EP0977512A1 - Vorrichtung und verfahren zur medizinischen bilddarstellung - Google Patents

Vorrichtung und verfahren zur medizinischen bilddarstellung

Info

Publication number
EP0977512A1
EP0977512A1 EP98918618A EP98918618A EP0977512A1 EP 0977512 A1 EP0977512 A1 EP 0977512A1 EP 98918618 A EP98918618 A EP 98918618A EP 98918618 A EP98918618 A EP 98918618A EP 0977512 A1 EP0977512 A1 EP 0977512A1
Authority
EP
European Patent Office
Prior art keywords
patient
video
transducer
imaging device
scanner
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP98918618A
Other languages
English (en)
French (fr)
Inventor
Peter J. Wilk
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wilk Patent Development Corp
Original Assignee
Wilk Patent Development Corp
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 US08/839,971 external-priority patent/US5871446A/en
Priority claimed from US08/892,955 external-priority patent/US6023632A/en
Priority claimed from US08/950,849 external-priority patent/US6319201B1/en
Application filed by Wilk Patent Development Corp filed Critical Wilk Patent Development Corp
Publication of EP0977512A1 publication Critical patent/EP0977512A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4483Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6843Monitoring or controlling sensor contact pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4209Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4227Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by straps, belts, cuffs or braces
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461Displaying means of special interest
    • A61B8/462Displaying means of special interest characterised by constructional features of the display
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461Displaying means of special interest
    • A61B8/463Displaying means of special interest characterised by displaying multiple images or images and diagnostic data on one display
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/56Details of data transmission or power supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022Monitoring a patient using a global network, e.g. telephone networks, internet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0866Detecting organic movements or changes, e.g. tumours, cysts, swellings involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4272Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/4455Features of the external shape of the probe, e.g. ergonomic aspects
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01SRADIO DIRECTION-FINDING; RADIO NAVIGATION; DETERMINING DISTANCE OR VELOCITY BY USE OF RADIO WAVES; LOCATING OR PRESENCE-DETECTING BY USE OF THE REFLECTION OR RERADIATION OF RADIO WAVES; ANALOGOUS ARRANGEMENTS USING OTHER WAVES
    • G01S15/00Systems using the reflection or reradiation of acoustic waves, e.g. sonar systems
    • G01S15/88Sonar systems specially adapted for specific applications
    • G01S15/89Sonar systems specially adapted for specific applications for mapping or imaging
    • G01S15/8906Short-range imaging systems; Acoustic microscope systems using pulse-echo techniques
    • G01S15/8909Short-range imaging systems; Acoustic microscope systems using pulse-echo techniques using a static transducer configuration
    • G01S15/8915Short-range imaging systems; Acoustic microscope systems using pulse-echo techniques using a static transducer configuration using a transducer array
    • G01S15/8925Short-range imaging systems; Acoustic microscope systems using pulse-echo techniques using a static transducer configuration using a transducer array the array being a two-dimensional transducer configuration, i.e. matrix or orthogonal linear arrays

Definitions

  • This invention relates to an imaging device or system.
  • the imaging device or system is
  • this invention relates to a device or
  • This invention also relates to a method
  • An object of the present invention is to provide an imaging device or system which is
  • a further object of the present invention is to provide a medical imaging system which exhibits reduced costs over conventional imaging systems such as CAT scanners and MRI
  • a particular object of the present invention is to provide a medical imaging system
  • Another object of the present invention is to provide a medical operating method which provides real time imaging in a cost effective manner.
  • c current source being operatively connected to the transducer for energizing the transducer
  • At least one acoustoelectric transducer is attached to the web, while an analyzing
  • component is operatively connected to the acoustoelectric transducer for determining three-
  • the web is provided with at least one
  • a video monitor is linked to the analyzing
  • the system preferentially includes a view selector
  • stage may be operatively connected to the analyzing component and the video monitor for
  • the web may be provided with a plurality of electroacoustic transducers attached to the web in a predetermined array
  • the system further comprises circuitry for
  • system further comprises circuit components for receiving signals from the acoustoelectric
  • the web is provided with a
  • system may be used for performing a complex diagnostic or surgical operation.
  • the web may be provided with at least one chamber for holding a fluid.
  • transducers are disposed in ultrasonic or pressure-wave communication with the chamber
  • the web may take the form of a garment such as a vest surrounding the chest region or
  • the web is disposed adjacent to a skin surface of the patient so that the web is in acoustic or pressure-wave-transmitting contact with the skin surface.
  • the medical instrument is inserted into the patient so that the distal end is disposed inside the
  • the electroacoustic transducer is energized with an electrical signal
  • the distal end of the medical instrument is inserted into the patient after the disposition of the web in contact with the patient's skin surface. Then, the insertion of the
  • instrument into the patient can be guided in response to real-time three-dimensional structural
  • the medical instrument may be passed into the patient through one of the apertures. In this way, laparoscopic surgery as well as other
  • Laparoscopic surgery is simplified by eliminating the need for a laparoscope.
  • Multitudinous operations are facilitated with the use of ultrasonically derived images of
  • Such operations include liver biopsies, kidney biopsies, and pleural
  • the method further comprises energizing the electroacoustic transducers
  • the method further comprises receiving signals
  • This printed image facilitates diagnosis by providing a quick and
  • Diagnosis is further facilitated by generating an electrical signal encoding the
  • an ultrasonic imaging device in accordance with the present invention is portable, at least significantly more portable than conventional imaging systems such as CAT scanners and MRI machines.
  • imaging, diagnosis and treatment is a feature that is associated with the present invention.
  • the images may be made even where patients do not have ready access to a hospital facility.
  • the images may be made even where patients do not have ready access to a hospital facility.
  • a medical imaging device comprising a container assembly defining a fluid- or liquid-filled
  • the container assembly includes a flexible wall or panel which is conformable to a
  • the container assembly has at least one electroacoustic transducer in operative
  • An a-c current source is operatively connected to the transducer for energizing the transducer with an electrical signal of a pre-established ultrasonic
  • At least one acoustoelectric transducer which is in operative contact
  • An analyzing component is operatively connected to the acoustoelectric transducer
  • the container assembly includes a bag or bladder defining the fluid-filled
  • chamber and further includes a plurality of substantially rigid walls or panels which partially
  • the flexible wall deforms to receive and cradle the patient and is
  • a flexible web or sheet may be placed over the patient after disposition of the patient on the fluid-filled bag.
  • the web or sheet may itself be provided with an ultrasonic
  • the web or cover sheet is preferably provided
  • a video monitor is linked to the analyzing component for displaying an image of
  • a view selector is operatively connected to the analyzing component
  • a filter stage may be operatively connected to the analyzing
  • acoustoelectric and electroacoustic transducers are contemplated generally.
  • the transducers may be attached
  • the transducers may be attached to or embedded in the flexible upper wall of the fluid-filled chamber which conforms to and engages the patient.
  • ultrasonic transducers With the patient received by the fluid-filled bag and covered by the flexible web or sheet, ultrasonic transducers may be disposed in an array virtually surrounding the patient.
  • This disposition of transducers provides a dense stream of organ position and configuration
  • the ultrasonic transducers may be disposed in a separate pad disposed, for example, beneath the fluid-filled bag prior to the placement of the patient on the bag.
  • the invention utilizes a medical instrument and container assembly which defines a fluid-filled chamber having a flexible wall which is conformable to a patient.
  • the container assembly is
  • the chamber is disposed adjacent to a skin surface of the patient so that the chamber is in acoustic or
  • the fluid-filled chamber is disposed adjacent to the skin surface.
  • the electroacoustic transducer is energized
  • the patient and at the distal end of the medical instrument in response to the first pressure wave are automatically analyzed to thereby determine three-dimensional shapes of the internal organs of the patient and a location of the distal end of the medical instrument relative to the internal organs, thereby enabling a real time manipulation of the instrument to effectuate a medical operation on a selected one of the internal organs.
  • An imaging device comprises, in accordance with the present invention, a flexible
  • the scanner is preferably provided with an analyzing
  • the substrate with the video screen is disposed on a selected body
  • the video screen substantially conform to the selected body portion and so that the video
  • the scanner is operated to provide a
  • the video signal to the video screen, the video signal encoding an image of internal organs of the
  • the video screen is operated to reproduce the image so that internal organ
  • representations as displayed on the video screen substantially overlie respective corresponding
  • the markers are easily recognized by the analyzing computer and
  • the position and orientation of each portion or area of the video screen relative to the internal organs of the patient is determined to enable the display on the video screen of images of organs underlying the
  • two or more overlapping screen areas may be provided with
  • the imaging device or system is preferably provided with a number of ancillary
  • the analyzing component may include a module
  • the highlighting may be implemented by changing the
  • Another ancillary component for enhancing the usefulness of the imaging device or
  • system is voice-recognition circuitry operatively connected to the analyzing computer Voice
  • recognition circuity is especially beneficial for medical applications in that doctors must frequently have their hands (and even feet) available for operating medical equipment.
  • circuitry of the present invention is used, for instance, to request highlighting of a selected
  • organs or tissues enables the user to view underlying organs. Viewing of the patient's internal structures may thus proceed in an ever more deeply penetrating sequence, with successive
  • Yet another ancillary component is speech synthesis circuitry operatively connected to the analyzing computer.
  • the voice recognition and speech synthesis circuitry together enable
  • the user to interface with the imaging device as if the device were an operating room assistant.
  • the analyzing computer's tasks may extend well beyond normal image analysis and
  • the computer may be programmed for automated diagnosis based on pattern
  • the computer may be programmed to recognize a bloated appendix
  • the computed diagnosis may be communicated to the physician via the speech synthesis
  • view of the imaging system are displayed on the video screen together with the selected
  • Laparoscopic surgery is simplified by eliminating the need for a laparoscope.
  • liver biopsies include liver biopsies, kidney biopsies, and pleural biopsies and the placement of tubular
  • drains and catheters for such techniques as thoracentesis and abscess
  • An additional ancillary component for enhancing the usefulness of the imaging device or system in accordance with the present invention is a transceiver interface for operatively
  • the image data is transmitted over the telecommunications link to a
  • the scanner utilizes
  • Such an ultrasonic scanner includes at least one
  • electroacoustic transducer an electroacoustic transducer, an a-c current generator operatively connected to the transducer
  • the analyzing for energizing the transducer with an electrical signal of a pre-established ultrasonic frequency to produce a first pressure wave, and at least one acoustoelectric transducer.
  • a computer is operatively connected to the acoustoelectric transducer for determining three- dimensional shapes of the objects by analyzing signals generated by the acoustoelectric transducer in response to second pressure waves produced at the objects in response to the first pressure wave.
  • At least one of the ultrasonic transducers is
  • the electroacoustic transducer is one of a plurality of
  • electroacoustic transducers and the acoustoelectric transducer is one of a plurality of
  • acoustoelectric transducers all mounted to the substrate. This configuration is especially portable: it is compact and lightweight.
  • the device comprises a planar substrate, a substantially flat video screen provided on the substrate, a flexible bag connected to the substrate, and a scanner operatively connected to the video
  • the bag is disposed on a side of the substrate
  • the video signal encodes an image of internal tissues of a patient upon
  • An imaging device comprises, in accordance with another embodiment of the present
  • the substrates to one another so that the substrates are extendable at a variable angle with
  • a scanner operatively connected to the video screens for providing respective video signals thereto, the video signals each encoding an image of objects located near a respective one of
  • the scanner is an ultrasonic scanner and includes at least one
  • electroacoustic transducer and at least one acoustoelectric transducer.
  • the transducers are both attached at least indirectly to the substrate(s) so that ultrasonic pressure waves can travel
  • the scanner is preferably provided with an analyzing component, generally a specially
  • the imaging device of the present invention is considered to be particularly compact
  • one or more video screens are disposed on a selected body portion of a patient, for example,
  • the scanner is operated to generate one or
  • the video screens are operated to
  • the video screens substantially overlie respective corresponding actual tissues (organs) of the
  • the imaging device or system is preferably
  • the analyzing component may include a module for highlighting a selected feature of the internal organs of
  • the device is configured to:
  • therapeutic may be performed with the aid of real-time visual images of the patient's internal tissues displayed on the video screens.
  • Laparoscopic surgery is simplified by eliminating the
  • Laparoscope elimination enables a reduction in the number of
  • instruments through the flexible video screen include liver biopsies, kidney biopsies, and pleural
  • tubular members including drains and catheters, for such techniques as thoracentesis and abscess drainage
  • At least one of the ultrasonic transducers is mounted to the substrate or to one of the substrates Typically, the electroacoustic transducer
  • the acoustoelectric transducer is one of
  • planar where the imaging device is used to diagnose or treat a limb or a joint, the planar
  • substrates and the video screens attached thereto have sizes and possibly shapes which facilitate substantial conformity with the limb or joint
  • a medical method in accordance with the present invention utilizes an imaging device including a plurality of planar substrates fastened to one another by flexible connectors, each of the substrates carrying a respective video screen, a scanner being operatively connected to the imaging device
  • the substrates with the video screens are disposed on a
  • the scanner is operated to provide video signals to the video screens, the
  • video signals encoding images of internal tissues of the patient.
  • the video screens are operated to reproduce the images so that internal
  • tissue representations as displayed on the video screens substantially overlie respective corresponding actual tissues of the patient
  • the method also contemplates the placing of markers on the patient for facilitating the placing of markers on the patient.
  • Fig. 1 is a block diagram of a medical diagnostic system, which may utilize or
  • Fig. 2 is a flow-chart diagram illustrating steps in a mode of operation of the diagnostic
  • Fig. 3 is a flow-chart diagram illustrating steps in another mode of operation of the
  • Fig. 4 a block diagram of a further medical diagnostic system.
  • Fig. 5 is a diagram showing the composition of a data string or module used in the
  • Fig. 6 is a block diagram of a computerized slide scanning system.
  • Fig. 7 is a block diagram of a device for measuring a diagnostic parameter
  • Fig. 8 is a diagram of an ultrasonography device
  • Fig. 9 is a diagram showing a modification of the device of Fig. 8.
  • Fig. 10 is a block diagram of an ultrasonographic imaging apparatus similar to the
  • Fig. 1 1 is a block diagram showing a modification of the apparatus illustrated in Fig.
  • Fig. 12 is partially a schematic perspective view and partially a block diagram showing
  • FIG. 13 is a partial schematic perspective view including a block diagram showing use
  • Fig. 14 is a schematic perspective view of yet another ultrasonographic imaging device which includes a sensor vest in a closed, use configuration.
  • Fig. 15 is a schematic perspective view of the sensor vest of Fig. 14, showing the vest in an open configuration.
  • Fig. 16 is partially a schematic perspective view and partially a block diagram of an
  • Fig. 17 is partially a schematic perspective view and partially a block diagram of the
  • ultrasonic diagnostic imaging device of Fig. 16 showing the device in use with a patient.
  • Fig. 18 is partially a schematic perspective view and partially a block diagram of
  • Another ultrasonic diagnostic imaging device showing the device in use with a patient.
  • Fig. 19 is partially a schematic perspective view and partially a block diagram of the
  • Fig. 20 is partially a schematic exploded perspective view and partially a block diagram
  • Fig. 21 is a schematic perspective view showing use of the system of Fig. 20 in
  • Figs. 22A and 22B are schematic perspective views showing use of another
  • Fig. 23 A is a schematic perspective view of a further ultrasonographic device related to the present invention.
  • Fig. 23B is a schematic perspective view showing use of the ultrasonographic device of
  • Fig. 24 is a schematic perspective view of an ultrasonographic device in accordance with the present invention.
  • Fig. 25 is a schematic perspective view of another ultrasonographic device in accordance with the present invention.
  • Fig. 26 is a schematic perspective view of the ultrasonographic device of Fig. 25,
  • Fig. 27A is a schematic front elevational view of a video screen display configuration
  • Fig. 27B is a schematic front elevational view of a further video screen display
  • Fig. 28 is a schematic partial perspective view of a modification of the ultrasonographic
  • the present invention is directed chiefly to an imaging device and particularly to an
  • ultrasonographic imaging device of the present invention is described generally hereinafter with
  • ultrasonographic imaging device and particularly image derivation or construction portions
  • imaging device can be employed in carrying out certain minimally invasive diagnostic or
  • a medical diagnostic system comprises a device 20 for
  • device 20 is juxtaposable to a patient for collecting individualized medical data about the
  • Device 20 may take the form of an electronic thermometer, an electronic blood pressure gauge, a pulmonary function apparatus, a Doppler study apparatus, an EEG machine, an EKG machine, an EMG machine, or a pressure measurement device, etc., or include a plurality of such components.
  • Monitoring and measuring device 20 is connected at an output to a digitizer 22 which
  • Digitizer 22 may be incorporated into a housing
  • digitizer may be an integral part of monitoring and measuring device 20.
  • Computer 24 receives instructions and additional input from a keyboard 26. Keyboard
  • 26 is used to feed computer 24 information for identifying the patient, for example, the
  • Such medical conditions may include past diseases and genetic predispositions.
  • Computer 24 is also connected to an external memory 28 and an output device 30 such
  • Memory 28 stores medical data for a multiplicity of previously
  • diagnosed medical conditions which are detectable by analysis of data provided by monitoring and measuring device 20.
  • monitoring and measuring device 20 detects a magnitude of a predetermined biological or physiological parameter in a step 32.
  • Digitizer 22 converts the detected magnitude into a pre-established digital format in a step 34 and transmits the digital signal to computer 24 in a step 36.
  • Computer 24 is operated in a step 38 to compare the
  • the diagnosis is then communicated to the
  • monitoring and measuring device 20 measures a physiological function characterized
  • one or more parameters e.g., a frequency packet.
  • the measured values of the pre-established parameters are then compared with parameter ranges stored in memory 28 for the type of
  • computer 28 communicates a "normalcy" finding via printer 30. If, on the contrary, the
  • the medical diagnostic system may comprise, in addition
  • Scanner 42 may take the form of an MRI apparatus, a CAT scanner, an
  • X-ray machine an ultrasonography apparatus (see Figs. 8-15 and 20), or a video camera with or without magnification optics for magnifying a sample on a slide.
  • the video camera can be
  • Scanner 42 is connected via an interface 44 to computer 24.
  • scanner 42 obtains an image of a tissue or organ in a step 46.
  • image is digitized, either by scanner 42 or interface 44 in a step 48, and is transmitted to computer 24 in a step 50.
  • Computer 24 is operated in a step 52 to analyze the image from
  • scanner 42 takes the particular form of a video camera for
  • the range of color variation e.g., whether bleeding is symptomatic.
  • Organs internal to the fetus may be similarly
  • physiological functions such as the heart rate of the fetus may be automatically
  • the analysis performed by computer 24 on the image from scanner 42 will depend in part on the region of the patient's body being scanned. If a woman's breast or a person's cortex
  • computer 24 is programmed to separate the tissue
  • the different textured regions are parameterized as to
  • a similar analysis is undertaken to evaluate a tissue specimen on a slide.
  • the texture and line scanning may be repeated at different magnification levels if, for example, the tissue
  • sample is a slice of an organ wall.
  • texture and line analysis On a high magnification level, the texture and line analysis
  • Memory 28 may store entire images related to different diseases. For example,
  • memory may store images of skin conditions in the event that scanner 42 takes the form of a
  • computer 24 compares the image of a patient's skin with previously stored images in memory
  • scanner 42 takes the form of an MRI apparatus, a CAT scanner or an
  • step 54 (Fig. 3),
  • Computer 24 partitions the image from the MRI apparatus or CAT
  • a medical diagnostic system comprises a plurality of remote
  • Each diagnostic station 60a, 60b may take the form
  • FIG. 1 local computer 24 communicating via link 62a, 62b with central computer 64.
  • each diagnostic station 60a, 60b may take the form shown in Fig. 4 and include a
  • Computer 68 is fed instructions and data from a keyboard 72 and communicates diagnostic results via a monitor 74 or printer 76. As discussed hereinabove with reference to monitoring
  • each monitoring and measuring device 66a, 66b, ... 66n is
  • Monitoring and measuring devices 66a, 66b, ... 66n may respectively take the form
  • a Doppler study apparatus an EEG machine, an EKG machine, an EMG machine,
  • Digitizers 70a, 70b, ... 70n convert normally analog type signals into coded binary
  • 70b, ... 70n may be incorporated into the housings or casing (not shown) enclosing all or part
  • Keyboard 72 is used to feed computer 68 information for identifying the patient, for
  • the patient's age, sex, weight, and known medical history and conditions may include past diseases and genetic predispositions.
  • a plurality of diagnostic image generating apparatuses or scanners 78a, 78b, ... 78i are also connected to central computer 64 via respective hard-wired
  • Scanners 78a, 78b, ... 78i each generate
  • Scanners 78a, 78b, ... 78i may each take the form of an MRI apparatus, a CAT scanner, an
  • X-ray machine an ultrasonography apparatus (Figs. 8-15 and 20), or a video camera with or
  • computer 64 is connected to a bank of memories 82 at a central storage and information processing facility 84. Diagnosis of patient conditions may be undertaken by central computer
  • a computerized slide scanning system comprises a slide carrier 100
  • slide carrier 100 for shifting the carrier along a path determined by a computer 104.
  • 104 may be connected to an optional transport or feed assembly 106 which delivers a series of slides (not shown) successively to slide carrier 100 and removes the slides after scanning.
  • Computer 104 is also connected to an optical system 108 for modifying the
  • optical system 108 is focused thereby onto a charge coupled device ("CCD”) 110 connected to computer 104 for feeding digitized video images thereto.
  • CCD charge coupled device
  • Computer 104 performs a line and texture analysis on the digitized image information
  • CCD 110 determines the presence of different organic structures and microorganisms.
  • the different textured regions are parameterized as to size, shape and location and the derived
  • Computer 104 may be connected to a keyboard 112, a printer 114, and a modem 16.
  • Modem 116 forms part of a telecommunications link for connecting computer 104 to a remote
  • Image generating apparatus 42 in Fig. 1 may take the form of the computerized slide scanning system of Fig. 6.
  • thermometer an electronic thermometer
  • electronic blood pressure an electronic blood pressure
  • gauge a pulmonary function apparatus, a Doppler study apparatus, an EEG machine, an EKG
  • Monitoring and measuring device 118 is connected at an output to a
  • Modulator 122 modulates a carrier
  • Transducer 126 via an amplifier 128.
  • Transducer 126 is removably attachable via a mounting
  • transducer 126 may be omitted and modulator 122 connected directly to a telephone line.
  • the system of Fig. 7 enables the transmission of specialized medical data directly over
  • a central computer e.g. computer 64 in Fig. 4 which utilizes the
  • Monitoring and measuring device 118 may include traditional medical instrumentation such as a stethoscope or modern devices such as a CCD.
  • Fig. 8 shows an ultrasonographic image generating apparatus which may be used in the
  • a flexible web 132 carries a
  • Transducers 134 are each connectable to an ultrasonic signal generator 136 via a switching circuit 138.
  • Switching circuit 138 is operated by a control unit 140 to connect tranducers 134
  • Web 132 also carries a multiplicity of acoustoelectric transducers or sensors 142 also
  • Sensors 142 are connected to a switching circuit
  • switching circuit 144 also operated by control unit 140.
  • An output of switching circuit 144 is connected to a
  • Web 132 is draped over or placed around a portion of a patient's body which is to be
  • Control unit 140 then energizes signal generator 136 and operates
  • control unit 140 the transducer or combination of transducers 134 which are activated, control unit 140
  • Pressure wave analyzer 146 and control unit 140 cofunction to determine
  • Control unit 140 is connected to ultrasonic signal generator 136 for varying the
  • Fig. 9 shows a modified ultrasonography web 150 having a limited number of
  • electroacoustic transducers 152 and generally the same number and disposition of sensors 154
  • Web 132 or 150 may be substantially smaller than illustrated and may corresponding
  • Control unit 140 and pressure wave analyzer 146 are programmed to
  • Fig. 10 illustrates a modification of the ultrasonography apparatus of Figs. 8 and 9
  • control unit 156 for performing operations of control unit 140 is
  • a diagnostician, surgeon or other medical specialist inserts a distal end of a medical instrument into a patient in response to video feedback provided by the ultrasonography apparatus including video monitor 158.
  • an a-c current or ultrasonic signal generator 160 is
  • Transducers 162 are mounted in interspaced fashion to a flexible web 166
  • Web is placed adjacent to a skin surface of a patient. In some cases, it may be
  • transducers 168 acoustoelectric transducers 168. Electrical signals generated by transducers 168 in response to
  • the reflected pressure waves are fed via a switching circuit 170 to control unit 156.
  • control unit 156 As discussed hereinabove with reference to control unit 140 in Fig. 8, control unit 156
  • the sequencing depends on the portion of the patient being monitored.
  • control unit 156 In addition to pressure wave or ultrasonic frequency analyzer 172, control unit 156 is
  • View selector 174 includes a view selector 174 and a filter stage 176.
  • View selector 174 is operatively connected
  • View selector 174 may be provided with an input 178 from a keyboard (not
  • the medical practitioner may sequentially select views from different
  • Filter stage 176 is operatively connected to analyzer 172 and video monitor 158 for
  • Filter stage 176 is provided
  • filter stage 176 blood moving through a vessel of the vascular system is deleted to enable viewing of the blood vessel walls on monitor 158. This deletion is easily effected
  • Filter stage 176 may also function to highlight selected organs.
  • the highlighting may be
  • control unit 156 is optionally connected at an output to
  • a frame grabber 182 for selecting a particular image for reproduction in a fixed hard copy via a
  • ultrasonically derived real-time image information may be encoded by
  • a modulator 186 onto a carrier wave sent to a remote location via a wireless transmitter 188.
  • Fig. 11 depicts the ultrasonography apparatus of Fig. 10 in a form wherein control unit 156 (Fig. 10) is realized as a specially programmed general purpose digital computer 190.
  • control unit 156 (Fig. 10) is realized as a specially programmed general purpose digital computer 190.
  • switching circuit or multiplexer 192 relays signals incoming from respective acoustoelectric
  • transducers 168 in a predetermined intercalated sequence to an analog-to-digital converter 194, the output of which is stored in a computer memory 196 by a sampling circuit
  • a wave analysis module 200 of computer 190 retrieves the digital data from memory 196 and processes the data to determine three dimensional organic structures inside a patient. This three-dimensional structural data is provided to a view selection module 202 for deriving two-dimensional images for display on monitor 158 (Fig. 10).
  • a filter module 204 is provided for removing selected organs from the image presented on the visual display or
  • filter module 204 are program-modified generic digital circuits of computer 190.
  • Fig. 12 shows a use of a flexible ultrasonic sensor web 206 which may be any of the
  • elongate diagnostic or therapeutic instruments such as laparoscopic surgical instruments 210 and 212 are inserted through respective openings 208 to perform a surgical operation on a designated internal organ of the
  • This operation is effectuated by viewing a real time image of the distal ends of the instruments 210 and 212 in relation to the patient's internal organic structures as determined
  • control unit 156 or computer 190.
  • image on monitor 158 is viewed during
  • video images on monitor 158 are viewed to enable a proper carrying out of the
  • laparoscopic surgical operation on the designated internal organ of the patient PI. Strictly speaking, this operation is not a laparoscopic operation, since a laparoscope is not used to
  • sonographic web 206 instead of a laparoscope.
  • viewing angles may be from under the patient where a
  • Web 206 may be used to insert tubular instruments such as catheters and drainage
  • tubes for example, for thoracentesis and abscess drainage.
  • the tubes or catheters are inserted
  • web 206 may be used to effectuate diagnostic investigations.
  • a biopsy instrument 214 may be inserted through an aperture 208 to perform a
  • breast biopsy a liver biopsy, a kidney biopsy, or a pleural biopsy.
  • a flexible ultrasonic sensor web 216 which may be any of the flexible ultrasonic sensor webs described herein, may be used in a diagnostic or therapeutic
  • Instrument 218 has a steering
  • a port 224 connected to an irrigant source 226 and another port 228 connected to a
  • instrument 218 is provided a biopsy channel (not shown) through
  • Instrument 218 is considerably simplified over a conventional endoscope in that
  • instrument 218 does not require fiber-optic light guides for carrying light energy into a patient P2 and image information out of the patient. Instead, visualization of the internal tissues and organ structures of patient P2 is effectuated via monitor 158 and control unit 156 or computer
  • the sonographic imaging apparatus if web
  • images may be provided from multiple angles
  • module 204 may function in further ways to facilitate viewing of internal organic structures.
  • a zoom capability may be
  • the zoom or magnification factor is limited only by the resolution of the imaging, which is determined in part by the frequency of the ultrasonic pressure waves.
  • Figs. 14 and 15 depict a specialized ultrasonic sensor web 232 in the form of a garment
  • Sensor vest 232 has arm holes 234 and 236, a neck opening 238 and fasteners
  • sensor vest 232 for closing the vest about a patient.
  • sensor vest 232 is provided with a
  • Fig. 14 shows a computer 246, a video monitor 248 and a printer
  • Sensor vest 232 may be understood as a container assembly having fluid-filled
  • an ultrasonography apparatus comprises a container assembly
  • Bladder or bag 306 is filled with a liquid and is sufficiently flexible to substantially conform to a patient when the container assembly 302 is placed onto a patient PT1, as illustrated in Fig. 17. A liquid may be deposited on the patient prior to the placement of container assembly 302 on patient PT1.
  • Plate 304 is provided with multiple ultrasonic pressure wave generators and detectors
  • detectors 308 are connected to a computer 310 having essentially the same functional
  • Computer 310 is connected
  • Computer 310 has the capability of alternately displaying organ images from different angles, as discussed above.
  • Fig. 18 depicts another ultrasonography apparatus useful for both diagnostic investigations and minimally invasive surgical operations.
  • the apparatus comprises a container
  • bag 316 include a flexible upper wall 318 which deforms to conform to the patient PT2 upon
  • Bag 316 is supported on tow or more sides by
  • Panels 320 and 322 are either integral with bag
  • Panels 320 and 322, as well as an interconnecting bottom panel are separable therefrom.
  • 324 may be provided with multiple ultrasonic pressure wave generators and detectors (not limited
  • generators and detectors are connected to a computer 326 having essentially the same functional structures and programming as computer 190 for implementing sequential generator
  • Computer 326 is connected
  • Computer 326 has
  • the ultrasonic pressure wave generators and detectors may be provided in a separate carrier 330 disposable, for example, between bottom panel 324 and bag 316, as shown in Fig. 18.
  • the ultrasonography apparatus of Fig. 19 may be used in
  • Web or cover sheet 332 is operatively connected to computer 326 for providing
  • the sheet is provided with apertures (see Fig. 12 and associated description) for enabling the introduction of minimally invasive surgical instruments into the
  • contact surfaces are advantageously wetted with liquid to facilitate
  • monitor 328 may take the form of a flexible video screen layer attached to web
  • the web or subtrate with the video screen is
  • a selected body portion of a patient for example, the abdomen (Figs. 12 and 21)
  • an ultrasonographic device or system comprises a flexible
  • substrate or web 350 which carries a plurality of piezoelectric electroacoustic transducers 352
  • Video screen 356 is attached to substrate or web 350 substantially coextensively therewith.
  • Video screen 356 may be implemented by a plurality of laser diodes (not shown) mounted in a planar array to a
  • the laser diodes are tuned to different frequency ranges, so as to reproduce the image in color.
  • the protective cover sheet may function also to disperse light emitted by the laser diodes, to
  • Substrate or web 350 and video screen 356 comprise an ultrasonic video coverlet or
  • Electroacoustic transducers 352 are connected to a-c or ultrasonic signal generator 160
  • Generator 160 for receiving respective a-c signals of different frequencies.
  • Generator 160 produces different frequencies which are directed to the respective electroacoustic transducers 352 by switching circuit 162. Pressure waveforms of different ultrasonic frequencies have different penetration
  • computer 360 is a specially programmed digital computer wherein functional modules are
  • switching circuit or multiplexer 192 As discussed above with reference to Fig. 11, switching circuit or multiplexer 192
  • Wave analysis module 200 retrieves the digital data from memory 196 and processes the data to determine three dimensional organic structures inside a patient. This three-dimensional structural data is provided to view selection
  • Filter module 204 serves to remove selected organs, for example, overlying organs, from the image
  • selection module 202 and filter module 204 are program-modified generic digital circuits of
  • Computer 360 contains additional functional modules, for example, an organ
  • organ highlighter 362 and a superposition module 364.
  • the functions of organ highlighter 362 are
  • Organ filter 176 and 204 discussed above with reference to organ filter 176 and 204 in Figs. 10 and 11.
  • highlighter 362 operates to provide a different color or intensity or cross-hatching to different
  • a gall bladder or an image to highlight a selected image feature.
  • a gall bladder or an image to highlight a selected image feature.
  • appendix may be shown with greater contrast than surrounding organs, thereby facilitating perception of the highlighted organ on video screen 356.
  • highlighter 362 operates to highlight one or more features of the encoded
  • Superposition module 364 effects the insertion of words or other symbols on the image displayed on video screen 356.
  • words or symbols may, for example, be a diagnosis or
  • alert signal produced by a message generator module 366 of computer 360 in response to a
  • 368 receives the processed image information from waveform analysis module 200 and
  • message generator 366 may be
  • organ filter 204 connected to organ filter 204 and organ highlighter 362, as well as to superposition module
  • the communication of an abnormal condition may be alternatively or additionally
  • the ultrasonically derived three-dimensional structural information As discussed above, the ultrasonically derived three-dimensional structural information
  • waveform analysis module 200 may be transmitted over a telecommunications link (not
  • the transmitted information may be modulated by a modulator 378 and a transmitter 380.
  • the transmitted information may be modulated by a modulator 378 and a transmitter 380.
  • a diagnosis be processed at a remote location, either by a physician or a computer, to generate a diagnosis.
  • This diagnosis may be encoded in an electrical signal and transmitted from the remote location to a receiver 382.
  • Receiver 382 is coupled with message generator module 366, which can
  • Computer 360 is connected at an output to a video signal generator 384 (which may be incorporated into the computer).
  • Video signal generator 384 inserts horizontal and vertical
  • Fig. 21 diagrammatically depicts a step in a "laparoscopic" cholecystectomy procedure
  • Coverlet or blanket 358 is disposed on the abdomen of a patient P2 in pressure-wave transmitting contact with the skin.
  • the gall bladder GB is highlighted (e.g., with greater contrast
  • organ filter 204 may be deleted entirely by organ filter 204.
  • Computer 360 is instructed as to the desired display features via a keyboard (not illustrated in
  • a voice recognition circuit 388 operatively connected to various modules 202, 204
  • speech synthesis circuit 374 and voice recognition circuit 388 enable computer 360 to carry on a conversation with a user. Thus the user may direct the
  • markers 390, 392, 394 are placed on the patient
  • P2 at appropriate identifiable locations such as the xyphoid, the umbilicus, the pubis, etc.
  • markers are of a shape and material which are easily detected by ultrasonic wave analysis and
  • view selector 202 may be utilized (via keyboard command or voice recognition circuit 388) to adjust the relative position of organ images on screen 356 with the corresponding actual organs.
  • the ultrasonographic device As discussed above with reference, for example, to Fig. 13, the ultrasonographic device or
  • system of Fig. 20 may be used in other kinds of procedures.
  • video screen (not separately designated) and connected computer 398 has a predefined shape
  • the coverlet or blanket 396 is flexible and thus deforms upon
  • the coverlet or blanket 396 has a memory so that it returns
  • coverlet or blanket 396 enables the display in real time of a filtered video image showing the
  • Fig. 23 A illustrates an ultrasonic video cuff 400 with a computer 402.
  • the cuff is
  • Cuff 400 attachable in pressure-wave transmitting contact to a knee KN, as depicted in Fig. 23B.
  • Cuff 400 conforms to the knee KN and follows the knee during motion thereof.
  • a knee joint KJ is imaged on the cuff during motion of the knee KN, thereby enabling a physician to study the
  • Cuf 400 has a memory and returns to its predefined shape (Fig. 23 A) after removal from knee KN.
  • Video screen 356, as well as other video monitors disclosed herein, may be a lenticular
  • the ultrasonic processor for presenting a stereographic image to a viewer.
  • computer 190 or 360 operates to display a three-dimensional image of the internal organs
  • Electroacoustic transducers 134, 164, 352 in an ultrasonographic coverlet or blanket 132, 166, 206, 216, 358 as described herein may be used in a therapeutic mode to dissolve clot
  • coverlet or blanket is wrapped around the relevant body part of a
  • electroacoustic transducers are energized to produce ultrasonic pressure waves of frequencies
  • transducers transmitting waves to the clot site simultaneously, the clot is disrupted and forced
  • a lenticular lens array (not shown) for generating a three- dimensional or stereoscopic display image when provided with a suitable dual video signal.
  • Such a dual signal may be generated by the waveform analysis computer 190, 310, 326, 360
  • surgeons may be used in a robotic surgical procedure wherein one or more surgeons are at a remote
  • remote location may be generated by the analysis of ultrasonic waves as disclosed herein.
  • ultrasonography devices or systems disclosed herein may be used in conjunction with
  • a medical imaging device comprises a planar firm substrate
  • Flexible bag 408 contains a fluidic medium such as water or gel
  • a scanner 410 including an ultrasonic waveform generator 412 and a computer-implemented ultrasonic signal processor
  • the video signal encodes an image of internal tissues of a patient PT4 upon placement of medium-
  • Video screen 406 and substrate 404 may be provided with aligned apertures 415 for
  • Figs. 25 and 26 show another medical imaging device comprising a flexible bag 416
  • Bag 416 serves in part to movably mount pads 418 with their respective video screens 420 to one another so that the orientations or relative
  • angles of the video screen can be adjusted to conform to a curving surface of a patient PT5, as
  • a scanner 422 including an ultrasonic waveform generator 424 and a
  • computer-implemented ultrasonic signal processor 426 is operatively connected to video
  • the video signals encode
  • the video images displayed on screen 420 may be substantially the same, with differences in the angle of view of a target organ ORG, depending on the locations and orientations of the
  • ORG may be displayed, with each screen 420 displaying only a part of the total image.
  • Scanners 410 and 422 are ultrasonic scanners with the same components as other
  • 410 and 422 each includes a plurality of electroacoustic transducers and a plurality of
  • acoustoelectric transducers disposed in respective arrays along the respective bag 408 or 416 so that ultrasonic pressure waves can travel through the fluidic medium in the respective bag from the electroacoustic transducers and to the acoustoelectric transducers.
  • processors 414 and 426 analyze incoming digitized ultrasonic sensor signals which are
  • processors 414 and 426 determine three-dimensional shapes of tissue interfaces and organs
  • markers be placed in prespecified locations on the patient to enable or facilitate an alignment of the displayed
  • each video screen 420 detectable.
  • internal tissues and organs of the patient PT5 are determined to enable the display on the video screens 420 of images of selected target tissues of the patient.
  • the reference markers facilitate the display on screens 420 of respective views of the same organ or tissues from
  • processor 414 and 426 may include a module 362, typically realized as a programmed general
  • the highlighting is achievable by modifying the color or intensity of the selected feature
  • An intensity change may be effectuated by essentially blacking or whiting out the other portions of the image so
  • the imaging devices of Figs. 24 and 26 are optionally provided with a voice-
  • the imaging device of Figs. 26 and 27 is advantageously
  • Passageways 428 receive respective tubular
  • cannulas 430 which extend both through the passageways and respective openings (not shown)
  • target tissues of patient PT5 essentially under direct observation as afforded by video screens 420.
  • the distal ends of the medical instruments 432, inserted into patient PT5 in the field of view of the imaging system, are displayed on one or more video screens 420 together with
  • passageways 428 as illustrated in Fig. 28 are substantially identical to the uses and modes of
  • bag 416 may be replaced by a plurality of bags (not illustrated) all
  • planar substrate or carrier pad 418 and its respective video screen may be attached to a
  • substrates 418 may be formed as carrier layers
  • the imaging devices of Figs. 24 and 25, 26 may include a transmitter 380 and a
  • computers or processors 414 and 426 to a long-distance hard- wired or wireless
  • telecommunications link to a video monitor at a remote location will enable observation of the patient's internal tissues by distant specialists who may also operate on the patients robotically via the telecommunications link.
  • imaging device of Figs. 25-28 is used to diagnose or treat a limb or a joint
  • planar substrates 418 and video screens 420 have sizes and two-dimensional shapes which facilitate substantial conformity with the limb or joint. To facilitate the use of the imaging
  • the images provided on video screens 420 may be stereoscopic or holographic.
  • the imaging device thus may include
  • the scanner including
  • window or video image may show an organ from one point of view or angle, while another window on the same screen may show the same organ from a different vantage point.
  • one window may show a first organ, while another window displays one or more
  • organs underlying the first organ may be shown in
  • one screen may display an overlying organ from one angle, while
  • a display window on a video screen of the present invention may be used alternatively for the display of textual
  • information may include diagnostic information determined by the analyzing computer.
EP98918618A 1997-04-24 1998-04-23 Vorrichtung und verfahren zur medizinischen bilddarstellung Withdrawn EP0977512A1 (de)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US08/839,971 US5871446A (en) 1992-01-10 1997-04-24 Ultrasonic medical system and associated method
US839971 1997-04-24
US08/892,955 US6023632A (en) 1997-07-16 1997-07-16 Ultrasonic medical system and associated method
US892955 1997-07-16
US950849 1997-10-15
US08/950,849 US6319201B1 (en) 1997-10-15 1997-10-15 Imaging device and associated method
PCT/US1998/008177 WO1998047428A1 (en) 1997-04-24 1998-04-23 Medical imaging device and associated method

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Publication Number Publication Date
EP0977512A1 true EP0977512A1 (de) 2000-02-09

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JP (1) JP2002511781A (de)
AU (1) AU748589B2 (de)
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WO (1) WO1998047428A1 (de)

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AU748589B2 (en) 2002-06-06
WO1998047428A1 (en) 1998-10-29

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