WO2020256197A1 - Dispositif à aiguilles multiples - Google Patents
Dispositif à aiguilles multiples Download PDFInfo
- Publication number
- WO2020256197A1 WO2020256197A1 PCT/KR2019/007552 KR2019007552W WO2020256197A1 WO 2020256197 A1 WO2020256197 A1 WO 2020256197A1 KR 2019007552 W KR2019007552 W KR 2019007552W WO 2020256197 A1 WO2020256197 A1 WO 2020256197A1
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- WO
- WIPO (PCT)
- Prior art keywords
- needle device
- present
- hollow microneedle
- target material
- injection
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
Definitions
- the present invention relates to a multi-needle device. Specifically, it can be applied to a technical field in which a specific substance is sensed through a multi-hollow microneedle inserted into the body and a corresponding substance is injected at the same time.
- Measuring and managing the concentration of blood glucose is an essential factor in managing diabetes, one of the chronic diseases of modern people.
- the self-measurement system is portable, and diabetes can be managed by using a measuring instrument and a disposable test strip to classify and check the daily changes in blood sugar before/after meals.
- a measuring instrument and a disposable test strip to classify and check the daily changes in blood sugar before/after meals.
- FIG. 1 shows an electrochemical system for measuring blood glucose.
- hydrogen peroxide is generated when the oxidase that degrades glucose in the blood decomposes glucose, and it is decomposed when a constant voltage is applied so that it is decomposed at the electrode. It appears as the intensity of a certain amount of current. At this time, the generated current is proportional to the concentration of blood glucose, so that the blood glucose level can be quantified.
- This basic mechanism can be applied to a continuous blood glucose measurement system in addition to a portable self-measurement system.
- 2 shows an embodiment using a microneedle as a continuous blood glucose measurement system of an electrochemical method.
- the continuous blood glucose monitoring system introduces various technologies to measure, and the most reliable and accurate method is the microneedle method.
- it is difficult to uniformly manufacture the needle and to uniformly and stably immobilize the glucose oxidase on a specific part of the needle inserted under the skin.
- the microneedles are made of metal, and there is a disadvantage that periodic management or replacement is required from the user's point of view because the needle is continuously in contact with various biomaterials while the needle is inserted under the skin. .
- the optical continuous blood glucose measurement system is a method of measuring the level of blood glucose by detecting the glare reaction of an optical sensor that reacts with fluorescence by binding to blood glucose.
- Optical thinning has advantages over electrochemical methods in terms of long-term use and sensitivity.
- the conventional optical method requires an incision procedure to insert or remove the optical sensor into the body, and there is still a limit on the use period because the maximum capacity of the battery does not exceed 180 days.
- FIG. 3 shows an embodiment of an optical sensor inserted into the body in a conventional optical continuous blood glucose meter
- FIG. 4 is an implementation of detecting light emission from an optical sensor inserted into the body through an external reader. An example is shown.
- the continuous blood glucose measurement system has advantages in that the user can measure blood sugar without cumbersome blood collection, and that it can measure blood sugar in real time.
- blood glucose measurement with regard to insulin injection,
- the present invention aims to solve the above-described problems and other problems through the specification of the present invention.
- An object of the present invention is not to separate detection of a target substance in the body and injection of a corresponding substance.
- An object of the present invention is to reduce the pain associated with a user in detecting a target substance in the body and injecting a corresponding substance.
- An object of the present invention is to continuously detect a target material and respond to it by injecting a corresponding material immediately.
- An object of the present invention is to easily detect a target material through a microneedle treated with hydrophilicity.
- An object of the present invention is to quantitatively inject a corresponding material through a microneedle subjected to hydrophobic treatment.
- An object of the present invention is to prevent interstitial fluid from flowing into the body through a microneedle treated with hydrophobicity and to inject a corresponding substance with a small pressure.
- An object of the present invention is to prevent an error in measuring the concentration of a target substance due to injection of a corresponding substance.
- a hydrophilic first hollow microneedle a sensor unit provided in the first hollow microneedle to detect a target material in the body
- a hydrophobic second hollow microneedle It provides a multi-needle device including a needle and an injection unit for injecting a corresponding material into the body through the second hollow microneedle.
- the first hollow microneedle has an inner flow path having a hydrophilic surface
- the second hollow microneedle is the second hollow microneedle
- the inner flow path has a hydrophobic surface
- the sensor unit is provided in the inner flow path of the first hollow microneedle, a fluorescence sensor that reacts with fluorescence by combining with the target material, and detects a fluorescence reaction of the fluorescence sensor. It provides a multi-needle device comprising a sensing unit.
- the sensor unit is provided in the inner flow path of the first hollow microneedle, and detects an electrode type enzyme that binds to the target material and a current passing through the electrode type enzyme. It provides a multi-needle device comprising a portion.
- the injection unit provides a multi-needle device, characterized in that the injection amount of the corresponding material is adjusted according to the concentration of the target material sensed through the sensor unit.
- the injection unit provides a multi-needle device, wherein the injection unit controls the injection time of the corresponding material in response to the concentration of the target material through the sensor unit.
- the sensor unit provides a multi-needle device, characterized in that after injecting the corresponding substance into the body through the injection unit and detecting the concentration of the target substance at a preset time difference.
- the sensor unit detects the concentration of the target material at a preset time term, and the injection unit injects the corresponding substance into the body at a preset time term by placing a parallax with the sensor unit. It provides a multi-needle device, characterized in that.
- the injection unit includes a receiving unit including the corresponding material, and an injection pump for injecting the corresponding material through the second hollow microneedle for adjusting the pressure of the receiving unit. It provides a multi-needle device, characterized in that.
- the injection pump provides a multi-needle device, characterized in that it includes a piezoelectric element for adjusting the internal pressure of the receiving portion.
- the first hollow microneedle provides a multi-needle device, characterized in that the length is different from the second hollow microneedle.
- the second hollow microneedle has a length longer than that of the first hollow microneedle and thus provides a multi-needle device, characterized in that it is inserted deeper into the body.
- the injection unit provides a multi-needle device, characterized in that injecting the corresponding material into the body through the second hollow microneedle.
- a multi-needle device wherein the target material is glucose and the corresponding material is glucagon.
- the present invention includes a plurality of microneedles, detecting a target material and simultaneously injecting a corresponding material into the body.
- the present invention detects a target substance using a microneedle and injects a corresponding substance into the body, thereby reducing pain accompanying a user.
- a target substance can be continuously detected and a corresponding substance is immediately injected in response to the concentration of the target substance in the body.
- the present invention can easily detect a target material including a microneedle treated with hydrophilicity.
- the present invention prevents the interstitial fluid from flowing into the body including the hydrophobically treated microneedle, so that the corresponding material can be injected with a small pressure.
- the present invention can prevent an error in measuring the concentration of the target substance due to the injection of the corresponding substance.
- 1 shows an electrochemical system for measuring blood glucose.
- FIG. 2 shows an embodiment using a microneedle as a continuous blood glucose measurement system of an electrochemical method.
- FIG 3 shows an embodiment of an optical sensor inserted into a body in a conventional optical continuous blood glucose meter.
- FIG 4 shows an embodiment of detecting light emission from an optical sensor inserted into a body through an external reader.
- FIG. 5 shows a schematic diagram of a multi-needle device according to the present invention.
- FIG. 6 is a diagram illustrating an embodiment of a sensing unit that detects a target material in a body using an optical method in a multi-needle device according to the present invention.
- FIG. 7 is a diagram illustrating an embodiment of a sensing unit that detects a target material in a body using an electrochemical method in a multi-needle device according to the present invention.
- FIG 8 shows an embodiment of an injection unit for injecting a corresponding substance into the body in a multi-needle device according to the present invention.
- FIG 9 shows a relationship between a pump of an injection unit and a corresponding material injection capacity in a multi-needle device according to the present invention.
- FIG. 10 is a diagram illustrating a difference between a time point when a sensing unit detects a specific substance and a time point at which the injection unit injects a corresponding substance according to the present invention.
- 11 and 12 show another embodiment of a multi-needle device according to the present invention.
- a biosensor can be defined as a biological material capable of detecting the presence of a substance or energy, but recently biosensors are used in a broader meaning and are often difficult to distinguish from actual chemical sensors. Accordingly, the present invention is not limited to the biosensor and is not described, and it is a matter of course that it may be broadly referred to as a chemical sensor.
- a chemical sensor can be defined as a device that can notify the existence of energy or a substance using one of the human senses, and fluorescence, color change, and electrochemical analysis methods are used to detect the substance or energy to be analyzed. I can.
- the optical measurement method is a method of confirming the presence of a specific substance by measuring the amount of light generated when a fluorescent sensor combined with a specific substance is stimulated by light irradiated from a light source.
- the optical measurement method has advantages such as excellent sensitivity to observe a signal even at a concentration of 10 ⁇ -9M, and a relatively simple measurement method.
- the conventional optical measurement method has a disadvantage of inserting and removing a fluorescent sensor part through an incision procedure, and there is a problem of a short use period due to a battery limitation.
- a fluorescence sensor is inserted into the body using a microneedle, omitting an incision procedure, and a portion into which the battery is inserted is exposed to the outside of the body, thereby solving the limitation of the use period.
- FIG. 5 shows a schematic diagram of a multi-needle device according to the present invention.
- the present invention relates to a multi-needle device that continuously senses a target substance present in a body using a microneedle and injects a corresponding substance in response thereto.
- the target substance sensed by the present invention may be glucose, and the corresponding substance injected in response thereto may be glucagon. That is, the present invention may be a device for controlling the amount of blood sugar in the body.
- the target substance sensed by the present invention is not limited to glucose, and the corresponding substance injected in response thereto is also not limited to glucagon.
- the microneedles provided in the present invention may be microneedles including an inner flow path connected to the tip of the hollow microneedles.
- the microneedles provided in the present invention may be manufactured by injection molding a polypropylene (PP) resin.
- PP polypropylene
- As a mold for manufacturing microneedles a silicon matter-type electroforming mold by MEMS process and ultra-precision cutting may be used.
- a hollow microneedle having a length of 1.2mm and a hole diameter of 0.06mm can be used.
- the device of the present invention can vary the length and hole diameter of the microneedles within a range that minimizes user pain.
- the present invention may provide a sensor unit 310 provided in the hydrophilic first hollow microneedle 210 and the first hollow microneedle 210 to detect a target material in the body.
- the first hollow microneedle 210 may include a first internal flow path 211.
- the body target material 410 flows in along the first internal flow path 211, and may be sensed through the sensor unit 310.
- An embodiment of detecting the target material 410 through the sensor unit 310 will be described in detail with reference to FIGS. 6 and 7.
- the first hollow microneedle 210 of the present invention may be made of a hydrophilic material, and in some cases, the surface of the first internal flow path 211 may be hydrophilic. According to the present invention, the first hollow microneedle 210 is hydrophilic, so that the target material 410 in the body can be easily introduced into the first internal flow path 211. In this case, the target material in the body may be a hydrophilic material. The present invention can expect the effect of sufficiently extracting the target material through capillary phenomenon without a separate suction pump.
- the present invention may include an injection unit 320 for injecting a corresponding material 420 in the body through the hydrophobic second hollow microneedle 220 and the second hollow microneedle 220.
- the second hollow microneedle 220 may include a second internal flow path 221.
- the corresponding material 420 provided in the injection unit 320 may be injected into the body along the second internal flow path 221.
- An embodiment of injecting the corresponding material 420 through the injection unit 320 will be described in detail with reference to FIGS. 8 and 9.
- the second hollow microneedle 220 of the present invention may be made of a hydrophobic material, and in some cases, the surface of the second inner flow path 221 may be subjected to hydrophobic treatment.
- the present invention can prevent the interstitial fluid from flowing into the body along the second internal flow path 221 by hydrophobic treatment of the second hollow microneedle 220.
- the second inner flow path 221 has a hydrophilic surface, once the hydrophilic counterpart material 420 is discharged, control may be difficult due to a capillary phenomenon.
- the second internal flow path 221 is manufactured to have a hydrophobic surface, so that the injection amount of the corresponding material 420 can be easily controlled.
- the second internal flow path 221 has a hydrophobic property, injection of the corresponding material 420 can be controlled without a separate valve device.
- the target material 410 may be a hydrophilic material.
- the present invention can expect the effect of sufficiently extracting the target material through capillary phenomenon without a separate suction pump.
- FIG. 6 is a diagram illustrating an embodiment of a sensing unit that detects a target material in a body using an optical method in a multi-needle device according to the present invention.
- FIG. 6 shows the first hollow microneedle 210 and the sensing unit 310 separated from the multi-needle device of the present invention.
- the first hollow microneedle 210 of the present invention may include a fluorescence sensor 311 that reacts fluorescence by being combined with a target material 410 (refer to FIG. 5) in the first internal flow path 211.
- the present invention can detect the presence or quantity of the target material 410 by detecting the fluorescence reaction of the fluorescence sensor 311.
- the fluorescence sensor 311 and the fluorescence sensor 311 reacting fluorescence by combining with the target material 410 It may include a sensing unit 213 for detecting the fluorescence reaction of.
- Fluorescence reaction is a phenomenon that occurs when a substance is stimulated by light, and is different from reflection.
- the sensor unit 310 of the present invention includes a light source 312 that irradiates light toward the fluorescent sensor 311, and the sensing unit 213 receives light of a wavelength different from the light emitted from the light source 312. Thus, the fluorescence reaction can be detected.
- the detection unit 213 of the present invention may detect the presence and quantity of the target material 410 through the degree of fluorescence reaction of the fluorescence sensor 311.
- the first internal flow path 211 of the present invention is hydrophilic, so that the target material 420 flows in without a separate suction pump, and the fluorescent sensor 311 can react with fluorescence.
- the sensing unit 213 of the present invention may include a communication unit that communicates with an external device and an injection unit 320 (see FIG. 5 ). Specifically, the sensing unit 213 communicates with an external device through a wireless communication method, and the injection unit 320 may provide information on the target material 410 detected through a wired communication method.
- FIG. 7 is a diagram illustrating an embodiment of a sensing unit that detects a target material in a body using an electrochemical method in a multi-needle device according to the present invention.
- FIG. 7 shows the first hollow microneedle 210 and the sensing unit 310 separated from the multi-needle device of the present invention.
- the first hollow microneedle 210 of the present invention may include an electrode-type enzyme 311 that binds to the target material 410 (see FIG. 5) in the first internal flow path 211 and performs an electrochemical reaction.
- the detection unit 313 of the present invention may detect the presence or quantity of the target material 410 by detecting a current generated by the electrode-type enzyme 311 chemically reacting with the target material 410.
- a current generated by a chemical reaction between the electrode-type enzyme 311 and the target material 410 may be guided to the sensing unit 313 along the conductive wire 312 of a metal material.
- the present invention includes a metal conductor 312 and an electrode type enzyme 311 in the first internal flow path 311 of the second hollow microneedle 210, so that the metal conductor 312 is exposed in the body. It is prevented from becoming, and the electrode-type enzyme 311 can be easily fixed.
- the first internal flow path 211 of the present invention is hydrophilic, so that the target material 420 is introduced without a separate suction pump, and electrochemical reaction with the electrode-type enzyme 311 is possible.
- the sensing unit 213 of the present invention may include a communication unit that communicates with an external device and an injection unit 320 (refer to FIG. 5 ). Specifically, the sensing unit 213 communicates with an external device through a wireless communication method, and the injection unit 320 may provide information on the target material 410 detected through a wired communication method.
- FIG 8 shows an embodiment of an injection unit for injecting a corresponding substance into the body in a multi-needle device according to the present invention.
- FIG. 8 shows the second hollow microneedle 220 and the injection part 320 separated from the multi-needle device of the present invention.
- the injection unit 320 of the present invention may adjust the injection amount of the corresponding substance 420 (refer to Fig. 5) in response to the concentration of the specific substance 410 (refer to Fig. 5) sensed by the sensor unit 310 (refer to Fig. 5). .
- the injection unit 320 of the present invention may obtain concentration information of the corresponding substance 420 in the body through the sensor unit 310 and inject the corresponding substance 420 into the body in response to the obtained concentration information.
- the injection unit 320 may adjust the injection amount of the corresponding substance 420 continuously injected into the body in response to the concentration of the specific substance 410 measured in real time.
- the injection unit 320 of the present invention controls the pressure of the receiving unit 321 and the receiving unit 331 including the corresponding material 420 to transfer the corresponding material 420 through the second hollow microneedle 220 frame. It may include an infusion pump 322 for injecting into the body.
- the injection unit 320 of the present invention may include an outlet unit capable of indicating the amount of the corresponding material 420 in the receiving unit 321.
- the user may charge the corresponding material 420 included in the receiving unit 321 when insufficient.
- the injection pump 322 of the present invention may include a piezoelectric element that adjusts the internal pressure of the receiving portion 321.
- the injection unit 320 of the present invention may control an internal pressure or an internal volume of the receiving unit 312 by adjusting a voltage applied to the piezoelectric element.
- FIG 9 shows a relationship between a pump of an injection unit and a corresponding material injection capacity in a multi-needle device according to the present invention.
- the injection part 320 of the present invention can adjust the internal pressure of the receiving part 321 (see FIG. 8) in consideration of the second inner flow path diameter 221 (see FIG. 5) of the second microneedle 220 (see FIG. 5). There is a need.
- the diameter of the second inner flow path 221 is small, it is necessary to inject the corresponding material 420 (see FIG. 5) with a small pressure.
- FIG. 9 shows the diameter R of the second inner flow path 221 and the pressure P for injecting the corresponding material 420 in correspondence with each other.
- the injection unit 320 of the present invention injects the corresponding material 420 through a flow path of a fine size, it may be difficult to inject the corresponding material 420 as much as the filling capacity at a time. Accordingly, the injection unit 320 of the present invention The injection amount of the corresponding substance 420 may be adjusted through the injection time.
- the injection unit 320 of the present invention may increase the injection time of the corresponding material 420 to inject the corresponding material 420 at a corresponding injection amount.
- FIG. 10 is a diagram illustrating a difference between a time point when a sensing unit detects a specific substance and a time point at which the injection unit injects a corresponding substance according to the present invention.
- the multi-needle device of the present invention is a device capable of performing detection of a target material 410 (see FIG. 5) and injection of a corresponding material 420 (see FIG. 5) together, and the first hollow microneedle 210 , See FIG. 5) and the second hollow microneedle 220 (see FIG. 5) may be provided adjacent to each other.
- the sensor unit 310 of the present invention injects the corresponding substance 420 into the body through the injection unit 320 (see FIG. 5), and the target substance 410 is Concentration can be detected.
- 11 and 12 show another embodiment of a multi-needle device according to the present invention.
- the multi-needle device may have a length h1 of the first microneedle 210 and a length h2 of the second microneedle 220 differently.
- the length h2 of the second microneedle 220 is longer than the length h1 of the first microneedle 210, the corresponding material 420 injected into the body is reabsorbed into the first microneedle 210. Can be prevented and more easily absorbed in the body.
- the length of the microneedles required to inject the corresponding material 420 and the length of the microneedles required to detect the target material 410 may be different. Accordingly, the present invention minimizes the lengths of the first hollow micro-needle 210 and the second hollow micro-needle 220 as required, thereby minimizing the pain a user feels when using the multi-needle device of the present invention. .
- the multi-needle device may detect the concentration of the target material 410 in the body through the plurality of first hollow microneedles 210.
- an error range may be large. Accordingly, the present invention can reduce an error range by detecting the concentration of the target material 410 in the body through the plurality of first hollow microneedles 210.
- the multi-needle device may inject the corresponding material 420 into the body through the plurality of second hollow microneedles 220. When the corresponding material 420 is injected through the single second hollow microneedle 220, an effect of rapidly coping with the change in the concentration of the target material 410 in the body can be expected.
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Abstract
La présente invention concerne un dispositif à aiguilles multiples comprenant : une première micro-aiguille creuse hydrophile; une unité capteur disposée dans la première micro-aiguille creuse de façon à détecter une substance cible dans le corps; une seconde micro-aiguille creuse hydrophobe; et une unité d'injection destinée à injecter une substance correspondante dans le corps par le biais de la seconde micro-aiguille creuse.
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PCT/KR2019/007552 WO2020256197A1 (fr) | 2019-06-21 | 2019-06-21 | Dispositif à aiguilles multiples |
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PCT/KR2019/007552 WO2020256197A1 (fr) | 2019-06-21 | 2019-06-21 | Dispositif à aiguilles multiples |
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Citations (5)
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US20090118672A1 (en) * | 2002-10-07 | 2009-05-07 | Gonnelli Robert R | Microneedle array patch |
KR20120041270A (ko) * | 2003-09-11 | 2012-04-30 | 테라노스, 인코포레이티드 | 피분석물의 모니터링 및 약물 전달을 위한 의료 기기 |
KR20120052729A (ko) * | 2010-11-16 | 2012-05-24 | 광운대학교 산학협력단 | 전극의 임피던스에 따라 약물의 주입량을 확인할 수 있는 약물주입장치 |
KR20140008134A (ko) * | 2012-07-10 | 2014-01-21 | 고려대학교 산학협력단 | 연속 혈당 측정용 니들 타입 바이오센서 |
KR20140078644A (ko) * | 2011-09-02 | 2014-06-25 | 더 리젠츠 오브 더 유니버시티 오브 캘리포니아 | 바이오센싱 및 약물 전달을 위한 마이크로니들 어레이 |
-
2019
- 2019-06-21 WO PCT/KR2019/007552 patent/WO2020256197A1/fr active Application Filing
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US20090118672A1 (en) * | 2002-10-07 | 2009-05-07 | Gonnelli Robert R | Microneedle array patch |
KR20120041270A (ko) * | 2003-09-11 | 2012-04-30 | 테라노스, 인코포레이티드 | 피분석물의 모니터링 및 약물 전달을 위한 의료 기기 |
KR20120052729A (ko) * | 2010-11-16 | 2012-05-24 | 광운대학교 산학협력단 | 전극의 임피던스에 따라 약물의 주입량을 확인할 수 있는 약물주입장치 |
KR20140078644A (ko) * | 2011-09-02 | 2014-06-25 | 더 리젠츠 오브 더 유니버시티 오브 캘리포니아 | 바이오센싱 및 약물 전달을 위한 마이크로니들 어레이 |
KR20140008134A (ko) * | 2012-07-10 | 2014-01-21 | 고려대학교 산학협력단 | 연속 혈당 측정용 니들 타입 바이오센서 |
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