PL3638114T3 - Sposób i system do dostarczania kryteriów akceptacji punktu kalibracji do kalibrowania czujnika analitu - Google Patents

Sposób i system do dostarczania kryteriów akceptacji punktu kalibracji do kalibrowania czujnika analitu

Info

Publication number
PL3638114T3
PL3638114T3 PL18818355.2T PL18818355T PL3638114T3 PL 3638114 T3 PL3638114 T3 PL 3638114T3 PL 18818355 T PL18818355 T PL 18818355T PL 3638114 T3 PL3638114 T3 PL 3638114T3
Authority
PL
Poland
Prior art keywords
calibrating
analyte sensor
calibration point
acceptance criteria
providing calibration
Prior art date
Application number
PL18818355.2T
Other languages
English (en)
Inventor
Xiaoxiao Chen
Andrew Dehennis
Srinivasan Rajaraman
Original Assignee
Senseonics, Incorporated
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 Senseonics, Incorporated filed Critical Senseonics, Incorporated
Publication of PL3638114T3 publication Critical patent/PL3638114T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031Implanted circuitry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14503Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/1459Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements 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
    • A61B5/6847Arrangements 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
    • A61B5/686Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/74Details of notification to user or communication with user or patient; User input means
    • A61B5/742Details of notification to user or communication with user or patient; User input means using visual displays
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0223Operational features of calibration, e.g. protocols for calibrating sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0242Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • A61B2560/0252Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value using ambient temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0026Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the transmission medium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142Devices intended for single use, i.e. disposable

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Optics & Photonics (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Emergency Medicine (AREA)
  • Diabetes (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Physiology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
PL18818355.2T 2017-06-16 2018-06-15 Sposób i system do dostarczania kryteriów akceptacji punktu kalibracji do kalibrowania czujnika analitu PL3638114T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762520852P 2017-06-16 2017-06-16
PCT/US2018/037901 WO2018232339A1 (en) 2017-06-16 2018-06-15 Methods and systems for providing calibration point acceptance criteria for calibrating an analyte sensor

Publications (1)

Publication Number Publication Date
PL3638114T3 true PL3638114T3 (pl) 2024-02-26

Family

ID=64656404

Family Applications (1)

Application Number Title Priority Date Filing Date
PL18818355.2T PL3638114T3 (pl) 2017-06-16 2018-06-15 Sposób i system do dostarczania kryteriów akceptacji punktu kalibracji do kalibrowania czujnika analitu

Country Status (5)

Country Link
US (2) US11723565B2 (pl)
EP (2) EP3638114B1 (pl)
ES (1) ES2963151T3 (pl)
PL (1) PL3638114T3 (pl)
WO (1) WO2018232339A1 (pl)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD940330S1 (en) * 2019-06-10 2022-01-04 Emfit Oy Body sensor
IL273038B (en) 2020-03-03 2022-02-01 Ben Zion Karmon bone graft

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7890295B2 (en) * 2000-02-23 2011-02-15 Medtronic Minimed, Inc. Real time self-adjusting calibration algorithm
US6895263B2 (en) 2000-02-23 2005-05-17 Medtronic Minimed, Inc. Real time self-adjusting calibration algorithm
US8160669B2 (en) 2003-08-01 2012-04-17 Dexcom, Inc. Transcutaneous analyte sensor
US7299082B2 (en) * 2003-10-31 2007-11-20 Abbott Diabetes Care, Inc. Method of calibrating an analyte-measurement device, and associated methods, devices and systems
US8989833B2 (en) 2004-07-13 2015-03-24 Dexcom, Inc. Transcutaneous analyte sensor
EP3718479B1 (en) 2004-07-13 2021-12-15 Dexcom, Inc. Transcutaneous analyte sensor
US8073548B2 (en) 2004-08-24 2011-12-06 Sensors For Medicine And Science, Inc. Wristband or other type of band having an adjustable antenna for use with a sensor reader
EP1991110B1 (en) 2006-03-09 2018-11-07 DexCom, Inc. Systems and methods for processing analyte sensor data
US7783442B2 (en) 2007-10-31 2010-08-24 Medtronic Minimed, Inc. System and methods for calibrating physiological characteristic sensors
US20110184268A1 (en) 2010-01-22 2011-07-28 Abbott Diabetes Care Inc. Method, Device and System for Providing Analyte Sensor Calibration
CN103988238B (zh) 2011-10-11 2017-05-10 传感技术股份有限公司 电动力场强触发系统
KR101669739B1 (ko) * 2011-11-14 2016-10-27 에프. 호프만-라 로슈 아게 샘플에서 적어도 하나의 분석물을 검출하기 위한 분석 장치
US9693714B2 (en) 2012-02-10 2017-07-04 Senseonics, Incorporated Digital ASIC sensor platform
US9414775B2 (en) 2012-03-29 2016-08-16 Senseonics, Incorporated Purification of glucose concentration signal in an implantable fluorescence based glucose sensor
US9211092B2 (en) 2013-01-03 2015-12-15 Dexcom, Inc. End of life detection for analyte sensors
US20160345830A1 (en) 2015-05-27 2016-12-01 Senseonics, Incorporated Wireless analyte monitoring
US10470660B2 (en) 2015-09-10 2019-11-12 Dexcom, Inc. Transcutaneous analyte sensors and monitors, calibration thereof, and associated methods

Also Published As

Publication number Publication date
US11723565B2 (en) 2023-08-15
EP4275600A3 (en) 2024-03-20
ES2963151T3 (es) 2024-03-25
WO2018232339A1 (en) 2018-12-20
US20240041368A1 (en) 2024-02-08
EP3638114A4 (en) 2021-01-20
EP3638114A1 (en) 2020-04-22
EP3638114B1 (en) 2023-10-11
EP4275600A2 (en) 2023-11-15
US20180360356A1 (en) 2018-12-20

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