Insertion apparatus assembly for inserting an analyte monitoring device - Patent Application 20070122997

Abstract

According to one embodiment of the present disclosure, there is provided an insertion device assembly including: a transmitter having an upper case, a lower case coupled to the upper case to form an internal storage space, a sensor disposed above the lower case, and a hollow holder disposed in the center of the lower case and above the sensor; an applicator to which the transmitter is attached, the applicator having an upper housing having an opening formed in a lower part and a button on an outer peripheral surface, a cap configured to be attached to 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 together with the upper housing, a needle assembly disposed above the transmitter 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 drive unit configured to supply power to the needle carrier.

Description

[Technical Field]

[0001] The present disclosure relates to an insertion device assembly, and in particular to an insertion device assembly for inserting a device for monitoring an in vivo analyte. [Background technology]

[0002] The discussion herein is merely intended to provide background information related to the present disclosure and may not constitute prior art.

[0003] In recent years, the preference for processed foods has increased, and people are becoming more exposed to simple sugars. This environment has also led to a rapid increase in diabetes. A sudden drop or rise in blood sugar can cause shock in diabetic patients, and in rare cases, can lead to death. Therefore, diabetic patients need to continuously monitor their blood sugar.

[0004] In conventional blood glucose measuring devices, a lancet is used to make an incision in the fingertip, and the blood of the diabetic patient that flows out from the incision is inserted into the blood glucose measuring device to measure blood glucose.

[0005] Such blood glucose measuring devices cause pain and fear to users, and it is practically difficult to injure your finger and make it bleed every hour.

[0006] To solve the above problems, continuous glucose monitoring (CGM) systems have been developed. A very thin sensor and an electronic device (hereafter referred to as a "transmitter") for analyzing the analyte (hereafter referred to as "blood glucose") measured by the sensor are attached to the skin of a diabetic patient, and blood glucose is continuously measured for one to ten days.

[0007] The transmitter sensor is very thin, making it difficult to penetrate the skin directly. Therefore, a needle must be inserted into the skin, the sensor inserted through the gap, and the needle then pulled out (hereinafter referred to as the "applicator").

[0008] Meanwhile, in Patent Document 1, the user must insert the sensor introducer (106) into the sensor inserter (500). At that time, the user must align the sensor introducer and insert it into the sensor inserter, which can cause fatigue for the user. Therefore, it is preferable that the insertion device assembly be configured with the applicator and transmitter integrated from the time of manufacture.

[0009] Furthermore, according to Patent Document 2, the on-skin assembly (102) is assembled while still positioned inside the applicator (100) without any particular sealing structure between the insertion assembly (118) and the sealing element (110), which may expose the on-skin assembly to contamination at a later date.

[0010] Furthermore, in Patent Document 3, a needle unit (550) containing a sensor unit (520) is positioned by penetrating the top and bottom of a body attachable unit (20). However, when the body attachable unit (20) is attached to the user's body and the needle unit (550) is removed, the pierced area is left open, which may lead to the risk of infection due to the inflow of water or foreign matter.

[0011] Furthermore, the sensor probe (521) exposed to the outside of the body attachable unit (20) on one side of the sensor unit (520) and the sensor body unit (522) located inside the body attachable unit (20) on the other side of the sensor unit (520) are bent at a right angle, which may damage the sensor unit (520) made of a flexible film.

[0012] Furthermore, sterilization methods for applicators using sterilizing gas take a long time and may leave residue. Therefore, E-beams are sometimes used to sterilize medical devices, but this may affect electronic devices.

[0013] Furthermore, it is difficult to inspect the interior of a typical applicator during the assembly process, which can lead to the risk of defective products not being properly inspected.

[0014] Additionally, maintaining sterility after sterilization of the insertion device assembly is important, and double or triple packaging to maintain sterility increases manufacturing costs and waste. [Prior art documents] [Patent documents]

[0015] [Patent Document 1] US Patent Application Publication No. 2021 / 0038131 [Patent Document 2] US Patent Application Publication No. 2022 / 0322975 [Patent Document 3] US Patent Application Publication No. 2021 / 0361197 [Non-patent literature]

[0016] [Non-Patent Document 1] ISO11737-2:2019, Sterilization if health care products - Microbiological methods-Part 2: Tests of sterilization performed in the definition, validation and maintenance of sterilization process Summary of the Invention [Problem to be solved by the invention]

[0017] SUMMARY OF THE INVENTION It is therefore an object of the present disclosure to provide an insertion device assembly in which the applicator and transmitter are manufactured as a single unit, and which is easy to prepare for use.

[0018] It is another object of the present disclosure to provide an insertion device assembly in which sterility is preserved by applying a double seal between the applicator and the transmitter.

[0019] A further object of the present disclosure is to provide an insertion device assembly that is free from the risk of failure even when subjected to sterilization using the E-beam method.

[0020] It is a further object of the present disclosure to provide an insertion device assembly that can be checked for defects during manufacturing.

[0021] It is a further object of the present disclosure to provide an insertion device assembly that is easy to manufacture and requires a simple sealing step to maintain sterility.

[0022] It is a further object of the present disclosure to provide an insertion device assembly that can seal the portion penetrated by the needle after the needle is removed from the transmitter.

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

[0024] The various problems that the present invention aims to solve are not limited to the above problems, and other problems not mentioned will be clearly understood by those skilled in the art from the following description. [Means for solving the problem]

[0025] According to one embodiment of the present disclosure, there is provided an insertion device assembly including: a transmitter having an upper case, a lower case coupled to the upper case to form an internal storage space, a sensor disposed above the lower case, and a hollow holder disposed in the center of the lower case and above the sensor; an applicator to which the transmitter is attached, the applicator having an upper housing having an opening formed in a lower part and a button on an outer peripheral surface, a cap configured to be attached to 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 together with the upper housing, a needle assembly disposed above the transmitter 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 drive unit configured to supply power to the needle carrier.

[0026] Furthermore, the needle assembly according to one embodiment of the present disclosure preferably includes a needle configured to penetrate the skin of a user, a grip portion coupled to one end of the needle carrier, and a needle ejection portion disposed between the needle and the grip portion and configured to be frictionally coupled to the holder.

[0027] Furthermore, when assembling the insertion device assembly according to one embodiment of the present disclosure, it is preferred that the needle ejection portion be coupled to the holder, and when using the insertion device assembly, the needle ejection portion be withdrawn from the holder.

[0028] Furthermore, the cap according to one embodiment of the present disclosure preferably includes an opening formed on the underside, a plurality of ribs at least a portion of which is disposed inside the lower housing and which extend from the inner peripheral surface of the cap toward the radially inward side of the cap, and a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle.

[0029] Furthermore, the needle assembly according to one embodiment of the present disclosure further includes a cap injection portion that corresponds to the shape of the upper surface of the needle accommodating portion and is positioned on the upper surface of the needle accommodating portion, and it is preferable that the cap injection portion contacts the lower surface of the lower case.

[0030] Furthermore, according to one embodiment of the present disclosure, the plurality of ribs are at least two and are arranged symmetrically around the needle accommodating portion, and the transmitter further includes an adhesive tape attached to the underside of the lower case and provided in the same number as the plurality of ribs, and it is preferable that the adhesive tape be inserted through the opening.

[0031] Furthermore, it is preferable that the transmitter according to one embodiment of the present disclosure further includes a PCB (Printed Circuit Board) accommodated in the accommodation space of the upper case and the lower case, and a dummy PCB connecting the sensor and the PCB.

[0032] Furthermore, the transmitter according to another embodiment of the present disclosure preferably further includes a packing portion located on the holder and made of an elastic material.

[0033] Furthermore, it is preferable that the transmitter according to one embodiment of the present disclosure includes a lower opening located in the lower case in which the holder is located, and an inclined track having an inclined surface formed so as to slope downward from one side of the lower opening, on which a portion of the sensor is placed.

[0034] Furthermore, it is preferable that the insertion portion of the sensor according to one embodiment of the present disclosure is located inside a needle that penetrates the holder, and that the inclined surface and the needle form two bent portions that form obtuse angles between one end and the other end of the sensor.

[0035] According to one embodiment of the present disclosure, there is provided an insertion device assembly including a transmitter and an applicator configured to have the transmitter attached thereto, wherein the insertion device assembly is divided into first to fourth assembly states according to an assembly order, and the first assembly includes a cap having open top and bottom portions, a lower housing disposed inside the cap, a lower case of the transmitter disposed above at least a portion of the lower housing, a sensor disposed above the lower case, a hollow holder disposed in the center of the lower case and above the sensor, and a needle assembly disposed above the transmitter and configured so that at least a portion of the needle assembly is inserted into the holder.

[0036] Furthermore, it is preferable that the second assembly according to one embodiment of the present disclosure further includes a PCB disposed above the lower case, and an upper case coupled to the lower case to form an internal storage space, in addition to the first assembly sterilized by E-beam.

[0037] Furthermore, the third assembly according to one embodiment of the present disclosure preferably further includes a needle carrier configured to linearly move the needle assembly in the second assembly, and a drive unit configured to supply power to the needle carrier.

[0038] Furthermore, it is preferable that the fourth assembly according to one embodiment of the present disclosure further includes an adhesive tape attached to the lower surface of the lower case, and a sealing portion configured to seal the open lower portion of the cap.

[0039] Furthermore, the needle assembly according to one embodiment of the present disclosure preferably includes a needle configured to penetrate the skin of a user, a grip portion coupled to one end of the needle carrier, and a needle ejection portion disposed between the needle and the grip portion and configured to be frictionally coupled to the holder.

[0040] Furthermore, the cap according to one embodiment of the present disclosure includes a plurality of ribs, at least a portion of which is positioned inside the lower housing and extending from the inner surface of the cap radially inward of the cap, a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle, and a cap ejection portion that corresponds to the shape of the upper surface of the needle accommodating portion and is positioned on the upper surface of the needle accommodating portion, and it is preferable that the cap ejection portion contacts the lower surface of the lower case.

[0041] Furthermore, according to one embodiment of the present disclosure, the number of ribs is at least two and they are arranged symmetrically around the needle accommodating portion, and the transmitter further includes an adhesive tape attached to the underside of the lower case and provided in the same number as the number of ribs, and it is preferable that the adhesive tape is inserted from the open bottom of the cap.

[0042] Furthermore, according to one embodiment of the present disclosure, there is provided an insertion device assembly including: a transmitter; an applicator to which the transmitter is attached, the applicator having an upper housing having an opening formed in a lower portion and a button on an outer peripheral surface; a cap configured to be attached to or removed from the upper housing and having open top and bottom portions; a lower housing disposed inside the cap and coupled to the open lower opening of the upper housing to form an internal space together with the upper housing; and a needle assembly having a needle configured to penetrate the transmitter, wherein at least a portion of the cap is disposed inside the lower housing and includes: a plurality of ribs extending radially inward from an inner peripheral surface of the cap; a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle; and a cap ejection portion corresponding to the shape of the upper surface of the needle accommodating portion, disposed on the upper surface of the needle accommodating portion, and in contact with the lower surface of the transmitter.

[0043] Furthermore, according to one embodiment of the present disclosure, the plurality of ribs may be at least two and may be arranged symmetrically around the needle accommodating portion, and the transmitter may further include an adhesive tape attached to the underside of the lower case and provided in the same number as the plurality of ribs, and the adhesive tape may be inserted from the open bottom of the cap. [Effects of the Invention]

[0044] As described above, according to one embodiment of the present disclosure, the applicator and transmitter are manufactured as a single unit, and when using the applicator, the needle protection structure is also removed at the same time by simply removing the cap, thereby providing convenience to the user.

[0045] Additionally, the double-sealed structure of the insertion device assembly effectively maintains sterility within the needle and applicator.

[0046] Furthermore, according to one embodiment of the present disclosure, when assembling the insertion device assembly, the PCB is assembled after E-beam sterilization, which has the advantage of eliminating the risk of failure of the electronic devices mounted on the PCB.

[0047] Furthermore, since the cap is made of a transparent material, it is possible to visually check whether the seal between the cap injection part and the transmitter is sealed, which is advantageous in that it is easy to inspect for defective products.

[0048] Furthermore, after the insertion device assembly is completed, all that is required is to attach the sealing portion to the bottom of the cap, which simplifies the sealing method and makes manufacturing more convenient.

[0049] Furthermore, a packing part made of an elastic material is located at the part of the transmitter where the needle is to pass through, and when the needle is removed, it seals the passed-through part, thereby preventing the inflow of water or foreign matter and the resulting infection.

[0050] Furthermore, since the sensor is installed using the track structure inside the case that forms the transmitter, the bending portion of the sensor is formed gently, which has the effect of preventing damage to the sensor. [Brief explanation of the drawings]

[0051] [Figure 1a] FIG. 1 is a front perspective view of an insertion device assembly according to one embodiment of the present disclosure. [Figure 1b] FIG. 1 is a front perspective view of an insertion device assembly according to one embodiment of the present disclosure. [Figure 2] FIG. 1 is an exploded perspective view of an insertion device assembly according to one embodiment of the present disclosure. [Figure 3] 1A and 1B are an overall perspective view and an exploded perspective view of a transmitter according to an embodiment of the present disclosure; [Figure 4] FIG. 13 illustrates an interior view of a cap according to one embodiment of the present disclosure. [Figure 5] FIG. 1 is a front perspective view of a lower housing according to one embodiment of the present disclosure. [Figure 6] 10 is a flowchart of a method for assembling an insertion device assembly according to one embodiment of the present disclosure. [Figure 7] 10A-10C illustrate an assembly sequence for an insertion device assembly according to one embodiment of the present disclosure. [Figure 8] 10A-10C are diagrams illustrating an assembly step of an insertion device assembly according to one embodiment of the present disclosure. [Figure 9] 10A-10C are diagrams illustrating an assembly step of an insertion device assembly according to one embodiment of the present disclosure. [Figure 10] 10A-10C are diagrams illustrating an assembly step of an insertion device assembly according to one embodiment of the present disclosure. [Figure 11] 10A-10C are diagrams illustrating an assembly step of an insertion device assembly according to one embodiment of the present disclosure. [Figure 12] FIG. 1 is an overall perspective view, seen from below, 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. [Figure 13] FIG. 10 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. [Figure 14] FIG. 10 is a perspective view illustrating a track structure of a lower case according to one embodiment of the present disclosure. [Figure 15] FIG. 10 is a perspective view illustrating a state in which a sensor is installed in a track structure of a lower case according to one embodiment of the present disclosure. [Figure 16] FIG. 10 is a longitudinal cross-sectional view illustrating a configuration of a sensor without a needle assembly coupled to a transmitter according to one embodiment of the present disclosure. [Figure 17] FIG. 10 is a longitudinal cross-sectional view illustrating a configuration of a sensor with a needle assembly coupled to a transmitter according to one embodiment of the present disclosure. [Figure 18] 10A-10C illustrate coupling of a needle assembly and a transmitter according to another embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0052] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the drawings. When assigning reference numerals to components in each drawing, the same reference numerals will be assigned to identical components even in different drawings as much as possible. Furthermore, when describing the present disclosure, if it is determined that a detailed description of related publicly known configurations or functions would obscure the gist of the present disclosure, such detailed description will be omitted.

[0053] In describing the components of the embodiments of the present disclosure, reference numerals such as 1, 2, i), ii), a), b) and the like are used. These reference numerals are merely used to distinguish the components from other components, and do not limit the essence, order, sequence, etc. of the components. In this specification, when a part "includes" or "has" a certain component, it does not mean that other components are excluded, but rather that other components may be further included, unless otherwise specified.

[0054] In this disclosure, the term "insertion device assembly" refers to an assembly in which an applicator and a transmitter are assembled together.

[0055] In addition, in this disclosure, the term "distal position" refers to a position that is relatively farther from the skin than the "proximal position." Note that distal and proximal are concepts regarding relative positions, and it will be understood that one element may be located proximally relative to another element, while the other element may be located distally relative to another element.

[0056] Additionally, in this disclosure, "fire" refers to the action of a user that activates the applicator and causes the needles to be inserted into the user's skin.

[0057] Furthermore, in this disclosure, "retraction" refers to the process of the needle returning to its original position after penetrating the user's skin.

[0058] Additionally, in this disclosure, "upward" means in a proximal to distal direction.

[0059] Additionally, in this disclosure, "downward" means in a distal to proximal direction.

[0060] Furthermore, in this disclosure, "horizontal" refers to the plane of the skin surface that the applicator comes into contact with when the applicator is in use. In this disclosure, the explanation is given assuming that the user's skin surface is flat, without taking into account the curvature of the skin surface.

[0061] 1. Applicator Description 1.1.Applicator Structure FIG. 1 is a front perspective view of an insertion device assembly according to one embodiment of the present disclosure.

[0062] Specifically, FIG. 1a shows a state in which a cap 130 is attached, and FIG. 1b shows a state in which the cap 130 has been removed.

[0063] An applicator 100 according to one embodiment of the present disclosure includes an upper housing 110, a button 120 configured to be inserted and press-fit into the outer surface of the upper housing 110, and a cap 130 that can be removed from the upper housing 110 (see FIG. 1a).

[0064] When the cap 130 of the applicator 100 is removed from the upper housing 110, a portion of the lower housing 140 is revealed (see FIG. 1b). With the cap 130 removed, the insertion device assembly is ready for use by the user.

[0065] FIG. 2 is an exploded perspective view of an insertion device assembly according to one embodiment of the present disclosure.

[0066] As shown in FIG. 2, an applicator 100 according to one embodiment of the present disclosure includes, in addition to an upper housing 110, a button 120, a cap 130, and a lower housing 140, all or part of a driver 150, a needle carrier 160, a needle assembly 170, a transmitter holder 180, a desiccant 190, and a seal 191.

[0067] The upper housing 110 is configured to be held by a user and is preferably substantially cylindrical in shape. The lower part of the upper housing 110 is open.

[0068] The button 120 is disposed on the outer circumferential surface of the upper housing 110 and configured to be pressed toward the inside of the upper housing 110 .

[0069] The cap 130 is configured to be attached to or removed from the upper housing 110, and protects the inside of the applicator 100 from external contaminants and impacts. The cap 130 is preferably substantially cylindrical.

[0070] The lower housing 140 is disposed inside the cap 130. The lower housing 140 is configured to form an internal space by being coupled to the lower part of the upper housing 110. The lower housing 140 is configured to come into direct contact with the user's skin when the applicator 100 is in use.

[0071] 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 linearly move the transmitter 200 and the needle assembly 170 in 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.

[0072] The spring 151 is a power source that supplies power to the needle carrier 160 so that the needle carrier 160 moves linearly. For this purpose, the spring 151 is preferably a wound reel spring. The spring 151 is assembled in a compressed state in an initial state. When the fastening portion that fixed the compression of the spring 151 is released by pressing the button 120, the spring 151 is stretched to return to its original state. This causes one end of the spring 151 to rotate. That is, a kind of Scotch yoke or double slider crank mechanism principle is applied, 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.

[0073] One side of the wheel 152 is fastened to one end of the spring 151 and configured to rotate together with the rotation of the spring 151. A groove for coupling with the locking member 153 may be formed on the outer circumferential surface of the wheel 152.

[0074] The locking member 153 is configured so that one end is coupled to the button 120 and the other end is fastened to the wheel 152. Here, a groove is formed in the other end of the locking member 153, which engages with the groove of the wheel 152. This prevents the wheel 152 from rotating and also prevents the spring 151 from being tensioned.

[0075] When button 120 moves toward the inside of applicator 100, locking member 153 also moves in conjunction with it. This releases the fastening between the other end of locking member 153 and the groove in cap 130, and wheel 152 rotates together due to the tension and rotation of spring 151.

[0076] The needle carrier 160 is configured to move linearly within the upper housing 110 and the lower housing 140. Here, the linear movement of the needle carrier 160 is induced by the rotational movement of the driver 150. For this reason, the needle carrier is preferably generally T-shaped. The needle carrier 160 is coupled to the other side of the wheel 152, thereby being subject to the rotational movement of the driver 150.

[0077] The needle assembly 170 is disposed in an 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 therewith in response to the linear movement of the needle carrier 160.

[0078] The needle assembly 170 includes all or part of a needle 171 , a gripping portion 172 and a needle ejection portion 173 .

[0079] The needle 171 is configured to penetrate the skin of a user.

[0080] The grip portion 172 is configured to be coupled to the lower end of the needle carrier 160. The needle 171 and the grip portion 172 are configured as a single unit and are preferably made entirely of a metal material, but are not necessarily limited to this.

[0081] The needle ejection portion 173 is disposed between the needle 171 and the grip portion 172. The needle ejection portion 173 is formed of a different material, preferably rubber, than the needle 171 and the grip portion 172. For this reason, the needle ejection portion 173 is preferably double-injected when the needle assembly 170 is fabricated.

[0082] Meanwhile, when manufacturing the insertion device assembly, the needle injection part 173 is inserted into the transmitter 200, and here, the needle injection part 173 is made of rubber, thereby forming a sealed structure with the transmitter 200. This will be described in detail later with reference to Figures 7 and 8.

[0083] According to one embodiment of the present disclosure, needle assembly 170 is prevented from rotating when coupled to transmitter 200 via needle ejection portion 173 .

[0084] Meanwhile, according to another embodiment of the present disclosure, instead of providing a separate needle injection portion in the needle assembly 170′, at least a portion of the upper surface of the transmitter 200′ is formed of an elastic portion, so that when the needle 171′ is coupled to the upper case 210′ ​​of the transmitter 200′, a sealed structure is formed and rotation of the needle 171′ is prevented (see FIG. 18 ), which will be described in detail below with reference to FIG. 18 .

[0085] 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 200 and configured to linearly move the transmitter 200 from distal to proximal. The transmitter holder 180 is pressed from distal to proximal by the needle carrier 160. Note that the transmitter holder 180 does not move from proximal to distal, but only moves from distal to proximal.

[0086] The dehumidifying agent 190 is inserted into the inside of the cap 130 from the bottom surface of the cap 130 and is configured to dehumidify the inside of the applicator 100.

[0087] The sealing portion 191 is attached to the open bottom surface of the cap 130 and is configured to seal the inside and outside of the applicator 100 .

[0088] FIG. 3 is an overall perspective view and an exploded perspective view of a transmitter according to one embodiment of the present disclosure.

[0089] According to one embodiment of the present disclosure, transmitter 200 is configured to be attached to a user's skin, analyze the concentration of an analyte in the user's body, and transmit the concentration and related information to an external device. Transmitter 200 is fabricated for insertion into applicator 100 during the production step of the insertion device assembly.

[0090] 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. The detailed configuration will be described later with reference to FIGS.

[0091] FIG. 4 is a view showing the inside of a cap according to one embodiment of the present disclosure.

[0092] 4, cap 130 according to one embodiment of the present disclosure is made of at least one material selected from the group consisting of ABS (Acrylonitrile butadiene styrene co-polymer) resin, PC (Polycarbonate) resin, and PE (Polyethylene) resin, but may be made of any material commonly used in medical devices such as applicators. For example, a combination of PC resin and ABS resin is used, but this may be changed as appropriate by the designer.

[0093] The cap 130 includes all or some of the opening 131, the ribs 132a, 132b, the needle receiving portion 133, the cap ejection portion 134, and the coupling protrusions 135a, 135b, 135c, and 135d.

[0094] An opening 131 is formed in the bottom surface of the cap 130 .

[0095] The ribs 132a and 132b are formed to extend radially inward from the inner circumferential surface of the cap 130. According to one embodiment of the present disclosure, two ribs 132a and 132b are formed symmetrically, but this is not necessarily limited to this, and the number and shape of the ribs may be changed as appropriate at the designer's discretion.

[0096] The ribs 132a, 132b are arranged along the diameter of the cap 130, so that the cap 130 has a bisected shape when viewed from the bottom or top. That is, the cap 130 has a substantially θ shape.

[0097] The needle accommodating portion 133 is formed at the center of the diameter of the cap 130 and is configured to accommodate the needle 171. For this purpose, the needle accommodating portion 133 includes an accommodating space therein and is cylindrical with an open top.

[0098] The needle accommodating portion 133 is supported by a rib 132a and another rib 132b.

[0099] Since the needle accommodating portion 133 is formed integrally with the cap 130, when using the applicator 100, simply removing the cap 130 removes the needle protection structure at the same time, which is convenient for the user.

[0100] The cap injection portion 134 is formed on the upper surface of the needle accommodating portion 133 and contacts the lower surface of the lower case 250 of the transmitter 200. Note that the cap injection portion 134 is formed by double injection above the needle accommodating portion 133 in the manufacturing step of the cap 130, but is not necessarily limited to this.

[0101] Meanwhile, when manufacturing the insertion device assembly, the cap injection part 134 comes into contact with the bottom surface of the transmitter 200, and here, since the cap injection part 134 is made of rubber, a sealed structure is formed with the transmitter 200. This will be described in detail later with reference to Figures 7 and 8.

[0102] At least one coupling protrusion 135a, 135b, 135c, and 135d protrudes radially inward from the inner circumferential surface of the cap 130. At least one coupling protrusion 135a, 135b, 135c, and 135d is configured to be coupled to the outer circumferential surface of the lower housing 140. This will be described with reference to FIG. 5.

[0103] FIG. 5 is a front perspective view of a lower housing according to one embodiment of the present disclosure.

[0104] As shown in FIG. 5, a lower housing 140 according to an embodiment of the present disclosure includes at least one coupling groove 141a, 141b formed on the outer circumferential surface.

[0105] The coupling grooves 141a and 141b are recessed radially inward from the outer circumferential surface of the lower housing 140, and the coupling protrusions 135a, 135b, 135c, and 135d are seated and coupled to the coupling grooves 141a and 141b. The number of the coupling grooves 141a and 141b is the same as the number of the coupling protrusions 135a, 135b, 135c, and 135d. Although this disclosure shows two coupling grooves 141a and 141b, it should be understood that two more coupling grooves are also formed on the side surface that is not visible.

[0106] Guide grooves 142a and 142b are further formed on one side of the coupling grooves 141a and 141b. The guide grooves 142a and 142b are recessed radially inward from the outer circumferential surface of the lower housing 140 and extend in the height direction of the lower housing 140. The width of the coupling grooves 141a and 141b is preferably greater than the width of the coupling protrusions 135a, 135b, 135c, and 135d. This allows the coupling protrusions 135a, 135b, 135c, and 135d to move up and down within the coupling grooves 141a and 141b.

[0107] For example, the guide grooves 142a and 142b may be formed continuously on the left side of the coupling grooves 141a and 141b. In this case, the coupling protrusions 135a, 135b, 135c, and 135d move leftward along the width of the coupling grooves 141a and 141b and the guide grooves 142a and 142b from a state in which they are coupled to the coupling grooves 141a and 141b, and then move downward along the height direction of the guide grooves 142a and 142b, and are 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 circumferential surface of the lower housing 140, and then moving the cap 130 downward along the height direction of the lower housing 140.

[0108] Meanwhile, according to one embodiment of the present disclosure, the lower housing 140 and the cap 130 are described as being coupled or uncoupled by the coupling protrusions 135a, 135b, 135c, and 135d and the coupling grooves 141a and 141b, but this is not necessarily limited to this. For example, the lower housing 140 and the cap 130 may be coupled by a hook coupling or a screw coupling. Alternatively, the cap 130 or the lower housing 140 may be fastened together by an open / close coupling between a blade member (not shown) provided on one of the cap 130 or the lower housing 140 and a locking hole (not shown) provided on the other.

[0109] 1.2. How to assemble the applicator Fig. 6 is a flowchart of a method for assembling an insertion device assembly according to an embodiment of the present disclosure. Fig. 7 is a diagram showing an assembly sequence of an insertion device assembly according to an embodiment of the present disclosure. Figs. 8 to 11 are diagrams illustrating the states of the assembly steps of an insertion device assembly according to an embodiment of the present disclosure.

[0110] A method of assembling and sterilizing an insertion device assembly according to one embodiment of the present disclosure will now be described with reference to Figures 6-11.

[0111] First, the cap 130, lower case 250, sensor 240, holder 230, needle assembly 170, and lower housing 140 are assembled in this 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 will be referred to as a first assembly ASSY 1.

[0112] The first assembly ASSY 1 is shown 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. As shown in FIG. 8(b), the needle ejection portion 173 is press-fitted into the holder 230, and the two are frictionally coupled. The needle ejection portion 173 prevents contaminants from flowing from the holder 230 into the needle 171. After the user fires the applicator 100, the transmitter 200 remains distal when the needle assembly 170 retracts. Therefore, the needle ejection portion 173, which was inserted into the holder 230, is pulled out of the holder 230.

[0113] In addition, the cap injection part 134 contacts the bottom surface of the lower case 250 to form a sealed structure. Here, the cap injection part 134 is supported while contacting the bottom surface of the lower case 250 due to the combination of the cap 130 and the lower housing 140.

[0114] It is preferable that at least a portion of the cap 130 is made of a transparent material, which has the advantage that it is possible to visually check whether or not a seal has been formed between the cap injection unit 134 and the transmitter 200, making it easier to inspect for defective products that are not sealed.

[0115] As described above, the insertion device assembly according to one embodiment of the present disclosure has an advantage in that it forms a double-sealed structure when assembled, thereby protecting the inside of the insertion device assembly from contaminants. Since the needle 171 is inserted directly through the user's skin, maintaining a sterilized state is extremely important, and the double-sealed structure of the insertion device assembly according to the present disclosure is highly effective in maintaining such a sterilized state.

[0116] Thereafter, the first assembly ASSY 1 is sterilized by irradiating it with an E-beam (S620). Because electronic devices are mounted on the PCB 220, direct exposure to the E-beam could result in loss of some functionality. However, according to the present disclosure, sterilization by E-beam is performed on the first assembly ASSY 1 without the PCB 220 installed, so there is no risk of damage to the electronic devices mounted on the PCB 220.

[0117] The PCB 220, the upper case 210, and the adhesive tape 260 are attached to the first assembly ASSY 1 (S630, FIG. 7(b)). Hereinafter, the assembly formed in step S630 will be referred to as a second assembly ASSY 2.

[0118] The second assembly ASSY 2 is shown 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.

[0119] 9(a) and 9(b), the upper case 210 is coupled to the lower case 250. Here, the upper case 210 and the lower case 250 are coupled to each other by ultrasonic welding or UV bonding.

[0120] Thereafter, the needle carrier 160 and the drive unit 150 are assembled to the second assembly ASSY 2 (S640, FIG. 7(c)). Note that in FIGS. 7, 10, and 11, only the needle carrier 160 is shown as being connected, but this is for the sake of convenience of explanation, and it should be understood that the drive unit 150 connected to the needle carrier 160 is also assembled. Hereinafter, the assembly formed in step S640 will be referred to as the third assembly ASSY 3.

[0121] The third assembly ASSY 3 is shown 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.

[0122] As shown in FIG. 10(a), the opening 131 of the cap 130 is still open.

[0123] 10(b), a connecting arm 161 formed at the lower end of the needle carrier 160 is fastened to a grip portion 172 of the needle assembly 170, thereby connecting the needle carrier 160 and the needle assembly 170. Here, a snap-fit ​​method is used to connect the connecting arm 161 and the grip portion 172, but this is not limited to this and screwing or the like may be used instead.

[0124] Thereafter, the adhesive tape 260, the dehumidifying agent 190, and the seal portion 191 are sequentially joined to the third assembly ASSY 3 (S650, FIG. 7(d)). Hereinafter, the assembly formed in step S650 will be referred to as a fourth assembly ASSY 4.

[0125] The fourth assembly ASSY 4 is shown 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.

[0126] 11(b), adhesive tape 260 is attached to the bottom surface of lower case 250. As described above, adhesive tape 260 is divided into two halves and inserted into openings 131 on the right and left sides of cap 130, respectively.

[0127] When the adhesive tape 260 is attached, the dehumidifying agent 190 is inserted into the cap 130, and the cap 130 is sealed by the seal portion 191.

[0128] On the other hand, according to one embodiment of the present disclosure, the insertion device assembly has an advantage that the sealing method is simple because it is only necessary to attach the sealing portion 191 to the bottom of the cap 130 during assembly.

[0129] 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 in the present disclosure, the description and detailed drawings thereof will be omitted.

[0130] 1.3. Results of sterilization tests on applicators and transmitters It has been determined that insertion device assemblies according to one or other embodiments of the present disclosure have been sterilized and no microbial growth has been observed.

[0131] Specifically, the test was carried out according to the method described in Non-Patent Document 1.

[0132] In addition, the following instruments and equipment were used: an incubator, a low-temperature incubator, a high-pressure steam sterilizer, and a clean bench.

[0133] The strain was then cultured in soybean casein digest medium (TSB) for 14 days at 30-35°C and 14 days at 20-25°C for a total of 28 days.

[0134] Here, when the E-beam irradiation dose was 25 kGy and 35 kGy, the presence or absence of microbial growth was confirmed after culturing each microorganism.

[0135] As a result of the test using the above experimental method, it was confirmed that no microorganisms grew at E-beam irradiation doses of both 25 kGy and 35 kGy. In other words, the method for assembling and sterilizing the insertion device assembly according to the embodiment of the present disclosure is highly effective in sterilization and preventing contamination from external contaminants.

[0136] 2. Transmitter Description Hereinafter, the configuration of the transmitter 200 of the insertion device assembly according to one embodiment of the present disclosure will be described in detail with reference to FIGS. 3 and 12 to 17.

[0137] As previously mentioned, FIG. 3 is a perspective overall view and an exploded perspective view of a transmitter 200 according to one embodiment of the present disclosure.

[0138] As shown in 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.

[0139] The upper case 210 and the lower case 250 are joined together vertically to form the exterior of the transmitter 200, and a predetermined receiving space is formed inside the transmitter 200.

[0140] 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.

[0141] A cylindrical holder 230 is positioned between the upper through-hole 211 and the lower through-hole 251, and the needle 171 is positioned to penetrate the upper case 210 and the lower case 250 with the needle injection part 173 pressed into the holder 230.

[0142] The PCB 220 is a printed circuit board (PCB) and is housed in the internal housing space of the upper case 210 and the lower case 250. The PCB 220 is equipped with various electronic components for analyzing the concentration of an analyte in the user's body detected by the sensor 240 and transmitting the concentration and related information to an external device.

[0143] The sensor 240 is located below the holder 230 in the internal storage space of the transmitter 200 .

[0144] 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 inside the needle 171, and is inserted into the user's body by firing, and the other side is connected to the lower part of the PCB 220 inside the transmitter 200.

[0145] Hereinafter, one end portion of the transmitter 200 that is inserted into the user's body outside the transmitter 200 will be referred to as an insertion portion, and the other end portion that is connected to the PCB 220 inside the transmitter 200 will be referred to as a connection portion.

[0146] The dummy PCB 245 will be described with reference to Figures 12 and 13. Figures 12 and 13 are an overall perspective view and an exploded perspective view, respectively, of the connection structure of the PCB 220, the sensor 240, and the dummy PCB 245, as viewed from below.

[0147] The dummy PCB 245 is located between the sensor 240 and the PCB 220. The dummy PCB 245 is similarly configured as a small printed circuit board, and electrically connects the sensor 240 and the electronic components mounted on the PCB 220.

[0148] Unlike the PCB 220, the dummy PCB 245 does not have any components mounted thereon, and is configured to include only a printed circuit for electrically connecting the sensor 240 and the PCB 220.

[0149] Explaining in more detail with reference to Figures 12 and 13, the dummy PCB 245 is located below the PCB 220 and above the sensor 240, with one side contacting the connection portion of the sensor 240 and the other side contacting the contact points on the peripheral side of the PCB 220, thereby physically and electrically connecting the sensor 240 and the PCB 220.

[0150] The sensor 240 and the dummy PCB 245 are connected by ultrasonic fusion or ACF (Anisotropic Conductive Film) bonding, and the dummy PCB 245 and the PCB 220 are connected by soldering.

[0151] 14 and 15 are perspective views of the lower case 250, showing the track structure located on the inner surface of the lower case 250 and the sensor 240 installed thereon.

[0152] As shown in FIG. 14, a fixed track 252 is located on the top surface of the lower case 250.

[0153] The fixed track 252 is formed with a concave step so that one side of the lower case 250 corresponds to the connecting portion side of the sensor 240, and the connecting portion of the sensor 240 is fitted into the fixed track 252, thereby fixing the sensor 240 to the lower case 250.

[0154] An inclined track 253 is located on one side of the fixed track 252. The inclined track 253 is formed such that the side of the fixed track 252 facing the lower through-hole 251 is inclined downward.

[0155] As shown in FIG. 15, when the sensor 240 is fitted into the fixed track 252, the portion of the sensor 240 between the connecting portion and the insertion portion rests on the inclined track 253.

[0156] FIG. 16 is a longitudinal cross-sectional view showing the configuration of the sensor 240 when the needle assembly 170 is not connected to the transmitter 200, and FIG. 17 is a longitudinal cross-sectional view showing the configuration of the sensor 240 when the needle assembly 170 is connected to the transmitter 200.

[0157] 16 and 17, the portion of the sensor 240 between the connecting portion and the insertion portion is placed on the inclined track 253, so that the sensor 240 extending from the lower through-hole 251 to the outside of the lower housing forms a first bent portion 241 bent at an obtuse angle around the inclined track 253. When the needle assembly 170 is coupled in this state, one end of the sensor 240, i.e., the insertion portion, is accommodated inside the needle 171 and forms a second bent portion 242 bent at an obtuse angle. In other words, the middle portion of the sensor 240 is not bent directly at a right angle, but rather two bent portions forming obtuse angles are formed 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 via the two bent portions thus formed.

[0158] Meanwhile, in this disclosure, for convenience of explanation, the bent portions 241 and 242 are shown as being formed by discontinuous surfaces, but it should be understood that they may also be formed in a shape that allows continuous bending.

[0159] Because the sensor 240 is made of a flexible film, it can be bent. However, if it is bent at a small angle, the electrodes of the sensor 240 or the material sputtered onto the sensor 240 may be damaged by cracks. However, by forming two bends in the sensor 240 in this way, it is possible to prevent damage to the film that constitutes the sensor 240 and the material sputtered onto the film.

[0160] Furthermore, before the needle 171 is assembled to the sensor 240, the sensor 240 forms a predetermined downward angle due to the first bent portion 241, making it easy to assemble the needle 171, which is connected at the top of the sensor 240, from the top to the bottom of the transmitter 200.

[0161] Furthermore, the tension applied to the electrodes can be reduced when the sensor is inserted into and fixed on the user's skin.

[0162] The adhesive tape 260 is located on the bottom surface of the lower case 250 and allows the transmitter 200 to be adhesively fixed onto the user's skin.

[0163] An opening is formed in the center of the adhesive tape 260 so that the sensor 240 extending from the lower case 250 can pass through and be positioned therein.

[0164] Also, as shown in FIG. 3, the adhesive tape 260 is configured to be divided according to the positions and number of ribs 132a, 132b formed inside the applicator cap.

[0165] In this embodiment, the two ribs 132a, 132b are arranged along the diameter of the cap 130, so that the cap 130 is configured in an approximately θ shape, which is bisected when viewed from the bottom or top, and therefore the adhesive tape 260 is also configured on the bottom surface of the lower case 250 in the shape of θ, which is bisected in the middle.

[0166] In this way, the adhesive tape 260 divided according to the shape of the ribs 132a, 132b is attached to the bottom surface of the lower case 250, and is inserted into the right and left openings 131 of the cap 130, respectively.

[0167] FIG. 18 is a diagram illustrating the coupling of a needle assembly and a transmitter according to another embodiment of the present disclosure.

[0168] Figure 18(a) is a front perspective view showing the state before the needle assembly 170' is coupled to the transmitter 200', and Figure 18(b) is a cross-sectional view showing the state after the needle assembly 170' is coupled to the transmitter 200'.

[0169] 18(a), a needle assembly 170' according to another embodiment includes a needle 171' and a grip portion 172'. A transmitter 200' according to another embodiment further includes a packing portion 235'.

[0170] The packing portion 235' is located inside a cylindrical holder 230' located inside the upper case 210' and the lower case 250'.

[0171] The packing part 235' is made of an elastic rubber material and seals the opening at the top of the holder 230'.

[0172] Although FIG. 18 shows the packing portion 235' as a separate component located on top of the holder 230', it may be made integral with the holder 230' by double injection molding.

[0173] As described above, the sterilization and assembly process is performed with the needle 171' portion of the needle assembly 170' penetrating the packing portion 235', and when the user fires the applicator and the needle assembly 170' retracts, the needle 171' inserted in the holder 230' is removed from the holder 230', and the portion where the needle 171' had penetrated is closed due to the elasticity of the rubber.

[0174] By doing so, when the transmitter 200' is attached and used, the portion where the needle 171' penetrated is closed by the packing portion 235', so it is not exposed to the outside, and in particular, the hydrophobicity of the rubber material prevents foreign matter such as water from entering, thereby reducing the risk of infection.

[0175] The above description merely exemplifies the technical idea of ​​the present disclosure, and a person skilled in the art to which the present disclosure pertains may make various modifications and variations without departing from the essential characteristics of the present disclosure. Therefore, the present embodiment is intended to explain the technical idea of ​​the present disclosure, but not to limit the technical idea of ​​the present disclosure. The scope of protection of the present disclosure should be interpreted by the scope of the claims, and any technical idea within the scope equivalent thereto should be interpreted as being included in the present disclosure.

Claims

1. a transmitter, The upper case and a lower case coupled to the upper case to form an internal storage space; a sensor disposed above the lower case; a transmitter having a hollow holder disposed at the center of the lower case and above the sensor; An applicator to which the transmitter is attached, an upper housing having an opening formed in a lower portion and a button on an outer peripheral surface; a cap configured to be attached to 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 together with the upper housing; a needle assembly disposed above the transmitter in the interior space and configured to be at least partially inserted into the holder; a needle carrier disposed in the interior space and configured to linearly move the needle assembly; a drive configured to power the needle carrier; Insertion device assembly.

2. The needle assembly a needle configured to penetrate the skin of a user; a grip portion coupled to one end of the needle carrier; a needle injection portion disposed between the needle and the grip portion and configured to be frictionally coupled to the holder; The insertion device assembly of claim 1 .

3. When assembling the insertion device assembly, the needle launcher is coupled to the holder; When using the insertion device assembly, the needle ejection portion is withdrawn from the holder. The insertion device assembly of claim 2 .

4. The cap is an opening formed on the lower surface; a plurality of ribs at least a portion of which is disposed inside the lower housing and which extend from an inner peripheral surface of the cap toward an inner side of the cap in a radial direction; a needle receiving portion supported by the plurality of ribs and configured to surround at least a portion of the needle; The insertion device assembly of claim 3 .

5. The needle assembly a cap injection portion that corresponds to the shape of the upper surface of the needle accommodating portion and is disposed on the upper surface of the needle accommodating portion; the cap injection portion contacts the lower surface of the lower case; The insertion device assembly of claim 4.

6. The plurality of ribs include at least two ribs, which are arranged symmetrically about the needle accommodating portion, the transmitter further includes adhesive tapes attached to a lower surface of the lower case, the number of the adhesive tapes being the same as the number of the plurality of ribs; The adhesive tape is inserted through the opening. The insertion device assembly of claim 4.

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

8. The transmitter The holder further includes a packing portion located on an upper portion of the holder and made of an elastic material. The insertion device assembly of claim 1 .

9. The transmitter a lower opening located in the lower case and in which the holder is located; a sloped track having an inclined surface formed to slope downward from one side of the lower opening, on which a portion of the sensor is placed, The insertion device assembly of claim 2 .

10. the insertion portion of the sensor is located inside a needle that penetrates the holder; the inclined surface and the needle form two bent portions at obtuse angles between one end and the other end of the sensor; The insertion device assembly of claim 9.

11. An insertion device assembly including a transmitter and an applicator configured to mount the transmitter, The insertion device assembly is divided into first to fourth assembly states according to the assembly order, The first assembly is a cap having an open top and bottom; a lower housing disposed inside the cap; a transmitter lower case disposed above at least a portion of the lower housing; a sensor disposed above the lower case; a hollow holder disposed at the center of the lower case and above the sensor; a needle assembly disposed on top of the transmitter and configured to be inserted at least partially into the holder; Insertion device assembly.

12. The second assembly is sterilized by E-beam to the first assembly. a PCB disposed above the lower case; an upper case coupled to the lower case to form an internal storage space, The insertion device assembly of claim 11.

13. The third assembly is connected to the second assembly. a needle carrier configured to linearly move the needle assembly; a drive configured to power the needle carrier. The insertion device assembly of claim 12.

14. The fourth assembly is connected to the third assembly. an adhesive tape attached to the bottom surface of the lower case; and a seal configured to seal the open bottom of the cap. The insertion device assembly of claim 13.

15. The needle assembly a needle configured to penetrate the skin of a user; a grip portion coupled to one end of the needle carrier; a needle injection portion disposed between the needle and the grip portion and configured to be frictionally coupled to the holder; The insertion device assembly of claim 13.

16. The cap is a plurality of ribs at least a portion of which is disposed inside the lower housing and which extend from an inner peripheral surface of the cap toward an inner side of the cap in a radial direction; a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle; a cap injection portion that corresponds to the shape of the upper surface of the needle accommodating portion and is disposed on the upper surface of the needle accommodating portion, the cap injection portion contacts the lower surface of the lower case; 16. The insertion device assembly of claim 15.

17. The plurality of ribs include at least two ribs, which are arranged symmetrically about the needle accommodating portion, the transmitter further includes adhesive tapes attached to a lower surface of the lower case, the number of the adhesive tapes being the same as the number of the plurality of ribs; The adhesive tape is inserted from the open bottom of the cap.

17. The insertion device assembly of claim 16.

18. A transmitter; An applicator to which the transmitter is attached, an upper housing having an opening formed in a lower portion and a button on an outer peripheral surface; a cap configured to be attached to or removed from the upper housing, the cap having an open top and bottom; a lower housing disposed inside the cap and coupled to the open lower opening of the upper housing to form an internal space together with the upper housing; and a needle assembly including a needle configured to penetrate the transmitter, The cap is a plurality of ribs at least a portion of which is disposed inside the lower housing and which extend from an inner peripheral surface of the cap toward an inner side of the cap in a radial direction; a needle accommodating portion supported by the plurality of ribs and configured to surround at least a portion of the needle; a cap injection portion that corresponds 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; Insertion device assembly.

19. The plurality of ribs include at least two ribs, which are arranged symmetrically about the needle accommodating portion, the transmitter further includes an adhesive tape attached to a lower surface of the transmitter, the adhesive tape being provided in the same number as the number of the plurality of ribs; The adhesive tape is inserted from the open bottom of the cap.

20. The insertion device assembly of claim 18.

Images