Body attachable unit
By manufacturing the body-attached unit for continuous blood glucose measurement in a state assembled in an applicator and integrating a wireless communication chip, the complexity and inconvenience of existing devices are addressed, resulting in improved usability, accuracy, and maintenance for continuous blood glucose monitoring.
Patent Information
- Application Number
- JP2025041578
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2018-09-27
- Filing Date
- 2025-03-14
- Publication Date
- 2025-06-10
- Estimated Expiration
- 2039-06-21
AI Technical Summary
Existing continuous blood glucose monitoring devices require complex and inconvenient operation procedures, including separate attachment of sensor modules and transmitters, which can lead to decreased measurement accuracy and device lifespan.
A body-attached unit for continuous blood glucose measurement is manufactured in a state assembled in an applicator, allowing for simple attachment to the body by operating the applicator, and equipped with a wireless communication chip for convenient communication with external terminals, enabling user-controlled operation start and stable measurement.
This solution minimizes user effort in attaching the body-attached unit, enhances measurement accuracy by allowing stable operation start, and simplifies maintenance through wireless communication, thereby improving the overall usability and effectiveness of continuous blood glucose monitoring.
Smart Images

Figure 2025087913000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a body-attached unit. More specifically, the body-attached unit can be manufactured in a state assembled in an applicator to minimize separate additional work and attached to the body simply by operating the applicator. In particular, by providing a wireless communication chip in the body-attached unit to enable communication with an external terminal, it can be used simply and conveniently without the additional work of connecting a separate transmitter, and maintenance and management can be more easily performed. By starting operation by the user's operation after the body-attached unit is attached to the body, the start time of operation can be adjusted at an appropriate time according to the user's needs, and it can start operation in a stabilized state and enable more accurate blood glucose measurement. The present invention relates to a body-attached unit for blood glucose measurement.
Background Art
[0002] Diabetes is a chronic disease that occurs frequently in modern people. In the case of our country, it has reached more than 2 million people, accounting for 5% of the total population.
[0003] Diabetes is caused by various factors such as obesity, stress, incorrect eating habits, and congenital inheritance, resulting in an absolute or relative deficiency of insulin produced by the pancreas, and the inability to quickly balance blood sugar. As a result, the sugar component in the blood increases absolutely, leading to the onset of the disease.
[0004] Normally, the blood contains a certain concentration of glucose, and tissue cells obtain energy from it.
[0005] However, if glucose increases more than necessary, it cannot be properly stored in the liver, muscles, or fat cells, etc., and accumulates in the blood. As a result, diabetic patients maintain much higher blood sugar than normal people, and excessive blood sugar passes through tissues and is excreted in urine, causing a deficiency of the sugar absolutely necessary for each tissue of the body and bringing abnormalities to each tissue of the body.
[0006] Diabetes is characterized by few symptoms in the early stage. However, as the disease progresses, specific symptoms such as excessive thirst, excessive hunger, polyuria, weight loss, general fatigue, skin itching, and persistent non-healing wounds on the hands and feet may appear. If the disease progresses further, complications such as visual impairment, hypertension, kidney disease, stroke, periodontal disease, muscle spasms and neuralgia, and gangrene may occur.
[0007] In order to diagnose such diabetes and manage it so that it does not progress to complications, systematic blood glucose measurement and treatment must be carried out simultaneously.
[0008] For diabetics and people who have not progressed to diabetes but have higher-than-normal blood sugar detected in their blood, many medical device manufacturers provide various types of blood glucose meters that allow them to measure blood glucose at home.
[0009] Blood glucose meters are available in two types: one in which the user takes a blood sample from the fingertip and performs blood glucose measurement in single units, and the other in which it adheres to the user's abdomen, arm, etc. and continuously performs blood glucose measurement.
[0010] In the case of diabetics, they generally alternate between hyperglycemia and hypoglycemia. Emergency situations occur in a hypoglycemic state. If they lose consciousness or the hypoglycemic state persists for a long time without sugar supply, they may even lose their lives. Therefore, the immediate detection of hypoglycemia is very important for diabetics, but there are limitations in accurately grasping this with a blood sampling type blood glucose meter that measures blood glucose intermittently.
[0011] Recently, in order to overcome such limitations, a continuous glucose monitoring system (CGMS) that is inserted into the human body and measures blood glucose levels at several-minute intervals has been developed, through which the management of diabetics and the response to emergency situations can be easily carried out.
[0012] In addition, for a blood sampling type blood glucose meter, blood glucose measurement is performed by pricking the fingertip, which is sensitive to pain, with a needle for diabetic patients to examine their own blood glucose. Therefore, pain and a sense of rejection are induced during the blood sampling process. In order to minimize such pain and sense of rejection, research and development on a continuous blood glucose measurement system that continuously measures blood glucose after inserting a needle-shaped sensor into relatively less painful areas such as the abdomen and arm has been carried out. Furthermore, research and development on a non-invasive blood glucose measurement system (Non-Invasive Glucose Monitoring System) that measures blood glucose without collecting blood has also been actively carried out.
[0013] For the non-invasive blood glucose measurement system, research has been carried out on various methods such as optical methods, electrical methods, and measurement by exhalation for measuring blood glucose without collecting blood over the past 40-odd years. Cygnus (Redwoo City, Ca, USA) developed and launched the Glucowatch G2 Biographer in the form of a wristwatch using reverse iontophoresis therapy, but its sales were discontinued in 2007 due to problems such as skin irritation problems, problems with assays, problems with the device stopping during sweating, and the inability to better recognize hypoglycemia compared to hyperglycemia. Although many bloodless blood glucose measurement technologies have been reported to have emerged to date, their accuracy has declined and they cannot be used practically.
[0014] The continuous blood glucose measurement device includes a sensor module that adheres to the body's skin to extract body fluid and measure blood glucose, a transmitter that sends the blood glucose value measured by the sensor module to a terminal device, and a terminal device that outputs the received blood glucose value. The sensor module is equipped with a sensor probe formed in a needle pattern that is inserted into subcutaneous fat to extract interstitial fluid, and a separate applicator is used to attach the sensor module to the body.
[0015] Such continuous blood glucose monitoring devices are manufactured in a very diverse form by each manufacturer, and their usage methods are also diverse. However, most continuous blood glucose monitors are manufactured and distributed in a way that the single-use sensor module is attached to the body through an applicator. Users have to perform many steps of work for the operation of the applicator for attaching the single-use sensor module to the body. After attaching the sensor module to the body, various subsequent procedures such as directly extracting the needle have to be performed.
[0016] For example, the packaging of the single-use sensor module has to be exposed and accurately inserted into the applicator. With the sensor module inserted into the applicator, the applicator has to be activated to insert the sensor module into the skin. After insertion, operations such as directly extracting the needle of the sensor module from the skin using a separate instrument have to be performed. Also, operations such as attaching a separate transmitter to the sensor module to send the blood glucose measurement result to the user terminal have to be performed.
[0017] Therefore, there is a problem that the work for measuring blood glucose using a continuous blood glucose monitor is very troublesome and inconvenient. Also, there is a problem that the operation start of the sensor module and the transmitter is not done by the user, which causes problems such as a decrease in the accuracy of blood glucose measurement results and a decrease in the device lifespan. Disclosure of the Invention Problems to be Solved by the Invention
[0018] The present invention is invented to solve the problems of the prior art. The object of the present invention is to manufacture the body attachment unit in a state assembled in the applicator, so that the additional operation of the user for attaching the body attachment unit to the body is minimized, and the body attachment unit can be attached to the body simply by operating the applicator. In particular, by providing a wireless communication chip in the body attachment unit to enable communication with an external terminal, it is possible to use it simply and conveniently without the additional operation of connecting a separate transmitter, and maintenance management can be more easily performed. The present invention provides a body attachment unit for continuous blood glucose measurement.
[0019] Another object of the present invention is to enable the operation to be started by the user's operation after the body attachment unit is attached to the body, so that the operation start time can be adjusted at an appropriate time according to the user's needs, and it is possible to start the operation in a stabilized state and perform more accurate blood glucose measurement. The present invention provides a body attachment unit for continuous blood glucose measurement.
Means for Solving the Problems
[0020] The present invention relates to a body attachment unit for continuous blood glucose measurement that is inserted and attached to the body through an applicator for continuous blood glucose measurement. It includes a housing whose bottom surface is formed to adhere to the skin, a PCB board disposed inside the housing, and a sensor member disposed inside the housing such that one end protrudes externally from the bottom surface of the housing and is inserted into the body when the housing adheres to the skin, and the other end is formed to be able to contact the electrical contact of the PCB board. It also includes a pressurizing operation module that operates by the user's operation to press the other end of the sensor member to contact the electrical contact of the PCB board. The pressurizing operation module is characterized in that it is fixed in a state different from before operation when the operation is completed by the user's operation, and provides a body attachment unit for continuous blood glucose measurement.
[0021] At this time, the pressurizing operation module can be formed such that the pre-operation and post-operation states are distinguishable by the naked eye.
[0022] Further, the pressing operation module is movably coupled to the housing, and includes a moving pressing body that moves by the pressing force of a user and presses at least a partial region of the other end of the sensor member against an electrical contact of the PCB substrate, and a button cover made of a soft material that is coupled to the housing so as to be externally exposed so that the user can perform a pressing operation in a form surrounding the upper surface of the moving pressing body.
[0023] Further, a pressing protrusion that protrudes upward is formed on the upper surface of the moving pressing body, and the button cover is mounted so as to be elastically deformed so as to be in close contact with the pressing protrusion and protrude upward by the pressing protrusion in a state before the operation of the pressing operation module, and when the pressing operation module operates and the moving pressing body moves downward, the close contact state with the pressing protrusion is released and it can return to a flat state.
[0024] Further, the moving pressing body can be formed to be fixed in position while moving in the pressing direction by the pressing force of a user.
[0025] Further, a protruding guide portion that protrudes along the moving direction of the moving pressing body is formed on the moving pressing body, a locking hook is formed on an outer peripheral surface of the protruding guide portion, and an engaging protrusion is formed on the housing so that the locking hook of the protruding guide portion can be engaged and coupled in a state where the moving pressing body has moved in the pressing direction, and the moving pressing body can be fixed in position by the locking hook being engaged and coupled with the engaging protrusion.
[0026] Further, it can be formed to be started by the other end of the sensor member coming into contact with the electrical contact of the PCB substrate by the operation of the pressing operation module.
Advantages of the Invention
[0027] According to the present invention, by manufacturing the body attachment unit in a state assembled in the applicator, it is possible to attach the body attachment unit to the body simply by minimizing the additional work of the user for attaching the body attachment unit to the body and only operating the applicator. In particular, by providing a wireless communication chip in the body attachment unit so as to be communicable with an external terminal device, it is possible to use it simply and conveniently without the additional work of connecting a separate transmitter, and maintenance management can be carried out more easily.
[0028] In addition, by making it possible to start operation by the operation of the user after the body attachment unit is attached to the body, the start time of operation can be adjusted at an appropriate time according to the needs of the user, and there is an effect that operation can be started in a stabilized state and more accurate blood glucose measurement is possible.
Brief Description of the Drawings
[0029]
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Embodiment for Carrying Out the Invention
[0030] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. First, when adding reference numerals to the components of each drawing, it should be noted that the same components are given as identical numerals as much as possible even if they are shown on other drawings. Further, in the description of the present invention, when it is determined that a specific description of a related known configuration or function may obscure the gist of the present invention, the detailed description thereof will be omitted.
[0031] FIG. 1 is a perspective view schematically showing the outer shape of a continuous blood glucose measuring device according to an embodiment of the present invention, FIG. 2 is a perspective view schematically showing the outer shape of a body attachment unit according to an embodiment of the present invention, FIG. 3 is an exploded perspective view schematically showing the configuration of a continuous blood glucose measuring device according to an embodiment of the present invention, FIG. 4 is a cross-sectional view taken along the "B-B" line of FIG. 1, and FIG. 5 is a cross-sectional view taken along the "A-A" line of FIG. 1.
[0032] In a continuous blood glucose measuring device according to an embodiment of the present invention, the body attachment unit 20 is assembled inside the applicator 10 to form a single unit product, and the usage method has a very simple structure in which the additional work of the user during the use of the continuous blood glucose measuring device is minimized.
[0033] The body attachment unit 20 is formed to be attachable to the body so as to extract body fluid and periodically measure blood glucose, and is formed to send the blood glucose measurement result to an external device such as an external terminal device (not shown). In such a body attachment unit 20, a sensor member 520 having one end inserted into the body and a wireless communication chip (see FIG. 27) 540 capable of wireless communication with an external terminal device are arranged inside, and it can be used without the need to additionally couple a separate transmitter.
[0034] The applicator 10 is formed such that the body attachment unit 20 is coupled and fixed therein, and operates to externally discharge the body attachment unit 20 by the operation of the user.
[0035] At this time, the body attachment unit 20 is assembled and manufactured in a state of being inserted inside the applicator 10, and is configured to move in the external discharge direction by the operation of the applicator 10 by the operation of the user and adhere to the body.
[0036] That is, in the manufacturing stage of the sensor applicator assembly 1 according to an embodiment of the present invention, the body attachment unit 20 is assembled and manufactured so as to adhere to the skin only by the operation of the applicator 10 in a state where the body attachment unit 20 is inserted inside the applicator 10, and is supplied to the user in this state. Therefore, the user can attach the body attachment unit 20 to the skin only by simply operating the applicator 10 without any separate additional operation for attaching the body attachment unit 20 to the skin. In particular, since the body attachment unit 20 is provided with a separate wireless communication chip 540 and there is no need to couple a separate transmitter, it can be used more conveniently.
[0037] Conventional general continuous blood glucose measuring devices are such that after uncovering the package of a separately packaged body attachment unit and accurately inserting it into the applicator, the applicator is operated after insertion to attach the body attachment unit to the skin. However, not only is the operation of accurately inserting the body attachment unit into the applicator troublesome and difficult, but in the case of children, the elderly, and the weak, there are problems such as a decrease in blood glucose measurement accuracy due to contamination of the body attachment unit during such an operation.
[0038] In one embodiment of the present invention, during the manufacturing stage, the body attachment unit 20 is manufactured and distributed while being inserted into the applicator 10. This eliminates the process of the user exposing the body attachment unit 20 and inserting it into the applicator 10. Simply by operating the applicator 10, the body attachment unit 20 can be attached to the skin. As a result, usability is improved epochally. In particular, contamination of the body attachment unit 20 can be prevented, and the blood glucose measurement accuracy can be improved.
[0039] Since the body attachment unit 20 is manufactured in a state where it is inserted into the applicator 10 in this way, it is desirable that the body attachment unit 20 and the applicator 10 be used once and cannot be reused. Due to such a non-reusable structure, the applicator 10 according to one embodiment of the present invention is formed such that after it has operated once to eject the body attachment unit 20 inserted inside to the outside, reinsertion of the body attachment unit 20 becomes impossible.
[0040] That is, the applicator 10 is formed in a form with one side open, and the body attachment unit 20 is configured to be ejected to the outside through the open side of the applicator 10. However, if the internal body attachment unit 20 is ejected to the outside through the first operation of the applicator 10, the insertion of the body attachment unit 20 by the user can be configured to be impossible so that another body attachment unit 20 cannot be inserted into the applicator 10 and used later.
[0041] On the other hand, a separate protective cap 200 can be detachably coupled to the applicator 10 so that the external exposure of the body attachment unit 20 inserted inside the applicator 10 is blocked. The user can be configured to operate the applicator 10 and attach the body attachment unit 20 to the body only after separating the protective cap 200.
[0042] At this time, an adhesive tape 560 is attached to the body contact surface of the body attachment unit 20 so that the body attachment unit 20 can adhere to the body. A shaped paper 561 is attached to the body contact surface of the adhesive tape 560 for protecting the adhesive tape 560. The shaped paper 561 of the adhesive tape 560 can be formed to be separated and removed from the adhesive tape 560 in the process of separating the protective cap 200 from the applicator 10.
[0043] For example, the shaped paper 561 can be configured such that one side is adhered to the protective cap 200. Thus, when the user separates the protective cap 200 from the applicator 10, it can be separated and removed from the adhesive tape 560 together with the protective cap 200. When the user separates the protective cap 200 in this way, the shaped paper 561 of the adhesive tape 560 is separated and removed. In this state, the applicator 10 can be activated to attach the body attachment unit 20 to the body.
[0044] Also, the applicator 10 can be formed to couple and fix the body attachment unit 20 when the body attachment unit 20 is inserted inside, and to release the coupled and fixed state with respect to the body attachment unit 20 when the body attachment unit 20 moves outwards and is ejected. Therefore, when the body attachment unit 20 is inserted and assembled inside the applicator 10, the body attachment unit 20 is maintained in a fixed state. When the applicator 10 is activated to eject the body attachment unit 20 outwards and attach it to the skin, the coupled and fixed state between the applicator 10 and the body attachment unit 20 is released. If the applicator 10 is separated in this state, it will be separated from the body attachment unit 20, and only the body attachment unit 20 will remain attached to the skin.
[0045] On the one hand, the body attachment unit 20 according to an embodiment of the present invention can be formed such that the sensor member 520 and the wireless communication chip 540 are started to operate through separate switch means operated by a user. That is, after the body attachment unit 20 is inserted and attached to the body through the applicator 10, the user can start the operation of the body attachment unit 20 through switch means or the like provided in the body attachment unit 20. From such a start time point, the sensor member 520 and the wireless communication chip 540 can operate to measure the blood glucose of the body and send the measurement results to an external terminal. At this time, the switch means operated by the user can be configured in various ways, and detailed descriptions of such switch means and the body attachment unit 20 will be described later with reference to FIGS. 26 to 37 as the center.
[0046] Also, in the body attachment unit 20, the sensor member 520 is disposed inside a housing 510 that is separately formed by an upper housing 512 and a lower housing 511, and one end of the sensor member 520 protrudes from the housing 510 to the outside and is formed to be inserted and attached to the body. The sensor member 520 includes a sensor probe portion 521 inserted into the body and a sensor body portion 522 disposed inside the housing 510. The sensor probe portion 521 and the sensor body portion 522 form one end and the other end of the sensor member 520 in a bent form, respectively.
[0047] At this time, a separate needle portion 550 can be detachably coupled to the housing 510 so that the process of inserting the sensor member 520 into the body is made smooth. The needle portion 550 is configured to surround one end of the sensor member 520 so that one end of the sensor member 520 is stably inserted into the body and is inserted into the body together with the sensor member 520.
[0048] Such a needle part 550 is detachably mounted in a direction penetrating the housing 510 of the body attachment unit 20 as shown in FIG. 2, is formed to surround the outside of the sensor member 520, and has a needle head 551 formed at its upper end. When the body attachment unit 20 moves in the external discharge direction by the applicator 10, such a needle part 550 is inserted into the body ahead of the sensor member 520 to assist the sensor member 520 to be stably inserted into the skin. The needle part 550 is coupled to the needle extraction body 400 of the applicator 10 through the needle head 551, and is formed to be pulled out and removed from the body by the needle extraction body 400 of the applicator 10 after the body attachment unit 20 is inserted and attached to the body by the operation of the applicator 10.
[0049] Next, look a little more closely at the detailed configuration of the applicator 10 according to an embodiment of the present invention.
[0050] The applicator 10 according to an embodiment of the present invention includes a main case 100 to which a pressure button 110 is mounted so as to be pressed by a user on one side, a plunger body 300 that is coupled and fixed to the first position inside the main case 100 and is released from the coupling and fixing at the first position by the operation of the pressure button 110 and linearly moves to the second position which is the external discharge direction, and a plunger elastic spring (S1) that applies an elastic force to the plunger body 300 so that the plunger body 300 linearly moves from the first position to the second position. The body attachment unit 20 is coupled to one end of the plunger body 300 and moves integrally with the plunger body 300 from the first position to the second position.
[0051] As described above, a separate protection cap 200 is detachably coupled to the lower end of the main case 100 to protect the internal body attachment unit 20.
[0052] The protective cap 200 can be configured to include an outer cover portion 201 formed to surround the outer peripheral surface of the applicator 10 in a manner of contacting it as shown in FIGS. 6 to 8 and coupled to one end of the applicator 10, an extension portion 202 extending from one end of the outer cover portion 201 in the inner center direction of the applicator 10, and an inner support portion 203 extending upward from the extension portion 202 to support the body contact surface of the body attachment unit 20 inserted into the applicator 10. At this time, a sensor protection portion 204 can be locally formed to protrude downward so as to surround the sensor probe 521 and the needle portion 550 protruding downward from the body contact surface of the body attachment unit 20 at the center portion of the inner support portion 203.
[0053] Therefore, the protective cap 200 not only blocks the external exposure of the body attachment unit 20 inserted into the applicator 10 but also performs a support function for the body attachment unit 20, and overall improves the structural safety of the applicator.
[0054] On the other hand, as shown in FIGS. 7 and 8, an adhesive tape 560 and a shaped paper 561 are attached to the body contact surface of the body attachment unit 20, and the shaped paper 561 of the adhesive tape 560 is formed to be separated and removed from the adhesive tape 560 together with the protective cap 200 in the process of separating the protective cap 200 from the applicator 10.
[0055] At this time, the irregular-shaped paper 561 can adhere to the upper surface of the inner support portion 203 of the protective cap 200 and can adhere to the inner support portion 203 of the protective cap 200 through a separate adhesive member 562. That is, as shown in FIG. 7, according to the irregular-shaped paper 561, a separate adhesive member 562 is adhered to one side, and such an adhesive member 562 is located between the upper surface of the inner support portion 203 of the protective cap 200 and the irregular-shaped paper 561, and the lower surface is adhered to the upper surface of the inner support portion 203. The adhesive force of the adhesive member 562 is formed to be even greater than the adhesive force between the irregular-shaped paper 561 and the adhesive tape 560. Therefore, when the protective cap 200 is separated from the applicator 10, the irregular-shaped paper 561 adhered to the inner support portion 203 of the protective cap 200 through the adhesive member 562 is separated together and separated and removed from the adhesive tape 560.
[0056] At this time, two cutting lines (not shown) having a separation distance equal to the width of the adhesive member 562 can be formed in parallel in a partial section on the irregular-shaped paper 561. Thus, as shown in FIG. 8, in the process of separating the protective cap 200, the irregular-shaped paper 561 together with the adhesive member 562 is first separated and detached from the adhesive tape 560 along the cutting lines. Subsequently, as the separation process of the protective cap 200 continues, that is, as the protective cap 200 moves downward continuously with reference to the direction shown in FIG. 8, the irregular-shaped paper 561 outside the cutting lines is pulled and separated and removed from the adhesive tape 560. Through such a process of separating and removing the irregular-shaped paper, the operation of separating and removing the irregular-shaped paper 561 can be performed more smoothly and stably.
[0057] A pressure button 110 is mounted on the main case 100 so as to be pressed by a user, and a shooting plate 150 that moves by the pressing operation of the pressure button 110 is movably coupled inside the main case 100.
[0058] The plunger body 300 is engaged and fixed with the shooting plate 150 at the first position and is disengaged by the movement of the shooting plate 150 and moves to the second position by the elastic force of the plunger elastic spring (S1).
[0059] The main case 100 can be separated into an outer case 101 to which a pressure button 110 is attached on one side, and an inner case 102 that is coupled inside the outer case 101 and is formed to guide the linear movement path of the plunger body 300. The shooting plate 150 can be stably supported and moved on the inner case 102.
[0060] The pressure button 110 is coupled to the outer case 101 so as to be pressure-operable. As shown in FIG. 9, button guide grooves 1011 are formed in the outer case 101 so that the pressure button 110 can be coupled to the outer case 101 so as to be pressure-operable. The pressure button 110 is configured to be pressure-operable in a form that rotates about a hinge shaft 112 formed on the upper end side, and a pressure load 111 is formed on the lower end side so as to be able to press the shooting plate 150. A separate fixing hook 113 is formed on one side to prevent the separation and detachment of the pressure button 110.
[0061] Such a pressure button 110 is mounted so that it can be mode-converted between a safety mode in which the pressure movement by the pressure operation is blocked and a pressure standby mode in which the pressure movement by the pressure operation is possible.
[0062] The pressure button 110 can be configured to slide along a certain section along the outer surface of the main case 100 in the safety mode state and be converted to the pressure standby mode state. Locking protrusions 1012 can be formed at the part of the main case 100 where the pressure button 110 is mounted. In the safety mode state, the pressure button 110 is engaged with the locking protrusions 1012 to block the pressure movement, and when it slides from the safety mode state to the pressure standby mode state, the engagement with the locking protrusions 1012 is released so that the pressure movement can be enabled.
[0063] That is, as shown in FIG. 10, the pressure button 110 is engaged with the locking projection 1012 of the external case 101 in the safe mode state, and the pressing operation is impossible. As shown in FIG. 11, if the pressure button 110 moves upward in the pressure standby mode state, the engagement with the locking projection 1012 of the external case 101 is released, and the pressing operation is possible.
[0064] Such a pressure button 110 can be formed so that when it slides from the safe mode state to the pressure standby mode state, it is position-fixed so as not to return to the safe mode state again.
[0065] For this purpose, a fixing projection 114 is formed on one side of the pressure button 110, and an elastically deformable cutout deformation part 1013 is formed on the bottom surface of the button guide groove 1011 of the external case 101 in a form in which a partial section is cut open. The cutout deformation part 1013 is formed with a receiving groove 1014 that can insert and accommodate the fixing projection 114 in a state where the pressure button 110 is positioned in the safe mode, and the end surface is engaged with the fixing projection 114 in a state where the pressure button 110 has completed moving to the pressure standby mode, so as to restrain the return movement of the pressure button 110.
[0066] With such a structure, the pressure button 110 can be pressed only when it is in the pressure standby mode state and slid. This prevents accidental pressing by the user and enables safe use. In particular, when it is converted from the safe mode state to the pressure standby mode state, it cannot return to the safe mode again, which induces the user to operate carefully and can maintain a stable operating state.
[0067] When the pressure button 110 is converted to the pressure standby mode state and pressed as shown in FIG. 12, the pressing load 111 of the pressure button 110 pressurizes and moves the shooting plate 150.
[0068] The shooting plate 150 is stably supported on the inner case 102 and is slidably coupled by the pressing operation of the pressure button 110. The plunger body 300 is engaged with the shooting plate 150 at the first position and disengaged from the shooting plate 150 by the movement of the shooting plate 150, and then moves to the second position by the elastic force of the plunger elastic spring (S1).
[0069] As shown in FIGS. 12 and 13, an engaging hook 310 is formed on the plunger body 300 so as to engage with the shooting plate 150. A locking protrusion 153 that can be engaged with the engaging hook 310 of the plunger body 300 is formed on one side of the shooting plate 150. The locking protrusion 153 is formed such that the engagement state with the engaging hook 310 is released when the shooting plate 150 slides.
[0070] A guide rail 162 is protruded from the inner case 102 to guide the sliding movement path of the shooting plate 150, and a guide slot 151 is formed on the shooting plate 150 so that the guide rail 162 is inserted and guided. An elastic member 163 that elastically supports the shooting plate 150 in a direction opposite to the sliding movement direction by the operation of the pressure button 110 is attached to the inner case 102. Therefore, since the shooting plate 150 is elastically supported toward the pressure button 110 by the elastic force of the elastic member 163, the engagement state with the engaging hook 310 of the plunger body 300 is stably maintained unless the pressure button 110 is pressed.
[0071] With such a structure, when the user presses the pressure button 110, the shooting plate 150 slides, thereby releasing the engagement state between the plunger body 300 and the shooting plate 150, and the plunger body 300 moves outwardly from the first position to the second position as shown in FIGS. 15 and 16 by the elastic force of the plunger elastic spring (S1).
[0072] The plunger body 300 can be formed with a stopper protrusion 320 so as to limit the movement range to the second position, and the stopper protrusion 320 can limit the movement of the plunger body 300 in such a way that the plunger body 300 meshes with one side of the inner case 102 when the plunger body 300 moves to the second position. That is, the plunger body 300 moves to the second position by the stopper protrusion 320 and is not discharged to the outside from the main case 100 beyond that range. At this time, the inner case 102 can be formed with a stopper fixing portion 1021 so as to mesh with the stopper protrusion 320 in a state where the plunger body 300 has moved to the second position and restrain the movement of the stopper protrusion 320.
[0073] Also, a sensor housing portion 301 is formed at one end of the plunger body 300 so that the body attachment unit 20 can be inserted and housed therein. The body attachment unit 20 is inserted and housed in the sensor housing portion 301 and linearly moves from the first position to the second position together with the plunger body 300. When the plunger body 300 and the body attachment unit 20 linearly move to the second position, the sensor probe 521 and the needle portion 550 of the body attachment unit 20 are inserted into the body.
[0074] At this time, a sensor fixing hook 330 is mounted on the edge of the sensor housing portion 301 so as to mesh and engage with the body attachment unit 20 inserted into the sensor housing portion 301 and couple and fix the body attachment unit 20. Engagement coupling grooves 5112 are formed at both end portions of the body attachment unit 20 so as to mesh with the sensor fixing hook 330 in a state where the body attachment unit 20 is inserted into the sensor housing portion 301.
[0075] The sensor fixing hook 330 is elastically rotatably coupled about the rotation axis 331. When the plunger body 300 is in the first position, as shown in FIG. 15, the sensor fixing hook 330 is elastically supported so as to be pressed inward so as to be engaged with the engagement coupling groove 5112 of the body attachment unit 20. When the plunger body 300 is in the second position, as shown in FIG. 16, in the process of separating the applicator 10 from the body attachment unit 20, the sensor fixing hook 330 can be configured to be disengaged from the engagement coupling groove 5112 of the body attachment unit 20. The process of disengaging the sensor fixing hook 330 from the body attachment unit 20 can be performed in such a way that the rotation axis 331 elastically rotates torsionally.
[0076] Although not shown, a hook guide portion (not shown) having a cross-sectional shape in which the inner wall surface of the inner case 102 presses the sensor fixing hook 330 inward so as to be engaged with the body attachment unit 20 and releases the pressure on the sensor fixing hook 330 in the state of the second position movement of the plunger body 300 can also be formed. That is, the hook guide portion can be formed in a form having a protruding surface and a concave surface on the inner wall surface of the inner case 102. The protruding surface is formed to press the sensor fixing hook 330 and the concave surface is formed to release the pressure on the sensor fixing hook 330. The concave surface is formed to release the pressure on the sensor fixing hook 330 in a state where the sensor fixing hook 330 moves to the second position together with the plunger body 300.
[0077] On the other hand, in the present invention, since the body attachment unit 20 is manufactured in a state of being inserted into the applicator 10, it is configured to prevent the insertion of another body attachment unit 20 into the applicator 10 and reuse as described above.
[0078] For this purpose, the main case 100 is provided with a return prevention means for preventing the plunger body 300 from returning to the first position after the plunger body 300 has moved to the second position.
[0079] The return prevention means can be configured to include an engagement body 340 formed on one side of the plunger body 300 as shown in FIGS. 17 to 19, and a return prevention hook 161 formed on the inner case 102 so as to be engaged and coupled with the engagement body 340 of the plunger body 300 when the plunger body 300 has completed its downward movement from the first position to the second position, thereby preventing the return movement of the plunger body 300.
[0080] The return prevention hook 161 is configured such that an elastic restoring force acts during the process of engaging with the engagement body 340 to effect the engagement. More specifically, the return prevention hook 161 can be configured in a form including a rotatable body 1611 elastically rotatably coupled about a rotation axis 1613 on one side of the inner case 102, and a hook body 1612 protruding so as to incline downward inwardly on the inner surface of the rotatable body 1611. At this time, the rotation axis 1613 is formed to elastically support the rotatable body 1611 in a direction in which the hook body 1612 protrudes inwardly by an elastic force due to the material characteristics of the elastic material.
[0081] By means of such a return prevention hook 161, the plunger body 300 is prevented from returning toward the first position again when the movement from the first position to the second position is completed, and thereby the user can also be prevented from arbitrarily inserting and using the other body attachment unit 20.
[0082] If you closely observe the operating state of the anti-return hook 161, when the plunger body 300 is in the first position as shown in FIG. 17 and moves to the second position by operating the pressure button 110, as shown in FIG. 18, during the process of the plunger body 300 moving to the second position, the engagement body 340 of the plunger body 300 presses the hook body 1612, causing the anti-return hook 161 to elastically rotate clockwise (outward direction) around the rotation axis 1613. Thereafter, when the plunger body 300 is moved to the second position as shown in FIG. 19, the pressing state of the hook body 1612 by the engagement body 340 is released, so the anti-return hook 161 returns and elastically rotates counterclockwise (inward direction) around the rotation axis 1613. Thus, due to the elastic return rotation of the anti-return hook 161, the lower end of the anti-return hook 161 is engaged and coupled with the upper end of the engagement body 340 of the plunger body 300, thereby preventing the plunger body 300 from returning to the first position due to the engaged state between the anti-return hook 161 and the engagement body 340.
[0083] On the other hand, the applicator 10 is configured to pull out and remove the needle portion 550 of the body attachment unit 20 from the body as the body attachment unit 20 externally discharges and moves from the first position to the second position. For this purpose, the applicator 10 can be provided with needle pulling means (N) that moves the needle portion 550 upward and pulls it out and removes it from the body as the plunger body 300 moves from the first position to the second position.
[0084] The needle pulling means (N) can include a needle pulling body 400 that is coupled to the needle head 551 of the needle portion 550, meshingly coupled to the plunger body 300, and linearly moving from the first position to the second position along the inner case 102 together with the plunger body 300, and a needle pulling elastic spring (S2) that applies an elastic force to the needle pulling body 400 in the direction in which the needle pulling body 400 moves upward toward the first position.
[0085] The needle extraction body 400 is meshed and coupled with the plunger body 300. For this purpose, a separate elastic hook 410 that can be elastically deformed is formed on the needle extraction body 400, and the elastic hook 410 is elastically deflected in a direction to be meshed and coupled with the hook meshing portion 350 of the plunger body 300. Therefore, if the plunger body 300 linearly moves from the first position to the second position by the operation of the pressure button 110, the needle extraction body 400 also linearly moves to the second position together with the plunger body 300.
[0086] At this time, on the inner case 102, a needle extraction pressing portion 130 is formed to press the elastic hook 410 in the inner direction so that the elastic hook 410 is disengaged from the hook meshing portion 350 of the plunger body 300 when the needle extraction body 400 moves to the second position.
[0087] When the pressure button 110 is pressed under such a structure, as shown in FIG. 19, the needle extraction body 400 linearly moves from the first position to the second position together with the plunger body 300. At the same time, the elastic hook 410 of the needle extraction body 400 is pressed by the needle extraction pressing portion 130 of the inner case 102, and the meshing state with the hook meshing portion 350 is released. Therefore, as shown in FIG. 20, the needle extraction body 400 moves upward and returns to the first position by the elastic force of the needle extraction elastic spring (S2).
[0088] At this time, since the needle extraction body 400 is coupled with the needle head 551 of the needle portion 550 through the needle head coupling portion 420 at one end, the needle portion 550 moves together and is pulled out and removed from the body during the upward return movement of the needle extraction body 400. The needle head coupling portion 420 is formed at the lower end of the needle extraction body 400 in a form that is meshed and coupled with the coupling groove 552 formed on the needle head 551.
[0089] On one hand, when the plunger body 300 moves to the second position by the elastic force of the plunger elastic spring (S1), the sensor probe 521 and the needle part 550 of the body attachment unit 20 are inserted into the body. However, during the process of inserting the needle part 550 into the body, insertion resistance may occur, and due to the reaction force, the needle part 550 may slightly retreat in the direction opposite to the body insertion direction. In this case, since the sensor probe 521 may not be inserted into the body at the normal depth, it is desirable to prevent the retreat of the needle part 550. For this purpose, a needle support block that supports the upper end of the needle part 550 downward so that the needle part 550 does not move relatively upward with respect to the needle extraction body 400 can be coupled to the needle extraction body 400.
[0090] Next, the usage state of the sensor applicator assembly described above will be examined in detail centering on FIGS. 21 to 25.
[0091] FIGS. 21 to 25 are drawings showing step by step the usage state of the continuous blood glucose measuring device according to an embodiment of the present invention according to the operation procedure.
[0092] First, as shown in FIG. 21, the protective cap 200 of the applicator 10 is separated. During the process of separating the protective cap 200, the release paper 561 of the adhesive tape 560 of the body attachment unit 20 is separated together with the protective cap 200 and removed from the adhesive tape 560. Thereafter, the sensor applicator assembly is positioned at the body position where the body attachment unit 20 is to be attached. In this state, after the pressure button 110 is converted to the pressure standby mode state in the safe mode, the pressure button 110 is operated under pressure.
[0093] When the pressing button 110 is pressed, the shooting plate 150 moves and the engagement with the plunger body 300 is released. As shown in FIGS. 22 and 23, the plunger body 300 moves downward in the direction of being externally ejected by the plunger elastic spring (S1). During this process, the needle portion 550 and the sensor probe 521 of the body attachment unit 20 are inserted into the body (E). Of course, at this time, the body attachment unit 20 is adhered to the surface of the body (E) by the adhesive tape 560 on the bottom surface. When the plunger body 300 moves in the direction of being externally ejected in this way, as shown in FIG. 23, the plunger body 300 is engaged by the anti-return hook 161 of the inner case 102 and cannot move upward again. Therefore, the applicator 10 that has been used once cannot be reused again.
[0094] On the other hand, as shown in FIG. 22, the plunger body 300 according to an embodiment of the present invention is formed such that the lower end surface of the plunger body 300 and the lower end surface of the body attachment unit 20 coupled to the plunger body 300 are at the same height as the lower end surface of the main case 100 in a state of moving to the second position which is the external ejection direction. However, as shown in the enlarged view of FIG. 22, the lower end surface of the plunger body 300 can also be formed to protrude downward by about X distance from the lower end surface of the main case 100. As a result, the lower end surface of the body attachment unit 20 coupled to the plunger body 300 also protrudes downward by about X distance from the lower end surface of the main case 100.
[0095] In this way, when the plunger body 300 elastically moves, the plunger body 300 is configured to protrude further from the opening of the main case 100. By doing so, the body attachment unit 20 coupled to the plunger body 300 can be more strongly attached to the body surface. In particular, when the user stealthily lifts the main case 100 from the body surface or moves it due to fear or the like during the process of operating the applicator, the plunger body 300 also operates so as to protrude further from the opening of the main case 100. Therefore, the body attachment unit 20 can be stably pressed against the body surface.
[0096] When the plunger body 300 moves downward, as shown in FIG. 23, the sensor fixing hook 330 of the sensor housing portion 301 may be disengaged from the meshing connection state with the body attachment unit 20. Further, the elastic hook 410 of the needle extraction body 400 is pressed inward by the needle extraction pressing portion 130 of the inner case 102, and the meshing state with the plunger body 300 is released.
[0097] Therefore, when the plunger body 300 moves downward, at the same time, as shown in FIG. 24, the needle extraction body 400 moves upward and returns by the needle extraction elastic spring (S2). At this time, since the needle portion 550 moves upward together with the needle extraction body 400, the needle portion 550 is pulled out and removed from the body (E).
[0098] In this state, as described above, since the engagement between the sensor fixing hook 330 and the body attachment unit 20 can be released, as shown in FIG. 25, the applicator 10 can be separated and removed upward. By separating and removing the applicator 10 in this way, only the body attachment unit 20 remains attached to the body (E).
[0099] Thereafter, the pressurizing operation module 570 of the body attachment unit 20 and the like can be operated to start the operation of the sensor member 520 and the wireless communication chip 540 of the body attachment unit 20, and thereby the blood glucose measurement result by the body attachment unit 20 is transmitted to a separate external terminal device. In the present invention, since the body attachment unit 20 is equipped with all of the sensor member 520 and the wireless communication chip 540, additional operations such as connecting a separate transmitter are unnecessary.
[0100] Next, take a closer look at the body attachment unit 20 according to an embodiment of the present invention.
[0101] FIG. 26 is a perspective view schematically showing the outer shape of the body attachment unit attached to the body according to an embodiment of the present invention, FIG. 27 is an exploded perspective view schematically showing the configuration of the body attachment unit according to an embodiment of the present invention, FIG. 28 is a cross-sectional view taken along the line "C-C" of FIG. 26, FIG. 29 is a cross-sectional view taken along the line "D-D" of FIG. 26, and FIG. 30 is a drawing schematically showing the operating state of the pressurizing operation module according to an embodiment of the present invention.
[0102] The body attachment unit 20 according to an embodiment of the present invention includes a housing 510 to which an adhesive tape 560 is attached so that the bottom surface adheres to the skin, a sensor member 520 disposed inside the housing 510 such that one end protrudes externally from the bottom surface of the housing 510 and is inserted into the body when the housing 510 adheres to the skin, and a PCB board 530 disposed inside the housing 510.
[0103] The sensor member 520 is formed such that one end is inserted into the body and the other end is formed to be able to contact the PCB board 530. A sensor body portion 522 is formed at the other end so as to be able to contact the electrical contact of the PCB board 530. At one end, a sensor probe portion 521 is formed which extends in a form bent from one side of the sensor body portion 522, protrudes from the housing 510 to the outside, and is inserted into the body. The sensor body portion 522 is formed in a form having a relatively large area, and the sensor probe portion 521 is formed in a relatively narrow and long form.
[0104] The housing 510 can be separately formed by an upper housing 512 and a lower housing 511 so that an internal accommodation space is formed. Inside the housing 510, a sensor support portion 5121 is formed to support the sensor body portion 522 at a certain distance from the electrical contact 531 of the PCB board 530. Also, a sensor guide portion (not shown) is formed to be able to guide while supporting a partial section of the sensor probe portion 521. Further, a board support portion 5113 for fixedly supporting the PCB board 530 at a certain position can be formed inside the housing 510.
[0105] An electrical contact 531 is formed on the PCB board 530 so as to be electrically connected to the sensor member 520, and a wireless communication chip 540 is mounted to send the blood glucose measurement result measured through the sensor member 520 to an external terminal device. In one embodiment of the present invention, by providing the wireless communication chip 540 inside the body-attached unit 20 in this way, it is possible to easily communicate with the external terminal device without a separate transmitter connection operation.
[0106] Also, a battery 535 is mounted inside the housing 510 to supply power to the PCB board 530. At this time, the battery 535 is not arranged in a form mounted on one side of the PCB board 530, but is arranged in an area independent of the PCB board 530. That is, the PCB board 530 and the battery 535 are independently arranged on the bottom surface of the housing 510 without overlapping areas in the area reflected on the bottom surface. By arranging the PCB board 530 and the battery 535 in independent areas from each other, the thickness of the body-attached unit 20 can be reduced and it can be made smaller. At this time, a separate contact terminal 532 can be formed to extend from the battery 535 side so as to be electrically connected to the battery 535 on the PCB board 530.
[0107] In the body-attached unit 20 according to an embodiment of the present invention, the other end of the sensor member 520, that is, the sensor body portion 522, is formed to contact the electrical contact 531 of the PCB board 530 by a user operation, and the body-attached unit 20 is configured to start operating by such electrical contact. That is, power supply is made by the electrical connection between the sensor member 520 and the PCB board 530 by a user operation, and the sensor member 520, the wireless communication chip 540, etc. can be configured to start operating.
[0108] In order to bring the electrical contact 531 between the other end of the sensor member 520 and the PCB board 530 into contact by a user operation, the housing 510 can be provided with a separate pressing operation module 570 that operates by a user operation.
[0109] The pressing operation module 570 can include a moving pressing body 571 that is movably coupled to the housing 510 and moves in the pressing direction by a user's pressing force, and at least a partial area of the other end of the sensor member 520 can be configured to be pressed and deformed by the moving pressing body 571 to contact the electrical contact 531 of the PCB board 530 by the movement of the moving pressing body 571.
[0110] Further, the pressurizing operation module 570 can further include a button cover 572 made of a flexible material that is coupled to be externally exposed to the housing 510 so that a user can perform a pressurizing operation in a form surrounding the external space of the moving pressurizing body 571, and the coupling portion between the button cover 572 and the housing 510 can be configured to be sealed.
[0111] At this time, the sealing method of the coupling portion between the button cover 572 and the housing 510 can be configured by using a double-sided tape 580. For example, the double-sided tape 580 is adhered along the periphery to one surface of the other end of the sensor member 520, that is, the sensor body portion 522, and the inner surface of the button cover 572 is adhered to the bonding surface of the double-sided tape 580 along the periphery, and the periphery of the button cover 572 can be sealed by such a double-sided tape 580. In this case, the double-sided tape 580 can also be adhered along the periphery to the bonding surface of the sensor body portion 522, and through this, the sensor body portion 522 can be adhered and fixed to the sensor support portion 5121 using the double-sided tape 580 along the periphery.
[0112] In a state where the periphery of the sensor body portion 522 is adhered and fixed to the sensor support portion 5121 through the double-sided tape 580, as shown in FIG. 30, the central region of the sensor body portion 522 can be pressurized and deformed by the moving pressurizing body 571 and brought into contact with the electrical contact 531 of the PCB substrate 530. The moving pressurizing body 571 moves in the pressurizing direction, but since the button cover 572 is made of a flexible material and the edge portion is adhered to the housing 510 by the double-sided tape 580, only the central region is deformed in the pressurizing direction and the edge portion is adhered and fixed to maintain the sealed state.
[0113] On the other hand, after the sensor body portion 522 comes into contact with the electrical contact 531 of the PCB substrate 530 by a user operation, it is desirable that the contact state be stably maintained for stable blood glucose measurement. For this purpose, the moving pressurizing body 571 can be formed to be position-fixed in a state of moving in the pressurizing direction by the user's pressing force.
[0114] For fixing the position of such a moving and pressing body 571, as shown in FIG. 31, a protruding guide portion 5711 protruding along the moving direction of the moving and pressing body 571 is formed on the moving and pressing body 571, and a locking hook 5712 can be formed on the outer peripheral surface of the protruding guide portion 5711. Further, an engaging protrusion 5124 can be formed on the housing 510, with which the locking hook 5712 of the protruding guide portion 5711 can be engaged and coupled in a state where the moving and pressing body 571 has moved in the pressing direction. The moving and pressing body 571 can be configured to be fixed in position by the locking hook 5712 being engaged and coupled with the engaging protrusion 5124 as shown in FIG. 30.
[0115] At this time, the engaging protrusion 5124 can be formed on the sensor support portion 5121 of the housing 510. However, at least two guide fixing portions 5123 surrounding the protruding guide portion 5711 of the moving and pressing body 571 are formed on the sensor support portion 5121 of the housing 510 so as to be spaced apart along the circumferential direction, and the engaging protrusion 5124 can be formed on each of the guide fixing portions 5123. Further, each of the guide fixing portions 5123 can be arranged in a form of being elastically supported by an elastic support portion 5125 that elastically deforms.
[0116] Therefore, in the process of the moving and pressing body 571 moving in the pressing direction, the guide fixing portion 5123 elastically deforms to smooth the movement of the moving and pressing body 571. When the movement of the moving and pressing body 571 is completed, the guide fixing portion 5123 elastically returns so that the locking hook 5712 is engaged and coupled with the engaging protrusion 5124, and since the guide fixing portion 5123 is elastically supported by the elastic support portion 5125, the engaged and coupled state between the locking hook 5712 and the engaging protrusion 5124 is stably maintained.
[0117] On the one hand, as described above, the sensor member 520 is composed of the sensor body portion 522 and the sensor probe portion 521. A pressure-deformable portion 523 that deforms by the pressure movement of the moving pressure body 571 and contacts the electrical contact 531 of the PCB substrate 530 is formed in the sensor body portion 522.
[0118] As shown in FIG. 32, the pressure-deformable portion 523 includes a first cut-open region 5231 that is cut open along a first cut-open line 5232 formed in the central region of the sensor body portion 522, and the first cut-open region 5231 can be formed so as to be pressure-deformed by the moving pressure body 571.
[0119] Further, the pressure-deformable portion 523 further includes a second cut-open region 5233 that is cut open along a second cut-open line 5234 formed in the outer contour region of the first cut-open line 5232 in the central region of the sensor body portion 522, and the first cut-open region 5231 and the second cut-open region 5233 can be formed so as to be pressure-deformed by the moving pressure body 571.
[0120] At this time, the first cut-open line 5232 is formed in a form in which a part of the closed loop is open, and the second cut-open line 5234 is formed in a closed loop form that surrounds the open section of the first cut-open line 5232 externally and has an open section at a position facing the open section of the first cut-open line 5232.
[0121] If the moving pressure body 571 is pressurized by such a structure, as shown in FIGS. 33(a) and (b), the first cut-open region 5231 of the pressure-deformable portion 523 is elastically deformed downward, and the second cut-open region 5233 formed in the outer contour region of the first cut-open region 5231 is continuously and sequentially elastically deformed downward. As a result, the first cut-open region 5231 that directly contacts the electrical contact 531 of the PCB substrate 530 contacts the electrical contact 531 of the PCB substrate 530 in a relatively horizontal state, so that the contact state with respect to the electrical contact 531 of the sensor body portion 522 can be maintained more stably.
[0122] On one hand, a plurality of electrical contacts 531 that make electrical contact with the sensor body portion 522 are formed on the PCB substrate 530 so as to protrude toward the sensor body portion 522. Among the plurality of electrical contacts 531, at least one of them can be formed with a higher protrusion height than the others.
[0123] For example, when two electrical contacts 531 are formed on the PCB substrate 530 as shown in FIG. 34, the protrusion height of one electrical contact 531 is formed higher than that of the remaining electrical contacts 531, whereby the separation intervals from the sensor body portion 522 are made different from each other as d1 and d2.
[0124] Through such an arrangement structure, it is possible to prevent the sensor body portion 522 from contacting the electrical contact 531 without the user's pressing operation due to reasons such as manufacturing and assembly tolerances.
[0125] Looking more closely, inside the housing 510 according to an embodiment of the present invention, the sensor body portion 522 of the sensor member 520 and the electrical contact 531 of the PCB substrate 530 are positioned so as to be separated from each other and are configured to come into mutual contact by the user's pressing operation. However, since the housing 510 is formed in a very thin form, it is very difficult to stably maintain the separated state between the sensor body portion 522 and the electrical contact 531 inside it. In particular, due to tolerances generated during the manufacturing and assembly processes, etc., the sensor body portion 522 and the electrical contact 531 can be manufactured and distributed in a mutually contacting state before the user's pressing operation.
[0126] As described above, if the protruding height of at least one of the plurality of electrical contacts 531 is made higher than the remaining electrical contacts 531, even if the sensor body portion 522 and the electrical contacts 531 come into contact with each other due to manufacturing and assembly tolerances, only the electrical contact 531 that protrudes the highest comes into contact with the sensor body portion 522, and the remaining electrical contacts 531 are maintained in a state of being separated from the sensor body portion 522. This is because the function of upwardly supporting the sensor body portion 522 is performed by the electrical contact 531 that protrudes the highest. At this time, the plurality of electrical contacts 531 can be formed so as to elastically protrude from the PCB board 530 in an elastically deformable form, and the support function and the contact function with respect to the sensor body portion 522 can be smoothly performed by such an elastic force.
[0127] In this way, even if the sensor body portion 522 and the electrical contacts 531 come into contact, if only one of the electrical contacts 531 comes into contact, the operation of the body attachment unit 20 is not started. That is, the operations of the sensor member 520, the wireless communication chip 540, etc. are not started, and the power supply through the battery 535 is not started either.
[0128] Such a function of preventing operation start can be achieved through a simple method such as configuring the pattern circuit of the PCB board 530 so that the operation starts only when all of the plurality of electrical contacts 531 come into contact with the sensor body portion 522.
[0129] When the plurality of electrical contacts 531 are formed so that their protruding heights are different from each other in this way, the moving distance of the moving pressurizing body 571 of the pressurizing operation module 570 must be formed to be equal to or greater than the separation distance between the electrical contact 531 having the lowest protruding height among the plurality of electrical contacts 531 and the sensor body portion 522.
[0130] Above, the configuration of the pressurizing operation module 570 that operates in a pressurizing manner with respect to the contact structure between the sensor body portion 522 and the electrical contact 531 by the user's operation has been described. However, it can be configured in various ways other than the pressurizing method. Hereinafter, some exemplary configurations will be examined in detail.
[0131] Figures 35 to 37 are drawings conceptually showing various configurations of the contact connection module according to an embodiment of the present invention.
[0132] Figures 35 to 37 show a contact connection module 590 that operates by the user's operation so as to bring the electrical contact 531 of the sensor body portion 522 and the PCB board 530 into contact. Such a contact connection module 590 can be configured to move by the user's operation in a state where it is positioned to block mutual contact between the electrical contact 531 of the sensor body portion 522 and the PCB board 530 and release the blocking of mutual contact.
[0133] More specifically, the electrical contact 531 of the PCB board 530 is formed to elastically protrude in the direction of contacting the sensor body portion 522. By operating the contact connection module 590 to release the blocking of the mutual contact between the electrical contact 531 of the sensor body portion 522 and the PCB board 530, the electrical contact 531 of the PCB board 530 can be configured to elastically move by the elastic force and contact the other end portion of the sensor member 520.
[0134] At this time, the contact connection module 590 can be configured to include a moving plate 591 that is disposed between the electrical contact 531 of the sensor body portion 522 and the PCB board 530 inside the housing and is movably mounted by the user's operation as shown in Figure 35.
[0135] As shown in Fig. 35(a), in the assembled state where the moving plate 591 is inserted inside the housing 510, it is positioned between the sensor body portion 522 and the electrical contact 531 to block the mutual contact between the sensor body portion 522 and the electrical contact 531. As shown in Fig. 35(b), if the moving plate 591 is moved in the direction of pulling out and removing it from the housing 510 by the operation of the user, the electrical contact 531 moves upward by the elastic force and comes into contact with the sensor body portion 522.
[0136] On the other hand, as shown in Fig. 36, the moving plate 591 is mounted so as to be movable from the first position to the second position by the operation of the user. A through hole 593 can be formed on one side of the moving plate 591 to press the electrical contact 531 toward the PCB board 530 side at the first position and release the pressing state of the electrical contact 531 at the second position.
[0137] Therefore, in the state where the moving plate 591 is located at the first position inside the housing 510 as shown in Fig. 36(a), the mutual contact between the sensor body portion 522 and the electrical contact 531 is blocked by the moving plate 591. If the moving plate 591 moves to the second position inside the housing 510 as shown in Fig. 36(b), since the through hole 593 of the moving plate 591 is positioned between the electrical contact 531 and the sensor body portion 522, the electrical contact 531 elastically moves through the through hole 593 and comes into contact with the sensor body portion 522.
[0138] At this time, a stopper portion 592 can be formed on the moving plate 591 to limit the moving range of the moving plate 591 from the first position to the second position.
[0139] On the other hand, the moving plate 591 can be formed so that it is fixed in position in the state of moving to the second position and cannot return to the first position again.
[0140] For example, a locking hook 594 is formed at one end of the moving plate 591, and an engaging protrusion 595 that can be engaged and coupled with the locking hook 594 in a state where the moving plate 591 has moved to the second position is formed inside the housing 510. The moving plate 591 can be fixed in position at the second position when the locking hook 594 is engaged and coupled with the engaging protrusion 595.
[0141] Also, as shown in FIG. 37, it can also be configured in such a way that a contact connection member 596 made of a conductive material is separately attached to the moving plate 591. This can be configured in a form where the contact connection member 596 is attached to a portion where the through hole 593 of the moving plate 591 is formed, or can be configured in a way that the moving electrical contact 531 and the sensor body portion 522 are electrically connected and contacted by the contact connection member 596 when the moving plate 591 moves.
[0142] FIGS. 38 and 39 are drawings schematically showing the structure of the mode conversion lock member of the pressure button according to an embodiment of the present invention.
[0143] The pressure button 110 according to an embodiment of the present invention is mounted so as to be mode-convertible between a safety mode in which the pressure movement by the pressing operation is blocked and a pressure standby mode in which the pressure movement by the pressing operation is possible, as described above.
[0144] At this time, a lock member 115 for blocking and releasing the mode conversion state of such a pressure button 110 is mounted on the pressure button 110.
[0145] The lock member 115 is configured to block and maintain the conversion of the pressure button 110 from the safety mode state to the pressure standby mode state and to be released from the block by the operation of the user.
[0146] The pressurizing button 110 is slidably mounted in the button guide groove 1011 of the main case 100 and is mode-converted to the safe mode or the pressurizing standby mode by sliding movement. That is, the pressurizing button 110 slides within the button guide groove 1011 and is converted to the pressurizing standby mode by the user's operation while being maintained in the safe mode state.
[0147] At this time, the locking member 115 blocks the mode conversion of the pressurizing button 110 by restraining the sliding movement of the pressurizing button 110. For example, one end of the locking member 115 can be configured to be coupled to the pressurizing button 110 and the other end to be engaged with the button guide groove 1011 to restrain the sliding movement of the pressurizing button 110.
[0148] More specifically, as shown in FIG. 38, the locking member 115 can include a lock body 1151 having one end coupled to the pressurizing button 110 so as to be operable by the user, and a lock hook 1152 protruding from one side of the lock body 1151 and engaged with the inner peripheral surface of the button guide groove 1011.
[0149] In this case, the lock body 1151 is rotatably coupled to the pressurizing button 110, and by the user rotating the lock body 1151, the engagement state of the lock hook 1152 with the button guide groove 1011 can be configured to be released. The rotatable structure of the lock body 1151 can be configured using a hinge or the like, but as shown in FIGS. 38 and 39, it can also be configured using a coupling portion of a soft material so that the user can easily perform a rotation operation.
[0150] Further, the lock body 1151 is formed to be elastically deformable, and it can also be configured such that when the user performs a rotation operation to elastically deform the lock body 1151, the engagement state of the lock hook 1152 with respect to the button guide groove 1011 is released. At the same time, the lock body 1151 is detachably coupled to the pressure button 110, and it can also be configured such that when the user separates and removes the lock body 1151, the engagement state of the lock hook 1152 with respect to the button guide groove 1011 is released.
[0151] In this way, by making the mode conversion be performed through a separate lock member 115 during the process of converting the pressure button 110 to the pressure standby mode in the safe mode, it is possible to guide the user to pay more attention during the mode conversion operation and prevent the applicator from being activated due to malfunction or mischief.
[0152] Also, the lock member 115 can be formed such that the operating state of blocking and unblocking the mode conversion of the pressure button 110 can be visually identified by the user. However, as described above, if the lock body 1151 of the lock member 115 is extended to protrude from one side of the pressure button 110 and configured in a manner that it is rotated and operated, the user can easily identify the lock member 115, and can easily grasp the operating state of the lock member 115, that is, whether the mode conversion is blocked or unblocked, thereby guiding safer use.
[0153] FIG. 40 and FIG. 41 are drawings schematically showing the structure and operating state of a pressure operating module according to another embodiment of the present invention.
[0154] The pressure operating module 570 includes a moving pressure body 571 that moves by the user's pressing force and presses the other end of the sensor member 520, and a button cover 572 made of a soft material that surrounds the upper surface of the moving pressure body 571, as described above.
[0155] Since the button cover 572 is made of a soft material and is coupled to the housing 510 in a form that surrounds the upper surface of the moving pressure body 571, after the moving pressure body 571 has completed its downward movement due to the user's pressing operation, the button cover 572 is maintained in a form where its shape is freely deformed due to the characteristics of the soft material because there is no separate support member. In this case, not only is it aesthetically unappealing, but it is also difficult to clearly distinguish whether the user has pressed the pressure operating module 570 or not.
[0156] The pressure operating module 570 according to another embodiment of the present invention is configured to be fixed in a state different from that before operation when the operation is completed by the user's operation, and in particular, the states before and after operation are formed to be visually distinguishable by the user.
[0157] For this purpose, as shown in FIG. 40, a pressure protrusion 5713 that protrudes upward is formed on the upper surface of the moving pressure body 571, and the button cover 572 is mounted so as to be elastically deformed to protrude upward by the pressure protrusion 5713 in the state before the operation of the pressure operating module 570. Therefore, an elastic protrusion 5721 that elastically deforms to protrude upward by the pressure protrusion 5713 of the moving pressure body 571 is formed at the center of the button cover 572.
[0158] Such a button cover 572 returns to a flat state by being released from the close contact state with the pressure protrusion 5713 when the pressure operating module 570 operates and the moving pressure body 571 moves downward, as shown in FIG. 41. That is, the elastic protrusion 5721 returns to a flat form.
[0159] With such a structure, the button cover 572 is elastically supported by its own elastic force with its upper surface forming a flat surface in a state where the moving pressure body 571 has moved downward due to the operation of the pressure operation module 570, and is fixed in a state. Further, before the pressure operation module 570 operates, an elastic protrusion 5721 protrudes from the center of the button cover 572. However, after the pressure operation module 570 operates, the elastic protrusion 5721 of the button cover 572 returns to a flat shape and is deformed. Therefore, the protruding and protruding release states of the elastic protrusion 5721 appear before and after the operation of the pressure operation module 570, and through this, the states before and after the operation can be easily identified with the naked eye.
[0160] Figure 42 is a drawing schematically showing the structure of a pressure operation module according to another embodiment of the present invention.
[0161] As shown in Figure 42, the moving pressure body 571 and the button cover 572 of the pressure operation module 570 can be integrally formed.
[0162] When the moving pressure body 571 made of a rigid material and the button cover 572 made of a soft material are independently formed, if the pressure operation module 570 operates and the moving pressure body 571 moves downward, problems such as the button cover 572 deforming freely may occur, and problems such as difficulty in manufacturing and increased costs due to separate manufacturing may occur.
[0163] To solve this, the moving pressure body 571 and the button cover 572 can be integrally formed. In this case, for improving the workability with respect to the pressure operation module 570, it can be formed of a soft material such as the material of the button cover 572, and in the case of the moving pressure body 571, it can be formed thick so as to have relatively high rigidity.
[0164] In this case, the moving pressure body 571 and the button cover 572 can be integrally manufactured in one process, and due to the characteristics of the soft material, the workability is excellent and damage to sensor members 520 and the like due to interference and wear is prevented.
[0165] FIG. 43 is a perspective view schematically showing the detailed configuration of a sensor member according to another embodiment of the present invention.
[0166] The sensor member 520 can be configured to include a sensor body portion 522 in which a pressure-deformable portion 523 is formed in a central region so as to contact an electrical contact of a PCB substrate as described above, and a sensor probe portion 521 that is formed to extend in a form bent from one side of the sensor body portion 522 and is inserted into the body.
[0167] At this time, the pressure-deformable portion 523 is formed in a form in which a partial region is cut open. However, in the sensor member 520 according to another embodiment of the present invention, a bridge portion 524 that is not cut open in a partial section is formed on the cut line of the pressure-deformable portion 523.
[0168] More specifically, the pressure-deformable portion 523 can be configured to include a first cut region 5231 that is cut along the first cut line 5232 as described above, and a second cut region 5233 that is cut along the second cut line 5234. However, the bridge portion 524 can be formed in a partial section of a plurality of fulcrums of the first cut line 5232 and the second cut line 5234.
[0169] By forming the bridge portion 524 in a form that is not cut open in a partial section on the cut line of the pressure-deformable portion 523 in this way, problems such as the cut region being deformed by its own weight or being deformed due to careless handling during the assembly process or the manufacturing process can be prevented.
[0170] That is, if the pressure-deformable portion 523 is formed in the cut-open region, the pressure-deformable portion 523 can be easily deformed due to mistakes such as operator's careless handling. However, if the pressure-deformable portion 523 is deformed independently of the user's operation in this way, problems such as the pressure-deformable portion 523 coming into contact with the electrical contacts without the user's operation may occur. In another embodiment of the present invention, by forming the bridge portion 524 on the cut-open line, the bridge portion 524 supports the pressure-deformable portion 523 to prevent it from being easily deformed, so that more accurate and stable operating performance can be maintained.
[0171] FIG. 44 is a perspective view exemplarily showing the form of the pressure-deformable portion of the sensor member according to an embodiment of the present invention.
[0172] As described above, the pressure-deformable portion 523 is formed in the sensor body portion 522 of the sensor member 520 in a form cut along the cut-open line.
[0173] At this time, the pressure-deformable portion 523 can be configured to include a first cut-open region 5231 cut along the first cut-open line 5232 and a second cut-open region 5233 cut along the second cut-open line 5234 formed in the outer region of the first cut-open line 5232.
[0174] Such a form is exemplary, and the cut-open line can be variously deformed and applied. For example, as shown in FIG. 44(a), the first cut-open line 5232 and the second cut-open line 5234 can also be formed in a curved form.
[0175] Also, as shown in FIG. 44(b), the first incision line 5232 can be formed in a spiral form. In this case, the moving pressure body 571 of the pressure operation module 570 can be formed to pressurize the central region along the spiral first incision line 5232. When pressurized by the moving pressure body 571, the first incision region 5231 will sequentially deform from the central region to the outer region along the spiral first incision line 5232. Therefore, it can stably contact the electrical contacts of the PCB substrate without a separate second incision line and second incision region.
[0176] FIG. 45 is a drawing exemplarily showing various modified examples of the sensor member according to an embodiment of the present invention. FIG. 46 is a cross-sectional view taken along the "E-E" line of FIG. 45 for explaining the electrode laminated structure of the sensor member according to an embodiment of the present invention. FIGS. 47 and 48 are cross-sectional views taken along the "E-E" line of FIG. 45 for explaining the electrode laminated structures of the sensor members according to another embodiment of the present invention.
[0177] The sensor member 520 is formed to be long in one direction such that one end is inserted into the body and the other end is formed to contact the electrical contacts of the PCB substrate.
[0178] The sensor member 520 forms a sensor body part 522 such that the other end contacts the electrical contacts, and one end forms a sensor probe part 521 that extends long from one side of the sensor body part 521 so as to be inserted into the body.
[0179] The form of such a sensor member 520 can be changed in a very diverse manner. For example, as shown in FIG. 45(a), the sensor body part 522 can be formed in a flat plate form having a relatively large area, or as shown in FIGS. 45(b) and 45(c), it can be formed in a thin and long form and bent in the intermediate region or formed in a non-bent form. This is exemplary, and it can be formed in various other forms.
[0180] The sensor probe portion 521 of such a sensor member 520 has a plurality of electrode layers formed thereon so as to be inserted into the body and measure information on various substances from body fluids.
[0181] More specifically, as shown in FIG. 46, a substrate 5201 having one end formed to be long in one direction so as to be inserted into the body, a first electrode layer 5202 laminated on the upper surface of at least one end of the substrate 5201, a first insulating layer 5203 laminated so as to surround the upper surface of the first electrode layer 5202, a second electrode layer 5204 laminated on the upper surface of the first insulating layer 5203, and a second insulating layer 5205 laminated so as to surround the upper surface of the second electrode layer 5204.
[0182] Looking in detail at the lamination process of such electrode layers, as shown in FIG. 46(a), the first electrode layer 5202, the first insulating layer 5203, the second electrode layer 5204, and the second insulating layer 5205 are sequentially laminated on the upper surface of the substrate 5201. Such electrode layers and insulating layers are formed in the entire section or a partial section along the length direction of the sensor probe portion 521, and are formed over the entire region in the width direction which is perpendicular to the length direction. In the state where such electrode layers and insulating layers are laminated, both side surfaces in the width direction are finished by cutting along the cutting lines shown by dotted lines in FIG. 46(a). Through such a cutting process, both side surfaces in the width direction of the sensor probe portion 521 become smooth side surfaces as shown in FIG. 46(b).
[0183] However, in the actual manufacturing process, during the process of cutting both side surfaces in the width direction, the first electrode layer 5202 and the second electrode layer 5204 come into contact with each other due to reasons such as flowing out by the cutting blade, resulting in a problem that they are electrically connected. In particular, since the electrode layer and the insulating layer are formed with a very fine thickness in the micro unit, such problems frequently occur. The first electrode layer 5202 and the second electrode layer 5204 can perform a normal sensor function only if they are perfectly separated through the first insulating layer 5203 therebetween. However, if the first electrode layer 5202 and the second electrode layer 5204 come into contact with each other during the side cutting process in this way, the sensor function cannot be normally performed and the product is treated as defective.
[0184] In one embodiment of the present invention, in order to prevent such a problem, it has a stacked structure as shown in FIG. 47. That is, of both side surfaces in the width direction of the sensor probe portion 521, one of the first electrode layer 5202 and the second electrode layer 5204 is exposed on one side surface, and the other one is exposed on the other side surface, and the first electrode layer 5202 and the second electrode layer 5204 are arranged to cross each other.
[0185] Taking the stacking process as an example and looking at it in detail, as shown in FIG. 47(a), the first electrode layer 5202 is stacked on the upper surface of the substrate 5201 so as to be eccentric to the left side in the width direction, and the first insulating layer 5203 is stacked on the substrate 5201 and the first electrode layer 5202 so as to surround the upper surface and the side surface of the first electrode layer 5202. The second electrode layer 5204 is stacked on the upper surface of the first insulating layer 5203, but is stacked so as to be eccentric to the right side in the width direction of the substrate 5201. The second insulating layer 5205 is stacked on the first insulating layer 5203 and the second electrode layer 5204 so as to surround the upper surface and the side surface of the second electrode layer 5204.
[0186] In the state where the electrode layer and the insulating layer are stacked in this way, both side surfaces in the width direction are cut and finished along the cutting line shown by the dotted line in FIG. 47(a). Through such a cutting process, on both side surfaces in the width direction of the sensor probe portion 521, the first electrode layer 5202 is exposed on one side surface and the second electrode layer 5204 is exposed on the other side surface as shown in FIG. 47(b).
[0187] At this time, unlike the laminated structure shown in FIG. 46, in the laminated structure shown in FIG. 47, since the first electrode layer 5202 and the second electrode layer 5204 are laminated so as to cross each other, even if the first electrode layer 5202 and the second electrode layer 5204 flow out by the cutting blade during the cutting process on both side surfaces in the width direction, the first electrode layer 5202 and the second electrode layer 5204 will not contact each other, and thus, the product defect occurrence rate will be significantly reduced.
[0188] On the other hand, as shown in FIG. 48, a separate third electrode layer 5206 can be formed on the lower surface of one end of the substrate 5201, and a third insulating layer 5207 can be laminated and formed on the substrate 5201 and the third electrode layer 5206 so as to surround the lower surface of the third electrode layer 5206. Since the third electrode layer 5206 is laminated and formed on the lower surface of the substrate 5201 different from the first and second electrode layers 5202 and 5204, the phenomenon of contacting the first and second electrode layers 5202 and 5204 does not occur during the cutting process on both side surfaces. Thus, it can be freely selected in a manner of being formed over the entire region in the width direction of the lower surface of the substrate 5201 or being formed only in the central region as shown in FIG. 48.
[0189] Of course, when two electrode layers are sequentially laminated and formed on the lower surface of the substrate 5201, it is desirable to laminate and form them so as to be arranged in a manner crossing each other, similar to the first electrode layer 5202 and the second electrode layer 5204.
[0190] When two electrode layers are formed in the sensor member, each electrode layer functions as a working electrode and a counter electrode. When three electrode layers are formed, each electrode layer can function as a working electrode, a counter electrode, and a reference electrode. In addition, an even larger number of electrode layers can be formed, and each can be used for applications of measuring different substances from each other.
[0191] In addition, the first electrode layer 5202 and the second electrode layer 5204 can be formed over the entire length direction section of the sensor probe part 521 of the sensor member 520 and extended and formed on the sensor body part 522 so as to contact the electrical contacts of the PCB substrate.
[0192] The above description merely exemplarily explains the technical idea of the present invention. Those with ordinary knowledge in the technical field to which the present invention pertains can make various modifications and variations without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in the present invention are not for limiting the technical idea of the present invention but for explaining it, and the scope of the technical idea of the present invention is not limited by such embodiments. The protection scope of the present invention must be interpreted according to the following claims, and all technical ideas within the equivalent scope should be interpreted as being included in the scope of rights of the present invention.
Prior Art Documents
Patent Documents
[0193]
Patent Document 1
Claims
1. a housing that is attached to the skin; a sensor member disposed within the housing; a PCB board disposed within the housing; and a pressure actuation module for applying pressure to one end of the sensor member, The pressurizing actuation module includes: a movable pressure body movably coupled to the housing for applying pressure to one end of the sensor member to contact an electrical contact of the PCB board; and a button cover that is integrally formed with the movable pressure body and is exposed to the outside of the housing while surrounding the upper surface of the movable pressure body; Body-attached unit for continuous blood glucose monitoring.
2. The movable pressure body is made of a soft material, which is the same as the button cover.
2. The body-attachable unit for continuous blood glucose measurement according to claim 1.
3. The movable pressurizing body is moved by a pressing force of a user, and the button cover is exposed to the outside of the housing so that the user can perform a pressing operation.
3. The body-attachable unit for continuous blood glucose measurement according to claim 1 or 2.
4. The pressure actuation module is actuated so that one end of the sensor member contacts an electrical contact of the PCB board, thereby starting the actuation.
4. A body-attachable unit for continuous blood glucose measurement according to claim 1.
5. The pressurizing actuation module includes: The housing is fixed in position by moving in a pressure direction.
5. A body-attachable unit for continuous blood glucose measurement according to claim 1.
Citation Information
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