Insertion device assembly for inserting an analyte monitoring device

Abstract

The present invention relates to an insertion device assembly for inserting a device for monitoring an analyte in the body, and may include: a transmitter including an upper case, a lower case, a sensor, a holder, and a through hole; an applicator including an upper housing, a lower housing, a needle assembly, a needle carrier, and a drive unit; and a needle assembly including a needle, a grip portion, a needle ejection portion, and a protruding portion.

Description

Technical Field

[0001] The present disclosure relates to an insertion device assembly, and more particularly, to an insertion device assembly for inserting a device for monitoring an in-vivo analyte.

Background Art

[0002] The content described in this section merely provides background information related to the present disclosure and does not constitute the prior art.

[0003] Recently, while the preference for processed foods has been increasing, people are easily exposed to simple sugars. Due to such an environment, diabetes has also been rapidly increasing. When blood sugar drops suddenly or rises suddenly, diabetic patients may experience shock and rarely may even die. Accordingly, diabetic patients need to continuously monitor their blood sugar.

[0004] In the case of conventional blood sugar measuring instruments, a lancet is used to incise the fingertip, and the blood of a diabetic patient that comes out of the incised gap is inserted into a blood sugar analyzer to calculate the blood sugar.

[0005] Such a blood sugar measuring instrument of this type gives pain and fear to the user. Also, it is realistically difficult to wound one's own finger every hour to draw blood.

[0006] To solve such problems, a continuous glucose monitoring (CGM) system has been developed. If a sensor having a fine thickness and an electronic device (hereinafter, "transmitter") for analyzing an analyte (hereinafter, "blood sugar") measured by the sensor are attached to the skin of a diabetic patient, the blood sugar is continuously measured over a period of one week to 10 days.

[0007] The transmitter's sensor is extremely thin, making it difficult to penetrate the skin directly. Therefore, a configuration is needed in which a needle is inserted into the skin, the sensor is inserted through the gap, and the needle is withdrawn (hereinafter referred to as "applicator").

[0008] On the other hand, according to US document 2021-0038131 A1, the user must insert the sensor introducer 106 into the sensor inserter 500. At that time, the sensor introducer must be oriented correctly when inserting it into the sensor inserter, and the user is likely to experience fatigue during this process. Therefore, it is preferable that the insertion device assembly be constructed with the applicator and transmitter integrated from the time of manufacture.

[0009] Furthermore, according to US document 2022-0322975 A1, the on-skin assembly 102 is assembled while remaining inside the applicator 100 without any special sealing structure between the insertion assembly 118 and the sealing element 110, and is therefore at risk of future contamination.

[0010] Furthermore, US document 2021-0361197 A1 states that the needle unit 550, which houses the sensor unit 520, is positioned to penetrate the upper and lower parts of the body attachable unit 20. However, after the body attachable unit 20 is attached to the user's body and the needle unit 550 is removed, the penetrating area is left open, potentially allowing water or foreign matter to enter and cause infection.

[0011] Furthermore, because the sensor probe 521, which is one part of the sensor unit 520 and is exposed to the outside of the body attachable unit 20, and the sensor body unit 522, which is the other part of the sensor unit 520 and is located inside the body attachable unit 20, are bent at a right angle, there is a risk that the sensor unit 520, which is made of flexible film, may be damaged.

[0012] Furthermore, sterilization methods using sterilization gases for applicators take a long time, and there is a risk of residue remaining. For this reason, E-beams are sometimes used during medical device sterilization, but in such cases, there is a risk of affecting electronic devices.

[0013] Furthermore, with typical applicators, it is difficult to inspect the internal components during the assembly process. This could lead to improper inspection of defective products.

[0014] Furthermore, it is important to maintain the sterile state of the insertion device assembly after sterilization. However, performing double or triple packaging to maintain the sterile state increases manufacturing costs and generates more waste. [Prior art documents] [Patent Documents]

[0015] [Patent Document 1] US 2021-0038131 A1 [Patent Document 2] US 2022-0322975 A1 [Patent Document 3] US 2021-0361197 A1 [Overview of the project] [Problems that the invention aims to solve]

[0016] Therefore, an object of the present disclosure is to provide an insertion device assembly in which an applicator and a transmitter are integrally manufactured and the preparation operation for use is simple.

[0017] Another object of the present disclosure is to provide an insertion device assembly capable of storing a sterilized state by applying a double-sealing structure between the applicator and the transmitter.

[0018] Another object of the present disclosure is to provide an insertion device assembly that is not likely to malfunction even when sterilized by the E-beam method.

[0019] Another object of the present disclosure is to provide an insertion device assembly in which defects can be confirmed during the manufacturing process.

[0020] Another object of the present disclosure is to provide an insertion device assembly that simplifies the sealing step for maintaining the sterilized state and is easy to manufacture.

[0021] Another object of the present disclosure is to provide an insertion device assembly that can seal the portion penetrated by the needle after the needle is removed from the transmitter.

[0022] Another object of the present disclosure is to provide an insertion device assembly that prevents damage to a sensor unit, which is an important component for analyzing the concentration of an analyte in the user's body, when inserted into the user's body.

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

Means for Solving the Problems

[0024] To achieve the above objective, the present invention provides a transmitter comprising: an upper case; a lower case coupled to the upper case and forming a housing space inside; a sensor disposed on the lower case; a holder disposed inside the lower case and positioned on the sensor; a lower through-hole located in the lower case and in which the holder is positioned; and an applicator on which the transmitter is mounted, comprising: an upper housing having an opening formed at the bottom and having a button on its outer circumferential surface; a lower housing coupled to the lower opening of the upper housing and forming an internal space with the upper housing; and an applicator disposed on top of the transmitter in the internal space. The present invention provides an insertion device assembly comprising: an applicator including a needle assembly configured to be inserted into the holder at least in part; a needle carrier disposed in the internal space and configured to cause the needle assembly to move linearly; and a drive unit configured to provide power to the needle carrier, wherein the needle assembly includes a needle configured to penetrate the user's skin; a grip portion coupled to one end of the needle carrier; a needle ejector portion disposed between the needle and the grip portion and configured to be coupled to the holder; and a projection formed to protrude from the end of the needle ejector portion and inserted into the holder.

[0025] Also, a transmitter, comprising: an upper case; a lower case coupled to the upper case to form an accommodation space therein; a sensor disposed on the lower case; a holder disposed inside the lower case and on the sensor; a lower through-hole located in the lower case where the holder is located; and a packing portion located on the upper portion of the holder and made of an elastic material; a transmitter including the same; and an applicator to which the transmitter is attached, comprising: an upper housing having an opening formed at the lower portion and buttons provided on the outer peripheral surface; a lower housing coupled to the lower opening of the upper housing to form an internal space with the upper housing; a needle assembly disposed in the internal space above the transmitter and configured such that at least a part thereof is inserted into the holder; a needle carrier disposed in the internal space and configured to linearly move the needle assembly; and a driving portion configured to provide power to the needle carrier; an applicator including the same; and an insertion device assembly including: 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 be coupled to the holder.

[0026] When assembling the insertion device assembly, it is preferable that the protrusion is inserted into the holder, and when using the insertion device assembly, the needle injection portion is pulled out from the holder.

[0027] When assembling the insertion device assembly, the needle is positioned in a state of penetrating the packing portion, and when using the insertion device assembly, the portion of the packing portion that was penetrated by the needle and removed from the holder is preferably closed elastically.

[0028] It is preferable that the upper portion of the holder and the inner upper surface of the upper case are integrally injection-molded.

[0029] Preferably, the upper housing further includes a cap configured to be attached to or removed from the upper housing, the cap comprising: an opening formed on its lower surface; a plurality of ribs, at least a portion of which are located inside the lower housing and which extend radially inward from the inner circumferential surface of the cap; and a needle housing supported by the plurality of ribs and configured to surround at least a portion of the needle.

[0030] The needle assembly further includes a cap injection part that corresponds to the shape of the upper surface of the needle housing and is disposed on the upper surface of the needle housing, wherein the cap injection part is in contact with the lower through-hole side of the lower case and preferably seals the lower through-hole of the lower case.

[0031] The cap injection section is preferably made of an elastic material.

[0032] The plurality of ribs consist of two or more, and are arranged symmetrically around the needle housing portion. The transmitter is attached to the lower surface of the lower case and further includes adhesive tape provided in the same number as the plurality of ribs, and it is preferable that the adhesive tape is inserted through the opening.

[0033] Preferably, the transmitter further includes a Printed Circuit Board (PCB) housed in the housing space of the upper and lower cases, and a dummy PCB connecting the sensor and the PCB.

[0034] Preferably, the transmitter includes an inclined surface formed to slope downward from one side of the lower through-hole, and the inclined surface further includes an inclined track on which a portion of the sensor is placed.

[0035] Preferably, the insertion portion of the sensor is located inside the needle that penetrates the holder, and the inclined surface and the needle form two obtuse-angled bends between one end and the other end of the sensor.

[0036] Furthermore, the present invention provides an insertion device assembly including a transmitter and an applicator configured to mount the transmitter, wherein the insertion device assembly is divided into first to fourth assembly states according to the assembly order, the first assembly including a cap with an open top and bottom; a lower housing disposed inside the cap; a lower case for the transmitter disposed on at least a portion of the lower housing; a sensor disposed on the lower case; a holder disposed inside the lower case and disposed on the sensor; and a needle assembly disposed on the top of the transmitter, configured such that a protruding end is inserted into the holder.

[0037] Furthermore, the present invention provides an insertion device assembly including a transmitter and an applicator configured to mount the transmitter, wherein the insertion device assembly is divided into first to fourth assemblies according to the assembly order, the first assembly including a cap with an open top and bottom; a lower housing disposed inside the cap; a lower case for the transmitter disposed on at least a portion of the lower housing; a sensor disposed on the lower case; a holder disposed inside the lower case and disposed on the sensor; a packing portion located above the holder and made of an elastic material; and a needle assembly located above the transmitter, with a needle located at its end penetrating the packing portion.

[0038] The second assembly preferably further includes the first assembly sterilized with an E-beam, a PCB placed on the lower case, and an upper case coupled to the lower case to form an internal storage space.

[0039] Preferably, the third assembly further includes, in addition to the second assembly, a needle carrier configured to cause the needle assembly to move in a linear motion; and a drive unit configured to provide power to the needle carrier.

[0040] Preferably, the fourth assembly further includes, in addition to the third assembly, an adhesive tape that adheres to the lower surface of the lower case; and a sealing portion configured to seal the open lower part of the cap.

[0041] The needle assembly preferably includes a needle configured to penetrate the user's skin; a grip portion coupled to one end of the needle carrier; a needle ejection portion positioned between the needle and the grip portion and configured to be coupled to the holder; and a projection formed to protrude from the end of the needle ejection portion and inserted into the holder.

[0042] The cap includes, at least a portion of which is disposed inside the lower housing, a plurality of ribs extending radially inward from the inner circumferential surface of the cap; a needle housing supported by the plurality of ribs and configured to surround at least a portion of the needle; and a cap injection part corresponding to the shape of the upper surface of the needle housing and disposed on the upper surface of the needle housing, wherein the cap injection part is preferably positioned in contact with the lower through-hole located on the lower surface of the lower case.

[0043] The plurality of ribs consist of two or more, and are arranged symmetrically around the needle housing. The transmitter is attached to the lower surface of the lower case and further includes adhesive tape provided in the same number as the plurality of ribs, and the adhesive tape is preferably inserted through the open lower part 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 an integrated unit, and when using the applicator, the needle protection configuration can be removed at the same time simply by removing the cap, which provides convenience to the user.

[0045] Furthermore, the double-sealed structure of the insertion device assembly has the effect of maintaining a sterile state inside the needle and applicator.

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

[0047] Furthermore, because the cap is made of a transparent material, it is possible to visually confirm whether or not a seal is formed between the cap injection part and the transmitter, which has the advantage of simplifying the inspection of defective products.

[0048] Furthermore, since only the sealing portion needs to be attached to the bottom of the cap after the insertion device assembly is complete, the sealing method is simple and convenient during manufacturing.

[0049] Furthermore, in the transmitter, an elastic packing section is located at the point where the needle penetrates, and by sealing the area after the needle is removed, it has the effect of preventing the inflow of water or foreign substances and the resulting infection.

[0050] Furthermore, by using the track structure inside the case that makes up the transmitter to mount the sensor, the bending portion of the sensor is formed gently, which has the effect of preventing damage to the sensor. [Brief explanation of the drawing]

[0051] [Figure 1] This is a front perspective view of an insertion device assembly according to one embodiment of the present disclosure. [Figure 2]This is an exploded perspective view of an insertion device assembly according to one embodiment of the present disclosure. [Figure 3] These are overall and exploded perspective views of a transmitter according to one embodiment of the present disclosure. [Figure 4] This shows the inside of a cap according to one embodiment of the present disclosure. [Figure 5] This is a front perspective view of the lower housing according to one embodiment of the present disclosure. [Figure 6] This is a flowchart of a method for assembling an insertion device assembly according to one embodiment of the present disclosure. [Figure 7] This shows the assembly sequence of an insertion device assembly according to one embodiment of the present disclosure. [Figure 8] This is intended to describe the state of an insertion device assembly during the assembly stage according to one embodiment of the present disclosure. [Figure 9] This is intended to describe the state of an insertion device assembly during the assembly stage according to one embodiment of the present disclosure. [Figure 10] This is intended to describe the state of an insertion device assembly during the assembly stage according to one embodiment of the present disclosure. [Figure 11] This is intended to describe the state of an insertion device assembly during the assembly stage according to one embodiment of the present disclosure. [Figure 12] This is an overall perspective view from below of the connecting structure of the PCB, sensor, and dummy PCB located inside the transmitter according to one embodiment of the present disclosure. [Figure 13] This is an exploded perspective view from below of the connecting structure of the PCB, sensor, and dummy PCB located inside the transmitter according to one embodiment of the present disclosure. [Figure 14] These are perspective views showing the track structure of the lower case and the installation of sensors thereon according to one embodiment of the present disclosure. [Figure 15] These are perspective views showing the track structure of the lower case and the installation of sensors thereon according to one embodiment of the present disclosure. [Figure 16]These are longitudinal cross-sectional views showing the configuration of the sensor when the needle assembly is not coupled to the transmitter according to one embodiment of the present disclosure, and the configuration of the sensor when the needle assembly is coupled to the transmitter, respectively. [Figure 17] These are longitudinal cross-sectional views showing the configuration of the sensor when the needle assembly is not coupled to the transmitter according to one embodiment of the present disclosure, and the configuration of the sensor when the needle assembly is coupled to the transmitter, respectively. [Figure 18] This shows how the holder and the upper case are integrally formed in a transmitter according to one embodiment of the present disclosure. [Figure 19] This is for illustrating the coupling of a needle assembly and a transmitter according to other embodiments of the present disclosure. [Figure 20] This shows how the holder and the upper case are integrally formed in a transmitter according to another embodiment of the present disclosure. [Modes for carrying out the invention]

[0052] Hereinafter, several embodiments of this disclosure will be described in detail with illustrative drawings. Note that in assigning reference numerals to the components in each drawing, the same component will be given the same reference numeral whenever possible, even if it is shown in other drawings. Furthermore, in describing this disclosure, if it is determined that a specific description of a relevant known configuration or function would obscure the gist of this disclosure, such detailed description will be omitted.

[0053] In describing the components of the embodiments of this disclosure, reference numerals such as 1st, 2nd, i), ii), a), b), etc., may be used. Such reference numerals are merely for distinguishing a component from other components, and do not limit the nature, order, or sequence of the component in question. Where the specification states that a part "includes" or "companies" a component, this means, unless otherwise clearly stated, that it may include other components rather than excluding them.

[0054] In this disclosure, “insertion device assembly” means an assembly comprising an applicator and a transmitter.

[0055] Furthermore, in this disclosure, "distal position" means a position that is relatively further from the skin than "proximal position." On the other hand, distal and proximal are concepts of relative positions, and can be understood as one element being proximal to another while simultaneously being distal.

[0056] Furthermore, in this disclosure, "fire" means the user's action of activating the applicator so that the needle is inserted into the user's skin.

[0057] Furthermore, in this disclosure, “retraction” means the process by which the needle returns to its original position after being inserted through the user’s skin.

[0058] Furthermore, in this disclosure, "upward" means the direction from the proximal to the distal.

[0059] Furthermore, in this disclosure, "downward" means the direction from distal to proximal.

[0060] Furthermore, in this disclosure, “horizontal” refers to the plane that the applicator contacts when it is used, and may mean the skin surface. In this disclosure, the curvature of the skin surface is not considered, and the explanation is based on the assumption that the user’s skin surface is flat.

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

[0062] Specifically, Figure 1a shows the state with the cap 130 attached, and Figure 1b shows the state with the cap 130 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 into and press-fitted onto the outer circumferential surface of the upper housing 110, and a cap 130 that can be attached to and detached from the upper housing 110 (see Figure 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 exposed (see Figure 1b). By removing the cap 130, the insertion device assembly becomes ready for use by the user.

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

[0066] Referring to Figure 2, an applicator 100 according to one embodiment of the present disclosure may include, in addition to the upper housing 110, button 120, cap 130, and lower housing 140, all or part of the drive unit 150, needle carrier 160, needle assembly 170, transmitter holder 180, desiccant 190, and sealing unit 191.

[0067] The upper housing 110 is configured to be grasped by the user and is preferably substantially cylindrical in shape. On the other hand, the lower part of the upper housing 110 is open.

[0068] The button 120 is positioned and provided on the outer circumferential surface of the upper housing 110 and is configured to pressurize toward the inside of the upper housing 110.

[0069] The cap 130 is configured to be attached to or detached from the upper housing 110 and can protect the inside of the applicator 100 from external contaminants and impacts. The cap 130 is preferably substantially cylindrical in shape.

[0070] The lower housing 140 is positioned 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. When the applicator 100 is in use, the lower housing 140 is configured to be in direct contact with the user's skin.

[0071] Referring further to Figure 2, the drive unit 150 is located in the internal space formed by the upper housing 110 and the lower housing 140. The drive unit 150 is configured to cause the transmitter 200 and the needle assembly 170 to move linearly along the longitudinal direction of the applicator 100. To this end, the drive 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 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 reel spring. The spring 151 is assembled in a compressed state. Meanwhile, the spring 151 is stretched to return to its original state as the fastener that was fixing the compression of the spring 151 is released by pressing the button 120. This causes one end of the spring 151 to rotate. That is, the rotational motion of the spring 151 is converted into the straight line motion of the needle carrier 160 and the needle assembly 170, and the principle of a kind of Scotch yoke or double slider-crank mechanism may be applied.

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

[0074] The locking member 153 is configured such that one end is connected to the button 120 and the other end is fastened to the wheel 152. At that time, a groove is formed on the other end of the locking member 153, which engages with the groove on the wheel 152. This prevents the wheel 152 from rotating and also prevents the spring 151 from being pulled.

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

[0076] The needle carrier 160 is configured to move linearly within the upper housing 110 and the lower housing 140. At that time, the linear motion of the needle carrier 160 is caused by the rotational motion of the drive unit 150. For this reason, the needle carrier is preferably T-shaped overall. The needle carrier 160 is subordinate to the rotational motion of the drive unit 150 by being coupled to the other side of the wheel 152.

[0077] The needle assembly 170 is positioned 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 is configured to move linearly together with the linear motion of the needle carrier 160, subordinate to its linear motion.

[0078] The needle assembly 170 includes all or part of the needle 171, the grip portion 172, and the needle injection portion 173.

[0079] The needle 171 is configured to penetrate the user's skin.

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

[0081] The needle injection section 173 is positioned between the needle 171 and the grip section 172. The needle injection section 173 is formed from different materials than the needle 171 and the grip section 172, and may preferably be made of rubber. For this reason, it is preferable that the needle injection section 173 is double-injected during the manufacturing of the needle assembly 170.

[0082] On the other hand, during the manufacturing of the insertion device assembly, the needle injection section 173 is inserted into the transmitter 200. At this time, the needle injection section 173 is made of rubber, thereby forming a sealed structure with the transmitter 200.

[0083] Furthermore, the end of the needle injection section 173 is formed to protrude, allowing it to be inserted from the top of the holder 230 of the transmitter 200 (see Figure 17). This will be explained in detail in Figures 7 and 8.

[0084] A needle assembly 170 according to one embodiment of the present disclosure can prevent rotation when coupled with a transmitter 200 via a needle injection unit 173.

[0085] On the other hand, according to another embodiment of the present disclosure, instead of the needle assembly 170' being provided with a separate needle injection section, 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 with the upper case 210' of the transmitter 200', a sealed structure is formed while preventing the rotation of the needle 171' (see Figure 19). In connection with this, a detailed explanation will be given below with reference to Figure 19.

[0086] The transmitter holder 180 is positioned 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 is configured to move the transmitter 200 in a linear motion from distal to proximal. The transmitter holder 180 is pressurized from distal to proximal by the needle carrier 160. On the other hand, the transmitter holder 180 can only move from distal to proximal, and not from proximal to distal.

[0087] The desiccant 190 is inserted into the cap 130 through its bottom surface and is configured to dehumidify the inside of the applicator 100.

[0088] 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.

[0089] Figure 3 is an overall perspective view and an exploded perspective view of a transmitter according to one embodiment of the present disclosure.

[0090] A transmitter 200 according to one embodiment of the present disclosure is configured to adhere to the user's skin, analyze the concentration of an analyte in the user's body, and transmit information related to the concentration to an external device. The transmitter 200 is manufactured by being inserted into the applicator 100 during the production stage of the insertion device assembly.

[0091] Referring to Figure 3, the transmitter 200 includes all or part of the upper case 210, PCB 220, holder 230, sensor 240, dummy PCB 245, lower case 250, and adhesive tape 260. A detailed configuration will be described below with reference to Figures 12 to 17.

[0092] Figure 4 shows the inside of a cap according to one embodiment of the present disclosure.

[0093] Referring to Figure 4, the cap 130 according to one embodiment of the present disclosure may be composed of one or more of the following materials: ABS (Acrylonitrile butadiene styrene copolymer), PC (Polycarbonate), and PE (Polyethylene) resins, but any material commonly used in medical devices such as applicators can be applied without limitation. For example, a combination of PC resin and ABS resin can be used, but this can be changed as appropriate according to the designer's choice.

[0094] The cap 130 includes all or part of the opening 131, ribs 132a, 132b, needle housing 133, cap injection part 134, and connecting protrusions 135a, 135b, 135c, 135d.

[0095] The opening 131 is formed on the bottom surface of the cap 130.

[0096] The ribs 132a and 132b are formed extending radially inward from the inner circumferential surface of the cap 130. In one embodiment of this disclosure, two ribs 132a and 132b are formed symmetrically, but the number and shape of the ribs can be appropriately changed according to the designer's choice.

[0097] Because the ribs 132a and 132b are arranged along the diameter of the cap 130, the cap 130 may be bisected when viewed from the bottom or top. That is, the cap 130 may be approximately θ-shaped.

[0098] The needle housing portion 133 is formed at the center of the diameter of the cap 130 and is shaped to accommodate the needle 171. For this purpose, the needle housing portion 133 may be cylindrical with an open top and an internal housing space.

[0099] The needle housing section 133 is supported by rib 132a and other ribs 132b.

[0100] Since the needle housing 133 is integrally formed with the cap 130, when using the applicator 100, the entire needle protection structure can be removed at once simply by removing the cap 130, which is convenient for the user.

[0101] The cap injection section 134 is formed on the upper surface of the needle housing section 133 and is in contact with the lower surface of the lower case 250 of the transmitter 200. On the other hand, the cap injection section 134 can be formed by double injection onto the needle housing section 133 during the manufacturing stage of the cap 130, but is not necessarily limited to this.

[0102] On the other hand, during the manufacturing of the insertion device assembly, the cap injection section 134 comes into contact with the bottom surface of the transmitter 200. At that time, because the cap injection section 134 is made of rubber, a sealed structure can be formed between it and the transmitter 200. This will be explained in detail in Figures 7 and 8.

[0103] One or more connecting protrusions 135a, 135b, 135c, and 135d are formed to project radially inward from the inner circumferential surface of the cap 130. One or more connecting protrusions 135a, 135b, 135c, and 135d are configured to connect to the outer circumferential surface of the lower housing 140. This will be explained with reference to Figure 5.

[0104] Figure 5 is a front perspective view of the lower housing according to one embodiment of the present disclosure.

[0105] Referring to Figure 5, a lower housing 140 according to one embodiment of the present disclosure includes one or more coupling grooves 141a, 141b formed on its outer circumferential surface.

[0106] The coupling grooves 141a and 141b are formed in a radial inward recess from the outer circumferential surface of the lower housing 140, allowing the coupling protrusions 135a, 135b, 135c, and 135d to be placed and coupled. At that time, the number of coupling grooves 141a and 141b is the same as the number of coupling protrusions 135a, 135b, 135c, and 135d. On the other hand, although this disclosure shows that two coupling grooves 141a and 141b are formed, it should be noted that two more coupling grooves are also formed on the unseen side.

[0107] Guide grooves 142a and 142b may be further formed in one of the coupling grooves 141a and 141b. The guide grooves 142a and 142b are formed as recesses radiating inward from the outer circumferential surface of the lower housing 140, but extend along the height direction of the lower housing 140. On the other hand, it is preferable that the width of the coupling grooves 141a and 141b be larger 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 inside the coupling grooves 141a and 141b.

[0108] As an example, guide grooves 142a and 142b may be formed continuously to the left of coupling grooves 141a and 141b. In such a case, coupling protrusions 135a, 135b, 135c, and 135d are coupled to coupling grooves 141a and 141b, but can be moved to the left along the width of coupling grooves 141a and 141b and guide grooves 142a and 142b, and then moved downward along the height direction of guide grooves 142a and 142b to be removed from 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.

[0109] On the other hand, while one embodiment of the present disclosure describes that the lower housing 140 and the cap 130 can be connected or disconnected via connecting protrusions 135a, 135b, 135c, 135d and connecting grooves 141a, 141b, the invention is not necessarily limited to this. For example, the lower housing 140 and the cap 130 can be connected by a hook connection or a screw connection. Alternatively, the two can be fastened together by an opening-and-closing connection between a wing member (not shown) provided on either the cap 130 or the lower housing 140 and a locking opening (not shown) provided on the other.

[0110] 1.2. How to assemble the applicator Figure 6 is a flowchart of the assembly method for an insertion device assembly according to one embodiment of the present disclosure. Figure 7 shows the assembly sequence of an insertion device assembly according to one embodiment of the present disclosure. Figures 8 to 11 illustrate the state of the insertion device assembly during the assembly stage according to one embodiment of the present disclosure.

[0111] Referring to Figures 6 to 11, a method for assembling and sterilizing an insertion device assembly according to one embodiment of the present disclosure will be described.

[0112] First, the cap 130, lower case 250, sensor 240, holder 230, needle assembly 170, and lower housing 140 are assembled in that order (S610, Figure 7(a)). Hereafter, 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 the first assembly (ASSY 1).

[0113] The first assembly (ASSY 1) is shown in Figure 8. Figure 8(a) is a front perspective view of the first assembly (ASSY 1), and Figure 8(b) is a cross-sectional view of the first assembly (ASSY 1). Referring to Figure 8(b), the protrusion of the needle injection unit 173 is inserted into the holder 230, and a friction coupling can be used for the connection between the two, but it is not limited to this, and other types of coupling can also be used.

[0114] When the needle assembly 170 is connected to the top of the transmitter 200, the protruding portion of the needle injection section 173 is inserted into the holder 230, thereby preventing contaminants from flowing into the needle 171 through the space between the needle injection section 173 and the holder 230. Furthermore, the connection between the needle injection section 174 and the holder 230 allows for sterility maintenance and sealing without the use of separate parts.

[0115] On the other hand, when the needle assembly 170 retracts after the applicator 100 has been fired by the user, the transmitter 200 remains distal. Consequently, the protruding portion of the needle ejection section 173, which was inserted into the holder 230, is withdrawn from the holder 230.

[0116] Furthermore, the cap injection section 134 contacts the bottom surface of the lower case 250, forming a structure that seals the lower through-hole 251 of the lower case 250. At that time, the connection between the cap 130 and the lower housing 140 allows the cap injection section 134 to be supported while remaining in contact with the bottom surface of the lower case 250.

[0117] Preferably, at least a portion of the cap 130 is made of a transparent material. This allows for visual confirmation of whether a seal is formed between the cap injection section 134 and the lower part of the transmitter 200, and has the advantage of facilitating acceptance testing for any defective products that are not properly sealed.

[0118] As described above, in one embodiment of the present disclosure, when assembled, the protruding portion of the needle injection section 173 is inserted into the holder 230, and the cap injection section 134 contacts the bottom surface of the lower case 250, forming a double-sealed structure that seals the lower through-hole 251 of the lower case 250 (see Figure 17). This prevents contaminants from flowing into the needle 171 from the upper side of the transmitter 200, i.e., between the needle injection section 173 and the holder 230, and also prevents contaminants from flowing into the needle 171 from the lower side of the transmitter 200, i.e., through the lower through-hole 251, thus protecting the inside of the insertion device assembly from contaminants.

[0119] Furthermore, in the case of needle 171, since it is a part that directly penetrates the user's skin, it is extremely important that a sterile state is maintained, and the double-sealed structure of the insertion device assembly according to this disclosure is remarkably effective in maintaining such a sterile state.

[0120] Furthermore, the double-sealed structure according to one embodiment of the present invention has the advantage of being able to be manufactured without the need for the joining of separate components for sealing and sterilization, and providing a simple structure for sealing and sterilization.

[0121] 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, if it is directly exposed to the E-beam, some functions may be lost. On the other hand, according to this disclosure, since sterilization by the E-beam proceeds in the state of the first assembly (ASSY 1) before the PCB 220 is assembled, there is no risk of the electronic devices mounted on the PCB 220 malfunctioning.

[0122] The PCB 220, upper case 210, and adhesive tape 260 are assembled to the first assembly (ASSY 1) (S630, Figure 7(b)). Hereafter, the assembly formed in step S630 will be referred to as the second assembly (ASSY 2).

[0123] The second assembly (ASSY 2) is shown in Figure 9. Figure 9(a) is a front perspective view of the second assembly (ASSY 2), and Figure 9(b) is a cross-sectional view of the second assembly (ASSY 2).

[0124] Referring to Figures 9(a) and (b), the upper case 210 is joined to the lower case 250. At that time, the upper case 210 and the lower case 250 can be joined by either ultrasonic fusion or UV bonding.

[0125] Subsequently, the needle carrier 160 and the drive unit 150 are assembled to the second assembly (ASSY 2) (S640, Figure 7(c)). On the other hand, Figures 7, 10, and 11 show only the needle carrier 160 being connected, but this is for the sake of explanation, and it should be understood that the drive unit 150 connected to the needle carrier 160 is also assembled together. Hereafter, the assembly formed in step S640 will be referred to as the third assembly (ASSY 3).

[0126] The third assembly (ASSY 3) is shown in Figure 10. Figure 10(a) is a bottom perspective view of the third assembly (ASSY 3), and Figure 10(b) is a cross-sectional view of the third assembly (ASSY 3).

[0127] Referring to Figure 10(a), the opening 131 of the cap 130 remains open.

[0128] Furthermore, referring to Figure 10(b), the needle carrier 160 and the needle assembly 170 can be connected by fastening the connecting arm 161 formed at the lower end of the needle carrier 160 to the grip portion 172 of the needle assembly 170. In this case, a snap-fit ​​method can be adopted for connecting the connecting arm 161 and the grip portion 172, but it is not necessarily limited to this, and screw connections or other methods can be adopted instead.

[0129] Subsequently, the adhesive tape 260, the desiccant 190, and the sealing part 191 are sequentially attached to the third assembly (ASSY 3) (S650, Figure 7(d)). Hereafter, the assembly formed in step S650 will be referred to as the fourth assembly (ASSY 4).

[0130] The fourth assembly (ASSY 4) is shown in Figure 11. Figure 11(a) is a bottom perspective view of the fourth assembly (ASSY 4), and Figure 11(b) is a cross-sectional view of the fourth assembly (ASSY 4).

[0131] Referring to Figure 11(b), the adhesive tape 260 is attached to the bottom surface of the lower case 250. At that time, as mentioned above, the adhesive tape 260 is divided into two parts and inserted through the right and left openings 131 of the cap 130, respectively.

[0132] Once the adhesive tape 260 is attached, the desiccant 190 is inserted into the cap 130, and the cap 130 is sealed by the sealing portion 191.

[0133] On the other hand, according to one embodiment of the present disclosure, the insertion device assembly has the advantage of being easy to seal because only the sealing portion 191 needs to be attached to the lower part of the cap 130 during assembly.

[0134] On the other hand, in this disclosure, after the assembly of the fourth assembly (ASSY 4), the upper housing 110, which is equipped with the button 120, is further assembled, but related explanations and detailed drawings are omitted in this disclosure.

[0135] 1.3. Sterilization test results of applicators and transmitters Sterilization results of insertion device assemblies according to one embodiment or another embodiment of this disclosure have confirmed that no microbial growth is observed.

[0136] Specifically, the test method was carried out according to ISO 11737-2:2019, Sterilization if health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of sterilization process.

[0137] In addition, incubators, low-temperature incubators, autoclavers, and clean benches were used.

[0138] Furthermore, the samples were cultured in soybean casein digestion medium (TSB) for a total of 28 days: 14 days at 30-35°C and 14 days at 20-25°C.

[0139] In this case, when the E-beam irradiation dose was 25 kGy and 35 kGy, the presence or absence of microbial growth was confirmed after microbial culture.

[0140] Tests conducted using the aforementioned experimental method confirmed that no microorganisms grew in all cases, including E-beam irradiation doses of 25 kGy and 35 kGy. This indicates that when the assembly and sterilization method of the insertion device assembly according to the embodiment of this disclosure is adopted, the sterilization and contamination prevention effects from external contaminants are excellent.

[0141] 2. Transmitter Description The configuration of the transmitter 200 of the insertion device assembly according to one embodiment of this disclosure will be described in detail below with reference to the attached Figures 3 and 12 to 17.

[0142] As described above, Figure 3 is an overall perspective view and an exploded perspective view of a transmitter 200 according to one embodiment of the present disclosure.

[0143] Referring to Figure 3, the transmitter 200 may include all or part of the upper case 210, PCB 220, holder 230, sensor 240, dummy PCB 245, lower case 250, and adhesive tape 260.

[0144] The upper case 210 and the lower case 250 are joined vertically to form the external appearance of the transmitter 200, and a predetermined housing space is formed inside the transmitter 200.

[0145] An upper through-hole 211 is formed in the upper case 210, and a lower through-hole 251 is formed in the lower case 250. According to one embodiment of the present invention, an upper through-hole 211 is formed in the central part of the upper case 210, and a lower through-hole 251 is formed in the central part of the lower case 250, but the present invention is not limited thereto.

[0146] The holder 230 is positioned between the upper through-hole 211 and the lower through-hole 251. The holder 230 may be formed in a hollow shape, but is not limited to this. With the needle injection section 173 press-fitted into the holder 230, the needle 171 is positioned to penetrate the upper case 210 and the lower case 250.

[0147] PCB220 is a printed circuit board and is housed in the internal space of the upper case 210 and the lower case 250. The PCB220 is equipped with various electronic components for analyzing the concentration of substances in the user's body detected by the sensor 240 and transmitting information related to the concentration to external devices.

[0148] The sensor 240 is located at the bottom of the holder 230 within the internal housing space of the transmitter 200.

[0149] One end of the sensor 240 extends outside the transmitter 200 through a lower through-hole 251 and is positioned inside the needle 171, and is inserted into the user's body by firing, while the other end is connected to the lower part of the PCB 220 inside the transmitter 200.

[0150] In the following, one end of the transmitter 200 that is inserted into the user's body from the outside will be referred to as the insertion end, and the other end that is connected to the PCB 220 inside the transmitter 200 will be referred to as the connection end.

[0151] The dummy PCB245 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 connected structure of PCB220, sensor240, and dummy PCB245, viewed from below.

[0152] Dummy PCB245 is located between sensor 240 and PCB220. Dummy PCB245 is also composed of a small printed circuit board and electrically connects sensor 240 and the electronic components mounted on PCB220.

[0153] Unlike PCB220, dummy PCB245 does not have any components mounted on it; it only contains printed circuitry for electrically connecting sensor240 and PCB220.

[0154] Referring specifically to Figures 12 and 13, the dummy PCB 245 is located below the PCB 220 and above the sensor 240. One end of the dummy PCB 245 is in contact with the connection point of the sensor 240, and the other end is in contact with the contact points on the periphery side of the PCB 220, thereby physically and electrically connecting the sensor 240 and the PCB 220.

[0155] Sensor 240 and dummy PCB 245 are connected by ultrasonic fusion or ACF (Anisotropic Conductive Film) bonding, and dummy PCB 245 and PCB 220 can be connected by soldering.

[0156] Figures 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 how the sensor 240 is installed thereon.

[0157] Referring to Figure 14, the fixed track 252 is located on the upper surface of the lower case 250.

[0158] The fixing track 252 is formed in a stepped shape by recessing one side of the lower case 250 in a manner corresponding to the connecting portion of the sensor 240, and the sensor 240 is fixedly installed in the lower case 250 by fitting the connecting portion of the sensor 240 into the fixing track 252.

[0159] An inclined track 253 is located on one side of the fixed track 252. The inclined track 253 is formed in such a way that the side of the lower through-hole 251 of the fixed track 252 is inclined downwards.

[0160] Referring to Figure 15, when the sensor 240 is fitted onto the fixed track 252, the portion of the sensor 240 between the connecting portion and the insertion portion is located on the inclined track 253.

[0161] Figure 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 Figure 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.

[0162] Referring to Figures 16 and 17, when the portion of the sensor 240 between the connecting portion and the insertion portion is placed on the inclined track 253, the sensor 240 extending 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 connected in this state, one end of the sensor 240, i.e., the insertion portion, is housed inside the needle 171 and forms a second bent portion 242 that is bent at an obtuse angle. In other words, the middle portion of the sensor 240 is not bent at a right angle directly, but rather two bent portions that form an obtuse angle are formed between one end and the other end of the sensor 240, and the one end and the other end of the sensor 240 are at a right angle with respect to these two bent portions.

[0163] On the other hand, for the sake of clarity in this disclosure, the bent portions 241 and 242 are shown to be formed by discontinuous surfaces, but it should be noted that they can also be continuously bent.

[0164] Although the sensor 240 is made of flexible film and can be bent, when it is bent and folded 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, damage to the film constituting the sensor 240 and the material sputtered onto the film can be prevented.

[0165] Furthermore, before the needle 171 is assembled to the sensor 240, the sensor 240 is formed at a predetermined angle downwards by the first bent portion 241, making it easy to assemble the needle 171, which connects to the upper part of the sensor 240 via the lower part of the transmitter 200.

[0166] Furthermore, the tension applied to the electrodes while the sensor is inserted and fixed in the user's skin can be reduced.

[0167] The adhesive tape 260 is located on the bottom surface of the lower case 250, so that the transmitter 200 is adhered to and secured to the user's skin.

[0168] An opening is formed in the adhesive tape 260 so that the sensor 240, which extends from the lower case 250, can pass through and be positioned within it.

[0169] Referring again to Figure 3, the adhesive tape 260 is divided and constructed according to the position and number of ribs 132a and 132b formed inside the applicator cap.

[0170] In this embodiment, since the two ribs 132a and 132b are arranged along the diameter of the cap 130, the cap 130 is configured in a roughly θ shape with a bisected form when viewed from the bottom or top, and the adhesive tape 260 is also configured on the bottom surface of the lower case 250 in a θ shape with the center divided in half.

[0171] As a result, the adhesive tape 260, which is divided according to the shape of the ribs 132a and 132b, is attached to the bottom surface of the lower case 250, and the cap 130 can be inserted through the right and left openings 131, respectively.

[0172] Furthermore, as shown in Figure 18, in a transmitter 200 according to one embodiment of the present disclosure, the holder 230 can be formed integrally with the upper case 210.

[0173] Specifically, the upper part of the holder 230 is integrally formed by injection molding so that it extends downward from the inner surface of the upper part of the upper case 210.

[0174] This makes it easier to assemble the transmitter 200 and allows for a more secure seal on the top of the transmitter 200.

[0175] Figure 19 illustrates the coupling of a needle assembly and a transmitter according to another embodiment of the present disclosure.

[0176] Figure 19(a) is a front perspective view showing the needle assembly 170' before it is coupled to the transmitter 200', and Figure 19(b) is a cross-sectional view showing the needle assembly 170' coupled to the transmitter 200'.

[0177] Referring to Figure 19(a), the needle assembly 170' according to another embodiment consists of a needle 171' and a grip portion 172'. The transmitter 200' according to another embodiment may further include a packing portion 235'.

[0178] The packing portion 235' is located inside the holder 230', which is situated within the upper case 210' and the lower case 250'. According to one embodiment of the present invention, the holder 230' may be formed in a hollow shape, and the packing portion 235' may also be formed in a corresponding shape.

[0179] The packing section 235' is made of an elastic rubber material and seals the opening at the top of the holder 230.

[0180] Figure 19 shows the packing section 235' as a separate component located on top of the holder 230', but it is also possible to manufacture it integrally with the holder 230' by double injection molding.

[0181] As described above, the sterilization and assembly process proceeds with the needle 171' portion of the needle assembly 170' penetrating the packing portion 235'. After the applicator is fired by the user, the needle assembly 170' retracts, removing the needle 171' that was inserted into the holder 230', and the portion through which the needle 171' had penetrated is closed by the elasticity of the rubber. As a result, when the transmitter 200' is attached and used, the portion through which the needle 171' had penetrated is closed by the packing portion 235' and not exposed to the outside. In particular, the hydrophobicity of the rubber material prevents foreign substances such as water from entering, which has the effect of reducing infection.

[0182] Similarly in this embodiment, the double sealing structure is formed when the cap injection section 134, in the state of the first assembly (ASSY 1), contacts the bottom surface of the lower case 250' and seals the lower through hole 251 of the lower case 250.

[0183] Furthermore, as shown in Figure 20, in the transmitter 200' according to this embodiment, the holder 230' is integrally formed with the upper case 210', thereby achieving the same effects as in the previous embodiment.

[0184] The above description is merely illustrative of the technical concept of this embodiment, and a person with ordinary skill in the art to which this embodiment belongs will be able to make various modifications and variations without departing from the essential characteristics of this embodiment. Therefore, this embodiment is for illustrative purposes only, not to limit the technical concept of this embodiment, and the scope of the technical concept of this embodiment is not limited by such embodiments. The scope of protection of this embodiment should be interpreted in accordance with the following claims, and all technical concepts within an equivalent scope should be interpreted as being included in the scope of rights of this embodiment. [Explanation of symbols]

[0185] 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: Seal part 200, 200': Transmitter 210, 210': Upper case 220: PCB 230, 230': Holder 235': Packing Department 240: Sensor 245: Dummy PCB 250, 250': Lower case 252: Fixed truck 253: Inclined Track 260: Adhesive tape

Claims

1. It is a transmitter, Upper case; A lower case that connects to the upper case to form an internal storage space; A sensor positioned on the lower case; A holder disposed inside the lower case and positioned on the sensor; and A transmitter including a lower through-hole located in the lower housing in which the holder is located; and An applicator to which the aforementioned transmitter is attached, An upper housing having an opening at the bottom and buttons on its outer surface; A lower housing that forms an internal space with the upper housing by being connected to the lower opening of the upper housing; A needle assembly positioned above the transmitter in the aforementioned internal space and configured such that at least a portion of it is inserted into the holder; and A needle carrier, positioned in the aforementioned internal space and configured to cause the needle assembly to move in a linear motion; An applicator including a drive unit configured to provide power to the needle carrier; The aforementioned needle assembly is A needle configured to penetrate the user's skin; A grip portion that connects to one end of the needle carrier; A needle injection unit positioned between the needle and the grip portion and configured to be coupled to the holder; and A protrusion formed at the end of the needle injection section and inserted into the holder; Insertion device assembly.

2. It is a transmitter, Upper case; A lower case that connects to the upper case to form an internal storage space; A sensor positioned on the lower case; A holder located inside the lower case and positioned on the sensor; A lower through-hole located in the lower case in which the holder is positioned; and A transmitter including a packing portion located at the top of the holder and made of an elastic material; and An applicator to which the aforementioned transmitter is attached, An upper housing having an opening at the bottom and buttons on its outer surface; A lower housing that forms an internal space with the upper housing by being coupled to the lower opening of the upper housing; and A needle assembly positioned above the transmitter in the aforementioned internal space, configured such that at least a portion of it is inserted into the holder; A needle carrier arranged in the internal space and configured to cause the needle assembly to move in a linear motion; and An applicator including a drive unit configured to provide power to the needle carrier; The aforementioned needle assembly is A needle configured to penetrate the user's skin; A grip portion that connects to one end of the needle carrier; and A needle injection unit is positioned between the needle and the grip portion and configured to be coupled to the holder; Insertion device assembly.

3. When assembling the aforementioned insertion device assembly, the protruding portion is inserted into the holder. When the insertion device assembly is used, the needle ejection section is pulled out from the holder. The insertion device assembly according to claim 1.

4. When assembling the insertion device assembly, the needle is positioned to penetrate the packing portion. When the insertion device assembly is used, the portion of the packing through which the needle passed is elastically closed as it is removed from the holder. The insertion device assembly according to claim 2.

5. The upper part of the holder and the inner upper surface of the upper case are integrally injection molded. The insertion device assembly according to claim 1 or 2.

6. The present invention further includes a cap configured to be attached to or removed from the upper housing, The aforementioned cap is An opening formed on the lower surface; A plurality of ribs, at least a portion of which are located inside the lower housing, extending radially inward from the inner circumferential surface of the cap; and A needle housing portion supported by the plurality of ribs and configured to surround at least a portion of the needle; The insertion device assembly according to claim 1 or 2.

7. The aforementioned needle assembly is The present invention further includes a cap injection section that corresponds to the shape of the upper surface of the needle housing section and is positioned on the upper surface of the needle housing section, The cap injection section is in contact with the lower through-hole side of the lower case and seals the lower through-hole of the lower case. The insertion device assembly according to claim 6.

8. The aforementioned cap injection section is made of an elastic material. The insertion device assembly according to claim 7.

9. The aforementioned plurality of ribs consist of two or more, and are arranged symmetrically around the needle housing portion. The transmitter further includes adhesive tape that adheres to the lower surface of the lower case, and is provided in the same number as the number of ribs. The adhesive tape is inserted through the opening. The insertion device assembly according to claim 6.

10. The aforementioned transmitter is The enclosure of the upper and lower cases contains a PCB (Printed Circuit Board) and a dummy PCB connecting the sensor and the PCB; further comprising The insertion device assembly according to claim 1 or 2.

11. The aforementioned transmitter is The inclined track includes an inclined surface formed to slope downward from one side of the lower through-hole, on which a portion of the sensor is placed; The insertion device assembly according to claim 1 or 2.

12. The insertion portion of the sensor is located inside the needle, which is positioned through the holder. The inclined surface and the needle form two obtuse-angled bends between one end and the other end of the sensor. The insertion device assembly according to claim 11.

13. An insertion device assembly including a transmitter and an applicator configured to mount the transmitter, The aforementioned insertion device assembly is classified into four states, from the first assembly to the fourth assembly, according to the assembly order. The first assembly is A cap with the top and bottom open; Lower housing positioned inside the cap; Lower case of transmitter positioned on at least a portion of the lower housing; A sensor positioned on the lower case; A holder disposed inside the lower case and positioned on the sensor; and A needle assembly positioned on top of the transmitter, with a protruding end configured to be inserted into the holder; Insertion device assembly.

14. An insertion device assembly including a transmitter and an applicator configured to mount the transmitter, The aforementioned insertion device assembly is classified into four states, from the first assembly to the fourth assembly, according to the assembly order. The first assembly is A cap with the top and bottom open; Lower housing positioned inside the cap; Lower case of transmitter positioned on at least a portion of the lower housing; A sensor positioned on the lower case; A holder located inside the lower case and positioned on the sensor; A packing portion located at the top of the holder and made of an elastic material; and A needle assembly positioned on top of the transmitter, with a needle located at its end that penetrates the packing portion; Insertion device assembly.

15. The second assembly is made by sterilizing the first assembly with E-beam. PCB placed on the lower case; and An upper case that is coupled to the lower case and forms an internal storage space; further comprising The insertion device assembly according to claim 13 or 14.

16. The third assembly is attached to the second assembly, A needle carrier configured to cause the needle assembly to move in a straight line; and A drive unit configured to provide power to the needle carrier; further comprising The insertion device assembly according to claim 13 or 14.

17. The fourth assembly is attached to the third assembly, Adhesive tape attached to the lower surface of the lower case; and A sealing portion configured to seal the open lower part of the cap; further comprising The insertion device assembly according to claim 16.

18. The aforementioned needle assembly is A needle configured to penetrate the user's skin; A grip portion that connects to one end of the needle carrier; A needle injection unit positioned between the needle and the grip portion and configured to be coupled to the holder; and A protrusion formed at the end of the needle injection section and inserted into the holder; The insertion device assembly according to claim 13 or 14.

19. The aforementioned cap is A plurality of ribs, at least a portion of which are located inside the lower housing, extending radially inward from the inner circumferential surface of the cap; A needle housing portion supported by the plurality of ribs and configured to surround at least a portion of the needle; and It includes a cap injection section that corresponds to the shape of the upper surface of the needle housing section and is positioned on the upper surface of the needle housing section, The cap injection section is positioned so as to be in contact with the lower through-hole located on the lower surface of the lower case. The insertion device assembly according to claim 13 or 14.

20. The aforementioned plurality of ribs consist of two or more, and are arranged symmetrically around the needle housing portion. The transmitter further includes adhesive tape that adheres to the lower surface of the lower case, and is provided in the same number as the number of ribs. The adhesive tape is inserted through the open lower part of the cap. The insertion device assembly according to claim 19.

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