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WO2019059930A1 - Système de mesure de l'hémoglobine totale dans le sang et son procédé de réalisation - Google Patents

Système de mesure de l'hémoglobine totale dans le sang et son procédé de réalisation Download PDF

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Publication number
WO2019059930A1
WO2019059930A1 PCT/US2017/053021 US2017053021W WO2019059930A1 WO 2019059930 A1 WO2019059930 A1 WO 2019059930A1 US 2017053021 W US2017053021 W US 2017053021W WO 2019059930 A1 WO2019059930 A1 WO 2019059930A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
total hemoglobin
measurement
blood sample
disposable body
Prior art date
Application number
PCT/US2017/053021
Other languages
English (en)
Inventor
Emmanuel Mpock
Original Assignee
Emmanuel Mpock
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 Emmanuel Mpock filed Critical Emmanuel Mpock
Priority to PCT/US2017/053021 priority Critical patent/WO2019059930A1/fr
Publication of WO2019059930A1 publication Critical patent/WO2019059930A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry

Definitions

  • the embodiments described herein relate generally to the measurement of hemoglobin in the blood, and more particularly, to methods and corresponding systems for measuring the total hemoglobin in whole blood using its physical, optical and electrical properties.
  • measuring the total amount of hemoglobin in blood is done indirectly by lysing the red blood cells exposing released hemoglobin molecules to other molecules to which they bind to form stable compounds with characteristics that allow them to be optically or electrochemically measured.
  • the resulting concentrations of these compounds are typically directly proportional to the amount of hemoglobin in the sample.
  • chemical interference from medications, other blood components, and incomplete reagent rehydration can impact the accuracy and prolong the reaction time required for known methods.
  • a system can be used for determining a total hemoglobin concentration in a blood sample.
  • the system has a strip that has a capillary channel having an entrance and a vent.
  • a disposable body is housed within the capillary channel and adapted to receive a flow of blood from the entrance such that air in the disposable body is pushed out through a vent.
  • a measurement system is configured to measure a property of the flow of blood.
  • a non-transitory computer readable medium stores a program in memory that causes a processor to execute a process for determining the total hemoglobin concentration in the blood sample. The process involves receiving a first measurement from the measurement system. Then, calculating the total hemoglobin concentration in the blood sample based on the property. Finally, displaying the total hemoglobin concentration in the blood sample.
  • Figure 1 shows a schematic of an embodiment of the solid disposable unitary body configured for optical measurements
  • Figure 2 shows a schematic of an embodiment of a solid disposable unitary body configured for electrical measurements
  • Figure 3 shows a graph of a flow to static delta versus reference total hemoglobin values (data from physical measurement);
  • Figure 4 shows a schematic of an embodiment of the system
  • Figure 5 is a graph of the total hemoglobin versus reciprocal of the broad blue signal (data from spectral measurement);
  • Figure 6 is a graph of the total hemoglobin versus multiple wavelength ratio like blue and red (data from spectral measurement);
  • Figure 7 is a graph of the total hemoglobin versus flow speed (data from physical measurement).
  • Figure 8 is a graph of the total hemoglobin versus impedance (data from electrical measurement).
  • Figure 9 is a schematic of an embodiment of a circuit for impedance or resistance measurement
  • Figure 10 is a schematic of an embodiment of a strip.
  • one embodiment of measurement system 10 comprises disposable body 12.
  • Disposable body 12 further comprises central channel 14.
  • Central channel 14 is adapted to receive a flow of whole unlysed blood 16. Flow of whole unlysed blood 16 will pass through central channel 14 unless valve 18 in central channel 14 is closed.
  • Diode for optical detection 20 is at a distal end of disposable body 12.
  • Radiation emitter 22 produces radiation 24 which travels through disposable body 12, channel 14, whole unlysed blood 16 and into diode for optical detection 20.
  • one embodiment of measurement system 110 comprises disposable body 112.
  • Disposable body 112 further comprises central channel 114.
  • Central channel 114 is adapted to receive a flow of whole unlysed blood 116.
  • Measurement circuit 126 further comprises power source 128 connected to first lead 130 and second lead 132. Measurement circuit 126 measures either resistance (if using direct current) or impedance (if using alternating circuit) to determine the total hemoglobin level of whole unlysed blood 116.
  • the disposable body may have any desired size and, in some embodiments, comprises a channel having a height of from about 0.002 to about 0.050 inches, a length of from about 0.25 to about 2.0 inches, and a width of from about 0.02 to about 0.2 inches.
  • the channel may hold a sample volume ranging from about 1 to about 10 microliters.
  • the channel may have a predesigned size adapted for making photometric or electrical measurements with undiluted whole whole unlysed blood or whole unlysed blood derivatives.
  • the body and channel may be cylindrical or a slide and may comprise a plastic or metal plastic hybrid.
  • measurement circuit 226 further comprises power source 228 in parallel with voltmeter 230, ammeter 232 and load 234.
  • power source 228 in parallel with voltmeter 230, ammeter 232 and load 234.
  • measurement system 10 can be embodied into strip 40.
  • Strip 40 further comprises capillary channel 42 which can house disposable body 12.
  • Capillary channel 42 further comprises entrance 44 and vent 46. This enables flow of whole unlysed blood 16 to push air from capillary channel 42 and out of vent 46.
  • Strip 40 must be made such that surface energy of material is the same on both sides of the strip. This controls movement of whole unlysed blood 16 and ensures that movement of whole unlysed blood 16 is accurate for measurement. For instance, a sufficiently hydrophilic material is needed such as glass. A hydrophobic material will result in whole unlysed blood 16 beading and causing errors in the reading. Whether a compound is sufficiently hydrophilic can be determined by measuring the number of Hydroxyl groups (- OH), found in alcohols which are polar and therefore hydrophilic.
  • a control light needs to be selected by the user.
  • white light will be slightly distorted if there is excessive amounts of fat in whole unlysed blood, but the wavelength could be broken up into red, orange, yellow, green, blue, indigo and violet.
  • An example using blue light is shown in Figure 3.
  • To complete this experiment light is first reflected from radiation emitter 22 into optical detection diode 24 to obtain a control optical density (or absorbance). After that, whole unlysed blood 16 is introduced into the system and the same light is passed through the whole unlysed blood. The absorbance is the natural log of the radiant flux transmitted divided by the radiant flux received. This is graphed for blue light to determine total hemoglobin in Figure 3. Approximately, 3-4 microliters of whole unlysed blood are required to complete this test, which is much less than the 10 microliters currently required in testing.
  • FIG. 4 conceptually illustrates an electronic system 200 with which some embodiments of the invention are implemented.
  • the electronic system 200 may be a computer, phone, PDA, or any other sort of electronic device.
  • Such an electronic system includes various types of computer readable media and interfaces for various other types of computer readable media.
  • Electronic system 200 includes a bus 205, processing unit(s) 210, a system memory 215, a read-only 220, a permanent storage device 225, input devices 230, output devices 235, and a network 240.
  • the bus 205 collectively represents all system, peripheral, and chipset buses that communicatively connect the numerous internal devices of the electronic system 200.
  • the bus 205 communicatively connects the processing unit(s) 210 with the read-only 220, the system memory 215, and the permanent storage device 225.
  • the processing unit(s) 210 retrieves instructions to execute and data to process in order to execute the processes of the invention.
  • the processing unit(s) may be a single processor or a multi-core processor in different embodiments.
  • the read-only-memory (ROM) 220 stores static data and instructions that are needed by the processing unit(s) 210 and other modules of the electronic system.
  • the permanent storage device 225 is a read- and- write memory device. This device is a non- volatile memory unit that stores instructions and data even when the electronic system 200 is off. Some embodiments of the invention use a mass-storage device (such as a magnetic or optical disk and its corresponding disk drive) as the permanent storage device 225.
  • the system memory 215 is a read-and- write memory device. However, unlike storage device 225, the system memory 215 is a volatile read-and- write memory, such as a random access memory.
  • the system memory 215 stores some of the instructions and data that the processor needs at runtime.
  • the invention's processes are stored in the system memory 215, the permanent storage device 225, and/or the read-only 220.
  • the various memory units include instructions for processing appearance alterations of displayable characters in accordance with some embodiments. From these various memory units, the processing unit(s) 210 retrieves instructions to execute and data to process in order to execute the processes of some embodiments.
  • the bus 205 also connects to the input and output devices 230 and 235.
  • the input devices enable the person to communicate information and select commands to the electronic system.
  • the input devices 230 include alphanumeric keyboards and pointing devices (also called “cursor control devices").
  • the output devices 235 display images generated by the electronic system 200.
  • the output devices 235 include printers and display devices, such as cathode ray tubes (CRT) or liquid crystal displays (LCD). Some embodiments include devices such as a touchscreen that functions as both input and output devices.
  • CTR cathode ray tubes
  • LCD liquid crystal displays
  • bus 205 also couples electronic system 200 to a network 240 through a network adapter (not shown).
  • the computer can be a part of a network of computers (such as a local area network (“LAN”), a wide area network (“WAN”), or an intranet), or a network of networks (such as the Internet). Any or all components of electronic system 200 may be used in conjunction with the invention.
  • Some embodiments include electronic components, such as microprocessors, storage and memory that store computer program instructions in a machine- readable or computer-readable medium (alternatively referred to as computer-readable storage media, machine-readable media, or machine-readable storage media).
  • electronic components such as microprocessors, storage and memory that store computer program instructions in a machine- readable or computer-readable medium (alternatively referred to as computer-readable storage media, machine-readable media, or machine-readable storage media).
  • Such computer-readable media include RAM, ROM, read-only compact discs (CD-ROM), recordable compact discs (CD-R), rewritable compact discs (CD-RW), read-only digital versatile discs (e.g., DVD-ROM, dual-layer DVD-ROM), a variety of recordable/rewritable DVDs (e.g., DVD-RAM, DVD-RW, DVD+RW, etc.), flash memory (e.g., SD cards, mini-SD cards, micro-SD cards, etc.), magnetic and/or solid state hard drives, read-only and recordable Blu-Ray® discs, ultra density optical discs, any other optical or magnetic media, and floppy disks.
  • RAM random access memory
  • ROM read-only compact discs
  • CD-R recordable compact discs
  • CD-RW rewritable compact discs
  • read-only digital versatile discs e.g., DVD-ROM, dual-layer DVD-ROM
  • flash memory e.g., SD cards, mini
  • the computer-readable media may store a computer program that is executable by at least one processing unit and includes sets of instructions for performing various operations.
  • Examples of computer programs or computer code include machine code, such as is produced by a compiler, and files including higher-level code that are executed by a computer, an electronic component, or a microprocessor using an interpreter.
  • the term "substantially” means that the actual value is within about 10% of the actual desired value, particularly within about 5% of the actual desired value and especially within about 1% of the actual desired value of any variable, element or limit set forth herein.
  • Embodiments of the disclosed invention can be useful for determining a total hemoglobin concentration in a whole unlysed blood sample.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente invention concerne la mesure de l'hémoglobine dans le sang. Auparavant, l'interférence chimique de médicaments, d'autres composants sanguins, et une réhydratation de réactif incomplet pouvaient impacter la précision et prolonger le temps de réaction requis pour déterminer l'hémoglobine totale dans le sang. Des modes de réalisation de la présente invention utilisent un corps jetable qui est logé à l'intérieur du canal capillaire et conçu pour recevoir un flux de sang à partir de l'entrée de telle sorte que l'air dans le corps jetable soit poussé vers l'extérieur par l'intermédiaire d'un évent. Un système de mesure est configuré pour mesurer une propriété du flux de sang. Cette propriété peut être corrélée au taux d'hémoglobine totale.
PCT/US2017/053021 2017-09-22 2017-09-22 Système de mesure de l'hémoglobine totale dans le sang et son procédé de réalisation WO2019059930A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2017/053021 WO2019059930A1 (fr) 2017-09-22 2017-09-22 Système de mesure de l'hémoglobine totale dans le sang et son procédé de réalisation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2017/053021 WO2019059930A1 (fr) 2017-09-22 2017-09-22 Système de mesure de l'hémoglobine totale dans le sang et son procédé de réalisation

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040156037A1 (en) * 2003-02-11 2004-08-12 Mawhirt James A. Hemoglobin test strip and analysis system
US20050136551A1 (en) * 2003-10-29 2005-06-23 Mpock Emmanuel C. Micro mechanical methods and systems for performing assays
US20050208677A1 (en) * 1999-01-15 2005-09-22 Medtox Scientific, Inc. Lateral flow test strip
US20060148096A1 (en) * 2002-11-05 2006-07-06 Jina Arvind N Assay device, system and method
US20110011738A1 (en) * 2003-06-20 2011-01-20 Burke David W Test strip with slot vent opening
US20160041104A1 (en) * 2011-12-23 2016-02-11 Abbott Point Of Care Inc. Reader Devices for Optical and Electrochemical Test Devices

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050208677A1 (en) * 1999-01-15 2005-09-22 Medtox Scientific, Inc. Lateral flow test strip
US20060148096A1 (en) * 2002-11-05 2006-07-06 Jina Arvind N Assay device, system and method
US20040156037A1 (en) * 2003-02-11 2004-08-12 Mawhirt James A. Hemoglobin test strip and analysis system
US20110011738A1 (en) * 2003-06-20 2011-01-20 Burke David W Test strip with slot vent opening
US20050136551A1 (en) * 2003-10-29 2005-06-23 Mpock Emmanuel C. Micro mechanical methods and systems for performing assays
US20160041104A1 (en) * 2011-12-23 2016-02-11 Abbott Point Of Care Inc. Reader Devices for Optical and Electrochemical Test Devices

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