Applicator and applicator assembly for medical device

Abstract

The applicator according to the present invention is a medical device applicator for attaching a medical device to a user's skin, and includes an applicator body; an insertion unit installed in the applicator body for inserting an insertion portion of the medical device, at least a portion of which is inserted into the user's skin, into the user's skin; an actuating portion installed in the applicator body so that at least a portion of the actuating portion can move from a non-activated position to an activated position for actuating the insertion unit; and a backstop portion for locking at least a portion of the actuating portion in the activated position so that at least a portion of the actuating portion cannot return to the non-activated position from the activated position.

Description

[Technical field]

[0001] The present invention relates to an applicator for a medical device, and more particularly to an applicator and applicator assembly for attaching a medical device to a user's skin when used. [Background technology]

[0002] Recently, with the development of medical technology, various medical devices that are attached to the body of a user have been developed and sold. The medical devices that are attached to the body of a user may be attached to the skin of a patient with a chronic disease and may be useful for monitoring biological information or treating the patient.

[0003] For example, chronic diseases such as diabetes require continuous management, and medical devices that are attached to the skin and measure blood glucose can be used to monitor the blood glucose of diabetic patients. Diabetes is characterized by having almost no subjective symptoms in the early stages, but as the disease progresses, specific symptoms such as excessive drinking, eating, urination, weight loss, general fatigue, itchy skin, and persistent wounds on the hands and feet that do not heal appear. As diabetes progresses further, complications such as vision problems, high blood pressure, kidney disease, stroke, periodontal disease, muscle spasms, neuralgia, and gangrene appear. In order to diagnose and manage diabetes so that the complications do not progress, systematic blood glucose measurement and treatment must be performed at the same time.

[0004] For diabetics and people who have not progressed with diabetes but still have higher than normal levels of sugar in their blood, many medical device manufacturers offer a variety of blood glucose measuring devices that can measure blood sugar.

[0005] There are two types of blood glucose measuring devices: one in which the user takes a blood sample from the tip of a finger and measures blood glucose one time, and one in which the device is attached to the user's abdomen or arm and measures blood glucose continuously.

[0006] Diabetic patients generally go back and forth between hyperglycemia and hypoglycemia, but emergency situations may come from hypoglycemia, leading to loss of consciousness, or even death if hypoglycemia continues for a long time without sugar supply. Therefore, immediate detection of hypoglycemia is very important for diabetic patients, but blood glucose measuring devices that measure blood glucose intermittently have limitations in accurately detecting it.

[0007] Recently, to overcome these limitations, a Continuous Glucose Monitoring System (CGMS) has been developed and is being used, which is inserted into the human body and measures blood glucose levels every few minutes. The Continuous Glucose Monitoring System measures blood glucose continuously by inserting a needle-shaped transcutaneous sensor into areas such as the abdomen and arm, where pain is relatively less, to minimize the user's pain and refusal to take blood.

[0008] The continuous blood glucose monitoring system comprises a sensor unit including a transcutaneous sensor that is inserted into the user's skin to measure blood glucose inside the body, a transmitter for transmitting the blood glucose value measured by the transcutaneous sensor, and a terminal for outputting the transmitted blood glucose value.

[0009] Medical systems using transdermal sensors are manufactured in a wide variety of forms by different manufacturers, and the methods of use are also diverse. Currently, most systems are manufactured and distributed in a way that a single-use sensor unit is attached to the body through an applicator. The user must perform many steps to attach the sensor unit to the skin using the applicator, and after attaching the sensor unit to the body, various follow-up procedures must be performed, such as directly removing the needle inserted into the skin along with the transdermal sensor.

[0010] For example, the user must unwrap the single-use sensor unit and place it correctly on the applicator, insert the sensor unit into the applicator, and then operate the applicator to attach the sensor unit to the skin. After attaching the sensor unit, the user must then remove the needle that was inserted into the skin and attach the transmitter to the sensor unit, which is inconvenient. Summary of the Invention [Problem to be solved by the invention]

[0011] The present invention has been devised in consideration of the above-mentioned points, and aims to provide a medical device applicator and applicator assembly that can be conveniently used to attach a medical device to the skin by minimizing additional work by a user to attach the medical device to the skin, while allowing the medical device to be manufactured in an assembled state.

[0012] Another object of the present invention is to provide an applicator and an applicator assembly for a medical device that prevents reuse of the applicator after the medical device is attached to the skin and allows the applicator to be safely disposed of. [Means for solving the problem]

[0013] In order to achieve the above-mentioned objects, the applicator according to the present invention is a medical device applicator for attaching a medical device to a user's skin, the applicator may include an applicator body, an insertion unit installed in the applicator body for inserting an insertion portion of the medical device, at least a portion of which is inserted into the user's skin, into the user's skin, an actuating portion installed in the applicator body such that at least a portion of the actuating portion can move from a non-activated position to an activated position for actuating the insertion unit, and a backstop portion for locking at least a portion of the actuating portion in the activated position so that at least a portion of the actuating portion cannot return to the non-activated position from the activated position.

[0014] The backstop portion may include a backstop detent provided on one of the applicator body and the actuating portion, and a backstop member provided on the other of the applicator body and the actuating portion to engage with the backstop detent after the actuating portion moves to the activated position.

[0015] The backstop member may include a backstop member body elastically deformably provided on the other one of the applicator body and the actuating portion, and a backstop member snap provided on one side of the backstop member body to engage with the backstop detent.

[0016] Either the applicator body or the actuating portion may be provided with a receiving groove into which at least a portion of the backstop member snap is received when the actuating portion is located at the inactivated position.

[0017] The actuating portion may be provided to be movable in a direction intersecting a direction in which the insertion portion is moved by the insertion unit.

[0018] The insertion unit includes a shuttle to which the insertion portion is detachably connected and which is movably installed on the applicator body to move the insertion portion from a first position at which the insertion portion is separated from the skin of a user to a second position at which the insertion portion is inserted into the skin of a user, and a forward elastic member that provides a moving force to the shuttle so that the shuttle can move to the second position. The actuating portion includes a button portion exposed to the outside of the applicator body, and a stopper portion that can move from the inactivated position to the activated position by the button portion, which engages with the shuttle to prevent the shuttle from moving to the first position from the inactivated position and disengages from the shuttle so that the shuttle can move to the second position from the activated position, and the backstop portion can lock the stopper portion in the activated position.

[0019] The insertion unit may include a needle that can be inserted into the user's skin together with the insertion portion, a carrier coupled to the needle and movably installed on the shuttle, and a retractable elastic member that applies an elastic force to the carrier in a direction from the second position to the first position, and the shuttle may include a fixed portion groove into which a portion of the retractable elastic member is inserted, a contact surface with which the portion of the retractable elastic member inserted into the fixed portion groove comes into contact, and a barrier portion protruding from the contact surface to prevent the portion of the retractable elastic member contacting the contact surface from escaping from the fixed portion groove.

[0020] The applicator according to the present invention includes a locking hook tiltably connected to the applicator body so as to engage with a base unit to detachably connect the base unit to the applicator body, the base unit being attached to the user's skin so that the insertion portion can be connected thereto, and the actuating portion can constrain movement of the locking hook so that the locking hook is not tilted when at least a portion of the actuating portion is located at the inactivated position, and can release the constraint on the locking hook when at least a portion of the actuating portion is located at the activated position.

[0021] The actuating portion may include a button portion exposed to the outside of the applicator body, a stopper portion that moves in a direction intersecting a moving direction of the insertion portion by the button portion, and a stopper protrusion that extends from the stopper portion toward the locking hook to contact one side of the locking hook and restrict the movement of the locking hook.

[0022] The applicator according to the present invention includes a locking body installed on the applicator body so as to be able to engage with or disengage from at least a portion of the working portion, and a moving tap linearly movably connected to the applicator body so as to move from a locking position in which at least a portion is located inside the applicator body to a removal position in which at least a portion is pulled outward from the locking body, wherein the moving tap contacts the locking body at the locking position to bias the locking body so as to engage with at least a portion of the working portion, and the locking body can be disengaged from the working portion when the moving tap moves to the removal position.

[0023] Meanwhile, to achieve the above-mentioned object, the applicator assembly according to the present invention includes an applicator body, a medical device having an insertion portion, at least a portion of which is inserted into a user's skin, and detachably connected to the applicator body, an insertion unit installed in the applicator body for inserting the insertion portion into the user's skin, an actuating portion installed in the applicator body such that at least a portion of the actuating portion can move from a non-activated position to an activated position for actuating the insertion unit, and a backstop portion for locking at least a portion of the actuating portion in the activated position so that at least a portion of the actuating portion cannot return to the non-activated position from the activated position. Effect of the Invention

[0024] According to the present invention, the medical device is manufactured in an assembled state within the applicator, minimizing the additional work required by the user to attach the medical device to the user's skin, and the medical device can be attached to the user's skin simply by operating the applicator.

[0025] In addition, according to the present invention, at least a part of the operating part operated by the user is moved to an activation position that operates the insertion unit and then locked in the activation position, so that the applicator is difficult to reuse after being used once and the applicator can be safely disposed of. [Brief description of the drawings]

[0026] [Figure 1] FIG. 1 is a perspective view showing an applicator assembly according to one embodiment of the present invention. [Diagram 2] FIG. 2 is a view showing a state in which a medical device of an applicator assembly according to an embodiment of the present invention is attached to a user's skin. [Diagram 3] FIG. 3 is a cross-sectional view showing the sensor unit and base unit of the medical device before they are coupled together. [Figure 4] FIG. 4 is a cross-sectional view showing the sensor unit and the base unit combined together. [Diagram 5] 5 and 6 are exploded perspective views showing the sensor unit of the medical device. [Figure 6] 5 and 6 are exploded perspective views showing the sensor unit of the medical device. [Figure 7] FIG. 7 is a diagram showing a state in which a needle is attached to a sensor unit. [Figure 8] FIG. 8 is a diagram showing a base unit of a medical device. [Figure 9] FIG. 9 is a cross-sectional view taken along line II in FIG. [Figure 10] FIG. 10 is a cross-sectional view taken along line II-II in FIG. [Figure 11] FIG. 11 is an exploded perspective view of an applicator assembly according to one embodiment of the present invention. [Figure 12] FIG. 12 shows the locking hook and moving tap of the applicator separated from the base frame. [Figure 13] FIG. 13 is a perspective view showing the middle frame of the applicator. [Figure 14] FIG. 14 is a perspective view showing the bottom surface of the middle frame. [Figure 15] FIG. 15 is an exploded view of the insertion unit assembly of the applicator. [Figure 16] FIG. 16 is an exploded perspective view showing a portion of the insertion unit assembly. [Figure 17] FIG. 17 is a perspective view showing the working portion of the applicator. [Figure 18] 18 and 19 are views showing the operating portion in a non-activated position. [Figure 19] 18 and 19 are views showing the operating portion in a non-activated position. [Figure 20] 20 and 21 are views showing the operating part in the activated position. [Figure 21] 20 and 21 are views showing the operating part in the activated position. [Figure 22] 22 to 28 are views showing a process of attaching a medical device to a user's skin using an applicator. [Diagram 23] 22 to 28 are views showing a process of attaching a medical device to a user's skin using an applicator. [Figure 24] 22 to 28 are views showing a process of attaching a medical device to a user's skin using an applicator. [Diagram 25]22 to 28 are views showing a process of attaching a medical device to a user's skin using an applicator. [Figure 26] 22 to 28 are views showing a process of attaching a medical device to a user's skin using an applicator. [Figure 27] 22 to 28 are views showing a process of attaching a medical device to a user's skin using an applicator. [Figure 28] 22 to 28 are views showing a process of attaching a medical device to a user's skin using an applicator. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the medical device applicator and the applicator assembly according to the present invention will be described in detail with reference to the drawings.

[0028] FIG. 1 is a perspective view showing an applicator assembly according to an embodiment of the present invention, and FIG. 2 is a view showing a medical device of the applicator assembly according to an embodiment of the present invention attached to a user's skin.

[0029] The applicator assembly 10 according to an embodiment of the present invention includes a sensor unit 100 having an insertion portion 116 to be inserted into the skin of a user, a base unit 200 which constitutes a medical device 20 together with the sensor unit 100, and an applicator 30 for attaching the medical device 20 to the skin of the user. The applicator assembly 10 may be provided to a user in a state in which the sensor unit 100 and the base unit 200 are separately attached to the applicator 30. The sensor unit 100 and the base unit 200 may be coupled to each other by the applicator 30 and attached to the skin of the user.

[0030] As shown in FIG. 2 , the medical device 20 is attached to the skin of a user to measure biological information and wirelessly transmit the measurement data to an external terminal 5. The external terminal 5 can be a variety of devices capable of receiving the measurement data of the medical device 20, such as a user's mobile terminal, a dedicated medical device, a PC, a server, etc. The biological information that the medical device 20 can measure is not limited to a specific one. As an exemplary embodiment, the medical device 20 can periodically measure the blood glucose of the user and transmit the blood glucose measurement information to the external terminal 5.

[0031] 3 and 4, the medical device 20 includes a sensor unit 100 for measuring biometric information of a user, and a base unit 200 attached to the skin of the user and coupled to the sensor unit 100. The base unit 200 may have electronic components installed therein. The base unit 200 is electrically connected to the sensor unit 100, and may process the biometric information measured by the sensor unit 100 and transmit the processed information to an external terminal 5.

[0032] 3 to 7, the sensor unit 100 includes a sensor 110 having an insertion portion 116 that is inserted into the user's skin, a sensor unit housing 120 to which the sensor 110 is coupled, and a sensor adhesive portion 149 and an adhesive pad 152 for fixing the sensor 110 to the sensor unit housing 120.

[0033] The sensor 110 has at least a portion inserted into the skin of a user to sense an analyte in the skin of the user and generate an electrical signal. The sensor 110 includes a sensor body 111, a connecting part 112 connected to one side of the sensor body 111, a middle part 113 connected to the sensor body 111 via the connecting part 112, and an insertion part 116 connected to the middle part 113 so as to be inserted into the skin of the user.

[0034] The sensor body 111 is disposed inside the sensor unit housing 120. The sensor body 111 is provided with a sensor mating portion 118. The connecting portion 112 extends from one side of the sensor body 111 and connects the sensor body 111 and the middle portion 113 so that they are placed on different planes. The sensor 110 may be manufactured such that the sensor body 111 is manufactured in a flat plate form so that the middle portion 113 and the insertion portion 116 are placed on the same plane, and then the connecting portion 112 is bent so that the sensor body 111 is placed on different planes from the middle portion 113 and the insertion portion 116.

[0035] The middle part 113 and the insertion part 116 are connected to the sensor body 111 so as to be placed on a different plane from the sensor body 111. Although the drawing shows the middle part 113 and the insertion part 116 being placed on the same plane and the middle part 113 being placed perpendicular to the sensor body 111, the angle between the middle part 113 and the sensor body 111 and the angle between the insertion part 116 and the sensor body 111 can be changed in various ways. The middle part 113 includes a first extension part 114 protruding from the connection part 112 in one direction, and a second extension part 115 protruding from the connection part 112 in a direction opposite to the protruding direction of the first extension part 114.

[0036] The insertion part 116 may be connected to the first extension part 114 and inserted into the user's skin. The insertion part 116 is formed in a relatively thin and long probe shape so that it can be smoothly inserted into the user's skin. The connection part 112, the middle part 113 and the insertion part 116 may be provided with conductive traces that are electrically connected to the electrodes of the sensor body 111. The sensor 110 may be coupled to the sensor unit housing 120 such that the sensor body 111, the connection part 112 and the middle part 113 are located inside the sensor unit housing 120 and only the insertion part 116 protrudes from the sensor unit housing 120.

[0037] The sensor unit housing 120 includes a housing base 121 and a housing cap 134 that covers an upper portion of the housing base 121. A space for accommodating the sensor 110 is provided inside the sensor unit housing 120.

[0038] The housing base 121 includes a base portion 122 that supports the sensor body 111, and a boss 127 protruding from a surface of the base portion 122. A through hole 124 is formed on one side of the base portion 122 in the thickness direction of the base portion 122. A detent groove 125 is formed on an edge of the base portion 122. A housing base hole 128 is formed in the boss 127. The insertion portion 116 and a needle 485 for inserting the insertion portion 116 into the skin of a user can be inserted into the housing base hole 128. A housing mating portion 130 that can be mated with the sensor mating portion 118 of the sensor 110 is formed on one side of the housing base 121. The sensor mating portion 118 is mated with the housing mating portion 130, so that the sensor 110 can be stably coupled to the housing base 121. Although the drawings show the sensor mating portion 118 including a hole and the housing mating portion 130 including a protrusion that can be inserted into the hole, the shape of the sensor mating portion 118 and the shape of the housing mating portion 130 can be changed in various ways.

[0039] The housing cap 134 is coupled to the housing base 121 to cover the sensor body 111 placed on the housing base 121 and the upper portion of the housing base 121. A housing cap hole 135 is formed in the middle of the housing cap 134 so as to penetrate the housing cap 134 in the thickness direction. The housing cap hole 135 is connected to the housing base hole 128 of the housing base 121. The needle 485 can be protruded to the outside of the sensor unit housing 120 through the housing cap hole 135 and the housing base hole 128. A sensor unit groove 138 is formed on the upper surface of the housing cap 134. In addition, the housing cap 134 is provided with a detent protrusion 138 that is inserted into the detent groove 125 of the housing base 121. A retention protrusion 136 is formed on the inner surface of the housing cap 134 facing the housing base 121.

[0040] The retention protrusion 136 is disposed such that its end faces the second extension part 115 of the middle part 113 inserted into the housing base hole 128, thereby restricting the movement of the middle part 113 so that the middle part 113 of the sensor 110 does not rise up. Due to the action of the retention protrusion 136, the insertion part 116 of the sensor 110 can be stably maintained in a state protruding a certain length from the sensor unit housing 120. Furthermore, due to the action of the retention protrusion 136, the insertion part 116 of the sensor 110 can be maintained in a state of being inserted into the user's skin at a certain depth without retracting from the user's skin when inserted into the user's skin.

[0041] The sensor adhesive part 149 is disposed between the housing base 121 and the sensor body 111 to attach the sensor body 111 to the housing base 121. The sensor adhesive part 149 may be in the form of a double-sided tape having adhesive properties on both sides. A sensor adhesive part opening 150 is formed in the middle of the sensor adhesive part 149 so as to penetrate the sensor adhesive part 149 in the thickness direction.

[0042] The adhesive pad 152 is disposed between the housing cap 134 and the sensor body 111 to attach the sensor body 111 to the housing cap 134. The adhesive pad 152 may be in the form of a double-sided tape having adhesive properties on both sides.

[0043] 3, 4 and 8, the base unit 200 includes a base unit housing 210 to which the sensor unit 100 is coupled, electronic components installed inside the base unit housing 210, an adhesive layer 230 provided on the base unit housing 210 to be attached to the sensor unit 100, and a protective sheet 240 covering the adhesive layer 230. The electronic components may include a substrate 223, an electrical contact 225 that contacts the sensor 110, a battery 228, etc. A processor chip for processing signals, a communication chip for wireless communication with an external terminal 5, etc. may be mounted on the substrate 223.

[0044] The base unit housing 210 includes an insertion hole 211 through which the insertion part 116 and the needle 485 of the sensor 110 can pass, and a mounting part 212 to which the sensor unit housing 120 is coupled. The mounting part 212 includes a base unit recess 213. The insertion hole 211 is formed in a shape in which the boss 127 of the sensor unit 100 can be fitted and coupled, and is disposed inside the base unit recess 213. The sensor unit housing 120 can be fitted and coupled to the base unit recess 213 to maintain a stable coupling state with the base unit housing 210. Since the sensor unit housing 120 is stably fitted and coupled to the base unit housing 210, moisture or foreign matter cannot easily enter the needle between the sensor unit housing 120 and the base unit housing 210. A housing groove 217 is formed on the outer edge of the base unit housing 210. A part of the locking hook 360 provided on the applicator 30 can be inserted into the housing groove 217.

[0045] The electrical contact 225 contacts the sensor 110 when the sensor unit 100 is coupled to the base unit 200. The electrical contact 225 is electrically connected to the substrate 223, and an upper end of the electrical contact 225 protrudes higher than the adhesive layer 230. The electrical contact 225 can contact the sensor body 111 through the through-hole 124 and the sensor adhesive opening 150 of the sensor unit 100 when the sensor unit 100 is coupled to the base unit 200. The electrical contact 225 can be elastically deformed when in contact with the sensor body 111 so as to be in stable contact with the sensor body 111.

[0046] The adhesive layer 230 is disposed on one side of the base unit housing 210. The adhesive layer 230 may be in the form of a double-sided tape having adhesive properties on both sides. The adhesive layer 230 may attach the sensor unit housing 120 to the base unit housing 210. Adhesive layer holes 231 and 232 are formed in the middle of the adhesive layer 230 so as to penetrate the adhesive layer 230 in the thickness direction. One adhesive layer hole 231 is connected to the insertion hole 211. The electrical contact portion 225 may protrude on the adhesive layer 230 through one different adhesive layer hole 232. The adhesive layer 230 may connect the sensor unit housing 120 and the base unit housing 210 when the sensor unit 100 is connected to the base unit 200, and may seal between the sensor unit housing 120 and the base unit housing 210 to prevent moisture or foreign matter from entering the electrical contact portion 225.

[0047] The protective sheet 240 covers and protects the adhesive layer 230. The protective sheet 240 is made of a material that can be detachably attached to the adhesive layer 230. If the adhesive layer 230 is exposed to air for a long period of time, the adhesiveness of the adhesive layer 230 may deteriorate. The protective sheet 240 covers the adhesive layer 230 to prevent the adhesiveness of the adhesive layer 230 from decreasing, and facilitates the handling of the base unit 200 by an operator during the manufacturing process of the base unit 200 and the process of assembling the base unit 200 to the applicator 30. The protective sheet 240 includes a protective portion 241 that covers the adhesive layer 230 and a wing portion 242 that extends from the protective portion 241. The protective portion 241 has a protective sheet opening 244 formed to penetrate the protective portion 241 in the thickness direction. When the protective portion 241 covers the adhesive layer 230, the protective sheet opening 244 can be connected to the adhesive layer hole 232 of the adhesive layer 230. A protective sheet hole 245 is formed in the wing portion 242 so as to penetrate the wing portion 242 in the thickness direction. The wing portion 242 extends outward from the base unit housing 210 so as to be coupled with the moving tap 600 of the applicator 30.

[0048] The shape of the protective sheet 240 is not limited to that shown in the drawings, and may be modified in various ways.

[0049] The base unit 200 is mounted on the applicator 30 with the protective sheet 240 attached to the adhesive layer 230. The protective sheet 240 can be separated from the adhesive layer 230 by a moving tap 600 before the sensor unit 100 is coupled to the base unit 200. After the protective sheet 240 is removed from the base unit 200 by the moving tap 600, the sensor unit 100 can move toward the base unit 200 and be coupled to the base unit 200.

[0050] An adhesive part 250 is provided on the surface of the base unit housing 210. The adhesive part 250 allows the base unit housing 210 to be attached to the skin of a user. A hole may be provided in the middle of the adhesive part 250 through which the insertion part 116 of the sensor 110 and the needle 485 can pass. The adhesive part 250 may be covered and protected by a protective sheet 260. The protective sheet 260 may be removed during the process of attaching the base unit 200 to the skin of a user.

[0051] The sensor unit 100 and the base unit 200 are installed in an applicator 30 in a mutually separated state, and are mutually coupled in the process of the applicator 30 operating to insert the sensor 110 into the skin of the user to form the medical device 20. The sensor unit 100 is mounted on the applicator 30 in a state in which the needle 485 is coupled, and can move toward the base unit 200 in a state in which the needle 485 is coupled, and be coupled to the base unit 200. After the sensor unit 100 is coupled to the base unit 200, the needle 485 is separated from the sensor unit 100, and only the medical device 20 remains on the skin of the user.

[0052] As another exemplary embodiment, the base unit 200 may be configured to simply support the sensor unit 100 without any electronic components so that it is not separated from the skin of the user. In this case, a separate electronic unit capable of processing biological information measured by the sensor unit 100 and transmitting the biological information to the external terminal 5 may be detachably coupled to the base unit 200. The separate electronic unit may be coupled to the base unit 200 so as to be electrically connected to the sensor unit 100 after the sensor unit 100 is coupled to the base unit 200.

[0053] 9 to 21, the applicator 30 operates with the sensor unit 100 and the base unit 200 attached to it, combines the sensor unit 100 and the base unit 200, and attaches the medical device 20, with the sensor unit 100 and the base unit 200 combined, to the skin of a user. After attaching the medical device 20 to the skin of a user, the applicator 30 is separated from the medical device 20, and the medical device 20 remains attached to the skin of the user by the adhesive part 250.

[0054] The applicator 30 includes an applicator body 300 to which the base unit 200 is detachably coupled, an insertion unit assembly 400 including an insertion unit 430 for inserting the sensor 110 into the skin of a user, an actuation part 500 installed on the applicator body 300 so as to be operable by a user, and a moving tap 600 for removing the protective sheet 240. The insertion unit 430 can move the sensor unit 100 from a first position spaced apart from the base unit 200 by a preset distance to a second position where the sensor unit 100 is coupled to the base unit 200.

[0055] The applicator body 300 includes a base frame 310 , a middle frame 330 disposed on the base frame 310 , and a top case 370 coupled to the middle frame 330 to cover the middle frame 330 .

[0056] The base frame 310 has a bottom 312 that can contact the skin of the user. The bottom 312 of the base frame 310 is provided with a recess 313 in which the base unit 200 is attached. At least a portion of the base unit 200 can be received in the recess 313 so that the adhesive part 250 faces the skin of the user. A base frame opening 314 is formed in the middle of the base frame 310 so as to penetrate the base frame 310 in the thickness direction. A penetrating part 316 is provided around the base frame opening 314. The penetrating part 316 can support the insertion unit assembly 400. Support parts 318 are provided on both sides of the base frame opening 314. The support parts 318 can rotatably support a locking hook 360 for detachably connecting the base unit 200 to the applicator body 300.

[0057] The locking hook 360 can be engaged with the base unit 200 mounted in the recess 313 to maintain the base unit 200 in a state in which it is placed in the recess 313. The locking hook 360 can be disengaged from the base unit 200 after the medical device 20 is attached to the skin of the user. The locking hook 360 is pivotally coupled to the support 318. The locking hook 360 includes a pivot portion 361 rotatably coupled to the support 318, a hook portion 362 protruding from one side of the pivot portion 361, and an extension portion 363 protruding from the other side of the pivot portion 361. An end of the hook portion 362 can be inserted into the housing groove 217 of the base unit 200 to engage with the base unit 200. An end of the hook portion 362 can be positioned within the recess 313 of the base frame 310 to engage with the base unit 200. The locking hook 360 can maintain the base unit 200 coupled to the applicator body 300 by restricting its movement by the actuator 500 when the hook portion 362 is engaged with the base unit 200. After the sensor unit 100 is coupled to the base unit 200, the locking hook 360 can be released from the restriction by the actuator 500 and disengaged from the base unit 200.

[0058] A stage 320 is provided inside the base frame 310. The stage 320 supports the moving tap 600 so that the moving tap 600 can move linearly stably. An inclined portion 321 is provided at one end of the stage 320.

[0059] In addition, the base frame 310 is provided with an entrance 322. The entrance 322 is formed on one side of the outer surface of the base frame 310. A moving tap 600 placed on the stage 320 can be pulled out to the outside of the base frame 310 through the entrance 322.

[0060] The specific configuration of the base frame 310 is not limited to that shown in the drawings and can be modified in various ways.

[0061] The middle frame 330 includes a stage 331 that supports the actuator 500. A middle frame opening 332 that is connected to the base frame opening 314 of the base frame 310 is provided in the middle of the stage 331. The column member 410 of the insertion unit assembly 400 can be inserted into the base frame opening 314 through the middle frame opening 332. Guide protrusions 334 are provided on both sides of the stage 331. The guide protrusions 334 can guide the actuator 500 to move linearly from the inactive position to the active position. Here, the inactive position is a position where the actuator 500 does not operate the insertion unit 430 so that the sensor unit 100 waits at the first position, and the active position is a position where the actuator 500 can operate the insertion unit 430 so that the sensor unit 100 moves to the second position.

[0062] The middle frame 330 is provided with a locking unit 338 for restricting the movement of the operating part 500 so that the operating part 500 does not move at the inactivated position, an elastic pressure part 345 for elastically supporting the operating part 500, and a backstop member 351 constituting a backstop part 350 for restricting the movement of the operating part 500. The backstop part 350 can lock the operating part 500, which has moved to the activated position, at the activated position so that the operating part 500 does not return to the inactivated position.

[0063] The locking unit 338 is disposed in a through hole 336 formed in the middle of the stage 331. The locking unit 338 includes a locking body 339 connected to the middle frame 330 so as to be engaged with the operating part 500 or disengaged from the operating part 500. The locking body 339 includes a body part 340 elastically connected to the middle frame 330, a hook part 341 connected to one side of the body part 340 so as to be engaged with the operating part 500, and a leg part 342 connected to the other side of the body part 340 so as to contact the moving tap 600. When the leg part 342 contacts the moving tap 600, the locking body 339 can be deflected in a direction in which the hook part 341 engages with the operating part 500. When the leg part 342 disengages from the moving tap 600, the locking body 339 can be deflected in a direction in which the hook part 341 disengages from the operating part 500. That is, when no external force is applied, the locking body 339 can maintain a position where the hook portion 341 does not engage with the operating part 500. Also, the locking body 339 is elastically deformed so that the hook portion 341 engages with the operating part 500 when the moving tap 600 contacts the leg portion 342.

[0064] The configuration of the locking unit 338 is not limited to the one shown in the figure and can be modified in various ways.

[0065] The elastic pressure member 345 contacts one side of the operating part 500 and elastically supports the operating part 500 so that the operating part 500 cannot easily move from the inactive position to the active position. That is, the elastic pressure member 345 can generate a resistance force that resists the force applied by the user to the operating part 500. The elastic pressure member 345 allows the operating part 500 to move when it receives a pressure force equal to or greater than a preset magnitude, thereby preventing accidental operation of the operating part 500.

[0066] The backstop member 351 is disposed in a recess 356 of the middle frame 330 and locks the operating part 500 in the activated position so that the operating part 500, which has moved to the activated position, cannot return to the non-activated position. The backstop member 351 includes a backstop member body 352 elastically connected to the middle frame 330, and a backstop member snap 353 provided on one side of the backstop member body 352 to engage with one side of the operating part 500. The backstop member snap 353 may protrude onto the stage 331. An inclined surface 354 is provided on one side of the backstop member snap 353. When the operating part 500 moves to the activated position, the backstop member 351 can lock the operating part 500 in the activated position by the backstop member snap 353 engaging with one side of the operating part 500.

[0067] The top case 370 covers the upper part of the middle frame 330. A top case opening 371 in which the operating part 500 is disposed is provided on one side of the top case 370.

[0068] The applicator body 300 may be modified to various other configurations in which it is combined with the insertion unit assembly 400 to support the insertion unit assembly 400 and the base unit 200 can be detachably combined therewith, other than the configuration including the base frame 310, the middle frame 330, and the top case 370 as shown in the drawings. Also, the applicator body 300 may be combined with the base unit 200 in various other ways other than the way using the tilting type locking hook 360.

[0069] The insertion unit assembly 400 includes a column member 410 fixed to the applicator body 300, and an insertion unit 430 supported by the column member 410 to be coupled with the sensor unit 100 and move the sensor unit 100 from a first position to a second position. The insertion unit 430 includes a shuttle 431 movably installed inside the column member 410, and a needle assembly 460 that can move together with the shuttle 431. The shuttle 431 is coupled with the sensor unit 100 and can move together with the sensor unit 100 from the first position to the second position. The needle assembly 460 includes a carrier 462 that can move relative to the shuttle 431, and a needle 485 that is coupled to the carrier 462 and can be inserted into the skin of a user.

[0070] The column member 410 is fixed to the applicator body 300 and supports the insertion unit 430. The column member 410 includes a column member body 411 having a column member opening 412 that is open to the outside at one end. A space capable of accommodating the insertion unit 430 is provided inside the column member body 411. A release portion 414 is provided on the inner surface of the column member body 411. The release portion 414 is a portion that can come into contact with a part of the carrier 462 when the carrier 462 moves toward the base unit 200. The release portion 414 releases the carrier 462 from engagement with the shuttle 431, allowing it to move relative to the shuttle 431.

[0071] A clamping portion 416 and a blocking portion 420 for restricting the movement of the shuttle 431 are provided on both sides of the column member body 411 .

[0072] The clamping portion 416 has a clamping portion detent 417 that can engage with one side of the shuttle 431. The insertion unit assembly 400 can be coupled to the applicator body 300 in a state in which the shuttle 431 is temporarily fixed to the column member 410 by the clamping portion 416. When the clamping portion detent 417 of the clamping portion 416 engages with the shuttle latch 438 of the shuttle 431, the shuttle 431 is temporarily fixed to the column member 410, and at this time, the shuttle 431 cannot move. If the shuttle 431 is temporarily fixed to the column member 410 using the clamping portion 416, it is possible to prevent the shuttle 431 from accidentally moving during the assembly of the insertion unit assembly 400. After the insertion unit assembly 400 is coupled to the applicator body 300 during the manufacturing process of the applicator assembly 10, the clamping portion 416 can be disengaged from the shuttle 431. As shown in FIG. 9, the applicator assembly 10 may be provided to a user with the clamping portion 416 disengaged from the shuttle 431.

[0073] The blocking portion 420 can be used to fix the shuttle 431, which has reached the second position, in the second position. The blocking portion 420 has a blocking portion detent 421 that engages with one side of the shuttle 431. After the shuttle 431 moves to the second position, the blocking portion 420 can prevent the shuttle 431 from returning to the first position from the second position by the blocking portion detent 421 engaging with the detent portion 439 of the shuttle 431. Since the blocking portion 420 restricts the movement of the shuttle 431, problems when the shuttle 431 is reloaded or the applicator 30 is reused can be prevented.

[0074] The shuttle 431 is installed in the column member 410 so as to be linearly movable. The shuttle 431 includes a shuttle body 432 having a space inside for accommodating the needle assembly 460. A shuttle protrusion 434 is provided on one side of the shuttle body 432. The shuttle protrusion 434 protrudes from the shuttle body 432 so as to contact the operating part 500. The shuttle 431 is fixed at a first position when the shuttle protrusion 434 contacts the operating part 500, and can move to a second position when the shuttle protrusion 434 is removed from the operating part 500. A shuttle detent 436 is provided inside the shuttle body 432 with which the carrier latch 476 of the carrier 462 can be engaged. When the carrier latch 476 is engaged with the shuttle detent 436, the carrier 462 moves together with the shuttle 431 and cannot move relative to the shuttle 431. When the carrier latch 476 is disengaged from the shuttle detent 436, the carrier 462 can move relative to the shuttle 431. A shuttle bottom 440 is provided at one end of the shuttle body 432, which contacts the sensor unit 100. The shuttle bottom 440 is provided with a shuttle through hole 441 and a push protrusion 442. The needle 485 can be protruded to the outside of the shuttle body 432 through the shuttle through hole 441. The push protrusion 442 is provided so as to be inserted into the sensor unit groove 138 of the sensor unit 100. When the sensor unit 100 is mounted on the insertion unit 430, the push protrusion 442 is inserted into the sensor unit groove 138 of the sensor unit 100, so that the sensor unit 100 does not move and can maintain a fixed position. A fixing part 444 is provided on the inside of the shuttle 431. The fixing part 444 is for fixing a needle release driver 490 that provides a moving force to the carrier 462. The fixing part 444 includes a fixing part groove 445, a contact surface 446, a barrier part 447, and an entrance 448. The contact surface 446 is disposed within the fixing portion groove 445, and the inlet 448 is disposed relatively outwardly of the fixing portion groove 445 and connected to the fixing portion groove 445. The barrier portion 447 is disposed between the fixing portion groove 445 and the inlet 448 and protrudes from the contact surface 446.

[0075] The shuttle 431 moves by receiving a moving force from the shuttle driver 450. The shuttle driver 450 includes a forward elastic member 451 that applies an elastic force to the shuttle 431 in a direction of moving from the first position to the second position. One end of the forward elastic member 451 contacts one side of the column member 410 and the other end contacts one side of the shuttle 431. The shuttle 431 may be installed inside the column member 410 in a state in which the forward elastic member 451 is elastically deformed. The shuttle 431 may wait at the first position in a state in which the shuttle protrusion 434 contacts the actuating part 500 and the forward elastic member 451 is elastically deformed. Then, when the actuating part 500 moves and the shuttle protrusion 434 leaves the actuating part 500, the shuttle 431 may move to the second position by the elastic force of the forward elastic member 451.

[0076] The shuttle driver 450 may be modified to various other configurations capable of providing a moving force to the shuttle 431 other than the configuration including the forward elastic member 451 in the form of a coil spring.

[0077] The needle assembly 460 includes a carrier 462 to which the sensor unit 100 is detachably coupled, and a needle 485 coupled to the carrier 462 so as to penetrate the sensor unit 100. The needle 485, while coupled to the sensor unit 100, can advance from a first position to a second position together with the sensor unit 100 and be inserted into the skin of a user. In addition, the needle 485 can retract together with the carrier 462 at the second position and be separated from the skin of the user and the sensor unit 100.

[0078] The carrier 462 is coupled to the shuttle 431 so as to be relatively movable. A portion of the carrier 462 engages with the shuttle 431, and thus the carrier 462 can move from a first position to a second position together with the shuttle 431. The carrier 462 can be disengaged from the shuttle 431 at the second position and can move backward in a direction away from the sensor unit 100. The carrier 462 includes a carrier body 463 to which a needle 485 is coupled, a plurality of carrier wings 471 extended from the carrier body 463 to be elastically deformed, and a plurality of grip arms 478 coupled to the sides of the carrier body 463. The carrier body 463 includes a fixing portion 469 to which a needle release driver 490 is coupled. The carrier wing 471 includes a wing body 472 elastically connected to the carrier body 463, and a trigger 474 and a carrier latch 476 protruding from the wing body 472. The trigger 474 can contact the release portion 414 of the column member 410 while the carrier 462 moves with the shuttle 431 from the first position to the second position.

[0079] As shown in FIG. 10, the release portion 414 is disposed inside the column member 410 so as to contact the trigger 474. When the carrier 462 moves from the first position to the second position, the trigger 474 contacts the release portion 414, and the carrier wing 471 can be elastically deformed. The carrier latch 476 protrudes outward from the wing body 472. The carrier latch 476 can engage with the shuttle detent 436 of the shuttle 431. When the carrier latch 476 engages with the shuttle detent 436, the carrier 462 can maintain a state in which the retraction elastic member 491 of the needle release driver 490 is elastically deformed, and cannot move in a direction in which the elastic force of the retraction elastic member 491 acts. When the trigger 474 contacts the release portion 414 and the carrier wing 471 is elastically deformed, the carrier latch 476 is released from the shuttle detent 436, and the carrier 462 can move.

[0080] The grip arm 478 is provided on the side of the carrier body 463 so as to be elastically deformable. A plurality of grip arms 478 are arranged on both sides of the carrier body 463 facing each other, and can engage with the sensor unit 100. The grip arm 478 has a grip protrusion 480 that engages with the sensor unit housing 120 and a protrusion 482 that contacts the inner wall 424 of the column member 410. The carrier 462 is coupled to the shuttle 431 such that the carrier body 463 is located inside the shuttle 431 and the end of the grip arm 478 protrudes from the shuttle 431. The carrier 462 can fix the sensor unit 100 in a manner in which the grip arm 478 engages with the sensor unit housing 120. At this time, the surface of the sensor unit housing 120 is in close contact with the shuttle bottom 440 of the shuttle 431, and the push protrusion 442 of the shuttle 431 is inserted into the sensor unit groove 138 of the sensor unit housing 120. Therefore, the sensor unit 100 can be maintained in a state where it is stably coupled to the shuttle 431 .

[0081] 9, the carrier 462 can position the sensor unit 100 in the first position when the insertion unit assembly 400 is coupled to the applicator body 300. When the carrier 462 is positioned in the first position, the protrusion 482 of the grip arm 478 contacts the inner wall 424 of the column member 410. Therefore, the grip arm 478 is biased in a direction to engage with the sensor unit housing 120, and the carrier 462 can maintain a state in which it is stably coupled to the sensor unit 100.

[0082] Meanwhile, when the sensor unit 100 and the carrier 462 move toward the base unit 200 and the sensor unit 100 is coupled to the base unit 200, the protrusion 482 comes off the inner wall 424 of the column member 410. Therefore, the fixing force of the grip arm 478 is weakened when the sensor unit 100 is coupled to the base unit 200. Since the sensor unit 100 is fixed to the base unit 200 by the adhesive layer 230, when the carrier 462 is pulled in a direction away from the medical device 20 by the needle release driver 490, the grip arm 478 can be separated from the sensor unit 100.

[0083] The carrier 462 can move relative to the shuttle 431 by the needle release driver 490. The needle release driver 490 includes a retractable elastic member 491 in the form of a tension spring. The retractable elastic member 491 applies an elastic force to the carrier 462 in a direction away from the sensor unit 100, so that the carrier 462 can be moved so as to be separated from the sensor unit 100 together with the needle 485. One end of the retractable elastic member 491 is coupled to the fixing part 444 of the shuttle 431. In the process of assembling the insertion unit 430, one end of the retractable elastic member 491 enters the fixing part groove 445 through the entrance 448. With one end of the retractable elastic member 491 in the fixing part groove 445, it is adhered to the contact surface 446 by the elastic force of the retractable elastic member 491. At this time, one end of the retractable elastic member 491 cannot be removed from the fixing part 444 by passing through the entrance 448 while being supported by the barrier part 447. Therefore, the retractable elastic member 491 can be stably connected to the fixed part 444. The other end of the retractable elastic member 491 is fixed to the fixed part 469 of the carrier 462. The fixed part 469 of the carrier 462 may have the same structure as the fixed part 444 of the shuttle 431, or may have a different structure.

[0084] The needle release driver 490 may be modified to various other configurations capable of providing a moving force to the carrier 462 other than the configuration including the retraction elastic member 491 in the form of a coil spring.

[0085] The needle 485 is fixed to the carrier 462 and can move from a first position to a second position while being coupled to the sensor unit 100. The needle 485 has a pointed end so that it can be smoothly inserted into the user's skin by passing through the user's skin. When the sensor unit 100 moves to the second position, the needle 485 pierces the user's skin before the sensor 110, so that the sensor 110 can be stably inserted into the skin. The needle 485 is separated from the user's skin after the sensor 110 is inserted into the user's skin. The needle 485 includes a needle body 486 that can be inserted into the user's skin and a needle head 487 coupled to the carrier 462. A needle cuff 489 for fixing the needle head 487 to the carrier 462 is coupled to the needle head 487. The needle cuff 489 is fixed inside the carrier 462 so that the needle head 487 can be fixed to the carrier 462.

[0086] The specific configuration of the needle 485 is not limited to the illustrated one and may be variously changed. Also, the method of coupling the needle 485 and the carrier 462 may be variously changed.

[0087] The insertion unit assembly 400 may be disposed in the applicator body 300 in a state in which the forward elastic member 451 of the shuttle driver 450 for moving the shuttle 431 and the backward elastic member 491 of the needle release driver 490 for moving the needle assembly 460 are elastically deformed. Also, the insertion unit assembly 400 may be coupled to the applicator body 300 in a state in which it is coupled to the sensor unit 100. In the applicator assembly 10 according to an embodiment of the present invention, the shuttle 431, the shuttle driver 450, the needle assembly 460, and the needle release driver 490 constituting the insertion unit 430 may be easily assembled to the applicator body 300 as one assembly together with the column member 410.

[0088] The actuating unit 500 is installed in the applicator body 300 so as to be operated by a user to move from a non-activated position to an activated position. The actuating unit 500 includes a button portion 510 exposed to the outside of the applicator body 300, a stopper portion 520 disposed inside the applicator body 300 to contact the shuttle 431, and a stopper protrusion 535 for limiting the movement of the locking hook 360. The actuating unit 500 may be installed in the applicator body 300 so as to move linearly in a direction intersecting the moving direction of the shuttle 431, more preferably in a direction perpendicular to and intersecting the moving direction of the shuttle 431.

[0089] The stopper part 520 includes a stopper part body 521 supported by the stage 331 of the middle frame 330, and a base part 526 for supporting the shuttle 431. A stopper part opening 522 is formed in the middle part of the stopper part body 521 so as to penetrate the stopper part body 521 in the thickness direction. A backstop detent 528 is provided on the lower surface of the stopper part body 521 with which the backstop member 351 can be engaged. The backstop detent 528 constitutes the backstop part 350 together with the backstop member 351. When the operating part 500 is moved to the activated position by the user, the backstop detent 528 engages with the backstop member snap 353 of the backstop member 351, so that the operating part 500 is locked in the activated position and cannot return to the inactivated position. A receiving groove 529 and a detent groove 530 are provided on the lower surface of the stopper part body 521, in which the backstop member snap 353 can be received.

[0090] As shown in Fig. 19, when the operating part 500 is located at the inactivated position, the backstop member snap 353 is received in the receiving groove 529. And, as shown in Fig. 22, when the operating part 500 is located at the activated position, the backstop member snap 353 is received in the detent groove 530 and engages with the backstop detent 528. An inclined surface 531 is provided between the receiving groove 529 and the detent groove 530. When the operating part 500 is pushed by a user from the inactivated position to the activated position, the inclined surface 354 of the backstop member 351 can move along the inclined surface 531 of the stopper part 520. Therefore, when the operating part 500 moves, the movement resistance force by the backstop member 351 can be reduced.

[0091] The configuration of the backstop portion 350 for locking the actuator 500 in the activated position may be modified in various ways. In another exemplary embodiment, the backstop member may be provided on the actuator, and a backstop detent may be disposed on the applicator body.

[0092] A stopper part detent 524 is provided on one side of the stopper part body 521. The stopper part 520 cannot move when the locking body 339 is engaged with the stopper part detent 524. At this time, even if the button part 510 is operated, the stopper part 520 cannot move from the inactive position and can maintain a state in which it supports the shuttle 431. The stopper part 520 can move from a state in which the locking body 339 is released from engagement with the stopper part detent 524 to the active position.

[0093] The underlay 526 is disposed on the edge of the stopper opening 522. The underlay 526 protrudes from the stopper body 521 and can support the shuttle protrusion 434 of the shuttle 431. When the stopper 520 is located at the inactivated position, the underlay 526 supports the shuttle protrusion 434 and can restrict the movement of the shuttle 431 placed at the first position. When the stopper 520 moves to the activated position, the underlay 526 is released from the shuttle protrusion 434, allowing the shuttle 431 to move to the second position.

[0094] The stopper protrusion 535 protrudes from the stopper body 521 so as to contact one side of the locking hook 360. When the operating part 500 is located at the inactive position, the stopper protrusion 535 can restrict the movement of the locking hook 360 so that the locking hook 360 is not tilted. Meanwhile, when the operating part 500 is located at the active position, the stopper protrusion 535 can release the restriction on the locking hook 360. As shown in FIG. 18, when the operating part 500 is located at the inactive position, the stopper protrusion 535 is located on the extension part 363 of the locking hook 360. At this time, since the stopper protrusion 535 can contact the extension part 363, the locking hook 360 cannot be tilted to be disengaged from the base unit 200. Therefore, when the operating part 500 is located at the inactive position, the base unit 200 can be connected to the applicator body 300 with the locking hook 360 stably engaged with the base unit 200. 20, when the operating part 500 is located at the activation position, the stopper protrusion 535 comes off from above the extension part 363. At this time, the locking hook 360 can be tilted without being interfered with by the stopper protrusion 535. Therefore, when the operating part 500 is located at the activation position, the locking hook 360 can be tilted to release its engagement with the base unit 200, and the base unit 200 can be removed from the applicator body 300.

[0095] The moving tap 600 is coupled to the applicator body 300 so that the protective sheet 240 can be removed by being operated by a user. At least a portion of the moving tap 600 can be pulled out from the inside to the outside of the applicator body 300 through the entrance 328 of the applicator body 300. The moving tap 600 is supported by the stage 320 of the applicator body 300 and can move linearly in a direction perpendicular to and intersecting with the moving direction of the sensor unit 100. The moving tap 600 can move from an initial position coupled with the protective sheet 240 of the base unit 200 located at the second position to a removal position where the protective sheet 240 is separated from the adhesive layer 230. The moving tap 600 includes a pressure unit 636 capable of applying pressure to the protective sheet 240. When the moving tap 600 is located at the initial position, the pressure unit 636 can apply pressure to the protective sheet 240 toward the adhesive layer 230. Therefore, before the protective sheet 240 is separated from the adhesive layer 230, the protective sheet 240 can maintain a state in which it stably covers the adhesive layer 230. When the moving tap 600 is pulled to the removal position, the pressure portion 636 can be elastically deformed by contacting the inclined portion 321 of the base frame 310.

[0096] In addition to the function of removing the protective sheet, the moving tap 600 also has a function of restricting the movement of the stopper part 520 together with the locking unit 338. As shown in Fig. 9, when the operating part 500 is located at the inactive position and the moving tap 600 is located at the initial position, the moving tap 600 supports the locking body 339 of the locking unit 338. At this time, the leg part 342 of the locking body 339 contacts the moving tap 600, so that the locking body 339 is deflected in a direction in which the hook part 341 engages with the stopper part detent 524 of the operating part 500. At this time, even if the operating part 500 is operated, the stopper part 520 cannot move. On the other hand, when the moving tap 600 is pulled out from the entrance 322, the locking body 339 is released from engagement with the operating part 500, and the operating part 500 can move.

[0097] The configuration of the moving tap 600 is not limited to the illustrated one, and may be modified in various ways. For example, the drawing shows the moving tap 600 completely passing through the entrance 328 when it moves to the removal position, but the moving tap 600 may be installed so that only a portion of it passes through the entrance 328 when it moves to the removal position, and the remaining portion is located inside the applicator body 300. In another exemplary embodiment, the moving tap may be installed as a push type. In this case, the moving tap is installed in the applicator body 300 so as to move linearly in a direction intersecting the movement direction of the sensor unit 100, and can be moved by the user to remove the protective sheet 240 or release the binding force against the actuation part 500. The moving tap may be installed in the applicator body 300 so as to be movable in various directions so as to be moved by the user.

[0098] In addition, although the drawings show the locking body 339 being installed in the applicator body 300 so as to be movable by the moving tap 600, the moving tap may have a structure in which the locking body is integrated. In this case, the locking body may be provided in a form capable of elastic deformation on the moving tap so as to engage with the operating part 500, or may be installed so as to be elastically supported.

[0099] Hereinafter, a process of attaching the medical device 20 to the skin of a user using an applicator 30 according to an embodiment of the present invention will be described with reference to FIGS.

[0100] First, as shown in Figures 22 to 24, the protective sheet 240 is removed using the moving tap 600. When the moving tap 600 is pulled by the user to move to the removal position, the moving tap 600 pulls the protective sheet 240 in a direction away from the adhesive layer 230 of the base unit 200, so that the protective sheet 240 can be removed from the adhesive layer 230. When the moving tap 600 moves to the removal position as shown in Figure 24, the locking body 339 is released from the moving tap 600. At this time, the locking body 339 is returned to its original position so as to be disengaged from the operating part 500, and the operating part 500 is converted into a state in which it can be moved by the user.

[0101] In this manner, when the moving tap 600 is moved to the removal position, the operating part 500 is converted into an operable state, so that the applicator 30 can be operated after the protective sheet 240 is removed from the base unit 200. Therefore, the sensor unit 100 can move toward the base unit 200 after the protective sheet 240 is removed from the base unit 200.

[0102] If the insertion unit 430 is operated and the sensor unit 100 moves to the second position without the protective sheet 240 being completely separated, a problem may occur in which the protective sheet 240 is pinched between the sensor unit 100 and the base unit 200, or the sensor unit 100 is connected to the base unit 200 without the protective sheet 240 being completely separated. The applicator 30 according to the present embodiment completes the separation operation of the protective sheet 240 before the sensor unit 100 moves to the first position, thereby preventing the problem of the sensor unit 100 reaching the base unit 200 without the protective sheet 240 being separated. Therefore, the risk of malfunction due to user carelessness can be reduced.

[0103] The applicator 30 is operated with the bottom 312 of the applicator body 300 in contact with the user's skin, and the sensor unit 100 can be moved toward the user's skin. When the bottom 312 of the applicator body 300 is in contact with the user's skin, the base unit 200 can be attached to the user's skin via the adhesive part 250.

[0104] As shown in Figures 25 and 26, when the actuator 500 is pressed by the user, the actuator 500 moves to the activated position while elastically deforming the elastic pressure member 345. At this time, the backstop member snap 353 of the backstop member 351 engages with the backstop detent 528 of the actuator 500, and the actuator 500 is locked in the activated position. When the actuator 500 moves to the activated position, the shuttle 431 is released from the stopper portion 520 and moves to the second position by the forward elastic member 451. When the shuttle 431 moves to the second position, the needle 485 and the sensor 110 are inserted into the user's skin, and the sensor unit 100 is attached to the base unit 200 by the adhesive layer 230. When the shuttle 431 moves to the second position, the trigger 474 of the carrier 462 comes into contact with the release portion 414 of the column member 410. At this time, the carrier wings 471 of the carrier 462 are elastically deformed, causing the carrier latch 476 to disengage from the shuttle detent 436 . When the carrier 462 is disengaged from the shuttle 431, the carrier 462 moves away from the user's skin due to the retraction elastic member 491, as shown in Fig. 27. At this time, the needle 485 slips out of the user's skin, and the medical device 20 maintains a state of being attached to the user's skin by the adhesive part 250. During the process of the needle 485 retracting, the shuttle bottom part 440 of the shuttle 431 located at the second position maintains a state of contact with the sensor unit 100. Also, the pushing protrusion 442 of the shuttle 431 can maintain a state of being inserted into the sensor unit groove 138 of the sensor unit 100.

[0105] After the sensor 110 is inserted into the skin of the user, the applicator body 300 can be separated from the medical device 20 attached to the skin. The locking hook 360 engaged with the base unit 200 while the actuator 500 is locked in the activated position can be tilted. Therefore, as shown in FIG 28, when the user lifts the applicator body 300 from the medical device 20, the locking hook 360 can be tilted and disengaged from the medical device 20.

[0106] As described above, in the applicator assembly 10 according to an embodiment of the present invention, after the user operates the moving tap 600 to remove the protective sheet 240 of the base unit 200, the insertion unit 430 is actuated to move the sensor unit 100 toward the base unit 200. This prevents malfunction due to user carelessness and allows for safe use.

[0107] Furthermore, in the applicator assembly 10 according to one embodiment of the present invention, the actuating part 500 is locked in the activated position and cannot return to the inactivated position after being moved by a user to the activated position for actuating the insertion unit 430. Therefore, the applicator 30 once used cannot be reused and can be safely disposed of.

[0108] Although the present invention has been described above with reference to preferred embodiments, the scope of the present invention is not limited to the embodiments described and illustrated above.

[0109] For example, although the drawings show the sensor unit being detachably coupled to a carrier coupled to a needle and moving from a first position to a second position, the sensor unit may be detachably coupled to the shuttle or a separate member provided on the shuttle and move together with the shuttle.

[0110] Additionally, although the medical device 20 is shown in the drawings as including a sensor 110 that is inserted into the skin of a user to sense an analyte within the skin, the medical device may have a variety of other configurations. In other exemplary embodiments, the medical device may have a variety of other configurations that include an insert portion that is at least partially inserted into the skin of a user in addition to the sensor 110.

[0111] In addition, although the actuation unit 500 is shown as being integral with the button unit 510 and the stopper unit 520 in the drawings, the button unit and the stopper unit may be separate parts. In this case, when a user operates the button unit, the stopper unit can be linked to the button unit to actuate the insertion unit. The button unit and the stopper unit may be installed on the applicator body so as to move in various directions. The backstop unit 350 may be configured to engage with at least a part of the actuation unit, i.e., with one of the button unit and the stopper unit, to lock one of the button unit and the stopper unit in an activated position. In addition, when the button unit and the stopper unit are separate parts, the locking unit 338 may be provided to engage with one of the button unit and the stopper unit to restrict the movement of one of the button unit and the stopper unit.

[0112] In addition, although the drawings show the moving tap for removing the protective sheet as being configured to move the locking unit 338, the moving tap may be installed so as not to affect the movement of the locking unit 338. In this case, a separate component for moving the applicator locking unit 338 may be included. In another exemplary embodiment, the locking unit may be omitted.

[0113] While the present invention has been shown and described in connection with preferred embodiments for illustrating the principles of the invention, the invention is not limited to the exact construction and operation shown and described therein, but rather, those skilled in the art will readily appreciate that numerous changes and modifications may be made to the invention without departing from the spirit and scope of the appended claims.

Claims

1. A medical device applicator for attaching a medical device to a user's skin, An applicator body; an insertion unit disposed on the applicator body for inserting an insertion portion of the medical device, the insertion portion including an insertion portion at least a portion of which is inserted into the skin of a user, into the skin of the user; an actuating portion disposed on the applicator body such that at least a portion of the actuating portion can move from a non-activated position to an activated position for actuating the insertion unit; and and a backstop portion that locks at least a portion of the actuating portion in the activated position so that the at least a portion of the actuating portion cannot return to the non-activated position in the activated position.

2. The backstop portion is a backstop detent provided on either the applicator body or the actuating portion; 2. The applicator of claim 1, further comprising a backstop member provided on the other of the applicator body and the actuating portion to engage with the backstop detent after the actuating portion moves to the activated position.

3. The backstop member is a backstop member body provided on the other one of the applicator body and the actuating portion in an elastically deformable manner; 3. The applicator of claim 2, further comprising a backstop member snap provided on one side of said backstop member body for engaging said backstop detent.

4. 4. The applicator of claim 3, wherein one of the applicator body and the actuating portion is provided with a receiving groove into which at least a portion of the backstop member snap is received when the actuating portion is located in the inactivated position.

5. The applicator according to claim 1 , wherein the actuating portion is adapted to be movable in a direction intersecting a direction in which the inserting portion is moved by the inserting unit.

6. The insertion unit includes: a shuttle movably mounted on the applicator body to move the insertion portion from a first position at which the insertion portion is detachably connected to the applicator body and away from the skin of a user to a second position at which the insertion portion is inserted into the skin of a user; a forward elastic member providing a moving force to the shuttle such that the shuttle can move to the second position; The actuation unit includes: a button portion exposed to the outside of the applicator body; the button portion is movable from the inactivated position to the activated position, and the stopper portion is engaged with the shuttle to prevent the shuttle from moving to the first position in the inactivated position, and is disengaged from the shuttle to allow the shuttle to move to the second position in the activated position, 2. The applicator of claim 1, wherein said backstop portion locks said stopper portion in said activated position.

7. The insertion unit includes: a needle that can be inserted into the skin of a user together with the insertion portion; a carrier coupled to the needle and movably mounted on the shuttle; a retraction elastic member that applies an elastic force to the carrier in a direction from the second position to the first position, 7. The applicator of claim 6, wherein the shuttle comprises a fixing groove into which a portion of the retractable elastic member is inserted, a contact surface with which the portion of the retractable elastic member inserted into the fixing groove comes into contact, and a barrier portion protruding from the contact surface to prevent the portion of the retractable elastic member contacting the contact surface from escaping from the fixing groove.

8. a locking hook that is tiltably coupled to the applicator body so as to engage with a base unit that is attached to the skin of a user so that the insertion portion can be coupled thereto, in order to detachably couple the base unit to the applicator body; 2. The applicator of claim 1, wherein the actuating portion constrains movement of the locking hook so that the locking hook is not tilted when at least a portion of the actuating portion is located at the inactivated position, and releases the constraint on the locking hook when at least a portion of the actuating portion is located at the activated position.

9. The actuation unit includes: a button portion exposed to the outside of the applicator body; a stopper portion that is moved by the button portion in a direction intersecting with a moving direction of the insertion portion; 9. The applicator according to claim 8, further comprising a stopper protrusion extending from the stopper portion toward the locking hook so as to contact one side of the locking hook and restrict the movement of the locking hook.

10. a locking body mounted on the applicator body so as to be engaged with or disengaged from at least a portion of the actuation portion; and a moving tap coupled to the applicator body so as to be linearly movable from a locking position at least a portion of which is located inside the applicator body to a removal position at least a portion of which is pulled outwardly from the locking body; the moving tap contacts the locking body at the locking position and biases the locking body to engage with at least a portion of the working portion; 2. The applicator of claim 1, wherein the locking body disengages from the actuating portion when the moving tap moves to the removal position.

11. An applicator body; a medical device having an insertion portion at least a portion of which is inserted into the skin of a user and detachably coupled to the applicator body; an insertion unit disposed on the applicator body for inserting the insertion portion into the skin of a user; an actuating portion disposed on the applicator body such that at least a portion of the actuating portion can move from a non-activated position to an activated position for actuating the insertion unit; and and a backstop portion that locks at least a portion of the actuating portion in the activated position such that the at least a portion of the actuating portion cannot return to the non-activated position in the activated position.

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