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EP3772371A1 - Mikromischer - Google Patents

Mikromischer Download PDF

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Publication number
EP3772371A1
EP3772371A1 EP20189472.2A EP20189472A EP3772371A1 EP 3772371 A1 EP3772371 A1 EP 3772371A1 EP 20189472 A EP20189472 A EP 20189472A EP 3772371 A1 EP3772371 A1 EP 3772371A1
Authority
EP
European Patent Office
Prior art keywords
channel
microfluidic
blood
main channel
chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20189472.2A
Other languages
English (en)
French (fr)
Inventor
Yoel EZRA
Natalya Mizrahi
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.)
Efa Engineering For All Ltd
Original Assignee
Efa Engineering For All Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/532,558 external-priority patent/US11400447B2/en
Application filed by Efa Engineering For All Ltd filed Critical Efa Engineering For All Ltd
Publication of EP3772371A1 publication Critical patent/EP3772371A1/de
Pending legal-status Critical Current

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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
    • B01L3/502746—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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/30—Micromixers
    • B01F33/3035—Micromixers using surface tension to mix, move or hold the fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/30—Micromixers
    • B01F33/304—Micromixers the mixing being performed in a mixing chamber where the products are brought into contact
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/50—Mixing receptacles
    • B01F35/53—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components
    • B01F35/531—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components with baffles, plates or bars on the wall or the bottom
    • B01F35/5312—Mixing receptacles characterised by the configuration of the interior, e.g. baffles for facilitating the mixing of components with baffles, plates or bars on the wall or the bottom with vertical baffles mounted on the walls
    • 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
    • B01L2300/0848—Specific forms of parts of containers
    • B01L2300/0851—Bottom walls
    • 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
    • B01L2300/0848—Specific forms of parts of containers
    • B01L2300/0858—Side walls
    • 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
    • B01L2300/12—Specific details about materials
    • B01L2300/123—Flexible; Elastomeric
    • 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
    • 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
    • B01L2400/08—Regulating or influencing the flow resistance
    • B01L2400/084—Passive control of flow resistance
    • B01L2400/086—Passive control of flow resistance using baffles or other fixed flow obstructions

Definitions

  • Rapid Diagnostic Tests provide instant results.
  • RDTs Rapid Diagnostic Tests
  • the computerized devices are single hand held devices which can be brought to remote areas, giving millions of people access to healthcare that they did not have previously. Since instant results are obtained, the unnecessary use (unnecessary administration) of drugs, such as unnecessary antibiotic and/or antimalarial agents is eliminated, as diseases and conditions are provided with certainty, on the spot. Additionally, since diseases and conditions are detected instantly, treatment protocols can begin immediately, eliminating the spread of infectious and deadly diseases and conditions.
  • the computerized device is a dual channel device, one channel for imaging or microscopy (optical), and one channel for electrochemistry (signals). Based on results from these two channels, a diagnosis can be made that is more accurate and effective than is presently possible in the field. This allows for rapid and safe treatment and follow-up of disease, inhibiting its spreading, as well as allowing for real-time mapping patients, in order to track movement of diseases in real-time and obtain other data for immediate and effective intervention of health authorities, studies, and the like.
  • the devices are, for example, a lab-on-hand computerized platform, which is programmable for various medical diagnostic applications based on the same RevDx hardware platform.
  • the patient can be treated much sooner that would be done conventionally. This preserves the health of the patient, and where the disease is contagious, prevents that disease from spreading.
  • the microfluidic chip and biosensor strip are both disposable and receive a blood sample at the time of testing, the process is sanitary, as disease does not pass between patients being tested, accurate, as there is no chance of blood spoliation, and many patients can be tested in a small amount of time by minimally trained or untrained medical personnel. Additionally, the micro fluidic chips and biosensor strips require small amounts of blood, usable as blood smears. The blood is obtained, for example, by a finger prick, which can be performed by the user or someone without medical training or with minimal medical training.
  • the process is inexpensive, as the microfluidic chips and biosensor strips are inexpensive, with the device used being a one-time purchase, capable of multiple uses.
  • Embodiments of the present invention are directed to a device for analyzing disease conditions.
  • the device comprises: an imaging channel configured for providing a viewable sample; and, a signal channel including a signal analyzer for analyzing received signals based on electrochemical responses emitted from an electrode having reacted to a sample, to determine the existence of the disease condition.
  • the device additionally comprises: an analytics module configured for scanning an image of the viewable sample, and determining the existence of the disease condition from the scanned image.
  • an analytics module configured for scanning an image of the viewable sample, and determining the existence of the disease condition from the scanned image.
  • the analytics module is configured for determining, from the scanned image, the existence of a disease condition selected from the group consisting of: G6PD deficiency output, blood glucose levels, malaria parasites including, P. falciparum, P. vivax , P. malaria. P. ovale, P. knowlesi and the disease stage, complete blood cell counts, multi-parasites including relapsing fever and Filarias, Tuberculosis, Pap smear analysis, urine tests and/or analysis and veterinary diseases.
  • a disease condition selected from the group consisting of: G6PD deficiency output, blood glucose levels, malaria parasites including, P. falciparum, P. vivax , P. malaria. P. ovale, P. knowlesi and the disease stage, complete blood cell counts, multi-parasites including relapsing fever and Filarias, Tuberculosis, Pap smear analysis, urine tests and/or analysis and veterinary diseases.
  • the device additionally comprises: a processor programmed to determine a treatment for the disease condition, the processor in communication with the analytics module.
  • the device additionally comprises: a processor programmed to determine a treatment for the disease condition, the processor in communication with the analytics module and the signal analyzer.
  • the imaging channel and the signal channel are configured to output the determination of the existence of the disease condition in real time.
  • the device includes a display in communication with the imaging channel and the signal channel.
  • the display includes one or more of: 1) a screen display, and, 2) a display output configured for communicating with an image sensor of an external computer device for displaying graphics on the display screen of the external computer device.
  • the imaging channel includes a first end for receiving the sample, and an oppositely disposed second end associated with the display.
  • the device additionally comprises: an analog to digital signal converter (ADC) in communication with the signal analyzer; and, a signal reader for reading the electrochemical signals (e.g., analog signals) emitted from the electrode having reacted to the sample, the signal reader in communication with the ADC.
  • ADC analog to digital signal converter
  • the signal analyzer is configured for analyzing signals determine disease conditions selected from the group consisting of: G6PD output, blood glucose levels, malaria parasites including: P. falciparum, P. vivax , P. malaria. P. ovale, and the disease stage, complete blood cell counts, multi-parasites including: relapsing fever and Filarias, Tuberculosis, Pap smear analysis, and veterinary diseases.
  • disease conditions selected from the group consisting of: G6PD output, blood glucose levels, malaria parasites including: P. falciparum, P. vivax , P. malaria. P. ovale, and the disease stage, complete blood cell counts, multi-parasites including: relapsing fever and Filarias, Tuberculosis, Pap smear analysis, and veterinary diseases.
  • the device additionally comprises: a processor programmed to transmit data to the display which causes presentation of a User Interface (UI) graphic display of the presence the disease condition.
  • UI User Interface
  • the device additionally comprises: a location module in communication with at least one of the imaging channel or the signal channel, the location module configured for displaying real-time location indications based on Global Positioning System (GPS) mapping of the detection of the disease condition.
  • GPS Global Positioning System
  • the device additionally comprises: a first port for receiving a microfluidic chip holding the sample for being rendered viewable in the imaging channel; and, a second port for receiving an electrode holding the sample in the signal channel.
  • the device additionally comprises: a microfluidic chip for sample preparation for receipt in the first port.
  • the device additionally comprises: a biosensor strip including an electrode for producing an electrochemical response when contacted by a sample, for receipt in the second port.
  • the sample includes portions of the same sample and the sample includes at least one of blood, urine, and tissue.
  • the microfluidic chip is configured for mixing the sample, with one or more of staining agents, imaging enhancers, and dilatants.
  • Embodiments of the invention are directed to a microfluidic apparatus, also known as a microfluidic chip or chip.
  • the microfluidic apparatus comprises: a substrate including oppositely disposed first and second sides; a chamber extending into the substrate from the first side toward the second side to a base, the chamber including protruding elements forming a wall of the chamber; and, a main channel extending along at least a portion of the wall of the chamber along the base of the chamber.
  • the microfluidic apparatus is such that it additionally comprises: at least one channel extending from the main channel, the at least one channel configured to align with optics of a device in which the substrate is being viewed.
  • the microfluidic apparatus is such that the plates are of a flexible and resilient material.
  • the microfluidic apparatus is such that the main channel is intermediate (elevationally) the plates forming the wall and the base.
  • the microfluidic apparatus is such that the main channel comprises oppositely disposed upper and lower walls with an outer wall intermediate to the upper and lower walls.
  • FIG. 1 shows an example embodiment of the invention, where an electronic device 100, in the form of a base (the electronic device 100 also known as a base, with these terms being used interchangeably herein), receives a mobile computing device, for example, a smart phone 102, including a display screen 103, in a mechanical engagement, so as to be directly linked to the optics and in electronic and/or data communication to each other.
  • the base 100 and smart phone 102 may also be linked to each other through communications networks, such as a wide area or public network such as the Internet. There may also be linking via near field communications and other electronic communication formats and direct links through an Input/Output (I/O) port of a communications module 254 ( FIG. 2 ).
  • I/O Input/Output
  • the other port 114 serves as a signal channel or electrochemical channel ("signal channel” and "electrochemical channel” used interchangeably herein), for analyzing electrochemical signals from the blood sample on the electrode 116b of the biosensor strip 116, and for example, for malaria infected patients, determining whether there is a Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency to decide on the appropriate and precise medication.
  • signal channel and electrochemical channel” used interchangeably herein
  • G6PD Glucose-6-Phosphate Dehydrogenase
  • FIG. 2 shows a block diagram of the base 100 and the smart phone 102.
  • the base 100 and smart phone 102 are shown directly connected to each other, and are linked to one or more networks 200, such as local area networks (LANs), and wide area networks (WANs), including public networks, such as the Internet, cellular networks and other communications networks.
  • networks 200 such as local area networks (LANs), and wide area networks (WANs), including public networks, such as the Internet, cellular networks and other communications networks.
  • CPU central processing unit
  • USB universal serial bus
  • the central processing unit (CPU) 202 is formed of one or more processors, in electronic and data communication with storage/memory 204, which stores machine executable instructions for execution by the CPU 202, to perform the processes of the dual channels.
  • the power source 206 is a battery or plug-in power source.
  • the communications module 208 provides network (e.g., Internet) connectivity and communication to and from the base 100, in addition to providing the direct connection, for electronic and data communication between the base 100 and the smart phone 102.
  • the imaging channel includes the port 110, which receives a microfluidic chip 112 ( FIG. 1 ), also known as a microfluidic apparatus.
  • the microfluidic chip 110 is made viewable by optics 308 ( FIG. 3 ), including an optomechanical system 212, and an optical relay system 214, and ends in an optical module lens 216, through which an image is transmitted.
  • the optics 308, for example, the optomechanical system 212 magnifies the sample and enhances the visual presentation, including images, to being able to achieve high-resolution of microns, thereof.
  • the microfluidic chip 112 operates based on capillary action, to transport the received blood, and stain it, in order to be properly viewed.
  • An optomechanical system 212 (with a controller 212a) provides for scanning the microfluidic chip 112 (the scanning provided by movement of a stand/drawer 302 on a scanning mechanism 304 ( FIG. 3 ) by the controller 212a) for microscopic viewing, by an optical relay system 214, which terminates in an optical module lens 216.
  • the optomechanical system 212 and optical relay system 214 are in electronic and/or data communication either directly or indirectly with the CPU 202, storage/memory 204, power source 206, and the communications module 208.
  • the microfluidic chip 112a shown in FIG. 6A includes a substrate 601, of glass or polymer or both or other material with/without hydrophilic coating, suitable for supporting blood and/or other fluids (liquids), such as urine, and which may also include other components, e.g., stain, for microscopy, and other substances (solid, liquid or gas), for example, as powders from breakable capsules.
  • a blood inlet 602 On the substrate 601 is a blood inlet 602, and a stain, encased in a blister (packet) 604, at one end 601a of the substrate 601.
  • pressure on the blister 604 ruptures the blister 604 from the tunnel side and press the stain through the microfluidic tunnel 606.
  • the blood and/or a diluted blood and stain travel via a microfluidic channel 606 to a serpentine shaped microfluidic channel 608 which serves as a mixing region 610 for the blood and stain.
  • the viewing region 614 is configured on the substrate 601 to align with the optics 308 of the optomechanical system 212 of the apparatus 100, 500.
  • the microfluidic chip 112b shown in FIG. 6B includes a substrate 601, for supporting blood and other components, e.g., stain, washing solution, for microscopy.
  • a blood inlet 622 On the substrate 601 is a blood inlet 622, a stain, encased in a blister (packet) 624, and a washing solution, encased in a blister (packet) 626, at one end of the substrate 601a.
  • blood from the blood inlet 622 flows through the microfluidic channel 628, leaving blood cells adhered to the walls of the microfluidic channel 628.
  • Pressure on the blister 624 ruptures the blister 624, causing the stain to flow through the microfluidic channel 628 over the adhered blood cells, such that stain and cells reach the staining and viewing region 630 on the substrate 601.
  • the staining and viewing region 630 is configured on the substrate 601 to align with the optics 308 of the optomechanical system 212 of the apparatus 100, 500.
  • pressure on the blister 626 ruptures the blister 626, causing the washing solution to flow through the microfluidic channel 628 removing any residual stain and dilute the blood-stain mixture.
  • the microfluidic chip 112c shown in FIG. 6C includes a substrate 601 for supporting blood and other components, e.g., stain, for microscopy.
  • a blood inlet 642 at one end 601a of the substrate 601
  • a microfluidic channel 644 which ends in a staining and viewing chamber 646 (at the other end 601b of the substrate 601).
  • the staining and viewing chamber 646 is configured on the substrate 601 to align with the optics 308 of the optomechanical system 212 of the apparatus 100, 500, 500'.
  • Stain in a dry state, is contained in the walls of the microfluidic channel 644, such that as blood or a diluted blood 647 flows through the microfluidic channel 644 to the staining and viewing region, the blood 647 picks up stain.
  • This microfluidic chip 112 is typically used for viewing single red blood cells.
  • the microfluidic channel is shallow, approximately 10 micrometers in diameter, since the blood is not being diluted.
  • the microfluidic chip 112d shown in FIG. 6D includes a substrate 601, for supporting blood and other components.
  • the substrate 601, at one end 601a supports a sample inlet 652, which joins a microfluidic channel 654, which, in turn, joins and terminates at a viewing chamber 656, at the other end 601b of the substrate 601.
  • a blood sample, diluted or non-diluted mixed with a stain 657 is placed into the sample inlet 652, where the stained sample flows to the viewing region 656.
  • the viewing chamber 656 is configured on the substrate 601 to align with the optics 308 of the optomechanical system 212 of the apparatus (devices) 100, 500, 500'.
  • FIGs. 6E-1A , 6E-1B , 6E-2 , 6E-3, 6E-4, 6E-5 and 6E-6 ( 6E-1A to 6E-6 ), which show another microfluidic chip 112e for the devices 100, 500, 500'.
  • a mixing chamber 662 extends into a substrate (body) 664, from a first side 666a, for example, an upper (top) side at the upper surface 666ax, to a base 668.
  • the base 668 is surrounded partially by a main channel 670 at a second side 666b, for example, a lower (bottom) side.
  • the base 668 is an extension of the mixing chamber 662, and serves as a pressure balancing reservoir, for example, for the collection of excess blood-stain mixture.
  • the base portion 668x is surrounded by the main channel 670, and together function as communicating vessels during blood-stain mixing.
  • the main channel 670 is substantially U-shaped, with a main C-shaped portion 670a outwardly extending portions 670b, which form the beginning of the channel 670, and, for example, serve as a receiving area for blood and other fluids.
  • the first side 666a and second side 666b are, for example, oppositely disposed from each other.
  • Inlet/outlet channels 672 terminating in apertures 673, each extend from the respective extending portion 670b of the main channel 670.
  • blood/fluid is inserted from the aperture 673 through the channel 672, where the blood/fluid fills the main channel 670 driven by capillary forces.
  • a scanning channel 674 which is configured to be aligned with the optics 308 of the optomechanical systems of the respective apparatus 100, 500, 500', extends from the main channel 670, through the substrate 664, to a pressure outlet channel 676.
  • the scanning channel 674 is oriented, for example, substantially perpendicular or perpendicular to the pressure outlet channel 676.
  • the pressure outlet channel 676 terminates in an aperture 678, which is initially sealed (closed).
  • an air inlet/outlet is created, such that blood (or fluid) and/or blood (or fluid)/stain mixture (which may also include other substances, such as those from a breakable capsule, as detailed below) fills the scanning channel 674.
  • the mixing chamber 662 extends into the substrate 664 in the form of an inward tapered (from the first side 666a to the second side 666b) truncated cone, which is, for example, rounded, substantially circular, or circular, although other shapes, including inwardly tapered shapes are also permissible.
  • the wall 680 of the mixing chamber 662 is formed of overlapping (interleaved) plates 682, or protruding elements. The plates 682 provide traction for mixing, when an element, such as a breakable or crushable capsule, is placed into the mixing chamber 662.
  • the wall 680 extends inward into the substrate 664, such that the plates 682 terminate at the main channel 670, at a first or upper wall 684 of the main channel 670.
  • the main channel 670 also includes an outer wall 685, which joins to the base 668 (the base 668 forms a third or lower wall of the channel 670, this third wall 668 oppositely disposed from the first wall 684).
  • the outer wall 685 is substantially perpendicular or perpendicular to the first wall 684 and the base 668, such that the main channel 670 is open along one side, as shown in FIGs 6E-4 and 6E-5 .
  • the substrate 664 is made of plastic material, allowing it to be optically translucent, and for example, transparent.
  • the plates 682 (forming the chamber wall 680) are made of an elastomeric material, which for example is flexible and resilient. All of the aforementioned materials can sterilized by heat and the like.
  • FIG. 6E-6 is a photograph of the second side 666b of the microfluidic chip 112e showing the main channel 670 having been filled with blood and/or fluid (which may also include stain and/or other substances) by capillary action.
  • FIG. 6F shows another embodiment of a microfluidic chip 112f, including a substrate 664.
  • This microfluidic chip 112f is similar in construction to the chip 112e of FIGs. 6E-1A to 6E-6 , with corresponding structures being having the same element numbers and description as detailed for the microfluidic chip 112e above, except where specifically indicated.
  • This microfluidic chip 112f includes two mixing chambers 662 and channel structures as described for the microfluidic chip 112e detailed above, but adds a fluid inlet 686.
  • the fluid (liquid) inlet 686 is in fluid communication with reference channels 688 and 688a, which lead to the main channels 670 of the respective mixing chambers 662.
  • the scanning channels 674 are configured to be aligned with the optics 308 of the optomechanical systems of the respective apparatus 100, 500, 500'.
  • the scanning channels 674 terminate in pressure channels (not shown), which terminate in apertures 678, in accordance with that detailed for the microfluidic chip 112e.
  • FIG. 6G shows another embodiment of a microfluidic chip 112g which is rounded. Elements similar to those of microfluidic chips 112e, 112f are provided with the same element numbers and are in accordance with the descriptions provided above, for the respective microfluidic chip 112e, 112f, except where specifically indicated.
  • the microfluidic chip 112g is formed of a substrate 664, and has two mixing chambers 662, which overlie main channels 690, which are similar to main channels 670, as they are U-shaped with outward extensions. Blood/fluid is received in a fluid inlet 692, which are in fluid communication with reference channels 693, which, in turn, are in fluid communication with the main channels 690 of the respective mixing chambers 662. Test channels 694, which are also reference channels, are in communication with the respective reference channels 693.
  • the main channels 690 are in fluid communication with scanning channels 696, and extend from the mixing chambers 662.
  • the scanning channels 696 are then rounded, with rounded portions 696a in accordance with the rounded shape of the microfluidic chip 112g and the substrate 664.
  • the scanning channels 696 (including portions 696a) are configured to be aligned with the optics of the optomechanical systems of the respective apparatus.
  • Pressure outlet channels 698 extend from the scanning channel 696 at the rounded portions 696a.
  • the pressure outlet channels 698 are oriented, for example, substantially perpendicular or perpendicular to scanning channels 696.
  • the pressure outlet channels 698 each terminate in an aperture 699, which is sealed, until opened, as detailed for the aperture 678, above.
  • microfluidic chips 112f, 112g operate similarly, and the description of operation for the microfluidic chip 112e is applicable for these microfluidic chips 112f, 112g.
  • blood or other fluid hereinafter blood to describe the example operation
  • the main channel 670 the fluid inlet 686 of the microfluidic chip 112f and the fluid inlet of 692 of the microfluidic chip 112g.
  • a breakable capsule or other substance is placed into the mixing chamber 662, and is crushed, for example, by applying pressure on the mixing chamber 662.
  • the encapsulated reagent mixes with the blood in the main channel 670.
  • the aperture 678 of the respective pressure outlet channel 676 is opened, so as to be at ambient pressure, such that the mixed blood/substance flows so as to fill the scanning channel 674, for viewing analysis by the optics of the device (apparatus) 100, 500, 500'.
  • the signal channel originates at the port 114, and includes a bio-sensor strip reader 222, which reads the electrical response (generated electrical current from the electrochemical reaction between the sample and the electrode 116b, output from the electrode 116b/biosensor strip 116 as an analog signal) from the disposable biosensor electrode 116b (e.g., at the operative end 116a of the biosensor strip 116), and amplifies the analog signal of the electrical response, the analog signal indicative of the electrochemical reaction, for a disease, condition, measurement, or the like.
  • the electrical response generated electrical current from the electrochemical reaction between the sample and the electrode 116b, output from the electrode 116b/biosensor strip 116 as an analog signal
  • the disposable biosensor electrode 116b e.g., at the operative end 116a of the biosensor strip 116
  • ADC analog to digital converter
  • signal analysis software module 226, which analyzes the digital signals to decide whether or not there is a G6PD deficiency in this sample, and which communicates with the communications module 208, to send the signals to the smart phone 102, for additional analysis.
  • the signal channel can be used for blood glucose level detection.
  • the biosensor strip reader 222 is additionally configured to amplify the analog signal(s), generated from the electrical response, from the disposable biosensor electrode (e.g., biosensor strip 116).
  • the analog signals correspond to blood glucose levels.
  • the analog to digital converter (ADC) 224 converts the analog signals from the reader 222 to digital signals, and a signal analysis module 226, analyzes the digital signals received from the ADC 224, to determine the blood glucose level in the blood sample.
  • ADC analog to digital converter
  • This blood glucose level is output in accordance with standard measurements for blood glucose, to the communications module 208, to send the signals to the smart phone 102, for additional analysis, and for presentation on the display screen (of the smart phone 102 or stand-alone device 500, 500' ( FIGs. 5A and 5B )).
  • biosensor strips 116 may include multiple biosensor electrodes 116b, including electrodes for producing electrical responses, convertible into signals readable for detecting G6PD deficiency and blood glucose levels contemporaneously, and for example, simultaneously.
  • the analog to digital converter (ADC) 224 converts the analog signals from the reader 222 to digital signals, and a signal analysis module 226 (programmed to determine the condition, e.g., presence of absence thereof), analyzes the digital signals received from the ADC 224, to determine the condition.
  • This condition determination is output, to the communications module 208, to send the signals of this determination to the smart phone 102, for presentation on the display screen (of the smart phone 102 or stand-alone device 500, 500' ( FIGs. 5A and 5B )).
  • the base 100 and smart phone 102 also link, via the network(s) 200 to a telemedicine provider 280, via a computer 280a or a smart phone 280b (via a cellular tower 282), for example.
  • the telemedicine provider 280 can provide a diagnosis, that is sent either to the cloud server 270 or back to the analytics module 246 of the smart phone 102.
  • FIG. 4A is a flow diagram of an example, microscopy process for the microscopy channel of the invention.
  • a blood sample is obtained and placed onto a microfluidic chip, such as microfluidic chip 112, detailed above, and the blood is stained, with the microfluidic chip 112 placed into the base 100, via the port 110, at block 402.
  • the microscopic image of the blood sample reaches the camera 260 of the smart phone or in a standalone device concept 102.
  • the image in the camera/image sensor unit 260 is converted to digital data, e.g., digital signals, at block 406.
  • the analytics module 564 analyzes the scanned sample, for example, by image identification, Artificial Intelligence and the like, to determine the existence or nonexistence of a disease and/or condition (e.g., diagnosis of malaria parasites), or a measurement (for example, blood glucose levels and complete blood cell counts).
  • the optical relay system 214 is optional, as the device 500 ( FIG. 5A ) can work as a standalone device, where the lens 216 and the optical relay system 214 are not needed, or with a smart phone or other device, where the optical relay system 214 and lens 216 may be needed.
  • the device 500' FIG. 5B ) lacks the optical relay system 214 and the lens 216, and as such, operates exclusively as a standalone device.
  • FIG. 5C shows the device 500' as a stand-alone unit, including a screen display 503, which is presenting a screen shot 580.
  • This device 500' is hand held and therefore portable and battery operated as well as option for recharging from external power supply and solar energy.
  • FIG. 7 shows a process as a decision diagram, for example, programmed into (and performed by) the CPU 202 of devices 100, 500, and 500' for treatment decision support (e.g., providing treatment recommendations, treatment protocols and the like).
  • the treatment recommendations and protocols appear for example, as user interfaces (UI) on screen displays, such as those on the screen display 503 of the stand-alone device 500', shown as screen displays (screen shots) 580a-580d in FIGs. 8A-8D , and detailed below.
  • UI user interfaces
  • Falciparum malaria is detected, at block 702.
  • a glucose check is performed to see if the subject is hypoglycemic, at block 704. If yes, a treatment with artemisinin combination therapy (ACT) is suggested, at block 706.
  • ACT artemisinin combination therapy
  • primaquine is used for prevention of a further transmission, G6PD deficiency testing, via devices 100, 500, 500' disclosed herein, may be used before treatment.
  • Non-Falciparum malaria or mixed infection is detected, at block 712.
  • Treatment is suggested with ACT or chloroquine as well as G6PD testing via devices disclosed 100, 500, 500' herein, at block 714. If G6PD is negative, treatment with primaquine is suggested, at block 716.
  • FIG. 8A shows the device 500' with a screen shot 580a showing the result of a malaria test, and suggesting a treatment protocol.
  • FIG. 8B shows the device 500' with a screen shot 580b showing the result of a malaria test, and providing information on medicines, which could be from the CPU 202 or a cloud server 270.
  • FIG. 8C shows the device 500' with a screen shot 580c detailing a white blood cell count.
  • FIG. 8D shows the device 500' with a screen shot 580d detailing a red blood cell count.
  • While the devices and methods disclosed above relate to diseases, such as malaria, these devices are also adaptable for diagnosing other diseases conditions and blood count such as white/red blood cell counts and white blood cell differentiation, with various modules programmed to recognize white/red blood cells and for analytics thereof.
  • the implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.
  • a data processor such as a computing platform for executing a plurality of instructions.
  • the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, non-transitory storage media such as a magnetic hard-disk and/or removable media, for storing instructions and/or data.
  • a network connection is provided as well.
  • a display and/or a user input device such as a keyboard or mouse or printer are optionally provided as well.
  • non-transitory computer readable (storage) medium may be utilized in accordance with the above-listed embodiments of the present invention.
  • the non-transitory computer readable (storage) medium may be a computer readable signal medium or a computer readable storage medium.
  • a computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing.
  • a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
  • a computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof.
  • a computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.
  • each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s).
  • the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Health & Medical Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
EP20189472.2A 2019-08-06 2020-08-04 Mikromischer Pending EP3772371A1 (de)

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Publication number Priority date Publication date Assignee Title
WO2023079436A1 (en) * 2021-11-02 2023-05-11 E.F.A. Engineering For All Ltd. Micromixer and method for concentration measurement of unknown sample

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Publication number Priority date Publication date Assignee Title
US20180304252A1 (en) * 2017-04-19 2018-10-25 Skyla Corporation Hsinchu Science Park Branch Detection apparatus and inlet structure thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180304252A1 (en) * 2017-04-19 2018-10-25 Skyla Corporation Hsinchu Science Park Branch Detection apparatus and inlet structure thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023079436A1 (en) * 2021-11-02 2023-05-11 E.F.A. Engineering For All Ltd. Micromixer and method for concentration measurement of unknown sample

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