EP4384080A1 - Dispositif et procédé de quantification non invasive de substances ferritiques dans un tissu - Google Patents

Dispositif et procédé de quantification non invasive de substances ferritiques dans un tissu

Info

Publication number
EP4384080A1
EP4384080A1 EP22761250.4A EP22761250A EP4384080A1 EP 4384080 A1 EP4384080 A1 EP 4384080A1 EP 22761250 A EP22761250 A EP 22761250A EP 4384080 A1 EP4384080 A1 EP 4384080A1
Authority
EP
European Patent Office
Prior art keywords
signal
frequency
ferritic
substances
tissue
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22761250.4A
Other languages
German (de)
English (en)
Inventor
Jin Yamamura
Friedrich Ueberle
Max KOLWA
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.)
Universitatsklinikum Hamburg Eppendorf
Universitaet Hamburg
Original Assignee
Universitatsklinikum Hamburg Eppendorf
Universitaet Hamburg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universitatsklinikum Hamburg Eppendorf, Universitaet Hamburg filed Critical Universitatsklinikum Hamburg Eppendorf
Publication of EP4384080A1 publication Critical patent/EP4384080A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Clinical applications involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/488—Diagnostic techniques involving Doppler signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0093—Detecting, measuring or recording by applying one single type of energy and measuring its conversion into another type of energy

Definitions

  • the present invention relates to non-invasive quantification of ferritics in tissue.
  • Substances accumulate in the tissues of living beings as a result of natural metabolic processes and also as a result of disease, which can influence and also damage the natural function of organs and systems. These substances can be absorbed from the environment or arise elsewhere in the body through degradation or synthesis processes.
  • ferritic minerals such as iron play an important role.
  • Certain vital organ systems such as the blood are dependent on iron levels in order to be able to fulfill their natural function.
  • Iron is found in all blood-carrying organs and structures of the body. Congenital iron overload (e.g. haemochromatosis) or iatrogenic iron overload caused by blood transfusion (transfusion-dependent anemia, e.g.
  • thalassemia or sickle cell anaemia can lead to excessive accumulation in individual organs.
  • Such an accumulation is known, for example, in the heart muscle and in various parenchymatous organs of the upper abdomen, which in the long term can lead to severe or fatal courses.
  • US Pat. No. 8,454,511 B2 discloses an imaging apparatus which is designed to apply a magnetic field to a cell provided with a large number of metallic nanoparticles, the magnetic field having a frequency of 1 Hz to 10 Hz and a magnetic flux density of at least 2T. Using an ultrasonic detection device, a movement of the cell with the magnetic nanoparticle is generated.
  • the magnetic nanoparticles are so-called synthetic spies, which have a uniform size of 20 nm, for example.
  • the object of the invention is to provide a device and a method for the non-invasive quantification of ferritic substances in tissue.
  • the object is achieved by a device having the features of claim 1 and by a measuring method having the features of claim 9.
  • Advantageous configurations and further developments form the subject matter of the dependent claims.
  • the device with the features of claim 1 is intended and intended to non-invasively quantify ferritic substances in tissue.
  • the device has a coil unit for generating a magnetic excitation field in a measurement volume.
  • a signal generator is also provided, which applies a time-varying current to the coil unit to generate the magnetic excitation field, the excitation field having an alternating field component and a constant DC field during the measurement period.
  • the coil device can preferably consist of one or more coils for the different field components, and additional magnets, such as permanent magnets, can also be provided.
  • the DC field is preferably constant over time and can be spatially homogeneous or inhomogeneous.
  • the device also has a sound converter system that uses a sound converter to direct sound signals onto the measurement volume and evaluates reflected sound signals from the measurement volume.
  • the sound transducer system has an evaluation unit that evaluates the reflected sound signals with regard to a quantitative determination of the ferritic substances. Furthermore, a signal generator is provided which has a frequency of the time variable current determined in such a way that the alternating field component in the measurement volume stimulates a vibration of ferritic substances in the tissue.
  • the invention is based on the insight that the body's own magnetizable substances can be moved in the tissue by a magnetic excitation field and can be detected using a sound transducer system. The movement itself takes place in the organs to be examined, which are enriched with ferritic substances, for example in the form of ferritic minerals, due to natural metabolism and/or due to illness.
  • the course of time, spatial variation and amplitude of the movement depend on a large number of parameters and can thus provide specific information.
  • the particular advantage here is that an imaging process is not absolutely necessary, which significantly reduces the effort involved in the evaluation. Also, no conversion to absolute values for the concentration of ferritic substances in the tissue is necessary. For a quantification, it is also sufficient if the measured values are compared with measured reference values that are specified or measured on another part of the body in which, for example, anatomical or physiological assessment does not show an increased concentration of ferritic substances, for example in the buttocks or thigh muscles. A comparison that indicates whether the concentration in the measurement volume is greater or less than the reference value is also regarded as a quantification with regard to the reference value.
  • the sound transducer system is designed as a Doppler ultrasound device.
  • a Doppler ultrasound sometimes also referred to as an ultrasound Doppler, is that this is a measurement method that is widely used in medicine.
  • the signal generator generates a current that varies over time for the coil unit.
  • Method two forms for the time-varying current have proven to be particularly advantageous.
  • the use of amplitude-modulated signals, in particular in the form of burst signals, and on the other hand, the use of frequency-modulated, so-called sweep signals, provides good resolution.
  • the magnetic excitation field which has an alternating field component and a constant field component, is generated via the time-varying current.
  • the alternating field component in the measuring volume excites the ferritic substances in the tissue to vibrate.
  • the resonant frequency of the ferritic substances in the tissue varies due to different physiological boundary conditions and patient-specific physiological and pathological changes.
  • the alternating field component contains a large number of different frequencies that can cause the ferritic substance in the tissue to be excited at its resonant frequency. Therefore, the vibration excitation does not occur with a single frequency, but with a certain frequency spectrum, which also contains the resonant frequency as the frequency to be excited. In the case of a sweep signal, the frequency is varied for a given signal, so that this signal covers a frequency range when the sweep is run through.
  • the frequency range results from the superimposition of a sinusoidal signal with a first frequency, which is preferably switched with a square-wave signal (0 or 1) or amplitude-modulated with a signal with a second frequency.
  • the superimposition of both signals then results in a continuous frequency spectrum.
  • the burst frequency When using an ultrasonic Doppler, it has proven to be particularly advantageous in the tests carried out to date for the burst frequency turned out to work with a square wave signal in the range of 0.5 to 2 Hz and a burst frequency of 225 Hz +/- 75 Hz.
  • the pulse duty factor of the square-wave signal can take on different values. Up to now, a ratio of 1:1 has been used, resulting in burst and pause sections of the same length.
  • the sound transducer system evaluates the reflected sound signals in a frequency range in which spectral lines occur as a function of a concentration of the ferritic substances in the tissue. This means that there are frequency ranges for the reflected sound in which spectral lines are particularly sensitive to the concentration of ferritic substances in the tissue.
  • the sound signals should be optimized for these frequency ranges.
  • the object according to the invention is also achieved by a measuring method with the features of claim 10.
  • the measuring method works with a magnetic excitation field that has an alternating field and a constant field.
  • the DC field leads to an improvement in the measurement results, especially in the case of paramagnetic substances.
  • at least one frequency in the alternating field is tuned in such a way that the alternating field in the measurement volume stimulates an oscillation of the ferritic substances in the tissue. Sound signals are then directed onto this measuring volume, the reflected sound signals from the measuring volume are recorded and evaluated with regard to the excited vibrations of the ferritic substances in the measuring volume.
  • the evaluation provides a quantitative statement on the concentration and distribution of the ferritic substances in the tissue.
  • a Doppler ultrasound signal is preferably used and evaluated for the signal.
  • a concentration of the ferritic substances is preferably determined by evaluating the frequency and amplitude of the reflected sound signals. The evaluation can also be based on reference values, these being measured, for example, on a part of the body in which, according to anatomical or physiological assessment, there is no increased concentration of ferritic substances.
  • Figure 1 is a schematic view of a measuring device with a
  • FIG. 2 shows a burst signal im connected with a square-wave signal
  • FIG. 1 shows, in a schematically simplified representation, a patient's body 6 with an organ 7 to be examined.
  • This can be the heart or liver, for example.
  • the lines of the magnetic flux density 5 are shown schematically; they are generated by a coil 4 .
  • the magnetic flux density 5 penetrates a part of the organ 7 to be examined. This part can be regarded as the measurement volume, ie the volume in which measurements and evaluations take place.
  • the coil is fed via a power amplifier 3, which takes its signal from a signal generator 1 which is connected to a burst gate 2 for generating a burst signal.
  • the measuring devices can be equipped as a mobile measuring device with a battery insert, for example a 9 V battery or a 48 V rechargeable battery. Alternatively or additionally, a low-voltage mains connection can be provided.
  • a battery insert for example a 9 V battery or a 48 V rechargeable battery.
  • a low-voltage mains connection can be provided.
  • a particular advantage of a burst signal is the reduced load on the coil and low power consumption.
  • the controlled input of power into the patient's body increases medical safety for the patient.
  • Another advantage is that broadband interference, for example caused by contact, movement inside, for example arteries, or also when used in hyperechoic tissue, i.e. tissue in which the signal power increases over the entire spectrum, can be identified well when using burst signals can be used and do not affect the measurement.
  • the burst signal makes it possible to compare the signals of the Doppler ultrasound with a changing magnetic field with the signals without a changing magnetic field and thus to evaluate the signals more precisely.
  • a sweep can be provided in a range in the natural frequency that is typical for the organ, which is followed by a burst sequence with the found natural frequency. Signal-free intervals are used for reference to the sine sections.
  • a spatially inhomogeneous part for example in the form of a spatial gradient, can also be set separately for the DC field component in order to obtain good signals.
  • the acoustic signals are obtained via the Doppler acoustic transducer 9, which is aimed at the organ 7 to be measured.
  • the reflected signals are evaluated by the sound transducer system.
  • One or more ultrasonic transducers can be used to detect the movement caused by the magnetic excitation field.
  • the movement can be detected by analyzing the reflected ultrasonic signal (echo) with regard to time shift, frequency change and/or signal shape change.
  • both the display as an ultrasound image with identification of movement, e.g. B. by color changes, as well as a display in text form, on a scale or in the form of a traffic light, which signals the degree of risk to the patient from iron overload by a traffic light color.
  • An acoustic display is also possible, in which the iron content is signaled acoustically by tones of different amplitude and/or frequency.
  • a visualization of the measurement results in the form of imaging can generally be dispensed with.
  • hemosiderin-ferritin complexes in particular does not serve as a basis for imaging, since these are endogenous and are distributed with homogeneous tissue. Imaging would therefore only differentiate the organ, for example the liver, from the rest of the tissue and is therefore not necessary for the actual goal of measuring iron overload.
  • no structures are marked by exogenously supplied SPIONs, but rather particles embedded in the tissue caused by the disease are examined.
  • a grading of the concentration of the hemosiderin-ferritin complexes would be conceivable as a color coding analogous to the possibilities described in the prior art, but is not necessary for the task according to the invention.
  • Imaging based on magnetic properties in the sense of tomography cannot take place with the stated technique. There are insufficient magnetic field strengths and the fields are neither suitable in their homogeneity, nor in their geometric extent. In addition, imaging would severely limit the excitation frequency, since an image refresh rate (factored with the resolution) would have to be above the excitation frequency. Aliasing effects could also occur.
  • the sound transducer system here consists of a Doppler sound transducer 9 which is fed by a Doppler signal generator 8 and supplies its received signals to Doppler receiving electronics 10 .
  • the signals from the receiving electronics are decoded in a Doppler decoder 11, with the signals from the signal generator and its control also being received here.
  • the Doppler decoder 11 supplies a signal to a frequency analyzer 12, with which it can then be evaluated. If a spatial representation is desired, the data from the frequency analyzer 12 can be presented in a display 13.
  • a controller 14 coordinates the magnetic excitation field 5 and the evaluation of the Doppler ultrasound.
  • the control controls both the signal generator 1 and the burst generator. By adjusting their corresponding frequency, it can be ensured that the magnetic excitation field leads to a clear and distinct excitation in the measurement volume.
  • the controller 14 is also set up to control the Doppler decoder 11 and the frequency analyzer 12 .
  • the Doppler decoder 11 for example, the burst frequency used in the signal generator 1 is of interest in order to be able to compare signals with and without magnetic excitation with one another.
  • the exciting signal frequency from the signal generator 1 is of interest for the frequency analyzer 12 .
  • a pilot signal can be used to better orient the practitioner.
  • Such a pilot signal could be used as a pure ultrasonic signal, for example as an A-mode (Representation of reflection amplitudes on structures along the ultrasound beam) Display reflections that allow orientation to bones or gas in the body. In the more or less homogeneous region of the liver, the reflections will therefore tend to be smaller.
  • the reflections can be measured by operating the same transducer used for measuring magnetic particle/tissue motion as a short pulse transmitter/receiver.
  • These different echoes could be classified by suitable signal analysis and visualized, for example, as a colored optical display element.
  • the practitioner can orientate himself by counting the ribs, as can the diagnosis of the heart.
  • a simple force sensor could be used on the measuring head.
  • FIG. 2 shows a schematic view of a burst signal which has a periodic signal curve for an average time duration TI and has no signal in the remaining time range T2, T3 before and after the sinusoidal signal duration.
  • FIG. 3a shows the relative power of the burst frequency to the total signal power of the signals obtained at different manganese concentrations.
  • the relative signal power is plotted here over time so that burst activity can be distinguished from pauses.
  • Relative signal power is shown as relative band power at 190Hz +/- 10Hz to instantaneous total power.
  • the measurements were performed on a phantom mass with a specified concentration of paramagnetic material.
  • Figures 3a and b show the concentrations of 2.0 mg/g, 5 mg/g and 10 mg/g.
  • FIG. 3b shows the absolute signal power of the acoustic signals at the above concentrations during the magnetic excitation. The power density spectra are shown as a function of the manganese concentration.
  • FIG. 3b is based on a representation in the frequency range, in which high amplitudes in all figures in a low-frequency range, for example up to 160 Hz. This part of the spectrum is therefore not sensitive to the ferrite concentration.
  • the conspicuous variance in the overall performance of the various signal spectra, as can be seen in FIG. 3b, is made comparable by relativizing, as shown in FIG. 3a, in favor of the selectivity between the various manganese concentrations.
  • the distribution of the signal power between the burst frequency (B) and the harmonics (H) is unobtrusive in Figure 3b, but can give an indication of a distortion of the sound due to the properties of the sound transmission path or the type of vibration excitation and should therefore be taken into account. It can also be observed that these signals decrease in a static magnetic field, generated for example by a permanent magnet. This phenomenon allows the assumption that the pulse activity of the Doppler already leads to an oscillation excitation. Due to the applied alternating magnetic field, sinusoidal signals appear in the frequency spectrum in the range of the burst frequency used. In addition, increases in the range of their harmonics are possible.
  • the magnetic field component that corresponds to the DC field is generated by the coil unit.
  • the coil unit for example, several coils can be provided which are controlled differently, or a permanent magnet can also be provided with which the static magnetic field is generated. through the Using a static magnetic field, together with an alternating field component, the measurement accuracy is significantly improved.
  • a numerical measure is recorded as a reference for the energy introduced into the tissue by acoustic waves.
  • the following are possible: Intensity or sound pressure amplitudes of the sound waves from the direct measurement on the sound transducer, amplitude/phase position of the frequency components via the discrete Fourier transformation and absolute pressure values, which, however, require the sound transducer to be calibrated.
  • Another measure of detection are the magnetic field signals with regard to their phase change and the distortion of the signal form as a potential measure for determining organ properties.
  • a resonant frequency can be determined so that it can be ruled out that other unintended structures such as air bubbles, cysts and the like have an effect on the measurement based on their resonance behavior.
  • the ultrasonic signals preferably pulsed signals can be used to tune the measurement to a specific depth. The number of ultrasonic oscillations per pulse determines the possible frequency resolution in the Doppler measurement. Provision can also be made for ultrasonic signals to be measured synchronously with the magnetic excitation, as a result of which distance-dependent differences, for example in the concentration, can be measured by a time delay. A direction of deflection of the ultrasonic signals can be effected, for example, by transfer to a digital intermediate memory and/or sample and hold for referencing according to quadrature and phase.
  • the method according to the invention is based on the detection of ferritic particles.
  • SPIONs endogenous and not exogenously supplied particles.
  • Ferritic particles are also stationary because they cannot be reached by the metabolism. As a rule, they are not water-soluble and have a variable particle size of ⁇ 20 nm, but are not produced synthetically.
  • Ferritic particles are predominantly homogeneously distributed in the parenchyma, so that there is no enrichment in specific structures.
  • Ferritin-hemosiderin complexes are equipped with a variable structure and variable iron content as metabolic degradation processes.
  • ferritic particles are the target structure of the measurement and are measured without using an additional contrast medium.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Physiology (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne un dispositif de quantification non invasive de substances ferritiques dans un tissu, ledit dispositif comprenant les éléments suivants : - une unité de bobine pour générer un champ d'excitation magnétique dans un volume de mesure, - un générateur de signaux qui applique un courant variable dans le temps à la bobine afin de générer le champ d'excitation magnétique, le champ d'excitation ayant un champ alternatif et un champ constant, - un système de transducteurs acoustiques constitué d'au moins un transducteur acoustique et d'une électronique de mesure et d'évaluation, le système de transducteur acoustique dirigeant des signaux sonores sur le volume de mesure et mesurant et évaluant des signaux sonores réfléchis à partir du volume de mesure, - le générateur de signaux déterminant au moins une fréquence du courant variable dans le temps de telle sorte que la composante de champ alternatif dans le volume de mesure excite une oscillation de substances ferritiques endogènes dans le tissu.
EP22761250.4A 2021-08-11 2022-08-11 Dispositif et procédé de quantification non invasive de substances ferritiques dans un tissu Pending EP4384080A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021120922.6A DE102021120922A1 (de) 2021-08-11 2021-08-11 Vorrichtung und Verfahren zur nicht-invasiven Quantifizierung von ferritischen Stoffen in Gewebe
PCT/EP2022/072561 WO2023017124A1 (fr) 2021-08-11 2022-08-11 Dispositif et procédé de quantification non invasive de substances ferritiques dans un tissu

Publications (1)

Publication Number Publication Date
EP4384080A1 true EP4384080A1 (fr) 2024-06-19

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ID=83115386

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22761250.4A Pending EP4384080A1 (fr) 2021-08-11 2022-08-11 Dispositif et procédé de quantification non invasive de substances ferritiques dans un tissu

Country Status (3)

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EP (1) EP4384080A1 (fr)
DE (1) DE102021120922A1 (fr)
WO (1) WO2023017124A1 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0145173A1 (fr) * 1983-10-17 1985-06-19 Electro-Biology, Inc Modification de la dynamique de la circulation du sang dans un corps vivant
US8036732B2 (en) * 2006-10-18 2011-10-11 Board Of Regents, The University Of Texas System Hemoglobin contrast in magneto-motive optical doppler tomography, optical coherence tomography, and ultrasound imaging methods and apparatus
US8355776B2 (en) 2005-05-27 2013-01-15 Board Of Regents, The University Of Texas System Hemoglobin contrast in magneto-motive optical doppler tomography, optical coherence tomography, and ultrasound imaging methods and apparatus
WO2009009786A2 (fr) 2007-07-12 2009-01-15 Board Of Regents, The University Of Texas System Détection ultrasonique magnétomotrice de nanoparticules magnétiques

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Publication number Publication date
WO2023017124A1 (fr) 2023-02-16
DE102021120922A1 (de) 2023-02-16

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