WO2021033863A1 - 연속 혈당 측정용 센서 부재 - Google Patents
연속 혈당 측정용 센서 부재 Download PDFInfo
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- WO2021033863A1 WO2021033863A1 PCT/KR2020/003521 KR2020003521W WO2021033863A1 WO 2021033863 A1 WO2021033863 A1 WO 2021033863A1 KR 2020003521 W KR2020003521 W KR 2020003521W WO 2021033863 A1 WO2021033863 A1 WO 2021033863A1
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- sensor
- substrate
- electrode
- via hole
- electrode layer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
- A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
- A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
- A61B5/1473—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
- A61B5/14865—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7225—Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation
Definitions
- the present invention relates to a sensor member for continuous blood glucose measurement. More specifically, by connecting the electrode layer formed on the other surface of the substrate to the sensor contact part on one surface of the substrate through a via hole, two electrode layers can be formed on opposite surfaces without the need to form on the same surface of the substrate, further reducing the width of the substrate.
- Diabetes is a chronic disease that occurs a lot in modern people, and in Korea, more than 2 million people, which account for 5% of the total population.
- Diabetes is caused by various causes such as obesity, stress, poor eating habits, autoimmunity, and so on. Insulin produced by the pancreas is absolutely insufficient or relatively insufficient, so that the balance of sugar in the blood cannot be corrected. It is caused by loss.
- Blood usually contains a certain concentration of glucose, and tissue cells are gaining energy from it.
- Diabetes is characterized by almost no subjective symptoms in the early stages, and when the disease progresses, symptoms peculiar to diabetes, polymorphism, polyuria, weight loss, systemic malaise, skin itching, and wounds on hands and feet last a long time without healing. When the disease progresses further, complications such as visual impairment, high blood pressure, kidney disease, stroke, periodontal disease, muscle spasms, neuralgia, and gangrene appear.
- the blood glucose meter there are a method in which a user collects blood from a fingertip and performs blood glucose measurement in a single unit, and a method in which a user attaches blood to a belly or arm to continuously perform blood glucose measurement.
- hypoglycemic state is very important to diabetic patients, but there is a limitation in accurately grasping this with a blood glucose meter that measures blood glucose intermittently.
- CGMS continuous glucose monitoring system
- the blood glucose meter is measured in a way that a diabetic patient collects blood by piercing a fingertip sensitive to pain with a needle in order to test his or her blood glucose, the blood glucose measurement is performed, causing pain and rejection during the blood collection process.
- a continuous blood glucose measurement system that continuously measures blood sugar after inserting a needle-type sensor into the area where the pain is relatively less, such as the stomach and arm, is being conducted.
- Research and development on a non-invasive glucose monitoring system that measures blood sugar without collecting blood has also been actively conducted.
- Non-invasive blood glucose measurement systems have been researching various methods for measuring blood glucose without collecting blood for the past 40 years, such as optical, electrical, and exhaled measurements.
- Cygnus (Cygnus, Redwoo City, Ca, USA) developed and released a wristwatch-type Glucowatch G2 Biographer using reverse ion osmosis, but problems with skin irritation and blackness, problems with the device stopping when sweating, and hyperglycemia.
- many non-blood glucose measurement techniques have appeared and are reported, but their accuracy is poor and they are not practically used.
- the continuous blood glucose measurement device includes a sensor module attached to the skin of the body to measure sugar in body fluids, a transmitter that transmits the blood sugar level measured by the sensor module to the terminal, and a terminal that outputs the transmitted blood sugar level. do.
- the sensor module is provided with a sensor probe or the like that is inserted into the subcutaneous fat and formed in a needle shape to extract interstitial fluid, and a separate applicator is used to attach the sensor module to the body.
- Such a continuous blood glucose measurement device is manufactured in a wide variety of forms for each manufacturer, and its usage is also varied.
- most of the continuous blood glucose meters are manufactured and distributed in a way that a disposable sensor module is attached to the body through an applicator, and an adhesive tape is attached to the bottom surface so that the sensor module can be attached to the body on the outer housing of the sensor module.
- the sensor module is maintained in a state attached to the body skin by an adhesive tape, and in this state, blood sugar is continuously measured.
- a plurality of electrode layers are formed to be inserted into the skin to measure information on various substances from body fluids, and the plurality of electrode layers extend to a part not inserted into the skin to separate It is connected to electronic devices through electrical contacts.
- the part of the sensor member inserted into the skin must be maintained for a considerable period of time while being inserted into the skin, it is formed in a very thin and narrow width so as not to cause pain to the user. Since the sensor member is formed in such a fine shape, it is difficult to form a complex structure such as a plurality of electrode layers and a connection contact with an external electrical contact on the sensor member, and the size of the sensor member is minimized by the structure of such a plurality of electrode layers. However, there is a problem that there is a limit. In addition, there is a problem such as an increase in product defect rates in the process of forming structures such as the electrode layer and the connection contact through a fine process.
- the present invention was invented to solve the problems of the prior art, and an object of the present invention is to expand the structure of the substrate or to have a separate connection structure by connecting the electrode layer formed on the other surface of the substrate to the sensor contact portion on one surface of the substrate through a via hole. It is possible to simplify the structure by connecting the electrode layer to the sensor contact part on one side of the substrate without further expanding the structure. Accordingly, two electrode layers can be formed on opposite sides without the need to form on the same side of the substrate, thereby further increasing the width of the substrate. It is to provide a sensor member for continuous blood glucose measurement that can be reduced and overall miniaturization and simplified structure are possible.
- Another object of the present invention is to form the electrode connection layer formed in the via hole only on the surface of the inner circumferential surface rather than filling the via hole, thereby preventing a filling defect occurring in the process of filling the via hole and the resulting electrical connection failure. It is to provide a sensor member for continuous blood glucose measurement that can achieve a stable structure.
- Another object of the present invention is to extend and form the electrode connection layer of the via hole to one side and the other side of the substrate, so that the electrode layer, the sensor contact part, and the electrode connection layer overlap each other, thereby improving the contact stability. It is to provide a sensor member for continuous blood glucose measurement.
- Another object of the present invention is to form a plurality of via holes and to form an electrode connection layer in each via hole, so that even if an electrode connection layer formed in one via hole is damaged or a defect occurs, electrical connection by the electrode connection layer formed in the remaining via hole Since this is maintained, it is to provide a sensor member for continuous blood glucose measurement capable of maintaining more stable performance.
- the present invention provides a continuous blood glucose measurement sensor member having one end inserted into a body for continuous blood glucose measurement, comprising: a substrate having a via hole formed at one side thereof; And a first electrode layer and a second electrode layer respectively formed on one surface and the other surface of the substrate, wherein the first electrode layer and the second electrode layer are respectively connected to separate external electrical contacts on one surface of the substrate. And a second sensor contact part is formed, an electrode connection layer made of a conductive material is formed on an inner peripheral surface of the via hole, and the second electrode layer is electrically connected to the second sensor contact part through the electrode connection layer.
- a sensor member for continuous blood glucose measurement is provided.
- the electrode connection layer is formed to extend from the inner circumferential surface of the via hole to a region adjacent to the via hole on one surface and the other surface of the substrate, and the second electrode layer covers the end portion of the electrode connection layer on the other surface of the substrate.
- the second sensor contact part may be formed to cover an end portion of the electrode connection layer on one surface of the substrate.
- the electrode connection layer may be formed by depositing conductive particles through a sputtering process.
- the first electrode layer, the first sensor contact part, and the second sensor contact part are printed on one surface of the substrate, and the second electrode layer is printed on the other surface of the substrate. I can.
- the sensor member includes a sensor body portion formed to contact the electrical contact, and a sensor probe portion extending in one direction in a form bent from one side of the sensor body portion to be inserted into the body, and the substrate
- the first electrode layer and the second electrode layer are formed to extend from the sensor body region to the sensor probe region, and the first sensor contact unit and the second sensor contact unit
- the via hole and the electrode connection layer may be formed in the sensor body area.
- the sensor body portion is deformed by a user's pressing operation to form a pressure deformation portion that contacts the electrical contact
- the first sensor contact portion is formed on one side of the pressure deformation portion region
- the first electrode layer It extends from the sensor body to the pressure deformation part in the form of a trace and is connected to the first sensor contact part
- the via hole and the second sensor contact part are formed on the other side of the pressure deformation part region
- the second electrode layer is the sensor It extends from the body part to the pressure deformation part in the form of a trace, is connected to the electrode connection layer of the via hole, and may be connected to the second sensor contact part through the electrode connection layer.
- the pressure deformation part may be formed in a form cut along a cut line formed in a central region of the sensor body part.
- the electrode layer formed on the other surface of the substrate to the sensor contact unit on one surface of the substrate through a via hole
- the electrode layer can be connected to the sensor contact unit on the surface of the substrate without expanding the structure of the substrate or further expanding a separate connection structure. Therefore, the structure can be simplified, and thus two electrode layers can be formed on opposite surfaces of the substrate without having to be formed on the same surface, so that the width of the substrate can be further reduced, and overall miniaturization and simplified structure are possible.
- the electrode connection layer formed in the via hole only on the inner circumferential surface of the via hole rather than filling the via hole, it is possible to prevent filling defects occurring in the process of filling the via hole and the resulting electrical connection failure, thereby achieving a more stable structure. It can have an effect.
- the electrode connection layer of the via hole by extending the electrode connection layer of the via hole to an area of one surface and the other surface of the substrate, the electrode layer, the sensor contact part, and the electrode connection layer overlap each other in such a way that contact stability is improved.
- FIG. 1 is a diagram schematically showing a basic system of a continuous blood glucose measurement apparatus according to an embodiment of the present invention
- FIG. 2 is a view schematically showing the shape of an applicator of a continuous blood glucose measurement apparatus according to an embodiment of the present invention
- FIG. 3 is a diagram schematically showing a configuration of a body attachment unit of a continuous blood glucose measurement apparatus according to an embodiment of the present invention
- FIG. 4 is a view conceptually showing the electrode layer formation structure of the sensor member according to an embodiment of the present invention.
- 5 and 6 are views for explaining the shape of an electrode layer formed on a sensor member according to an embodiment of the present invention.
- FIG. 7 is a perspective view schematically showing the appearance of a body attachment unit according to an embodiment of the present invention.
- FIG. 8 is an exploded perspective view schematically showing the configuration of a body attachment unit according to an embodiment of the present invention.
- FIG. 9 is a perspective view schematically showing a shape of a sensor member according to an embodiment of the present invention.
- FIG. 10 is a view for conceptually explaining the operating state of the body attachment unit according to an embodiment of the present invention based on the cross section taken along the line "A-A" of FIG.
- FIG. 1 is a diagram schematically showing a basic system of a continuous blood glucose measurement apparatus according to an embodiment of the present invention
- FIG. 2 is a diagram schematically showing a shape of an applicator of a continuous blood glucose measurement apparatus according to an embodiment of the present invention
- FIG. 3 is a diagram schematically showing a configuration of a body attachment unit of a continuous blood glucose measurement apparatus according to an embodiment of the present invention.
- the continuous blood glucose measurement apparatus is configured to attach a body attachment unit 20 having a sensor member 520 inserted into the body for continuous blood glucose measurement through an applicator 10, and , By operating the applicator 10, the body attachment unit 20 is inserted and attached to the body to continuously measure blood sugar from the body, and blood glucose measurement information periodically measured through the body attachment unit 20 is a separate terminal 30 ) To be transmitted and output.
- the body attachment unit 20 is assembled inside the applicator 10 to be manufactured as a unit product, and the user's additional work is minimized when using the continuous blood glucose measurement device, and the use method is made in a very simple structure.
- the body attachment unit 20 is formed to be attached to the body so as to periodically measure blood sugar by extracting body fluid, and is formed to transmit the blood sugar measurement result to an external device such as the external terminal 30.
- a sensor member 520 having one end inserted into the body and a wireless communication chip are disposed inside so as to wirelessly communicate with the external terminal 30, so that a separate transmitter needs to be additionally coupled. It can be manufactured in a form that can be used without the need.
- the applicator 10 is formed so that the body attachment unit 20 is coupled and fixed therein, and operates to discharge the body attachment unit 20 to the outside by a user's pressing operation on the pressing button 110.
- the body attachment unit 20 is assembled and manufactured in a state inserted into the applicator 10, and is configured to be attached to the body by moving in the external discharge direction according to the operation of the applicator 10 by the user's manipulation.
- the body attaching unit 20 is inserted into the applicator 10 at the manufacturing stage, and the body attaching unit 20 is attached to the skin only by the operation of the applicator 10. Since it is assembled and manufactured to be attached, and supplied to the user in this state, the user can install the body attachment unit 20 by simply operating the applicator 10 without additional work to attach the body attachment unit 20 to the skin. Can be attached to the skin. In particular, since a separate wireless communication chip is provided in the body attachment unit 20, there is no need to combine a separate transmitter, so it can be used more conveniently.
- the body attachment unit which is separately packaged, is removed from the package and inserted into an applicator, and after insertion, the applicator is operated to attach the body attachment unit to the skin.
- the accuracy of blood glucose measurement is deteriorated in the case of children and the elderly, such as contaminating the body attachment unit during this operation.
- the user by manufacturing and distributing the body attachment unit 20 inserted into the applicator 10 in the manufacturing step, the user peels off the body attachment unit 20 and inserts it into the applicator 10, etc. This is omitted, and since the body attachment unit 20 can be attached to the skin simply by operating the applicator 10, usability is remarkably improved, and in particular, contamination of the body attachment unit 20 can be prevented. It can improve blood glucose measurement accuracy.
- a separate protective cap 200 may be detachably coupled to the applicator 10 so that external exposure is blocked while the body attachment unit 20 is inserted into the applicator 10, and the user may have a protective cap 200 It may be configured to be attached to the body by operating the applicator 10 only after separating the body attachment unit 20 by discharging the body attachment unit 20 to the outside to the side where the protective cap 200 is removed.
- the 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, and the adhesive tape 560 is protected on the body contact surface of the adhesive tape 560.
- a release paper (not shown) is attached, and the release paper of the adhesive tape 560 may be formed to be separated and removed from the adhesive tape 560 in the process of separating the protective cap 200 from the applicator 10.
- the release paper of the adhesive tape 560 may be configured such that one side is adhered to the protective cap 200, and thus, when the user separates the protective cap 200 from the applicator 10, the protective cap 200 ) Can be separated and removed from the adhesive tape 560 together. Accordingly, when the user separates the protective cap 200, the release paper of the adhesive tape 560 is separated and removed, so that the applicator 10 is operated in this state to attach the body attachment unit 20 to the body.
- the applicator 10 is fixed to the body attachment unit 20 when the body attachment unit 20 is inserted therein, and the body attachment unit 20 is attached to the body attachment unit 20 when the body attachment unit 20 is discharged and moved to the outside. It can be formed to release the fixed state of the engagement. Therefore, when the body attachment unit 20 is inserted and assembled into the applicator 10, the body attachment unit 20 is maintained in a fixed state, and the body attachment unit 20 is externally operated by operating the applicator 10. In the case of discharging and attaching to the skin, the coupling and fixing state of the applicator 10 and the body attachment unit 20 is released. Therefore, when the applicator 10 is removed in this state, it is separated from the body attachment unit 20, and Only the body attachment unit 20 remains attached.
- the body attachment unit 20 may be formed so that the sensor member 520 and the wireless communication chip are started to operate through a separate switch means operated by a user. That is, after inserting and attaching the body attachment unit 20 to the body through the applicator 10, the user can start the operation of the body attachment unit 20 through a switch means provided in the body attachment unit 20. Also, from the start of the operation, the sensor member 520 and the wireless communication chip operate to measure the blood sugar of the body and transmit the measurement result to the external terminal 30.
- the switch means operated by the user may be configured in various ways.
- the sensor member 520 is disposed inside the housing 510, and one end of the sensor member 520 protrudes from the bottom surface of the housing 510 to be inserted and attached to the body. Is formed.
- the sensor member 520 is composed of a sensor probe part inserted into the body and a sensor body part disposed inside the housing 510, and the sensor probe part and the sensor body part are bent, respectively, with one end of the sensor member 520 The other end is formed.
- a separate insertion guide needle 550 may be detachably coupled to the housing 510 so that the body insertion process of the sensor member 520 is smoothly performed.
- the insertion guide needle 550 surrounds one end of the sensor member 520 so that one end of the sensor member 520 is stably inserted into the body, and is configured to be inserted into the body together with the sensor member 520.
- the insertion guide needle 550 is detachably mounted in a direction penetrating the housing 510 of the body attachment unit 20 up and down, as shown in FIG. 3, and is formed in a shape surrounding the outside of the sensor member 520 And a needle head 551 is formed at the upper end.
- the insertion guide needle 550 is inserted into the body before the sensor member 520 when the body attachment unit 20 moves in the external discharge direction by the applicator 10, and the sensor member 520 is stably inserted into the skin. Assist as possible.
- the insertion guide needle 550 is coupled to the needle withdrawal body (not shown) of the applicator 10 through the needle head 551, and the body attachment unit 20 is inserted and attached to the body by the operation of the applicator 10. Thereafter, it is formed to be removed from the body by the needle withdrawing body of the applicator 10.
- the body attachment unit 20 After the insertion guide needle 550 is removed from the body, the body attachment unit 20 remains inserted and attached to the body, and the sensor member 520 of the body attachment unit 20 has one end inserted into the skin.
- blood sugar information is measured from body fluids.
- a plurality of electrode layers are formed on the sensor member 520, and each electrode layer is formed to be connected to an electrical contact of a separate external electronic device.
- FIG. 4 is a diagram conceptually showing a structure of forming an electrode layer of a sensor member according to an embodiment of the present invention.
- the sensor member 520 includes a sensor body part 522 in the form of a flat plate, and a sensor that extends in one direction in a form bent from one side of the sensor body part 522 and is inserted into the body.
- a probe portion 521 is formed, a substrate 5201 formed to form the sensor body portion 522 and the sensor probe portion 521, and a first electrode layer 5202 formed on one surface and the other surface of the substrate 5201, respectively.
- the first electrode layer 5202 and the second electrode layer 5204 are configured to measure blood sugar information from bodily fluids by functioning as working electrodes and counter electrodes, respectively, and methods and principles of measuring blood sugar information through these working electrodes and counter electrodes are known. Since it is a technology, a detailed description thereof will be omitted.
- a first sensor contact portion 5202a and a second sensor contact portion 5204a are formed on one surface of the substrate 5201 so that the first electrode layer 5202 and the second electrode layer 5204 are connected to separate external electrical contacts, respectively.
- a via hole 5201a is formed on one side of the substrate 5201, an electrode connection layer 5201b made of a conductive material is formed on the inner circumferential surface of the via hole 5201a, and a second electrode layer 5204 formed on the other surface of the substrate 5201 ) Is electrically connected to the second sensor contact portion 5204a through the electrode connection layer 5201b of the via hole 5201a.
- a first electrode layer 5202 is formed on one surface of the substrate 5201
- a second electrode layer 5204 is formed on the other surface of the substrate 5201
- a first sensor contact portion 5202a is formed on one surface of the substrate 5201.
- a second sensor contact portion 5204a are formed, wherein the first sensor contact portion 5202a is directly connected to the first electrode layer 5202 formed on one surface of the substrate 5201, and the second sensor contact portion 5204a Is connected through a second electrode layer 5204 formed on the other surface of the substrate 5201 and an electrode connection layer 5201b.
- the electrode connection layer 5201b is formed on the inner circumferential surface of the via hole 5201a penetrating the substrate 5201.
- a second sensor contact portion 5204a formed on one surface of the substrate 5201 through an electrode connection layer 5201b using a via hole 5201a for the second electrode layer 5204 formed on the other surface of the substrate 5201 By connecting with, it is possible to connect the second electrode layer 5204 to the second sensor contact portion 5204a without expanding the structure of the substrate 5201 or further expanding a separate connection structure. Accordingly, the first electrode layer 5202 And since the second electrode layer 5204 does not need to be formed on the same surface of the substrate 5201, that is, the first electrode layer 5202 and the second electrode layer 5204 can be formed on opposite surfaces of the substrate 5201, Overall, the width of the substrate 5201 may be minimized.
- the electrode connection layer 5201b is not formed in a form that fills the via hole 5201a penetrating through the substrate 5201, but is formed thinly on the inner circumferential surface of the via hole 5201a as shown in FIG. It is formed so that the 5201a is not filled and is maintained as it is.
- the electrode connection layer 5201b is formed only on the inner circumferential surface rather than filling the via hole 5201a, thereby preventing a filling defect occurring in the process of filling the via hole 5201a and a resulting electrical connection failure. A more stable structure can be achieved.
- the electrode connection layer 5201b is formed to extend from the inner circumferential surface of the via hole 5201a to a region adjacent to the via hole 5201a on one surface and the other surface of the substrate 5201, and the second electrode layer 5204 is the other surface of the substrate 5201. Is formed to cover the end portion of the electrode connection layer 5201b and is connected to the electrode connection layer 5201b, and the second sensor contact portion 5204a is the end of the electrode connection layer 5201b on one surface of the substrate 5201 It may be formed to cover the portion and connected to the electrode connection layer 5201b.
- the electrode connection layer 5201b extends to one and the other surface regions of the substrate 5201, so that the second electrode layer 5204 and the second sensor contact portion 5204a and the electrode connection layer 5201b overlap each other and contact Therefore, the contact stability is further improved.
- a plurality of via holes 5201a may be formed on the substrate 5201, and electrode connection layers 5201b are formed in the same manner in each of the plurality of via holes 5201a, so that the second electrode layer 5204 ) And the second sensor contact portion 5204a, even if the electrode connection layer 5201b formed in any one via hole 5201a is damaged or defective, the electrode connection layer 5201b formed in the other via hole 5201a is Because electrical connection is maintained, more stable performance can be maintained.
- the electrode connection layer 5201b may be formed by depositing conductive particles, for example, metal particles such as Au and Ag, on the inner circumferential surface of the via hole 5201a and a region adjacent thereto through a sputtering process.
- conductive particles for example, metal particles such as Au and Ag
- the first electrode layer 5202, the first sensor contact portion 5202a, and the first sensor contact portion 5202a, and the first electrode layer 5202, the first sensor contact portion 5202a, and the first electrode layer 5202 are printed through a printing process of a conductive paste containing conductive particles on one surface of the substrate 5201. 2
- a sensor contact part 5204a may be formed, and a second electrode layer 5204 may be formed on the other surface of the substrate 5201 through a printing process of a conductive paste.
- 5 and 6 are views for explaining the shape of an electrode layer formed on a sensor member according to an embodiment of the present invention.
- 5 and 6 illustrate a specific application form for the electrode layer-related structure of the sensor member 520 conceptually described in FIG. 4 by way of example.
- the sensor member 520 includes a sensor body 522 formed to contact a separate external electrical contact, and a shape bent from one side of the sensor body 522.
- a sensor probe part 521 which is extended in one direction and inserted into the body is formed.
- the sensor probe part 521 shown in FIGS. 5 and 6 is shown to be located on the same plane as the sensor body part 522, which is for convenience of explanation of the electrode layer to be described later, and after the electrode layer formation is completed , The sensor body part 522 is bent to form a right angle (see FIG. 9).
- the substrate 5201 forms the basic structure of the sensor member 520, and is formed to form the sensor body part 522 and the sensor probe part 521, and the first electrode layer 5202 and the second electrode layer 5204 It is formed extending from the body part 522 area to the sensor probe part 521 area, and the first sensor contact part 5202a and the second sensor contact part 5204a, the via hole 5201a, and the electrode connection layer 5201b are It is formed in the area of the sensor body 522.
- the sensor member 520 may be configured in such a way that it is connected to and operated by an electrical contact by a switch means.
- the sensor body part 522 is formed in a flat plate shape, and in the center thereof, the user presses
- the pressure deformation portion 523 may be formed to be deformed by manipulation to contact the external electrical contact.
- the pressure deformation part 523 is formed in a shape cut along the cut line CL formed in the center region of the sensor body part 522, and the cut line CL may be formed in a spiral shape.
- a first electrode layer 5202 extends to the sensor body portion 522 and the sensor probe portion 521 as shown in FIGS. 5 and 6A, and the substrate 5201 ), a second electrode layer 5204 is formed extending to the sensor body 522 and the sensor probe 521 as shown in FIGS. 5 and 6B.
- the first sensor contact portion 5202a is formed on one surface of the substrate 5201 and is formed on one side of the pressure deformation portion 523 area, and the first electrode layer 5202 is in the form of a trace in the outer area of the sensor body portion 522
- the furnace is extended to the pressure deformation part 523 and is connected to the first sensor contact part 5202a.
- the traces extending from the first electrode layer 5202 to the first sensor contact portion 5202a are formed in a shape that does not cross the cut line CL of the pressure deformation portion 523.
- the via hole 5201a is formed on the other side of the pressure deformation portion 523 area, and the second sensor contact portion 5204a is formed on one surface of the substrate 5201, and is formed on the other side of the pressure deformation portion 523 area.
- the electrode connection layer 5201b formed in the via hole 5201a extends to one surface and the other surface of the substrate 5201, and is contact-connected in a manner that overlaps with the second sensor contact portion 5204a on one surface of the substrate 5201.
- the second electrode layer 5204 extends from the outer region of the sensor body part 522 to the pressure deformation part 523 in the form of a trace and overlaps the electrode connection layer 5201b of the via hole 5201a on the other surface of the substrate 5201. Is connected in a contact way.
- the second electrode layer 5204 formed on the other surface of the substrate 5201 is connected to the second sensor contact portion 5204a formed on the one surface of the substrate 5201 through the electrode connection layer 5201b.
- the trace extending from the second electrode layer 5204 to the electrode connection layer 5201b is formed in a form that does not cross the cut line CL of the pressure deformation portion 523.
- the cross-sectional shape of the via hole 5201a may be formed in various shapes such as a circular shape, a star shape, and a square shape, and an inner diameter thereof may also be formed in various sizes according to a user's need.
- FIG. 7 is a perspective view schematically showing the appearance of a body attachment unit according to an embodiment of the present invention
- Figure 8 is an exploded perspective view schematically showing the configuration of the body attachment unit according to an embodiment of the present invention
- 9 is a perspective view schematically showing a shape of a sensor member according to an embodiment of the present invention
- FIG. 10 is a body attachment unit according to an embodiment of the present invention based on a cross section taken along line "AA" of FIG. 7 It is a diagram for conceptually explaining the operating state of.
- the body attachment unit 20 is discharged to the outside by manipulation of an applicator and inserted into the body, and the housing 510 with an adhesive tape attached so that the bottom surface can be attached to the skin,
- the sensor member 520 is disposed inside the housing 510 so that one end protrudes outward from the bottom surface of the housing 510 so that one end is inserted into the body when the housing 510 is attached to the skin, and inside the housing 510 It is configured to include a PCB substrate 530 to be disposed.
- the sensor member 520 is formed such that one end is inserted into the body and the other end is formed to contact the PCB substrate 530, and the other end of the sensor body part ( A sensor probe part 521 is formed at one end of the sensor body part 522 to extend from one side of the sensor body part 522 and protrude from the housing 510 to be inserted into the body.
- the sensor body portion 522 is formed in a shape having a relatively large area, and the sensor probe portion 521 is formed in a relatively narrow and long shape.
- the housing 510 may be separated into an upper housing 512 and a lower housing 511 to form an internal accommodation space, and the sensor body part 522 is connected to the electrical contact of the PCB board 530 inside the housing 510.
- a sensor support part 5121 supporting spaced apart from 531 at a predetermined interval is formed, and a sensor guide part (not shown) capable of supporting and guiding a partial section of the sensor probe part 521 is formed.
- a substrate support portion for fixing and supporting the PCB substrate 530 at a predetermined position may be formed inside the housing 510.
- An electrical contact 531 is formed on the PCB substrate 530 to be electrically connected to the sensor member 520, and a wireless communication chip 540 to transmit the blood glucose measurement result measured through the sensor member 520 to an external terminal. Is implemented.
- the wireless communication chip 540 is provided inside the body attachment unit 20, it is possible to easily communicate with an external terminal without a separate transmitter connection operation.
- a battery 535 is mounted inside the housing 510 so as to supply power to the PCB substrate 530, at this time, the battery 535 is not disposed in a form mounted on one surface of the PCB substrate 530 It is disposed in an area independent from the PCB substrate 530. That is, the PCB substrate 530 and the battery 535 are independently disposed without the areas projected on the bottom surface of the housing 510 overlap each other. As such, the PCB substrate 530 and the battery 535 are disposed in regions independent from each other, so that the thickness of the body attachment unit 20 can be reduced and further downsized. In this case, a separate contact terminal may be formed extending toward the battery 535 on the PCB substrate 530 so as to be electrically connected to the battery 535.
- the other end of the sensor member 520 is the electrical contact 531 of the PCB substrate 530 by the user's manipulation. It is formed so as to contact, and the body attachment unit 20 is configured to start operating according to this electrical contact. That is, power is supplied by electrical connection between the sensor member 520 and the PCB board 530 by the user's manipulation, and the sensor member 520 and the wireless communication chip 540 may be configured to start operating. .
- the housing 510 includes a separate pressure operation module 570 operated by the user's manipulation. It can be provided.
- the pressurizing operation module 570 may include a moving pressurizing body 571 that is movably coupled to the housing 510 and moves in a pressurizing direction by a user's pressing force, and according to the movement of the moving pressurizing body 571 At least a partial region of the other end of the sensor member 520 may be pressed and deformed by the moving pressing body 571 to contact the electrical contact 531 of the PCB substrate 530.
- the moving pressurizing body 571 is formed with a protruding guide portion 5711 protruding along the moving direction of the moving pressurizing body 571, and the moving pressurizing body 571 guides the protruding guide portion 5711 in the housing 510
- a housing guide part 5114 may be formed to guide the pressing movement direction of the.
- the pressure operation module 570 further includes a button cover 572 made of a soft material that is externally exposed to the housing 510 so as to allow a user's pressure operation in a form surrounding the outer space of the moving pressure body 571. It may include, and the coupling portion between the button cover 572 and the housing 510 may be configured to be sealed.
- the sealing treatment method of the bonding portion of the button cover 572 and the housing 510 may be configured by using a double-sided tape.
- a double-sided tape is adhered to the other end of the sensor member 520, that is, one surface of the sensor body 522 along the circumference of the edge, and the inner side of the button cover 572 is formed of the double-sided tape along the circumference of the edge. It is adhered to the other surface, and the periphery of the button cover 572 may be sealed by such double-sided tape.
- a double-sided tape may be adhered along the periphery of the other surface of the sensor body part 522, through which the sensor body part 522 is adhered and fixed to the sensor support part 5121 using a double-sided tape. I can.
- the central region of the sensor body portion 522 is pressed by the moving pressure body 571 as shown in FIG. It may be deformed and may contact the electrical contact 531 of the PCB substrate 530.
- the moving pressing body 571 moves in the pressing direction, but the button cover 572 is made of a soft material, and the edge portion is adhered to the housing 510 by double-sided tape, so only the center area is deformed in the pressing direction, and the edge portion is adhered. It is fixed and remains sealed.
- the body 571 may be formed to be fixed in position while moving in the pressing direction by the user's pressing force.
- the sensor member 520 is composed of a sensor body part 522 and a sensor probe part 521 as described above, and the sensor body part 522 is deformed by the pressure movement of the moving press body 571 to be A pressure deformation portion 523 that contacts the electrical contact 531 of the substrate 530 is formed.
- the pressure deformation part 523 is formed in a form cut along the helical cut line CL formed in the center area of the sensor body part 522 as shown in FIG. 9, and is formed by the moving pressure body 571. It may be formed to be deformed under pressure.
- the pressurizing deformable portion 523 formed along the cut line CL is elastically deformed downward, as shown in FIGS. 10A and 10B. It comes into contact with the electrical contact 531 of the PCB substrate 530.
- the first sensor contact portion 5202a and the second sensor contact portion 5204a described in FIGS. 4 to 6 are formed on the pressure deformation portion 523, and the pressure deformation portion 523 is deformed downwardly.
- the first sensor contact portion 5202a and the second sensor contact portion 5204a are in contact with the electrical contact 531 of the PCB substrate 530. Accordingly, the first electrode layer 5202 and the second electrode layer 5204 formed on the sensor member 520 are electrically connected to the electrical contact 531 of the PCB substrate 530.
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Abstract
Description
Claims (7)
- 연속 혈당 측정을 위해 일단부가 신체에 삽입되는 연속 혈당 측정용 센서 부재에 있어서,일측에 비아홀이 형성되는 기판; 및상기 기판의 일면 및 타면에 각각 형성되는 제 1 전극층 및 제 2 전극층을 포함하고, 상기 기판의 일면에는 상기 제 1 전극층 및 제 2 전극층이 각각 별도의 외부 전기 접점과 연결되도록 제 1 센서 접점부 및 제 2 센서 접점부가 형성되며,상기 비아홀의 내주면에는 전도성 재질의 전극 연결층이 형성되며, 상기 제 2 전극층은 상기 전극 연결층을 통해 상기 제 2 센서 접점부와 전기적으로 연결되는 것을 특징으로 하는 연속 혈당 측정용 센서 부재.
- 제 1 항에 있어서,상기 전극 연결층은 상기 비아홀의 내주면으로부터 상기 기판의 일면 및 타면의 상기 비아홀과 인접한 영역까지 연장 형성되고,상기 제 2 전극층은 상기 기판의 타면에서 상기 전극 연결층의 끝단 부위를 덮는 형태로 형성되고, 상기 제 2 센서 접점부는 상기 기판의 일면에서 상기 전극 연결층의 끝단 부위를 덮는 형태로 형성되는 것을 특징으로 하는 연속 혈당 측정용 센서 부재.
- 제 2 항에 있어서,상기 전극 연결층은 전도성 입자를 스퍼터링 공정을 통해 증착시키는 방식으로 형성되는 것을 특징으로 하는 연속 혈당 측정용 센서 부재.
- 제 3 항에 있어서,상기 전극 연결층이 증착 형성된 상태에서, 상기 기판의 일면에 상기 제 1 전극층, 제 1 센서 접점부 및 제 2 센서 접점부가 인쇄 형성되고, 상기 기판의 타면에 상기 제 2 전극층이 인쇄 형성되는 것을 특징으로 하는 연속 혈당 측정용 센서 부재.
- 제 1 항 내지 제 4 항 중 어느 한 항에 있어서,상기 센서 부재에는상기 전기 접점에 접촉할 수 있도록 형성되는 센서 바디부와, 상기 센서 바디부의 일측으로부터 절곡되는 형태로 일방향으로 길게 연장 형성되어 신체에 삽입되는 센서 프로브부가 형성되고,상기 기판은 상기 센서 바디부와 센서 프로브부를 이루도록 형성되고, 상기 제 1 전극층 및 제 2 전극층은 상기 센서 바디부 영역으로부터 상기 센서 프로브부 영역까지 연장 형성되며, 상기 제 1 센서 접점부 및 제 2 센서 접점부와 상기 비아홀 및 전극 연결층은 상기 센서 바디부 영역에 형성되는 것을 특징으로 하는 연속 혈당 측정용 센서 부재.
- 제 5 항에 있어서,상기 센서 바디부에는 사용자의 가압 조작에 의해 변형하여 상기 전기 접점에 접촉하는 가압 변형부가 형성되고,상기 제 1 센서 접점부는 상기 가압 변형부 영역의 일측에 형성되고, 상기 제 1 전극층은 상기 센서 바디부에서 트레이스 형태로 상기 가압 변형부까지 연장되어 상기 제 1 센서 접점부와 연결되고,상기 비아홀 및 제 2 센서 접점부는 상기 가압 변형부 영역의 타측에 형성되고, 상기 제 2 전극층은 상기 센서 바디부에서 트레이스 형태로 상기 가압 변형부까지 연장되어 상기 비아홀의 전극 연결층과 연결되고 상기 전극 연결층을 통해 상기 제 2 센서 접점부와 연결되는 것을 특징으로 하는 연속 혈당 측정용 센서 부재.
- 제 6 항에 있어서,상기 가압 변형부는 상기 센서 바디부의 중심 영역에 형성된 절개 라인을 따라 절개된 형태로 형성되는 것을 특징으로 하는 연속 혈당 측정용 센서 부재.
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP20855167.1A EP3991650A4 (en) | 2019-08-19 | 2020-03-13 | SENSOR ELEMENT FOR CONTINUOUS BLOOD SUGAR MEASUREMENT |
JP2022505477A JP7440610B2 (ja) | 2019-08-19 | 2020-03-13 | 連続血糖測定用センサー部材 |
AU2020334509A AU2020334509B2 (en) | 2019-08-19 | 2020-03-13 | Continuous blood sugar measuring sensor member |
US17/628,561 US20220257153A1 (en) | 2019-08-19 | 2020-03-13 | Sensor unit for continuous blood glucose measurement |
JP2024020829A JP2024054341A (ja) | 2019-08-19 | 2024-02-15 | 連続血糖測定用センサー部材 |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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KR10-2019-0101000 | 2019-08-19 | ||
KR1020190101000A KR102283296B1 (ko) | 2019-08-19 | 2019-08-19 | 연속 혈당 측정용 센서 부재 |
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WO2021033863A1 true WO2021033863A1 (ko) | 2021-02-25 |
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PCT/KR2020/003521 WO2021033863A1 (ko) | 2019-08-19 | 2020-03-13 | 연속 혈당 측정용 센서 부재 |
Country Status (6)
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US (1) | US20220257153A1 (ko) |
EP (1) | EP3991650A4 (ko) |
JP (2) | JP7440610B2 (ko) |
KR (1) | KR102283296B1 (ko) |
AU (1) | AU2020334509B2 (ko) |
WO (1) | WO2021033863A1 (ko) |
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KR102534848B1 (ko) | 2021-06-29 | 2023-05-30 | 주식회사 아이센스 | 생체 정보 측정용 센서 유닛 |
KR102438798B1 (ko) | 2021-12-22 | 2022-09-01 | 제일기술(주) | 연속혈당측정장치 |
KR20230163224A (ko) * | 2022-05-23 | 2023-11-30 | 주식회사 유엑스엔 | 플렉시블한 전기 화학적 센서를 포함하는 연속식 분석물 측정기 |
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JP2018057726A (ja) * | 2016-10-07 | 2018-04-12 | 帝国通信工業株式会社 | 生体用フレキシブル回路基板 |
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EP3170453B1 (en) * | 2015-11-19 | 2021-03-17 | Roche Diabetes Care GmbH | Sensor assembly for detecting at least one analyte in a body fluid and method of assembling a sensor assembly |
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CN110177501B (zh) * | 2016-12-22 | 2022-04-29 | 圣维塔医疗公司 | 持续葡萄糖监测系统及方法 |
KR102388991B1 (ko) * | 2017-05-22 | 2022-04-22 | 삼성전자주식회사 | 바이오 센서, 바이오 센서의 제조방법 및 생체신호 측정장치 |
EP3632320A4 (en) | 2017-06-02 | 2021-04-14 | I-sens, Inc. | SENSOR APPLICATOR KIT FOR CONTINUOUS GLUCOSE MONITORING SYSTEM |
-
2019
- 2019-08-19 KR KR1020190101000A patent/KR102283296B1/ko active IP Right Grant
-
2020
- 2020-03-13 WO PCT/KR2020/003521 patent/WO2021033863A1/ko unknown
- 2020-03-13 AU AU2020334509A patent/AU2020334509B2/en active Active
- 2020-03-13 EP EP20855167.1A patent/EP3991650A4/en active Pending
- 2020-03-13 JP JP2022505477A patent/JP7440610B2/ja active Active
- 2020-03-13 US US17/628,561 patent/US20220257153A1/en active Pending
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2024
- 2024-02-15 JP JP2024020829A patent/JP2024054341A/ja active Pending
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JPH0232925B2 (ko) * | 1985-07-22 | 1990-07-24 | Kumagai Gumi Co Ltd | |
US20170128011A1 (en) * | 2014-07-28 | 2017-05-11 | Roche Diabetes Care, Inc. | Medical sensor assembly |
JP2017073424A (ja) * | 2015-10-05 | 2017-04-13 | 日本特殊陶業株式会社 | 配線基板及びその製造方法 |
JP2018057726A (ja) * | 2016-10-07 | 2018-04-12 | 帝国通信工業株式会社 | 生体用フレキシブル回路基板 |
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Also Published As
Publication number | Publication date |
---|---|
KR20210021726A (ko) | 2021-03-02 |
JP2022543754A (ja) | 2022-10-14 |
US20220257153A1 (en) | 2022-08-18 |
AU2020334509B2 (en) | 2024-01-11 |
JP7440610B2 (ja) | 2024-02-28 |
KR102283296B1 (ko) | 2021-07-29 |
EP3991650A4 (en) | 2023-06-21 |
EP3991650A1 (en) | 2022-05-04 |
JP2024054341A (ja) | 2024-04-16 |
AU2020334509A1 (en) | 2022-02-03 |
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