Insertion Device Assembly for Inserting Analyte Monitoring Device

Abstract

According to one embodiment of the present disclosure, an insertion device assembly is provided, comprising: a transmitter including an upper case; a lower case coupled to the upper case to form an internal receiving space; a sensor disposed on the lower case; and a hollow holder disposed in the center of the lower case and disposed on the sensor; and an applicator on which the transmitter is mounted, comprising an upper housing having an opening formed in the lower portion and a button provided on the outer surface; a cap configured to be mounted on or removed from the upper housing; a lower housing disposed inside the cap and coupled to the open lower opening of the upper housing to form an internal space with the upper housing; a needle assembly disposed on the upper portion of the transmitter in the internal space and configured such that at least a portion is inserted into the holder; a needle carrier disposed in the internal space and configured to cause the needle assembly to move linearly; and a driving unit configured to provide power to the needle carrier.

Description

Technology Field

[0001] The present disclosure relates to an insertion device assembly, and specifically to an insertion device assembly for inserting a device for monitoring analytes in the body. Background Technology

[0003] The content described in this section merely provides background information regarding the present disclosure and does not constitute prior art.

[0004] With the recent rise in preference for processed foods, people are easily exposed to simple sugars. Due to this environment, diabetes is also rapidly increasing. If blood sugar levels drop or rise sharply, diabetic patients may go into shock, and in rare cases, it can lead to death. For this reason, diabetic patients need to continuously monitor their blood sugar levels.

[0005] In the case of conventional blood glucose measuring devices, a lancet is used to make an incision in the fingertip, and the blood of a diabetic patient coming out through the incision is inserted into a blood glucose analyzer to calculate the blood glucose level.

[0006] This type of blood glucose meter causes pain and fear to the user. Furthermore, it is realistically difficult to cut one's finger and draw blood every hour.

[0007] To address these problems, a continuous glucose monitoring (CGM) system was developed. When a sensor with a fine thickness and an electronic device (hereinafter referred to as a "transmitter") for analyzing the analyte measured by the sensor (hereinafter referred to as "blood glucose") are attached to the skin of a diabetic patient, blood glucose is continuously measured for a period of one to ten days.

[0008] The sensor of the transmitter is very thin, making it difficult to penetrate the skin directly. Therefore, a configuration (hereinafter referred to as an "applicator") is required to insert a needle into the skin, insert the sensor through the gap, and withdraw the needle.

[0009] Meanwhile, according to US 2021-0038131 A1, the user must insert a sensor introducer (106) into a sensor inserter (500). At this time, the sensor introducer must be inserted into the sensor inserter while aligning its orientation, and there is a high risk that the user will experience fatigue during this process. Therefore, it is desirable for the insertion device assembly to have the applicator and transmitter configured as a single unit from the time of manufacturing.

[0010] In addition, according to US 2022-0322975 A1, the on-skin assembly (102) is assembled by being placed inside the applicator (100) without any sealing structure between the insertion assembly (118) and the sealing element (110), so there is a risk of exposure to contamination later.

[0011] In addition, in the US 2021-0361197 A1 document, a needle unit (550) in which a sensor unit (520) is housed is positioned through the upper and lower parts of a body attachable unit (20), but after the body attachable unit (20) is attached to the user's body and the needle unit (550) is removed, the penetrating part is left open, so there is a risk of water or foreign substances entering and causing infection.

[0012] Also, since the sensor probe (521), which is exposed to the outside of the body attachable unit (20) as one side of the sensor unit (520), and the sensor body unit (522), which is located inside the body attachable unit (20) as the other side of the sensor unit (520), are positioned by being folded at a right angle, there is a risk that the sensor unit (520), which is composed of a flexible film, may be damaged.

[0013] In addition, sterilization of applicators using sterilization gas takes a long time and there is a risk of residue remaining. For this reason, E-beams are sometimes applied when sterilizing medical devices, but in such cases, there is a risk of affecting electronic devices.

[0014] Furthermore, in the case of conventional applicators, it is difficult to inspect the interior during the assembly process. As a result, there is a concern that defective product inspection may not be properly carried out.

[0015] In addition, it is important to maintain the sterile condition after sterilizing the insertion device assembly. However, there is a problem in that double or triple packaging is used to maintain the sterile condition, which increases manufacturing costs and waste. The problem to be solved

[0017] Accordingly, the present disclosure aims to provide an insertion device assembly in which the applicator and transmitter are manufactured as a single unit and the preparation for use is simple.

[0018] In addition, the present disclosure aims to provide an insertion device assembly capable of preserving a sterile state by applying a double sealing structure between the applicator and the transmitter.

[0019] In addition, the present disclosure aims to provide an insertion device assembly that is free from the risk of failure even when sterilized using an E-beam method.

[0020] In addition, the present disclosure aims to provide an insertion device assembly capable of identifying defects during the manufacturing process.

[0021] In addition, the present disclosure aims to provide an insertion device assembly that is easy to manufacture by simplifying the sealing step for maintaining a sterile state.

[0022] Additionally, the present disclosure aims to provide an insertion device assembly capable of sealing the portion through which the needle penetrated after the needle is removed from the transmitter.

[0023] In addition, the present disclosure aims to provide an insertion device assembly that prevents damage to a sensor unit, which is one of the important components inserted into a user's body to analyze the concentration of an analyte in the body.

[0024] The problems that the present invention aims to solve are not limited to those mentioned above, and other unmentioned problems will be clearly understood by a person skilled in the art from the description below. means of solving the problem

[0026] According to one embodiment of the present disclosure, an insertion device assembly is provided, comprising: a transmitter including an upper case; a lower case coupled to the upper case to form an internal receiving space; a sensor disposed on the lower case; and a hollow holder disposed in the center of the lower case and disposed on the sensor; and an applicator on which the transmitter is mounted, comprising an upper housing having an opening formed in the lower portion and a button provided on the outer surface; a cap configured to be mounted on or removed from the upper housing; a lower housing disposed inside the cap and coupled to the open lower opening of the upper housing to form an internal space with the upper housing; a needle assembly disposed on the upper portion of the transmitter in the internal space and configured such that at least a portion is inserted into the holder; a needle carrier disposed in the internal space and configured to cause the needle assembly to move linearly; and a driving unit configured to provide power to the needle carrier.

[0027] Additionally, preferably, the needle assembly according to one embodiment of the present disclosure comprises: a needle configured to penetrate the skin of a user; a grip portion coupled to one end of the needle carrier; and a needle injection portion disposed between the needle and the grip portion and configured to frictionally engage with the holder.

[0028] Additionally, preferably, when assembling the insertion device assembly according to one embodiment of the present disclosure, the needle injection part is coupled to the holder, and when using the insertion device assembly, the needle injection part is withdrawn from the holder.

[0029] Additionally, preferably, according to one embodiment of the present disclosure, the cap comprises: an opening formed on the lower surface; a plurality of ribs, at least a portion of which is disposed inside the lower housing and extending from the inner circumference of the cap toward the radially inner side of the cap; and a needle receiving portion supported by the plurality of ribs and configured to surround at least a portion of the needle.

[0030] Additionally, preferably, the needle assembly according to one embodiment of the present disclosure further includes a cap injection portion disposed on the upper surface of the needle receiving portion, corresponding to the shape of the upper surface of the needle receiving portion, and the cap injection portion contacts the lower surface of the lower case.

[0031] Additionally, preferably, according to one embodiment of the present disclosure, the plurality of ribs are two or more and are symmetrically arranged around the needle receiving portion, and the transmitter is attached to the lower surface of the lower case and further includes an adhesive tape provided in a number equal to the number of the plurality of ribs, and the adhesive tape can be inserted through the opening.

[0032] Additionally, preferably, the transmitter according to one embodiment of the present disclosure further comprises a PCB (Printed Circuit Board) accommodated in the receiving space of the upper case and the lower case, and a dummy PCB connecting the sensor and the PCB.

[0033] Additionally, preferably, the transmitter according to another embodiment of the present disclosure further includes a packing portion located on the upper part of the holder and made of an elastic material.

[0034] Additionally, preferably, the transmitter according to one embodiment of the present disclosure comprises: a lower opening located in the lower case where the holder is located; and an inclined track formed to be inclined downward from one side of the lower opening, on which a part of the sensor is placed.

[0035] Additionally, preferably, the insertion portion of the sensor according to one embodiment of the present disclosure is located inside the needle penetrating the holder, and two bends are formed at an obtuse angle between one end and the other end of the sensor by the inclined surface and the needle.

[0036] According to one embodiment of the present disclosure, an insertion device assembly comprising a transmitter and an applicator configured to mount the transmitter, wherein the insertion device assembly is divided into a first assembly to a fourth assembly state according to the assembly order, the first assembly comprises: a cap with an open top and bottom; a lower housing disposed inside the cap; a lower case of a transmitter disposed on at least a portion of the lower housing; a sensor disposed on the lower case; a hollow holder disposed in the center of the lower case and disposed on the sensor; and a needle assembly disposed on the top of the transmitter and configured such that at least a portion is inserted into the holder.

[0037] Additionally, preferably, the second assembly according to one embodiment of the present disclosure further comprises: a PCB disposed on the lower case on the first assembly sterilized by an E-beam; and an upper case coupled to the lower case to form an internal receiving space.

[0038] Additionally, preferably, the third assembly according to one embodiment of the present disclosure further comprises: a needle carrier configured to move the needle assembly in a linear motion in the second assembly; and a driving unit configured to provide power to the needle carrier.

[0039] Additionally, preferably, the fourth assembly according to one embodiment of the present disclosure further comprises: an adhesive tape attached to the lower surface of the lower case on the third assembly; and a sealing portion configured to seal the open lower portion of the cap.

[0040] Additionally, preferably, the needle assembly according to one embodiment of the present disclosure comprises: a needle configured to penetrate the skin of a user; a grip portion coupled to one end of the needle carrier; and a needle injection portion disposed between the needle and the grip portion and configured to frictionally engage with the holder.

[0041] Additionally, preferably, the cap according to one embodiment of the present disclosure comprises: a plurality of ribs extending from the inner circumferential surface of the cap toward the radially inner side of the cap, at least a portion thereof disposed within the lower housing; a needle receiving portion supported by the plurality of ribs and configured to surround at least a portion of the needle; and a cap injection portion disposed on the upper surface of the needle receiving portion, corresponding to the shape of the upper surface of the needle receiving portion, wherein the cap injection portion contacts the lower surface of the lower case.

[0042] Additionally, preferably, according to one embodiment of the present disclosure, the plurality of ribs are two or more and are symmetrically arranged around the needle receiving portion, and the transmitter is attached to the lower surface of the lower case and further includes an adhesive tape provided in a number equal to the number of the plurality of ribs, and the adhesive tape can be inserted through the open lower portion of the cap.

[0043] Additionally, according to one embodiment of the present disclosure, an insertion device assembly is provided, comprising: a transmitter; an applicator on which the transmitter is mounted, the applicator comprising: an upper housing having an opening formed at the bottom and a button provided on the outer surface; a cap configured to be mounted or removed from the upper housing and having an open top and bottom; a lower housing disposed inside the cap and forming an internal space with the upper housing by being coupled to the open bottom opening of the upper housing; and a needle assembly comprising a needle configured to penetrate the transmitter; wherein the cap comprises: a plurality of ribs extending from the inner surface of the cap toward the radially inner side of the cap, at least a portion thereof disposed inside the lower housing; a needle receiving portion supported by the plurality of ribs and configured to surround at least a portion thereof; and a cap injection portion corresponding to the shape of the upper surface of the needle receiving portion and disposed on the upper surface of the needle receiving portion, and in contact with the lower surface of the transmitter.

[0044] Additionally, according to one embodiment of the present disclosure, the plurality of ribs are two or more and are symmetrically arranged around the needle receiving portion, and the transmitter is attached to the lower surface of the lower case and further includes adhesive tapes provided in the same number as the plurality of ribs, and the adhesive tapes can be inserted through the open lower portion of the cap. Effects of the invention

[0046] As described above, according to one embodiment of the present disclosure, the applicator and the transmitter are manufactured as a single unit, and when using the applicator, the needle protection component can be removed at once simply by removing the cap, thereby providing convenience to the user.

[0047] In addition, the double sealing structure of the insertion device assembly has the effect of keeping the inside of the needle and applicator in a sterile state.

[0048] In addition, according to one embodiment of the present disclosure, when assembling an insertion device assembly, the PCB is assembled after sterilization by an E-beam, so there is an effect that there is no risk of electronic devices mounted on the PCB failing.

[0049] In addition, since the cap is made of a transparent material, the seal between the cap injection part and the transmitter can be visually checked, which has the advantage of simplifying the inspection of defective products.

[0050] In addition, since only the sealing part needs to be attached to the bottom of the cap after the assembly of the insertion device assembly is completed, the sealing method is simple, which has the effect of being convenient during manufacturing.

[0051] In addition, an elastic packing is positioned in the part of the transmitter through which the needle penetrates, thereby sealing the penetrated area after the needle is removed, which has the effect of preventing the ingress of water or foreign substances and the resulting infection.

[0052] In addition, by installing the sensor using the track structure inside the transmitter case, the bending portion of the sensor is formed smoothly, thereby preventing damage to the sensor. Brief explanation of the drawing

[0054] FIG. 1 is a front perspective view of an insertion device assembly according to one embodiment of the present disclosure. FIG. 2 is an exploded perspective view of an insertion device assembly according to one embodiment of the present disclosure. FIG. 3 is an overall and exploded perspective view of a transmitter according to one embodiment of the present disclosure. FIG. 4 shows the interior of a cap according to one embodiment of the present disclosure. FIG. 5 is a front perspective view of a lower housing according to one embodiment of the present disclosure. FIG. 6 is a flowchart of a method for assembling an insertion device assembly according to one embodiment of the present disclosure. FIG. 7 shows the assembly sequence of an insertion device assembly according to one embodiment of the present disclosure. FIGS. 8 to 11 are intended to explain the state during the assembly step of an insertion device assembly according to one embodiment of the present disclosure. FIG. 12 is an overall perspective view of the connection structure of a PCB, a sensor, and a dummy PCB located inside a transmitter according to one embodiment of the present disclosure, viewed from below. FIG. 13 is an exploded perspective view of the connection structure of a PCB, a sensor, and a dummy PCB located inside a transmitter according to one embodiment of the present disclosure, viewed from below. FIGS. 14 and FIGS. 15 are perspective views showing a track structure of a lower case and a sensor installed thereon according to one embodiment of the present disclosure. FIGS. 16 and FIGS. 17 are cross-sectional views showing the shape of a sensor when the needle assembly is not coupled to a transmitter according to one embodiment of the present disclosure, and the shape of a sensor when the needle assembly is coupled to a transmitter, respectively. FIG. 18 is intended to illustrate the combination of a needle assembly and a transmitter according to another embodiment of the present disclosure. Specific details for implementing the invention

[0055] Some embodiments of the present disclosure are described in detail below with reference to the exemplary drawings. It should be noted that in assigning reference numerals to the components of each drawing, the same components are given the same reference numeral whenever possible, even if they are shown in different drawings. Furthermore, in describing the present disclosure, if it is determined that a detailed description of related known components or functions could obscure the essence of the present disclosure, such detailed description is omitted.

[0056] In describing the components of the embodiments according to the present disclosure, symbols such as first, second, i), ii), a), b), etc., may be used. These symbols are intended only to distinguish the components from other components, and the essence, order, or sequence of the components is not limited by the symbols. When a part in the specification is described as 'comprising' or 'having' a component, this means that, unless explicitly stated otherwise, it does not exclude other components but may include additional components.

[0057] In the present disclosure, "insertion device assembly" refers to an assembly in which an applicator and a transmitter are assembled.

[0058] Additionally, in this disclosure, "distal position" refers to a location that is relatively further from the skin than "proximal position." Meanwhile, distal and proximal are concepts regarding relative positions, and can be understood as an element being proximal to another element while simultaneously being distal.

[0059] Additionally, in the present disclosure, "fire" refers to the user's act of operating an applicator to insert a needle into the user's skin.

[0060] Additionally, in the present disclosure, "retraction" refers to the process of the needle returning to its original position after being inserted through the user's skin.

[0061] Additionally, in this disclosure, "upward" means a direction from proximal to distal.

[0062] Additionally, in this disclosure, "downward" means a direction from the distal to the proximal.

[0063] Additionally, in this disclosure, "horizontal" refers to a plane that the applicator contacts when the applicator is used, and may mean a skin surface. In this disclosure, curvature of the skin surface is not considered, and the description assumes that the user's skin surface is flat.

[0065] 1. Description of the Applicator

[0066] 1.1 Structure of the applicator

[0067] FIG. 1 is a front perspective view of an insertion device assembly according to one embodiment of the present disclosure.

[0068] Specifically, FIG. 1a shows the state with the cap (130) mounted, and FIG. 1b shows the state with the cap (130) removed.

[0069] An applicator (100) according to one embodiment of the present disclosure includes an upper housing (110), a button (120) configured to be inserted into and press-fitted into the outer surface of the upper housing (110), and a cap (130) that can be detachably attached to the upper housing (110) (see FIG. 1a).

[0070] When the cap (130) of the applicator (100) is removed from the upper housing (110), a portion of the lower housing (140) is exposed (see FIG. 1b). With the cap (130) removed, the insertion device assembly becomes ready for use by a user.

[0072] FIG. 2 is an exploded perspective view of an insertion device assembly according to one embodiment of the present disclosure.

[0073] Referring to FIG. 2, an applicator (100) according to one embodiment of the present disclosure may include, in addition to an upper housing (110), a button (120), a cap (130) and a lower housing (140), all or part of a driving part (150), a needle carrier (160), a needle assembly (170), a transmitter holder (180), a desiccant (190), and a sealing part (191).

[0074] The upper housing (110) is configured to be held by a user and is preferably approximately cylindrical in shape. Meanwhile, the lower part of the upper housing (110) is open.

[0075] The button (120) is positioned and provided on the outer surface of the upper housing (110) and configured to be pressed toward the inside of the upper housing (110).

[0076] The cap (130) is configured to be mounted on or removed from the upper housing (110) and can protect the interior of the applicator (100) from external contaminants or impacts. The cap (130) is preferably approximately cylindrical in shape.

[0077] The lower housing (140) is positioned inside the cap (130). The lower housing (140) is configured to form a space inside by being coupled to the lower part of the upper housing (110). When the applicator (100) is used, the lower housing (140) is configured to come into direct contact with the user's skin.

[0078] The driving unit (150) is disposed in the internal space formed by the upper housing (110) and the lower housing (140). The driving unit (150) is configured to move the transmitter (200) and the needle assembly (170) in a straight line along the longitudinal direction of the applicator (100). To this end, the driving unit (150) includes all or part of a spring (151), a wheel (152), and a locking member (153).

[0079] 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, the spring (151) is preferably a wound reel spring. The spring (151) is assembled by being compressed in an initial state. Meanwhile, when the fastening part that fixed the compression of the spring (151) is released by the pressure of the button (120), the spring (151) can be tensioned to return to its original state. As a result, one end of the spring (151) rotates. That is, the principle of a kind of Scotch yoke or double slider crank mechanism may be applied, in which the rotational movement of the spring (151) is converted into the straight movement of the needle carrier (160) and the needle assembly (170).

[0080] One side of the wheel (152) is connected to one end of the spring (151) and configured to rotate together with the rotation of the spring (151). A groove for connection with a locking member (153) may be formed on the outer surface of the wheel (152).

[0081] One end of the locking member (153) is connected to the button (120), and the other end is configured to be connected to the wheel (152). At this time, a groove is formed in the other end of the locking member (153) so that it can engage with the groove of the wheel (152). As a result, rotation of the wheel (152) is prevented, and furthermore, tension of the spring (151) is prevented.

[0082] When the button (120) moves toward the inside of the applicator (100), the locking member (153) also moves in conjunction with it. As a result, the connection between the other end of the locking member (153) and the groove of the cap (130) is released, and the wheel (152) can rotate together due to the tension and rotation of the spring (151).

[0083] The needle carrier (160) is configured to move linearly within the upper housing (110) and the lower housing (140). At this time, the linear movement of the needle carrier (160) can be induced by the rotational movement of the drive unit (150). To this end, it is preferable that the needle carrier be in the shape of the letter T overall. The needle carrier (160) can be subordinate to the rotational movement of the drive unit (150) by being coupled to the other side of the wheel (152).

[0084] The needle assembly (170) is disposed in the internal 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 configured to move linearly together with the linear movement of the needle carrier (160).

[0085] The needle assembly (170) includes all or part of the needle (171), grip portion (172), and needle injection portion (173).

[0086] The needle (171) is configured to penetrate the user's skin.

[0087] The grip portion (172) is configured to be coupled to the lower portion of the needle carrier (160). The needle (171) and the grip portion (172) may be formed as a single unit, and while it is preferable that the entire unit be made of metal, it is not necessarily limited thereto.

[0088] The needle injection portion (173) is positioned between the needle (171) and the grip portion (172). The needle injection portion (173) is formed from a material different from that of the needle (171) and the grip portion (172), and preferably may be rubber. To this end, it is preferable that the needle injection portion (173) be double-injected during the manufacture of the needle assembly (170).

[0089] Meanwhile, when manufacturing the insertion device assembly, the needle injection part (173) is inserted into the interior of the transmitter (200). At this time, the needle injection part (173) is formed of rubber so that a sealed structure can be formed with the transmitter (200). This is explained in detail in FIGS. 7 and 8.

[0090] In one embodiment of the present disclosure, the needle assembly (170) can be prevented from rotating when coupled with the transmitter (200) through the needle injection part (173).

[0091] Meanwhile, according to another embodiment of the present disclosure, instead of a separate needle injection part being provided in the needle assembly (170'), at least a portion of the upper surface of the transmitter (200') is formed as an elastic part so that when the needle (171') is coupled with the upper case (210') of the transmitter (200'), a sealed structure is formed while preventing rotation of the needle (171') (see FIG. 18). This is described in detail in FIG. 18.

[0092] The transmitter holder (180) is placed in the internal space formed by the upper housing (110) and the lower housing (140). The transmitter holder (180) is coupled with the transmitter (200) and configured to move the transmitter (200) in a linear motion from distal to proximal. The transmitter holder (180) is pressed from distal to proximal by the needle carrier (160). Meanwhile, the transmitter holder (180) does not move from proximal to distal and can only move from distal to proximal.

[0093] The dehumidifier (190) is inserted into the interior of the cap (130) through the bottom surface of the cap (130) and is configured to dehumidify the interior of the applicator (100).

[0094] The sealing portion (191) is attached to the open bottom surface of the cap (130) and is configured to shield the inside and outside of the applicator (100).

[0096] FIG. 3 is an overall perspective view and an exploded perspective view of a transmitter according to one embodiment of the present disclosure.

[0097] A transmitter (200) according to one embodiment of the present disclosure is configured to be attached to a user's skin to analyze the concentration of an analyte in the user's body and to transmit information related to the concentration to an external device. The transmitter (200) may be manufactured by being inserted into the interior of an applicator (100) during the production stage of an insertion device assembly.

[0098] Referring to FIG. 3, the transmitter (200) includes all or part of an upper case (210), a PCB (220), a holder (230), a sensor (240), a dummy PCB (245), a lower case (250), and an adhesive tape (260), and the detailed configuration is described in FIG. 12 to 17.

[0100] FIG. 4 shows the interior of a cap according to one embodiment of the present disclosure.

[0101] Referring to FIG. 4, a cap (130) according to one embodiment of the present disclosure may be composed of one or more materials including ABS (Acrylonitrile butadiene styrene copolymer) resin, PC (Polycarbonate) resin, and PE (Polyethylene) resin, but any material commonly used in medical devices such as applicators 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.

[0102] The cap (130) includes all or part of an opening (131), ribs (132a, 132b), a needle receiving portion (133), a cap injection portion (134), and connecting protrusions (135a, 135b, 135c, 135d).

[0103] An opening (131) is formed on the bottom surface of the cap (130).

[0104] The ribs (132a, 132b) are formed extending radially inward from the inner surface of the cap (130). According to one embodiment of the present disclosure, two ribs (132a, 132b) are formed symmetrically, but are not necessarily limited thereto, and the number and shape thereof may be appropriately changed according to the designer's choice.

[0105] As the ribs (132a, 132b) are arranged along the diameter of the cap (130), the cap (130) may be bisected when viewed from the bottom or top surface. That is, the cap (130) may be approximately θ-shaped.

[0106] The needle receiving portion (133) is formed at the center of the diameter of the cap (130) and is formed to receive a needle (171). To this end, the needle receiving portion (133) may be in the shape of a cylinder with an open top surface and containing a receiving space inside.

[0107] The needle receiving portion (133) is supported by a rib (132a) and another rib (132b).

[0108] Since the needle receiving portion (133) is formed integrally with the cap (130), the needle protection component can be removed at once by simply removing the cap (130) when using the applicator (100), which has the advantage of being convenient for the user.

[0109] The cap injection portion (134) is formed on the upper surface of the needle receiving portion (133) and contacts the lower surface of the lower case (250) of the transmitter (200). Meanwhile, the cap injection portion (134) may be formed by double injection on the needle receiving portion (133) during the manufacturing stage of the cap (130), but is not necessarily limited thereto.

[0110] Meanwhile, when manufacturing the insertion device assembly, the cap injection part (134) comes into contact with the bottom surface of the transmitter (200). At this time, the cap injection part (134) is formed of rubber, thereby forming a sealed structure with the transmitter (200). This is explained in detail in FIGS. 7 and 8.

[0111] One or more coupling protrusions (135a, 135b, 135c, 135d) are formed to protrude radially inward from the inner surface of the cap (130). One or more coupling protrusions (135a, 135b, 135c, 135d) are configured to be coupled to the outer surface of the lower housing (140). In this regard, reference is made to FIG. 5.

[0113] FIG. 5 is a front perspective view of a lower housing according to one embodiment of the present disclosure.

[0114] Referring to FIG. 5, a lower housing (140) according to one embodiment of the present disclosure includes one or more coupling grooves (141a, 141b) formed on the outer surface.

[0115] The coupling grooves (141a, 141b) are formed by being recessed radially inward from the outer surface of the lower housing (140), and coupling protrusions (135a, 135b, 135c, 135d) can be mounted and coupled thereto. At this time, the number of coupling grooves (141a, 141b) is equal to the number of coupling protrusions (135a, 135b, 135c, 135d). Meanwhile, although the present disclosure is illustrated as if two coupling grooves (141a, 141b) are formed, it should be noted that two additional coupling grooves are formed on the unseen side.

[0116] A guide groove (142a, 142b) may be further formed on one side of the coupling groove (141a, 141b). The guide groove (142a, 142b) is formed by being recessed radially inward from the outer surface of the lower housing (140) and extends along the height direction of the lower housing (140). Meanwhile, it is preferable that the width of the coupling groove (141a, 141b) be formed to be larger than the width of the coupling projection (135a, 135b, 135c, 135d). As a result, the coupling projection (135a, 135b, 135c, 135d) can move up and down within the coupling groove (141a, 141b).

[0117] In one exemplary case, the guide grooves (142a, 142b) may be formed continuously to the left of the coupling grooves (141a, 141b). In this case, the coupling projections (135a, 135b, 135c, 135d) are coupled to the coupling grooves (141a, 141b), then 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 they can be removed to the outside of the lower housing (140). That is, the user can release the coupling between the cap (130) and the lower housing (140) by rotating the cap (130) to the right along the outer surface of the lower housing (140) and then moving the cap (130) downward along the height direction of the lower housing (140).

[0118] Meanwhile, according to one embodiment of the present disclosure, the lower housing (140) and the cap (130) may be connected or disconnected through connecting protrusions (135a, 135b, 135c, 135d) and connecting grooves (141a, 141b), but are not necessarily limited thereto. For example, the lower housing (140) and the cap (130) may be connected by means such as hook connection or screw connection. Alternatively, the two may be connected by an opening and closing method of a wing member (not shown) provided on either the cap (130) or the lower housing (140) and a locking member (not shown) provided on the other.

[0120] 1.2. Method of assembling the applicator

[0121] FIG. 6 is a flowchart of a method for assembling an insertion device assembly according to one embodiment of the present disclosure. FIG. 7 shows the assembly sequence of an insertion device assembly according to one embodiment of the present disclosure. FIG. 8 to 11 are for explaining the state during the assembly step of an insertion device assembly according to one embodiment of the present disclosure.

[0122] Referring to FIGS. 6 to 11, a method for assembling and sterilizing an insertion device assembly according to one embodiment of the present disclosure will be described.

[0123] First, the cap (130), lower case (250), sensor (240), holder (230), needle assembly (170), and lower housing (140) are assembled in that order (S610, FIG. 7 (a)). Hereinafter, the assembly of the cap (130), lower case (250), sensor (240), holder (230), needle assembly (170), and lower housing (140) is referred to as the first assembly (ASSY 1).

[0124] The first assembly (ASSY 1) is illustrated in FIG. 8. FIG. 8 (a) is a front perspective view of the first assembly (ASSY 1), and FIG. 8 (b) is a cross-sectional view of the first assembly (ASSY 1). Referring to FIG. 8 (b), a needle injection part (173) is pressed into the interior of the holder (230), and the two are frictionally coupled. The needle injection part (173) can prevent contaminants from entering the needle (171) through the holder (230). Meanwhile, when the needle assembly (170) retracts after the applicator (100) is fired by the user, the transmitter (200) remains in the circular position. Accordingly, the needle injection part (173) that was inserted into the holder (230) is removed from the holder (230).

[0125] Additionally, the cap injection part (134) comes into contact with the bottom surface of the lower case (250) and forms a sealed structure. At this time, due to the combination of the cap (130) and the lower housing (140), the cap injection part (134) can be supported while in contact with the bottom surface of the lower case (250).

[0126] It is preferable that at least a portion of the cap (130) be formed of a transparent material. This allows the seal between the cap injection part (134) and the transmitter (200) to be visually confirmed, which has the advantage of making it easy to inspect for any defective products that are not sealed.

[0127] According to the above description, the insertion device assembly according to one embodiment of the present disclosure has the advantage that the interior of the insertion device assembly can be protected from contaminants by forming a double sealing structure during assembly. In the case of the needle (171), since it is a part that directly penetrates the user's skin, it is very important to maintain a sterile state, and the double sealing structure of the insertion assembly according to the present disclosure is highly effective in maintaining such a sterile state.

[0129] Subsequently, the first assembly (ASSY 1) is sterilized by irradiating it with an E-beam (S620). Since the PCB (220) has electronic devices mounted on it, there is a risk that some functions may be lost if it is directly exposed to an E-beam. Meanwhile, according to the present disclosure, sterilization by the E-beam is performed in the state of the first assembly (ASSY 1) without the PCB (220) being assembled, so there is no risk that the electronic devices mounted on the PCB (220) will malfunction.

[0131] A PCB (220), an upper case (210), and an adhesive tape (260) are assembled to the first assembly (ASSY 1) (S630, (b) of FIG. 7). Hereinafter, the assembly formed according to step S630 is referred to as the second assembly (ASSY 2).

[0132] The second assembly (ASSY 2) is illustrated in FIG. 9. FIG. 9 (a) is a front perspective view of the second assembly (ASSY 2), and FIG. 9 (b) is a cross-sectional view of the second assembly (ASSY 2).

[0133] Referring to FIG. 9 (a) and (b), the upper case (210) is combined with the lower case (250). At this time, the upper case (210) and the lower case (250) can be combined by either ultrasonic welding or UV bonding.

[0135] Subsequently, a needle carrier (160) and a drive unit (150) are assembled to the second assembly (ASSY 2) (S640, (c) of FIG. 7). Meanwhile, FIG. 7, FIG. 10, and FIG. 11 show only the needle carrier (160) being coupled, but this is for convenience of explanation and should be understood as the drive unit (150) coupled to the needle carrier (160) also being assembled together. Hereinafter, the assembly formed according to step S640 is referred to as the third assembly (ASSY 3).

[0136] The third assembly (ASSY 3) is illustrated in FIG. 10. FIG. 10 (a) is a bottom perspective view of the third assembly (ASSY 3), and FIG. 10 (b) is a cross-sectional view of the third assembly (ASSY 3).

[0137] Referring to FIG. 10 (a), the opening (131) of the cap (130) is still open.

[0138] Additionally, referring to FIG. 10(b), the needle carrier (160) and the needle assembly (170) can be joined by connecting the connecting arm (161) formed at the bottom of the needle carrier (160) and the grip portion (172) of the needle assembly (170). At this time, a snap-fit ​​method may be adopted for connecting the connecting arm (161) and the grip portion (172), but it is not necessarily limited to this, and a screw connection or the like may be adopted instead.

[0140] Afterwards, an adhesive tape (260), a desiccant (190), and a sealing part (191) are sequentially attached to the third assembly (ASSY 3) (S650, (d) of FIG. 7). Hereinafter, the assembly formed according to step S650 is referred to as the fourth assembly (ASSY 4).

[0141] The fourth assembly (ASSY 4) is illustrated in FIG. 11. FIG. 11 (a) is a bottom perspective view of the fourth assembly (ASSY 4), and FIG. 11 (b) is a cross-sectional view of the fourth assembly (ASSY 4).

[0142] Referring to Fig. 11 (b), an adhesive tape (260) is attached to the bottom surface of the lower case (250). At this time, as previously described, the adhesive tape (260) can be inserted through the right and left openings (131) of the cap (130) respectively, in a divided state.

[0143] When the adhesive tape (260) is attached, a desiccant (190) is inserted into the cap (130), and the cap (130) is sealed by the sealing portion (191).

[0144] Meanwhile, according to one embodiment of the present disclosure, the insertion device assembly has the advantage of being easy to seal because, when assembled, only the sealing portion (191) needs to be attached to the lower part of the cap (130).

[0146] Meanwhile, in the present disclosure, after the assembly of the fourth assembly (ASSY 4), an upper housing (110) equipped with a button (120) is further assembled, but related descriptions or detailed drawings are omitted in the present disclosure.

[0148] 1.3. Sterilization Test Results of Applicator and Transmitter

[0149] As a result of sterilizing an insertion device assembly according to one embodiment or another embodiment of the present disclosure, it was confirmed that no proliferation of microorganisms was observed.

[0150] Specifically, the test method was performed in accordance with ISO11737-2:2019, Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of sterilization process.

[0151] In addition, instruments and equipment such as incubators, low-temperature incubators, high-pressure steam sterilizers, and clean benches were used.

[0152] In addition, the samples were cultured in soybean casein digestion medium (TSB) for 14 days at 30 to 35 ℃ and for 14 days at 20 to 25 ℃ for a total of 28 days.

[0153] At this time, when the irradiation dose of the E-beam was 25 kGy and 35 kGy, the proliferation of microorganisms was checked after culturing the microorganisms, respectively.

[0154] As a result of testing using the experimental method described above, it was confirmed that microorganisms did not proliferate in all cases where the irradiation dose of the E-beam was 25 kGy and 35 kGy. In other words, it can be seen that when the assembly and sterilization method of the insertion device assembly according to the embodiments of the present disclosure is adopted, the sterilization and prevention of contamination from external contaminants are very excellent.

[0156] 2. Description of the Transmitter

[0157] Hereinafter, with reference to the attached FIG. 3 and FIG. 12 to 17, the configuration of a transmitter (200) of an insertion device assembly according to one embodiment of the present disclosure will be described in detail.

[0158] As described above, FIG. 3 is an overall perspective view and an exploded perspective view of a transmitter (200) according to one embodiment of the present disclosure.

[0159] Referring to FIG. 3, the transmitter (200) includes all or part of an upper case (210), a PCB (220), a holder (230), a sensor (240), a dummy PCB (245), a lower case (250), and an adhesive tape (260).

[0160] The upper case (210) and the lower case (250) are joined vertically to form the exterior of the transmitter (200), and a predetermined receiving space is formed inside the transmitter (200).

[0161] An upper through hole (211) is formed in the center of the upper case (210), and a lower through hole (251) is formed in the center of the lower case (250).

[0162] A cylindrical holder (230) is positioned between the upper through hole (211) and the lower through hole (251), and the needle (171) can be positioned to penetrate the upper case (210) and the lower case (250) while the needle injection part (173) is pressed into the holder (230).

[0163] The PCB (220) is a printed circuit board and is housed in the internal housing space of the upper case (210) and the lower case (250). Each electronic component is mounted on the PCB (220) to analyze the concentration of analytes in the user's body detected by the sensor (240) and to transmit information related to the concentration to an external device.

[0164] The sensor (240) is located at the bottom of the holder (230) in the receiving space inside the transmitter (200).

[0165] One side of the sensor (240) extends to the outside of the transmitter (200) through the lower through hole (251) of the transmitter (200) and is placed within the needle (171) and inserted into the user's body by firing, while the other side is connected to the lower part of the PCB (220) inside the transmitter (200).

[0166] In the following, the part that is inserted into the user's body from the outside of the transmitter (200) may be called the insertion part, and the part that is connected to the PCB (220) from the inside of the transmitter (200) may be called the connection part.

[0167] A dummy PCB (245) is described with reference to FIGS. 12 and FIGS. 13. FIGS. 12 and FIGS. 13 are an overall perspective view and an exploded perspective view of the connection structure of the PCB (220), sensor (240), and dummy PCB (245) viewed from below.

[0168] A dummy PCB (245) is located between the sensor (240) and the PCB (220). The dummy PCB (245) is composed of a small printed circuit board and electrically connects the electronic components mounted on the sensor (240) and the PCB (220).

[0169] Unlike the PCB (220), the dummy PCB (245) does not have components mounted on it, and is configured to include only printed circuits for electrically connecting the sensor (240) and the PCB (220).

[0170] With reference to FIGS. 12 and 13, the dummy PCB (245) is located on the lower part of the PCB (220) and on the upper part of the sensor (240), and one side thereof contacts the connection part of the sensor (240), and the other side contacts the contact part on the periphery side of the PCB (220), thereby physically and electrically connecting the sensor (240) and the PCB (220).

[0171] The sensor (240) and the dummy PCB (245) are connected by ultrasonic welding or ACF (Anisotropic Conductive Film) bonding, and the dummy PCB (245) and the PCB (220) can be connected by soldering.

[0172] FIGS. 14 and 15 are perspective views of a lower case (250), showing a track structure located on the inner surface of the lower case (250) and a sensor (240) installed thereon.

[0173] Referring to FIG. 14, a fixed track (252) is located on the upper surface of the lower case (250).

[0174] The fixed track (252) is formed such that one side of the lower case (250) is concavely stepped in a shape corresponding to the connection side of the sensor (240), and the sensor (240) can be fixedly installed on the lower case (250) by fitting the connection side of the sensor (240) to the fixed track (252).

[0175] An inclined track (253) is located on one side of the fixed track (252). The inclined track (253) is formed in a shape that is inclined toward the lower side of the lower through hole (251) of the fixed track (252).

[0176] Referring to FIG. 15, when the sensor (240) is fitted to the fixed track (252), the portion between the connecting part and the insertion part of the sensor (240) is placed on the inclined track (253).

[0177] FIG. 16 is a cross-sectional view showing the shape of the sensor (240) when the needle assembly (170) is not coupled to the transmitter (200), and FIG. 17 is a cross-sectional view showing the appearance of the sensor (240) when the needle assembly (170) is coupled to the transmitter (200).

[0178] Referring to FIGS. 16 and 17, the portion between the connecting part and the insertion part of the sensor (240) is placed on the inclined track (253), so that the sensor (240), which extends to the outside of the lower housing through the lower through hole (251), forms a first bent portion (241) that is bent at an obtuse angle with respect 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 part, is received inside the needle (171) and forms a second bent portion (242) that is bent at an obtuse angle. That is, the middle part of the sensor (240) is not directly bent at a right angle, but rather two bent portions that form an obtuse angle are formed between the one end and the other end of the sensor (240), and the one end and the other end of the sensor (240) form a right angle with the two bent portions formed in this way in between.

[0179] Meanwhile, for convenience of explanation in the present disclosure, the bent portions (241, 242) are depicted as being formed by discontinuous surfaces, but it should be noted that they may be in a shape that is continuously bent.

[0180] Since the sensor (240) is made of a flexible film, it can be folded, but when folded at a small angle, the electrode of the sensor (240) or the material sputtered on the sensor (240) may be damaged by cracks. By forming two folded portions on the sensor (240) in this way, damage to the film constituting the sensor (240) and the material sputtered on the film can be prevented.

[0181] Additionally, before the needle (171) is assembled to the sensor (240), the sensor (240) forms a predetermined angle downward by the first bending portion (241), so that the assembly of the needle (171) which is coupled to the upper part of the sensor (240) through the lower part from the upper part of the transmitter (200) is easy.

[0182] In addition, the tension applied to the electrode can be reduced while the sensor is inserted into and fixed to the user's skin.

[0183] The adhesive tape (260) is located on the bottom surface of the lower case (250) and allows the transmitter (200) to be adhered to and fixed on the user's skin.

[0184] An opening is formed in the central part of the adhesive tape (260) so that a sensor (240) extending from the lower case (250) can pass through and be positioned.

[0185] Referring again to FIG. 3, the adhesive tape (260) is divided and configured according to the position and number of ribs (132a, 132b) formed inside the cap of the applicator.

[0186] In this embodiment, since two ribs (132a, 132b) are arranged along the diameter of the cap (130), the cap (130) is configured in a roughly θ shape in a bisected form when viewed from the bottom or top surface, so the adhesive tape (260) is also configured on the bottom surface of the lower case (250) in a bisected θ shape with the center divided.

[0187] Thus, with the adhesive tape (260) divided according to the shape of the ribs (132a, 132b) attached to the bottom surface of the lower case (250), it can be inserted through the right and left openings (131) of the cap (130), respectively.

[0189] FIG. 18 is intended to illustrate the combination of a needle assembly and a transmitter according to another embodiment of the present disclosure.

[0190] FIG. 18 (a) is a front perspective view showing the needle assembly (170') before being combined with the transmitter (200'), and FIG. 18 (b) is a cross-sectional view showing the needle assembly (170') combined with the transmitter (200').

[0191] Referring to FIG. 18 (a), a needle assembly (170') according to another embodiment is composed of a needle (171') and a grip portion (172'). Additionally, a transmitter (200') according to another embodiment may further include a packing portion (235').

[0192] The packing portion (235') is located inside a cylindrical holder (230') located within the upper case (210') and the lower case (250').

[0193] The packing portion (235') is made of an elastic rubber material and seals the opening at the top of the holder (230).

[0194] In FIG. 18, the packing portion (235') is shown as being located on the upper part of the holder (230') as a separate component, but it can be manufactured integrally with the holder (230') by double injection molding.

[0195] As described above, the sterilization and assembly process proceeds with the needle (171') of the needle assembly (170') penetrating the packing portion (235'), and after the applicator is fired by the user, the needle assembly (170') retracts, the needle (171') inserted into the holder (230') is removed from the holder (230'), and the portion through which the needle (171') penetrated is closed by the elasticity of the rubber.

[0196] Thus, when the transmitter (200') is attached and used, the part through which the needle (171') penetrates is closed by the packing part (235') and is not exposed to the outside. In particular, the hydrophobicity of the rubber material prevents foreign substances such as water from entering, thereby reducing the risk of infection.

[0197] The above description is merely an illustrative explanation of the technical concept of the present embodiment, and a person skilled in the art to which the present embodiment belongs would be able to make various modifications and variations within the scope of the essential characteristics of the present embodiment. Accordingly, the present embodiments are intended to explain, not limit, the technical concept of the present embodiment, and the scope of the technical concept of the present embodiment is not limited by these embodiments. The scope of protection of the present embodiment shall be interpreted by the claims below, and all technical concepts within an equivalent scope shall be interpreted as being included within the scope of rights of the present embodiment. Explanation of the symbols

[0199] 100: Applicator 110: Upper housing 120: Button 130: Cap 140: Lower housing 150: Drive unit 160: Needle Carrier 170,170': Needle Assembly 180: Transmitter holder 190: Dehumidifier 191: Ceiling part 200, 200': Transmitter 210, 210': Upper case 220: PCB 230, 230': Holder 235': Packing section 240: Sensor 245: Dummy PCB 250, 250': Lower case 252: Fixed Track 253: Inclined track 260: Adhesive tape

Claims

Claim 1 A transmitter comprising: an upper case; a lower case coupled to the upper case to form an internal receiving space; a sensor disposed on the lower case; and a hollow holder disposed in the center of the lower case and disposed on the sensor; and an applicator on which the transmitter is mounted, comprising: an upper housing having an opening formed at the bottom and a button provided on the outer surface; a cap configured to be mounted on or removed from the upper housing and including a needle receiving portion configured to surround at least a portion of a needle; a lower housing disposed inside the cap and coupled to the open lower opening of the upper housing to form an internal space with the upper housing; a needle assembly disposed above the transmitter in the internal space and configured such that at least a portion is inserted into the holder; a needle carrier disposed in the internal space and configured to cause the needle assembly to move linearly; and a driving unit configured to provide power to the needle carrier; wherein the needle assembly comprises: a needle configured to penetrate the user's skin; and a grip portion coupled to one end of the needle carrier. An insertion device assembly comprising: a needle injection portion disposed between the needle and the grip portion and configured to frictionally engage with the holder; and a cap injection portion disposed on the upper surface of the needle receiving portion; wherein the cap injection portion contacts the lower surface of the lower case to form a sealing structure between the transmitter and the needle receiving portion. Claim 2 delete Claim 3 An insertion device assembly according to claim 1, wherein when the insertion device assembly is assembled, the needle injection part is coupled to the holder, and when the insertion device assembly is used, the needle injection part is withdrawn from the holder. Claim 4 In paragraph 3, the cap comprises an opening formed on the lower surface; and a plurality of ribs, at least a portion of which is disposed inside the lower housing and extends from the inner circumferential surface of the cap toward the radially inner side of the cap; and the needle receiving portion is supported by the plurality of ribs, an insertion device assembly. Claim 5 In paragraph 4, the above-mentioned cap injection portion has a shape corresponding to the shape of the upper surface of the above-mentioned needle receiving portion, an insertion device assembly. Claim 6 An insertion device assembly according to claim 4, wherein the plurality of ribs are two or more and are symmetrically arranged around the needle receiving portion, and the transmitter is attached to the lower surface of the lower case and further includes adhesive tapes provided in the same number as the plurality of ribs, and the adhesive tapes can be inserted through the opening. Claim 7 The insertion device assembly according to claim 1, wherein the transmitter further comprises a PCB (Printed Circuit Board) accommodated in the receiving space of the upper case and the lower case, and a dummy PCB connecting the sensor and the PCB. Claim 8 An insertion device assembly according to claim 1, wherein the transmitter further comprises a packing portion located on the upper part of the holder and composed of an elastic material. Claim 9 An insertion device assembly according to claim 1, wherein the transmitter comprises: a lower opening located in the lower case where the holder is located; and an inclined surface formed to be inclined downward from one side of the lower opening, on which a part of the sensor is placed. Claim 10 An insertion device assembly according to claim 9, wherein the insertion portion of the sensor is located inside the needle penetrating the holder, and two bending portions forming an obtuse angle are formed between one end and the other end of the sensor by the inclined surface and the needle. Claim 11 An insertion device assembly comprising a transmitter and an applicator configured to mount the transmitter, wherein the insertion device assembly is divided into a first assembly to a fourth assembly state according to the assembly order, the first assembly comprises: a cap having a needle receiving portion configured to surround at least a portion of a needle, with the top and bottom open; a lower housing disposed inside the cap; a lower case of a transmitter disposed on at least a portion of the lower housing; a sensor disposed on the lower case; a hollow holder disposed in the center of the lower case and disposed on the sensor; and a needle assembly disposed on the upper part of the transmitter and configured such that at least a portion is inserted into the holder; wherein the needle assembly comprises: a needle configured to penetrate the skin of a user; a grip portion coupled to one end of the needle carrier; and a needle injection portion disposed between the needle and the grip portion and configured to frictionally engage with the holder. An insertion device assembly comprising: a cap injection portion disposed on the upper surface of the needle receiving portion; wherein the cap injection portion contacts the lower surface of the lower case to form a sealing structure between the transmitter and the needle receiving portion. Claim 12 In claim 11, the insertion device assembly further comprises: a PCB disposed on the lower case of the first assembly sterilized by an E-beam; and an upper case coupled to the lower case to form an internal receiving space. Claim 13 In claim 12, the insertion device assembly further comprises: a needle carrier configured to move the needle assembly in a linear motion in the second assembly; and a driving unit configured to provide power to the needle carrier. Claim 14 In claim 13, the insertion device assembly further comprises: an adhesive tape attached to the lower surface of the lower case on the third assembly; and a sealing portion configured to seal the open lower portion of the cap. Claim 15 delete Claim 16 An insertion device assembly according to claim 11, wherein the cap comprises a plurality of ribs extending from the inner circumferential surface of the cap toward the radially inner side of the cap, at least a portion thereof disposed inside the lower housing, and the needle receiving portion is supported by the plurality of ribs, and the cap injection portion has a shape corresponding to the shape of the upper surface of the needle receiving portion. Claim 17 An insertion device assembly according to claim 16, wherein the plurality of ribs are two or more and are symmetrically arranged around the needle receiving portion, and the transmitter is attached to the lower surface of the lower case and further comprises adhesive tapes provided in the same number as the plurality of ribs, and the adhesive tapes can be inserted through the open lower portion of the cap. Claim 18 An insertion device assembly comprising: a transmitter; and an applicator on which the transmitter is mounted, the applicator comprising: an upper housing having an opening formed at the bottom and a button provided on the outer surface; a cap configured to be mounted or removed from the upper housing and having an open top and bottom; a lower housing disposed inside the cap and forming an internal space with the upper housing by being coupled to the open bottom opening of the upper housing; and a needle assembly comprising a needle configured to penetrate the transmitter; wherein the cap comprises a plurality of ribs extending from the inner surface of the cap toward the radially inner side of the cap, at least a portion thereof disposed inside the lower housing; a needle receiving portion supported by the plurality of ribs and configured to surround at least a portion thereof; and a cap injection portion corresponding to the shape of the upper surface of the needle receiving portion and disposed on the upper surface of the needle receiving portion and contacting the lower surface of the transmitter, and the needle assembly comprises a needle injection portion configured to frictionally engage with the opening of the transmitter. An insertion device assembly further comprising: a cap injection portion disposed on the upper surface of the needle receiving portion; wherein the cap injection portion contacts the lower surface of the lower case to form a sealing structure between the transmitter and the needle receiving portion. Claim 19 An insertion device assembly according to claim 18, wherein the plurality of ribs are two or more and are symmetrically arranged around the needle receiving portion, and the transmitter is attached to the lower surface of the transmitter and further comprises adhesive tapes provided in the same number as the plurality of ribs, and the adhesive tapes can be inserted through the open lower portion of the cap.

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