WO2022218688A1 - Chambre d'introduction pour l'introduction d'un dispositif d'échantillonnage dans un dispositif micro-fluidique, dispositif micro-fluidique, procédé de fonctionnement et procédé de production d'un dispositif micro-fluidique - Google Patents

Chambre d'introduction pour l'introduction d'un dispositif d'échantillonnage dans un dispositif micro-fluidique, dispositif micro-fluidique, procédé de fonctionnement et procédé de production d'un dispositif micro-fluidique Download PDF

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Publication number
WO2022218688A1
WO2022218688A1 PCT/EP2022/058258 EP2022058258W WO2022218688A1 WO 2022218688 A1 WO2022218688 A1 WO 2022218688A1 EP 2022058258 W EP2022058258 W EP 2022058258W WO 2022218688 A1 WO2022218688 A1 WO 2022218688A1
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WO
WIPO (PCT)
Prior art keywords
input chamber
input
sampling device
sample
area
Prior art date
Application number
PCT/EP2022/058258
Other languages
German (de)
English (en)
Inventor
Dieter Amesoeder
David Minzenmay
Daniel Sebastian Podbiel
Jochen Hoffmann
Original Assignee
Robert Bosch 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 Robert Bosch Gmbh filed Critical Robert Bosch Gmbh
Publication of WO2022218688A1 publication Critical patent/WO2022218688A1/fr

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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
    • B01L3/502715—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 interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
    • 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
    • B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/0074—Vaginal or cervical secretions
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/023—Adapting objects or devices to another adapted for different sizes of tubes, tips or container
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B01L2200/027—Fluid interfacing between devices or objects, e.g. connectors, inlet details for microfluidic devices
    • 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
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0684—Venting, avoiding backpressure, avoid gas bubbles
    • 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
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0689—Sealing
    • 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
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • 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
    • B01L2300/02—Identification, exchange or storage of information
    • 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
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/042—Caps; Plugs
    • 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
    • B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • 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
    • B01L2300/0887—Laminated structure
    • 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
    • B01L2400/0457—Moving fluids with specific forces or mechanical means specific forces passive flow or gravitation

Definitions

  • Input chamber for loading a sampling device into a microfluidic device, microfluidic device, method for
  • the invention is based on an input chamber for introducing a sampling device into a microfluidic device, a microfluidic device with an input chamber, a method for operating a microfluidic device and a method for producing a microfluidic device according to the species of the independent claims.
  • Microfluidic analysis systems so-called lab-on-chips, LoCs for short, allow automated, reliable, fast, compact and cost-effective processing of patient samples for medical diagnostics.
  • complex molecular diagnostic test sequences can be carried out on a lab-on-chip cartridge.
  • lab-on-chip cartridges can be manufactured inexpensively from polymers using mass production processes such as injection molding, stamping or laser transmission welding.
  • lab-on-chip cartridges are designed to be fluid-tight, apart from ventilation openings, so that the sample can be processed in the lab-on-chip cartridge without contamination after it has been entered into the lab-on-chip cartridge.
  • the greatest risk of contamination of the environment by the sample or, conversely, the sample by the environment therefore exists in particular when the sample is being input into the lab-on-chip cartridge, which is usually done manually by the user.
  • the invention presented here advantageously offers a simple and particularly safe option, ie one that is as contamination-free as possible, for sample input into a lab-on-chip cartridge, which can also be used by personnel who are not specially trained. Furthermore, a high degree of reliability is made possible when the sample material is transferred from a sampling device into the microfluidic system.
  • An input chamber for loading a sampling device having a walled sample loading area for receiving at least a portion of the sampling device, the sample loading area having an input opening for loading the sampling device.
  • the input chamber comprises a surrounding area formed with further walls for further receiving at least a part of the sampling device from the sample input area, wherein the surrounding area is adjacent to the sample input area.
  • the flushing area is preferably designed to flush the sampling device with a transfer fluid in order to at least partially extract the sample material attached to the sampling device from the sampling device.
  • the input chamber can in particular be part of a microfluidic device for analyzing sample material.
  • the sample material can, for example, have been taken from a patient by means of a swab sample.
  • sample material can be taken from the patient using a so-called swab.
  • the swab can be a sampling device, such as a swab with a flocked tip, consisting of an elongated rod with a length in the range of about 10 to 20 cm, usually about 15 cm, which consists of a flexible elastic base material and can have a casing with a receptive or absorbent material at a front end, which can be used for sampling, for example, by bringing it into mechanical contact with a surface of the patient.
  • the rod of the sampling device can have a predetermined breaking point, which can be realized, for example, about 8 cm from the front end of the sampling device with the receptive sheath.
  • a predetermined breaking point can be realized, for example, about 8 cm from the front end of the sampling device with the receptive sheath.
  • the swab sample can be taken from the surface of wounds or mucous membranes, for example, using the sampling device.
  • a distinction can be made, for example, between a nose and throat swab (nasopharynx swab), a wound swab or a vaginal swab.
  • Swab samples of this type can be examined for bacterial, viral or parasitic pathogens, for example.
  • Swab samples of this type are therefore of particular interest for use in microfluidic analysis systems or microfluidic devices for analyzing sample material.
  • the device can be designed to analyze sample material detached from the sampling device by means of a transfer fluid, and for this purpose can comprise, for example, a network of microfluidic channels, chambers and valves.
  • the transfer fluid which can also be referred to as a transfer medium or as a transport medium, can be, for example, an aqueous solution that can be fed into the washing area of the input chamber in order to wash the sampling device arranged there Detach sample material from the sampling device and transfer it from the input chamber to other areas of the microfluidic network.
  • the input chamber presented here is advantageously designed to make it as easy as possible to enter the sample removal device into the microfluidic device and to completely detach the sample material from the sample removal device, even with a limited liquid volume of the transfer fluid , for example with an amount in the range from 350 to 500 pl.
  • the sample input area of the input chamber comprises an input opening, which can be arranged, for example, on an upper side of the input chamber, and a rinsing area.
  • the sample-taking device can, for example, be at least partially inserted into the sample input area and then guided further into the rinsing area.
  • the rinsing area can have, for example, at least one injection opening for injecting the transfer fluid in order to rinsing the sampling device with the transfer fluid and thus detaching the sample material.
  • the transfer fluid enriched with the sample material can then be transferred from the input chamber into the network of the microfluidic device, for example through a collection opening.
  • the sample input area can be arranged above the flushing area and the injection opening can be arranged above the collection opening within the flushing area.
  • the input chamber can preferably have a shoe shape.
  • a shoe shape of the input chamber can be understood in particular as meaning that the sample input area and the surrounding area together have the shape of a shoe or low shoe, with the sample input area with the input opening corresponding to a rear part and the surrounding area corresponding to a front part of the shoe.
  • the input chamber is designed in such a way that a front part or head of the sampling device, in particular the flocked tip in the case of a swab, via the input opening initially along a first direction in the
  • the sample input area can be introduced and then brought into the rinsing area by changing the direction, in particular by tilting the sample removal device by up to 90 degrees, along a second direction, with the first direction and the second direction being at an angle of up to 90 degrees to one another, for example.
  • the input chamber is thus preferably designed in such a way that the sampling device can be inserted into the washing area in the same type of movement as a foot is inserted into the front area of a shoe.
  • the input chamber can have a greater height in the sample input area than in the rinsing area.
  • the input chamber as part of the microfluidic device may be formed as a ridge relative to a major surface of the device.
  • the height of the sample input area can be greater than the height of the rinsing area, as a result of which, as explained above, an approximately shoe-shaped configuration of the input chamber can result.
  • the sample input area can have a large-area input opening, for example, which can enable the sample-taking device to be easily inserted into the input chamber.
  • the rinsing area can have a significantly reduced cross-sectional area, for example, in order to achieve as complete rinsing as possible of that part of the sampling device to which the sample material can be attached, even with small volumes of liquid.
  • the flushing can thereby advantageously be made possible in an optimized manner even when using types of sampling devices with different specifications with regard to their spatial dimensions. Due to the special shoe-shaped design of the input chamber, on the one hand a particularly simple and reliable input of the sample-taking device can be achieved and on the other hand a reliable flushing of the sample-taking device can be made possible.
  • the sample input area can have a rod feedthrough recess arranged in a wall for guiding a rod of the sampling device.
  • the Sampling device can include, for example, a rod with a length in the range of about 15 cm, which can consist of a flexible elastic base material and can have a sheath with an absorbent or absorbent material at a front end.
  • the sheathed end can also be referred to as a head or tip and can be designed to take up sample material, for example by means of a swab sample.
  • the rod can be guided, for example, through the rod feedthrough recess, which can, for example, be directly adjacent to the input opening at a rear end of the input chamber.
  • the head can first be inserted into the sample input area via the input opening and then moved further into the rinsing area by changing the direction, in particular tilting the rod, while a middle or rear part of the rod is introduced into the rod passage recess and preferably at least fixed laterally.
  • the insertion and fixing of a sampling device into the input chamber can thus advantageously be facilitated with the aid of the rod feedthrough recess, with the microfluidic device being able to be designed in a particularly compact manner.
  • the rod feed-through recess can also advantageously serve to guide the rod. In this way, a particularly simple, reproducible and reliable input of the sampling device into the input chamber can be made possible.
  • the rod feed-through recess can advantageously also serve as a ventilation opening of the input chamber in the case of microfluidic processing.
  • the input chamber can comprise a cover for closing the input chamber.
  • the cover can, for example, rest on the walls of the input chamber and close the input opening after the sampling device has been inserted.
  • the cover can comprise at least one positioning pin for positioning the sampling device within the input chamber.
  • the positioning pin which can also be referred to as a positioning pin, can be positioned between the input area and the flushing area when the input chamber is in the operational state.
  • the positioning pin can, for example, at least partially enclose a sampling device introduced through the input area into the rinsing area.
  • a positioning pin on the cover, the position of the sampling device can advantageously be fixed within the input chamber, so that, for example, the head of the sampling device is in the surrounding area. In this way it is possible to achieve a particularly reliable flushing of the head for loosening sample material.
  • the cover can have at least one window for optically determining the spatial position of the sampling device, wherein the window can be arranged over the rinsing area when the input chamber is in the ready-to-operate state.
  • the cover can have a sealing surface for fluid-tight sealing of the input opening.
  • the sealing surface can, for example, be arranged essentially at right angles to a main surface of the cover and be shaped in accordance with an outer contour of the input opening.
  • the cover can include a sealing pin for sealing the rod feed-through recess.
  • the sealing pin can, for example, be arranged parallel to a positioning pin arranged in the input chamber and be designed to at least partially enclose a rod of the sampling device arranged in the rod passage opening. This has the advantage that the input chamber can also be sealed when the sampling device is inserted.
  • the cover can be formed as part of a cover element for covering at least a partial area of the microfluidic device, wherein the cover element can be formed with a recess for passing through the sampling device and with at least one stiffening element adjoining the recess.
  • the cover element can, for example, be formed in order to completely cover the microfluidic device, wherein a recess for the passage of the sampling device can be arranged in the area of the input chamber. Manufacturing costs can advantageously be saved as a result of the one-piece molding of the cover element and lid.
  • the cover can have at least one marking for optically checking the position of the sampling device introduced into the input chamber.
  • the marking can be arranged, for example, in the form of an imprint or an indentation on the window of the lid. The marking can advantageously be used by a user to check whether the sampling device is optimally arranged for rinsing in the rinsing area of the input chamber.
  • a microfluidic device with a variant of the previously presented input chamber is presented.
  • the device can be designed to analyze sample material detached from the sampling device by means of a transfer fluid, and for this purpose can comprise, for example, a network of microfluidic channels, chambers and valves.
  • the network can include a storage chamber for long-term stable Pre-storage of the transfer fluid and, for example, a liquid storage chamber for storing the transfer fluid enriched with sample material and additionally or alternatively a filter element for filtering the enriched transfer fluid.
  • the microfluidic device can have an interface to a temperature control device for temperature control of the input chamber, and additionally or alternatively there can be an interface to a sonotrode in order to couple ultrasound into the input chamber.
  • all of the aforementioned advantages can be optimally implemented through a combination of a microfluidic device with the input chamber.
  • the device presented here not only can a liquid sample be entered into the device for analysis, but the device also enables the entry of a sample removal device designed as a swab with a flocked tip with a swab sample and the transfer of the sample material from the sample removal device into the microfluidic system.
  • the device can advantageously be designed to accommodate both sampling devices that, unlike a liquid sample, have a spatially fixed geometry, as well as, for example, different types of sampling devices that can sometimes differ significantly in their specifications such as the spatial dimensions.
  • a sampling device up to a predetermined breaking point can have a comparatively large spatial extent for the input into a microfluidic lab-on-chip cartridge that is as compact as possible: From the head of the sampling device to the predetermined breaking point, the length of the rod can usually be in a size range between 60 and 90 mm lie. Furthermore, sample material attached to the sampling device can first be detached from the sampling device for transfer to the microfluidic analysis system.
  • the liquid volume of the transport medium for detaching the sample material from the sampling device which can be stored upstream in the device, can be limited, for example to an amount in the range of 350-500 pl. With the device presented here, the entire head can advantageously be flushed as completely as possible of the sampling device can be optimized with the limited liquid volume of transport medium.
  • the device can have a fluidic decoupling reservoir, it being possible for the decoupling reservoir to be arranged on the sample input area of the input chamber.
  • the decoupling reservoir can be arranged under the rod feedthrough recess when the microfluidic device is in the operational state.
  • the realization of a fluidic decoupling reservoir below the rod feedthrough recess at the rear end of the chamber can advantageously reduce the risk of liquid escaping undesirably from the input chamber and the microfluidic device.
  • the device can comprise at least one fixing element for fixing the rod of the sampling device.
  • the fixing element can be shaped, for example, to receive a rod of a sampling device introduced into the input chamber and to fix it in a position.
  • the fixing element is a projection, for example in the form of an edge or wall, with a recess for receiving and laterally locking the rod.
  • Implementing one or more fixing elements for the rod, for example behind the input chamber, can advantageously promote a particularly defined input of the sampling device and reliable breaking off of the rod, for example at a predetermined breaking point.
  • a method for operating a variant of the microfluidic device presented above having a step of inserting at least part of the sample removal device into the sample input area of the input chamber.
  • the method includes a step of introducing the at least one part of the sampling device into the rinsing area of the input chamber and a step of processing sample material attached to the sampling device in the microfluidic device.
  • a method for producing a variant of the microfluidic device presented above is presented, the method comprising a step of providing at least two components, a first component forming the input chamber and part of a microfluidic network, and a second component forming a further part of the network.
  • the method includes a step of assembling the components in order to produce the microfluidic device.
  • This method can be implemented, for example, in software or hardware or in a mixed form of software and hardware, for example in a control unit.
  • FIG. 1 shows a schematic top view illustration of an embodiment of a microfluidic device
  • Fig. 2 shows a schematic side view of an embodiment of an input chamber
  • FIG. 3 shows a schematic top view illustration of an embodiment of an input chamber
  • FIG. 4 shows a schematic bottom view of an embodiment of an input chamber
  • FIG. 5 shows a schematic rear view of an exemplary embodiment of an input chamber
  • Fig. 6 is a schematic front view of an embodiment of an input chamber; 7 shows a schematic side view of an exemplary embodiment of an input chamber with a cover;
  • FIG. 8 shows a perspective plan view of an embodiment of an input chamber with a cover
  • FIG. 9 shows a schematic top view illustration of an embodiment of an input chamber with a cover
  • FIG. 10 shows a schematic top view illustration of an exemplary embodiment of a wash-around area with a cover
  • FIG. 11 shows a schematic rear view of an exemplary embodiment of an input chamber with a cover
  • FIG. 12 shows a flowchart of a method for operating a microfluidic device according to an embodiment
  • FIG. 13 shows a flowchart of a method for operating a microfluidic device according to an embodiment
  • FIG. 14 shows a flow chart of a method for producing a microfluidic device according to an embodiment
  • FIG. 15 shows a flowchart of a method for producing a microfluidic device according to an embodiment.
  • Fig. 1 shows a schematic top view representation of an embodiment of a microfluidic device 100 with an input chamber 105.
  • microfluidic device 100 has a carrier body 110 with an input chamber 105 and a microfluidic network 120, which in turn has at least two microfluidic connections, in the form of at least one injection opening 121 and one collection opening 122, to the input chamber 105 in order to inject fluids into the Introduce input chamber 105 or to be able to pump it out.
  • the network 120 includes various microfluidic channels 125, pump chambers 130 and valves 135, for example.
  • the carrier body 110 corresponds to the microfluidic device 100 and is constructed in multiple layers from a plurality of components.
  • an uppermost layer of the carrier body 110 comprises not only the microfluidic channels 125 but also chambers such as the pumping chambers 130 and the input chamber 105.
  • the carrier body can also be formed as part of the microfluidic device, for example as a transparent plastic layer.
  • the device in this embodiment includes a pre-storage chamber 140 for long-term stable pre-storage of the transfer fluid, as well as a liquid storage chamber 145 for storing the sample material-enriched transfer fluid and a filter chamber with a filter element 150 for filtering the enriched transfer fluid.
  • the device in the area of the input chamber can have a heat exchange interface to an external temperature control device for temperature control of the input chamber and/or there can be an interface to a sonotrode to couple ultrasound into the input chamber.
  • the device 100 has, for example, lateral external dimensions of 118 mm ⁇ 78 mm and the microfluidic channels have cross-sectional dimensions of 600 ⁇ 400 ⁇ m 2 .
  • the device can have external dimensions of 70 mm x 50 mm to 300 mm x 150 mm, preferably 90 mm x 60 mm to 200 mm x 100 mm, and the cross-sectional dimensions of the microfluidic channels can be 100 ⁇ 100 ⁇ m 2 to 3 ⁇ 3 mm 2 , preferably 300 ⁇ 300 ⁇ m 2 to 1 ⁇ 1 mm 2 .
  • the microfluidic device 100 and in particular the carrier body 110 in this exemplary embodiment is produced as a polymeric multilayer structure made of polycarbonate (PC) and polyurethane (TPU) by means of injection molding, stamping and laser transmission welding.
  • PC polycarbonate
  • TPU polyurethane
  • other polymers such as polystyrene (PS), polypropylene (PP), polyethylene (PE), cycloolefin copolymer (COP, COC), polymethyl methacrylate (PMMA), polydimethylsiloxane (PDMS) or other thermoplastic elastomers (TPE ) such as styrene block copolymer (TPS), as well as alternative series production processes such as thermoforming.
  • PS polystyrene
  • PP polypropylene
  • PE polyethylene
  • COC cycloolefin copolymer
  • PMMA polymethyl methacrylate
  • PDMS polydimethylsiloxane
  • TPE thermoplastic elast
  • Fig. 2 shows a schematic side view of an embodiment of an input chamber 105.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figure and is in the operational state in a carrier body 110 of a microfluidic device, as described in the previous figure .
  • the input chamber 105 is shown in the figure shown here with an input sampling device 200 .
  • the rod 205 of the sampling device 200 leads through the sample input area 215 formed with walls 210, while the head 220 with attached sample material 222 is arranged in the surrounding flushing area 230, which is formed with further walls 225 and is directly adjacent to the sample input area.
  • the input chamber 105 is shoe-shaped.
  • the sample input area 215 has a greater height 235 than the rinsing area 230, only by way of example.
  • the sample input area 215 has an input opening 240, only by way of example, on an upper side opposite the microfluidic device, which can also be referred to as a sample input opening and only by way of example with a Lid, as shown in the following figures 7 to 11, can be closed.
  • the input chamber 105 in the advantageous embodiment shown here includes a rod feed-through recess 245 for guiding the rod 205, the rod feed-through recess 245 being arranged in a wall 210 at the rear end of the sample input area 215 by way of example only.
  • Rod feed-through recess 245 is configured to guide rod 205, which may also be referred to as a sampler rod, upon entry of sampler 200 into the chamber.
  • a fixing element 250 is also arranged behind the input chamber 105 to fix the rod 205, while the head 220 of the sampling device 200 is arranged inside the rinsing area 230 as shown in this figure.
  • the rinsing area 230 is designed to rinse the sampling device 200 with a transfer fluid in order to extract the sample material 222 bound to the sampling device 200 from the sampling device 200 .
  • injection openings 121, 260, 261 are arranged on the underside of the rinsing area 230, which are fluidically connected to the microfluidic device by a microfluidic injection channel 263 and are designed to introduce transfer fluid into the input chamber 105.
  • a collection port 122 is fluidly connected to the device by a collection channel 265 and is configured to drain transfer fluid enriched with sample material 222 from the input chamber 105 . In this way, microfluidic processing of the head 220 in the rinsing area 230 of the sample input chamber 105 is made possible.
  • the input chamber can be aligned in particular to a gravitational field, such as the earth's gravitational field, in order to optimize microfluidic processing of the head in the washing area of the input chamber, with no liquid being able to escape from the input chamber via the rod passage recess.
  • a gravitational field such as the earth's gravitational field
  • the rinsing area 230 is designed, merely by way of example, with a cross-sectional area of 40 ml/mm, a length of 16 mm, a width of 6 mm and a volume of 640 ml.
  • the rinsing area can have a cross-sectional area of 10 ml/mm to 60 ml/mm, preferably 25 ml/mm to 40 ml/mm, a length of 5 mm to 25 mm, preferably 12 mm to 20 mm, a width of 3 mm to 12 mm, preferably 5 mm to 9 mm, and a volume, without sampling device, of 50 ml to 1500 ml, preferably 300 ml to 800 ml.
  • the entire input chamber 105 consisting of sample input area 215 and rinsing area 230 has lateral outer dimensions of 8 ⁇ 36 mm 2 in this exemplary embodiment.
  • the input chamber can be designed with dimensions of 5 ⁇ 10 mm 2 to 12 ⁇ 60 mm 2 , preferably 7 ⁇ 20 mm 2 to 10 ⁇ 40 mm 2 .
  • FIG 3 shows a schematic plan view of an embodiment of an input chamber 105.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figures.
  • the input opening 240 is formed with a length of 18 mm and a width of 6 mm in this exemplary embodiment.
  • the input opening can have a length of 7 mm to 25 mm, preferably 10 mm to 20 mm, and a width of 3 mm to 10 mm, preferably 5 mm to 8 mm.
  • a fluidic decoupling reservoir 300 which is designed to hold liquid, is arranged below the rod feedthrough recess 245.
  • the rod 205 of the sampling device 200 extends beyond the decoupling reservoir 300 and is fixed in this position by a fixing element 250 .
  • the rod 205 has a predetermined breaking point 305, merely by way of example, in order to break it off behind the fixing element 250, for example directly behind it.
  • the sampling device 200 is formed with an overall length, i.e.
  • the sampling device can have an overall length of 100 mm to 200 mm, preferably 120 mm to 180 mm, in particular 145 mm to 155 mm, and a length from the tip of the head 220 to the predetermined breaking point 305 of 60 mm to 120 mm, preferably 75 mm up to 100 mm.
  • the head 220 of the sampling device 200 in this exemplary embodiment is formed with a displacement volume of 190 pl only by way of example, a length of 15 mm and a diameter of 4 mm.
  • the head can have a maximum total displacement volume of 30 pl to 400 ml, preferably 50 ml to 325 ml, a displacement volume of 5 ml/mm to 35 ml/mm, preferably 7 ml/mm to 20 ml/mm, a Length of 5 mm to 20 mm, preferably 8 mm to 16 mm, and a maximum diameter of 2 mm to 8 mm, preferably 3 mm to 5 mm.
  • the rod 205 is formed with a diameter of 2 mm and a displacement volume of only 3 ml/mm, for example.
  • the rod can have a maximum diameter of 2 mm to 4 mm, preferably 2 mm to 3 mm, a minimum diameter of 0.5 mm to 4 mm, preferably 0.8 mm to 3 mm and a displacement volume of 0.5 ml/mm to 10 ml/mm, preferably 1 ml/mm to 5 ml/mm.
  • a liquid sample can be input, for example, by using a pipette and introducing the sample into a closable sample input chamber by means of the pipette.
  • a sample input chamber can therefore in particular have a closable opening which is provided for the input of the sample by pipetting and which can be closed after the sample has been input.
  • Fig. 4 shows a schematic bottom view of an embodiment of an input chamber 105.
  • the input chamber 105 shown here corresponds to or is similar to the input chamber described in the previous figures, with the surrounding area in this embodiment five injection openings 121, 260, 261, 400, 401, which only for example along a longitudinal axis 405 and one arranged at right angles to the longitudinal axis 405 Transverse axis 410 are offset from one another, with longitudinal axis 405 corresponding to a direction in which sample-taking device 200 is pushed into sample-input chamber 105 .
  • the injection openings 121, 260, 261, 400, 401 are designed only by way of example in order to introduce a transfer fluid from a microfluidic injection channel 263 into the rinsing area 230 of the input chamber 105.
  • the transfer fluid can be drained from the input chamber 105 through a collection opening 122 and a microfluidic collection channel 265 connected thereto.
  • FIG. 5 shows a schematic rear view of an exemplary embodiment of an input chamber.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figures.
  • the rod feed-through recess 245 is directly adjacent to the input opening 240 .
  • the rod 205 of the sampling device 200 can be inserted into the input chamber 105 from above and, for example, tilted at a 90-degree angle through the rod feedthrough recess 245, so that the sampling device 200 can be pushed into the rinsing area described in the previous figures.
  • Fig. 6 shows a schematic front view of an embodiment of an input chamber.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figures, with a sampling device 200 being arranged in the input chamber.
  • Fig. 7 shows a schematic side view of an embodiment of an input chamber 105 with a cover 700.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figures, with the difference that the input opening 240 is closed with the cover 700.
  • the cover 700 has a positioning pin 705 which controls the positioning of the sampling device 200 within the Input chamber 105 defines, so that in particular the head 220 is arranged in the surrounding area 230 of the input chamber 105 .
  • the input opening 240 of the input chamber 105 is sealed by means of the cover 700 via a sealing surface 710, for example.
  • the input chamber 105 can also be vented, for example, via the rod passage recess 245, which is only partially sealed.
  • the input chamber or the cover can have a separate ventilation opening and, additionally or alternatively, the cover can be designed to completely fluid-tightly close the input chamber, ie gas and liquid-tight, apart from the ventilation opening.
  • Fig. 8 shows a perspective top view of an embodiment of an input chamber 105 with a cover 700.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figures and the cover 700 shown here corresponds or is similar to the cover described in the previous figure 7.
  • the cover 700 also has a window 800 above the rinsing area 230 of the input chamber 105, which can be used for an optical position check, i.e. to determine the spatial position of the sampling device 200 within the input chamber 105.
  • Fig. 9 shows a schematic plan view of an embodiment of an input chamber 105 with a cover 700.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figures and the cover 700 shown here corresponds or is similar to the cover shown in the previous figures 7 and 8 , with the difference that the cover 700 is formed as part of a cover element 900 in this exemplary embodiment.
  • the lid 700 can also be separate from the cover element 900 .
  • the cover element 900 is only embodied by way of example to cover a partial area of the microfluidic device, as described in FIG became to cover.
  • the cover 700 is characterized not only by the provision of the sealing functionality, but also in particular by an optically transparent window 800 for checking the position of the
  • the cover 700 and the covering element 900 include further markings 905, 906, 907, 908, 909 which can be recognized and interpreted by a user and which serve as indicators for checking that the sampling device 200 has been correctly inserted into the input chamber 105.
  • the cover element 900 in this exemplary embodiment has a recess 910 which is designed for the rod 205 of the sampling device 200 to pass through.
  • stiffening elements 911, 912 are arranged adjacent to the recess 910. The stiffening elements 911, 912 can optionally be shaped in addition to stiffening the cover element 900 for guiding the rod 205.
  • a fixing element 915 is arranged on the back of cover element 900 directly adjacent to recess 910, which, for example only, prevents rod 205 from slipping out of recess 910 and facilitates easier handling, for example when breaking off sample-taking device 200 at a predetermined breaking point, such as as described in Figure 3, is allowed.
  • Fig. 10 shows a schematic plan view of an embodiment of a rinsing area 230 with a cover 700.
  • the input chamber 105 shown here corresponds or is similar to the input chamber described in the previous figures and the cover 700 shown here corresponds or is similar to that described in the previous figures 7 to 9 Lid.
  • the cover 700 has a marking 909 for optically checking the position of the sampling device 200 introduced into the rinsing area 230 .
  • FIG. 11 shows a schematic rear view of an exemplary embodiment of an input chamber 105 with a cover 700.
  • the input chamber 105 shown here corresponds or is similar to that in the preceding figures described input chamber and the cover 700 shown here corresponds or is similar to the cover described in the previous figures 7 to 10.
  • the rod 205 of the sampling device 200 is guided through the rod passage recess 245 of the input chamber 105 .
  • a fixing element 915 is arranged above the rod 205 in order to fix its position and to facilitate breaking off at the predetermined breaking point 305 .
  • FIG. 12 shows a flowchart of a method 1200 for operating a microfluidic device according to an embodiment.
  • the apparatus used in this method 1200 is the same as or similar to the apparatus described in the previous Figure 1 having an input chamber as described in the previous Figures.
  • the head of the sampling device is inserted into the sample input area of the input chamber via the input opening.
  • the head is inserted into the surrounding area of the input chamber.
  • the rod can be guided in particular by means of the rod feed-through recess.
  • the positioning of the head within the input chamber can optionally be determined via an optical window in the cover of the input chamber, in particular to check that the head has been completely inserted into the washing area of the input chamber.
  • FIG. 13 shows a flowchart of a method 1200 for operating a microfluidic device according to an embodiment.
  • the method 1200 shown here corresponds to or is similar to the method described in the previous figure 12, with the difference that the method 1200 includes additional steps.
  • the method 1200 includes an additional step 1300 of sealing after the step 1210 of inserting.
  • this step 1300 of closing the input opening of the sample input area is closed with a cover, just as an example, so that a sealing surface is formed between the wall inside and additionally or alternatively a wall outside of the input chamber and the cover.
  • the positioning of the sampling device in the input chamber can optionally be fixed by closing the input chamber with the lid via the optionally available positioning pin of the lid.
  • the rod of the sampling device is cut off in this exemplary embodiment.
  • the rod can be separated in particular by breaking at a predetermined breaking point integrated into the rod. Fixing the sampling device within the input chamber via the positioning pin, the rod feedthrough recess, the cover, the fixing element and the fixing element allows particularly simple and reliable handling when separating the rod.
  • the bar can also be separated by cutting off the bar using a cutting tool or by breaking it over an edge present, for example, on the rear side of the cover element.
  • the step 1305 of severing is followed by a step 1310 of aligning.
  • the microfluidic device which is entered into an analysis device with the sampling device arranged in the input chamber, together with the input chamber is suitably aligned with a gravitational field, so that it enters the input chamber introduced liquid collects by the force of gravity acting on this in the lower part of the input chamber, ie in particular at the lower end of the surrounding area.
  • the gravitational field is the earth's gravitational field, merely by way of example.
  • step 1215 of processing takes place only after step 1310 of alignment.
  • the microfluidic device is processed within an analysis device. Sample material present at the sampling device is transferred into the microfluidic device and analyzed there by means of the analysis device, purely by way of example.
  • the microfluidic device is output from the analysis device and an analysis result is additionally output only by way of example.
  • individual steps can also be omitted, for example the separating step can optionally be omitted.
  • FIG. 14 shows a flow chart of a method 1400 for manufacturing a microfluidic device according to an embodiment.
  • the method 1400 includes a step 1405 of providing at least two components for forming the microfluidic device and in particular the carrier body.
  • a first component forms the input chamber and a part of a microfluidic network
  • a second component forms a further part of the network and additionally or alternatively a part of the input chamber.
  • Step 1405 may also be referred to as a creating step.
  • the components forming the device are produced separately, merely by way of example, by injection molding of polymer components.
  • the provision can additionally or alternatively take place by punching polymer films.
  • the input chamber and the network of the microfluidic device are composed of at least two polymer components, which are disposed together in the next step of the method.
  • the polymer components are either transparent or absorbent at a predetermined wavelength, for example within the near infrared range, for example by adding carbon black particles, in order to enable the components to be joined by means of laser transmission welding in the next step of the method 1400 .
  • the step 1405 of providing is followed by the step 1410 of assembling the components to produce the microfluidic device.
  • the components produced in the first step 1405 are joined in the second step 1410 in order to form the microfluidic device with an input chamber therefrom.
  • the components are joined in particular by means of laser transmission welding in order to provide a particularly simple, cost-effective and technically reliable manufacturing solution.
  • FIG. 15 shows a flowchart of a method 1400 for manufacturing a microfluidic device according to an embodiment.
  • the method 1400 shown here corresponds to or is similar to the method described in the preceding FIG. 14, with the difference that the method 1400 includes an additional step.
  • step 1405 of providing and step 1410 of assembling is followed by a further step 1500 of plugging.
  • step 1500 the cover element with the lid is placed on the assembly that forms the microfluidic device with the input chamber.
  • the cover element snaps into place with the cover in the assembly by means of snap-in lugs and snap-in hooks.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne une chambre d'introduction (105) pour l'introduction d'un dispositif d'échantillonnage (200) dans un dispositif micro-fluidique pour analyser un matériau échantillon (222), la chambre d'introduction (105) comportant une région d'introduction d'échantillon (215) destinée à recevoir le dispositif d'échantillonnage (200), la région d'introduction d'échantillon étant formée par des parois (210), et la région d'introduction d'échantillon (215) comportant une ouverture d'introduction (240) pour l'introduction du dispositif d'échantillonnage (200). La chambre d'introduction (105) comprend en outre une région de rinçage (230) pour la réception supplémentaire du dispositif d'échantillonnage (200) depuis la région d'introduction d'échantillon (215), la région de rinçage (230) étant formée par des parois supplémentaires (225), et la région de rinçage (230) étant attenante à la région d'introduction d'échantillon (215) et étant conçue pour rincer le dispositif d'échantillonnage (200) avec un fluide de transfert afin d'extraire au moins partiellement le matériau échantillon (222) lié au dispositif d'échantillonnage (200) du dispositif d'échantillonnage (200).
PCT/EP2022/058258 2021-04-13 2022-03-29 Chambre d'introduction pour l'introduction d'un dispositif d'échantillonnage dans un dispositif micro-fluidique, dispositif micro-fluidique, procédé de fonctionnement et procédé de production d'un dispositif micro-fluidique WO2022218688A1 (fr)

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DE102021203637.6A DE102021203637A1 (de) 2021-04-13 2021-04-13 Eingabekammer zum Eingeben einer Probenentnahmevorrichtung in eine mikrofluidische Vorrichtung, mikrofluidische Vorrichtung, Verfahren zum Betreiben und Verfahren zum Herstellen einer mikrofluidischen Vorrichtung
DE102021203637.6 2021-04-13

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69428798T2 (de) * 1993-08-02 2002-06-20 Quidel Corp Gerät für die medizinische diagnostik mit lateralem fluss und einer vorrichtung zur probenextraktion
US20130295573A1 (en) * 2012-05-02 2013-11-07 Stat-Diagnostica & Innovation, S.L. Swab Elution Chamber in a Test Cartridge
WO2015044227A1 (fr) * 2013-09-24 2015-04-02 General Electric Company Ensemble d'aide de collecte et de stockage d'échantillons
WO2018060405A1 (fr) * 2016-09-30 2018-04-05 Koninklijke Philips N.V. Système pour l'application d'un réactif a un échantillon

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7704728B2 (en) 2001-07-18 2010-04-27 The University Of Michigan Microfluidic gravity pump with constant flow rate
EP3083940A4 (fr) 2013-12-20 2017-08-23 President and Fellows of Harvard College Dispositifs microfluidiques à faible cisaillement et leurs procédés d'utilisation et de fabrication

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE69428798T2 (de) * 1993-08-02 2002-06-20 Quidel Corp Gerät für die medizinische diagnostik mit lateralem fluss und einer vorrichtung zur probenextraktion
US20130295573A1 (en) * 2012-05-02 2013-11-07 Stat-Diagnostica & Innovation, S.L. Swab Elution Chamber in a Test Cartridge
WO2015044227A1 (fr) * 2013-09-24 2015-04-02 General Electric Company Ensemble d'aide de collecte et de stockage d'échantillons
WO2018060405A1 (fr) * 2016-09-30 2018-04-05 Koninklijke Philips N.V. Système pour l'application d'un réactif a un échantillon

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