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

    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1495—Calibrating or testing of in-vivo probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14503—Measuring 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
    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532—Measuring 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
    • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring 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
    • A61B5/1459—Measuring 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • 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
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0242—Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • A61B2560/0247—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value
    • A61B2560/0252—Operational features adapted to measure environmental factors, e.g. temperature, pollution for compensation or correction of the measured physiological value using ambient temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0026—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the transmission medium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142—Devices 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) EP4275600A3 (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
US8233959B2 (en) 2003-08-22 2012-07-31 Dexcom, Inc. Systems and methods for processing analyte sensor data
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
US7946984B2 (en) * 2004-07-13 2011-05-24 Dexcom, Inc. Transcutaneous analyte sensor
EP2335585B1 (en) 2004-07-13 2016-09-07 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
US7783442B2 (en) 2007-10-31 2010-08-24 Medtronic Minimed, Inc. System and methods for calibrating physiological characteristic sensors
EP2558970A4 (en) * 2010-01-22 2013-11-06 Abbott Diabetes Care Inc METHOD, DEVICE AND SYSTEM FOR CARRYING OUT ANALYST SENSOR CALIBRATION
WO2013055962A1 (en) 2011-10-11 2013-04-18 Senseonics, Incorporated Electrodynamic field strength triggering system
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
US20140188402A1 (en) 2013-01-03 2014-07-03 Dexcom, Inc. Outlier detection for analyte sensors
WO2016191710A1 (en) * 2015-05-27 2016-12-01 Senseonics, Incorporated Wireless analyte monitoring
WO2017044654A1 (en) 2015-09-10 2017-03-16 Dexcom, Inc. Transcutaneous analyte sensors and monitors, calibration thereof, and associated methods

Also Published As

Publication number Publication date
EP3638114A1 (en) 2020-04-22
US20240041368A1 (en) 2024-02-08
EP3638114A4 (en) 2021-01-20
US11723565B2 (en) 2023-08-15
ES2963151T3 (es) 2024-03-25
EP3638114B1 (en) 2023-10-11
WO2018232339A1 (en) 2018-12-20
US12697053B2 (en) 2026-08-04
EP4275600A3 (en) 2024-03-20
US20180360356A1 (en) 2018-12-20
EP4275600A2 (en) 2023-11-15

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