EP3794135A1 - Membrane de limitation de glucose thermiquement stable pour capteurs de glucose - Google Patents

Membrane de limitation de glucose thermiquement stable pour capteurs de glucose

Info

Publication number
EP3794135A1
EP3794135A1 EP19728814.5A EP19728814A EP3794135A1 EP 3794135 A1 EP3794135 A1 EP 3794135A1 EP 19728814 A EP19728814 A EP 19728814A EP 3794135 A1 EP3794135 A1 EP 3794135A1
Authority
EP
European Patent Office
Prior art keywords
sensor
analyte
layer
reaction mixture
glucose
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP19728814.5A
Other languages
German (de)
English (en)
Inventor
Jenn-Hann Larry Wang
Dero Hovanes
Poonam S. Gulati
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Minimed Inc
Original Assignee
Medtronic Minimed Inc
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
Priority claimed from US15/981,681 external-priority patent/US11134872B2/en
Application filed by Medtronic Minimed Inc filed Critical Medtronic Minimed Inc
Publication of EP3794135A1 publication Critical patent/EP3794135A1/fr
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001—Enzyme electrodes
    • C12Q1/002—Electrode membranes
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G18/00—Polymeric products of isocyanates or isothiocyanates
    • C08G18/06—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen
    • C08G18/28—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen characterised by the compounds used containing active hydrogen
    • C08G18/40—High-molecular-weight compounds
    • C08G18/48—Polyethers
    • C08G18/50—Polyethers having heteroatoms other than oxygen
    • C08G18/5021—Polyethers having heteroatoms other than oxygen having nitrogen
    • C08G18/5024—Polyethers having heteroatoms other than oxygen having nitrogen containing primary and/or secondary amino groups
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G18/00—Polymeric products of isocyanates or isothiocyanates
    • C08G18/06—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen
    • C08G18/70—Polymeric products of isocyanates or isothiocyanates with compounds having active hydrogen characterised by the isocyanates or isothiocyanates used
    • C08G18/72—Polyisocyanates or polyisothiocyanates
    • C08G18/74—Polyisocyanates or polyisothiocyanates cyclic
    • C08G18/76—Polyisocyanates or polyisothiocyanates cyclic aromatic
    • C08G18/7657—Polyisocyanates or polyisothiocyanates cyclic aromatic containing two or more aromatic rings
    • C08G18/7664—Polyisocyanates or polyisothiocyanates cyclic aromatic containing two or more aromatic rings containing alkylene polyphenyl groups
    • C08G18/7671—Polyisocyanates or polyisothiocyanates cyclic aromatic containing two or more aromatic rings containing alkylene polyphenyl groups containing only one alkylene bisphenyl group

Definitions

  • FIGS. 4A-B show a comparison of morphology of various counter and working electrodes after testing, in accordance with one or more embodiments of the invention.
  • FIG. 10A shows bubbles (or craters) generated at the counter electrode after usage. Bubbles formation at the counter electrode may trigger delamination or unwanted biological responses (due to texture change or rough surface).
  • FIG. 10B shows that the MDI_polycarnobate_GLM can enhance the GLM adhesion, so that bubbles (or craters) are not generated at the counter electrode after usage;
  • FIGS. 7A-B provide graphs of data from thermal degradation studies for various formulations and the compositions of the formulations.
  • FIG. 7A provides the results from a thermal degradation study at 45°C comparing the degradation of polymeric materials (as observed by a decrease in molecular weight) useful as biocompatible membranes (e.g. analyte modulating layers in glucose sensors), while FIG. 7B provides the results from a similar thermal degradation study at 60°C.
  • FIGS. 7A provides the results from a thermal degradation study at 45°C comparing the degradation of polymeric materials (as observed by a decrease in molecular weight) useful as biocompatible membranes (e.g. analyte modulating layers in glucose sensors)
  • FIG. 7B provides the results from a similar thermal degradation study at 60°C.
  • polycarbonate polyol refers those polymers having hydroxyl functionality at the chain termini and ether and carbonate functionality within the polymer chain.
  • the alkyl portion of the polymer will typically be composed of C2 to C4 aliphatic radicals, or in some embodiments, longer chain aliphatic radicals, cycloaliphatic radicals or aromatic radicals.
  • hydrophilic diamines refers to any of the above hydrophilic diols in which the terminal hydroxyl groups have been replaced by reactive amine groups or in which the terminal hydroxyl groups have been derivatized to produce an extended chain having terminal amine groups.
  • reaction flask Upon mixing of the reactants, an exotherm is typically observed, with the temperature rising to about 90-120° C. After the initial exotherm, the reaction flask can be heated at from 75° C. to 125° C., with 90°. C. to 100 0 C. being an exemplary temperature range. Heating is usually carried out for one to two hours.
  • Solution polymerization can be carried out in a similar manner. Solvents which are suitable for solution polymerization include dimethylformamide, dimethyl sulfoxide, dimethylacetamide, halogenated solvents such as 1,2,3-trichloropropane, and ketones such as 4-methyl-2-pentanone. Typically, THF is used as the solvent. When polymerization is carried out in a solvent, heating of the reaction mixture is typically carried out for three to four hours.
  • the embodiment shown in FIG. 1 includes a base layer 102 to support the sensor 100.
  • the base layer 102 can be made of a material such as a metal and/or a ceramic and/ or a polymeric substrate, which may be self-supporting or further supported by another material as is known in the art.
  • Embodiments of the invention include a conductive layer 104 which is disposed on and/or combined with the base layer 102.
  • the conductive layer 104 comprises one or more electrodes.
  • An operating sensor 100 typically includes a plurality of electrodes such as a working electrode, a counter electrode and a reference electrode. Other embodiments may also include a plurality of working and/or counter and/or reference electrodes and/or one or more electrodes that performs multiple functions, for example one that functions as both as a reference and a counter electrode.
  • Sensors of the invention typically include a base constituent (see, e.g. element 102 in FIG. 1).
  • the term“base constituent” is used herein according to art accepted terminology and refers to the constituent in the apparatus that typically provides a supporting matrix for the plurality of constituents that are stacked on top of one another and comprise the functioning sensor.
  • the base constituent comprises a thin film sheet of insulative (e.g. electrically insulative and/ or water impermeable) material.
  • This base constituent can be made of a wide variety of materials having desirable qualities such as dielectric properties, water impermeability and hermeticity. Some materials include metallic, and/ or ceramic and/ or polymeric substrates or the like.
  • the electrochemical sensors of the invention can include one or more adhesion promoting (AP) constituents (see, e.g. element 114 in FIG. 1).
  • AP adhesion promoting
  • the term“adhesion promoting constituent” is used herein according to art accepted terminology and refers to a constituent that includes materials selected for their ability to promote adhesion between adjoining constituents in the sensor.
  • the adhesion promoting constituent is disposed between the analyte sensing constituent and the analyte modulating constituent.
  • the adhesion promoting constituent is disposed between the optional protein constituent and the analyte modulating constituent.
  • embodiments of the invention disclosed herein have a wider range of geometrical configurations (e.g. planar) than existing sensors in the art.
  • certain embodiments of the invention include one or more of the sensors disclosed herein coupled to another apparatus such as a medication infusion pump.
  • the analyte sensors of the invention can be coupled with other medical devices such as medication infusion pumps.
  • replaceable analyte sensors of the invention can be coupled with other medical devices such as medication infusion pumps, for example by the use of a port couple to the medical device (e.g. a subcutaneous port with a locking electrical connection).

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Des modes de réalisation de l'invention concernent des compositions utiles dans des capteurs d'analytes ainsi que des procédés de fabrication et d'utilisation de ces compositions et capteurs. Selon des modes de réalisation typiques de l'invention, le capteur est un capteur de glucose comportant une membrane de modulation d'analytes formée à partir d'un mélange réactionnel de polymère formé pour inclure des quantités de limitation de composés de catalyseurs et/ou de polycarbonate pour procurer à de telles membranes des propriétés matérielles améliorées telles qu'une stabilité thermique et hydrolytique améliorée.
EP19728814.5A 2018-05-16 2019-05-16 Membrane de limitation de glucose thermiquement stable pour capteurs de glucose Pending EP3794135A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15/981,681 US11134872B2 (en) 2016-06-06 2018-05-16 Thermally stable glucose limiting membrane for glucose sensors
PCT/US2019/032660 WO2019222499A1 (fr) 2018-05-16 2019-05-16 Membrane de limitation de glucose thermiquement stable pour capteurs de glucose

Publications (1)

Publication Number Publication Date
EP3794135A1 true EP3794135A1 (fr) 2021-03-24

Family

ID=66770579

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19728814.5A Pending EP3794135A1 (fr) 2018-05-16 2019-05-16 Membrane de limitation de glucose thermiquement stable pour capteurs de glucose

Country Status (4)

Country Link
EP (1) EP3794135A1 (fr)
CN (1) CN112088217A (fr)
CA (1) CA3100384A1 (fr)
WO (1) WO2019222499A1 (fr)

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CN113493558A (zh) * 2020-03-18 2021-10-12 微泰医疗器械(杭州)有限公司 植入式生物传感器用三嵌段共聚物及其应用和制备方法
AU2021306551A1 (en) * 2020-07-07 2022-12-08 F. Hoffmann-La Roche Ag Analyte sensor and its manufacturing
US11998330B2 (en) * 2021-01-29 2024-06-04 Medtronic Minimed, Inc. Interference rejection membranes useful with analyte sensors
CN113304683B (zh) * 2021-06-17 2022-12-13 江南大学 葡糖酰胺封端聚醚型表面活性剂、其制备方法及应用
CN115651525B (zh) * 2022-12-09 2023-03-21 乐普（北京）医疗器械股份有限公司 一种葡萄糖扩散限制性聚合物外膜及其制备方法和应用

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Also Published As

Publication number Publication date
CN112088217A (zh) 2020-12-15
WO2019222499A1 (fr) 2019-11-21
CA3100384A1 (fr) 2019-11-21

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