Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
  • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
  • G01N27/28—Electrolytic cell components
  • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
  • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
  • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
  • G01N27/28—Electrolytic cell components
  • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
  • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
  • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
  • G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
• • 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
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
  • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
  • G01N27/28—Electrolytic cell components
  • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
  • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
  • G01N27/3275—Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
• • 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
• • 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
  • G01N33/483—Physical analysis of biological material
• • 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
  • G01N33/483—Physical analysis of biological material
  • G01N33/487—Physical analysis of biological material of liquid biological material
  • G01N33/48707—Physical analysis of biological material of liquid biological material by electrical means
• • 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
• • 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
  • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
  • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals

Definitions

• the present invention relates to a method of manufacturing strips for biomedical sensors and strips produced according to this method
• the invention is in the field of biomedical sensors with biological measurement strips for diagnostic tests near the customer called in English Point of Care Tests (POCT) and relates in particular to strips for measuring glucose levels for monitoring diabetics.
• POCT Point of Care Tests
• biosensor strip is the glucometer used by diabetics to measure the concentration of glucose in the blood.
• the sensitive element of this biosensor can in particular be an enzyme such as glucose oxidase, which converts glucose into gluconic acid which will modify electrical parameters at the level of the electrodes of a strip on which the biosensor is placed, these parameters being measured by an associated measuring device to which the strip is connected.
• measuring strips comprising a flexible insulating substrate on which conductive tracks comprising a succession of metal layers are made, for which the last layer is a layer of gold and / or palladium.
• Such strips in general of reduced size, comprise at one end of the tracks of the contact pads for the connection of the strip with contacts of a measuring device and at a second end of the tracks of the electrodes receiving a bioactive material by example based on an enzyme which produces a biosensor.
• Their manufacture comprises for example the deposition of a resin layer on a flexible insulating substrate, the deposition of a copper foil and then by means of a photosensitive resin technique and chemical etching the production of copper tracks on which will be deposited additional metallic layers by means of techniques such as vapor deposition (PVD), chemical deposition or electrolytic deposition.
• PVD vapor deposition
• electrolytic deposition vapor deposition
• the invention therefore relates to a method of manufacturing flexible circuits of biological measurement strips which aims in particular to reduce the amount of noble metal such as gold or palladium deposited on conductive tracks of the strip in locating this deposit on the connection areas of the conductive tracks.
• the process also allows the dimensions of the gold deposit to be adjusted in thickness, but also in length and width.
• the present invention provides a method of producing strips for biological measurement, from flexible circuits on a carrier strip, provided with a flexible insulating substrate provided on at least one of its faces with conductive tracks, pellets contact and electrodes, said method comprising an application on said face of masking means leaving the contact pads and / or the electrodes of the strip visible and a selective deposition of a layer of noble metal on said contact pads and / or electrodes through the masking means.
• the production of the carrier strip comprises a succession of steps comprising the deposition or the rolling of a first metal or metal alloy layer, for example a copper or copper alloy layer, on the carrier strip and production of the tracks, contact pads and electrodes by a photo-lithography or laser engraving (laser etching) process on said layer.
• the method comprises, before selective deposition, a deposition of a second metal or metal alloy layer, such as for example a layer of nickel with or without phosphorus, on the tracks, contact pads and electrodes.
• the method is a reel to reel process, producing a plurality of strips aligned next to each other on the carrier strip.
• the reel-to-reel process is advantageously carried out continuously on the carrier strip which is unwound from a first reel and which is then rewound on a second reel.
• the carrier strip is unwound again and the method comprises depositing a bioactive material on the electrodes of the measurement strips and one or more steps of rolling and cutting the measurement strips.
• the masking means for the selective deposition may in particular be chosen from a film, a masking belt, a tool such as a plastic tool forming a stencil or a foam masking tape.
• the thickness of the first metal or metal alloy layer can in particular be chosen between 10 pm and 20 pm.
• the deposit of the second metal or metal alloy layer may have a thickness of 1 ⁇ m to 10 ⁇ m and preferably 2 ⁇ m to 5 ⁇ m.
• the selective deposition of the noble metal layer can advantageously have a thickness of 10nm to 50nm.
• the strip is of a width of 35mm to 150mm.
• the invention further relates to a strip for biological measurement produced according to the method of the invention for which the material of the flexible insulating substrate is chosen from polyetherimide (PEI), polyethylene terephthalate (PET), polynaphthalate. ethylene (PEN), polyimide (PI), a glass epoxy composite and a suitable paper.
• PEI polyetherimide
• PET polyethylene terephthalate
• PEN polynaphthalate. ethylene
• PI polyimide
• glass epoxy composite a suitable paper.
• the strip is such that the tracks are copper tracks having a copper thickness between 10 pm and 20 pm,
• the tracks are provided with a nickel coating with a thickness between 2pm and 5pm,
• the contact pads and the electrodes are coated with noble metal with a deposit with a thickness of 10nm to 100nm.
• FIG. 1 shows an example of a strip applicable to the process of the present application
• FIG. 2 shows a schematic view of steps of an example of a process according to the present application
• FIG. 3 shows a schematic view of additional process steps.
• the present application relates to strips for biomedical sensors for carrying out biological measurements.
• Such strips comprise a flexible substrate, contact pads 102, here square in shape, intended to make an electrical connection with complementary contacts of a connection device of the measuring device receiving the strip, connected to electrodes 103, 104 by tracks 101.
• the electrodes receive an active product such as an enzyme which during a reaction with a bodily fluid comprising a given marker, for example glucose in the case of a strip for monitoring a diabetic person, will modify a electrical characteristic of the strip.
• the strips are made from a carrier strip 1 provided with lateral drive perforations 120, which forms the flexible insulating substrate of the strips, on which are arranged the tracks, pads and electrodes by means of a method advantageously reel to reel (roll to roll in English).
• the material of the carrier strip which will form the flexible insulating substrate of the strips can be a polyetherimide (PEI) a polyethylene terephthalate (PET), an ethylene polynaphthalate (PEN), a polyimide (PI), a glass composite epoxy or a suitable paper.
• PEI polyetherimide
• PET polyethylene terephthalate
• PEN ethylene polynaphthalate
• PI polyimide
• the width of the strip is adapted as a function of the length of the strips which will be made side by side on the strip. Depending on the traditional tape sizes used in the field and reel-to-reel devices, the width of the tape can be 35mm, 70mm or 150mm.
• the thickness of the carrier strip is in the range 50pm to 350pm.
• the method shown schematically in Figure 2 comprises in the first step the deposition of tracks, pellets and metal electrodes, for example copper or copper-based alloy on the substrate formed by the carrier strip.
• These are for example produced by photo-lithography of a copper layer bonded and / or laminated to the substrate or of a layer resulting from a copper deposit such as an electrolytic deposit. They can also be deposited by rolling.
• the copper foil 2 can itself come from a coil 12 unwound and applied continuously to the strip. carrier unwound from the coil 11.
• the gluing is carried out according to traditional techniques for producing flexible electronic circuits and for example the glue may have 2 types:
• the gluing process will then be a roller or slit coating
• a cooking step can be carried out with a temperature which can vary from 20 to 120 ° C.
• the thickness of the copper foil 2 is traditionally chosen between 10pm and 20pm and more particularly 12pm or 18pm.
• the method comprises the production of copper tracks from the copper sheet, by a photo-lithography process which uses a step 20 of applying a photosensitive varnish and a mask 20, a step of exposure of the varnish on the unmasked parts 21, the dissolution of the exposed varnish parts followed by a chemical attack 22 which removes the copper parts in the areas which are no longer covered by the varnish.
• the electrical contact areas can also be mechanically cut to form a conductive grid which is then co-laminated with the substrate.
• the process optionally continues by depositing a layer of nickel with or without phosphorus on the copper tracks so as to protect them from oxidation.
• This layer can be deposited by electrodeposition or autocatalytic deposition.
• the layer of nickel has a thickness which offers adequate corrosion resistance, preferably between 2 pm and 5 pm.
• the process of the application comprises an application 40 on the strip on the track side of masking means 41 leaving the contact pads and the electrode areas of the strip visible and a selective deposit 50 of a noble metal layer on said contact pads and electrode areas through masking means 41.
• these means 41 will include cutouts 42 leaving visible the contact pads and / or electrodes to allow the selective deposition of the noble metal on the latter.
• the masking means may consist of a film provided with openings allowing selective deposition of the noble metal
• They can also consist of a masking belt (inlay in English) provided with openings allowing selective deposition and applying to the strip during its movement in an electrolytic bath or on an applicator of deposition liquid ;
• They can also consist of a tool, for example a plastic tool forming a stencil, provided with cutouts leaving visible the contact pads and electrodes and which is deposited on the strip and applied to the tracks of the carrier strip at the level a noble metal deposit station;
• a tool for example a plastic tool forming a stencil, provided with cutouts leaving visible the contact pads and electrodes and which is deposited on the strip and applied to the tracks of the carrier strip at the level a noble metal deposit station;
• They can also consist of a foam masking tape applied to the tape and provided with said cutouts leaving visible the contact pads and electrodes.
• the masking means are positioned in the manufacturing process to achieve a selective deposition by applying to the strip during its movement in an electrolytic bath or on an applicator of deposition liquid, the openings leaving the tablets visible. contact and / or electrodes.
• the process steps are carried out continuously successively on the unwound carrier strip.
• the manufacturer making the carrier strip forming the flexible circuits to produce the strips can then punch the unnecessary segments of the tracks 105 and rewind the strip with its flexible circuits on a reel 13 to possibly store it before delivering it to the company which proceed to the step of depositing the biosensor on the strips or to transfer it internally to a production line suitable for handling biological products in order to complete the strips.
• the carrier strip 1 is unwound again from the reel 13 in order to deposit 61 of bioactive material with a deposit device 60 on the electrodes.
• the bioactive material can for example be an enzyme suitable for measuring glucose in the treatment of diabetes.
• one or more rolling steps are performed and the strips 100 are separated in one or more cutting steps 70, 71 for example by means of a first cutting blade which separates the blanks of strips and a punch 71 which cuts out the strips.
• the present application offers an optimized solution for the manufacture of large series biosensor strips, in particular in the context of a coil-to-coil process and a reduction in the quantity of gold or noble metal required for this manufacture.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Physics & Mathematics (AREA)
• Molecular Biology (AREA)
• Immunology (AREA)
• General Health & Medical Sciences (AREA)
• Analytical Chemistry (AREA)
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• Pathology (AREA)
• General Physics & Mathematics (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Urology & Nephrology (AREA)
• Electrochemistry (AREA)
• Biophysics (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Food Science & Technology (AREA)
• Medicinal Chemistry (AREA)
• Microbiology (AREA)
• Biotechnology (AREA)
• Organic Chemistry (AREA)
• Spectroscopy & Molecular Physics (AREA)
• Cell Biology (AREA)
• Proteomics, Peptides & Aminoacids (AREA)
• Wood Science & Technology (AREA)
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• Bioinformatics & Cheminformatics (AREA)
• General Engineering & Computer Science (AREA)
• Genetics & Genomics (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

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• 2019
  • 2019-07-09 FR FR1907663A patent/FR3098598B1/fr active Active
• 2020
  • 2020-06-23 EP EP20747027.9A patent/EP3997451A1/fr active Pending
  • 2020-06-23 WO PCT/FR2020/051092 patent/WO2021005279A1/fr unknown
  • 2020-06-23 CN CN202080044561.5A patent/CN113994201A/zh active Pending
  • 2020-06-23 KR KR1020217039797A patent/KR20220027835A/ko unknown
  • 2020-06-23 US US17/625,232 patent/US20220268724A1/en active Pending

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