WO2013047216A1 - Capteur - Google Patents

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Publication number
WO2013047216A1
WO2013047216A1 PCT/JP2012/073406 JP2012073406W WO2013047216A1 WO 2013047216 A1 WO2013047216 A1 WO 2013047216A1 JP 2012073406 W JP2012073406 W JP 2012073406W WO 2013047216 A1 WO2013047216 A1 WO 2013047216A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
living body
hardness
main body
living
Prior art date
Application number
PCT/JP2012/073406
Other languages
English (en)
Japanese (ja)
Inventor
松本淳
陳嵩
時本貴平
Original Assignee
テルモ株式会社
オリンパス株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社, オリンパス株式会社 filed Critical テルモ株式会社
Publication of WO2013047216A1 publication Critical patent/WO2013047216A1/fr

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Classifications

    • 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
    • A61B5/1455—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 optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459—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 optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6848—Needles

Definitions

  • the present invention relates to a sensor that is embedded in a living body and detects the concentration of an analyte component.
  • a sensor is placed or embedded in the living body of a subject (user), and an analyte in the blood or body fluid of the subject, for example, a blood glucose level in blood is detected.
  • this sensor is loaded into an insertion device having an insertion needle for puncturing the skin, and the insertion needle loaded with the sensor is punctured to a subject.
  • the sensor moves out of the living body together with the insertion needle in conjunction with the operation of pulling the insertion needle out of the living body. Bending may cause an error.
  • the sensor must be reinserted into the insertion device and inserted into the living body, or another new sensor must be used, which is complicated and increases the burden on the subject. Will end up.
  • an inflammatory reaction of tissue in the living body may occur, and an inflammatory film may be formed around the sensor, and an analyte (for example, blood or body fluid component) is formed by the film. May be blocked. As a result, the analyte concentration cannot be measured with high accuracy by the sensor.
  • analyte for example, blood or body fluid component
  • a general object of the present invention is to provide a sensor that can measure the concentration of an analyte component with higher accuracy, and can be prevented from being taken out or bent out of the living body when the insertion needle is removed. Is on purpose.
  • the present invention is a sensor that is inserted into a living body and detects an analyte component in the living body, A sensor body; A detector that is housed in the sensor body and detects the analyte component; With The sensor body is made of a biocompatible material that wets when in contact with the fluid in the living body, and is inserted into the living body with a first hardness in a state before the sensor body is inserted into the living body, A second hardness wetted in a living body, wherein the first hardness is higher than the second hardness.
  • the sensor main body constituting the sensor is formed with a first hardness from, for example, a biocompatible material that wets when in contact with a fluid in a living body, so that only the sensor can be produced without using an insertion needle.
  • the sensor body can gradually soften and soften to the second hardness by inhaling a fluid such as moisture as time passes. Therefore, it is not necessary to leave the sensor in the living body using the insertion needle and take out only the insertion needle out of the living body.
  • the sensor body can suitably diffuse and permeate the analyte component to the inside and is formed of a biocompatible material that gets wet when in contact with the fluid in the living body, The component can be detected with high accuracy.
  • FIG. 1 is an external perspective view of a sensor according to a first embodiment of the present invention. It is sectional drawing of the sensor of FIG. 3A shows a state before the sensor of FIG. 2 is inserted into the living body, FIG. 3B shows a state where the sensor is inserted into the living body, and FIG. 3C shows that a part of the sensor of FIG. 3B is softened. It is explanatory drawing which shows the state which carried out.
  • FIG. 6 is a partially omitted cross-sectional view of a sensor according to a second embodiment of the present invention. 5A shows a state before the sensor of FIG. 4 is inserted into the living body, FIG. 5B shows a state where the sensor is inserted into the living body, and FIG. 5C shows a part of the sensor of FIG. 5B softened. It is explanatory drawing which shows the state which carried out.
  • reference numeral 10 indicates a sensor according to the first embodiment of the present invention.
  • the sensor 10 includes a cylindrical sensor main body 12, a base substrate 14 provided in the sensor main body 12, and a frame shape provided on the base substrate 14. Sealing body 20 and a photoelectric conversion element 22 provided on the base substrate 14.
  • the sensor 10 includes a filter 16 provided on the upper surface of the photoelectric conversion element 22, a light emitting element 18 attached to the base substrate 14 via the filter 16, and the base substrate 14 inside the sensor body 12. And a transparent resin layer 30 filled in a space formed by the sealing body 20 and an indicator layer 24 provided on the upper surface of the transparent resin layer 30.
  • the left side of the sensor body 12 that is, the insertion direction (direction of arrow A) when the sensor 10 is inserted into the living body S (see FIGS. 3A to 3C) is the “tip” side.
  • the right side (arrow B direction) of the sensor body 12 is referred to as the “base end” side, and the same applies to the other drawings.
  • the sensor body 12 has a sharp shape so that the tip along the axial direction (arrow A, B direction) can puncture a living body, and gradually tapers along the axial direction (arrow A direction). Formed to be.
  • the analyte measured by the sensor 10 can be variously selected. For example, in addition to components such as glucose, uric acid, cholesterol, protein, and mineral contained in body fluids such as blood, pH, microorganisms, enzymes, and other fluorescent dyes can be selected. It can respond to various uses by selection.
  • the sensor body 12 is made of a biocompatible material that gets wet when in contact with a fluid (for example, moisture) in a living body.
  • biocompatible materials that wet when in contact with a fluid in a living body include polyacrylamide, polyvinyl alcohol (PVA), 2-hydroxyethyl methacrylate (HEMA), and a copolymer of acrylamide and acrylic acid.
  • a material having high biocompatibility including the hydrogel is used and is formed from the above-described material with a hardness having a first strength.
  • the surface of the sensor main body 12 may be formed of gelatin instead of the polyacrylamide described above.
  • the first hardness is, for example, a hardness obtained when the above-described biocompatible material is dried, and may have a hardness that can puncture a living body, for example, several GPa.
  • the second hardness has a soft state in which the sensor body 12 is softened, and is a hardness equal to or lower than the first hardness, for example, about several kPa to 1000 kPa.
  • the senor main body 12 is used for biocompatible materials that wet when in contact with a fluid in a living body serving as a base, for example, hydrogel, for example, inflammation inhibitors such as steroids and acetylsalicylic acid, heparin, dextran sulfate, anti An antithrombotic agent having thrombin inhibitory action such as thrombin III is contained.
  • a fluid in a living body serving as a base for example, hydrogel, for example, inflammation inhibitors such as steroids and acetylsalicylic acid, heparin, dextran sulfate, anti An antithrombotic agent having thrombin inhibitory action such as thrombin III is contained.
  • the base substrate 14 for example, various materials such as metal, semiconductor, glass, ceramic, silicon, and resin material can be used.
  • a light-shielding material when used as the sensor, it is preferable to use a light-shielding material because light shielding from the outside is necessary.
  • a configuration in which a light-shielding film is attached may be used.
  • the photoelectric conversion element etc. which are mentioned later can be produced directly.
  • the base substrate 14 is provided with a photoelectric conversion element (detection unit) 22 capable of converting an optical signal such as fluorescence into an electric signal on the surface thereof.
  • a photoelectric conversion element 22 include a photodiode element and a phototransistor element, and an element having a sensitivity characteristic optimum for a specific fluorescence wavelength can be selected and used.
  • a filter 16 is provided on the surfaces of the base substrate 14 and the photoelectric conversion element 22 so as to cover the photoelectric conversion element 22.
  • the filter 16 for example, a multi-interference filter composed of a single layer of silicon, silicon carbide, a silicon oxide layer, a silicon nitride layer, or a multilayer layer, or a light absorption filter can be used. It is possible to use a film formation technique of a known semiconductor process such as, for example, and it is also possible to use an adhesive.
  • the filter 16 prevents light emitted from a light emitting element 18 described later from directly entering the photoelectric conversion element 22, and only fluorescent light having a target wavelength is transmitted to the base substrate 14 side.
  • the light emitting element 18 emits excitation light
  • the indicator layer 24 emits fluorescence corresponding to the amount of analyte in blood and body fluid components by the excitation light emitted by the light emitting element 18.
  • a light emitting element that emits excitation light having a desired wavelength such as an LED element, an organic EL element, an inorganic EL element, or a laser diode element, can be selected.
  • the light emitting element 18 is made by selecting a material that transmits the fluorescence emitted by the indicator layer 24. Furthermore, it is preferable to use an LED element as the light-emitting element 18 from the characteristics such as transmittance, light generation efficiency, degree of freedom in wavelength selection of excitation light, and emission of light other than a wavelength having an excitation action. More preferably, the LED element is particularly preferably an ultraviolet LED element made of a gallium nitride compound semiconductor formed on a sapphire substrate having a high transmittance with respect to fluorescence having a visible light wavelength.
  • the sealing body 20 is formed in a frame shape on the upper side of the base substrate 14, and forms a box-shaped storage portion 21 whose one surface is opened with the base substrate 14.
  • the same material as that of the base substrate 14 can be used as the sealing body 20.
  • a transparent resin layer 30 is provided in a storage portion 21 formed by the base substrate 14 and the sealing body 20, and the transparent resin layer 30 can transmit both excitation light and fluorescence, and does not easily emit autofluorescence at the excitation wavelength.
  • the material is preferable, and examples thereof include quartz, glass, fluorine, and silicone resin materials.
  • the transparent resin layer 30 may have an optical function such as a lens or a prism. When it has the function of condensing excitation light, the amount of fluorescence emitted by the indicator layer 24 can be increased.
  • the transparent resin layer 30 is formed by a known adhesion technique such as adhesion, pressure bonding, or coating.
  • the indicator layer 24 is made of a material containing a fluorescent dye that emits fluorescence according to the analyte concentration and emits fluorescence according to the analyte concentration, and the base material is excited light from the light emitting element 18.
  • the fluorescent dye may be the analyte itself.
  • Examples of the base material that can be used for the indicator layer 24 include an acrylic hydrogel prepared by polymerizing a polysaccharide such as methyl cellulose or dextran, a monomer such as acrylamide, methylol acrylamide, or hydroxyethyl acrylate, or polyethylene glycol and diisocyanate. Urethane hydrogel prepared from the above can be used.
  • the base material may be formed by encapsulating a fluorescent dye in a hydrogel that easily contains water.
  • the fluorescent dye in the indicator layer 24 can be selected according to the type of analyte, and may be any fluorescent dye that reversibly changes the amount of fluorescence emitted according to the amount of analyte.
  • phenylboronic acid derivatives are suitable for measuring saccharides such as glucose.
  • the present invention can be applied to various uses such as an enzyme sensor, a pH sensor, and an immunosensor.
  • the indicator layer 24 is provided on the transparent resin layer 30, and is bonded and fixed via an adhesive layer made of a silane coupling agent or the like, or the indicator layer 24 is formed on the transparent resin layer 30 in a container shape. You may provide so that all or one part of 24 may be fixed.
  • a cover layer (not shown) is provided on the surface of the indicator layer 24 on the living body side. Although the analyte passes through the cover layer, the cover layer shields light (disturbance light) from the outside of the sensor 10.
  • a porous cellulose film having a thickness of several tens of micrometers and carbon black or the like can be used.
  • the sensor 10 according to the first embodiment of the present invention is basically configured as described above. Next, the operation, action, and effect will be described.
  • the subject grips the sensor 10 and makes the front end face the subject side (arrow B direction), and then punctures the subject's skin to attach the sensor 10. It inserts in the living body S up to the position to be placed. At this time, since the sensor body 12 has the first hardness that is strong enough to puncture a living body, it can puncture the living body.
  • the sensor main body 12 of the sensor 10 when the sensor 10 is inserted to a desired position in the living body, the sensor main body 12 of the sensor 10 is covered with the tissue in the living body. Then, as shown in FIG. 3C, the sensor main body 12 inhales moisture and the like of the tissue and gradually softens to have a second hardness as time passes.
  • the inflammation inhibitor contained in the sensor body 12 is diffused into the living body S, and accordingly, intense inflammation of the sensor body 12 with the tissue in the living body can be suppressed, and the diffusion of the analyte component is prevented. Thick film formation is avoided.
  • the light emitting element 18 emits light by energization from a power source (not shown), and the emitted light enters the indicator layer 24, whereby the indicator layer 24 emits fluorescence corresponding to the glucose concentration (analide component concentration).
  • the fluorescence from the indicator layer 24 is received by the photoelectric conversion element 22 after passing through the light emitting element 18 and the filter 16. Then, the photoelectric conversion element 22 converts the electric signal.
  • the converted electrical signal is transmitted to a receiver (not shown) outside the living body (not shown) and the glucose concentration is measured.
  • a biocompatible material for example, hydrogel
  • the sensor main body 12 can inhale moisture and the like and soften to the second hardness as time passes (in FIG. 3C, Solid line shape). Therefore, when the sensor 10 is placed in the living body S, it is not necessary to take out only the insertion needle outside the living body after inserting the sensor using the insertion needle. As a result, it is possible to reliably prevent the occurrence of errors due to withdrawal or bending after the insertion, which has been a concern in the case of a sensor inserted into the living body S using a conventional insertion needle. .
  • the insertion needle is not required, and the sensor 10 is taken out when the insertion needle is pulled out of the living body S. There will be no inconvenience.
  • the sensor 10 by adding an inflammation inhibitor to the base hydrogel, the sensor 10 is inserted into the living body S, and then the inflammation inhibitor is placed around the sensor body 12 in the living body. Since it diffuses into S, it is possible to avoid excessive inflammation between the tissue in the living body S and the sensor body 12 and the formation of a thick film that prevents the dispersion of the analyte component. In other words, the conventional sensor has a problem in that a large measurement delay is caused by the inflammatory film formed around the sensor.
  • the sensor 10 is connected to the living body S. After insertion, the coating film with good permeability can be formed quickly, and the delay in measurement can be kept to a minimum.
  • glucose can be suitably permeated through the sensor body 12 made of hydrogel, and the glucose concentration can be detected quickly and with high accuracy.
  • the same referential mark is attached
  • the sensor main body 52 is formed of a biocompatible material, and the base end side thereof is electrically connected to an electric device unit (not shown).
  • An insertion hole 56 through which the lead wire 54 connected to is extended.
  • the insertion hole 56 communicates with the storage portion 21 surrounded by the sealing body 20, and the lead wire 54 is connected to the photoelectric conversion element 22 provided in the storage portion 21.
  • the subject grasps the sensor 50 and punctures the subject's skin from the tip. Is inserted into the living body S to the position where it should be placed (see FIG. 5B). At this time, the sensor main body 52 has the first hardness having such a strength that the living body S can be punctured.
  • the sensor 50 covered with the tissue in the living body S gradually inhales moisture or the like of the tissue and softens as the predetermined time elapses. It will be in the state which has.
  • the inflammation inhibitor is diffused into the living body S, and as a result, intense inflammation with the tissue in the living body S of the sensor body 52 occurs. A thick film that prevents the diffusion of the analyte component can be avoided.
  • the sensor main body 52 constituting the sensor 50 is formed of hydrogel, and the lead wire 54 inserted through the sensor main body 52 is also formed of a soft material. Therefore, after the sensor body 52 is softened and has the second hardness, it can be easily extracted out of the living body S.
  • the senor according to the present invention is not limited to the above-described embodiment, and it is needless to say that various configurations can be adopted without departing from the gist of the present invention.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Optics & Photonics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne un capteur devant être introduit dans le corps. L'intérieur d'un corps de capteur (12) constituant un capteur (10) reçoit un substrat de base (14), un filtre (16) et un élément émettant de la lumière (18), et le corps de capteur (12) est formé à une dureté prédéterminée par exemple à partir d'hydrogel. Le corps de capteur (12) contient un agent anti-inflammatoire tel que, par exemple, un médicament stéroïde ou de l'acide acétylsalicylique, sur l'hydrogel servant de base. Lorsque le capteur (10) est introduit dans le corps, le corps de capteur (12) commence à se ramollir au cours du temps et l'agent anti-inflammatoire diffuse autour du corps de capteur (12).
PCT/JP2012/073406 2011-09-30 2012-09-13 Capteur WO2013047216A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011215766A JP2014236758A (ja) 2011-09-30 2011-09-30 センサ
JP2011-215766 2011-09-30

Publications (1)

Publication Number Publication Date
WO2013047216A1 true WO2013047216A1 (fr) 2013-04-04

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ID=47995249

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Application Number Title Priority Date Filing Date
PCT/JP2012/073406 WO2013047216A1 (fr) 2011-09-30 2012-09-13 Capteur

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WO (1) WO2013047216A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016133841A1 (fr) * 2015-02-16 2016-08-25 Verily Life Sciences Llc Capteur électrochimique pour système de surveillance de glucose en continu de type bandage
KR102578444B1 (ko) * 2018-10-15 2023-09-14 엘지전자 주식회사 니들 타입 바이오 센서

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005514179A (ja) * 2002-01-15 2005-05-19 スリーエム イノベイティブ プロパティズ カンパニー マイクロニードル装置および製造方法
JP2006521886A (ja) * 2003-03-31 2006-09-28 ローズデイル メディカル インコーポレイテッド 体液サンプリング構造及び技術
JP2007504905A (ja) * 2003-09-11 2007-03-08 セラノス， インコーポレイテッド 検体の監視および薬物送達のための医療デバイス
WO2010013598A1 (fr) * 2008-08-01 2010-02-04 株式会社ライトニックス Détecteur à fine aiguille munie d’un canal
WO2010040271A1 (fr) * 2008-10-07 2010-04-15 Tuo Jin Micro-aiguilles polymères à transition de phase
JP2012205676A (ja) * 2011-03-29 2012-10-25 Terumo Corp センサ

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005514179A (ja) * 2002-01-15 2005-05-19 スリーエム イノベイティブ プロパティズ カンパニー マイクロニードル装置および製造方法
JP2006521886A (ja) * 2003-03-31 2006-09-28 ローズデイル メディカル インコーポレイテッド 体液サンプリング構造及び技術
JP2007504905A (ja) * 2003-09-11 2007-03-08 セラノス， インコーポレイテッド 検体の監視および薬物送達のための医療デバイス
WO2010013598A1 (fr) * 2008-08-01 2010-02-04 株式会社ライトニックス Détecteur à fine aiguille munie d’un canal
WO2010040271A1 (fr) * 2008-10-07 2010-04-15 Tuo Jin Micro-aiguilles polymères à transition de phase
JP2012205676A (ja) * 2011-03-29 2012-10-25 Terumo Corp センサ

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