Blood glucose measuring device

Abstract

Regarding continuous blood glucose monitoring devices, accurate blood glucose measurements are detected from the initial stage of operation. This improves the accuracy of blood glucose measurement. [Solution] The present invention relates to a continuous blood glucose monitoring device, wherein the body-attachment unit is formed such that the incision site made by the guide needle does not enclose at least a portion of the sensing area formed on the sensor member when the body-attachment unit is inserted and attached to the body, thereby preventing the formation of an incision site around the sensing area, and thereby preventing the phenomenon of blood glucose measurement values ​​decreasing due to the incision site, and enabling accurate blood glucose measurement values ​​from the start of operation. Furthermore, by adjusting the insertion depth of the guide needle through the applicator during the process of the body-attachment unit being inserted and attached to the body, the separation distance between the incision site made by the guide needle and the sensing area can be adjusted, thereby improving the accuracy of blood glucose measurement.

Description

Technical Field

[0001] The present invention relates to a blood glucose measuring device. More specifically, in a state where a body-attached unit is inserted and attached to the body, the incision site by the guide needle is formed so as not to surround at least a part of the sensing area formed in the sensor member, so that no incision site is formed around the sensing area. As a result, it is possible to prevent the phenomenon of a decrease in the blood glucose measurement value caused by the incision site and detect an accurate blood glucose measurement value from the initial stage of operation. Also, by adjusting the insertion depth of the guide needle through an applicator during the process of inserting and attaching the body-attached unit to the body, it is possible to adjust the separation distance between the incision site by the guide needle and the sensing area and improve the accuracy of blood glucose measurement. The present invention relates to a continuous blood glucose measuring device.

Background Art

[0002] Diabetes is a chronic disease that frequently occurs in modern people. In the case of [country name], it has reached more than 2 million people, which is equivalent to 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, making it impossible to correct the balance of sugar in the blood. As a result, the sugar component in the blood increases absolutely, leading to the onset of the disease.

[0004] Normally, blood contains a certain concentration of glucose, and tissue cells obtain energy from it.

[0005] However, when glucose increases more than necessary, it is not properly stored in the liver, muscles, or fat cells, etc., and accumulates in the blood. As a result, diabetic patients maintain much higher blood glucose than normal people. Excessive blood glucose passes through tissues and is excreted in urine, resulting in a deficiency of the sugar absolutely necessary for each tissue of the body and causing abnormalities in each tissue of the body.

[0006] Diabetes is characterized by having almost no noticeable symptoms in its early stages. However, as the disease progresses, characteristic symptoms of diabetes appear, such as excessive thirst, increased appetite, frequent urination, weight loss, general fatigue, itchy skin, and wounds on the hands and feet that do not heal and last a long time. Further progression of the disease can lead to complications such as vision impairment, high blood pressure, kidney disease, stroke, periodontal disease, muscle spasms and neuralgia, and gangrene.

[0007] To diagnose this type of diabetes and manage it to prevent it from progressing to complications, systematic blood glucose monitoring and treatment must be carried out in parallel.

[0008] Many medical device manufacturers offer a variety of blood glucose meters for home use to measure blood glucose levels in people with diabetes and those who have not progressed to diabetes but have higher-than-normal levels of sugar in their blood.

[0009] Blood glucose meters come in two types: one where the user draws blood from their fingertip and measures blood glucose levels one at a time, and another where the device is attached to the user's stomach or arm and measures blood glucose levels continuously.

[0010] In diabetic patients, blood sugar levels generally fluctuate between high and low, but the emergency situation often arises from hypoglycemia, which can lead to loss of consciousness or, if hypoglycemia persists for a long time without glucose supply, can be fatal. Therefore, immediate detection of hypoglycemia is crucial for diabetic patients, but blood glucose meters that measure blood glucose intermittently have limitations in accurately detecting it.

[0011] Recently, to overcome these limitations, continuous glucose monitoring systems (CGMS) have been developed, which are inserted into the human body to measure blood glucose levels at intervals of water absorption. Through these systems, the management of diabetic patients and the response to emergency situations can be easily carried out.

[0012] Furthermore, blood glucose meters that use blood sampling require diabetic patients to prick their sensitive fingertips with a needle to collect blood, which inevitably induces discomfort and aversion during the blood sampling process. To minimize this discomfort and aversion, research and development is being conducted on continuous glucose monitoring systems that continuously measure blood glucose after inserting a needle-shaped sensor into relatively less sensitive areas such as the abdomen or arm. Moreover, research and development has also been actively pursued on non-invasive glucose monitoring systems that measure blood glucose without collecting blood.

[0013] For the past 40 years or so, research has been ongoing on various methods of non-immersion blood glucose measurement, including optical, electrical, and breath-based methods, to measure blood glucose without taking blood samples. Cygnus (Redwoo City, Ca, USA) developed and marketed the Glucowatch G2 Biographer, a wristwatch-type device utilizing reverse ion osmosis therapy. However, sales were discontinued in 2007 due to issues such as skin irritation, calibration problems, device malfunction due to sweating, and inability to accurately detect hypoglycemia compared to hyperglycemia. To date, many non-blood glucose measurement technologies have emerged and been reported, but their accuracy is often lacking, making them impractical for everyday use.

[0014] A continuous glucose monitoring device consists of a sensor module that is inserted into the skin to extract bodily fluids and measure glucose, a transmitter that sends the glucose values ​​measured by the sensor module to a terminal, and a terminal that outputs the transmitted glucose values. The sensor module is equipped with a sensor probe with a needle-like pattern that is inserted into the subcutaneous fat to extract interstitial fluid, and a separate applicator is used to insert and attach the sensor module to the body.

[0015] Such continuous glucose monitoring devices are manufactured in a wide variety of forms by different manufacturers, and their usage methods are also diverse. However, most continuous glucose monitoring devices are manufactured and distributed in a way that a single-use sensor module is inserted into the body via an applicator, and the external housing of the sensor module has adhesive tape on the bottom to allow the sensor module to adhere to the body. With this structure, once the sensor module is inserted into the skin via the applicator, it remains attached to the skin by the adhesive tape during this process, and in this state, blood glucose can be measured periodically and continuously.

[0016] Since the portion of the sensor module's sensor component that is inserted into the skin is made of a flexible material, a guide needle is provided to guide the process of inserting the sensor component into the skin. Specifically, the portion of the sensor component that is inserted into the skin is positioned to protrude outward from the bottom surface of the sensor module's outer housing, and the guide needle is positioned to surround this portion of the sensor component. As the sensor module is attached to the skin via the applicator, the guide needle is inserted into the skin together with the sensor component. The guide needle is configured to be removed from the skin by the applicator once the process of inserting the sensor component into the skin is complete.

[0017] Such continuous blood glucose monitoring devices typically exhibit reduced accuracy in the initial stages of operation after the sensor module is attached to the body, with accuracy improving only after a considerable amount of time has elapsed. While various studies are underway to address this initial decrease in accuracy, satisfactory results have yet to be achieved. [Overview of the Initiative] [Problems that the invention aims to solve]

[0018] The present invention was made to solve the problems of the prior art, and the object of the present invention is to provide a continuous blood glucose monitoring device in which, when the body attachment unit is inserted and attached to the body, the incision site made by the guide needle does not enclose at least a part of the sensing area formed on the sensor member, thereby preventing the formation of an incision site around the sensing area, and thereby preventing the phenomenon of a decrease in blood glucose measurement values ​​caused by the incision site, and enabling accurate blood glucose measurement values ​​to be detected from the start of operation.

[0019] Another object of the present invention is to provide a continuous blood glucose monitoring device that can improve the accuracy of blood glucose measurement by adjusting the separation distance between the incision site by the guide needle and the sensing area by adjusting the insertion depth of the guide needle through the applicator during the process in which the body attachment unit is inserted and attached to the body. [Means for solving the problem]

[0020] The present invention provides a continuous blood glucose monitoring device comprising a body-attachment unit formed to be inserted into and attached to the body so as to measure blood glucose periodically, and an applicator operated by the user so as to insert and attach the body-attachment unit to the body, wherein the body-attachment unit comprises a sensor member having a sensing region formed on one side so as to be inserted into the body and to react with blood glucose within the body, and a guide needle formed to surround the sensor member externally and to be withdrawn and removed after being inserted into the body together with the sensor member, wherein the incision site inside the body made by the guide needle is formed so as not to surround at least a portion of the sensing region externally.

[0021] In this case, the guide needle can be inserted before or at the same time as the sensor member during the body insertion process.

[0022] Further, the sensor member includes a sensor probe portion that is formed long along the body insertion direction so that at least a partial section thereof is inserted into the body, and the sensing region can be formed at the distal end portion of the sensor probe portion.

[0023] Further, the guide needle is formed in a form that wraps the sensor probe portion externally, and can be inserted at a shallower depth than the sensor probe portion and then pulled out and removed.

[0024] Further, the distal end of the guide needle can be inserted to a depth at a position that is further adjacent to the skin surface than the maximum deep layer fulcrum of the sensing region.

[0025] Further, the distal end of the guide needle can be inserted to a depth at a position that is further adjacent to the skin surface than the outermost contour fulcrum of the sensing region.

[0026] Further, the guide needle includes an incision portion formed at the front distal end portion so as to incise the skin of the body during the process of being inserted into the body, and an insertion support portion formed by extending from the rear end of the incision portion and continuously inserted into the body along the portion incised by the incision portion. The boundary fulcrum between the insertion support portion and the incision portion can be inserted to a depth at a position that is further adjacent to the skin surface than the maximum deep layer fulcrum of the sensing region.

[0027] Further, the applicator is equipped with needle extraction means for pulling out and removing the guide needle from the body in a state where the guide needle is inserted into the body, and the needle extraction means can be operated to pull out and remove the guide needle from the body before the sensor member is completely inserted into the body.

[0028] Further, the sensor member and the guide needle can be inserted into the body by the applicator so that the sensor member is inserted at a faster insertion speed than the guide needle in the section after being inserted into the body.

[0029] Further, the sensor member can be inserted into the body by the applicator so that it can be additionally inserted even after the guide needle has been inserted to a preset insertion depth with the sensor member inserted into the body together with the guide needle.

Advantages of the Invention

[0030] According to the present invention, by forming the incision site by the guide needle so as not to cover at least a partial region of the sensing region formed in the sensor member in a state where the body attachment unit is inserted and attached to the body, an incision site is not formed around the sensing region, thereby preventing the phenomenon of a decrease in the blood glucose measurement value generated by the incision site and enabling accurate detection of the blood glucose measurement value from the initial stage of operation.

[0031] Further, by adjusting the insertion depth of the guide needle through the applicator in the process of inserting and attaching the body attachment unit to the body, the separation distance between the incision site by the guide needle and the sensing region can be adjusted, thereby improving the accuracy of blood glucose measurement.

Brief Description of the Drawings

[0032] [Figure 1] FIG. 1 is a drawing schematically showing a basic system of a continuous blood glucose measurement device according to an embodiment of the present invention. [Figure 2] FIG. 2 is a drawing schematically showing the shape of an applicator of a continuous blood glucose measurement device according to an embodiment of the present invention. [Figure 3] FIG. 3 is a drawing schematically showing the configuration of a body attachment unit of a continuous blood glucose measurement device according to an embodiment of the present invention. [Figure 4] FIG. 4 is a drawing schematically showing the form of a sensor member and a guide needle of a body attachment unit according to a first embodiment of the present invention. [Figure 5] FIG. 5 is a drawing conceptually showing the process of inserting and attaching a body attachment unit to the body according to a first embodiment of the present invention. [Figure 6]Figure 6 is a conceptual diagram showing the body insertion configuration of the sensor member and guide needle according to the first embodiment of the present invention. [Figure 7] Figure 7 is a conceptual diagram showing the arrangement of the body incision site and sensor member generated by the guide needle according to the first embodiment of the present invention. [Figure 8] Figure 8 is a conceptual diagram showing the body insertion configuration of the sensor member and guide needle according to the second embodiment of the present invention. [Figure 9] Figure 9 is a conceptual diagram showing the arrangement of the body incision site and sensor member generated by the guide needle according to the second embodiment of the present invention. [Figure 10] Figures 10 to 12 are illustrative diagrams showing the structure and operating state of an applicator for realizing a body insertion configuration of a sensor member and guide needle according to a second embodiment of the present invention. [Figure 11] Figures 10 to 12 are illustrative diagrams showing the structure and operating state of an applicator for realizing a body insertion configuration of a sensor member and guide needle according to a second embodiment of the present invention. [Figure 12] Figures 10 to 12 are illustrative diagrams showing the structure and operating state of an applicator for realizing a body insertion configuration of a sensor member and guide needle according to a second embodiment of the present invention. [Modes for carrying out the invention]

[0033] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. First, it should be noted that in assigning reference numerals to the components in each drawing, identical components will be given the same reference numeral whenever possible, even if they are shown in other drawings. Furthermore, in describing the present invention, if it is determined that a specific description of a related known configuration or function would obscure the gist of the invention, such a detailed description will be omitted.

[0034] Figure 1 is a schematic diagram showing the basic system of a continuous blood glucose monitoring device according to one embodiment of the present invention, Figure 2 is a schematic diagram showing the applicator shape of a continuous blood glucose monitoring device according to one embodiment of the present invention, and Figure 3 is a schematic diagram showing the configuration of the body attachment unit of a continuous blood glucose monitoring device according to one embodiment of the present invention.

[0035] A continuous blood glucose monitoring device according to one embodiment of the present invention is configured to attach a body-attachment unit 20, which is equipped with a sensor member 520 inserted into the body for continuous blood glucose measurement, to the body via an applicator 10. The applicator 10 is activated to insert and attach the body-attachment unit 20 to the body, and blood glucose is measured periodically and continuously from the body. The blood glucose measurement information measured periodically through the body-attachment unit 20 is transmitted to a separate terminal 30 and output.

[0036] The body-attachment unit 20 can be assembled inside the applicator 10 and manufactured as a single unit product. In this case, the usage method is very simple, minimizing the additional work required from the user when using the continuous blood glucose monitor. Of course, it can also be manufactured in various ways, such as supplying the body-attachment unit 20 separately from the applicator 10 to the user, who then inserts the body-attachment unit 20 into the applicator 10 to activate it.

[0037] The body-attachment unit 20 is formed to be attachable to the body so that it can extract bodily fluids and periodically measure blood glucose, and is also formed to send the blood glucose measurement results to an external device such as an external terminal 30. Such a body-attachment unit 20 may contain a sensor member 520 with one end inserted into the body, and a wireless communication chip (not shown) that can communicate wirelessly with the external terminal 30.

[0038] The applicator 10 is formed so that the body attachment unit 20 is attached and fixed inside, and is operated to discharge the body attachment unit 20 to the outside when the user applies pressure to the pressure button 110.

[0039] At this time, the body attachment unit 20 is assembled and manufactured with the applicator 10 inserted inside, and is configured to move in the direction of external discharge and attach to the body when the applicator 10 is operated by the user.

[0040] In other words, the sensor applicator assembly according to one embodiment of the present invention is assembled and manufactured so that the body attachment unit 20 is inserted into the applicator 10 during the manufacturing stage, and the body attachment unit 20 adheres to the skin simply by operating the applicator 10. It can then be supplied to the user in this state, allowing the user to attach the body attachment unit 20 to their skin simply by operating the applicator 10, without any additional work required to attach the body attachment unit 20 to their skin. In particular, the body attachment unit 20 is equipped with a separate wireless communication chip, eliminating the need to connect a separate transmitter, making it even more convenient to use.

[0041] A separate protective cap 200 can be detachably attached to the applicator 10 so as to prevent external exposure when the body attachment unit 20 is inserted inside the applicator 10. The user can then operate the applicator 10 after detaching the protective cap 200 to eject the body attachment unit 20 to the side from which the protective cap 200 was removed, thereby attaching it to the body.

[0042] At this time, adhesive tape 560 is attached to the body contact surface of the body attachment unit 20 so that the body attachment unit 20 adheres to the body, and a shaped paper (not shown) is attached to the body contact surface of the adhesive tape 560 to protect the adhesive tape 560. However, the shaped paper of the adhesive tape 560 can be formed so that it is separated and removed from the adhesive tape 560 during the process of separating the protective cap 200 from the applicator 10.

[0043] The applicator 10 can be configured to bind and fix the body attachment unit 20 when the body attachment unit 20 is inserted inside, and to release the binding and fixation to the body attachment unit 20 when the body attachment unit 20 is ejected to the outside. 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, and when the applicator 10 is operated to eject the body attachment unit 20 to the outside and attach it to the skin, the binding and fixation state between the applicator 10 and the body attachment unit 20 is released. In this state, if the applicator 10 is separated, it will be separated from the body attachment unit 20, and only the body attachment unit 20 will remain attached to the skin.

[0044] The body attachment unit 20 is formed such that a sensor member 520 is placed inside a separate housing 510, with one end of the sensor member 520 protruding outward from the bottom surface of the housing 510 so as to be inserted into and attached to the body. The sensor member 520 consists of a sensor probe portion 521 (see Figure 5) that is inserted into the body and a sensor body portion 522 (see Figure 5) that is placed inside the housing 510, but the sensor probe portion and the sensor body portion are bent in shape and form one end and the other end of the sensor member 520, respectively.

[0045] At this time, a separate guide needle 550 can be detachably connected to the housing 510 to ensure that the process of inserting the sensor member 520 into the body is smooth. The guide needle 550 is configured to wrap around one end of the sensor member 520 and be inserted into the body together with the sensor member 520 so that one end of the sensor member 520 is stably inserted into the body.

[0046] As shown in Figure 2, such a guide needle 550 is detachably attached to the housing 510 of the body attachment unit 20 in a direction that penetrates the housing 510 vertically, and is formed in a manner that wraps around the outside of the sensor member 520, with a needle head 551 formed at its upper end. When the body attachment unit 20 is moved outward by the applicator 10, such a guide needle 550 is inserted into the body before the sensor member 520, guiding the sensor member 520 to be stably inserted into the skin. The guide needle 550 is connected to a needle extraction means (not shown) of the applicator 10 through the needle head 551, and is formed to be extracted and removed from the body by the needle extraction means of the applicator 10 after the body attachment unit 20 has been inserted and attached to the body by the operation of the applicator 10.

[0047] Below, we will examine the configuration of the sensor member 520 and guide needle 550 of the body attachment unit 20 in more detail.

[0048] Figure 4 is a schematic diagram showing the shape of the sensor member and guide needle of the body attachment unit according to the first embodiment of the present invention; Figure 5 is a conceptual diagram showing the body insertion and attachment process of the body attachment unit according to the first embodiment of the present invention; Figure 6 is a conceptual diagram showing the body insertion configuration of the sensor member and guide needle according to the first embodiment of the present invention; and Figure 7 is a conceptual diagram showing the arrangement configuration of the body incision site and sensor member created by the guide needle according to the first embodiment of the present invention.

[0049] As described above, the sensor member 520 of the body-attached unit 10 includes a sensor body portion 522 positioned inside the housing 510 and a sensor probe portion 521 that is bent downward from the sensor body portion 522 and positioned to protrude downward from the lower side of the housing 510. The sensor probe portion 521 is formed to be long along the body insertion direction so that at least a portion of it is inserted into the body, and a sensing region 5211 that reacts with blood glucose in the body is formed at the end of the sensor probe portion 521 so that blood glucose in the body can be measured. The degree of reaction with blood glucose through the sensing region 5211 is converted into an electrical signal and analyzed to measure blood glucose in the body.

[0050] The sensor probe portion 521 can be formed in a flat plate shape as shown in Figure 4, and the sensing region 5211 can be formed on one surface of the flat sensor probe portion 521.

[0051] The guide needle 550 is formed to enclose the sensor probe portion 521 externally, but it can be formed in a channel shape with a "⊂" pattern, where one surface is open along the length direction. Of course, the shape of the guide needle 550 can also be formed in various hollow pipe shapes, where a portion of the area is open along the length direction.

[0052] Such a guide needle 550 guides the insertion of the sensor member 520 into the body, and as it is inserted into the body together with the sensor member 520, it is inserted into the body before the sensor member 520 and cuts into the body skin. For this purpose, an incision portion 550a is formed at the anterior end of the guide needle 550 in a manner that allows it to cut into the body skin as it is inserted into the body, and an insertion support portion 550b is extended from the posterior end of the incision portion 550a and is continuously inserted into the body along the area cut by the incision portion 550a. The insertion support portion 550b of the guide needle 550 is positioned to enclose the sensor probe portion 521 of the sensor member 520 from the outside, and the sensing region 5211 formed at the end of the sensor probe portion 521 is also positioned to be enclosed from the outside by the insertion support portion 550b of the guide needle 550.

[0053] As described above, the sensor member 520 and the guide needle 550 are coupled to the housing 510 and inserted into the skin by the applicator 10. After the sensor member 520 and the housing 510 are in contact with the skin, the guide needle 550 is withdrawn and removed from the skin by the applicator 10.

[0054] At this time, due to the arrangement of the sensor member 520 and the guide needle 550, the insertion depth (ND) of the guide needle 550 is formed to be deeper than the insertion depth (SD) of the sensor member 520, as shown in Figure 5(a). Since the insertion support portion 550b of the guide needle 550 is positioned to wrap around the sensor member 520, as shown in Figure 6, the insertion depth (ND) of the end of the incision portion 550a of the guide needle 550, as well as the insertion depth of the end of the insertion support portion 550b, are formed to be deeper than the insertion depth (SD) of the sensor member 520. The guide needle 550 makes an incision in the body skin (E) and leaves a wound inside the body skin (E). However, after the guide needle 550 is inserted into the body, if the guide needle 550 is withdrawn and removed, the incision site inside the body skin (E) made by the guide needle 550 will remain at a depth equal to the insertion depth (ND) of the guide needle 550, as shown in Figure 5(b).

[0055] After the guide needle 550 is withdrawn and removed from the body skin (E), if we examine the positional relationship between the incision site created by the guide needle 550 within the body skin (E) and the sensor member 520 in more detail, as shown in Figure 7, the incision site (CA) created by the guide needle 550 is formed so as to be separated from both sides of the sensor member 520 with respect to a cross-section perpendicular to the body skin (E). At this time, if the separation distance between the sensor member 520 and the guide needle 550 is very small or if they are in a state of contact without separation, the incision site (CA) created by the guide needle 550 within the body skin (E) may be formed in contact with the sensor member 520.

[0056] The incision sites (CA) formed on both sides of the sensor member 520 within the body skin (E) are substantially created by the insertion support portion 550b of the guide needle 550, and the incision site created by the incision portion 550a of the guide needle 550 can be formed in a manner that extends further in an inclined direction from the incision site (CA) created by the insertion support portion 550b, as shown by the dotted line in Figure 7. The depth of creation of the incision site (CA) by the incision portion 550a of the guide needle 550 is ND, and the depth of creation of the incision site (CA) by the insertion support portion 550b of the guide needle 550 is ND1, and in this case the insertion depth of the sensor member 520 is SD.

[0057] Therefore, around the sensing region 5211 formed on one surface of the sensor probe portion 521 of the sensor member 520, an incision site (CA) formed by the insertion support portion 550b of the guide needle 550 is formed within the body skin (E) in a manner that encloses the sensing region 5211 externally.

[0058] The incision site (CA) made by the guide needle 550 corresponds to an internal wound in the body. As a result, a small amount of bleeding occurs at the incision site (CA), and as shown in the enlarged view of Figure 7, white blood cells (BC) gather at the incision site (CA) due to the body's immune response. When white blood cells (BC) gather at the incision site (CA) in this way, the amount of blood glucose response changes in the sensing area 5211 of the sensor member 520 located in the surrounding area, and the accuracy of blood glucose measurement decreases.

[0059] In other words, after the guide needle 550 is withdrawn and removed, if white blood cells (BCs) begin to gather at the incision site (CA) made by the guide needle 550, surrounding glucose substances (glucose) will bind to the white blood cells (BCs), thereby reducing the amount of glucose substances that react with the sensing area 5211. Due to this concentration of white blood cells (BCs) and the resulting decrease in glucose substances that react with the sensing area 5211, the blood glucose measurement value measured by the sensor member 520 will be a significantly reduced value, rather than the steady-state blood glucose measurement value. This change in blood glucose measurement value due to the influence of white blood cells (BCs) may persist for several days until the incision site (CA) has fully recovered.

[0060] Therefore, since the body-attachment unit 10 of the continuous blood glucose monitor has a guide needle 550 inserted into the body along with the sensor member 520, the accuracy of blood glucose measurement decreases in the initial stages of operation when the body-attachment unit 10 is first inserted and attached to the body, due to the incision site created by the guide needle 550.

[0061] Below, we will examine in detail the structure designed to minimize the decrease in blood glucose accuracy described above.

[0062] Figure 8 is a conceptual diagram showing the body insertion configuration of the sensor member and guide needle according to the second embodiment of the present invention, and Figure 9 is a conceptual diagram showing the arrangement configuration of the body incision site and sensor member created by the guide needle according to the second embodiment of the present invention.

[0063] As described above, the sensor member 520 and guide needle 550 in the second embodiment of the present invention are formed such that the guide needle 550 encloses the sensor probe portion 521 of the sensor member 520 from the outside.

[0064] The guide needle 550 is inserted before or at the same time as the sensor member 520 during the body insertion process, and is withdrawn and removed by the applicator 10 after insertion into the body. In order for the guide needle 550 to be inserted before or at the same time as the sensor member 520, the end of the guide needle 550 is positioned closer to the body skin (E) than the end of the sensor member 520 in the region prior to body insertion, as shown in Figure 8(a).

[0065] At this time, the guide needle 550 according to the second embodiment of the present invention is inserted in such a manner that the incision site (CA) inside the body incised by the guide needle 550 does not enclose at least a portion of the sensing area 5211 in the external area of ​​the sensor member 520.

[0066] For example, as shown in Figures 8(b) and (c), after the body insertion process of the sensor member 520 and the guide needle 550 is completed, the guide needle 550 can be inserted into the body skin (E) such that its insertion depth (ND) is even smaller than the insertion depth (SD) of the sensor member 520. That is, the guide needle 550 can be inserted to a depth even shallower than the sensor probe portion 521 of the sensor member 520. Thereafter, the guide needle 550 is withdrawn and removed at that depth without being inserted any further, as shown in Figures 8(b) and (c).

[0067] More specifically, as shown in Figure 8(b), the guide needle 550 can be inserted to a depth such that the insertion depth (ND) of its tip is further in contact with the skin surface than the outermost fulcrum 5211a of the sensing region 5211. In addition, as shown in Figure 8(c), the guide needle 550 can be inserted to a depth such that the insertion depth (ND) of its tip is further in contact with the skin surface than the deepest fulcrum 5211b of the sensing region 5211. After being inserted to such depths, the guide needle 550 is withdrawn and removed from the skin, leaving a wound (CA) in the skin (E) at the incision site caused by the insertion of the guide needle 550.

[0068] As the insertion path of the guide needle 550 into the body skin (E) forms an incision site (CA), if the guide needle 550 is inserted to a depth shallower than the sensor probe portion 521, the incision site (CA) created by the guide needle 550 will also be formed inside the body at a depth shallower than the sensor probe portion 521.

[0069] If the incision site (CA) created by the guide needle 550 is formed at a depth even shallower than the sensor probe portion 521, as shown in Figure 9, the incision site (CA) will not be formed in the surrounding area opposite the sensing region 5211. As a result, leukocytes (BCs) that would normally concentrate in the incision site (CA) will not be located adjacent to the sensing region 5211. This reduces the loss of glucose substances by leukocytes (BCs) around the sensing region 5211, thereby improving the accuracy of blood glucose measurements through the sensing region 5211.

[0070] In other words, the smaller the incision site (CA) created by the guide needle 550 in the peripheral region opposite the sensing region 5211, or to put it another way, the further the incision site (CA) created by the guide needle 550 is from the sensing region 5211, the less blood glucose loss by white blood cells (BCs) around the sensing region 5211 is reduced, resulting in more accurate blood glucose measurements.

[0071] As shown in Figure 9, when the incision site (CA) made by the guide needle 550 is examined in detail with respect to a cross-section perpendicular to the body skin (E), the incision site (CA) made by the insertion support portion 550b of the guide needle 550 is formed on both sides of the sensor probe portion 521, and the incision site (CA) made by the incision portion 550a of the guide needle 550 is formed to extend in an inclined direction from the end of the incision site (CA) made by the insertion support portion 550b, as shown by the dotted line.

[0072] Therefore, since the incision site (CA) made by the insertion support portion 550b is formed to face a region more adjacent to the sensing region 5211 than the incision site (CA) made by the incision portion 550a of the guide needle 550, the incision site (CA) made by the insertion support portion 550b will have a greater influence on the phenomenon of blood glucose loss by leukocytes (BC) around the sensing region 5211. Thus, the degree to which the incision site (CA) made by the insertion support portion 550b is farther from the sensing region 5211 will have a greater influence on the accuracy of blood glucose measurement.

[0073] If the insertion depth (ND) of the end of the incision portion 550a of the guide needle 550 is located closer to the skin surface than the outermost support point 5211a of the sensing region 5211 (i.e., located shallower), then as shown in Figure 9(a), the depth (ND) to the end of the incision site (CA) by the incision portion 550a will be located even shallower than the outermost support point 5211a of the sensing region 5211. In this case, the depth (ND1) of the incision site (CA) by the insertion support portion 550b will be located even shallower than the depth (ND) to the end of the incision site (CA) by the incision portion 550a, so the incision of the guide needle 550 The incision site (CA) formed by part 550a and insertion support part 550b is positioned further away from the sensing region 5211 so as not to enclose the sensing region 5211 externally, and to be in closer contact with the skin surface. Therefore, since there is no incision site (CA) in the area surrounding the sensing region 5211, the leukocytes (BC) that would normally concentrate at the incision site (CA), as shown in the enlarged view of Figure 9(a), are positioned relatively farther away from the sensing region 5211. Consequently, there is almost no loss of glucose substances from the sensing region 5211 by leukocytes (BC), allowing for more accurate blood glucose measurements.

[0074] Furthermore, if the insertion depth (ND) of the end of the incision portion 550a of the guide needle 550 is located between the outermost support point 5211a and the deepest support point 5211b of the sensing region 5211, then, as shown in Figure 9(b), the depth (ND) to the end of the incision site (CA) by the guide needle 550 will be located even shallower than the deepest support point 5211b of the sensing region 5211, and the depth (ND1) of the incision site (CA) by the insertion support portion 550b of the guide needle 550 can be located even shallower or deeper than the position of the outermost support point 5211a of the sensing region 5211. In this case, the incision site (CA) formed by the incision portion 550a of the guide needle 550 or the incision site (CA) formed by the insertion support portion 550b encloses a portion of the sensing region 5211 externally (i.e., a portion of the sensing region 5211 is not enclosed externally). However, even in this case, the incision site (CA) of the guide needle 550 does not enclose the entire sensing region 5211. Therefore, the loss of glucose substances by leukocytes (BCs) generated at the incision site (CA) is considerably reduced around the sensing region 5211, thereby relatively improving the accuracy of the blood glucose measurement.

[0075] By making the insertion depth of the guide needle 550 shallower than the depth of the sensor probe portion 521, the incision site (CA) created by the guide needle 550 does not enclose at least a portion of the sensing region 5211 externally. This minimizes the reduction of blood glucose substances by leukocytes (BCs) generated at the incision site (CA), thereby improving the accuracy of measurement for the sensing region 5211.

[0076] Next, we will examine in detail the insertion depth adjustment configuration between the sensor member 520 and the guide needle 550 of the body attachment unit 10 described above.

[0077] Figures 10 to 12 are illustrative diagrams showing the structure and operating state of an applicator for realizing a body insertion configuration of a sensor member and guide needle according to a second embodiment of the present invention.

[0078] As described above, an applicator 10 according to one embodiment of the present invention is a device that operates to insert and attach a body attachment unit 10 to the body by the user's operation, and can be configured to include a main case 100 with one side open, a plunger body 300 that moves inside the main case 100 with the open side facing outwards, and a plunger elastic spring (S1) that applies an elastic force to the plunger body 300 so that the plunger body 300 moves in the direction of outward discharge, or the body attachment unit 10 can be coupled to the plunger body 300 and configured to move together with the plunger body 300 in the direction of outward discharge.

[0079] The main case 100 is equipped with an operating part, such as a pressure button (not shown), which can be operated by the user. The plunger body 300 is coupled and fixed to a first position inside the main case 100. By operating the operating part, the coupling and fixing at the first position is released, and the plunger body moves linearly to a second position, which is in the direction of external discharge, by the elastic force of the plunger elastic spring (S1). The body attachment unit 10 is coupled to one end of the plunger body 300 and moves linearly with the plunger body 300 in the direction of external discharge to be inserted into and attached to the body skin (E).

[0080] As described above, the body attachment unit 10 consists of a housing 510, a sensor member 520 including a sensor body portion 522 and a sensor probe portion 521, and a guide needle 550 which is positioned to enclose the sensor probe portion 521 externally and is detachably coupled to the housing 510.

[0081] When the body attachment unit 10 is ejected to the outside, the sensor probe portion 521 of the sensor member 520 is positioned to protrude outward from the bottom surface of the housing 510 so that it is inserted into the body skin (E), and the guide needle 550 wraps around the sensor probe portion 521 on the outside and is inserted into the body skin (E) together with the sensor probe portion 521.

[0082] After the guide needle 550 is inserted into the body skin (E), it is withdrawn and removed from the skin (E). The applicator 10 is equipped with a needle withdrawal means (N) for withdrawing and removing the guide needle 550 from the body skin (E) while the guide needle 550 is inserted into the body skin (E).

[0083] The needle extraction means (N) can be configured to include a needle extraction body 400 that engages with and is coupled to a plunger body 300 and moves linearly with the plunger body 300 in the outward discharge direction to connect with a needle head 551 formed at the upper end of the guide needle 550, and a needle extraction elastic spring (S2) that applies an elastic force to the needle extraction body 400 in the opposite direction to the outward discharge direction. The plunger body 300 has a hook engagement portion 350 that can restrain the elastic movement of the needle extraction body 400, and an elastic hook 410 that engages with and is coupled to the hook engagement portion 350 is formed on the upper part of the needle extraction body 400. When the elastic hook 410 engages with the hook engagement portion 350, the needle pull-out body 400 moves together with the plunger body 300 in the outward discharge direction. Once it has moved a predetermined distance, the engagement between the elastic hook 410 and the hook engagement portion 350 is released by a separate locking release means (not shown). In this state, the needle pull-out body 400 can be moved upward in the opposite direction to the outward discharge direction by the needle pull-out elastic spring (S2).

[0084] At this time, the needle withdrawal means (N) can be operated to withdraw and remove the guide needle 550 from the body skin (E) before the sensor member 520 is fully inserted into the body skin (E), as shown in Figure 10, and through this, the sensor member 520 can be inserted deeper into the body skin (E) than the guide needle 550.

[0085] Looking at it in more detail, in the state shown in Figure 10(a), when the operating part of the applicator 10 is operated by the user, the housing 510 of the body attachment unit 10 moves together with the plunger body 300 to a second position (internal lower end region) in the direction of external discharge at the first position (internal upper end region) of the internal space of the main case 100, as shown in Figures 10(b) and (c). The sensor probe portion 521 of the sensor member 520 moves together with the plunger body 300 and the housing 510 to the second position and is inserted into the body skin (E) to a preset insertion depth of SD, as shown in Figure 10(c).

[0086] At this time, as the guide needle 550 moves to the second position together with the plunger body 300 and housing 510, it moves toward the first position by the needle extraction means (N) at the third position, which is an intermediate section, as shown in Figure 10(b), and is extracted and removed from the body. That is, when the guide needle 550 reaches the third position together with the plunger body 300 and housing 510, the engagement between the elastic hook 410 of the needle extraction body 400 and the hook engagement portion 350 of the plunger body 300 is released, and at the same time the needle extraction body 400 moves upward toward the first position by the elastic force of the needle extraction elastic spring (S2), and in this process the guide needle 550 moves upward together with the needle extraction body 400 and is extracted and removed from the body skin (E).

[0087] To summarize, the guide needle 550 is inserted into the body skin (E) before the sensor member 520 during the process of penetrating and inserting it externally, guiding the insertion of the sensor member 520. However, it does not move to the second position together with the sensor member 520, but rather moves upward toward the first position by the needle extraction means (N) while inserted to an intermediate third position, i.e., a depth of ND which is smaller than the insertion depth SD of the sensor member 520, and is then extracted and removed from the body.

[0088] Therefore, once the body attachment unit 10 is finally inserted and attached to the body skin (E), the sensor member 520 is inserted to a depth of approximately SD, as shown in Figure 10(c), and the guide needle 550 is inserted to a depth of approximately ND, which is less than SD. The insertion depth (ND) of the guide needle 550 can be set to various depths according to the user's needs.

[0089] On the other hand, as shown in Figure 11, the sensor member 520 and the guide needle 550 can be inserted into the body skin (E) by the applicator 10 in such a way that the sensor member 520 is inserted at a faster speed than the guide needle 550 in the section after insertion into the body skin (E), and through this, the sensor member 520 can be inserted deeper into the body skin (E) than the guide needle 550.

[0090] For this purpose, a separate rack and pinion gear structure can be used. For example, housing rec gears (T3) are formed on both sides of the housing 510 along the outward discharge direction, and a case rec gear (T2) is formed on the lower end section of the inner side of the main case 100 of the applicator 10 along the outward discharge direction. A pinion gear (T1) is rotatably coupled to one side of the plunger body 300, which can mesh and couple simultaneously with the housing rec gear (T3) and the case rec gear (T2). The plunger body 300 and the housing 510 are arranged so that the pinion gear (T1) and the housing rec gear (T3) are meshed with each other, as shown in Figure 11(a), in the state prior to the operation of the applicator 10.

[0091] With this structure, when the operating part of the applicator 10 is operated by the user, the plunger body 300 and housing 510 move together from the state shown in Figure 11(a) to the state shown in Figure 11(b), at which point the guide needle 550 begins to be inserted into the body skin (E). In this state, the pinion gear (T1) also begins to mesh with the case rec gear (T2). Subsequently, as shown in Figure 11(c), when the plunger body 300 moves to the second position which is the external discharge direction, the pinion gear (T1) rotates due to meshing with the case rec gear (T2), and the rotation of the pinion gear (T1) causes the housing rec gear (T3) to move in the external discharge direction (downward). In other words, in the section from the state shown in Figure 11(b) to the state shown in Figure 11(c), when the plunger body 300 moves downward, the pinion gear (T1) is rotated by the case rec gear (T2), and the rotation of the pinion gear (T1) causes the housing rec gear (T3) to move downward.

[0092] As shown above, in the section from (b) to (c) in Figure 11, the housing reck gear (T3) moves downward, so the housing 510 moves downward together with the housing reck gear (T3). Therefore, in this section, the housing 510 moves downward with the plunger body 300 at a speed that is a combination of the basic speed (v1: downward movement speed due to the plunger elastic spring (S1)) and an additional downward movement speed (v2: speed of downward movement together with the housing reck gear (T3)). At this time, the sensor member 520 is coupled to the housing 510 and moves together with the housing 510, so the sensor member 520 moves downward at a downward movement speed equal to the downward movement speed of the housing 510 (v1 + v2), but the guide needle 550 moves downward at a downward movement speed (v1) equal to the plunger body 300 due to the needle pull-out body 400 which is constrained to the plunger body 300.

[0093] Therefore, from the moment the guide needle 550 begins to be inserted into the body skin (E), the insertion speed of the sensor member 520 (v1+v2) is formed even faster than the insertion speed of the guide needle 550 (v1), and as a result, the insertion depth (SD) of the sensor member 520 is ultimately formed to be deeper than the insertion depth (ND) of the guide needle 550, as shown in Figure 11(c).

[0094] Once the insertion and movement of the guide needle 550 and the sensor member 520 is complete, the engagement between the elastic hook 410 of the needle pull-out body 400 and the hook engagement portion 350 of the plunger body 300 is released, as shown in Figure 11(c), and the guide needle 550 is pulled out and removed from the body skin (E) by the needle pull-out means (N).

[0095] On the other hand, as shown in Figure 12, the sensor member 520 can be inserted into the body skin (E) by the applicator 10 even after the guide needle 550 has been inserted to a predetermined insertion depth, while the sensor member 520 is inserted into the body skin (E) together with the guide needle 550, and through this, the sensor member 520 can be inserted deeper into the body skin (E) than the guide needle 550.

[0096] For this purpose, separate springs and rotating links can be used. For example, a housing spring (S3) that can elastically move the housing 510 coupled to the plunger body 300 in the outward discharge direction can be placed in the space between the plunger body 300 and the housing 510, and a rotating locking link (LK) that can restrain and release the downward movement of the housing 510 from the plunger body 300 can be rotatably coupled to the plunger body 300. As shown in Figure 12(a), the rotating locking link (LK) is maintained in a rotationally restrained state with its outer end in close contact with the inner surface of the main case 100 of the applicator 10. An operating groove (LH) in the form of a recess is formed at the end of the inner surface of the main case 100 in the outward discharge direction, and one end of the rotating locking link (LK) is released from rotational restraint by such an operating groove (LH).

[0097] With this structure, when the operating part of the applicator 10 is operated by the user, the plunger body 300 and housing 510 are ejected outward by the plunger elastic spring (S1) in the state shown in Figure 12(a). In this process, the rotation locking link (LK) comes into close contact with the inner surface of the main case 100 and is rotationally restrained, so the housing 510 is restrained to move by the rotation locking link (LK) and does not move relative to the plunger body 300 but moves downward together with the plunger body 300. Subsequently, as shown in Figure 12(b), once the ejection movement of the plunger body 300 is complete, the rotation locking link (LK) reaches the operating groove (LH) region, thereby releasing the rotational restraint of the rotation locking link (LK). Therefore, as shown in Figures 12(b) and (c), the rotation locking link (LK) rotates, thereby releasing the housing 510 from restraint and allowing it to move further downward by the housing spring (S3).

[0098] At this time, the sensor member 520 moves together with the housing 510 and is additionally inserted into the body skin (E). Regardless of the additional downward movement of the housing 510, once the plunger body 300 has completed its downward movement, the guide needle 550 is pulled out and removed from the body skin (E) by the needle pulling means (N) when the engagement between the elastic hook 410 of the needle pulling body 400 and the hook engagement portion 350 of the plunger body 300 is released, as shown in Figure 12(b).

[0099] Therefore, once the body attachment unit 10 is inserted into the body by the operation of the applicator 10, the guide needle 550 moves together with the plunger body 300 as shown in Figures 12(b) and (c), and after being inserted to an insertion depth of approximately ND, it is withdrawn and removed. Thereafter, the sensor member 520 moves further downward together with the housing 510 and is inserted into the body skin (E) to a depth of approximately SD, which is deeper than the ND depth.

[0100] The sensor member 520 and the guide needle 550 insertion depth adjustment configuration described above are illustrative examples and can be modified and applied in a variety of other ways.

[0101] The above description is merely illustrative of the technical concept of the present invention, and a person with ordinary skill in the art to which the present invention belongs will be able to make various modifications and variations without deviating from the essential characteristics of the present invention. Therefore, the embodiments disclosed herein are for illustrative purposes only, not to limit the technical concept of the present invention, 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 in accordance with the claims below, and all technical concepts within an equivalent scope should be interpreted as being included in the scope of rights of the present invention.

Claims

1. Guide needle and, Pinion gear and A body-attachment unit that is inserted into and attached to the body, The applicator includes a part of the body attachment unit that is inserted into and attached to the body. The body attachment unit is housed inside the applicator so as to be separated from one open side of the applicator. The body attachment unit is A housing having a housing rack gear on the outside, It has a sensor member that is inserted into the body and has a sensing area formed therein that measures blood glucose levels in the body, The applicator has, on the inside, Main case and, The body attachment unit has a plunger body that moves the body attachment unit from a first position to a second position along one direction, The aforementioned guide needle is The outside of the sensor member is wrapped while it is separated from the sensor member. The plunger body moves linearly from the first position to the second position, The aforementioned main case is The housing rack gear is positioned opposite to the case rack gear, The aforementioned pinion gear is By rotating while meshing with the housing rack gear and the case rack gear, the body attachment unit is further moved from the second position along the one direction. Blood sugar measuring device.

2. The aforementioned guide needle is Inserted before or at the same time as the sensor member during the body insertion process The blood glucose measuring device according to claim 1.

3. The aforementioned sensor member is It includes a sensor probe portion that is formed to be elongated along the body insertion direction so that at least a portion of it is inserted into the body, The sensing region is formed at the end of the sensor probe portion. The blood glucose measuring device according to claim 2.

4. The aforementioned guide needle is The sensor probe portion is formed in a manner that encloses it externally, It is inserted to a depth even shallower than the aforementioned sensor probe portion, and then withdrawn and removed. The blood glucose measuring device according to claim 3.

5. The aforementioned guide needle is Its end is inserted to a depth even closer to the skin surface than the deepest point of the sensing region. The blood glucose measuring device according to claim 4.

6. The aforementioned guide needle is Its end is inserted to a depth further adjacent to the skin surface than the outermost point of the sensing area. The blood glucose measuring device according to claim 5.

7. The aforementioned guide needle is An incision is formed at the anterior end portion to cut the skin of the body during the process of insertion into the body, An insertion support portion is formed as an extension at the rear end of the incision and is continuously inserted into the body along the area incised by the incision. Includes, The boundary between the insertion support portion and the incision portion is inserted to a depth adjacent to the skin surface beyond the deepest point of the sensing region. The blood glucose measuring device according to claim 3.

8. The applicator is equipped with a needle extraction means for withdrawing and removing the guide needle from the body while the guide needle is inserted into the body. The needle extraction means operates to pull out and remove the guide needle from the body before the sensor member is fully inserted into the body. A blood glucose measuring device according to claim 4 or claim 7.

9. The sensor member and the guide needle are, The sensor member is inserted into the body by the applicator in the section after it has been inserted into the body, such that it is inserted at a faster insertion speed than the guide needle. A blood glucose measuring device according to claim 4 or claim 7.

10. The aforementioned sensor member is The applicator is inserted into the body together with the guide needle, and is inserted further into the body after the guide needle has been inserted to a predetermined insertion depth. A blood glucose measuring device according to claim 4 or claim 7.

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