, the needle assembly 170 and the lower housing 140 are assembled in sequence (S610, Figure 7 Hereinafter, the assembly of the cover 130, the lower housing 250, the sensor 240, the retainer 230, the needle assembly 170 and the lower housing 140 is referred to as a first assembly ASSY 1.

[0128] The first component ASSY 1 in Figure 8 Shown in. Figure 8 (a) is a front perspective view of the first component ASSY 1, and Figure 8 (b) is a cross-sectional view of the first component ASSY 1. Figure 8 (b), the needle injection molded portion 173 is pressed into the retainer 230, and the two are frictionally coupled. The needle injection molded portion 173 can prevent contaminants from flowing into the needle 171 through the retainer 230. At the same time, when the user launches the applicator 100 and then the needle assembly 170 is retracted, the launcher 200 remains in the distal position. Therefore, the needle injection molded portion 173 inserted into the retainer 230 is separated from the retainer 230.

[0129] In addition, the cover injection portion 134 contacts the bottom surface of the lower housing 250 to form a sealing structure. In this case, due to the coupling of the cover 130 and the lower case 140, the cover injection portion 134 can be supported while contacting the bottom surface of the lower housing 250.

[0130] Preferably, at least a portion of the cover 130 is made of a transparent material. Therefore, it is possible to visually confirm whether a sealing structure is formed between the cover injection molding portion 134 and the emitter 200, thereby having the advantage of being easy to check whether there are any unsealed defective products.

[0131] According to the above description, the insertion device assembly according to the embodiment of the present disclosure has the advantage that the interior of the insertion device assembly can be protected from contamination by contaminants by forming a double sealing structure during the assembly process. In the case of the needle 171, since it is the part that directly pierces the user's skin, it is very important to maintain a sterile state, and the double sealing structure of the insertion device assembly according to the present disclosure is very effective in maintaining such a sterile state.

[0132] Thereafter, the first assembly ASSY 1 is sterilized by irradiating the first assembly ASSY 1 with an electron beam (S620). Since the PCB 220 has electronic devices mounted thereon, there is a risk that some functions may be lost when it is directly exposed to the electron beam. Meanwhile, according to the present disclosure, since the electron beam sterilization is performed in a state where the first assembly ASSY 1 of the PCB 220 is not assembled, there is no need to worry that the electronic devices mounted on the PCB 220 will be damaged.

[0133] Assemble the PCB 220, the upper housing 210 and the tape 260 in the first assembly ASSY 1 (S630, Figure 7 (b)). Hereinafter, the assembly formed according to step S630 is referred to as a second assembly ASSY 2.

[0134] The second component ASSY 2 is Fig. 9 Shown in. Fig. 9 (a) is a front perspective view of the second component ASSY 2, and Fig. 9 (b) is a cross-sectional view of the second component ASSY 2.

[0135] refer to Fig. 9 In (a) and (b), the upper housing 210 is coupled to the lower housing 250. In this case, the upper housing (210) and the lower housing 250 may be coupled by ultrasonic welding or UV bonding.

[0136] Thereafter, the needle carrier 160 and the drive unit 150 are assembled in the second assembly ASSY (S640, Figure 7 (c)). At the same time, Figure 7 , Fig.10 and Fig.11 As shown, only the needle carrier 160 is coupled, but this is for convenience of explanation, and it should be understood that the driving unit 150 coupled to the needle carrier 160 is also assembled together. Hereinafter, the assembly formed according to step S640 is referred to as a third assembly ASSY 3.

[0137] The third component ASSY 3 is Fig.10 Shown in. Fig.10 (a) is a bottom perspective view of the third component ASSY 3, and Fig.10(b) is a cross-sectional view of the third component ASSY 3.

[0138] refer to Fig.10 (a), the opening 131 of the cover 130 is still open.

[0139] In addition, reference Fig.10 (b), the needle carrier 160 and the needle assembly 170 can be coupled by coupling the coupling arm 161 formed at the bottom of the needle carrier 160 with the gripping portion 172 of the needle assembly 170. In this case, the coupling of the coupling arm 161 and the gripping portion 172 can adopt a snap-fit ​​method, but the present invention is not necessarily limited thereto, and a threaded coupling or the like can also be adopted.

[0140] Thereafter, the tape 260, the desiccant 190, and the sealing portion 191 are sequentially coupled to the third assembly ASSY 3 (S650, Figure 7 (d)). Hereinafter, the assembly formed according to step S650 is referred to as a fourth assembly ASSY 4.

[0141] ASSY 4 Fig.11 Shown in. Fig.11 (a) is a bottom perspective view of the fourth component ASSY 4, and Fig.11 (b) is a cross-sectional view of the fourth component ASSY 4.

[0142] refer to Fig.11 (b), the tape 260 is attached to the bottom surface of the lower housing 250. In this case, as described above, the tape 260 may be inserted into the right opening 131 and the left opening 131 of the cover 130 in a bisected state, respectively.

[0143] When the tape 260 is attached, the desiccant 190 is inserted into the cover 130 , and the cover 130 is sealed by the sealing portion 191 .

[0144] Meanwhile, according to an embodiment of the present disclosure, the insertion device assembly has an advantage of being easily sealed because only the sealing portion 191 needs to be attached to the lower portion of the cover 130 during assembly.

[0145] Meanwhile, in the present disclosure, after assembling the fourth assembly ASSY 4, the upper housing 110 provided with the button 120 is further assembled, but the related description or detailed drawings will be omitted in the present disclosure.

[0146] 1.3. Sterilization test results of applicators and emitters

[0147] As a result of sterilizing the insertion device assembly according to one or another embodiment of the present disclosure, it was confirmed that no proliferation of microorganisms was observed.

[0148] Specifically, the test method is based on ISO11737-2:2019 "Sterilization of health care products - Microbiological methods - Part 2: Sterility testing during qualification, validation and maintenance of sterilization processes.

[0149] In addition, instruments and equipment such as incubators, low-temperature incubators, high-pressure steam sterilizers and clean benches are also used.

[0150] Furthermore, in soybean casein digest medium (TSB), the microorganisms were cultured at 30 to 35°C for 14 days and at 20 to 25°C for 14 days, for a total of 28 days.

[0151] In this case, when the irradiation doses of the electron beam were 25 kGy and 35 kGy, respectively, proliferation of the microorganisms was confirmed after culturing the microorganisms.

[0152] The results of the above test method confirmed that there was no microbial proliferation in all cases where the irradiation dose of the electron beam was 25 kGy and 35 kGy. That is, when the assembly and sterilization method of the insertion device assembly according to the embodiment of the present disclosure is adopted, it can be seen that the sterilization effect and the effect of preventing contamination by external pollutants are excellent.

[0153] 2. Transmitter Description

[0154] In the following, reference will be made to Figure 3 and Figures 12 to 17 The configuration of the transmitter 200 of the insertion device assembly according to the embodiment of the present disclosure is described in detail.

[0155] As mentioned above, Figure 3 are a complete perspective view and an exploded perspective view of a transmitter 200 according to an embodiment of the present disclosure.

[0156] refer to Figure 3 , the transmitter 200 includes all or part of the following: an upper housing 210 , a PCB 220 , a holder 230 , a sensor 240 , a dummy PCB 245 , a lower housing 250 , and a tape 260 .

[0157] The upper case 210 and the lower case 250 are vertically coupled to form an exterior appearance of the transmitter 200 , and form a predetermined accommodation space inside the transmitter 200 .

[0158] An upper through hole 211 is formed at the center of the upper case 210 , and a lower through hole 251 is formed at the center of the lower case 250 .

[0159] The cylindrical holder 230 is located between the upper through hole 211 and the lower through hole 251 , and the needle 171 may be disposed to pass through the upper housing 210 and the lower housing 250 while the needle injection portion 173 is pressed into the holder 230 .

[0160] The PCB 220 is a printed circuit board and is accommodated in an inner accommodation space between the upper housing 210 and the lower housing 250. Each electronic component is mounted on the PCB 220 to analyze the concentration of the user's body analyte detected by the sensor 240 and transmit information on the concentration to an external device.

[0161] The sensor 240 is located below the holder 230 in the internal accommodation space of the transmitter 200 .

[0162] One side of the sensor 240 extends to the outside of the transmitter 200 through the lower through hole 251 of the transmitter 200, is placed in the needle 171 and inserted into the user's body by transmission, and the other side of the sensor 240 is connected to the lower part of the PCB 220 in the transmitter 200.

[0163] Hereinafter, a portion of the transmitter 200 inserted into the user's body from the outside may be referred to as an insertion portion, and another portion of the transmitter 200 connected to the PCB 220 from the inside may be referred to as a connection portion.

[0164] refer to Fig.12 and Fig.13 Describe the virtual PCB 245. Fig.12 and Fig.13 It is a complete perspective view and an exploded perspective view of the connection structure of the PCB 220, the sensor 240, and the dummy PCB 245 viewed from below.

[0165] The dummy PCB 245 is located between the sensor 240 and the PCB 220. The dummy PCB 245 is also composed of a small printed circuit board, and electrically connects the sensor 240 with electronic components mounted on the PCB 220.

[0166] Different from the PCB 220 , the dummy PCB 245 does not have any components mounted thereon but only includes a printed circuit for electrically connecting the sensor 240 and the PCB 220 .

[0167] Specifically, refer to Fig.12 and Fig.13 , the dummy PCB 245 is located below the PCB 220 and above the sensor 240. One side of the dummy PCB 245 contacts the connection portion of the sensor 240, and the other side thereof contacts the contact point on the peripheral side of the PCB 220, thereby physically and electrically connecting the sensor 240 and the PCB 220.

[0168] The sensor 240 and the dummy PCB 245 may be connected to each other by ultrasonic welding or anisotropic conductive film (ACF) bonding, and the dummy PCB 245 and the PCB 220 may be connected to each other by soldering.

[0169] Fig.14 and Fig.15 2 is a perspective view of the lower housing 250, showing the appearance of the rail structure located on the inner surface of the lower housing 250 and the sensor (240) installed therein.

[0170] refer to Fig.14 , the fixing rail 252 is located on the upper surface of the lower housing 250 .

[0171] The fixing rail 252 is formed in a concave and stepped shape, wherein one side of the lower housing 250 corresponds to the connection portion of the sensor 240 , and the sensor 240 may be fixedly installed in the lower housing 250 by fitting the connection portion of the sensor 240 into the fixing rail 252 .

[0172] The inclined rail 253 is located at one side of the fixed rail 252. The inclined rail 253 is formed in a shape inclined downward from one side of the lower through hole 251 of the fixed rail 252.

[0173] refer to Fig.15 , when the sensor 240 is assembled into the fixing rail 252 , a portion between the connecting portion and the inserting portion of the sensor 240 is placed on the inclined rail 253 .

[0174] Fig.16 2 is a longitudinal sectional view showing a state of the sensor 240 when the needle assembly 170 is not coupled to the transmitter 200 . Fig.17 2 is a longitudinal sectional view showing a state of the sensor 240 when the needle assembly 170 is coupled to the transmitter 200 .

[0175] refer to Fig.16 and Fig.17 , the portion between the connection portion and the insertion portion of the sensor 240 is placed on the inclined track 253, so that the sensor 240 extending to the outside of the lower housing through the lower through hole 251 forms a first bent portion 241 bent at an obtuse angle relative to the inclined track 253. When the needle assembly 170 is coupled in this state, one end of the sensor 240, that is, the insertion portion of the sensor 240, is accommodated in the needle 171 and bent at an obtuse angle, thereby forming a second bent portion 242. That is, the middle portion of the sensor 240 is not directly bent at a right angle, but two bent portions are formed at an obtuse angle between one end and the other end of the sensor 240, and one end and the other end of the sensor 240 form a right angle with the two bent portions formed therebetween in the above manner.

[0176] Meanwhile, for convenience of explanation, the present disclosure illustrates that the bent portions 241 and 242 are formed of discontinuous surfaces, but it should be noted that they may have a continuously bent shape.

[0177] The sensor 240 can be bent because it is made of a flexible film, but when it is bent at a small angle and folded, the electrodes of the sensor 240 or the material sputtered on the sensor 240 may be damaged by cracks. When two bent portions are formed in the sensor 240 in the above manner, damage to the film constituting the sensor 240 and the material sputtered on the film can be prevented.

[0178] Furthermore, since the sensor 240 is downwardly angled by the first bent portion 241 before the needle 171 is assembled into the sensor 240, it is easy to assemble the needle 171 coupled to the upper portion of the sensor 240 through the lower portion of the transmitter 200.

[0179] Furthermore, in a state where the sensor is inserted into the user's skin and fixed, the tension applied to the electrodes can be reduced.

[0180] The adhesive tape 260 is located on the bottom surface of the lower housing 250 and allows the transmitter 200 to adhere and be fixed to the user's skin. An opening is formed in the center of the adhesive tape 260 so that the sensor 240 extending from the lower housing 250 can pass through the opening and be placed therein.

[0181] Reference again Figure 3 , the tape 260 is configured to be segmented according to the location and number of ribs 132a and 132b formed in the applicator cap.

[0182] In this embodiment, since the two ribs 132a and 132b are arranged along the diameter of the cover 130, when viewed from the bottom or top, the cover 130 is configured to have a roughly θ shape that bisects the shape, so that the tape 260 is also configured on the bottom surface of the lower shell 250, having a roughly θ shape that bisects the center.

[0183] Therefore, when the tape 260 divided according to the shapes of the ribs 132 a and 132 b is attached to the bottom surface of the lower case 250 , the divided tape 260 may be respectively inserted into the right opening 131 and the left opening 131 of the cover 130 .

[0184] Fig.18 The coupling of a needle assembly and a transmitter according to another embodiment of the present disclosure is shown.

[0185] Fig.18 (a) is a front perspective view showing the appearance of the needle assembly 170' before being coupled with the transmitter 200', Fig.18 (b) is a cross-sectional view showing the appearance of the needle assembly 170' coupled to the transmitter 200'.

[0186] refer to Fig.18(a), the needle assembly 170' according to another embodiment includes a needle 171' and a gripping portion 172'. In addition, the transmitter 200' according to another embodiment may further include a packaging portion 235'.

[0187] The packaging portion 235' is located within a cylindrical holder 230', which is located within the upper housing 210' and the lower housing 250'.

[0188] The packaging portion 235' is made of an elastic rubber material and seals the opening at the top of the holder 230'.

[0189] although Fig.18 2 , the packaging portion 235 ′ is shown as a separate component on the holder 230 ′, but the packaging portion 235 ′ may be formed integrally with the holder 230 ′ by double injection molding.

[0190] As described above, after the sterilization and assembly process is performed with needle 171' of needle assembly 170' passing through packaging portion 235' and the applicator is fired by the user, needle 171' inserted into retainer 230' is separated from retainer 230', and needle assembly 170' is retracted, and the portion through which needle 171' passes is sealed by the elasticity of rubber.

[0191] Therefore, when the transmitter 200' is attached and used, the portion through which the needle 171' passes is sealed by the packaging portion 235' to be exposed to the outside, and in particular, the hydrophobicity of the rubber material prevents the inflow of foreign matter such as water, thereby providing an effect of reducing the risk of infection.

[0192] Those skilled in the art will appreciate that the present invention as described above can be implemented in other specific forms without departing from its technical spirit or essential features. Therefore, it should be understood that the above embodiments are intended to be illustrative in all aspects, rather than restrictive. The scope of the present invention is represented by the attached claims to be described below rather than a detailed description, and should be interpreted as the meaning and scope of the attached claims and all changes or modifications derived from their equivalents are within the scope of protection of the present invention.

Claims

1. An insertion device assembly, comprising: Transmitter; and an applicator including said emitter mounted therein, Wherein, the transmitter includes: an upper housing; a lower housing coupled to the upper housing to form a receiving space therein; a sensor disposed on the lower housing; a hollow holder disposed at the center of the lower housing and disposed on the sensor; and Wherein, the applicator includes: an upper shell having an opening formed in a lower portion thereof and having a button on a periphery thereof; a cover configured to be mounted on or separated from the upper shell; a lower shell disposed inside the cover and coupled to the opening at the open lower portion of the upper shell to form an internal space with the upper shell; a needle assembly disposed in the internal space at an upper portion of the transmitter and configured to have at least a portion inserted into the retainer; a needle carrier disposed in the internal space and configured to cause the needle assembly to move linearly; and a drive unit configured to provide power to the needle carrier.

2. The insertion device assembly according to claim 1, in, The needle assembly includes a needle configured to pierce the skin of a user; a grip portion coupled to one end of the needle carrier; and a needle injection molded portion disposed between the needle and the grip portion and configured to be frictionally coupled to the retainer.

3. The insertion device assembly according to claim 2, in, When the insertion device assembly is assembled, the needle injection molded portion is coupled to the retainer, and When the insertion device assembly is in use, the needle injection molded portion is decoupled from the retainer.

4. The insertion device assembly according to claim 3, in, The cover includes: an opening formed on a lower surface thereof; a plurality of ribs, at least some of which are disposed in the lower housing and extend radially inward from an inner periphery of the cover; and a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle.

5. The insertion device assembly according to claim 4, in, The needle assembly further includes a cover injection molded portion having a shape corresponding to the shape of the upper surface of the needle accommodating portion and disposed on the upper surface of the needle accommodating portion, and The cover injection-molded portion contacts a lower surface of the lower housing.

6. The insertion device assembly according to claim 4, in, The plurality of ribs are two or more and are symmetrically arranged with respect to the center of the needle accommodating portion, The transmitter further includes an adhesive tape attached to the lower surface of the lower housing, the number of the adhesive tape being equal to the number of the plurality of ribs, and The tape is inserted through the opening.

7. The insertion device assembly according to claim 1, in, The transmitter further includes a PCB (Printed Circuit Board) accommodated in the accommodation space between the upper housing and the lower housing, and a dummy PCB connecting the sensor and the PCB.

8. The insertion device assembly according to claim 1, in, The launcher also includes a packaging portion located on the holder and made of an elastic material.

9. The insertion device assembly according to claim 2, in, The transmitter includes: a lower opening in the lower housing, a holder disposed in the lower opening; and an inclined rail having an inclined surface formed to be inclined downward from one side of the lower opening, a portion of the sensor being placed on the inclined surface.

10. The insertion device assembly according to claim 9, in, The insertion portion of the sensor is located in the needle passing through the holder, and Two bent portions are formed between one end and the other end of the sensor by the inclined surface and the needle, the two bent portions forming an obtuse angle.

11. An insertion device assembly comprising: Transmitter; and An applicator configured to mount the transmitter on in, The insertion device components are divided into first to fourth components according to the assembly sequence, and The first component includes: a cover including an open upper portion and an open lower portion; a lower shell disposed in the cover; a lower shell of the transmitter, the lower shell being disposed on at least a portion of the lower shell; a sensor disposed on the lower shell; a hollow retainer disposed at the center of the lower shell and disposed on the sensor; and a needle assembly disposed on the transmitter and configured to allow at least a portion thereof to be inserted into the retainer.

12. The insertion device assembly according to claim 11, in, The second component further includes, on the first component sterilized by electron beam: a PCB disposed on the lower housing; and an upper housing coupled to the lower housing to form a receiving space therein.

13. The insertion device assembly according to claim 12, in, The third component further includes on the second component: a needle carrier configured to linearly move the needle assembly; and a driving unit configured to provide power to the needle carrier.

14. The insertion device assembly according to claim 13, in, The fourth component further includes, on the third component: an adhesive tape attached to a lower surface of the lower housing; and a sealing portion configured to seal an open lower portion of the cover.

15. The insertion device assembly according to claim 13, in, The needle assembly includes a needle configured to pierce the skin of a user; a grip portion coupled to one end of the needle carrier; and a needle injection molded portion disposed between the needle and the grip portion and configured to be frictionally coupled to the retainer.

16. The insertion device assembly according to claim 15, in, The cover includes: a plurality of ribs, at least some of which are provided in the lower housing and extend radially inward from the inner periphery of the cover; a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle; and a cover injection molding portion having a shape corresponding to a shape of an upper surface of the needle accommodating portion and provided on the upper surface of the needle accommodating portion, and The cover injection-molded portion contacts a lower surface of the lower housing.

17. The insertion device assembly according to claim 16, in, The plurality of ribs are two or more and are symmetrically arranged with respect to the center of the needle accommodating portion, The transmitter further includes an adhesive tape attached to the lower surface of the lower housing, the number of the adhesive tape being equal to the number of the plurality of ribs, and The tape is inserted through the open lower portion of the cover.

18. An insertion device assembly comprising: Transmitter; and an applicator including said emitter mounted therein, The applicator includes: an upper shell having an opening formed at a lower portion thereof and having a button on an outer periphery thereof; a cover configured to be mounted on or separated from the upper shell, the upper and lower portions of the cover being open; a lower shell disposed inside the cover and coupled to the opening at the open lower portion of the upper shell to form an internal space with the upper shell; and a needle assembly including a needle configured to pass through the transmitter, Wherein, the cover includes: a plurality of ribs, at least some of which are arranged in the lower shell and extend radially inward from the inner periphery of the cover; a needle accommodating portion, which is supported by the plurality of ribs and configured to surround at least a portion of the needle; and a cover injection molding portion, which has a shape corresponding to the shape of the upper surface of the needle accommodating portion, is arranged on the upper surface of the needle accommodating portion, and contacts the lower surface of the transmitter.

19. The insertion device assembly according to claim 18, in, The plurality of ribs are two or more and are symmetrically arranged with respect to the center of the needle accommodating portion, The launcher further includes a tape attached to a lower surface of the launcher, the number of the tape being equal to the number of the plurality of ribs, and The tape is inserted through the open lower portion of the cover.

Citation Information

Patent Citations

  • Sensor inserter with disposal lockout state

    US20210038131A1

  • Body attachable unit for continuous blood glucose measurement

    US20210361197A1

  • Applicators for applying transcutaneous analyte sensors and associated methods of manufacture

    US20220322975A1