EP1784260A2 - Systeme microfluidique et procede de fabrication dudit systeme - Google Patents

Systeme microfluidique et procede de fabrication dudit systeme

Info

Publication number
EP1784260A2
EP1784260A2 EP05780984A EP05780984A EP1784260A2 EP 1784260 A2 EP1784260 A2 EP 1784260A2 EP 05780984 A EP05780984 A EP 05780984A EP 05780984 A EP05780984 A EP 05780984A EP 1784260 A2 EP1784260 A2 EP 1784260A2
Authority
EP
European Patent Office
Prior art keywords
microfluidic system
microchannel
carrier body
layer
indicates
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.)
Withdrawn
Application number
EP05780984A
Other languages
German (de)
English (en)
Inventor
Irio Guiseppe Calasso
Patrick Griss
Emad Sarofim
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.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics GmbH
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 F Hoffmann La Roche AG, Roche Diagnostics GmbH filed Critical F Hoffmann La Roche AG
Priority to EP05780984A priority Critical patent/EP1784260A2/fr
Publication of EP1784260A2 publication Critical patent/EP1784260A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502707—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the manufacture of the container or its components
    • 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
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
    • 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
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • 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
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/15045—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin comprising means for capillary action
    • 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
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502746—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means for controlling flow resistance, e.g. flow controllers, baffles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/12—Specific details about manufacturing devices
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces

Definitions

  • the invention relates to a microfluidic system with a carrier body preferably provided with a lancing member and a semi-open microchannel located thereon for the capillary transport of a liquid from a receiving site to a target site.
  • the invention further relates to a preferred use of such a system and to a method for its production.
  • microfluidics is also characterized by ever smaller sized structural elements which permit exploitation of capillary forces and must be realized inexpensively in so-called disposables and suitable for mass production.
  • photochemical etching the materials used there can scarcely be used for mechanically stressed structures, above all because of their brittleness.
  • the hydrophilization must be sufficiently storage stable.
  • the object of the invention is to avoid the disadvantages which have arisen in the prior art and to improve a system and a production method such that structures for effective transport of small quantities of liquid are provided with favorable measures.
  • any limitations based on the sole use of wetting agents should be reduced.
  • the carrier body is coated with a build-up layer for the liquid transport that laterally delimits the microchannel, at least in the upper area and with the exception of one floor area.
  • the coating allows in a simple manner a firmly adhering structure formation with a previously shapeless substance, wherein the channel formation or channel increase in the structural layer or on the side wall of a liquid-carrying fluidic function is realized, which rests on an increase in capillarity be ⁇ .
  • the support body may be formed at the same time as a lancing element for piercing the skin or else fulfill a separate from a piercing element removal or recording function.
  • the microchannel has a lower cross-sectional area which is introduced into the carrier body and is preferably etched, and an upper cross-sectional area formed above it and formed in the build-up layer. It is also possible for the build-up layer to laterally delimit the microchannel over its entire depth and thus to assume a liquid-conducting function alone.
  • the make coat consists of a photoresist, preferably a thick-film photoresist.
  • a photoresist preferably a thick-film photoresist.
  • the make coat has a layer thickness of more than 50 microns, preferably 200 to 500 microns.
  • a further aspect of the invention consists in that the microchannel has a plurality of partial cross-sections etched into the depth by successive etching steps from a surface of the carrier body. Also in this way it is possible in an isotropic etchable carrier material, a large ratio of - A -
  • this aspect ratio is greater than 0.5, preferably greater than 0.8.
  • the microchannel has a clear width in the range of 50 to 500 ⁇ m, j
  • a further advantageous embodiment provides that the partial cross sections are formed in the carrier body by photochemical mask etching.
  • the capillarity can also be increased by virtue of the fact that the microchannel has an undercut which is preferably formed by undercutting in the region of its longitudinal edges.
  • a further embodiment provides that the carrier body consists of an isotropically etchable material, wherein the desired properties, such as favorable handling, strength, inertness and biocompatibility, can be realized especially with a flat preform, preferably made of metal, in particular stainless steel.
  • the carrier body formed from flat material has a thickness of 100 to 450 .mu.m, preferably 150 to 300 .mu.m.
  • the make coat has an additional substance or composition which increases the hydrophilicity, or if the wettability of a wall of the microchannel is increased by a chemical surface treatment.
  • a further improvement provides that at least one substructure of the carrier body outside the microchannel region, preferably the piercing member, is formed by etching or stamping, so that the different structuring processes are created by uniform processes.
  • a preferred application relates to a disposable sample removal element comprising a microfluidic system according to the invention.
  • a further preferred use of a microfluidic system according to the invention is the transport of a sample liquid from a receiving site to a target site, in particular for transport into a detection area.
  • the object stated in the introduction is achieved in that a liquid transporting the microchannel is increased or formed by a photoresist layer applied to a carrier body, in particular a thick-film photoresist.
  • the photoresist is sprayed or scrape-dried onto the carrier body as a thick film or applied by dip coating.
  • a further advantageous measure is that a microchannel is etched into the carrier body by mask etching of a first photoresist layer, and that after removal of the first photoresist layer, a second photoresist layer is applied and photostructured to increase the microchannel.
  • Fig. 1 shows a sampling element as a microfluidic system for
  • FIG. 2 to 4 the system of Figure 1 with different construction layer of a microchannel in cross section. 5a to f successive process steps for channel-height photo structuring of the system according to FIG. 1 in cross section; and
  • the microfluidic system shown in the drawing enables dispensing and capillary transport of small quantities of bodily fluid as a disposable sampling element 10.
  • a disposable sampling element 10 for this purpose, it comprises a flat carrier body 12, a lancing member 14 formed thereon and a capillary microchannel 16, which may be delimited at least partially by a build-up layer 18 of the carrier body 12.
  • the carrier body 12 is made as a strip-shaped flat part made of steel with a thickness of about 150 to 300 microns. Its proximal end portion forms a Garbreich 20 for handling during the lancing process, while the integrally formed at the distal end lancing member 14 in the skin of a user creates a small wound to remove microscopic volumes of blood or tissue fluid can.
  • the microchannel 16 is groove-shaped or semi-open over its length, so that photolithographic production is possible as described below.
  • an effective liquid absorption from the skin or from the skin surface is possible over the half-open cross section without tissue parts being able to completely close the inlet cross section as in conventional hollow cannulas.
  • the liquid transport takes place via the capillary channel 16 to the target site 24 which is at a distance from the piercing member 14 and at which an analysis of the body tissue is carried out.
  • liquid can take place. This can be achieved, for example, by reflection-spectroscopic or electrochemical detection methods in a manner known per se.
  • the channel cross section may be constant over the length of the microchannel 16 or vary.
  • the width of the channel is in the range of 50 to 500 microns, while the so-called aspect ratio between depth and width in terms of improved capillarity greater than 0.5, preferably greater than 0.8. It should be noted that when the channel 16 is isotropically inserted into the carrier body 12, an approximately semicircular cross section is obtained in which the aspect ratio is only 0.5.
  • the semicircular lower channel region 26 formed by isotropic etching can be increased as the bottom region in the carrier body or substrate 12 through the build-up layer 18 with lateral delimitation of an upper edge-open channel region 28, so that overall a higher aspect ratio and so that a better capillary action for the liquid transport is achieved.
  • the build-up layer 18 should, for this purpose, have a layer thickness of more than 50 ⁇ m, preferably 200 to 500 ⁇ m.
  • the make coat 18 is not laminated as a prefabricated body on the carrier body 12, but applied from a previously shapeless material as a firmly adhering coating.
  • a liquid coating material is provided, in particular a photoresist 30 ("photoresist").
  • photoresist is particularly suitable.
  • a thick film photoresist for example epoxy based.
  • the photoresist 30 is subsequently applied after the etching of the lower region 26, so that the complementary o-channel region 28 can additionally conduct liquid.
  • the hydrophilicity of the layer 18 is increased by suitable additives or a corresponding lacquer composition. It is also possible to improve the water affinity of the channel wall by a chemical surface treatment after the structure formation.
  • the photoresist 30 used for the etching of the lower region 26 on the carrier body 12 as a mask was not removed but retained for a supplementary fluidic function.
  • the carrier body 12 can be patterned by preceding (isotropic) etching, for example by free-etching the piercing member 14.
  • FIG. 5 illustrates a process flow for photostructuring the channel 16 on a previously etched support structure.
  • the carrier body 12 is provided as a substrate with a first photoresist layer 30 '(FIG. 5a, b).
  • UV exposure is performed through the photomask 32, whereby the photoresist 30 "is polymerized or hardened under the transparent mask regions, while the masked regions 34 are rinsed free after exposure and development (FIGS. 5c, d)
  • the thus generated cut-out 36 in the layer 30 ' is subsequently exposed to an etching agent, wherein the channel region 26 is etched isotropically, after the removal of the photoresist layer 30' (FIG.
  • the aspect ratio of the channel 16 is increased by a plurality of successive etching steps.
  • an upper partial cross section 40 of the channel 16 in the carrier body 12 is formed in accordance with the above description with respect to FIGS. 5a to 5f (FIGS. 6a to f).
  • a recessed partial cross section 42 is produced in a second or further etching, so that the channel 16 passes through almost the entire carrier body 12, but without extending isotropically into the width (FIG. 6g to k).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Dispersion Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Manufacturing & Machinery (AREA)
  • Dermatology (AREA)
  • Micromachines (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

L'invention concerne un système microfluidique présentant un corps support (12), de préférence pourvu d'un organe de piqûre (14), ainsi qu'un microcanal semi-ouvert (16), situé sur le corps support et destiné au transport capillaire d'un échantillon liquide entre un point de prélèvement et un point cible (22, 24). L'objectif de cette invention est d'obtenir un rapport d'aspect supérieur. A cet effet, le corps support (12) est enduit d'une couche constitutive (18) délimitant latéralement le microcanal (16) au moins dans la zone supérieure et permettant le transport du liquide.
EP05780984A 2004-08-20 2005-08-18 Systeme microfluidique et procede de fabrication dudit systeme Withdrawn EP1784260A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05780984A EP1784260A2 (fr) 2004-08-20 2005-08-18 Systeme microfluidique et procede de fabrication dudit systeme

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP04019759A EP1627684A1 (fr) 2004-08-20 2004-08-20 Système microfluidique et son procédé de fabrication
EP05780984A EP1784260A2 (fr) 2004-08-20 2005-08-18 Systeme microfluidique et procede de fabrication dudit systeme
PCT/EP2005/008934 WO2006021361A2 (fr) 2004-08-20 2005-08-18 Systeme microfluidique et procede de fabrication dudit systeme

Publications (1)

Publication Number Publication Date
EP1784260A2 true EP1784260A2 (fr) 2007-05-16

Family

ID=34926238

Family Applications (2)

Application Number Title Priority Date Filing Date
EP04019759A Withdrawn EP1627684A1 (fr) 2004-08-20 2004-08-20 Système microfluidique et son procédé de fabrication
EP05780984A Withdrawn EP1784260A2 (fr) 2004-08-20 2005-08-18 Systeme microfluidique et procede de fabrication dudit systeme

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP04019759A Withdrawn EP1627684A1 (fr) 2004-08-20 2004-08-20 Système microfluidique et son procédé de fabrication

Country Status (6)

Country Link
US (1) US20070197937A1 (fr)
EP (2) EP1627684A1 (fr)
JP (1) JP2008510505A (fr)
CN (1) CN101010139A (fr)
CA (1) CA2577265A1 (fr)
WO (1) WO2006021361A2 (fr)

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EP1887355B1 (fr) * 2006-08-02 2017-09-27 F. Hoffmann-La Roche AG Procédé de revêtement d'un système microfluidique.
EP1884188A1 (fr) * 2006-08-02 2008-02-06 F.Hoffmann-La Roche Ag Empaquetage pour un objet avec un enduit avec une surface hydrophile
EP2025287A1 (fr) * 2007-08-16 2009-02-18 F.Hoffmann-La Roche Ag Dispositif diagnostic à usage unique de coin et son procédé de fabrication
US7766846B2 (en) * 2008-01-28 2010-08-03 Roche Diagnostics Operations, Inc. Rapid blood expression and sampling
EP2208459A1 (fr) * 2009-01-16 2010-07-21 F. Hoffmann-Roche AG Système et procédé destinés à l'analyse d'un liquide corporel
EP2210558A1 (fr) 2009-01-21 2010-07-28 Roche Diagnostics GmbH Lancette dotée d'un canal capillaire et d'une protection stérile ainsi que procédé de fabrication d'une telle lancette
CN201838746U (zh) * 2010-02-03 2011-05-18 番禺得意精密电子工业有限公司 电连接器
EP2520225B1 (fr) * 2011-05-06 2014-05-21 Roche Diagnostics GmbH Lancette
CA2845517C (fr) * 2011-09-23 2017-12-05 F. Hoffmann-La Roche Ag Procede de gravure par masque d'un organe de piqure
TW201350760A (zh) 2012-06-12 2013-12-16 Pro Iroda Ind Inc 金屬燈芯結構
KR101759059B1 (ko) * 2015-01-14 2017-07-19 서울대학교산학협력단 마이크로 구조체 및 이를 포함하는 액체 이송체

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EP0949002A2 (fr) * 1998-04-08 1999-10-13 Roche Diagnostics GmbH Méthode de fabrication d'élements d' analyse
US20030029723A1 (en) * 2000-12-06 2003-02-13 The Regents Of The University Of California Thin film capillary process and apparatus

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US20030029723A1 (en) * 2000-12-06 2003-02-13 The Regents Of The University Of California Thin film capillary process and apparatus

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Title
See also references of WO2006021361A2 *

Also Published As

Publication number Publication date
JP2008510505A (ja) 2008-04-10
US20070197937A1 (en) 2007-08-23
WO2006021361A2 (fr) 2006-03-02
WO2006021361A3 (fr) 2006-08-17
CN101010139A (zh) 2007-08-01
EP1627684A1 (fr) 2006-02-22
CA2577265A1 (fr) 2006-03-02

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