WO2009091187A2 - Bio-disque - Google Patents

Bio-disque Download PDF

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Publication number
WO2009091187A2
WO2009091187A2 PCT/KR2009/000206 KR2009000206W WO2009091187A2 WO 2009091187 A2 WO2009091187 A2 WO 2009091187A2 KR 2009000206 W KR2009000206 W KR 2009000206W WO 2009091187 A2 WO2009091187 A2 WO 2009091187A2
Authority
WO
WIPO (PCT)
Prior art keywords
bio
disc
chamber
diagnostic
blood
Prior art date
Application number
PCT/KR2009/000206
Other languages
English (en)
Other versions
WO2009091187A3 (fr
Inventor
Chan Ho Park
Jae Yeol Kim
Yong Cheol Park
Sung Hoon Kim
Yoon Young Chang
In Ho Choi
Jeong Kyo Seo
Sung Ho Hong
Original Assignee
Lg Electronics Inc.
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 KR1020080004620A external-priority patent/KR20090078683A/ko
Priority claimed from KR1020080011506A external-priority patent/KR20090085746A/ko
Priority claimed from KR1020080013436A external-priority patent/KR20090088088A/ko
Priority claimed from KR1020080021569A external-priority patent/KR20090096156A/ko
Priority claimed from KR1020080032319A external-priority patent/KR20090106916A/ko
Priority claimed from KR1020080032318A external-priority patent/KR20090106915A/ko
Priority claimed from KR1020080071591A external-priority patent/KR20100010631A/ko
Priority claimed from KR1020080071590A external-priority patent/KR20100010630A/ko
Priority claimed from KR1020080094158A external-priority patent/KR20100034917A/ko
Priority claimed from KR1020080103227A external-priority patent/KR20100043956A/ko
Priority claimed from KR1020080104754A external-priority patent/KR20100045688A/ko
Priority claimed from KR1020080105156A external-priority patent/KR20100046353A/ko
Application filed by Lg Electronics Inc. filed Critical Lg Electronics Inc.
Publication of WO2009091187A2 publication Critical patent/WO2009091187A2/fr
Publication of WO2009091187A3 publication Critical patent/WO2009091187A3/fr

Links

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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14535—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring haematocrit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis

Definitions

  • the present invention relates to a bio-disc, and more particularly, to a bio-disc suitable for use in health diagnosis through an optical drive.
  • Assaying a body fluid such as blood is important for disease diagnosis.
  • the diagnosis and assay have been generally conducted using complicated equipment by those skilled in the art.
  • the diagnosis and assay typically involve a long time and high costs. Accordingly, there is a demand for rapider and simpler diagnosis methods and a variety of methods satisfying this demand have been suggested .
  • erythrocyte When centrifuged, blood is separated into erythrocyte, buffy coat (leukocyte) and plasma layers, based on the difference in density between constituent components of the blood.
  • buffy coat leukocyte
  • a volume fraction between the separated layers provides essential information required for checking blood condition (patients' condition) , and the volume of respective layers must be accurately 00206
  • a buffy coat volume fraction in blood is less than 1% of the total blood volume, thus making it difficult to accurately measure. Furthermore, subjects who wish to undergo blood testing must go to the hospital for health diagnosis through blood testing which inevitably involves a long time.
  • An object of the present invention is to provide a bio-disc wherein health diagnosis using blood can be simply performed in the home or hospital by applying an optical drive.
  • the object of the present invention can be achieved by providing a bio-disc comprising: a diagnostic region in which writing and reading data is protected; and a recording region, except for the diagnostic region, in which writing and reading data is permitted, wherein the diagnostic region includes: an injection chamber provided with an inlet through which a reagent is injected, and at least one diagnostic channel to assay the reagent, connected to the injection chamber.
  • FIG. 1 is a graph showing correlation between hematocrit level and blood viscosity
  • FIG. 2 is a schematic view illustrating an overall example of a health diagnosis system using a bio-disc ;
  • FIG. 3 is a schematic diagram illustrating an application of a health diagnosis system using a bio-disc
  • FIG. 4 is a plan view illustrating a bio-disc according to one embodiment
  • FIG. 5 is a block diagram illustrating the overall structure of a health diagnosis system.
  • FIG. 6 is a detailed block diagram illustrating a health diagnosis system according to one embodiment ;
  • FIG. 7 is a detailed block diagram illustrating a health diagnosis system according to another embodiment .
  • FIG. 8 is a schematic diagram illustrating a process wherein a pick-up scans a diagnostic channel of the bio-disc,-
  • FIG. 9 is a graph showing information read according to the position of the diagnostic channel;
  • FIGs. 10 to 17 illustrate bio-discs according to the position of the diagnostic channel according to exemplary embodiments ;
  • FIG. 18 is a schematic diagram showing examples of information recorded in the bio-disc.
  • FIGs. 19 to 24 are schematic views illustrating examples of an information recording region of the bio-disc ;
  • FIGs. 25 to 29 are schematic views illustrating other examples of information recorded in the bio-disc.
  • FIGs. 30 to 33 are sectional views illustrating the structure of the bio-disc,-
  • FIG. 34 is a graph showing reflectance of metals used for a reflective layer of the bio-disc.
  • FIG. 35 is a schematic view illustrating a diagnostic channel of the bio-disc
  • FIGs. 36 to 38 are schematic views illustrating a process for measuring hematocrit using the diagnostic channel in FIG. 35;
  • FIGs. 39 to 41 are views illustrating examples of a float inserted into the diagnostic channel
  • FIGs. 42 to 63 are views illustrating examples of the bio-disc including various diagnostic channels ;
  • FIG. 64 is a schematic view illustrating a process for measuring hematocrit using the diagnostic channel
  • FIG. 65 is a graph showing one example wherein spindle motor rotation frequency is controlled upon hematocrit measurement
  • FIG. 66 is a graph showing another example wherein spindle motor rotation frequency is controlled upon hematocrit measurement
  • FIGs. 67 and 68 are schematic views illustrating a process wherein a pick-up detects a bio-disc diagnostic channel
  • FIG. 69 is a graph showing the base area and diagnostic channel detected by the pick-up.
  • FIG. 70 is a partially exploded perspective view illustrating the cross-section including a reflective layer of a bio-disc
  • PIG. 71 is an enlarged view illustrating the cross - section of the diagnostic channel shown in FIG 70;
  • PIGs. 72 and 73 are views illustrating material detection, based on the difference in reflectance
  • FIGs. 74 to 76 are schematic views illustrating a method for recording information associated with the bio-disc ;
  • FIGs. 77 to 79 are schematic views illustrating a process for measuring hematocrit using the diagnostic channel in FIG. 60;
  • FIG. 80 is a graph showing a rotation speed control of the bio-disc
  • FIG. 81 is a flow chart illustrating a process for detecting a centrifugation end point.
  • FIGs. 82 to 86 are views illustrating a process for detecting the diagnostic channel and the base area using the pick-up.
  • Blood is generally separated into plasma, an intermediate layer (also called "buffy coat"), blood cells, etc, in order of density.
  • the intermediate layer consists of leukocytes, platelets and a small amount of cells, which is present in an amount of about 1% of the blood.
  • diagnosis of the intermediate layer cannot be carried out using general equipment and thus inevitably requires the use of an expensive system for counting cells such as a flow-cytometer .
  • Such a system is highly accurate, but is expensive and difficult to handle, thus being unsuitable for use in general patients. Accordingly, in an attempt to solve these disadvantages, the present invention provides a bio- disc and a diagnostic apparatus for blood analysis, which are applicable to general optical drives and are used for measuring plasma, blood cells, leukocytes, etc. in the blood.
  • bio-disc and optical drive of the present invention it is possible to assay the amount of blood components by measuring the volume of the plasma, erythrocytes and buffy coat separated from the blood of animals or humans .
  • the optical disc which operates in a disc drive can rotate at a high rate, and the rotation speed and direction thereof can be controlled. Accordingly, in the case where an optical disc includes a channel suited to accept blood or other liquids targeted for diagnosis, the disc is used as a bio-disc, based on the centrifugation capability through disc rotation.
  • an erythrocyte volume fraction in blood is about 35 to 55% for normal people.
  • the most important function of erythrocytes in the blood is to carry oxygen.
  • a disease such as anemia may occur.
  • blood is thick and blood circulation disorders such as dementia and heart attack may thus occur.
  • An erythrocyte volume fraction in blood can be simply obtained by calculating the proportion of plasma and blood cells separated from the centrifuged blood.
  • a blood cell volume fraction in blood may be measured using a hematocrit test to determine the volume occupied by blood cells in blood.
  • FIG. 1 is a graph showing correlation between hematocrit level and. blood viscosity. Out of normal hematocrit level, erythrocytes containing components such as hemoglobin are lacking, thus causing diseases such as anemia.
  • hematocrit level is closely related to the treatment of patients that suffer from cardiovascular diseases.
  • a system that comprises an interior/exterior optical drive 300 to measure hematocrit and a bio- disc 100 to enable measurement of hematocrit using the optical drive 300 is "loan" to "patients” suffering from cardiovascular diseases in accordance with "doctor's prescription", to allow the patients to control a hematocrit level in the home, without going to the hospital .
  • this hematocrit level can be continuously fed back by delivering the bio-disc 100, where diagnosis results are recorded, to diagnosticians such as physicians via off-line or on-line .
  • the bio-disc 100 and the optical drive 300 operating the same may be mounted on or connected to devices such as personal computers (PC) or AV players, on which the optical drive 300 can be set upon use in personal medical applications.
  • PC personal computers
  • AV players on which the optical drive 300 can be set upon use in personal medical applications.
  • the optical drive 300 that operates hematocrit diagnosis can be mounted not only on a desktop 530 or a notebook PC 540, but also other on apparatuses on which the optical drive 300 may be mounted.
  • the optical drive 300 may be a stand-alone drive 550 using an input/output system (displays and switches) .
  • the hematocrit system is applicable to an internal/external optical drive 300 and may use all of CD, DVD and BD wavelengths as a light source .
  • the bio-disc 100 for blood analysis into which the blood of users is injected using the optical drive 300 and the system, it is possible to measure hematocrit.
  • the measurement results thus obtained are transmitted to the hospital, for example, over the Internet, and remote health care of users can thus be realized.
  • the length of a blood- containing channel can be measured using an optical pick-up, thus eliminating the necessity of metering the blood and contributing to user convenience and enabling the use of only a small amount of blood. Furthermore, due to small volume and low price of the overall system, the system may be widely utilized in a variety of applications including home, private hospitals and animal hospitals.
  • the bio-disc 100 for hematocrit diagnosis operated by the optical drive 300 may comprise N diagnostic channels 200 and a base line 230 to detect the position of the N diagnostic channels .
  • the system comprises an optical drive 300 that centrifuges blood present in the diagnostic channel by controlling the bio-disc 100 and an operation control system 360, on which the optical drive 300 is mounted, that controls rotation speed and direction of the bio-disc 100 and analyzes the centrifuged blood present in the diagnostic channel in the bio-disc 100 using the pick-up of the optical drive 100, based on the difference in light reflectance.
  • the operation control system 360 may comprise a detector 361 to detect the difference in light reflectance of the centrifuged blood present in the diagnostic channel of the bio-disc 100 using the pick-up of the optical drive 300, an analyzer 362 to process the data detected from the detector 361 into a form suitable for use in diagnosis, and a recorder 363 to record the data obtained in the analyzer 362.
  • the recorder 363 may be arranged in a recording region where the diagnostic channel of the bio-disc 100 is not located, or in an additional storage device and memory.
  • analysis data of the blood recorded in the recorder 363 in the previous step may be transmitted through a transmitter 370 to a computer of diagnosis subjects.
  • the system for measuring hematocrit may comprise a pick-up 310 to read signals from the bio-disc 100 and a servo (RFIC) 340 to control operation of the pick-up 310.
  • the pick-up 310 may be transferred through a sled motor 320 and the bio-disc 100 may be rotated through a spindle motor 330.
  • the pick-up 310 is provided with a laser 311 to irradiate light of the laser 311 to the bio-disc 100, and a light-receiving device 312 to receive the light reflected from a reflective layer after irradiation.
  • the pick-up 310 and the serve portion 340 can provide signals to a controller (DSP) 350 and receive signals therefrom through an DSP (DSP) 350 and receive signals therefrom through an DSP
  • AD converter 365' and a DA converter 366 that convert analog and digital signals into one another.
  • the controller (hereinafter, referred to as
  • DSP 350 controls the pick-up 310 to record data in the bio-disc 100 or diagnoses samples contained in channel regions of the diagnostic disc using information read in the pick-up 310.
  • the DSP 350 may be provided with a hematocrit measurement algorithm which may be included in the personal computer on which the optical drive 300 is mounted .
  • the DSP 350 may comprise a spindle controller to control a rotation speed and forward/reverse rotation of the bio-disc 100, a base line detector and a channel sensor to detect the diagnostic channel of the bio-disc 100, and an RF signal detection remover that detects defects present on the bio-disc 100 and then removes the same to prevent detection failure of the base line or channel .
  • the DSP 350 controls the focus, tracking and sled motors of the pick-up 310 through the DA converter 366, and signals received in the pick-up 310 are transferred through the servo 340 and then the AD converter 365 to the DSP 350.
  • the DSP 350 may be connected to peripheral devices such as monitors, input devices and switches .
  • a bio-disc 100 into which blood has been injected is centrifuged.
  • the diagnostic channel into which blood has been injected can be detected in accordance with the afore-mentioned algorithm.
  • the centrifuged blood is analyzed by the pickup 310 in the afore-mentioned process, to measure hematocrit and the resulting data is processed to be suitable for use in diagnosis.
  • the data thus obtained may be recorded in an additional storage device, and more specifically, may be recorded in a region where there is no diagnostic channel of the bio-disc 100, or in additional storage devices or memories connected to computers .
  • the overall system may comprise the pick-up 310 to read signals from the bio-disc 100 and a servo (RFIC) 340 to control the operation of the pick-up 310.
  • RFIC servo
  • the pick-up 310 and the servo 340 provide signals to a controller (DSP) 350 and receive signals therefrom through an AD converter
  • a DA converter 366 that convert analog and digital signals into one another.
  • the controller 350 comprises a microcomputer (micom) 351 that controls the pick-up 310 to record data in the bio-disc 100 or diagnoses samples contained in channel regions of diagnostic disc using information read in the pick-up 310.
  • the DSP 350 may comprise a laser power controller 352 to control a laser installed in the pick-up 310, a serve/spindle controller 353, an interface 354 to enable connection to a personal computer 390 and a peripheral system controller 356.
  • the DSP 350 may further comprise a hematocrit measurement algorithm 400 which may be mounted on the personal computer 390.
  • the DSP 350 may further comprise a spindle controller 357 to control a rotation speed and forward/reverse rotation of the bio-disc 100, a base line detector 358a and a channel sensor 358b to detect the diagnostic channel of the bio-disc 100, and an RF signal detection remover 359 that detects defects present on the bio-disc 100 and removes the same to prevent detection problems of the base line or channels.
  • a spindle controller 357 to control a rotation speed and forward/reverse rotation of the bio-disc 100
  • a base line detector 358a and a channel sensor 358b to detect the diagnostic channel of the bio-disc 100
  • an RF signal detection remover 359 that detects defects present on the bio-disc 100 and removes the same to prevent detection problems of the base line or channels.
  • the RF signal detection remover 359 detects the width of RF signals received in the light-receiving device of the pick-up 310. Specifically, in a case where the width of RF low signals is excessively short or long, the RF signal detection remover 359 recognizes the case as a defect and thus prevents channel detection of the base line.
  • the base line detector 358a detects the base line provided on the bio-disc 100 and diagnostic channels through the position thereof, and the channel sensor 358b detects the order of the channels arranged on the disc through the base line detected in the base line detector.
  • the DSP 350 controls the focus, tracking and sled motors of the pick-up 310 through the DA converter 366, and signals received in the pick-up 310 are transferred through the servo 340 and then the AD converter 365 to the DSP 350.
  • the DSP 350 may be connected to a peripheral device 380 such as a monitor, an input device and a switch.
  • a peripheral device 380 such as a monitor, an input device and a switch.
  • FIG. 8 is a schematic diagram illustrating a pick-up 310 to scan a diagnostic channel 200 of the bio-disc.
  • FIG. 9 shows information read according to the position of the diagnostic channel 200.
  • the pick-up 310 comprises a laser diode (LD) 311 as a light source, a reflector 313 to reflect light emitted from the LD 311, and a lens 314 and a photo diode (PD) 312 to collect light emitted from the LD 311 on the reflective layer 110 of the bio- disc 100.
  • the pick-up 310 may comprise a variety of optical devices, in addition to the reflector 313 and the lens 314, but a detailed explanation thereof will be omitted.
  • the LD 311 is a semiconductor laser that emits a predetermined wavelength of laser light, and whether or not the LD 311 emits light is controlled by light-emission control signal of the controller 350. That is, the LD 311 outputs light signals of the power corresponding to electric signals received from the controller 350.
  • the laser light emitted from the LD 311 is irradiated to the bio-disc 100 through the reflector 313 and then the lens 314, and the irradiated laser light is reflected from the reflective layer 110 of the bio-disc 100, and the reflected light is detected by the PD 312 through the lens 314 and the reflector 313.
  • the pick-up 310 is moved by the sled motor 320 along a diameter direction of the disc 100. That is, the pick-up 310 moves from position (a) to position (b) in FIG. 8.
  • the diagnosis material can be detected according to the position in one diagnostic channel 200. For example, when blood is injected into the diagnostic channel 200 and the bio-disc 100 is then rotated at a predetermined rotation speed or higher, erythrocytes and plasma are separated from the diagnosis material.
  • FIG. 10 illustrates the structure of the bio- disc 100 according to one embodiment of the present invention.
  • the disc 100 may comprise an inner region 101 that has a conventional optical disc structure having a radius of 8 cm to record or re-record data and an outer region 102 having a radius of 8 cm to 12 cm, provided with a plurality of diagnostic channels (valve, diagnosis reagent storage) 200 for diagnosis tests.
  • diagnostic channels valve, diagnosis reagent storage
  • the inner region 101 includes a data region to store diagnosis results and the structure thereof may be varied depending on the type of discs such as
  • CD-R CD-RW, DVD-R, DVD+R, DVD-RW, DVD+RW, DVD-RAM,
  • the diagnostic channels 200 may be arranged in the inner region 101 and the data recording region may be arranged in the outer region 102.
  • the diagnostic channels 200 may be arranged on the interface between the inner region 101 and the outer region 102.
  • FIG. 12 When the structure shown in FIG. 12 is incompatible with the conventional optical drive, a stand-alone disc reader may be applicable thereto.
  • the disc suggested in FIGs. 10 to 12 is an integral type.
  • a separate - type disc 100 wherein an inner region 101 typically having a radius of 8 cm is isolated from the outer region 102 that has a radius of 8 cm to 12 cm and comprises donut-shape diagnostic channels 200, may be used.
  • the reason for the necessity of such a separate- type bio-disc is that, according to diagnosis contents, a storage temperature range of diagnosis reagents is greatly wide, i.e., from -20 0 C to ambient temperature, thus requiring cold storage, and that methods for manufacturing the diagnostic disc may be different from methods for manufacturing conventional optical discs.
  • a storage temperature range of diagnosis reagents is greatly wide, i.e., from -20 0 C to ambient temperature, thus requiring cold storage, and that methods for manufacturing the diagnostic disc may be different from methods for manufacturing conventional optical discs.
  • the inner region 101 and the outer region 102 i.e., the optical disc for recording and the diagnostic channel-containing disc may be combined with or isolated from each other using additional components 103 and 104.
  • the size of the bio-disc may be varied depending on diagnosis contents and the size of an inner disc containing the recording region may also be varied depending on diagnosis contents.
  • the disc size be not more than 12 cm.
  • the disc may have a size higher than 12 cm.
  • the disc may be manufactured such that it has a size less than 8 cm.
  • a first method is that information is stored in an 8 cm lead-in area.
  • Conventional optical discs store their information in an address in pre-groove (ADIP) or in an embossing region of a lead-in area, and the disc drive detects details from the information and performs internal servo and set operations suitable therefor .
  • ADIP pre-groove
  • such a bio-disc can put its information in ADIP or a lead-in area of an inner 8 cm disc.
  • the 8 cm inner disc is a
  • DVDR/+R version information depending on the type of bio-disc or diagnosis may be stored in physical format information present in the embossing region of lead-in area or the ADIP region.
  • bio-disc information may be stored in other forms in a reserved zone for compatibility with conventional optical disc lead-in structures.
  • a bio-disc version indicates a DVD-Bio disc
  • a bio-disc version indicates cancer diagnosis
  • a compatible part version is '0010b'
  • a bio-disc version indicates diabetes diagnosis
  • a compatible part version is '0100b'
  • a bio-disc version indicates DNA extract.
  • a second method is to store bio-disc information in the outer region having a radius of 8 cm to 12 cm.
  • disc information to identify the bio-disc may be inserted into a circumference area 107 interposed between the inner region 101 and the outer region 102 without varying the size of the optical disc of the inner region 101.
  • This structure can be advantageously manufactured without varying specs of the conventional disc having an inner radius of 8 cm and is available in the separate-type bio-disc 100.
  • disc information may include bio-disc identification information to indicate the type of the disc and version information to indicate the type of diagnostic channels.
  • version information to indicate the type of diagnostic channels.
  • '0001b 1 indicates cancer diagnosis
  • '0010b' indicates diabetes diagnosis
  • '0100b' indicates
  • version information may be 1 0011b' .
  • Different channels to diagnose a variety of diseases or repetitive identical channels may be arranged on the circumference of the bio-disc.
  • a diagnosis result pattern of one channel may be arranged at a large angle to a circumferential direction diagnosis or in a plane over a wide radius. Accordingly, so that the optical pick-up can scan patterns obtained from diagnosis results, relative positions of the optical pick-up and the patterns, i.e., positions along a circumferential direction and in a radial direction must be identified.
  • the positions of the pick-up and spindle motors must be accurately controlled. For this purpose, as shown in FIG.
  • the bio-disc 100 comprises a circumference 108 where circumferential position information is recorded, and a light-emitting device 311 and a light- receiving device 312 to read the information.
  • this circumferential position information can be indicated by a plurality of high- reflection regions and a plurality of low-reflection regions which alternate in a circumferential direction .
  • the position information may be recorded in a region free from the pick-up inside the lead-in area or the outermost circumference, or in a diagnosis area-neighboring region along a circumferential direction for improvement of accuracy.
  • a data track for tracking servo may be not present in the bio-disc, it is quite difficult to find the position toward the radial direction upon scanning of diagnosis result patterns.
  • the position of the pick-up can only be indirectly found through the number of rotation steps of a low level of sled motors.
  • radial position information is recorded along a radial direction in the outer region 102 interposed between diagnostic channels.
  • the recording of the radial position information is designed such that position information patterns in adjacent radiuses are different from each other so that the pick-up can gradually move by a predetermined distance toward the circumference through an actuator and a sled motor for tracking servo, and at the same time, that the position information patterns are recorded by a predetermined width (w) in a circumferential direction so that the pick-up can detect radial position information formed on the radius of the rotating disc.
  • the pick-up After scanning diagnosis result patterns on the present radius of concentric circle, the pick-up moves an object lens to the next radius spaced apart by a predetermined distance (d) from the present radius and then scans diagnosis result patterns on the corresponding radius of centric circle. In this process, whether or not the pick-up moves by the desired distance can be found from signals detected in the position information patterns.
  • the details of circumferential position information or radial position information depend on resolution of diagnosis result patterns. In the case where diagnosis result patterns are dense, the position information patterns may also be dense, and when diagnosis result patterns are sparse, position information patterns may also be sparse.
  • FIG. 22 is a schematic view illustrating the bio-disc 100 according to another embodiment.
  • the bio-disc 100 according to the present embodiment comprises a channel region 120 including a plurality of diagnostic channels 200 to enable injection of diagnosis materials, and a diagnostics information area 122 adjacent to a clamping area 121 of the bio-disc 100.
  • Diagnostics process information for analysis of the diagnosis material and position information of diagnostic channels 200 may be recorded in the diagnostics information area 122.
  • the position information and diagnostics process information may be detected using an optical sensor or an optical pick-up.
  • a diagnostics information area 122 may include a variety of essential information such as a position information clock, diagnostic channel process information, media information and track servo correction information. A detailed explanation of the diagnostics process information and position information will be described below.
  • FIG. 23 is a schematic view illustrating the bio-disc according to another embodiment.
  • the bio-disc 100 may comprise a diagnostics process area 123 in which diagnostics process information is recorded, and a position information area 124 in which channel position information is recorded.
  • the diagnostics process information and channel position information may be recorded as a wobble or a land pre-pit (LPP) of the disc 100. However, information may be physically recorded using other kinds of signals rather than wobble or land pre-pit (LPP) signals.
  • the diagnostics process area 123 is located inside the channel area 120, and the position information area 124 is located outside of the channel area 120. Alternatively, the positions of these areas may be switched.
  • a position information area 126 may be present in the clamping area 121 inside the disc 100 In this case, the positions of these areas may be switched .
  • Diagnostics process information and position information can be recorded by adhering a barcode or a specific clock-form containing position information or clock information to the clamping area 121 and detected using an optical sensor such as a light-receiving device and a light-emitting device .
  • FIG. 25 shows an example of information diagnosed by the afore-mentioned disc 100.
  • the diagnostics information includes position information associated with diagnostics channels and information associated with diagnostics processes. With position information about diagnostics channels and diagnostics process information, it is possible to perform a series of diagnostics processes on the corresponding bio-disc. Accordingly, only with information recorded on the bio-disc, diagnosis can be performed without aid of other applications.
  • FIG. 25 illustrates an example of diagnostics information.
  • the mode of the diagnostics information may be different from that shown in FIG. 25.
  • FIG. 26 illustrates an example of position information of diagnostic channels. To find diagnostic channels on the bio-disc, control of the position in radial and tangential directions is required. As shown in FIG. 26, position information of the channels information includes information that indicates the presence/absence of diagnostic channels and information that indicates X and Y coordinate information of diagnostic channels on the bio-disc.
  • FIGs. 27 to 29 illustrate examples of diagnostics process information. Specifically, FIG. 27 illustrates information associated with diagnostics type of channels, and FIGs. 28 and 29 illustrate diagnostics processing operation of channels .
  • a series of processes to analyze information of diagnosis materials are performed using the information shown in FIGs. 27 to 29. That is, the type and version of diagnostics are detected from the information shown in FIG. 27 and the diagnostics processing operation is thus determined from the detection results.
  • a series of processes are performed, which comprise operating a spindle motor to rotate the disc and then operating a sled motor to move the pick-up, thereby detecting diagnosis results.
  • heating may be performed by irradiating laser output from the pick-up to the diagnosis material injected into the diagnostic channels, or light absorbance or reflectance of the diagnosis material may be measured .
  • the bio-disc 100 as used herein, as shown in FIG. 30, comprises a plurality of diagnostic channels 200 through which a liquid for diagnosis is injected into a specific region inside a disc body.
  • the bio-disc 100 may further comprise a base area 230 to detect the position of the diagnostic channels 200.
  • the bio-disc 100 has a stack structure comprising a channel layer 130 including a diagnostic channel 200 arranged in an irradiation direction, a recording layer 140 arranged on the channel layer 130, and a reflective layer 110 arranged on the recording later.
  • the bio- disc 100 may comprise no additional recording layer, and may comprise a reflective layer 150 serving as the recording layer.
  • the overall bio-disc 100 is divided into a diagnostic channel-free area M and a diagnostic channel-containing area N.
  • bio-disc 100 having the structure shown in FIG. 33 may be used.
  • Such a bio- disc 100 has a structure wherein a reflective layer 160 and a substrate 170 are arranged on the channel layer 130 provided with the diagnostic channels 200, and a recording layer 180 and a cover layer 190 are arranged on a lower substrate 171 under the channel layer 130.
  • the bio-disc 100 may have a structure applicable to systems such as compact disc (CD) systems, digital versatile discs (DVDs) and HD-DVD and blu-ray disc (BD) systems.
  • CD compact disc
  • DVDs digital versatile discs
  • BD blu-ray disc
  • the pick-up provided in an optical drive of the bio-disc 100 irradiates a laser to the diagnostic channel-free area M
  • the diagnostic channel 200 is not present on the passage of the laser reflected from the reflective layers 110, 150 and 160, the reflected laser is affected only by recording layers 140 and 180. Accordingly, the optical drive can read data stored in the recording layer 140.
  • the pick-up irradiates a laser to the diagnostic channel-containing area N
  • the diagnostic channel 200 is present on the passage of the laser reflected from the reflective layers 110, 150 and 160, the reflected laser is affected by the diagnostic channels 200 as well as the recording layers 140 and 180.
  • the recording layers 140 and 180 By eliminating the influence of the recording layers 140 and 180 on the reflected laser, it is possible to extract only the influence caused by the diagnostic channel 200 and thus detect the diagnostic channel 200 using the same.
  • Diagnostics process information for analysis of the diagnosis material and position information of the diagnostic channel 100 may be recorded in the recording layers 140 and 180. This position information and diagnostics process information may be detected using an optical sensor or an optical pick-up.
  • the diagnostics process information and channel position information may be recorded as a wobble signal or a land pre-pit (LPP) of the disc.
  • the information may be physically recorded using other kinds of signals rather than wobble or land pre-pit (LPP) signals .
  • high-reflectance materials must be used as reflective layers 110, 150 and 160.
  • Materials for the reflective layer 110, 150 and 160 are varied depending on the wavelength of light emitted. Accordingly, different materials of reflective layers 110, 150 and 160 are used according to the wavelength of light used for reading the bio-disc, to maximize reflectance and thus improve readability of the system.
  • FIG. 34 is a graph showing variation in reflectance between materials used for the reflective layer, as a function of the wavelength of emitted light. Because a disc reflectance may decrease depending on the type of the diagnostic channels, in order to impart high reflectance and good performance to the disc, it is important to select suitable materials, taking into consideration the reflectance and price according to the wavelength. As shown in FIG. 34, the CD-type bio- disc according to the present embodiment realizes high reflectance using a material such as Cu or Ag. In addition, DVD type using a wavelength of 650 nm may use Ag or Cu. Because selection of the material is varied depending on the type of diagnostic channels or wavelength of light used, selection of reflective layer material having an optimum reflectance is important.
  • the diagnostic channel 200 arranged on the afore-mentioned bio-disc 100 comprises an injection portion 210 provided with an inlet 211 and a main chamber 220 connected to the injection portion 210.
  • Blood diagnosis may be carried out using the diagnostic channel 200 of the bio-disc 100 in the following procedure.
  • the blood 400 is injected through the diagnostic channel 200 into the inlet 211 and the bio-disc 100 is then operated.
  • the blood 400 injected into the injection portion 210 moves to the main chamber 220, as shown in FIG. 37.
  • a centrifugal force is applied in a circumferential direction to the blood 400 of the bio-disc 100.
  • the blood 400 is centrifuged, as shown in FIG. 38.
  • the centrifuged blood 400 is separated into plasma 410, a leukocyte layer (buffy-coat) 420 and an erythrocyte layer 430, based differences in density therebetween .
  • the rotation frequency of the bio-disc 100 is decreased and hematocrit is then measured by measuring lengths of respective layers of the centrifuged blood 400 using the pick-up.
  • the volume of the leukocyte layer 420 is only about 1% of the total blood, thus making it difficult to accurately measure.
  • a float 50 as shown in FIG. 39 may be inserted into the main chamber 220 of the diagnostic channel 200.
  • the float 50 is provided with a slit 52 to extend a length of the leukocyte layer 420 which is centrifuged from the blood 400 injected through the injection portion 210 of the diagnostic channel 200.
  • the slit 52 is formed by two blocks 51 arranged on both sides of the slit 52, and the blocks 51 are joined to a supporter 53 to maintain the length of the slit 52 interposed between the blocks 51.
  • the blocks 51 may have a trapezoidal shape and are symmetrical to each other with respect to the slit 52.
  • the trapezoidal surface may be curved.
  • the space present inside the main chamber 220 is connected in the form of a curved surface to the slit 52 of the float 50.
  • the supporter 53 detects a reflected light amount through the pick-up of the optical drive and allows light to transmit, enabling measurement of the interface and volume of the erythrocyte layer 430, the leukocyte layer 420 and the plasma layer 410. Accordingly, the supporter 53 may be composed of a transparent substrate.
  • a supporter 54 may take the form of a bridge, connecting the blocks 51 to each other.
  • Such a bridge-type supporter 54 is a plural form, enabling the structure of the slit 52 interposed between the blocks 51 to be maintained, as shown in FIG. 40.
  • the blood When the blood is centrifuged under the condition that the float 50 is inserted into the diagnostic channel 200, as shown in FIG. 41, it is separated into the plasma layer 410, the leukocyte layer 420 and the erythrocyte layer 430. At this time, the leukocyte layer 420 may be arranged inside the slit 52.
  • the density of the float 50 is substantially equivalent to that of leukocytes in blood within a general error. Accordingly, the float 50 may be in the same level as the leukocyte layer 420 during the centrifugation proc e s s .
  • the volume of the slit 52 in the float 50 is preferably 0.5 to 2% of the total blood volume.
  • the leukocyte layer 420 may be arranged in the slit 52.
  • the difference between the materials and the position of the interface therebetween can be detected, based on the difference in the reflected light amount or light absorption rate.
  • the bio-disc 100 includes a plurality of diagnostic channels 230 arranged thereon .
  • the diagnostic channel 230 comprises an injection portion 231 provided with an inlet 232, through which a sample is injected, and. a main chamber 233 connected to the injection portion 231.
  • the injection portion 231 is provided with a waste chamber 234 where the remaining sample, which is not injected into the main chamber 233 at an initial analysis stage for diagnosis, is temporarily stored.
  • the volume of the blood components thus separated can be measured with the function of the disc drive and a ratio of the volumes can thus be obtained. That is, the point at which each layer is separated can be determined with the pick-up, based on the difference in color between the respective layers, and the volume of the layer can be obtained from the point .
  • the bio-disc 100 shown in FIG. 45 comprises a plurality of diagnostic channels 240 having the structure as shown in FIG. 46 arranged in a radial line.
  • the diagnostic channel 240 comprises an injection portion 241 provided with an inlet 242, through which a sample is injected, and a main chamber 243 connected to the injection portion 241.
  • the main chamber 243 is arranged along a radial line R which corresponds to the shortest distance between the center and an external point of the disc 100.
  • a sub-chamber 244 narrower than the main chamber 243 is arranged in a specific area A in the main chamber 243.
  • the sub-chamber 244 is bent several times, and a main part that occupies the longest area of the bent shape is arranged along a radial line R' .
  • a vent 245 through which a sample present in the main chamber 243 is introduced into the sub- chamber 244 is arranged at an end of the sub-chamber 244.
  • the injection portion 241 is provided with a waste chamber 246 where the remaining sample, which is not injected into the main chamber 243 at an initial analysis stage for diagnosis is temporarily stored.
  • the volume of sample injected through the inlet 242 exceeds the capacity of the main chamber 243, the surplus sample is injected into the waste chamber 246.
  • An erythrocyte volume fraction in blood is in the range of 30 to 55%.
  • the point A in which the main chamber 263 is connected to the sub-chamber 244, when the main chamber 243 is divided into Dl and D2, on the basis of the point A, is arranged in a region where D2 / (Dl + D2) is 30% or less. That is, at the point at which D2 is 30% or less of the total length of the main chamber 243, the main chamber 263 is connected to the sub-chamber 244.
  • the point A is arranged under a region where an erythrocyte volume fraction with respect to the total blood is 30 to 55%.
  • the sub-chamber 244 is located in the right side of the main chamber 243.
  • a blood sample is injected into the inlet 242 of the diagnostic channel 240, it passes through the injection portion 241 and is then contained in the main chamber 243, as shown in FIG. 47.
  • the main chamber 243 is connected to the sub- chamber 244 through a capillary tube which is designed so that the sample contained in the main chamber 243 does not move to the sub-chamber 244, when a predetermined pressure Pc or higher is not applied thereto.
  • the bio-disc 100 is charged in the afore-mentioned disc driver and is then operated, to centrifuge the sample.
  • the rotation speed of the disc 100 is controlled such that it is lower than a rotation speed Rc at which the pressure generated at the point A by the centrifugal force reaches a predetermined pressure Pc .
  • the whole blood is separated into three layers, i.e., erythrocyte, buffy coat and plasma.
  • erythrocyte volume fraction in blood is in the range of 30 to 55% and the point A at which the sub-chamber 244 is connected to the main chamber is located in a region where the value D2/ (Dl + D2) of the main chamber 243 is 30% or less, the interface B between the buffy coat and the erythrocyte is always arranged under the connection point A between the sub-chamber 244 and the main chamber 243.
  • the blood thus centrifuged is rotated at a speed higher than the rotation speed Rc such that a pressure higher than the pressure Pc is generated at the point A.
  • Rc rotation speed
  • Pc pressure higher than the pressure
  • the centrifuged blood present in the main chamber 243 moves to the sub- chamber 244, as shown in FIG. 49.
  • the air contained in the sub-chamber 244 is discharged outside through the vent 245.
  • the blood transferred to the sub-chamber 244 is separated into erythrocyte, buffy coat and plasma in this order, since the point is always located under the interface B.
  • the size of the sub-chamber 244 is designed such that the volume of buffy coat passes through the point A.
  • the depth of buffy coat transferred to the sub- chamber 244 is lengthened, depending on a ratio of the width of the main chamber 243 Wm and the width of the sub-chamber 244 Ws. For example, when Wm is 3 mm and Ws is 1 mm, the depth of buffy coat increases three fold.
  • the volume of buffy coat can be measured more accurately and constituent layers, i.e., granulocyte, non-granulocyte and platelet, of the buffy coat can be distinguished from one another
  • constituent layers i.e., granulocyte, non-granulocyte and platelet
  • a barrier 249 that can be removed under specific conditions is interposed between the main chamber 243 and the reaction chamber 247, to allow the reagent contained in the barrier 248 to be centrifuged and then introduced into the reaction chamber 247.
  • the barrier 248 may take the form of a thin film and may often be in the form of a valve.
  • the barrier 248 may be removed by the pressure applied by varying the rotation speed or direction of the disc 100.
  • the reaction chamber 247 may contain a diagnosis reagent which reacts with any centrifuged layer and the reaction can be confirmed by measuring variation in reflectance using the pick-up. That is, as the reaction proceeds, the color of the reagent varies, and the variation can be detected by the disc driver.
  • reaction chamber 247 may be connected to the sub-chamber 244.
  • the data such as the volume of respective layers measured in the centrifugation may be recorded in an additional storage device, or in a region where there is no diagnostic channel of the disc 100 (See. the area M in FIGs. 31 and 32) or in a specific region such as additional memorie s .
  • the analysis of the centrifuged blood may be utilized in health diagnosis. For example, the interface between erythrocyte and buffy coat, or the interface between the buffy coat and plasma is measured.
  • the depth ratio between the separated components may be important for the blood.
  • hematocrit levels can be obtained from the depth ratio of the components, and the health condition can be diagnosed by calculating values such as hemoglobin and erythrocyte levels per unit volume from the hematocrit levels .
  • the health condition can be diagnosed with the specific reagent-containing reaction chamber 247. That is, the barrier 248 arranged in an entrance of the reaction chamber 247 can be removed by varying the rotation speed or direction of the disc 100, and in this process, one component of the centrifuged blood may be introduced into the reaction chamber 247 and then reacted with the reagent . By monitoring the reaction, health diagnosis can be performed more thoroughly .
  • reaction chamber 247 may contain a reagent for various tests, and a variety of items can thus be simultaneously diagnosed with one bio-disc 100.
  • Health condition diagnosis results are obtained from analysis of reagents such as blood and are then recorded.
  • the recording may be carried out using the same method as the afore-mentioned method for recording the reading interface position.
  • the health diagnostics process may be continuously carried out through the centrifugation, followed by an automated series of processes. That is, diagnosis of health condition through blood of diagnosis subjects using the bio- disc 100 comprises a series of automated processes of: centrifuging the blood; diagnosing a variety of items from the centrifugation results; and recording the diagnosis results in the bio-disc 100.
  • the blood of diagnosis subjects is injected into the disc 100, charged in the disc driver and then analyzed to obtain the disc 100 recorded with diagnosis results.
  • the bio-disc 100 as shown in FIG. 51 comprises a plurality of diagnostic channels 250 having the structure as shown in FIG. 52 arranged in a radial line .
  • the diagnostic channel 250 comprises an injection portion 251 provided with an inlet 252, through which a sample is injected, and a main chamber 253 connected to the injection portion 251.
  • the main chamber 253 is arranged along a radial line R which corresponds to the shortest distance between the center and an external point of the disc 100.
  • a sub-chamber 254 narrower than the main chamber 253 is arranged in a specific area A in the main chamber 243.
  • the sub-chamber 254 is bent several times, and a main part that occupies the longest area of the bent shape is arranged along a radial line R' .
  • a vent 255 through which a sample present in the main chamber 253 is introduced into the sub- chamber 254 is arranged at an end of the sub-chamber 254.
  • the injection portion 251 is provided with a waste chamber 254 where the remaining sample which is not injected into the main chamber 253 at an initial analysis stage for diagnosis is temporarily stored.
  • the present embodiment is a case where the sub- chamber 254 is located in the left side of the main chamber 253 and exerts different effects with the afore-mentioned embodiment along the rotation direction of the disc 100.
  • the bio-disc 100 as shown in FIG. 53 comprises a plurality of diagnostic channels 260 having the structure as shown in FIG. 54 arranged in a radial shape .
  • the diagnostic channel 260 comprises an injection portion 261 provided with an inlet 262, through which a sample is injected, and a main chamber 263 connected to the injection portion 261.
  • the main chamber 263 is arranged along a radial line R which corresponds to the shortest distance between the center and an external point of the disc 100.
  • a sub-chamber 264 narrower than the main chamber 263 is arranged in a specific area A in the main chamber 263.
  • the sub-chamber 264 is bent several times, and a main part that occupies the longest area of the bent shape is arranged along a radial line R' .
  • the sub-chamber 264 has a main portion which is not arranged on the radial line, i.e., is at a predetermined angle to the main chamber 263 and is bent once.
  • the sub-chamber 264 is arranged in the right side of the main chamber 263.
  • a vent 265 through which a sample present in the main chamber 263 is introduced into the sub- chamber 264 is arranged at an end of the sub-chamber 264.
  • the injection portion 261 is provided with a waste chamber 264 where the remaining sample which is not injected into the main chamber 263 at an initial analysis stage for diagnosis is temporarily stored.
  • the point A in which the main chamber 263 is connected to the sub-chamber 264, when the main chamber 263 is divided into Dl and D2, on the basis of the point A, is arranged in a region where D2 /
  • (Dl + D2) is 30% or less. That is, at the point at which D2 is 30% or less of the total length of the main chamber 263, the main chamber 263 is connected to the sub-chamber 264.
  • the bio-disc 100 as shown in FIG. 55 comprises a plurality of diagnostic channels 270 having the structure as shown in FIG. 56 arranged in a radial line .
  • the diagnostic channel 270 comprises an injection portion 271 provided with an inlet 272, through which a sample is injected, and a main chamber 273 connected to the injection portion 271.
  • the main chamber 273 is arranged along a radial line R which corresponds to the shortest distance between the center and an external point of the disc 100.
  • the sub-chamber 274 has a main part which is not arranged on the radial line, is at a predetermined angle to the main chamber 273 and is arranged in a direction different from the aforementioned embodiments, i.e. , in the left side of the main chamber 273.
  • the sub-chamber 274 exerts different effects with the afore-mentioned embodiment along the rotation direction of the disc 100.
  • the bio-disc 100 as shown in FIG. 57 comprises a plurality of diagnostic channels 280 having the structure as shown in FIG. 58 arranged in a radial shape .
  • the diagnostic channel 280 comprises an injection portion 281 provided with an inlet 282, through which a sample is injected, and a main chamber 283 connected to the injection portion 2 8 1 .
  • the main chamber 283 is not arranged along a radial line R which corresponds to the shortest distance between the center, but is at an angle to the radial line R,
  • a sub-chamber 284 narrower than the main chamber 283 is arranged in a specific point A in the main chamber 283.
  • the sub-chamber 284 is at a predetermined angle to the main chamber 283 and is bent once.
  • the sub- chamber 284 is arranged in the left side of the main chamber 283.
  • the injection portion 281 is provided with a waste chamber 284 where the remaining sample which is not injected into the main chamber 283 at an initial analysis stage for diagnosis is temporarily stored.
  • the point A in which the main chamber 283 is connected to the sub-chamber, when the main chamber 283 is divided into Dl and D2 , on the basis of the point A, is arranged in a region where D2 / (Dl + D2) is 30% or less. That is, at the point in which D2 is 30% or less of the total length of the main chamber 283, the main chamber 283 is connected to the sub-chamber 284.
  • the bio-disc 100 as shown in FIG. 59 comprises a plurality of diagnostic channels 600 having the structure as shown in FIG. 59 arranged in a radial shape .
  • the diagnostic channel 600 comprises a whole blood chamber 610 provided with an inlet 611, through which a sample is injected, and a buffy coat chamber 620 to measure buffy coat in blood, connected to the whole blood chamber 610.
  • the buffy coat chamber 620 is connected to a waste chamber 630 which is bent several times and is provided with a vent 631, through which blood present in the whole blood chamber 610 or the buffy coat chamber 620 is transferred and introduced into the waste chamber 630, arranged at an end of the waste chamber 630.
  • the waste chamber 630 may comprise a main chamber 632 which has the same width as the whole blood chamber 610, a connection chamber 633 arranged in the side direction of the main chamber 632, and an extension chamber 634 which is bent at the connection chamber 633 and is provided with a vent 631.
  • the whole blood chamber 610 is connected to the buffy coat chamber 620 through a first microvalve 640, and the buffy coat chamber 620 is connected to the waste chamber 630 through a second microvalve 650.
  • These microvalves 640 and 650 may have a capillary tube structure, through which blood passes, when a predetermined or higher speed of centrifugal force is applied. At least part of the whole blood chamber
  • the buffy coat chamber 620 and the waste chamber 630 is arranged on the radial line, i.e., the smallest passage between the center and the end, of the disc 100.
  • the buffy coat chamber 620 is designed such that it contains the buffy coat layer, after blood introduced into the inlet 611 of the whole blood chamber 610 is centrifuged, and that it has a vertical section smaller than the whole blood chamber 610 and the waste chamber 630.
  • the buffy coat chamber 620 may be in a line shape which connects the whole blood chamber 610 to the waste chamber 630. Accordingly, the buffy coat layer which occupies a small volume fraction of blood extends in the buffy coat chamber, enabling easy measurement of buffy coat layer volume fraction in blood.
  • FIGs. 61 to 63 illustrate diagnostic channels 600 having various shapes of buffy coat chambers according to exemplary embodiments.
  • the diagnostic channel 600 comprises a whole blood chamber 610 provided with an inlet 111, through which a sample is injected, and a buffy coat chamber 621, 622 or 623 to measure a buffy coat fraction in blood, and a waste chamber 630 connected to the whole blood chamber 610.
  • FIG. 61 illustrates an example using a buffy coat chamber 621 taking a wave pattern wound several times (spiral shape)
  • FIG. 62 illustrates an example using a buffy coat chamber 622 bent in an S- shape.
  • FIG. 63 illustrates a buffy coat chamber 623 having bent sharp corners (a zig-zag shape) .
  • the buffy coat chambers 621, 622 and 623 may have a variety of shapes, but they have a diameter smaller than the whole blood chamber 610 and the waste chamber 630 and are thus easy to measure. That is, the buffy coat chamber can act as a buffy coat extension chamber.
  • Blood diagnosis may be carried out using the diagnostic channel of the bio-disc 100 according to the process described with reference to FIGs. 36 to 38.
  • the blood 400 is centrifuged, as shown in FIG. 38.
  • the centrifuged blood 400 is separated into plasma 410, a buffy-coat layer 420 and an erythrocyte layer 430, based on differences in density therebetween.
  • the rotation frequency of the bio-disc 100 is decreased and hematocrit is then measured by measuring lengths of respective layers of the centrifuged blood 400 using the pickup.
  • the hematocrit measurement can be measured by detecting the difference in light reflectance between the centrifuged blood components present in diagnostic channel of the bio-disc using pick-up of the optical drive.
  • the diagnostic channel 200 is irradiated to a laser, and the interface between respective layers is detected using the resulting transmission or reflectance information, thereby measuring hematocrit .
  • Data measured from transmission or reflectance information may be processed to be suitable for diagnosis by diagnosticians such as computer programs or doctors and the processed data may be recorded in other parts of the disc 100 or in an additional storage device.
  • a graph showing rotation per minute (rptn) of the spindle motor which rotates the bio-disc 100 is illustrated in FIG. 65.
  • the diagnostic channel 200 of the bio-disc 100 may further comprise an additional extension chamber to extend the length of leukocyte layer (not shown) , and the extension chamber may be connected to the main chamber 220 through a capillary tube-shape valve. Accordingly, in order to move the centrifuged blood 400 to the extension chamber, as shown in FIG. 66, the spindle motor is rotated at a higher rpm in a direction opposite to a normal rotation direction to allow the blood 400 to pass through the valve and then reach the extension chamber. Then, the depth of the leukocyte lengthened in the extension chamber at a decreased rpm can be measured using the pick-up,
  • the hematocrit measurement system using the bio-disc 100 checks the presence of foreign materials or air using the pick-up and detects the error of test diagnosis, thus securing high reliability. Furthermore, the system monitors the completion of centrifugation while reading photo diode (PD) signals using the pick-up, thus readily accelerating the diagnostics process and ensuing superior reliability.
  • PD photo diode
  • Conventional hematocrit systems for example, conventional hematocrit discs that measure light absorbance using LEDs, are designed such that a surplus volume of blood is transferred to an overflow chamber, provided in a diagnostic channel for accurate metering.
  • the system suggested in the present embodiment can measure the total depth of blood introduced in the channel and the depth of erythrocytes after centrifugation, while maintaining the focus of the pick-up on the reflective layer of the bio-disc using a focus servo and transferring the pick-up using a sled motor, thus eliminating the necessity of any overflow chamber.
  • the size of the injection portion 210 of the diagnostic channel 200 be smaller than that of the main chamber 220.
  • FIGs. 67 and 68 illustrate a passage of light migrating from the pick-up on the bio-disc in the process of detecting information of the centrifuged blood on the bio-disc using the pick-up.
  • Constituent components, such as the controller and pick-up, included in the optical drive may be seen in the construction of the system as shown in FIGs . 6 to 9.
  • the controller When the controller operates the spindle motor, resulting in rotation of the bio-disc 100 in a direction A, the pick-up to read the bio-disc 100 moves in a direction B. At this time, the pick-up passes through a base area 230 and then reaches the diagnostic channel 200a.
  • the controller of the drive defines, as a first diagnostic channel 200a, the diagnostic channel that the pick-up firstly reaches, after passing through the base area 230.
  • the controller of the drive sequentially defines a second, third and fourth diagnostic channels 200b, 200c and 20Od arranged from the first diagnostic channel 200a in this order.
  • FIG. 67 illustrates the case wherein there are four diagnostic channels 200a, 200b, 200c and 20Od, for better understanding.
  • the controller detects the sequence of respective diagnostic channels 200a, 200b, 200c and 20Od.
  • the drive operating the bio-disc 100 shown in FIG. 67 moves the pick-up in a diameter direction of the bio-disc 100 by a predetermined distance D, when the controller detects that the bio-disc 100 rotates once on a basis of the base area 230. That is, when the controller detects that the pick-up passes through the base area 230, it permits the sled motor to move the pick-up .
  • the controller Since a general optical disc including the bio- disc 100 rotates at a high speed, the controller thereof cannot readily and accurately detect and control the position of the pick-up present on the bio-disc 100. On the other hand, the controller according to the present embodiment can readily detect whether or not the bio-disc 100 rotates once by confirming whether or not the controller has reached the base area 230.
  • the controller permits the sled motor to move the pick-up on the base area 230, thereby allowing the pick-up to read information which corresponds to the positions x and y in the same diagnostic channels 200a, 200b, 200c and 20Od.
  • the controller of the drive operating the bio-disc 100 permits the sled motor to move the pick-up in a diameter direction of the bio-disc 100, while the bio-disc 100 rotates once .
  • the controller may receive a signal as shown in FIG. 69 through the pick-up. That is, FIG. 69 illustrates a graph showing the signal of light entering the pick-up through the reflective layer of the bio-disc 100, as a function of time, when the pick-up moves as shown in FIG. 67.
  • the pick-up sequentially passes through a position x of the first diagnostic channel 200a and other regions corresponding to the position x not shown in diagnostic channels 200b, 200c and 20Od.
  • the sled motor moves the pick-up by a determined distance D, thus allowing the pick-up to pass through a position y of the first diagnostic channel 200a and then other regions corresponding to the position y not shown in diagnostic channels 200b, 200c and 20Od.
  • the pick- up of the optical drive moves from the position x to y in diagnostic channels 200a, 200b, 200c and 20Od.
  • leukocytes and plasma are separated from the blood.
  • An explanation of other blood components such as erythrocytes is omitted. That is, due to the difference in light transmission between plasma and leukocytes, the intensity of light reflected by the reflective layer and then received by the PD is varied. That is, leukocytes and plasma are separated into the position x and the position y of the bio- disc 100, respectively.
  • the afore-mentioned bio- disc 100 comprises the diagnostic channel 200 and a reflective layer 110, thereby separating materials contained in the diagnostic channel 200 using an optical pick-up 310 of a system for recording/reproducing data such as an optical drive.
  • an optical pick-up 310 of a system for recording/reproducing data such as an optical drive.
  • FIG. 71 is an enlarged view of the section of the diagnostic channel 200 shown in FIG. 70.
  • FIG. 72 is a graph showing signal intensity according to the position of the pick-up 310.
  • FIG. 73 is a graph illustrating the type and separation principle of diagnosis material contained in the diagnostic channel 200.
  • materials are contained in at least one diagnostic channel 200 located in the channel layer 130 of the disc 100, and a reflective layer 110 is arranged on the diagnostic channel 200. All or one of the materials A to D as herein used may be targeted for diagnosis.
  • the optical pick-up 310 of the data recording/reproducing system separates a material in the disc 100 in the following principle.
  • the optical pick-up 310 irradiates light to the material, while moving from M to N and receives the light reflected from the reflective layer 110.
  • the optical pick-up 310 receives light which is irradiated from the optical pick-up 310 and then transmitted by the diagnostic channel 200.
  • the material contained in respective diagnostic channels 200 can be identified. As shown in FIG. 73, although the same intensity of light is irradiated to the materials A to D through the optical pick-up 310, the light undergoes variation in intensity, while being reflected by the reflective layer 110 and then received by the optical pick-up 310. Accordingly, based on the light intensity disc 100, materials in the diagnostic channel 200 can be distinguished from one another .
  • the materials can be more simply separated.
  • FIGs. 74 to 76 illustrate a method for recording information associated with a recording medium according to exemplary embodiments.
  • FIG. 74 illustrates an example wherein information associated with the speed of a rotating recording medium is recorded.
  • FIG. 75 illustrates an example wherein information associated with the structure of a recording medium is recorded.
  • FIG. 76 illustrates an example wherein other basic information of a recording medium is recorded .
  • information associated with the speed of the rotating recording medium includes speed and acceleration, etc. That is, in recording/reproducing data in the recording medium of a data recording/reproducing device, speed and/or acceleration of a suitably rotating recording medium may or may not be measured. In preparation for the case wherein measurement is not possible, information associated with the rotation speed or acceleration required for recording/reproducing of the corresponding recording medium in a specific region among several regions of the reflective layer can be recorded.
  • information associated with speed may be recorded in a region 710 where there is no channel region in the reflective layer, for example, the outermost circumference of the reflective layer, in a recording medium 100.
  • the information associated with the speed may be continuously recorded.
  • information associated with the structure of the recording medium 100 may include not only information associated with the number or position of diagnostic channel regions containing materials targeted for diagnosis, but also other information associated with the structure of the recording medium 100.
  • This structure information may be recorded in a region 720 where there is a channel region present in the lower layer of the reflective surface. Accordingly, in the case where information associated with the structure as shown in FIG. 75 is recorded in the recording medium 100, when the data recording/reproducing device reproduces data, it can detect the structure of the recording medium 100 more simply, thus enabling easy reproduction and reducing reproduction error.
  • the basic information of the recording medium 100 may include not only information to identify the type of the corresponding recording medium 100 (for example, information to identify whether or not the corresponding recording medium is a bio-disc) , but also other information except for those recorded in FIGs. 74 to 76.
  • the basic information is recorded in a region which does not overlap the channel region present in the lower layer among several regions included in the reflective surface, for example, in an inner part 730 of the reflective surface as shown in FIG. 76.
  • FIG. 77 blood 400 injected through an inlet 611 provided in a whole blood chamber 610 is stored in the whole blood chamber 610, Then, the bio-disc 100 is operated by the spindle motor of the optical drive and is rotated at a first rotation speed Wi to perform centrifugation .
  • the blood is centrifuged as shown in FIG. 78. That is, the blood 400 in the whole blood chamber 610 is separated into a plasma layer 410, a buffy coat layer 420 and an erythrocyte layer 430 in this order from the inlet 611.
  • the volume of respective layers separated from the blood 400 can be measured using the pick-up of the optical drive. That is, as shown in FIG. 78, the volume fraction of respective layers in the blood can be determined by measuring the laser reflectance of the pick-up, and hematocrit defined as a blood cell volume in the blood 400 can be obtained from the volume fraction.
  • the rotation speed W M of the disc 100 may be lower than the first rotation speed Wi, that is, the centrifugation speed.
  • the centrifuged blood 400 contained in the whole blood chamber 610 is transferred to the buffy coat chamber 620, enabling accurate measurement of the buffy coat 420.
  • the blood 400 must pass through the first microvalve 640.
  • the disc 100 is rotated at a second rotation speed W 2 higher than the rotation speed, i.e., Wthreshoiai at which the blood can pass through the first microvalve 640.
  • W 2 the rotation speed
  • the intermediate layer, i.e., the buffy coat layer 420, of the centrifuged blood is then transferred to the buffy coat chamber 620.
  • the disc 100 is rotated at a third rotation speed W 3 higher than the rotation speed (i.e., W t hreshoid2) at which blood can pass through the second microvalve 650, to transfer the lowermost layer (i.e., erythrocyte layer 430) of the blood 400 to the waste chamber 630, and whether or not the buffy coat layer 420 is located in the buffy coat chamber 620 is measured and then determined by the pick-up of the optical drive.
  • W 3 higher than the rotation speed (i.e., W t hreshoid2) at which blood can pass through the second microvalve 650, to transfer the lowermost layer (i.e., erythrocyte layer 430) of the blood 400 to the waste chamber 630, and whether or not the buffy coat layer 420 is located in the buffy coat chamber 620 is measured and then determined by the pick-up of the optical drive.
  • the rotation speed is reduced to prevent the buffy coat layer 420 present in the buffy coat chamber 620 from escaping to the second microvalve 650.
  • the rotation speed of the disc 100 may be reduced to the rotation speed for hematocrit measurement, i.e., W M •
  • the pick-up of the optical drive is located in the buffy coat chamber 620, to measure the length of the buffy coat layer 420.
  • leukocytes and erythrocytes (430) in the buffy coat layer 420 are separated using a reagent ⁇ e.g., Hispatoque 1077) having a density between that of the buffy coat layer 420 and the erythrocyte layer 430 and the length of the buffy coat layer 420 can be measured.
  • a reagent ⁇ e.g., Hispatoque 1077
  • centrifugation process a centrifugation process will be illustrated with reference to FIG. 81 and a diagnostic channel 200 shown in FIG. 35.
  • the centrifugation process may be carried out using the afore-mentioned bio-disc and may also be applied to a conventional centrifuge which rotates using an additional vessel.
  • a centrifuging method using the afore -mentioned bio-disc will be described in detail,
  • a sample is introduced into a diagnostic channel 200 of the bio-disc as shown in FIG. 35 (SlO) .
  • the sample- containing bio-disc is placed into an optical drive and then rotated for a predetermined time T2 at a rotation speed R2 or at a maximum rotation speed Rmax of the spindle motor to centrifuge the sample (S20) .
  • the rotation time T2 may be determined taking into consideration factors such as the type of sample, the rotation speed, the structure of the channel 200, and calculated on a real time. Then, the interface in the sample obtained from centrifugation for the rotation time T2 is measured.
  • the interface measurement may be carried out using a reflection- or transmission- type pick-up of the optical drive. That is, an optical sensor, arranged on one side of the pick-up on which a laser is installed, detects light emitted from the laser and then reflected from the disc, thereby realizing the measurement of the interface .
  • the interface measurement may be carried out by causing the optical sensor arranged in the opposite side of the pick-up to detect light emitted from the laser of the pick-up and then passing through the disc.
  • the optical sensor may be arranged in both the transmission part and the reflection part to detect the interface position.
  • the interface position Pl thus detected may be recorded ( S30) .
  • the interface position Pl thus detected may be recorded in a region where there is no diagnostic channel of the disc 200 or in a specific region such as additional memory.
  • the disc is rotated at the rotation speed R3 for a predetermined time T3 to centrifuge the sample (S40) .
  • An interface position P2 is detected and recorded in the same manner as mentioned above (S50) That is, in the manner used in step S30, the position of the interface P2 is detected and then recorded .
  • Pl is different from P2, the centrifugation of the sample is not complete, the position of the interface stored in P2 is stored in Pl (S70) , the process then returns to step S40 and the aforementioned series of steps is then repeated, until Pl is the same as P2. That is, the position of the interface stored in P2 is stored in Pl and the disc is rotated at the rotation speed R3 for T3 to centrifuge the sample (S40) , the interface position P2 is detected and recorded (S50), and the position Pl is then compared with the position P2 to determine the completion of centrifugation (S60) .
  • analysis of the centrifuged sample may be used for health diagnosis.
  • analysis of the centrifuged sample may be used for health diagnosis.
  • blood is used as a sample
  • completely centrifuged blood is separated into erythrocyte, buffy-coat and plasma.
  • the interface between erythrocytes and buffy coat, or the interface between buffy coat and plasma can be measured.
  • FIG. 82 illustrates a bio-disc 100 including N diagnostic channels 200, wherein the outermost left diagnostic channel is referred to as a 1st chamber 201, and diagnostic channels arranged clockwise from the first chamber 201 are referred to as a 2nd chamber 202, a 3rd chamber 203 and an Nth chamber 204.
  • a focus serve is arranged on the reflective layer of the bio-disc 100
  • a high RF signal is output (high signal)
  • a low signal is output on the surface of the diagnostic channel 200 present in the bio-disc 100 by reagent or samples.
  • a base line 230 to detect the position of the respective chambers is interposed between the N chambers .
  • a process for detecting the chamber position using the base line 230 will be described in detail .
  • the diagnostic channels 200 are arranged at an identical angle and the base line 230 is then interposed therebetween.
  • RF signals are obtained as shown FIG. 84.
  • the base lines and chambers (channels) can be detected in the following manner . That is, as shown in FIG. 85, first, error values are initialized (SlO) .
  • error values are initialized (SlO) .
  • SIl the condition that the RF_old value is higher than 2- fold RF and the RF_old2 value is higher than 2-fold RF is satisfied.
  • SIl the condition that the RF_old value is higher than 2- fold RF and the RF_old2 value is higher than 2-fold RF is satisfied
  • the RF low area may be detected as the first diagnostic channel (1st chamber; 201) (S14).
  • the area may be detected as diagnostic channels such as the second chamber 202 and third chamber 203 wherein the number of the corresponding channels is increased by one. That is, whether or not the post-detected RF high area is equivalent to 0.9- to 1.1- times the maximum (Max) is determined (S15), and when this condition is satisfied, the next diagnostic channel is detected (S16), and this channel is detected after the first chamber 201 and is thus determined as the second chamber 202.
  • the step of measuring the corresponding diagnostic channel is skipped and the pick-up is transferred to measure the next diagnostic channel.
  • the channel can be detected in the following manner.
  • FIG. 86 (a) when an RF signal is sliced to a specific level A or less, the signal shown in FIG. 86 (b) can be obtained.
  • the count of a width at which the RF signal drops to an RF low level is out of the range of a predetermined level X (C ⁇ X ⁇ B in FIG. 86 (a))
  • it can be detected as a defect signal See FIG. 86 (c) ) .
  • sliced and defect signals are obtained as shown in FIG. 86 (b) and (c) , and channel signals shown in FIG. 86 (d) are then obtained therefrom, thereby detecting the channels using the afore-mentioned algorithm.
  • the present invention provides a diagnostic disc to more accurately measure a buffy coat volume fraction in blood and separate constituent layers (i.e., granulocytes, non-granulocytes and platelets) of the buffy coat.
  • one component of the centrifuged blood may be introduced into a reaction chamber and then react with a reagent.
  • the bio- disc identifies the reaction/non-reaction therebetween and enables more accurate health diagnosis .
  • Diagnosis of health condition through blood of diagnosis subjects using the bio-disc is carried out through a series of automated processes comprising: centrifuging blood; diagnosing a variety of items from the centrifugation result; and recording the diagnosis result in the diagnostic disc.
  • the blood of diagnosis subjects is introduced into the disc and is then placed in an optical drive, to finally obtain the disc in which diagnosis results are recorded.

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  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
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  • Optical Record Carriers And Manufacture Thereof (AREA)

Abstract

L'invention concerne un bio-disque, et plus précisément, un bio-disque qui permet d'exécuter un diagnostic de santé au moyen d'un lecteur optique. Le bio-disque comporte une zone de diagnostic où l'écriture et la lecture de données sont protégées, et une zone d'enregistrement, à l'exception de la zone de diagnostic, où l'écriture et la lecture de données sont autorisées, la zone de diagnostic comportant une chambre d'injection pourvue d'une admission par laquelle on injecte un réactif, et au moins un canal de diagnostic pour analyser le réactif, relié à la chambre d'injection.
PCT/KR2009/000206 2008-01-15 2009-01-15 Bio-disque WO2009091187A2 (fr)

Applications Claiming Priority (24)

Application Number Priority Date Filing Date Title
KR1020080004620A KR20090078683A (ko) 2008-01-15 2008-01-15 바이오 디스크
KR10-2008-0004620 2008-01-15
KR10-2008-0011506 2008-02-05
KR1020080011506A KR20090085746A (ko) 2008-02-05 2008-02-05 바이오 디스크, 이를 이용한 진단방법 및 진단장치
KR1020080013436A KR20090088088A (ko) 2008-02-14 2008-02-14 바이오 디스크
KR10-2008-0013436 2008-02-14
KR10-2008-0021569 2008-03-07
KR1020080021569A KR20090096156A (ko) 2008-03-07 2008-03-07 기록매체, 상기 기록매체의 기록 방법 및 데이터 기록/재생장치
KR1020080032319A KR20090106916A (ko) 2008-04-07 2008-04-07 바이오 디스크, 이를 이용한 진단방법 및 진단장치
KR10-2008-0032319 2008-04-07
KR1020080032318A KR20090106915A (ko) 2008-04-07 2008-04-07 바이오 디스크, 이를 이용한 진단방법 및 진단장치
KR10-2008-0032318 2008-04-07
KR10-2008-0071590 2008-07-23
KR1020080071591A KR20100010631A (ko) 2008-07-23 2008-07-23 진단 디스크 및 이를 이용한 진단 시스템
KR1020080071590A KR20100010630A (ko) 2008-07-23 2008-07-23 원심분리 장치 및 그 방법
KR10-2008-0071591 2008-07-23
KR1020080094158A KR20100034917A (ko) 2008-09-25 2008-09-25 플로트 및 플로트가 삽입된 진단 채널을 갖는 바이오 디스크
KR10-2008-0094158 2008-09-25
KR10-2008-0103227 2008-10-21
KR1020080103227A KR20100043956A (ko) 2008-10-21 2008-10-21 바이오 디스크 및 이를 이용한 혈액 측정 방법
KR1020080104754A KR20100045688A (ko) 2008-10-24 2008-10-24 바이오 디스크를 이용한 건강 진단 시스템 및 그 진단 방법
KR10-2008-0104754 2008-10-24
KR10-2008-0105156 2008-10-27
KR1020080105156A KR20100046353A (ko) 2008-10-27 2008-10-27 바이오 디스크의 기준선 및 채널 검출방법 및 이를 이용한 건강 진단 방법

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PCT/KR2009/000205 WO2009091186A2 (fr) 2008-01-15 2009-01-15 Système de diagnostic de santé utilisant un bio disque et procédé de diagnostic de santé l'utilisant

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KR101252260B1 (ko) 2011-12-12 2013-04-08 포항공과대학교 산학협력단 디스크형 미세 유체 시스템 및 혈구의 변형도 측정 방법

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KR20000075815A (ko) * 1997-02-28 2000-12-26 번스타인 리차드 디스크 내부 장치
KR20050037275A (ko) * 2003-10-18 2005-04-21 (주)나노스토리지 바이오칩 탑재용 카트리지

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