Continuous Glucose Monitoring Device

Abstract

A continuous blood glucose measuring device detects accurate blood glucose measurements from the beginning of operation, improving the accuracy of blood glucose measurements. [Solution] The present invention relates to a continuous blood glucose measuring device, and when the body-attachable unit is inserted and attached to the body, the incision made by the guide needle is formed so as not to enclose at least a portion of the sensing area formed in the sensor member, so that no incision is made around the sensing area, preventing a decrease in blood glucose measurement value caused by the incision and enabling accurate blood glucose measurement from the initial stage of operation.The present invention provides a continuous blood glucose measuring device that has a simple structure and can improve the accuracy of blood glucose measurement by having the guide needle have a shape that does not enclose at least a portion of the sensing area, so that no additional device is required and no incision is made around the sensing area inside the body.

Description

Technical Field

[0001] The present invention relates to a continuous blood glucose measurement device. More specifically, in a state where a body attachment unit is inserted and attached to the body, the incision site by the guide needle is formed so as not to cover 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. By making the guide needle have a shape that does not cover at least a part of the sensing area, the incision site of the guide needle is not formed in the peripheral part of the sensing area inside the body without a separate additional device, and the blood glucose measurement accuracy can be improved with a simple structure. The present invention relates to a continuous blood glucose measurement device.

Background Art

[0002] Diabetes is a chronic disease that occurs frequently in modern people. In the case of our country, it has reached more than 2 million people, which corresponds 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, which cannot correct the balance of sugar in the blood. As a result, the sugar component in the blood becomes absolutely high and the disease develops.

[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 a much higher blood glucose level than normal people. The excess blood glucose passes through the tissues as it is and is excreted in the urine, resulting in a deficiency of the sugar that is absolutely necessary for each tissue of the body and causing abnormalities in each tissue of the body.

[0006] Diabetes is characterized by few initial symptoms. However, as the disease progresses, specific symptoms such as excessive thirst, excessive hunger, polyuria, weight loss, general malaise, itchy skin, non-healing and persistent sores on the hands and feet may appear. If the disease progresses further, complications such as visual impairment, hypertension, kidney disease, stroke, periodontal disease, muscle cramps and neuralgia, and gangrene may occur.

[0007] To diagnose such diabetes and manage it so that it does not progress to complications, systematic blood glucose measurement and treatment must be carried out in parallel.

[0008] For diabetic patients and people who have not developed diabetes but have more sugar in their blood than normal, many medical device manufacturers offer various types of blood glucose meters that allow them to measure their blood glucose at home.

[0009] Blood glucose meters are available in two types: one where the user takes a blood sample from the fingertip and performs blood glucose measurement unit by unit, and another that attaches to the user's abdomen, arm, etc. and continuously performs blood glucose measurement.

[0010] In the case of diabetic patients, they generally alternate between hyperglycemic and hypoglycemic states. Emergency situations often start with hypoglycemia. If the patient loses consciousness or the hypoglycemic state persists for a long time without sugar supply, they may even lose their life. Therefore, the immediate detection of hypoglycemia is very important for diabetic patients, but there are limitations in accurately grasping this with the blood sampling type blood glucose meter that measures blood glucose intermittently.

[0011] Recently, to overcome such limitations, a continuous glucose monitoring device (CGMS: Continuous Glucose Monitoring System) that is inserted into the human body and measures blood glucose values at intervals has been developed, making it easier to manage diabetic patients and handle emergency situations.

[0012] In addition, for a blood-sampling type blood glucose meter, since blood glucose measurement is performed by pricking the fingertip, which is sensitive to pain, with a needle for a diabetic patient to examine their own blood glucose, pain and a sense of rejection are induced during the blood-sampling process. In order to minimize such pain and sense of rejection, research and development on a continuous blood glucose measurement system that continuously measures blood glucose after inserting a needle-shaped sensor into areas such as the abdomen and arm where pain is relatively less has been carried out. Furthermore, research and development on a non-invasive blood glucose measurement system (Non-Invasive Glucose Monitoring System) that measures blood glucose without collecting blood has also been actively progressing.

[0013] For the non-invasive blood glucose measurement system, research has been carried out on various methods such as optical methods, electrical methods, and measurement by exhalation for measuring blood glucose without collecting blood over the past more than 40 years. Cygnus (Redwoo City, Ca, USA) developed and launched the Glucowatch G2 Biographer in the form of a wristwatch using reverse iontophoresis therapy, but its sales were discontinued in 2007 due to problems such as skin irritation problems, problems with calibration, problems with the device stopping during sweating, and the inability to well recognize hypoglycemia compared to hyperglycemia. To date, many non-blood-sampling blood glucose measurement technologies have emerged and been reported, but their accuracy has decreased and they cannot be used practically.

[0014] The continuous blood glucose measurement device is composed of a sensor module that is inserted and attached to the body's skin to extract body fluid and measure blood glucose, a transmitter that sends the blood glucose value measured by the sensor module to a terminal device, and a terminal device that outputs the transmitted blood glucose value. The sensor module is equipped with a sensor probe formed in the shape of a needle that is inserted into 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 blood glucose monitoring devices are manufactured in a very diverse range of forms by each manufacturer, and their usage methods are also diverse. However, most continuous blood glucose monitors are manufactured and distributed in a way that the one-time use sensor module is inserted and attached to the body through an applicator. An adhesive tape is attached to the bottom surface of the external housing of the sensor module so that the sensor module can be attached to the body. With such a structure, when the sensor module is inserted into the body skin through the applicator, during this process, the sensor module is maintained in a state of being attached to the body skin by the adhesive tape, and in this state, blood glucose can be measured periodically and continuously.

[0016] Among the sensor members of the sensor module, the part inserted into the skin is formed of a soft material, so a guide needle is provided to guide the process of the sensor member being inserted into the skin. That is, the part of the sensor member inserted into the skin is arranged to protrude externally from the bottom surface of the external housing of the sensor module, and the guide needle is arranged to surround the part of such a sensor member inserted into the skin externally. During the process of the sensor module being attached to the skin through the applicator, the guide needle is inserted into the skin together with the sensor member. The guide needle is configured to be removed from the skin by the applicator when the process of inserting the sensor member into the skin is completed.

[0017] In general, such continuous blood glucose monitoring devices show the characteristic that the accuracy of blood glucose measurement decreases in the initial operating state when the sensor module is attached to the body, and the accuracy improves after a considerable period of time has passed. Although various studies are being conducted to solve the problem of the current decrease in the accuracy of initial measurements, the actual situation is that there are still no satisfactory research results. Summary of the Invention Problems to be Solved by the Invention

[0018] The present invention is invented to solve the problems of the prior art. The object of the present invention is that when the body attachment unit is inserted and attached to the body, the incision site by the guide needle does not cover at least a part of the sensing area formed in the sensor member, so that an incision site is not formed around the sensing area, thereby preventing the decrease phenomenon of the blood glucose measurement value generated by the incision site and detecting an accurate blood glucose measurement value from the initial stage of operation, and providing a continuous blood glucose measurement device.

[0019] Another object of the present invention is to provide a continuous blood glucose measurement device that can improve the accuracy of blood glucose measurement with a simple structure without forming an incision site of the guide needle around the sensing area inside the body without a separate additional device by making the guide needle have a shape that does not cover at least a part of the sensing area.

Means for Solving the Problems

[0020] The present invention includes a body attachment unit that is inserted and attached to the body by a separate applicator and is formed to be able to measure blood glucose periodically. The body attachment unit includes a sensor member having a sensing area formed on one side so as to be inserted into the body and react with blood glucose in the body, a guide needle formed to surround at least a part of the sensor member so as to guide the insertion of the sensor member into the body, moving linearly integrally with the sensor member and being inserted into the body and then pulled out and removed, The present invention provides a continuous blood glucose measurement device, characterized in that the end of the guide needle is arranged to protrude further or equally in the body insertion direction from the end of the sensor member, and the guide needle is formed to have a shape that does not surround at least a part of the sensing area outside.

[0021] At this time, the sensor member includes a sensor probe portion that is formed long along the body insertion direction such that at least a partial section is inserted into the body, and the sensing region can be formed at the distal end portion of the sensor probe portion.

[0022] Further, the guide needle is formed in a form that wraps around the sensor probe portion outside, and an opening portion can be formed at the distal end portion so as not to wrap around at least a partial region of the sensing region of the sensor member.

[0023] Further, the opening portion of the guide needle can be formed in a form that does not wrap around the entire region of the sensing region.

[0024] Further, the opening portion of the guide needle can be formed in a form that does not wrap around a partial region of the sensing region.

[0025] Further, the sensor probe portion is formed in a flat plate form that is arranged long along the body insertion direction, the sensing region is formed on one surface of the sensor probe portion, and the opening portion of the guide needle can be formed in a form in which a region facing one surface of the sensor probe portion where the sensing region is formed is open.

[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 that is formed to extend from the rear end of the incision portion and is continuously inserted into the body along the portion incised by the incision portion, and the opening portion can be formed in the incision portion region.

Advantages of the Invention

[0027] According to the present invention, in a state where the body attachment unit is inserted and attached to the body, the incision site by the guide needle is formed so as not to cover at least a part of the sensing region formed in the sensor member, so that an incision site is not formed around the sensing region. As a result, it is possible to prevent 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.

[0028] Further, by making the guide needle have a shape that does not cover at least a part of the sensing region, the incision site of the guide needle is not formed in the peripheral region of the sensing region inside the body without a separate additional device, and the accuracy of blood glucose measurement can be improved with a simple structure.

Brief Description of the Drawings

[0029]

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DETAILED DESCRIPTION OF THE INVENTION

[0030] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. First, when adding reference numerals to the components of each drawing, it should be noted that equal components have equal numerals as much as possible even if they are shown on other drawings. Also, in describing the present invention, if it is determined that a specific description of a related known configuration or function may obscure the gist of the present invention, the detailed description thereof will be omitted.

[0031] FIG. 1 is a drawing schematically showing the basic system of a continuous blood glucose measuring device according to an embodiment of the present invention, FIG. 2 is a drawing schematically showing the shape of an applicator of a continuous blood glucose measuring device according to an embodiment of the present invention, and FIG. 3 is a drawing schematically showing the configuration of a body attachment unit of a continuous blood glucose measuring device according to an embodiment of the present invention.

[0032] A continuous blood glucose measuring device according to an embodiment of the present invention is configured to attach a body attachment unit 20 including a sensor member 520 inserted into the body for continuous blood glucose measurement to the body through an applicator 10, operate the applicator 10 to insert and attach the body attachment unit 20 to the body, continuously measure blood glucose periodically from the body, and the blood glucose measurement information measured periodically through the body attachment unit 20 is transmitted to a separate terminal device 30 and output.

[0033] 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 made into a very simple structure in a form that minimizes the additional work of the user when using the continuous blood glucose monitoring device. Of course, the body attachment unit 20 can be manufactured in various ways, such as being supplied to the user separately from the applicator 10 and the user inserting the body attachment unit 20 inside the applicator 10 to operate it.

[0034] The body attachment unit 20 is formed to be attachable to the body so that it can extract body fluid and periodically measure blood glucose, and is formed to send the blood glucose measurement result to an external device such as the external terminal 30. Such a body attachment unit 20 can have a sensor member 520 with one end inserted into the body and a wireless communication chip (not shown) that can wirelessly communicate with the external terminal 30 disposed inside.

[0035] The applicator 10 is formed so that the body attachment unit 20 is coupled and fixed inside, and operates to eject the body attachment unit 20 externally by the user's pressing operation on the pressure button 110.

[0036] 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 ejection direction and adhere to the body by the operation of the applicator 10 by the user's operation.

[0037] That is, the sensor applicator assembly according to an embodiment of the present invention is assembled and manufactured such that, at the manufacturing stage, with the body attachment unit 20 inserted inside the applicator 10, the body attachment unit 20 can be attached to the skin only by operating the applicator 10, and in this state, it can be supplied to the user. Thus, the user can attach the body attachment unit 20 to the skin simply by operating the applicator 10 without any separate additional operation for attaching the body attachment unit 20 to the skin. In particular, the body attachment unit 20 is equipped with a separate wireless communication chip, and there is no need to connect a separate transmitter, so it can be used more conveniently.

[0038] A separate protective cap 200 can be detachably coupled to the applicator 10 so as to block external exposure with the body attachment unit 20 inserted inside the applicator 10. After the user separates the protective cap 200, the applicator 10 can be operated to externally discharge the body attachment unit 20 to the side from which the protective cap 200 has been removed and attach it to the body.

[0039] At this time, an adhesive tape 560 is attached to the body contact surface of the body attachment unit 20 so that the body attachment unit 20 can be attached to the body. A shaped paper (not shown) is attached to the body contact surface of the adhesive tape 560 for protecting the adhesive tape 560. However, the shaped paper of the adhesive tape 560 can be formed so as to be separated and removed from the adhesive tape 560 in the process of separating the protective cap 200 from the applicator 10.

[0040] Applicator 10 can be formed to couple and fix the body-attached unit 20 when the body-attached unit 20 is inserted inside, and to release the coupling and fixing state with respect to the body-attached unit 20 when the body-attached unit 20 moves outwards and discharges. Therefore, when the body-attached unit 20 is inserted and assembled inside the applicator 10, the body-attached unit 20 is maintained in a fixed state. When the applicator 10 is operated to discharge the body-attached unit 20 to adhere to the skin, the coupling and fixing state between the applicator 10 and the body-attached unit 20 is released. Thus, if the applicator 10 is separated in this state, it will be separated from the body-attached unit 20, and only the body-attached unit 20 will remain adhered to the skin.

[0041] The body-attached unit 20 has a sensor member 520 disposed inside a separate housing 510, and one end of the sensor member 520 protrudes externally from the bottom surface of the housing 510 to be formed to be inserted and adhered to the body. The sensor member 520 is composed of a sensor probe part 521 (see FIG. 5) inserted into the body and a sensor body part 522 (see FIG. 5) disposed inside the housing 510. The sensor probe part and the sensor body part form one end and the other end of the sensor member 520 in a bent form, respectively.

[0042] At this time, a separate guide needle 550 can be detachably coupled to the housing 510 so that the process of inserting the sensor member 520 into the body is made smooth. The guide needle 550 is configured to surround one end of the sensor member 520 so that one end of the sensor member 520 is stably inserted into the body and is inserted into the body together with the sensor member 520.

[0043] Such a guide needle 550 is detachably attached to the housing 510 of the body attachment unit 20 in a direction penetrating the housing 510 vertically as shown in FIG. 2, and is formed in a form surrounding the outside of the sensor member 520, and a needle head 551 is formed at the upper end. When the body attachment unit 20 moves in the external discharge direction by the applicator 10, such a guide needle 550 is inserted into the body ahead of the sensor member 520 to guide the sensor member 520 to be stably inserted into the skin. The guide needle 550 is coupled to a needle extraction means (not shown) of the applicator 10 through the needle head 551, and is formed to be pulled out and removed from the body by the needle extraction means of the applicator 10 after the body attachment unit 20 is inserted and attached to the body by the operation of the applicator 10.

[0044] Hereinafter, the configurations of the sensor member 520 and the guide needle 550 of the body attachment unit 20 will be examined in more detail.

[0045] FIG. 4 is a drawing schematically showing the form of the sensor member and the guide needle of the body attachment unit according to the first embodiment of the present invention, FIG. 5 is a drawing conceptually showing the process of inserting and attaching the body attachment unit to the body according to the first embodiment of the present invention, FIG. 6 is a drawing conceptually showing the form of inserting the sensor member and the guide needle into the body according to the first embodiment of the present invention, and FIG. 7 is a drawing conceptually showing the form of the body incision site generated by the guide needle and the arrangement of the sensor member according to the first embodiment of the present invention.

[0046] As described above, the sensor member 520 of the body attachment unit 10 includes a sensor body part 522 disposed inside the housing 510, and a sensor probe part 521 that is bent downward from the sensor body part 522 and is disposed so as to protrude downward on the lower side of the housing 510. The sensor probe part 521 is formed long along the body insertion direction so that at least a partial section thereof 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 part 521 so that the 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 the blood glucose in the body.

[0047] As shown in FIG. 4, the sensor probe part 521 can be formed in a flat plate form, and the sensing region 5211 can be formed on one surface of the sensor probe part 521 in a flat plate form.

[0048] The guide needle 550 is formed in a form that wraps around the sensor probe part 521 externally, but may be formed in a "C"-shaped channel form with one side open along the length direction. Of course, the shape of the guide needle 550 can also be formed in a hollow pipe form with various shapes in which a partial region is open along the length direction.

[0049] Such a guide needle 550 guides the insertion of the sensor member 520 into the body, and in the process of being inserted into the body together with the sensor member 520, it is inserted into the body before the sensor member 520 and cuts the body muscle. For this purpose, a cutting part 550a is formed at the front end part of the guide needle 550 in a form that can cut the body muscle in the process of being inserted into the body, and at the rear end of the cutting part 550a, an insertion support part 550b that is continuously inserted into the body along the part cut by the cutting part 550a is extended and formed. The insertion support part 550b of the guide needle 550 is disposed in a form that wraps around the sensor probe part 521 of the sensor member 520 externally, and the sensing region 5211 formed at the end of the sensor probe part 521 is also disposed so as to be wrapped around externally by the insertion support part 550b of the guide needle 550.

[0050] As described above, the sensor member 520 and the guide needle 550 are coupled to the housing 510 and inserted and attached to the body skin by the applicator 10. After the sensor member 520 and the housing 510 are attached to the body skin, the guide needle 550 is pulled out and removed from the body skin by the applicator 10.

[0051] At this time, due to the arrangement relationship between the sensor member 520 and the guide needle 550, as shown in Fig. 5(a), the insertion depth (ND) of the guide needle 550 is formed deeper than the insertion depth (SD) of the sensor member 520. Since the insertion support portion 550b of the guide needle 550 is arranged to surround the sensor member 520, as shown in Fig. 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 both formed deeper than the insertion depth (SD) of the sensor member 520. The guide needle 550 incises the body skin (E) and leaves a wound in the body skin (E). However, after the guide needle 550 is pulled out and removed after being inserted into the body, as shown in Fig. 5(b), the incision site in the body skin (E) by the guide needle 550 remains at a depth equal to the insertion depth (ND) of the guide needle 550.

[0052] After the guide needle 550 is pulled out and removed from the body skin (E) in this way, looking at the arrangement relationship between the incision site formed by the guide needle 550 in the body skin (E) and the sensor member 520 in more detail, as shown in Fig. 7, the incision site (CA) by the guide needle 550 is formed to be separated from both side surfaces of the sensor member 520 based on the vertical cross-section with respect to the body skin (E). At this time, when the separation interval between the sensor member 520 and the guide needle 550 is very small or in a contact state where they are not separated, the incision site (CA) by the guide needle 550 formed in the body skin (E) can also be formed in a state where it is in contact with the sensor member 520.

[0053] The incision sites (CA) formed on both sides of the sensor member 520 within the body muscle (E) are substantially generated by inserting the insertion support portion 550b of the guide needle 550. Thus, the incision site generated by the incision portion 550a of the guide needle 550 can be formed in a form that extends deeper in a direction inclined from the incision site (CA) by the insertion support portion 550b as shown by the dotted line in FIG. 7. The generation depth of the incision site (CA) by the incision portion 550a of the guide needle 550 is ND, and the generation depth of the incision site (CA) by the insertion support portion 550b of the guide needle 550 is ND1. In this case, the insertion depth of the sensor member 520 is SD.

[0054] Therefore, in the peripheral portion of the sensing region 5211 formed on one surface of the sensor probe portion 521 of the sensor member 520, the incision site (CA) by the insertion support portion 550b of the guide needle 550 is formed within the body muscle (E) in a form that encircles the sensing region 5211 from the outside.

[0055] Since the incision site (CA) by the guide needle 550 corresponds to an injury within the body, a small amount of bleeding occurs at the incision site (CA), and as shown in the enlarged view of FIG. 7, white blood cells (BC) gather at the incision site (CA) due to the body's immune reaction. When the white blood cells (BC) gather at the incision site (CA) in this way, the amount of blood glucose reaction changes in the sensing region 5211 of the sensor member 520 located in the vicinity, and the accuracy of blood glucose measurement decreases.

[0056] That is, after the guide needle 550 is withdrawn and removed, if white blood cells (BC) come to gather at the incision site (CA) by the guide needle 550, the surrounding blood sugar substances (glucose) will bind to the white blood cells (BC), and thereby the reaction amount of the blood sugar substances reacting with the sensing region 5211 will decrease. Thus, due to the concentration of white blood cells (BC), the decrease in the blood sugar substances reacting with the sensing region 5211 causes the blood sugar measurement value measured by the sensor member 520 to show a value that is considerably decreased rather than the blood sugar measurement value in the steady state. Such a change in the blood sugar measurement value due to the influence of white blood cells (BC) may continue for several days until the incision site (CA) completely recovers.

[0057] Therefore, since the guide needle 550 is inserted into the body together with the sensor member 520 in the body attachment unit 10 of the continuous blood sugar measurement device, a phenomenon occurs in which the accuracy of blood sugar measurement decreases at the initial stage of operation when the body attachment unit 10 starts to be inserted and attached to the body due to the incision site generated by the guide needle 550.

[0058] Hereinafter, a detailed look will be taken at the structure for minimizing the phenomenon of decreased accuracy of blood sugar measurement described above.

[0059] FIG. 8 is a drawing schematically showing the form of the sensor member and the guide needle of the body attachment unit according to the second embodiment of the present invention, FIG. 9 is a drawing conceptually showing the form of the sensor member and the guide needle inserted into the body according to the second embodiment of the present invention, and FIG. 10 is a drawing conceptually showing the arrangement form of the body incision site generated by the guide needle and the sensor member according to the second embodiment of the present invention.

[0060] The sensor member 520 and the guide needle 550 according to the second embodiment of the present invention are formed in such a form that the guide needle 550 externally wraps the sensor probe portion 521 of the sensor member 520 as described above.

[0061] The guide needle 550 is inserted prior to or simultaneously with the sensor member 520 during the body insertion process, and is pulled out and removed by the applicator 10 after being inserted into the body. Since the guide needle 550 is inserted into the body prior to or simultaneously with the sensor member 520, the end of the guide needle 550 protrudes further or equally in the body insertion direction from the end of the sensor member 520 as shown in FIG. 8.

[0062] At this time, the guide needle 550 is formed to externally wrap the sensor probe portion 521 of the sensor member 520, but does not externally wrap the entire region of the sensor probe portion 521, but is formed in a form that does not externally wrap at least a partial region of the sensing region 5211 formed in the sensor probe portion 521.

[0063] For this purpose, an opening portion (EP) can be formed at the end portion of the guide needle 550 so as not to wrap at least a partial region of the sensing region 5211 as shown in FIGS. 8 and 9. The opening portion (EP) can be formed in a form in which a part of the guide needle 550 is cut and removed, and such an opening portion (EP) can be formed in the region of the incision portion 550a formed at the end of the guide needle 550, or can also be formed in a form in which the incision portion 550a is extended.

[0064] For example, the guide needle 550 can be formed with opening portions (EP) that are symmetric to each other at the end portions of the regions facing the both side surfaces of the sensor probe portion 521 in a flat plate form as shown in FIGS. 8 and 9(a). Alternatively, the guide needle 550 can also be formed with an opening portion (EP) only at the end portion in the region facing the sensing region 5211 of the sensor probe portion 521 as shown in FIGS. 8 and 9(b). That is, the opening portion (EP) may be formed only in the region facing one surface of the sensor probe portion 521 where the sensing region 5211 is formed, and may not be formed in the region facing the other surface of the sensor probe portion 521.

[0065] When the opening part (EP) is formed only in the area facing one side of the sensor probe part 521 in which the sensing area 5211 is formed in this way, during the process of inserting the guide needle 550 into the body skin, the skin incision function can be smoothly performed through the incision part 550a in the area where the opening part (EP) is not formed.

[0066] Also, the opening part (EP) can be formed in a form that does not cover the entire area of the sensing area 5211 as shown by the solid line in FIG. 9, and can also be formed in a form that does not cover a partial area of the sensing area 5211 as shown by the dotted line in FIG. 9.

[0067] By forming the opening part (EP) in the guide needle 550 in this way, since the sensing area 5211 of the sensor member 520 is not externally covered by the guide needle 550, after the body attachment unit 20 is completely inserted into the body skin (E), no incision part (CA) by the guide needle 550 is formed in the peripheral part of the sensing area 5211 within the body skin (E).

[0068] If no incision part (CA) is formed in the peripheral area of the sensing area 5211 in this way, the white blood cells (BC) concentrated in the incision part (CA) will not exist in the position adjacent to the sensing area 5211. Therefore, the loss of blood glucose substances by white blood cells (BC) around the sensing area 5211 is reduced, and the accuracy of the blood glucose measurement value through the sensing area 5211 is further improved.

[0069] That is, the smaller the incision part (CA) by the guide needle 550 is in the peripheral area facing the sensing area 5211, in other words, the farther the incision part (CA) by the guide needle 550 is from the sensing area 5211, the less the loss of blood glucose substances by white blood cells (BC) around the sensing area 5211, and the more accurate blood glucose measurement value can be obtained.

[0070] As described with reference to FIG. 7, the incision site (CA) 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) by the incision portion 550a of the guide needle 550 is formed to extend in a direction inclined from the end of the incision site (CA) by the insertion support portion 550b as shown by the dotted line in FIG. 7.

[0071] Therefore, since the incision site (CA) by the insertion support portion 550b is formed to face a region even more adjacent to the sensing region 5211 than the incision site (CA) by the incision portion 550a of the guide needle 550, the incision site (CA) by the insertion support portion 550b has a greater impact on the loss phenomenon of blood glucose substances by white blood cells (BC) around the sensing region 5211. Thus, the incision site (CA) by the insertion support portion 550b has a great impact on the blood glucose measurement accuracy depending on the degree to which it is far from the sensing region 5211.

[0072] In the second embodiment of the present invention, since the opening portion (EP) is formed in the region of the incision portion 550a of the guide needle 550, as shown in FIG. 10, the incision site (CA') by the opening portion (EP) is formed to extend from the end of the incision site (CA) by the insertion support portion 550b according to the shape of the opening portion (EP). The incision site (CA) by the opening portion (EP) and the incision site (CA') by the incision portion 550a are shown by dotted lines in FIG. 10.

[0073] For example, if the release portions (EP) of the guide needle 550 are respectively formed in regions facing both side surfaces of the sensor probe portion 521 as shown in FIGS. 8(a) and 9(a), after the body attachment unit 20 is completely inserted into the body skin (E), the incision site (CA) by the guide needle 550 is not formed only in the peripheral portion of the region facing the sensing region 5211 as shown in FIG. 10(a), but also in the peripheral portion of the non-facing region. More specifically, the incision site (CA) by the insertion support portion 550b of the guide needle 550 is not formed in the peripheral portion of the region facing the sensing region 5211, and the incision site (CA') by the release portion (EP) extends from the end of the incision site (CA) by the insertion support portion 550b as shown by the dotted line. Since the release portion (EP) is formed in a form that does not surround the sensing region 5211, the incision site (CA') by the release portion (EP) does not surround the sensing region 5211.

[0074] If the release portion (EP) of the guide needle 550 is formed only in the region facing one side surface of the sensor probe portion 521 in which the sensing region 5211 is formed as shown in FIGS. 8(b) and 9(b), after the body attachment unit 20 is completely inserted into the body skin (E), the incision site (CA) by the guide needle 550 is not formed in the peripheral portion of the region facing the sensing region 5211 as shown in FIG. 10(b) (in this case, the incision site (CA) is formed in the peripheral portion of the non-facing region). More specifically, the incision site (CA) by the insertion support portion 550b of the guide needle 550 is not formed in the peripheral portion of the region facing the sensing region 5211, and the incision site (CA') by the release portion (EP) extends from the end of the incision site (CA) by the insertion support portion 550b as shown by the dotted line. Since the release portion (EP) is formed in a form that does not surround the sensing region 5211, the incision site (CA') by the release portion (EP) does not surround the sensing region 5211. Of course, the incision site (CA) by the insertion support portion 550b) is formed in the peripheral portion of the non-facing region, and the incision site (CA) by the cutting portion 550a extends from the end thereof as shown by the dotted line in the straight path.

[0075] When arranged schematically, as shown in FIG. 10, the insertion depth of the sensor member 520 is SD, the insertion depth of the distal end of the guide needle 550 is formed in a state of ND deeper than SD, and the incision site (CA) by the guide needle 550 is formed at a depth ND equal to the insertion depth of the guide needle 550.

[0076] In the state of FIG. 10(a), the depth of the incision site (CA) by the insertion support portion 550b of the guide needle 550 is ND1 shallower than SD. In particular, the depth ND1 of the incision site (CA) is shallower than the sensing region 5211. In the state of FIG. 10(b), the depth of the incision site (CA) by the insertion support portion 550b of the guide needle 550 is ND1 in the region facing the sensing region 5211, and ND2 in the region not facing the sensing region 5211. At this time, ND2 can be formed deeper than SD, but ND1 is formed shallower than SD as in FIG. 10(a) and of course shallower than the sensing region 5211.

[0077] Since the fact that the incision site (CA) is not formed in the peripheral portion of the region facing the sensing region 5211 has a greater impact on improving the accuracy of blood glucose measurement, in both cases of FIGS. 10(a) and 10(b), the incision site (CA) is not formed by the open portion (EP) in the peripheral portion of the region facing the sensing region 5211, so that the loss of blood glucose substances by white blood cells (BC) is prevented and the accuracy of blood glucose measurement can be improved.

[0078] That is, by forming the guide needle 550 so as not to surround the sensing region 5211 externally by the open portion (EP), the incision site (CA) by the guide needle 550 is in a form that does not surround the sensing region 5211 externally, thereby minimizing the phenomenon of blood glucose substance reduction by white blood cells (BC) occurring at the incision site (CA) and further improving the accuracy of blood glucose measurement for the sensing region 5211.

[0079] The above description merely exemplifies the technical idea of the present invention, and those with ordinary knowledge in the technical field to which the present invention pertains may make various modifications and variations without departing from the essential characteristics of the present invention. Therefore, the embodiments disclosed in the present invention are for the purpose of explanation rather than for limiting the technical idea of the present invention, and the scope of the technical idea of the present invention is not limited by such embodiments. The protection scope of the present invention shall be construed according to the following claims, and it will be construed that all technical ideas within the equivalent scope are included in the scope of rights of the present invention.

Claims

1. A continuous blood glucose measurement device comprising a body attachment unit formed to be inserted and attached to the body by a separate applicator and to periodically measure blood glucose, wherein the body attachment unit includes a sensor member inserted into the body and having a sensing region formed at a distal end thereof to react with blood glucose in the body, and a guide needle formed to surround at least a partial region of the sensor member outside the body so as to guide the insertion of the sensor member into the body, and integrally linearly moving with the sensor member and being inserted into the body and then withdrawn and removed, wherein a distal end of the guide needle is arranged to protrude further or equally in the body insertion direction than a distal end of the sensor member, and the guide needle is formed to have a shape that does not surround at least a partial region of the sensing region formed at the distal end of the sensor member, wherein the guide needle includes an incision portion formed at a 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 to extend from a rear end of the incision portion and continuously inserted into the body along an incision site incised by the incision portion, wherein the insertion support portion has a constant width along the body insertion direction, and the incision portion gradually narrows in width along the body insertion direction, wherein in a state of being inserted into the body, a depth of an incision site (CA) in a region where the insertion support portion is located is formed shallower than an insertion depth of the sensor member, and a sensing region formed at a distal end of the sensor member is arranged in a region where the incision portion is located characterized in that.

2. The sensor member includes a sensor probe portion formed to be long along the body insertion direction so that at least a partial section thereof is inserted into the body, The continuous blood glucose measurement device according to claim 1, wherein the sensing region is formed at a distal end portion of the sensor probe portion.

3. The guide needle is formed in a form that surrounds the sensor probe portion outside the body, The continuous blood glucose measurement device according to claim 2, characterized in that an opening portion is formed at a distal end portion so as not to surround at least a partial region of the sensing region of the sensor member.

4. The opening portion of the guide needle is formed in a form that does not surround the entire region of the sensing region at all. The continuous blood glucose measurement device according to claim 3, characterized in that.

5. The opening portion of the guide needle The continuous blood glucose measurement device according to claim 3, characterized in that a partial area of the sensing area is formed in a form that does not cover it.

6. The sensor probe unit is formed in a flat plate shape that is arranged long along the body insertion direction, the sensing area is formed on one surface of the sensor probe unit, The continuous blood glucose measurement device according to claim 3, characterized in that the opening of the guide needle is formed in a form in which an area facing one surface of the sensor probe unit where the sensing area is formed is opened.

7. The continuous blood glucose measurement device according to claim 3, characterized in that the opening is formed in the incision part.

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