Continuous glucose measurement device

Abstract

The present invention relates to a continuous blood glucose measuring device, and provides a continuous blood glucose measuring device formed such that a cut site generated by a guide needle does not enclose at least a part of a sensing area formed in a sensor part in a state in which a body attachment unit is inserted to be attached to a body, so that the cut site is not formed in a periphery of the sensing area, thereby preventing a blood glucose measurement value decrease phenomenon caused by the cut site, so that an accurate blood glucose measurement value can be detected from an initial operation, and the insertion depth of the guide needle is adjusted by an applicator during a process in which the body attachment unit is inserted to be attached to the body, so that the accuracy of blood glucose measurement can be improved by adjusting the separation distance of the cut site generated by the guide needle from the sensing area.

Description

TECHNICAL FIELD

[0001] The present invention relates to a continuous blood glucose measuring device. In more detail, the present invention relates to a continuous blood glucose measuring device formed such that a cut site generated by a guide needle does not enclose at least a part of a sensing region formed in a sensor part, so that the cut site is not formed at a periphery of the sensing region, thereby preventing a blood glucose measurement value decrease phenomenon caused by the cut site, so that an accurate blood glucose measurement value can be detected from an initial operation, and an insertion depth of the guide needle is adjusted by an applicator during a process in which a body attachment unit is inserted to be attached to a body, so that an accuracy of blood glucose measurement can be improved by adjusting a separation distance of the cut site generated by the guide needle from the sensing region. BACKGROUND

[0002] Diabetes is a chronic disease that is frequently occurring in modern people, and in Korea, more than 2 million people, i.e., 5% of the total population, are suffering from diabetes.

[0003] Diabetes is caused by an absolute or relative deficiency of insulin produced by a pancreas due to obesity, stress, wrong eating habits, congenital heredity, etc., and cannot correct a balance of sugar in blood, resulting in an absolute increase in a sugar component in blood.

[0004] Blood usually contains a certain concentration of glucose, from which tissue cells obtain energy.

[0005] However, when the glucose is increased more than necessary, it is not properly stored in a liver or muscle or fat cells, etc., but is accumulated in blood, and thus, blood glucose of a diabetic patient is maintained much higher than that of a normal person, and with excessive blood glucose directly passing through tissues and being excreted with urine, a sugar component absolutely required by each tissue of the body becomes insufficient, thereby causing abnormalities in each tissue of the body.

[0006] Diabetes is characterized in that there are almost no subjective symptoms in an initial stage, but as the disease progresses, symptoms peculiar to diabetes, such as polydipsia, polyphagia, polyuria, weight loss, general fatigue, skin itching, and a long healing of wounds in hands and feet, etc., appear, and when the disease further progresses, complications, such as visual impairment, hypertension, nephropathy, stroke, periodontal disease, muscle spasm, neuralgia, gangrene, etc., develop.

[0007] In order to diagnose such diabetes and manage it so as not to develop into a complication, blood glucose measurement and treatment should be performed in parallel.

[0008] In order for a diabetic patient and a person who has not developed into a diabetic patient but has more than normal sugar detected in blood, many medical instrument manufacturers provide various blood glucose meters so as to be able to measure blood glucose in a home.

[0009] The blood glucose measurement instrument adopts a method in which the user collects blood from a fingertip and measures blood glucose in one unit, and a method in which a continuous blood glucose measurement is performed by attaching a device to the abdomen or arm of the user.

[0010] For diabetic patients, it is common to alternate between hyperglycemic and hypoglycemic states, and an emergency situation comes from the hypoglycemic state, and when losing consciousness or the hypoglycemic state continues for a long time without sugar supply, it can also be fatal. Therefore, it is extremely important for diabetic patients to immediately find the hypoglycemic state, but the blood collection type blood glucose measurement instrument, which measures blood glucose intermittently, has limitations in accurately grasping the blood glucose state.

[0011] Recently, in order to overcome such limitations, a continuous blood glucose monitoring system (CGMS) that measures blood glucose values at intervals of several minutes by being inserted into the human body has been developed, and using the same, it is possible to easily manage diabetic patients and respond to emergency situations.

[0012] In addition, since the blood collection type blood glucose measurement instrument measures blood glucose by piercing the fingertip, which is sensitive to pain, with a needle to collect blood in order for the diabetic patient to check his or her own blood glucose, pain and resistance are caused during blood collection. In order to minimize such pain and resistance, research and development of a continuous blood glucose measurement system that continuously measures blood glucose after inserting a needle-shaped sensor into a site such as the abdomen or arm, which is relatively less sensitive to pain, is being conducted, and further, development of a non-invasive blood glucose measurement system (Non-Invasive Glucose Monitoring System) that measures blood glucose without collecting blood is actively being conducted.

[0013] For the non-invasive blood glucose measurement system, in the past 40 years, in order to measure blood glucose without collecting blood, research has been conducted on various methods such as an optical method, an electrical method, measurement in exhaled breath, etc. Cygnus (Redwood City, California, USA) developed and marketed Glucowatch G2 Biographer in the form of a wristwatch using a counter-ion electro-osmosis method, but due to problems with skin irritation and identification, a problem in which the device stops when sweating, a problem in which hypoglycemia is not well recognized relative to hyperglycemia, etc., sales were discontinued in 2007. Although many non-blood collection blood glucose measurement techniques have been developed and reported to date, they have not been practically used due to low accuracy.

[0014] A continuous blood glucose measuring device includes a sensor module inserted to adhere to the skin of a body to measure blood glucose by extracting body fluid, a transmitter to transmit a blood glucose value measured by the sensor module to a terminal, and a terminal to output the received blood glucose value, etc. In the sensor module, a sensor probe formed in a needle shape to be inserted into subcutaneous fat and extract interstitial fluid, etc. is provided, and a separate applicator is used to insert the sensor module to adhere to the body.

[0015] Such a continuous blood glucose measuring device is manufactured in a very diverse form by each manufacturer, and the usage thereof is also diverse. However, most of the continuous blood glucose measuring devices are manufactured and circulated in a manner that a disposable sensor module is inserted to adhere to the body by an applicator, and an adhesive tape is attached to the bottom surface of the housing of the sensor module in a manner that the sensor module can be adhered to the body. According to this structure, when the sensor module is inserted to the skin of the body by the applicator, the sensor module maintains the state of being adhered to the skin of the body by the adhesive tape during this process, and blood glucose is continuously measured periodically in this state.

[0016] Since the portion of the sensor module that is inserted into the skin is formed of a flexible material, a guide needle is provided to guide the process of inserting the sensor module into the skin. That is, the portion of the sensor module that is inserted into the skin is protrusively provided from the bottom surface of the housing of the sensor module to the outside, and the guide needle is provided to surround the portion of the sensor module that is inserted into the skin from the outside, and, during the process of adhering the sensor module to the skin by the applicator, the guide needle is inserted into the skin together with the sensor module. The guide needle is configured to be removed from the skin by the applicator when the process of inserting the sensor module into the skin is completed.

[0017] The characteristic that is exhibited by such a continuous blood glucose measuring device is that the accuracy of blood glucose measurement is generally decreased in the initial state of the work of adhering the sensor module to the body, and the accuracy is improved after a considerable amount of time has passed. Although various studies have been conducted to solve the problem of the decrease in the initial measurement accuracy, satisfactory research results have not been obtained. SUMMARY

[0018] TECHNICAL PROBLEM

[0019] The present application is conceived to solve the problems of the related art, and the object thereof is to provide a continuous blood glucose measuring device formed in a manner that, in the state in which the body adhering unit is inserted to adhere to the body, the cut site generated by the guide needle does not surround at least a portion of the sensing region formed in the sensor module, so that the cut site is not formed in the periphery of the sensing region, thereby preventing the decrease in the blood glucose measurement value caused by the cut site, so that an accurate blood glucose measurement value can be detected from the initial stage of the work.

[0020] Another object of the present application is to provide a continuous blood glucose measuring device that can improve the accuracy of blood glucose measurement by adjusting the distance between the incision site created by the guide needle and the sensing area.

[0021] Technical Solution

[0022] The present application provides a continuous blood glucose measuring device, characterized by including: a body attachment unit formed to be inserted to be attached to a body to periodically measure blood glucose; and an applicator that operates in a manner that the body attachment unit is inserted to be attached to the body by a user's operation, the body attachment unit including: a sensor part that is inserted into the body and formed with a sensing area on one side in a manner that reacts to blood glucose within the body; and a guide needle formed to externally surround the sensor part and withdrawn and removed after being inserted into the body together with the sensor part, and formed to externally surround an incision site within the body in which at least a part of the sensing area is not incised by the guide needle.

[0023] At this time, the guide needle can be inserted into the body before the sensor part or at the same time as the sensor part during the insertion into the body.

[0024] Further, the sensor part can include a sensor probe part that is formed longer in a body insertion direction in a manner that at least a part of the interval is inserted into the body, and the sensing area is formed at a tip part of the sensor probe part.

[0025] Further, the guide needle can be formed in a manner that externally surrounds the sensor probe part, and is withdrawn and removed after being inserted to a depth shallower than the sensor probe part.

[0026] Further, a tip of the guide needle can be inserted to a depth closer to a skin surface than a deepest part of the sensing area.

[0027] Further, a tip of the guide needle can be inserted to a depth closer to a skin surface than an outermost contour of the sensing area.

[0028] Further, the guide needle can include: an incision part formed at a front tip part in a manner that incises the skin of the body during the insertion into the body; and an insertion support part that is extended and formed at a rear end of the incision part to be continuously inserted into the body along the part incised by the incision part, the insertion support part being inserted to a depth closer to a skin surface than a deepest part of the sensing area at a boundary with the incision part.

[0029] In addition, the applicator may be provided with a needle withdrawal mechanism that withdraws and removes the guide needle from the body while the guide needle is inserted into the body. The needle withdrawal mechanism operates in such a way that the guide needle is withdrawn and removed from the body before the sensor component completes its insertion into the body.

[0030] Furthermore, the sensor component and the guide pin can be inserted into the body via the applicator in a manner that allows the sensor component to be inserted at a faster insertion speed than the guide pin in the interval after insertion into the body.

[0031] Furthermore, the sensor component can be inserted into the body via the applicator in a manner that, after the guide needle has been inserted to a predetermined insertion depth, it is further inserted while the guide needle is already inserted into the body.

[0032] The effects of the invention

[0033] According to the present invention, the following effect is achieved: the cut portion generated by the guide needle in the state where the body attachment unit is inserted and attached to the body does not surround at least a portion of the sensing area formed on the sensor component, so that the cut portion is not formed around the sensing area, thereby preventing the drop in blood glucose measurement value caused by the cut portion, so that accurate blood glucose measurement value can be detected from the beginning of operation.

[0034] In addition, it has the following effect: during the process of inserting the body patch unit into the body, the insertion depth of the guide needle can be adjusted by the patch applicator, thereby improving the accuracy of blood glucose measurement by adjusting the distance between the cut area created by the guide needle and the sensing area. Attached Figure Description

[0035] Figure 1 This is a schematic diagram illustrating the basic system of a continuous blood glucose measurement device according to an embodiment of the present invention.

[0036] Figure 2 This is a schematic diagram illustrating the shape of the patch of a continuous blood glucose measuring device according to an embodiment of the present invention.

[0037] Figure 3 This is a schematic diagram illustrating the structure of the body attachment unit of a continuous blood glucose measurement device according to an embodiment of the present invention.

[0038] Figure 4 This is a schematic diagram illustrating the shape of the sensor component and guide pin of the body attachment unit according to the first embodiment of the present invention.

[0039] Figure 5 This is a diagram conceptually illustrating the body insertion and attachment process of the body attachment unit according to a first embodiment of the present invention.

[0040] Figure 6 This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a first embodiment of the present invention.

[0041] Figure 7 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the first embodiment of the present invention.

[0042] Figure 8 This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a second embodiment of the present invention.

[0043] Figure 9 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the second embodiment of the present invention.

[0044] Figures 10 to 12 This is an exemplary diagram showing the structure and working state of an applicator in a body insertion configuration for implementing the second embodiment of the present invention, comprising a sensor component and a guide needle. Detailed Implementation

[0045] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings. First, when affixing reference numerals to the constituent elements of each drawing, even if they are shown in different drawings, the same reference numerals will be assigned to the same constituent elements as much as possible. Furthermore, in describing the present invention, detailed descriptions of related well-known components or functions will be omitted if it is determined that a detailed description of such components or functions may obscure the main points of the present invention.

[0046] Figure 1 This is a schematic diagram illustrating the basic system of a continuous blood glucose measurement device according to an embodiment of the present invention. Figure 2 This is a schematic diagram illustrating the shape of the patch of a continuous blood glucose measuring device according to an embodiment of the present invention. Figure 3 This is a schematic diagram illustrating the structure of the body attachment unit of a continuous blood glucose measurement device according to an embodiment of the present invention.

[0047] One embodiment of the continuous blood glucose measurement device of the present invention is configured to attach a body patch unit 20 having a sensor component 520 inserted into the body for continuous blood glucose measurement to the body via a patch 10, and to operate the patch 10 to insert and attach the body patch unit 20 to the body and periodically and continuously measure blood glucose from the body, and the blood glucose measurement information periodically measured by the body patch unit 20 is transmitted to a separate terminal 30 for output.

[0048] The body attachment unit 20 can be assembled to the inside of the applicator 10 to make one unit product, in which case, a structure formed in a form to minimize the additional work of the user when using a continuous blood glucose measuring device makes the use very simple. Of course, it can be made in various ways, such as being supplied to the user separately from the applicator 10 and being inserted into the inside of the applicator 10 by the user to make it work, etc.

[0049] The body attachment unit 20 is formed to be attachable to the body in a manner to extract a body fluid and periodically measure blood glucose, and is formed to be able to transmit the blood glucose measurement result to an external device such as the external terminal 30. In such a body attachment unit 20, a sensor part 520 having one end inserted into the body and a wireless communication chip (not shown) capable of wireless communication with the external terminal 30 can be provided inside.

[0050] The applicator 10 is formed to incorporate and fix the body attachment unit 20 inside, and works in a manner to externally discharge the body attachment unit 20 by the pressing operation of the pressing button 110 by the user.

[0051] At this time, the body attachment unit 20 is assembled and made in a state of being inserted into the inside of the applicator 10, and is configured to move in the external discharge direction to be attached to the body as the applicator 10 works by the operation of the user.

[0052] That is, the sensor applicator assembly of one embodiment of the present application is assembled and made in a manufacturing step, and the body attachment unit 20 is attached to the skin only by the work of the applicator 10 in a state in which the body attachment unit 20 is inserted into the inside of the applicator 10, and can be supplied to the user in this state, so that the user can attach the body attachment unit 20 to the skin only by performing the work of making the applicator 10 work without performing a separate additional work for attaching the body attachment unit 20 to the skin. In particular, since a separate wireless communication chip is provided in the body attachment unit 20, so that a separate transmitter is not required to be incorporated, it can be used more conveniently.

[0053] In the applicator 10, a separate protective cap 200 can be detachably incorporated in a manner to prevent the body attachment unit 20 from being exposed to the outside in a state in which the body attachment unit 20 is inserted into the inside of the applicator 10, and can be configured such that the user makes the applicator 10 work to externally discharge the body attachment unit 20 toward the side from which the protective cap 200 is removed to be attached to the body after separating the protective cap 200.

[0054] At this time, the body attachment unit 20 is attached to the body in a manner that the body attachment unit 20 can be attached to the body on the body contact surface of the body attachment unit 20 with an adhesive tape 560 attached thereto, and a release paper (not shown) is attached to the body contact surface of the adhesive tape 560 to protect the adhesive tape 560, and the release paper of the adhesive tape 560 can be formed to be separated from the adhesive tape 560 and removed during the process of separating the protective cap 200 from the applicator 10.

[0055] The applicator 10 can be formed to combine and fix the body attachment unit 20 in a state in which the body attachment unit 20 is inserted into the inside, and to release the combined and fixed state with the body attachment unit 20 in a state in which the body attachment unit 20 is discharged and moved to the outside. Therefore, in a state in which the body attachment unit 20 is inserted and assembled in the inside of the applicator 10, the body attachment unit 20 is maintained in a fixed state, and in a case in which the applicator 10 is operated to discharge the body attachment unit 20 to the outside and attach it to the skin, the combined and fixed state of the applicator 10 and the body attachment unit 20 is released, and thus if the applicator 10 is separated in this state, it is separated from the body attachment unit 20, and only the body attachment unit 20 remains in a state of being attached to the skin.

[0056] The body attachment unit 20 is formed to provide the sensor part 520 in the inside of the separate housing 510, and one end portion of the sensor part 520 can be protruded to the outside from the bottom surface of the housing 510 to be inserted and attached to the body. The sensor part 520 is configured of a sensor probe part 521 (refer to Figure 5 ) inserted into the body and a sensor body part 522 (refer to Figure 5 ) provided in the inside of the housing 510, and the sensor probe part and the sensor body part are curved and respectively configured of one end portion and the other end portion of the sensor part 520.

[0057] At this time, the separate guide needle 550 can be detachably combined to the housing 510 to smoothly perform the body insertion process of the sensor part 520. The guide needle 550 is configured to surround the one end portion of the sensor part 520 and to be inserted into the body together with the sensor part 520 to stably insert the one end portion of the sensor part 520 into the body.

[0058] As Figure 2As shown, the guide needle 550 is detachably mounted on the housing 510 along the direction of vertical penetration through the housing 510 of the body application unit 20, and is formed to surround the outside of the sensor component 520, with a needle tip 551 formed at its upper end. This guide needle 550 is inserted into the body before the sensor component 520 when the body application unit 20 moves in the external discharge direction via the applicator 10, and guides the sensor component 520 to be stably inserted into the skin. The guide needle 550 is configured to engage with the needle removal mechanism (not shown) of the applicator 10 via the needle tip 551, and is withdrawn and removed from the body by the needle removal mechanism of the applicator 10 after the body application unit 20 is inserted and applied to the body by the operation of the applicator 10.

[0059] The structure of the sensor component 520 and the guide pin 550 of the body attachment unit 20 will be described in more detail below.

[0060] Figure 4 This is a schematic diagram illustrating the shape of the sensor component and guide pin of the body attachment unit according to the first embodiment of the present invention. Figure 5 This is a diagram conceptually illustrating the body insertion and attachment process of the body attachment unit according to the first embodiment of the present invention. Figure 6 This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a first embodiment of the present invention. Figure 7 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the first embodiment of the present invention.

[0061] As previously described, the sensor component 520 of the body attachment unit 10 includes: a sensor body portion 522 disposed inside the housing 510; and a sensor probe portion 521, which bends downward from the sensor body portion 522 and protrudes downward toward the lower part of the housing 510. The sensor probe portion 521 is formed elongated along the body insertion direction such that at least a portion of it is inserted into the body, and a sensing area 5211 that reacts with blood glucose within the body is formed at the distal end of the sensor probe portion 521 in a manner capable of measuring blood glucose levels. The degree of reaction with blood glucose through the sensing area 5211 is converted into an electrical signal and analyzed to measure blood glucose levels within the body.

[0062] like Figure 4 As shown, the sensor probe portion 521 can be formed in the form of a flat plate, and the sensing area 5211 can be formed on one side of the flat plate-shaped sensor probe portion 521.

[0063] The guide pin 550 is formed to surround the sensor probe portion 521 from the outside, and can be formed as a "one side open along the length direction". The shape of the channel is "V". Of course, the shape of the guide needle 550 can also be formed into a hollow tube of various shapes with some areas open along the length direction.

[0064] Such a guide needle 550 guides the sensor component 520 into the body. During insertion into the body together with the sensor component 520, the guide needle 550 is inserted before the sensor component 520 to cut the skin. For this purpose, a cutting portion 550a is formed at the front end of the guide needle 550 in a shape that allows it to cut the skin during insertion. An insertion support portion 550b extends from the rear end of the cutting portion 550a and is continuously inserted into the body along the cut portion 550a. The insertion support portion 550b of the guide needle 550 is configured to surround the sensor probe portion 521 of the sensor component 520 from the outside, and the sensing area 5211 formed at the end of the sensor probe portion 521 is also surrounded from the outside by the insertion support portion 550b of the guide needle 550.

[0065] As previously described, the sensor component 520 and the guide needle 550 are combined with the housing 510 and inserted into the skin via the applicator 10. After the sensor component 520 and the housing 510 are attached to the skin, the guide needle 550 is withdrawn from the skin and removed by the applicator 10.

[0066] At this time, according to the setting relationship between the sensor component 520 and the guide pin 550, such as Figure 5 As shown in (a), the insertion depth ND of the guide pin 550 is formed to be deeper than the insertion depth SD of the sensor component 520. Since the insertion support portion 550b of the guide pin 550 is configured to surround the sensor component 520, as... Figure 6 As shown, in addition to the insertion depth ND of the end of the cutting portion 550a of the guide needle 550, the insertion depth of the end of the insertion support portion 550b is also formed to be deeper than the insertion depth SD of the sensor component 520. The guide needle 550 leaves a wound in the skin E when it cuts the body skin E. After the guide needle 550 is inserted into the body, when the guide needle 550 is withdrawn and removed, as... Figure 5 As shown in (b), the depth of the incision site created by the guide needle 550 and remaining in the skin E is the same as the insertion depth ND of the guide needle 550.

[0067] Thus, after the guide needle 550 is withdrawn and removed from the body skin E, the relationship between the incision site created by the guide needle 550 within the body skin E and the setting of the sensor component 520 can be observed in more detail. Figure 7As shown, the incision site CA generated by the guide needle 550 is formed to be spaced apart from both sides of the sensor member 520 with respect to a vertical cross section of the body skin E. At this time, when the sensor member 520 is in a state of being spaced apart from the guide needle 550 by a small distance or in a state of being in contact without being spaced apart, the incision site CA generated by the guide needle 550 formed in the body skin E can also be formed in a state of being in contact with each other.

[0068] The incision sites CA formed in both sides of the sensor member 520 in the body skin E are substantially generated when the insertion support portion 550b of the guide needle 550 is inserted, as shown by a dotted line in Figure 7 The incision site generated by the incision portion 550a of the guide needle 550 can be formed to extend deeper in an inclined direction from the incision site CA generated by the insertion support portion 550b, as shown by a dotted line in

[0069] Therefore, the incision site CA generated by the insertion support portion 550b of the guide needle 550 is formed in the body skin E in a form of surrounding the sensing region 5211 from the outside at a peripheral portion of the sensing region 5211 of one face of the sensor probe portion 521 of the sensor member 520.

[0070] The incision site CA generated by the guide needle 550 corresponds to a wound in the body, and thus, a small amount of bleeding occurs at the incision site CA, and at the same time, as shown in an enlarged view of Figure 7 white blood cells BC are gathered to the incision site CA by an immune response of the body. When the white blood cells BC are thus gathered to the incision site CA, the amount of blood sugar reacting in the sensing region 5211 of the sensor member 520 located at the periphery is changed, thereby reducing the accuracy of blood sugar measurement.

[0071] That is, when the white blood cells BC are gathered to the incision site CA generated by the guide needle 550 after the guide needle 550 is withdrawn and removed, the blood sugar substance (glucose) at the periphery is combined with the white blood cells BC, thereby reducing the amount of blood sugar substance reacting with the sensing region 5211. Thus, since the amount of blood sugar substance reacting with the sensing region 5211 is reduced due to the concentration of the white blood cells BC, the blood sugar measurement value measured by the sensor member 520 is not a normal blood sugar measurement value, but a value showing a considerable reduction. The change in the blood sugar measurement value due to the influence of the white blood cells BC can continue for several days until all the incision sites CA are recovered.

[0072] Therefore, in the body attachment unit 10 of the continuous glucose measurement device, the guide needle 550 and the sensor component 520 are inserted into the body together. As a result, due to the cut created by the guide needle 550, the accuracy of glucose measurement decreases in the initial stage of operation when the body attachment unit 10 is inserted and attached to the body.

[0073] The following describes the structure used to minimize the decrease in the accuracy of the above-mentioned blood glucose measurements.

[0074] Figure 8 This is a conceptual illustration of the body insertion configuration of the sensor component and guide pin according to a second embodiment of the present invention. Figure 9 This is a conceptual illustration of the arrangement of the body incision site and sensor component generated by the guide needle according to the second embodiment of the present invention.

[0075] As described above, in the second embodiment of the present invention, the sensor component 520 and the guide pin 550 are configured such that the guide pin 550 surrounds the sensor probe portion 521 of the sensor component 520 from the outside.

[0076] The guide pin 550 is inserted into the body before or simultaneously with the sensor component 520, and is withdrawn and removed by the applicator 10 after insertion. To ensure the guide pin 550 is inserted into the body before or simultaneously with the sensor component 520, as follows... Figure 8 As shown in (a), in the region before insertion into the body, the end of the guide needle 550 protrudes in a manner that is closer to the body skin E than the end of the sensor component 520.

[0077] At this time, the guide pin 550 of the second embodiment of the present invention is inserted in such a way that the cut portion CA in the body cut by the guide pin 550 is in a shape that does not surround at least a portion of the sensing area 5211 in the outer region of the sensor component 520.

[0078] For example, such as Figure 8 As shown in (b) and (c), in the state where the process of inserting the sensor component 520 and the guide needle 550 into the body is completed, the guide needle 550 can be inserted into the skin E of the body in such a way that the insertion depth ND of the guide needle 550 is smaller than the insertion depth SD of the sensor component 520. That is, the guide needle 550 can be inserted to a shallower depth than the sensor probe portion 521 of the sensor component 520. Afterwards, the guide needle 550... Figure 8 In the states shown in (b) and (c), the insertion will not go deeper; instead, it will be withdrawn and removed at that depth.

[0079] More specifically, such as Figure 8As shown in (b) of FIG. 5, the guide needle 550 can be inserted to a corresponding depth in such a manner that the insertion depth ND of the tip thereof is more proximate to the skin surface than the outermost portion 5211a of the sensing region 5211. Unlike this, as shown in (c) of FIG. 5, the guide needle 550 can be inserted to a corresponding depth in such a manner that the insertion depth ND of the tip thereof is more proximate to the skin surface than the deepest portion 5211b of the sensing region 5211. After being inserted to such a depth, the guide needle 550 is withdrawn from the skin and removed, and the incision site CA resulting from the insertion of the guide needle 550 remains as a wound inside the skin E. Figure 8

[0080] Since the incision site CA is formed inside the body skin E along the body skin insertion path of the guide needle 550, when the guide needle 550 is inserted to a shallower depth than the sensor probe portion 521, the incision site CA incised by the guide needle 550 is also formed at a shallower depth inside the body than the sensor probe portion 521.

[0081] Thus, when the incision site CA incised by the guide needle 550 is formed at a shallower depth than the sensor probe portion 521, as shown in (b) of FIG. 5, the incision site CA resulting from the insertion of the insertion support portion 550b of the guide needle 550 is not formed in the peripheral region opposite the sensing region 5211, so that the white blood cells BC concentrated in the incision site CA do not exist in a position adjacent to the sensing region 5211, thus reducing the loss of blood sugar substances due to the white blood cells BC at the periphery of the sensing region 5211, thereby further improving the accuracy of the blood sugar measurement value through the sensing region 5211. Figure 9

[0082] That is, as the incision site CA resulting from the guide needle 550 in the peripheral region opposite the sensing region 5211 is minimized, in other words, as the incision site CA resulting from the guide needle 550 is distanced from the sensing region 5211, the loss of blood sugar substances due to the white blood cells BC at the periphery of the sensing region 5211 is reduced, so that a more accurate blood sugar measurement value can be obtained.

[0083] As shown in (b) of FIG. 5, if the incision site CA resulting from the guide needle 550 is observed with reference to a vertical cross section of the body skin E, the incision site CA resulting from 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 resulting from the incision portion 550a of the guide needle 550 is formed in an inclined direction extending from the tip of the incision site CA resulting from the insertion support portion 550b, as shown by a dotted line. Figure 9

[0084] ​​​Therefore, compared to the cut portion CA created by the cutting portion 550a of the guide needle 550, the cut portion CA created by the insertion support portion 550b is formed opposite to the area closer to the sensing area 5211. Consequently, the cut portion CA created by the insertion support portion 550b has a greater impact on the loss of glucose substances caused by white blood cells (BCs) around the sensing area 5211. Therefore, the cut portion CA created by the insertion support portion 550b has a greater impact on the accuracy of blood glucose measurement depending on its distance from the sensing area 5211.

[0085] When the insertion depth ND of the end of the cutting portion 550a of the guide needle 550 is located closer to the skin surface than the outermost contour 5211a of the sensing area 5211 (when it is located at a shallower position), such as Figure 9 As shown in (a), the depth ND of the end of the incision CA generated by the incision portion 550a is shallower than the outermost contour 5211a of the sensing area 5211. In this case, the depth ND1 of the incision CA generated by the insertion support portion 550b is shallower than the depth ND of the end of the incision CA generated by the incision portion 550a. Therefore, the incision portion 550a of the guide needle 550 and the incision CA generated by the insertion support portion 550b will be further away from the sensing area 5211 than from the outside, so that the incision portion 550a of the guide needle 550 and the incision CA generated by the insertion support portion 550b will be closer to the skin surface and farther away from the sensing area 5211. Thus, there is no incision CA in the peripheral area of ​​the sensing area 5211, such as... Figure 9 As shown in the enlarged view of (a), the white blood cells (BCs) concentrated at the incision site CA are relatively far away from the sensing area 5211. Therefore, there is almost no loss of glucose substances caused by white blood cells (BCs) in the sensing area 5211, thus obtaining more accurate blood glucose measurements.

[0086] Furthermore, when the insertion depth ND of the end of the cut portion 550a of the guide needle 550 is located between the outermost contour 5211a and the maximum depth 5211b of the sensing area 5211, such as Figure 9As shown in (b), the depth ND of the end of the cut portion CA generated by the guide needle 550 can be located shallower than the maximum depth 5211b of the sensing area 5211, and the depth ND1 of the cut portion CA generated by the insertion support portion 550b of the guide needle 550 can be located shallower or deeper than the outermost contour 5211a of the sensing area 5211. In this case, the cut portion CA generated by the cut portion 550a of the guide needle 550 or the cut portion CA generated by the insertion support portion 550b is formed to surround a portion of the sensing area 5211 from the outside (i.e., a portion of the sensing area 5211 that does not surround the sensing area 5211 from the outside). Similarly, since the cut portion CA of the guide needle 550 does not completely surround the entire area of ​​the sensing area 5211, the loss of glucose substances caused by white blood cells BC occurring at the cut portion CA is reduced by a considerable portion around the sensing area 5211, thereby relatively improving the accuracy of the blood glucose measurement value.

[0087] Thus, by making the insertion depth of the guide needle 550 shallower than the depth of the sensor probe portion 521, the cutting portion CA generated by the guide needle 550 is shaped so that it does not surround at least a portion of the sensing area 5211 from the outside, thereby minimizing the reduction of blood glucose substances caused by white blood cells BC occurring at the cutting portion CA, thereby further improving the measurement accuracy of the sensing area 5211.

[0088] Next, the adjustment structure for the insertion depth between the sensor component 520 and the guide pin 550 of the body attachment unit 10 will be described.

[0089] Figures 10 to 12 This is an exemplary diagram showing the structure and working state of an applicator in a body insertion configuration for implementing the second embodiment of the present invention, comprising a sensor component and a guide needle.

[0090] As described above, an embodiment of the present invention, the applicator 10, is a device that operates by inserting and attaching the body attachment unit 10 to the body through user operation. It may include a main shell 100 with one side open, a plunger body 300 that moves inside the main shell 100 in a direction toward the open side and outward discharge, and a plunger elastic spring S1 that applies an elastic force to the plunger body 300 in a way that moves the plunger body 300 in the outward discharge direction. It may also be configured such that the body attachment unit 10 is attached to the plunger body 300 and moves together with the plunger body 300 in the outward discharge direction.

[0091] An operation part such as a push button (not shown) operable by a user is provided outside the main case 100, the plunger body 300 is fixedly engaged to the first position inside the main case 100, and is disengaged from the first position by operation of the operation part and linearly moves to the second position which is the external discharge direction by the elastic force of the plunger elastic spring S1. The body attachment unit 10 is engaged to one end of the plunger body 300 to linearly move together with the plunger body 300 in the external discharge direction and is inserted into the body skin E to be attached thereto.

[0092] As described above, the body attachment unit 10 includes a housing 510, a sensor part 520 including a sensor body part 522 and a sensor probe part 521, and a guide needle 550 provided so as to externally surround the sensor probe part 521 and is detachably engaged to the housing 510.

[0093] The sensor probe part 521 is externally projected from the bottom surface of the housing 510 in a manner that the sensor probe part 521 of the sensor part 520 is inserted into the body skin E when the body attachment unit 10 is externally discharged, and the guide needle 550 externally surrounds the sensor probe part 521 and is inserted into the body skin E together with the sensor probe part 521.

[0094] The guide needle 550 is withdrawn from the skin E and removed after being inserted into the body skin E, and a needle withdrawal mechanism N is provided in the applicator 10 to withdraw and remove the guide needle 550 from the body skin E in a state where the guide needle 550 is inserted into the body skin E.

[0095] The needle withdrawal mechanism N can include a needle withdrawal body 400 engaged to the plunger body 300 to linearly move together with the plunger body 300 in the external discharge direction and engaged to a needle 551 formed at the upper end of the guide needle 550, and a needle withdrawal elastic spring S2 applying an elastic force to the needle withdrawal body 400 in the opposite direction of the external discharge direction. A hook engagement part 350 capable of restricting elastic movement of the needle withdrawal body 400 is formed in the plunger body 300, and an elastic hook 410 engaged to the hook engagement part 350 is formed at the upper portion of the needle withdrawal body 400. The elastic hook 410 is engaged to the hook engagement part 350 so that the needle withdrawal body 400 moves together with the plunger body 300 in the external discharge direction, and when a predetermined distance is moved, the engaged state of the elastic hook 410 and the hook engagement part 350 is released by a separate locking release mechanism (not shown), in which state, the needle withdrawal body 400 can be moved upward in the opposite direction of the external discharge direction by the needle withdrawal elastic spring S2.

[0096] At this time, as Figure 10As shown, the needle withdrawal mechanism N can operate in such a way that the guide needle 550 is withdrawn from and removed from the body skin E before the sensor component 520 completes its insertion into the body skin E, thereby allowing the sensor component 520 to be inserted into the body skin E deeper than the guide needle 550.

[0097] More specifically, in Figure 10 In the state shown in (a), when the operating part of the applicator 10 is operated by the user, such as Figure 10 As shown in (b) and (c), the outer shell 510 of the body attachment unit 10 moves together with the plunger body 300 from a first position (upper inner region) in the internal space of the main shell 100 to a second position (lower inner region) in the direction of external discharge. The sensor probe portion 521 of the sensor component 520 moves together with the plunger body 300 and the outer shell 510 to the second position, and as shown in (b) and (c)... Figure 10 (c) shows the insertion depth SD pre-set within the skin E of the body.

[0098] At this time, as the guide needle 550 moves together with the plunger body 300 and the outer casing 510 to the second position, Figure 10 As shown in (b), the needle moves from the third position, which is the intermediate interval, toward the first position via the needle withdrawal mechanism N to be withdrawn and removed from the body. That is, when the guide needle 550 reaches the third position together with the plunger body 300 and the housing 510, the engagement state of the elastic hook 410 of the needle withdrawal body 400 and the hook engagement portion 350 of the plunger body 300 is released. At the same time, the needle withdrawal body 400 moves upward back toward the first position by the elastic force of the needle withdrawal elastic spring S2. During this process, the guide needle 550 moves upward together with the needle withdrawal body 400 to be withdrawn and removed from the body skin E.

[0099] In summary, after the guide needle 550 is inserted into the skin E before the sensor component 520 to guide the insertion of the sensor component 520, it does not move to the second position together with the sensor component 520. Instead, it moves upward toward the first position through the needle withdrawal mechanism N to be withdrawn and removed from the body when it is inserted into the third position, which is the intermediate interval, that is, the depth ND, which is less than the insertion depth SD of the sensor component 520.

[0100] Thus, in the state where the body attachment unit 10 has finally completed its insertion and attachment to the body skin E, as... Figure 10 As shown in (c), the sensor component 520 is inserted to a depth SD, and the guide pin 550 is inserted to a depth ND less than SD. The insertion depth ND of such guide pin 550 can be set to various depths according to the user's needs.

[0101] On the other hand, such as Figure 11As shown, the sensor component 520 and the guide needle 550 can be inserted into the skin E through the applicator 10 in such a way that the sensor component 520 is inserted at a faster speed than the guide needle 550 in the area after insertion into the skin E, thereby allowing the sensor component 520 to be inserted deeper into the skin E than the guide needle 550.

[0102] For this purpose, separate rack and pinion structures can be used. For example, a housing rack T3 is formed on both sides of the housing 510 along the external discharge direction, and a housing rack T2 is formed on the lower section of the inner side of the main housing 100 of the applicator 10 along the external discharge direction. A pinion T1, capable of simultaneously meshing with both the housing rack T3 and the housing rack T2, is rotatably coupled to one side of the plunger body 300. For example... Figure 11 As shown in (a), the plunger body 300 and the housing 510 are configured such that the pinion T1 and the housing rack T3 are in a meshing state before the applicator 10 is activated.

[0103] According to this structure, when the operating part of the applicator 10 is operated by the user, the plunger body 300 and the housing 510 integrally move from... Figure 11 The state shown in (a) moves to Figure 11 In the state shown in (b), the guide needle 550 begins to insert into the skin E. In this state, the pinion T1 also begins to mesh with the housing rack T2. Afterwards, as... Figure 11 As shown in (c), when the plunger body 300 continues to move to the second position, which is the external discharge direction, the pinion T1 rotates during this process by meshing with the housing rack T2, and the housing rack T3 moves in the external discharge direction (downward) by the rotation of the pinion T1. That is, from Figure 11 The state shown in (b) to Figure 11 In the interval of state shown in (c), when the plunger body 300 moves downward, the pinion T1 rotates through the housing rack T2, and the housing rack T3 moves downward through the rotation of the pinion T1.

[0104] Thus, from Figure 11the interval of (b) to (c), the housing rack T3 moves downward, and thus the housing 510 moves downward together with the housing rack T3. Thus, in this interval, the housing 510 moves downward at a speed (vl: a speed of moving downward by the plunger elastic spring Sl) at which the plunger main body 300 moves downward, plus an additional downward movement speed (v2: a speed of moving downward together with the housing rack T3). At this time, since the sensor member 520 moves integrally with the housing 510 in combination with the housing 510, the sensor member 520 moves downward at the same downward movement speed (vl + v2) as the housing 510, but the guide needle 550 moves downward at the same downward movement speed vl as the plunger main body 300 by being restrained to the needle retraction main body 400 of the plunger main body 300.

[0105] Thus, from the time point at which the guide needle 550 starts to be inserted into the body skin E, the body insertion speed (vl + v2) of the sensor member 520 is faster than the body insertion speed vl of the guide needle 550, and thus, as shown in (c) of FIG. 6, the insertion depth SD of the sensor member 520 is deeper than the insertion depth ND of the guide needle 550. Figure 11

[0106] Thus, when the insertion movement of the guide needle 550 and the sensor member 520 ends, as shown in (c) of FIG. 6, the engagement state of the elastic hook 410 of the needle retraction main body 400 and the hook engagement portion 350 of the plunger main body 300 is released, and thus the guide needle 550 is withdrawn from the body skin E by the needle retraction mechanism N and removed. Figure 11

[0107] On the other hand, as shown in (c) of FIG. 6, the sensor member 520 can be configured to be inserted into the body skin E by the applicator 10 in a manner of being further inserted after the guide needle 550 is inserted to a preset insertion depth, in a state of being inserted into the body skin E together with the guide needle 550, and thus the sensor member 520 can be inserted deeper into the body skin E than the guide needle 550. Figure 12

[0108] To this end, a separate spring and a rotation link member, or the like can be used. For example, a housing spring S3 capable of elastically moving the housing 510 combined to the plunger main body 300 in an external discharge direction can be provided in a space between the plunger main body 300 and the housing 510, and a rotation latching link member LK capable of performing downward movement and release of restraint of the housing 510 from the plunger main body 300 can be rotatably combined to the plunger main body 300. As shown in (c) of FIG. 6, the housing spring S3 can be provided in a space between the plunger main body 300 and the housing 510, and the rotation latching link member LK can be rotatably combined to the plunger main body 300. Figure 12 ​​​As shown in (a) of FIG. 10, the rotation locking link LK is maintained in a state in which the outer end is in close contact with the inner side surface of the main case 100 of the applicator 10 to restrict rotation. A working groove LH in a concave form is formed at the outer end portion of the inner side surface of the main case 100 in the outward discharge direction, and one end of the rotation locking link LK is released from the restriction of rotation by the working groove LH.

[0109] According to this structure, when the operation portion of the applicator 10 is operated by the user, the plunger body 300 and the outer case 510 are moved in the outward discharge direction by the plunger elastic spring S1 in the state shown in (a) of FIG. 10, and in this process, the rotation locking link LK is in close contact with the inner side surface of the main case 100 to be restricted from rotating, so the outer case 510 is restricted from moving by the rotation locking link LK and thus moves downward integrally with the plunger body 300, rather than moving with respect to the plunger body 300. Thereafter, as shown in (b) of FIG. 10, when the outward discharge movement of the plunger body 300 ends, the rotation locking link LK reaches the working groove LH region, so the rotation restriction of the rotation locking link LK is released. Thus, as shown in (c) of FIG. 10, the rotation locking link LK rotates, so the outer case 510 is released from the restriction and further moves downward by the outer case spring S3. Figure 12 Figure 12 As shown in (a) of FIG. 10, the rotation locking link LK is maintained in a state in which the outer end is in close contact with the inner side surface of the main case 100 of the applicator 10 to restrict rotation. A working groove LH in a concave form is formed at the outer end portion of the inner side surface of the main case 100 in the outward discharge direction, and one end of the rotation locking link LK is released from the restriction of rotation by the working groove LH. Figure 12

[0110] At this time, the sensor member 520 moves integrally with the outer case 510 and is further inserted into the body skin E. With respect to the guide needle 550, regardless of the further downward movement of the outer case 510, in the state in which the downward movement of the plunger body 300 ends, as shown in (b) of FIG. 10, the engagement state of the elastic hook 410 of the needle withdrawal body 400 and the hook engagement portion 350 of the plunger body 300 is released, and the guide needle 550 is withdrawn from the body skin E by the needle withdrawal mechanism N and is removed. Figure 12

[0111] Thus, as the applicator 10 operates, the process in which the body attachment unit 10 is inserted to be attached to the body ends, as shown in (b) and (c) of FIG. 10, the guide needle 550 moves integrally with the plunger body 300 to be withdrawn and removed after being inserted to the insertion depth ND, and thereafter, the sensor member 520 further moves downward with the outer case 510 to be inserted deeper than the depth ND to the depth SD inside the body skin E. Figure 12

[0112] The structure related to the insertion depth adjustment of the above-described sensor member 520 and guide needle 550 is exemplary, and in addition thereto, can be changed and applied in various ways.

[0113] ​​​​The above description is merely illustrative of the technical idea of the present application, and those skilled in the art to which the present application pertains will be able to make various modifications and changes within the scope of the essential characteristics of the present application. Therefore, the disclosed embodiments of the present application are not intended to limit the technical idea of the present application, but to explain the technical idea of the present application, and the scope of the technical idea of the present application is not limited by such embodiments. The scope of protection of the present application should be interpreted by the following claims, and any technical idea within the equivalent scope thereof should be interpreted as falling within the scope of the rights of the present application.

Claims

1. A continuous blood glucose measurement device, characterized by, Comprises: a body attachment unit formed so as to be inserted to be attached to a body to measure blood sugar periodically; and an applicator which operates in a manner that the body attachment unit is inserted to be attached to a body by a user's operation, the body attachment unit comprises: a sensor member which is inserted into a body and formed with a sensing region at one end in a manner that it reacts with blood sugar in the body; and a guide needle which is formed so as to surround the sensor member from the outside and is withdrawn and removed after being inserted into the body together with the sensor member, and in a state where the sensor member and the guide needle are inserted into the body, at least a part of the region formed as the sensing region is not cut by a cut site in the body which is surrounded from the outside by the guide needle, and the insertion depth of the guide needle is smaller than the insertion depth of the sensor member.

2. The continuous blood sugar measurement device according to claim 1, wherein the guide needle is inserted into the body before the sensor member or at the same time as the sensor member during the process of being inserted into the body.

3. The continuous blood sugar measurement device according to claim 2, wherein the sensor member comprises a sensor probe portion which is formed longer in the body insertion direction in a manner that at least a part of the interval is inserted into the body, and the sensing region is formed at a tip portion of the sensor probe portion.

4. The continuous blood sugar measurement device according to claim 3, wherein the guide needle is formed in a form that it surrounds the sensor probe portion from the outside, and is withdrawn and removed after being inserted to a depth shallower than the sensor probe portion.

5. The continuous blood sugar measurement device according to claim 4, wherein the tip of the guide needle is inserted to a depth more proximal to the skin surface than the deepest part of the sensing region.

6. The continuous blood sugar measurement device according to claim 5, wherein the tip of the guide needle is inserted to a depth more proximal to the skin surface than the outermost part of the sensing region.

7. The continuous blood sugar measurement device according to claim 3, wherein the guide needle comprises: a cut portion which is formed at a front tip portion in a manner that it cuts the skin of the body during the process of being inserted into the body; and an insertion support portion which is extended to a rear end of the cut portion to be inserted into the body continuously along the portion cut by the cut portion, the insertion support portion is inserted to a depth more proximal to the skin surface than the deepest part of the sensing region at a boundary with the cut portion.

8. The continuous blood sugar measurement device according to claim 4 or 7, wherein a needle withdrawal mechanism which withdraws and removes the guide needle from the body in a state where the guide needle is inserted into the body is provided in the applicator, the needle withdrawal mechanism operates in a manner that the guide needle is withdrawn and removed from the body before the sensor member completes the insertion into the body.

9. The continuous blood sugar measurement device according to claim 4 or 7, wherein The sensor member and the guide needle are inserted into the body by the applicator in such a manner that the sensor member is inserted at a faster insertion speed than the guide needle in a section after insertion into the body.

10. The continuous blood glucose measurement device according to claim 4 or 7, wherein The sensor member is inserted into the body by the applicator in such a manner that the sensor member is further inserted after the guide needle is inserted to a predetermined insertion depth in a state where the sensor member and the guide needle are inserted into the body together.

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