Continuous blood glucose measuring device

Abstract

The present invention relates to a continuous blood glucose measurement device, and provides a continuous blood glucose measurement device which is formed such that, in a state in which a body attachment unit is inserted and attached to a body, a cut-out region generated by a guide pin does not surround at least a partial region of a sensing region formed in a sensor member so that the cut-out region is not formed around the sensing region. The present invention prevents a decrease in blood glucose measurement value caused by an incision site so as to be able to detect an accurate blood glucose measurement value from the initial stage of operation, and adjusts the insertion depth of a guide pin by an applicator in the process of inserting and attaching a body attachment unit to the body, thereby improving the accuracy of blood glucose measurement value detection. Therefore, the accuracy of blood glucose measurement can be improved by adjusting the distance between the incision part generated by the guide pin and the sensing area.

Description

[0001] This application is a divisional application of the invention patent application entitled "Continuous Blood Glucose Measurement Device", application number 202180017003.4, filed on March 2, 2021. Technical Field

[0002] This invention relates to a continuous glucose measurement device. More specifically, it relates to a continuous glucose measurement device in which the cut portion generated by the guide needle, when the body attachment unit is inserted and attached to the body, does not surround at least a portion of the sensing area formed on the sensor component, thereby preventing the cut portion from forming around the sensing area and thus preventing a drop in glucose measurement value caused by the cut portion. This allows for the detection of accurate glucose measurement values ​​from the initial stage of operation. Furthermore, during the insertion and attachment of the body attachment unit to the body, the insertion depth of the guide needle is adjusted by the applicator, thereby improving the accuracy of glucose measurement by adjusting the distance between the cut portion generated by the guide needle and the sensing area. Background Technology

[0003] Diabetes is a common chronic disease in modern people. In South Korea, more than 2 million people, or 5% of the total population, have diabetes.

[0004] Diabetes is caused by a variety of factors, including obesity, stress, poor dietary habits, and congenital heredity, resulting in an absolute or relative deficiency of insulin produced by the pancreas, which fails to correct the balance of sugar in the blood, leading to an absolute increase in the sugar content in the blood.

[0005] Blood usually contains a certain concentration of glucose, from which tissue cells obtain energy.

[0006] However, when glucose levels rise excessively, it cannot be properly stored in the liver, muscles, or fat cells and instead accumulates in the blood. As a result, the blood sugar levels of diabetic patients are maintained at a much higher level than normal. As excess blood sugar is directly excreted through the tissues in the urine, the body's tissues do not have enough sugar to meet their absolute needs, leading to abnormalities in various tissues.

[0007] The characteristic of diabetes is that there are almost no noticeable symptoms in the early stages, but as the disease progresses, it manifests as unique symptoms such as polydipsia, polyphagia, polyuria, weight loss, general fatigue, itchy skin, and slow-healing wounds on the hands and feet. When the disease progresses further, complications such as vision impairment, high blood pressure, kidney disease, stroke, periodontal disease, muscle spasms, neuralgia, and gangrene may occur.

[0008] In order to diagnose such diabetes and manage it to prevent the development of complications, systematic blood glucose monitoring and treatment should be carried out in parallel.

[0009] For people with diabetes and those who have not developed diabetes but have higher than normal levels of sugar in their blood, many medical device manufacturers offer a wide variety of blood glucose meters so that blood glucose can be measured at home.

[0010] Blood glucose meters can be measured in two ways: by having the user draw blood from their fingertip and measuring blood glucose in a single unit, or by attaching the meter to the user's abdomen or arm and measuring blood glucose continuously.

[0011] For diabetic patients, the condition typically alternates between hyperglycemia and hypoglycemia. Emergencies arise from hypoglycemia, which can be fatal if loss of consciousness occurs or if hypoglycemia persists for an extended period without glucose supply. Therefore, immediate detection of hypoglycemia is crucial for diabetic patients. However, intermittent blood glucose meters have limitations in accurately assessing blood glucose levels.

[0012] Recently, in order to overcome such limitations, a continuous glucose monitoring system (CGMS) has been developed that is inserted into the human body and measures blood glucose levels at intervals of several minutes. This system can be used to easily manage diabetic patients and respond to emergencies.

[0013] Furthermore, since blood sampling glucose meters require diabetic patients to prick their painful fingertips to collect blood for blood glucose testing, this process causes pain and resistance. To minimize this pain and resistance, research and development are underway on continuous glucose measurement systems that measure blood glucose continuously by inserting a needle-shaped sensor into less painful areas such as the abdomen and arm. Additionally, efforts are being made to develop non-invasive glucose monitoring systems that measure blood glucose without collecting blood.

[0014] Over the past 40 years, various methods, including optical, electrical, and breath-based measurements, have been researched for non-invasive blood glucose measurement systems to measure blood glucose without blood collection. Cygnus (Redwood City, California, USA) developed and marketed the Glucowatch G2Biographer in wristwatch form using reverse iontophoresis, but it was discontinued in 2007 due to skin irritation and identification issues, device malfunction during sweating, and poor recognition of hypoglycemia relative to hyperglycemia. Although many bloodless blood glucose measurement technologies have emerged and been reported to date, their low accuracy has prevented their practical application.

[0015] The continuous glucose monitoring device includes a sensor module that is inserted into the skin of the body to measure blood glucose by extracting bodily fluids, a transmitter that transmits the blood glucose values ​​measured by the sensor module to a terminal, and a terminal that outputs the received blood glucose values. The sensor module includes a sensor probe shaped like a needle to insert into subcutaneous fat and extract intercellular fluid, and a separate applicator is used to insert and attach the sensor module to the body.

[0016] Such continuous glucose monitoring devices are produced by each manufacturer in a wide variety of forms, and their usage also varies. However, most continuous glucose monitors are manufactured and circulated by inserting a disposable sensor module into the body via an applicator, with adhesive tape affixed to the bottom surface of the sensor module's casing to ensure proper adhesion. With this configuration, when the sensor module is inserted into the skin via the applicator, it remains attached to the skin by the adhesive tape, and in this state, blood glucose levels are measured periodically and continuously.

[0017] Because the skin-insertion portion of the sensor component in the sensor module is made of a flexible material, a guide pin is provided to guide the insertion of the sensor component into the skin. Specifically, the skin-insertion portion of the sensor component protrudes outward from the bottom of the sensor module's housing, and the guide pin is configured to surround this skin-insertion portion of the sensor component from the outside. Furthermore, during the application of the sensor module to the skin using an applicator, the guide pin is inserted into the skin along with the sensor component. The guide pin is configured to be removed from the skin by the applicator when the insertion process of the sensor component is completed.

[0018] Such continuous glucose monitoring devices exhibit a characteristic where the accuracy of glucose measurements generally decreases initially after the sensor module is attached to the body, but improves after a considerable period of time. Although various studies have been conducted to address this initial decrease in accuracy, satisfactory results have not yet been obtained. Summary of the Invention

[0019] Technical issues

[0020] The present invention is conceived to solve the problems of the prior art. The object of the present invention is to provide a continuous blood glucose measurement device in which the cut portion generated by the guide needle in the state of the body attachment unit being inserted and attached to the body does not surround at least a portion of the sensing area formed on the sensor component, so that the cut portion is not formed around the sensing area, thereby preventing the blood glucose measurement value drop caused by the cut portion, so as to enable accurate blood glucose measurement value to be detected from the beginning of operation.

[0021] Another object of the present invention is to provide a continuous blood glucose measurement device in which the insertion depth of the guide needle is adjusted by the patch during the insertion and attachment of the body patch unit to the body, thereby improving the accuracy of blood glucose measurement by adjusting the distance between the cut portion generated by the guide needle and the sensing area.

[0022] Technical solution

[0023] The present invention provides a continuous glucose measurement device, characterized in that it comprises: a body attachment unit configured to be inserted and attached to the body for periodic glucose measurement; and an applicator configured to operate by means of user operation to insert and attach the body attachment unit to the body, the body attachment unit comprising: a sensor component inserted into the body and having a sensing area formed on one side in a manner that reacts with glucose within the body; and a guide needle configured to surround the sensor component from the outside and to be withdrawn and removed after being inserted into the body together with the sensor component, and configured such that at least a portion of the sensing area is not surrounded from the outside by a cut portion within the body cut by the guide needle.

[0024] At this time, the guide needle can be inserted before or simultaneously with the sensor component during the insertion process into the body.

[0025] In addition, the sensor component may include a sensor probe portion that is formed elongated along the body insertion direction such that at least a portion thereof is inserted into the body, and the sensing area is formed at the end of the sensor probe portion.

[0026] Furthermore, the guide pin can be configured to surround the sensor probe from the outside, and can be withdrawn and removed after being inserted to a depth shallower than the sensor probe.

[0027] Furthermore, the tip of the guide needle can be inserted to a depth closer to the skin surface than the maximum depth of the sensing area.

[0028] Furthermore, the tip of the guide needle can be inserted to a depth closer to the skin surface than the outermost contour of the sensing area.

[0029] In addition, the guide needle may include: a cutting portion formed at the anterior end portion in such a way as to cut the skin of the body during insertion into the body; and an insertion support portion extending from the rear end of the cutting portion to be continuously inserted into the body along the portion cut by the cutting portion, wherein the insertion support portion is inserted at a depth closer to the skin surface than the maximum depth of the sensing area at the boundary between the insertion support portion and the cutting portion.

[0030] In addition, the applicator may be provided with a needle withdrawal mechanism that withdraws and removes the guide needle from the body while the guide needle is inserted into the body. The needle withdrawal mechanism operates in such a way that the guide needle is withdrawn and removed from the body before the sensor component completes its insertion into the body.

[0031] Furthermore, the sensor component and the guide pin can be inserted into the body via the applicator in a manner that allows the sensor component to be inserted at a faster insertion speed than the guide pin in the interval after insertion into the body.

[0032] Furthermore, the sensor component can be inserted into the body via the applicator in a manner that, after the guide needle has been inserted to a predetermined insertion depth, it is further inserted while the guide needle is already inserted into the body.

[0033] The effects of the invention

[0034] According to the present invention, the following effect is achieved: the cut portion generated by the guide needle in the state where the body attachment unit is inserted and attached to the body does not surround at least a portion of the sensing area formed on the sensor component, so that the cut portion is not formed around the sensing area, thereby preventing the drop in blood glucose measurement value caused by the cut portion, so that accurate blood glucose measurement value can be detected from the beginning of operation.

[0035] In addition, it has the following effect: during the process of inserting the body patch unit into the body, the insertion depth of the guide needle can be adjusted by the patch applicator, thereby improving the accuracy of blood glucose measurement by adjusting the distance between the cut area created by the guide needle and the sensing area. Attached Figure Description

[0036] Figure 1 This is a schematic diagram illustrating the basic system of a continuous blood glucose measurement device according to an embodiment of the present invention.

[0037] Figure 2 This is a schematic diagram illustrating the shape of the patch of a continuous blood glucose measuring device according to an embodiment of the present invention.

[0038] Figure 3 This is a schematic diagram illustrating the structure of the body attachment unit of a continuous blood glucose measurement device according to an embodiment of the present invention.

[0039] Figure 4 This is a schematic diagram illustrating the shape of the sensor component and guide pin of the body attachment unit according to the first embodiment of the present invention.

[0040] Figure 5 This is a diagram conceptually illustrating the body insertion and attachment process of the body attachment unit according to a first embodiment of the present invention.

[0041] Figure 6 This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a first embodiment of the present invention.

[0042] Figure 7 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the first embodiment of the present invention.

[0043] Figure 8 This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a second embodiment of the present invention.

[0044] Figure 9 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the second embodiment of the present invention.

[0045] Figures 10 to 12 This is an exemplary diagram showing the structure and working state of an applicator in a body insertion configuration for implementing the second embodiment of the present invention, comprising a sensor component and a guide needle. Detailed Implementation

[0046] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings. First, when affixing reference numerals to the constituent elements of each drawing, even if they are shown in different drawings, the same reference numerals will be assigned to the same constituent elements as much as possible. Furthermore, in describing the present invention, detailed descriptions of related well-known components or functions will be omitted if it is determined that a detailed description of such components or functions may obscure the main points of the present invention.

[0047] Figure 1 This is a schematic diagram illustrating the basic system of a continuous blood glucose measurement device according to an embodiment of the present invention. Figure 2 This is a schematic diagram illustrating the shape of the patch of a continuous blood glucose measuring device according to an embodiment of the present invention. Figure 3 This is a schematic diagram illustrating the structure of the body attachment unit of a continuous blood glucose measurement device according to an embodiment of the present invention.

[0048] One embodiment of the continuous blood glucose measurement device of the present invention is configured to attach a body patch unit 20 having a sensor component 520 inserted into the body for continuous blood glucose measurement to the body via a patch 10, and to operate the patch 10 to insert and attach the body patch unit 20 to the body and periodically and continuously measure blood glucose from the body, and the blood glucose measurement information periodically measured by the body patch unit 20 is transmitted to a separate terminal 30 for output.

[0049] The body patch unit 20 can be assembled inside the patch 10 to create a single unit product. In this case, it is configured to minimize additional work for the user when using the continuous glucose monitoring device, resulting in a very simple usage structure. Of course, it can be manufactured in various ways, such as supplying the body patch unit 20 separately from the patch 10 to the user, and having the user insert the body patch unit 20 into the patch 10 to make it work.

[0050] The body-attachment unit 20 is formed to be attached to the body in a manner that allows it to extract bodily fluids and periodically measure blood glucose, and is configured to transmit blood glucose measurement results to an external device such as an external terminal 30. In such a body-attachment unit 20, a sensor component 520 with one end inserted into the body and a wireless communication chip (not shown) capable of wireless communication with the external terminal 30 can be internally provided.

[0051] The applicator 10 is configured to internally attach and fix the body attachment unit 20, and to operate by discharging the body attachment unit 20 externally through a user pressing the button 110.

[0052] 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 to adhere to the body as the applicator 10 is operated by the user.

[0053] That is, in one embodiment of the present invention, the sensor applicator assembly is assembled and manufactured such that, with the body attachment unit 20 inserted inside the applicator 10, the body attachment unit 20 is attached to the skin solely by the operation of the applicator 10, and can be supplied to the user in this state. Thus, the user only needs to operate the applicator 10 to attach the body attachment unit 20 to the skin without performing a separate additional operation for attaching the body attachment unit 20 to the skin. In particular, since a separate wireless communication chip is provided in the body attachment unit 20, there is no need to combine it with a separate transmitter, thus making it more convenient to use.

[0054] In the applicator 10, a separate protective cap 200 can be detachably combined in such a way that the body attachment unit 20 is prevented from being exposed to the outside while it is inserted inside the applicator 10, and can be configured so that the user can operate the applicator 10 after removing the protective cap 200 to discharge the body attachment unit 20 outward toward the side where the protective cap 200 has been removed for attachment to the body.

[0055] At this time, adhesive tape 560 is attached to the body contact surface of the body attachment unit 20 in such a way that the body attachment unit 20 can be attached to the body. Release paper (not shown) is attached to the body contact surface of the adhesive tape 560 to protect the adhesive tape 560. The release paper of the adhesive tape 560 can be formed to separate and remove from the adhesive tape 560 during the process of separating the protective cap 200 from the applicator 10.

[0056] The applicator 10 can be configured to engage and fix the body adhesion unit 20 when it is inserted inside, and to release the engagement and fixation when the body adhesion unit 20 is ejected and moved to the outside. Therefore, when the body adhesion unit 20 is inserted into the applicator 10, it is held in a fixed position. The engagement and fixation between the applicator 10 and the body adhesion unit 20 is released when the applicator 10 is operated to eject the body adhesion unit 20 to the outside and adhere it to the skin. Thus, if the applicator 10 is separated in this state, it separates from the body adhesion unit 20, leaving only the body adhesion unit 20 adhering to the skin.

[0057] The body attachment unit 20 is configured such that a sensor component 520 is disposed inside a separate housing 510, and one end of the sensor component 520 protrudes outward from the bottom surface of the housing 510 to be inserted and attached to the body. The sensor component 520 consists of a sensor probe portion 521 inserted into the body (see reference). Figure 5 ) and the sensor body 522 disposed inside the housing 510 (see reference ) Figure 5 The sensor component 520 is composed of a sensor probe and a sensor body, which are curved and form one end and the other end of the sensor component 520, respectively.

[0058] At this time, the individual guide pin 550 can be detachably attached to the housing 510 to facilitate the insertion of the sensor component 520 into the body. The guide pin 550 is configured to surround one end of the sensor component 520 and is inserted into the body together with the sensor component 520 to ensure that one end of the sensor component 520 is stably inserted into the body.

[0059] like Figure 2As shown, the guide needle 550 is detachably mounted on the housing 510 along the direction of vertical penetration through the housing 510 of the body application unit 20, and is formed to surround the outside of the sensor component 520, with a needle tip 551 formed at its upper end. This guide needle 550 is inserted into the body before the sensor component 520 when the body application unit 20 moves in the external discharge direction via the applicator 10, and guides the sensor component 520 to be stably inserted into the skin. The guide needle 550 is configured to engage with the needle removal mechanism (not shown) of the applicator 10 via the needle tip 551, and is withdrawn and removed from the body by the needle removal mechanism of the applicator 10 after the body application unit 20 is inserted and applied to the body by the operation of the applicator 10.

[0060] The structure of the sensor component 520 and the guide pin 550 of the body attachment unit 20 will be described in more detail below.

[0061] Figure 4 This is a schematic diagram illustrating the shape of the sensor component and guide pin of the body attachment unit according to the first embodiment of the present invention. Figure 5 This is a diagram conceptually illustrating the body insertion and attachment process of the body attachment unit according to the first embodiment of the present invention. Figure 6 This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a first embodiment of the present invention. Figure 7 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the first embodiment of the present invention.

[0062] As previously described, the sensor component 520 of the body attachment unit 10 includes: a sensor body portion 522 disposed inside the housing 510; and a sensor probe portion 521, which bends downward from the sensor body portion 522 and protrudes downward toward the lower part of the housing 510. The sensor probe portion 521 is formed elongated along the body insertion direction such that at least a portion of it is inserted into the body, and a sensing area 5211 that reacts with blood glucose within the body is formed at the distal end of the sensor probe portion 521 in a manner capable of measuring blood glucose levels. The degree of reaction with blood glucose through the sensing area 5211 is converted into an electrical signal and analyzed to measure blood glucose levels within the body.

[0063] like Figure 4 As shown, the sensor probe portion 521 can be formed in the form of a flat plate, and the sensing area 5211 can be formed on one side of the flat plate-shaped sensor probe portion 521.

[0064] The guide pin 550 is formed to surround the sensor probe portion 521 from the outside, and can be formed into a "U"-shaped channel with one side open along the length direction. Of course, the shape of the guide pin 550 can also be formed into a hollow tube of various shapes with a portion open along the length direction.

[0065] Such a guide needle 550 guides the sensor component 520 into the body. During insertion into the body together with the sensor component 520, the guide needle 550 is inserted before the sensor component 520 to cut the skin. For this purpose, a cutting portion 550a is formed at the front end of the guide needle 550 in a shape that allows it to cut the skin during insertion. An insertion support portion 550b extends from the rear end of the cutting portion 550a and is continuously inserted into the body along the cut portion 550a. The insertion support portion 550b of the guide needle 550 is configured to surround the sensor probe portion 521 of the sensor component 520 from the outside, and the sensing area 5211 formed at the end of the sensor probe portion 521 is also surrounded from the outside by the insertion support portion 550b of the guide needle 550.

[0066] As previously described, the sensor component 520 and the guide needle 550 are combined with the housing 510 and inserted into the skin via the applicator 10. After the sensor component 520 and the housing 510 are attached to the skin, the guide needle 550 is withdrawn from the skin and removed by the applicator 10.

[0067] At this time, according to the setting relationship between the sensor component 520 and the guide pin 550, such as Figure 5 As shown in (a), the insertion depth ND of the guide pin 550 is formed to be deeper than the insertion depth SD of the sensor component 520. Since the insertion support portion 550b of the guide pin 550 is configured to surround the sensor component 520, as... Figure 6 As shown, in addition to the insertion depth ND of the end of the cutting portion 550a of the guide needle 550, the insertion depth of the end of the insertion support portion 550b is also formed to be deeper than the insertion depth SD of the sensor component 520. The guide needle 550 leaves a wound in the skin E when it cuts the body skin E. After the guide needle 550 is inserted into the body, when the guide needle 550 is withdrawn and removed, as... Figure 5 As shown in (b), the depth of the incision site left in the skin E by the guide needle 550 is the same as the insertion depth ND of the guide needle 550.

[0068] Thus, after the guide needle 550 is withdrawn and removed from the body skin E, the relationship between the incision site created by the guide needle 550 within the body skin E and the setting of the sensor component 520 can be observed in more detail. Figure 7 As shown, the cutting portion CA generated by the guide needle 550 is formed at a distance from the two sides of the sensor component 520, based on a vertical cross-section relative to the skin E. At this time, when the distance between the sensor component 520 and the guide needle 550 is small or they are in contact without separation, the cutting portion CA generated by the guide needle 550 within the skin E can also be formed to be in contact with the sensor component 520.

[0069] The cut-out portions CA formed on both sides of the sensor component 520 within the skin E are actually generated when the insertion support portion 550b of the guide needle 550 is inserted, such as... Figure 7 As shown by the dashed line, the cut portion 550a of the guide pin 550 can be formed such that the cut portion CA generated from the insertion support portion 550b extends deeper in an inclined direction. The generation depth of the cut portion CA generated by the cut portion 550a of the guide pin 550 is ND, and the generation depth of the cut portion CA generated by the insertion support portion 550b of the guide pin 550 is ND1. In this case, the insertion depth of the sensor component 520 is SD.

[0070] Therefore, in the periphery of the sensing area 5211 on one side of the sensor probe portion 521 of the sensor component 520, the cutting portion CA generated by the insertion support portion 550b of the guide needle 550 is formed in the body skin E in a form that surrounds the sensing area 5211 from the outside.

[0071] The incision site CA created by the guide needle 550 corresponds to a wound inside the body. Therefore, while a small amount of bleeding occurs at the incision site CA, such as Figure 7 As shown in the enlarged image, white blood cells (B and C) aggregate at the incision site CA through the body's immune response. When white blood cells (B and C) aggregate at the incision site CA, the amount of blood glucose response in the sensing area 5211 of the surrounding sensor component 520 changes, thereby reducing the accuracy of blood glucose measurement.

[0072] That is, after the guide needle 550 is withdrawn and removed, when white blood cells (BCs) aggregate at the cut site CA created by the guide needle 550, the surrounding glucose molecules bind to the BCs, thereby reducing the amount of glucose molecules reacting with the sensing area 5211. Thus, due to the reduced amount of glucose reacting with the sensing area 5211 caused by the concentration of BCs, the blood glucose measurement value measured by the sensor component 520 is not the normal blood glucose measurement value, but rather shows a significantly reduced value. This change in blood glucose measurement value caused by the influence of BCs may persist for several days until all cut sites CA have recovered.

[0073] Therefore, in the body attachment unit 10 of the continuous glucose measurement device, the guide needle 550 and the sensor component 520 are inserted into the body together. As a result, due to the cut created by the guide needle 550, the accuracy of glucose measurement decreases in the initial stage of operation when the body attachment unit 10 is inserted and attached to the body.

[0074] The following describes the structure used to minimize the decrease in the accuracy of the above-mentioned blood glucose measurements.

[0075] Figure 8This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a second embodiment of the present invention. Figure 9 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the second embodiment of the present invention.

[0076] As described above, in the second embodiment of the present invention, the sensor component 520 and the guide pin 550 are configured such that the guide pin 550 surrounds the sensor probe portion 521 of the sensor component 520 from the outside.

[0077] The guide pin 550 is inserted into the body before or simultaneously with the sensor component 520, and is withdrawn and removed by the applicator 10 after insertion. To ensure the guide pin 550 is inserted into the body before or simultaneously with the sensor component 520, as follows... Figure 8 As shown in (a), in the region before insertion into the body, the end of the guide needle 550 protrudes in a manner that is closer to the body skin E than the end of the sensor component 520.

[0078] At this time, the guide pin 550 of the second embodiment of the present invention is inserted in such a way that the cut portion CA in the body cut by the guide pin 550 is in a shape that does not surround at least a portion of the sensing area 5211 in the outer region of the sensor component 520.

[0079] For example, such as Figure 8 As shown in (b) and (c), in the state where the process of inserting the sensor component 520 and the guide needle 550 into the body is completed, the guide needle 550 can be inserted into the skin E of the body in such a way that the insertion depth ND of the guide needle 550 is smaller than the insertion depth SD of the sensor component 520. That is, the guide needle 550 can be inserted to a shallower depth than the sensor probe portion 521 of the sensor component 520. Afterwards, the guide needle 550... Figure 8 In the states shown in (b) and (c), the insertion will not go deeper; instead, it will be withdrawn and removed at that depth.

[0080] More specifically, such as Figure 8 As shown in (b), the guide needle 550 can be inserted to a corresponding depth such that the insertion depth ND of its tip is closer to the skin surface than the outermost contour 5211a of the sensing area 5211, unlike, as Figure 8 As shown in (c), the guide needle 550 can be inserted to a depth such that the insertion depth ND of its tip is closer to the skin surface than the maximum depth 5211b of the sensing area 5211. After insertion at such depth, the guide needle 550 is withdrawn from the skin and removed, and the incision CA created by the insertion of the guide needle 550 remains as a wound inside the skin E.

[0081] Since a cutting site CA is formed in the skin E along the insertion path of the guide needle 550, when the guide needle 550 is inserted to a depth shallower than the sensor probe portion 521, the cutting site CA formed by the guide needle 550 is also formed to a depth shallower than the sensor probe portion 521 inside the body.

[0082] Thus, when the cut portion CA of the guide pin 550 is formed at a shallower depth than that of the sensor probe portion 521, such as Figure 9 As shown, no cutting site CA is formed in the peripheral area opposite to the sensing area 5211, so the white blood cells BC concentrated in the cutting site CA will not exist in the position adjacent to the sensing area 5211. Therefore, the loss of blood glucose substances caused by white blood cells BC in the periphery of the sensing area 5211 is reduced, thereby further improving the accuracy of blood glucose measurement values ​​through the sensing area 5211.

[0083] That is, as the cutting portion CA generated by the guide needle 550 in the peripheral area opposite to the sensing area 5211 is minimized, in other words, as the cutting portion CA generated by the guide needle 550 moves away from the sensing area 5211, the loss of blood glucose substances caused by white blood cells BC in the periphery of the sensing area 5211 is reduced, thereby obtaining a more accurate blood glucose measurement value.

[0084] like Figure 9 As shown, if the cutting portion CA generated by the guide needle 550 is viewed with reference to a vertical section relative to the skin E, the cutting portion CA generated by the insertion support portion 550b of the guide needle 550 is formed on both sides of the sensor probe portion 521. The cutting portion CA generated by the cutting portion 550a of the guide needle 550 is formed as shown by the dashed line, extending from the end of the cutting portion CA generated by the insertion support portion 550b in an inclined direction.

[0085] Therefore, compared to the cut portion CA created by the cutting portion 550a of the guide needle 550, the cut portion CA created by the insertion support portion 550b is formed opposite to the area closer to the sensing area 5211. Consequently, the cut portion CA created by the insertion support portion 550b has a greater impact on the loss of glucose substances caused by white blood cells (BCs) around the sensing area 5211. Therefore, the cut portion CA created by the insertion support portion 550b has a greater impact on the accuracy of blood glucose measurement depending on its distance from the sensing area 5211.

[0086] When the insertion depth ND of the end of the cutting portion 550a of the guide needle 550 is located closer to the skin surface than the outermost contour 5211a of the sensing area 5211 (when it is located at a shallower position), such as Figure 9As shown in (a), the depth ND of the end of the incision CA generated by the incision portion 550a is shallower than the outermost contour 5211a of the sensing area 5211. In this case, the depth ND1 of the incision CA generated by the insertion support portion 550b is shallower than the depth ND of the end of the incision CA generated by the incision portion 550a. Therefore, the incision portion 550a of the guide needle 550 and the incision CA generated by the insertion support portion 550b will be further away from the sensing area 5211 from the skin surface in a form that does not completely surround the sensing area 5211 from the outside. Thus, there is no incision CA in the peripheral area of ​​the sensing area 5211, such as... Figure 9 As shown in the enlarged view of (a), the white blood cells BC concentrated at the incision site CA are relatively far away from the sensing area 5211. Therefore, there is almost no loss of blood glucose substances caused by white blood cells BC in the sensing area 5211, thus a more accurate blood glucose measurement can be obtained.

[0087] Furthermore, when the insertion depth ND of the end of the cut portion 550a of the guide needle 550 is located between the outermost contour 5211a and the maximum depth 5211b of the sensing area 5211, such as Figure 9 As shown in (b), the depth ND of the end of the cut portion CA generated by the guide needle 550 can be located shallower than the maximum depth 5211b of the sensing area 5211, and the depth ND1 of the cut portion CA generated by the insertion support portion 550b of the guide needle 550 can be located shallower or deeper than the outermost contour 5211a of the sensing area 5211. In this case, the cut portion CA generated by the cut portion 550a of the guide needle 550 or the cut portion CA generated by the insertion support portion 550b is formed to surround a portion of the sensing area 5211 from the outside (i.e., a portion of the sensing area 5211 that does not surround the sensing area 5211 from the outside). Similarly, since the cut portion CA of the guide needle 550 does not completely surround the entire area of ​​the sensing area 5211, the loss of glucose substances caused by white blood cells BC occurring at the cut portion CA is reduced by a considerable portion around the sensing area 5211, thereby relatively improving the accuracy of the blood glucose measurement value.

[0088] Thus, by making the insertion depth of the guide needle 550 shallower than the depth of the sensor probe portion 521, the cutting portion CA generated by the guide needle 550 is shaped so that it does not surround at least a portion of the sensing area 5211 from the outside, thereby minimizing the reduction of blood glucose substances caused by white blood cells BC occurring at the cutting portion CA, thereby further improving the measurement accuracy of the sensing area 5211.

[0089] Next, the adjustment structure for the insertion depth between the sensor component 520 and the guide pin 550 of the body attachment unit 10 will be described.

[0090] Figures 10 to 12 This is an exemplary diagram showing the structure and working state of an applicator in a body insertion configuration for implementing the second embodiment of the present invention, comprising a sensor component and a guide needle.

[0091] As described above, an embodiment of the present invention, the applicator 10, is a device that operates by inserting and attaching the body attachment unit 10 to the body through user operation. It may include a main shell 100 with one side open, a plunger body 300 that moves inside the main shell 100 in a direction toward the open side and outward discharge, and a plunger elastic spring S1 that applies an elastic force to the plunger body 300 in a way that moves the plunger body 300 in the outward discharge direction. It may also be configured such that the body attachment unit 10 is attached to the plunger body 300 and moves together with the plunger body 300 in the outward discharge direction.

[0092] An operable control part, such as a press button (not shown), is provided on the outside of the main housing 100. The plunger body 300 is fixedly attached to a first position inside the main housing 100, and is released from the first position upon operation of the control part. It then moves linearly to a second position, which is the external discharge direction, by the elastic force of the plunger spring S1. The body attachment unit 10 is attached to one end of the plunger body 300 and moves linearly along the external discharge direction with the plunger body 300 to be inserted and attached to the skin E.

[0093] As previously described, the body attachment unit 10 includes: a housing 510; a sensor component 520, which includes a sensor body portion 522 and a sensor probe portion 521; and a guide pin 550, which is configured to surround the sensor probe portion 521 from the outside and be detachably attached to the housing 510.

[0094] When the body attachment unit 10 is discharged to the outside, the sensor probe portion 521 of the sensor component 520 is inserted into the body skin E. The sensor probe portion 521 is provided to protrude outward from the bottom surface of the housing 510, and the guide pin 550 surrounds the sensor probe portion 521 from the outside and is inserted into the body skin E together with the sensor probe portion 521.

[0095] After the guide needle 550 is inserted into the skin E, it is withdrawn and removed from the skin E. The applicator 10 is provided with a needle withdrawal mechanism N, which withdraws and removes the guide needle 550 from the skin E while it is inserted into the skin E.

[0096] The needle retraction mechanism N may include: a needle retraction body 400, which engages with a plunger body 300 to move linearly along the external discharge direction together with the plunger body 300, and engages with a needle tip 551 formed at the upper end of a guide needle 550; and a needle retraction spring S2, which applies an elastic force to the needle retraction body 400 in the opposite direction to the external discharge direction. A hook engagement portion 350 is formed in the plunger body 300 to constrain the elastic movement of the needle retraction body 400, and an elastic hook 410 is formed on the upper part of the needle retraction body 400 to engage with the hook engagement portion 350. The elastic hook 410 engages with the hook engagement part 350, causing the needle retraction body 400 and the plunger body 300 to move together in the external discharge direction. When the movement reaches a predetermined distance, the engagement state of the elastic hook 410 and the hook engagement part 350 is released by a separate locking release mechanism (not shown). In this state, the needle retraction body 400 can be moved upward in the opposite direction of the external discharge direction by the needle retraction elastic spring S2.

[0097] At this time, as Figure 10 As shown, the needle withdrawal mechanism N can operate in such a way that the guide needle 550 is withdrawn from and removed from the body skin E before the sensor component 520 completes its insertion into the body skin E, thereby allowing the sensor component 520 to be inserted into the body skin E deeper than the guide needle 550.

[0098] More specifically, in Figure 10 In the state shown in (a), when the operating part of the applicator 10 is operated by the user, as Figure 10 As shown in (b) and (c), the outer shell 510 of the body attachment unit 10 moves together with the plunger body 300 from a first position (upper inner region) in the internal space of the main shell 100 to a second position (lower inner region) in the direction of external discharge. The sensor probe portion 521 of the sensor component 520 moves together with the plunger body 300 and the outer shell 510 to the second position, and as shown in (b) and (c)... Figure 10 (c) shows the insertion depth SD pre-set within the skin E of the body.

[0099] At this time, as the guide needle 550 moves together with the plunger body 300 and the outer casing 510 to the second position, Figure 10 As shown in (b), the needle moves from the third position, which is the intermediate interval, toward the first position via the needle withdrawal mechanism N to be withdrawn and removed from the body. That is, when the guide needle 550 reaches the third position together with the plunger body 300 and the housing 510, the engagement state of the elastic hook 410 of the needle withdrawal body 400 and the hook engagement portion 350 of the plunger body 300 is released. At the same time, the needle withdrawal body 400 moves upward back toward the first position by the elastic force of the needle withdrawal elastic spring S2. During this process, the guide needle 550 moves upward together with the needle withdrawal body 400 to be withdrawn and removed from the body skin E.

[0100] In summary, after the guide needle 550 is inserted into the skin E before the sensor component 520 to guide the insertion of the sensor component 520, it does not move to the second position together with the sensor component 520. Instead, it moves upward toward the first position through the needle withdrawal mechanism N to be withdrawn and removed from the body when it is inserted into the third position, which is the intermediate interval, that is, the depth ND, which is less than the insertion depth SD of the sensor component 520.

[0101] Thus, in the state where the body attachment unit 10 has finally completed its insertion and attachment to the body skin E, as... Figure 10 As shown in (c), the sensor component 520 is inserted to a depth SD, and the guide pin 550 is inserted to a depth ND less than SD. The insertion depth ND of such guide pin 550 can be set to various depths according to the user's needs.

[0102] On the other hand, such as Figure 11 As shown, the sensor component 520 and the guide needle 550 can be inserted into the skin E through the applicator 10 in such a way that the sensor component 520 is inserted at a faster speed than the guide needle 550 in the area after insertion into the skin E, thereby allowing the sensor component 520 to be inserted deeper into the skin E than the guide needle 550.

[0103] For this purpose, separate rack and pinion structures can be used. For example, a housing rack T3 is formed on both sides of the housing 510 along the external discharge direction, and a housing rack T2 is formed on the lower section of the inner side of the main housing 100 of the applicator 10 along the external discharge direction. A pinion T1, capable of simultaneously meshing with both the housing rack T3 and the housing rack T2, is rotatably coupled to one side of the plunger body 300. For example... Figure 11 As shown in (a), the plunger body 300 and the housing 510 are configured such that the pinion T1 and the housing rack T3 are meshed together before the applicator 10 is activated.

[0104] According to this structure, when the operating part of the applicator 10 is operated by the user, the plunger body 300 and the housing 510 integrally move from... Figure 11 The state shown in (a) moves to Figure 11 In the state shown in (b), the guide needle 550 begins to insert into the skin E. In this state, the pinion T1 also begins to mesh with the housing rack T2. Afterwards, as... Figure 11 As shown in (c), when the plunger body 300 continues to move towards the second position, which is the external discharge direction, the pinion T1 rotates during this process by meshing with the housing rack T2, and the housing rack T3 moves in the external discharge direction (downward) due to the rotation of the pinion T1. That is, from... Figure 11 The state shown in (b) to Figure 11 In the interval of state shown in (c), when the plunger body 300 moves downward, the pinion T1 rotates through the housing rack T2, and the housing rack T3 moves downward through the rotation of the pinion T1.

[0105] Thus, from Figure 11 In the interval from (b) to (c), the housing rack T3 moves downward, and therefore the housing 510 moves downward together with the housing rack T3. Thus, in this interval, the housing 510 moves downward at a basic speed (v1: the speed of downward movement via the plunger elastic spring S1) plus an additional downward speed (v2: the speed of downward movement via the housing rack T3) that moves downward together with the plunger body 300. At this time, since the sensor component 520 is attached to the housing 510 and moves integrally with the housing 510, the sensor component 520 moves downward at the same downward speed (v1+v2) as the housing 510, but the guide needle 550 moves downward at the same downward speed v1 as the plunger body 300 via the needle retraction body 400 constrained to the plunger body 300.

[0106] Therefore, from the point in time when the guide needle 550 begins to be inserted into the skin E, the insertion speed (v1+v2) of the sensor component 520 into the body is faster than the insertion speed v1 of the guide needle 550 into the body, thus, as Figure 11 As shown in (c), the insertion depth SD of the final sensor component 520 is deeper than the insertion depth ND of the guide pin 550.

[0107] Thus, when the insertion and movement of the guide pin 550 and the sensor component 520 ends, as... Figure 11 As shown in (c), the engagement state of the elastic hook 410 of the needle retraction body 400 and the hook engagement portion 350 of the plunger body 300 is released, so the guide needle 550 is withdrawn from the body skin E and removed by the needle retraction mechanism N.

[0108] On the other hand, such as Figure 12 As shown, the sensor component 520 can be configured to be inserted into the skin E of the body along with the guide needle 550, and then further inserted through the applicator 10 after the guide needle 550 has been inserted to a predetermined insertion depth, thereby allowing the sensor component 520 to be inserted into the skin E deeper than the guide needle 550.

[0109] For this purpose, separate springs and rotary links can be used. For example, a housing spring S3, capable of elastically moving the housing 510 attached to the plunger body 300 in the external discharge direction, can be provided in the space between the plunger body 300 and the housing 510, and a rotary locking link LK, capable of downward movement of the housing 510 from the plunger body 300 and release of constraint, can be rotatably attached to the plunger body 300. Figure 12 As shown in (a), the rotation locking link LK is kept in a state where its outer end is in close contact with the inner surface of the main housing 100 of the applicator 10 to restrain rotation. A recessed working groove LH is formed at the end of the inner surface of the main housing 100 in the external discharge direction, and one end of the rotation locking link LK is released from rotation constraint through such a working groove LH.

[0110] According to this structure, when the operating part of the applicator 10 is operated by the user, the plunger body 300 and the housing 510 are in... Figure 12 In the state shown in (a), external discharge movement is performed by the plunger elastic spring S1. During this process, the rotating locking link LK is in close contact with the inner side of the main housing 100 and is constrained to rotate. Therefore, the outer housing 510 is constrained to move by the rotating locking link LK, thus moving downward together with the plunger body 300, rather than moving relative to the plunger body 300. Afterwards, as Figure 12 As shown in (b), when the external discharge movement of the plunger body 300 ends, the rotating locking link LK reaches the working groove LH region, thereby releasing the rotational constraint of the rotating locking link LK. Therefore, as Figure 12 As shown in (b) and (c), the rotating locking link LK rotates, thereby releasing the housing 510 from its constraint and allowing it to move further downward via the housing spring S3.

[0111] At this point, the sensor component 520 moves integrally with the housing 510 and is further inserted into the skin E. Regarding the guide needle 550, regardless of the further downward movement of the housing 510, in the state where the downward movement of the plunger body 300 has ended, as... Figure 12 As shown in (b), the engagement state of the elastic hook 410 of the needle retraction body 400 and the hook engagement portion 350 of the plunger body 300 is released, and the guide needle 550 is withdrawn from the body skin E and removed through the needle retraction mechanism N.

[0112] Therefore, as the applicator 10 operates, the process of inserting and attaching the body attachment unit 10 to the body ends, as... Figure 12 As shown in (b) and (c), the guide needle 550 moves integrally with the plunger body 300 to insert to the insertion depth ND and is then withdrawn and removed. Afterward, the sensor component 520 moves further downward with the housing 510 to insert into the interior of the body skin E to a depth SD that is deeper than the depth ND.

[0113] The structure related to the insertion depth adjustment of the sensor component 520 and the guide pin 550 described above is exemplary, and can be modified and applied in various other ways.

[0114] The above description is merely an exemplary illustration of the technical concept of the present invention. Those skilled in the art will be able to make various modifications and variations without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in this invention are not intended to limit the technical concept of the present invention, but rather to illustrate it, and the scope of the technical concept of the present invention is not limited by such embodiments. The scope of protection of the present invention should be interpreted by the following claims, and all technical concepts within their equivalent scope should be interpreted as falling within the scope of the claims of the present invention.

Claims

1. A continuous glucose measurement device, characterized in that, include: A body attachment unit, which is configured to be inserted and attached to the body; as well as An applicator configured to allow the body attachment unit to be inserted and attached to the body. The body attachment unit includes: Sensor components, configured to be inserted into the body; and A guide pin is arranged to surround at least a portion of the exterior of the sensor component. When the guide needle and the sensor component are inserted into the body, the sensor component advances beyond the distal end of the guide needle.

2. The continuous glucose measurement device according to claim 1, characterized in that, During the insertion process, the guide pin is inserted into the body before or simultaneously with the sensor component.

3. The continuous glucose measurement device according to claim 2, characterized in that, The sensor component includes a sensor probe portion that is elongated along the body insertion direction such that at least a portion thereof is inserted into the body. The sensing area is formed at the end of the sensor probe to react with blood glucose levels in the body.

4. The continuous glucose measurement device according to claim 3, characterized in that, The guide pin is formed to surround the sensor probe from the outside and is inserted to a depth shallower than the sensor probe.

5. The continuous glucose measurement device according to claim 4, characterized in that, The tip of the guide needle is inserted to a depth shallower than the maximum depth of the sensing area.

6. The continuous glucose measurement device according to claim 5, characterized in that, The tip of the guide pin is inserted to a depth shallower than the outermost contour of the sensing area.

7. The continuous glucose measurement device according to claim 3, characterized in that, The guide pin includes: A cutting portion is formed at the anterior end of the guide needle in such a way that it cuts through the skin of the body during insertion of the guide needle; and An insertable support is formed to extend from the rear end of the cut portion and is configured to be inserted into the body along the portion cut by the cut portion. The insertion support portion is inserted at a depth closer to the skin surface than the maximum depth of the sensing area at the boundary between the insertion support portion and the cutting portion.

8. The continuous glucose measurement device according to claim 4 or 7, characterized in that, The applicator includes a needle withdrawal mechanism that withdraws and removes the guide needle from the body while it is inserted into the body. The needle withdrawal mechanism is configured to withdraw and remove the guide needle before the sensor component completes its insertion into the body.

9. The continuous glucose measurement device according to claim 4 or 7, characterized in that, The applicator is configured to insert the sensor component and the guide pin into the body in such a way that the sensor component is inserted at a faster insertion speed than the guide pin in the interval after insertion into the body.

10. The continuous glucose measurement device according to claim 4 or 7, characterized in that, The sensor component is inserted into the body via the applicator in such a manner that, after the guide needle has been inserted to a predetermined insertion depth, it is further inserted while the guide needle is inserted into the body together with the applicator.

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