WO1994028795A1

WO1994028795A1 - Method and apparatus for diagnostics of internal organs

Info

Publication number: WO1994028795A1
Application number: PCT/US1993/011655
Authority: WO
Inventors: Eduard E. Godik
Original assignee: E.G. Vision, Inc.
Priority date: 1992-12-24
Filing date: 1993-12-01
Publication date: 1994-12-22
Also published as: AU6120394A

Abstract

The invention related to medicine, or exactly to methods of non-invasive investigations of living organism state, it could be used, in particular, for diagnostics of pathological changes in tissues of human and animal organism. The method is confined to illuminating of the investigated body with infrared radiation (2, 3) of 0.6-1.5 um wavelength range and simultaneous scanning of the investigated organ volume with a focal spot (5) of a focused beam (4) of an amplitude modulated ultrasound wave, at least one of the parameters appearing under these conditions modulate the intensity of the transmitted and/or backscattered infrared radiation (9, 10) being recorded.

Description

This method, being simple for realization, has however, a considerable disadvantage: strong scattering of optical radiation in tissues, provoked by their micro - inhomogeneity, does not permit revealing a pathology hearth in the investigated organ depth, if the hearth size is much less than the distance separating it from the organ front and bottom surfaces.

The known apparatus for the realization of the transillumination method [5] contains an IR-radiation source with an optical system and a photodetecting device, coupled to a recorder. The investigated organ, mammary gland, for example, is placed between two transparent plates, compressing the organ and shaping it into a plane-parallel, trapezoid or other forms. The means of moving "IR-radiation source - photodetecting device" pair over the organ surface are also available. The main disadvantage of the apparatus is its low sensitivity to the pathology revealing at an early stage, of principle, due to the above mentioned strong scattering of IR-radiation by biological tissues.

The task of the invention is elimination of the above mentioned disadvantages of the prototype, i.e. to achieve increasing in the spatial resolution under the conditions of a strong optical IR-radiation scattering by the investigated tissues.

THE INVENTION DISCLOSURE

The invention essence is confined of introducing to the method of optical diagnostics of human body internal organs, based on the illumination of the investigated organ with IR-radiation of 0.6 - 1.5 um wavelength range and recording of the transmitted and/or back scattered radiation parameters at several discrete wavelengths, an additional focused beam of the amplitude-modulated ultrasound waves, the focal spot of this beam scanning the volume of the body investigated and, simultaneously, at least one of the parameters of modulation of the intensity of the transmitted and/or of back scattered radiation of the infrared radiation, appearing under these conditions, being recorded, the presence and the type of pathology being judged by the value and/or the character of the relative change in the above mentioned parameters during the scanning process. A pulse modulation of the intensity of the ultrasound waves beam is employed, and the amplitude of the appearing under thesee conditions infrared radiation modulation is recorded.

During the diagnostics process, the duration and the duty circle of the pulses of the intensity modulation of the ultrasound waves beam are varied, and at least one of the parameters of the transient process of the intensity modulation of the scattered infrared radiation is recorded.

An apparatus for realization of the method includes a transparent basement for abody investigated, illuminators and detectors of the radiation placed from the both sides of the basement, a scanning system, a block of the signal processing and control, a reflecting device and an oscillator of ultrasound focused waves with an electrical generator, a modulator, illuminators and photodetectors control blocks, an amplifier and a synchronous integrator, the ultrasound focusing oscillator being coupled to the scanning system in the plane of the transparent basement and connected with the generator and the modulator; manageable spectrally-selective photodetectors are connected with the block of signal processing and control via the sequentially connected photodetectors control block, amplifier and synchronous integrator; the modulator output is connected with the synchronizing input of the synchronous integrator, and the illuminators inputs are connected with the corresponding control block outputs, the synchronizing inputs of the illuminators and photodetectors control blocks being connected with the outputs of the signal processing and control block.

The apparatus basement can be fulfilled in the form of plates, transparent both for infrared and ultrasound radiation, the photodetectors can be placed inside the plates body and turned by their sensitive surfaces to each other. Besides, the photodetectors and the illuminators radiating elements can be placed inside the body of at least one plate. The ultrasound focuε-ng ocsillator is placed at a camera, filled with an i sersion medium and covered by the basement transparent plate, the oscillator acoustic axis crossing the plate plane.

The oscillator can be fulfilled in the form of piezo-electric transformer with the electrodes of the divided into sections and connected via manageable phase rotators to the generator, the control inputs of the latter being connected with the signal processing and control block.

The invention is explained by drawings in which: fig. 1 gives a general block-scheme of the apparatus for the method realization; fig. 2 shows the IR-radiation signals under the conditions of the meander modulation of the ultrasound probe; fig. 3 shows the IR-radiation signals under the conditions of the modulation by the rectangular pulses, the pulse duration and intervals between them exceeding the relaxation times of the tissue optical characteristics; fig. 4 shows the arrangement of the ultrasound oscillator and the illuminator; in fig. 5 the fulfillment of the photodetecting device in the form of the light diodes arranged at one of the plates is shown; fig. 6 shows a scheme of the ultrasound oscillator and the photodetecting device when the body investigated is accessible only from one side.

DISCLOSURE OF THE INVENTION

The essence of the invention is based upon the fact, established by the author for the first time, that the spatial resolution of the optical transillumination method can be considerably increased by employment of the ultrasound waves under the conditions of strong inhomogeneity of the subject investigated. As it was already mentioned above, optical inhomogeneity of the investigated subject results in an abrupt deterioration of the metrological characteristics of the transillumination method, since the "shadow" recorded can exceed considerably the size of a pathological hearth and, besides, it is connected in a rather complex way with the pathology location in the strongly scattering medium.

The use of an ultrasound beam makes it possible to realize quite a new approach to the pathology hearths revealing. The effect of the intensity modulation of optical radiation, transmitted through or/and back scattered by biological tissue, is connected with periodical changes in the tissue density under the influence of deformation (pressure) , periodically switched on and off at the focus of the amplitude-modulated ultrasound beam. Biological tissues are known to change their transparence under the pressure application [6] as a result of changes in the real and imaginary parts of the medium dielectric permeability. The real part (the refraction coefficient) is changed practically non-inertially under pressure application, due to "condensing" of scatterers [7], and changes in the imaginary part (the absorption coefficient, mainly by blood) take place with a delay of several seconds, as a result of blood expelling from the capillaries. This effect represents, to the point, some kind of the acoustic optical palpation, making up the basis for the pathology revealing via the compressing contrast, the latter being transformed into the amplitude modulation contrast of the transmitted or/and back scattered optical beam.

Another sensor (but not the tissue) mechanism of the "acoustic optical palpation" is possible to be realized at much less ultrasound beam densities. In the latter variant, modulated ultrasound beam irritates the biological tissue receptors (blood vessels cell walls, for the first time) . It could be mechanical receptors, thermal receptors and non-specific nerve outer sheaths. As a result, capillary blood flow at the receptors zones is modulated, for example, at the dermatomers connected with internal organs - Zakharjina-Geda zones. This produces the corresponding modulation of the optical transparency of the tissue investigated. The latter effect is more inertial ( from several seconds to minutes) , but the necessary intensities of the ultrasound waves are very small and are determined by the reception threshold. The contrast, necessary to reveal a pathology hearth in this case, is formed as a result of the differences in the sensitivity thresholds for normal and pathological tissues to the influence of the modulated ultrasound beam . Both effects of the "acoustic optical palpation" - the tissue and the sensor ones - could be used in cooperation for pathology revealing and identification.

In particular, the changes _in the modulation amplitude and/or the parameters, characterizing the transient process at the beginning or/and the end of the ultrasound beam influence, of the scattered optical radiation (transmitted through or back scattered by the tissue investigated) at the pathology area as compared with normal tissues, i.e. the "contrast" value, serve as an indicator of pathology. Or, in the other words, focused ultrasound beam performs the function of the probe. The use of such a probe permits not only to reveal the pathology , but also to identify it by means of recording the dependence of the modulation amplitude and/or the transient parameters on the wavelength of IR-radiation, as well as on the parameters of the ultrasound waves modulation: the frequency and power of the ultrasound beam, the duration of the influencing pulses and their duty circle etc. All above described opens up, in fact, the possibility of performing a non-invasive spectral analysis of a suspected pathological area inside the investigated organism depth, for,example in the.mammary gland, in liver etc.

Ultrasound probes (US - probes) , i.e. the sources of ultrasound waves, representing ultrasound focusing transformers supplied with the scanning means, are known in biology and medicine [8]. Their main destination is to provoke local changes in the tissue features from point to point over the scanning direction and to compare the features of the nearby sites. Biological influence of the focused ultrasound waves is caused by the joint action of a number of factors (mechanical, thermal etc.), it could be recorded both via changes in the acoustic characteristics [9], and changes in electrical tissue conductivity [10]. In the latter case, ultrasound waves are modulated and the electric signal received is separated by a synchronous detecting at the ultrasound frequency modulation.

The working regime of the US - probe is chosen on the basis of the considerations followed.

The density of the ultrasound waves at the focal spot area is to be set up not higher than 1 kW/m of a continuous ultrasound radiation, since such a "diagnostic" ultrasound waves at the range of frequencies of 0.3 - 10 MHz and the exposition times from 1 s up to 500 s are known not to be accompanied by any irreversible effects [11]. In addition, the work should be performed • under the pain threshold of sensitivity, the latter, being dependent on the type of organ investigated, can aggravate the above mentioned restrictions [8].

The frequency of the ultrasound waves is to be chosen at the range of 0.3 - 10 MHz. In this case, the diameter of the focal spot in the investigated tissue would be about one millimeter - tenth of millimeter, depending on the modulation frequency.

A pulse modulation of the ultrasound beam is used. The frequency of the pulses is usually chosen to be at the range from tenth of hertz to tens of kilohertz. When the ultrasound beam is the meander modulated, the amplitude of the first harmonics of the scattered infrared radiation modulation, appearing under these conditions, is synchronously recorded. When US-beam is pulse modulated with the intervals between pulses, exceeding the time constant of the recovery of the tissue optical characteristics after the deformation, provoked by the influence of the US-beam, then not only the amplitude of the modulation of the scattered IR-radiation is measured, but also the form of the pulses of this radiation is recorded with the help of a strobe - integrator, besides, the parameters of the transient processes are measured following the US-beam switching on and off, including time delay between the beginning of changes in the intensity of IR-radiation in answer to these switchings. The following parameters of the pulse modulation are chosen : the pulse duration of the ultrasound waves, from tens of seconds to milliseconds; sequence frequency, from tenth of hertz to tens of kilohertz. The optimal pulse durations and intervals between them are selected for different tissues during special experiments.

The invention is satisfying to the patent applicability criteria of the "industrial application", the "novelty" in the view of the absence at the previous technology level of any information on the similar investigations, and also "the invention level", since the method and the apparatus do not follow from the existing technology level, but are based on the author own knowledge.

The method can be realized with the help of an apparatus shown in fig. 1. Investigated body (or its organ) 1 is illuminated from illuminators 2 and 3 by IR-radiation beam, the beam width being unlimited and could be of the same magnitude as the size of the organ investigated. Simultaneously, investigated body 1 is scanned by focused beam 4 with focal spot 5 from ultrasound oscillator 6. Oscillator 6 is coupled to a high frequency generator 7 of continuous electrical oscillations, the modulation of the latter being performed with modulator 8. The transmitted and back scattered IR-radiation is recorded with help of photodetectors 9,10, supplied with a lens and a reflector, harvesting the scattered light, which is coupled via photodetector 11 control block to amplifier 12. The signal from the output of amplifier 12 is received by synchronous integrator 13, and then by block 14 of >the signal processing and control. Synchronizing signal is received by block 13 from modulator 8. When meander modulation of the US-beam is performed, a synchronous detector is usually used as integrator 13. Under the conditions of the modulation with pulses of a sufficiently small duty circle, a strobe-integrator with an electric control is used [12]. Block 14 can be fulfilled in an analog or a digital form; in the latter case, a personal computer is sufficient for performing the apparatus control via the input-output controller, as well as for the data processing and their reflection at a display. Information from block 14 of the signal processing and control is received by reflecting device 15. Ultrasound oscillator 6 is supplied with scanning driver 16, connected with block 17 of US-probe scanning. Scanning block 17 output is connected with input of block 14 of signal processing and control. The intensity and the spectral composition of IR-radiation is set up with the help of illuminator control block 18.

The method is realized as follows. Investigated body l, or a part of it, is placed at basement elements 19. Simultaneously with illumination of investigated body 1 with the help of the IR- radiation source, the scanning of the area investigated by a focused beam 4 of the ultrasound waves is performed. Focal spot 5 is moved up and down, as well as from right to left, in accordance with a scanning regime, put up by blocks 14 and 17, and at each point scanned the modulated scattered IR-radiation (transmitted or back scattered) is received and recorded by photodetectors 9 and 10. To increase the intensity of the light received, light gathering lens are placed before the photodetectors sensitive plates and a reflector behind them.

When the meander modulation of the US-beam is applied, the form of the appearing modulation of the scattered IR-radiation is close to the sinusoidal (see fig. 2: the upper curve shows the form of the US-beam modulation, and the lower one that of the IR- radiation) . It is convenient to use also a pulse modulation with the pulse duration, and, especially, with the intervals between pulses of the US-beam switching on, larger than the recovery time of the investigated tissue optical characteristics after the US-beam switching on and off. In this case, not only the amplitude of the modulation of the scattered IR- radiation, provoked by the ultrasound deformation, but also the transient processes parameters -a delay in the beginning of the changes in the IR-radiation intensity after switching on and off the ultrasound waves, the time constant of these processes, the position at the time axis and the extre a amplitudes etc. - are recorded. Under these conditions, the form of the modulation pulses of the scattered IR-radiation is recorded synchronously with the help of the strobe- integrator (see fig.3, the disposition of the curves the same as in fig. 2) . To realize the influence of the modulated ultrasound beam on the given area, insread of special modulator 8, a periodical shifting of an usual, non-modulated US-beam from one part of the body investigated to the other one is performed with the help of scanning block 17, the latter being managed by control block 14, according to the assigned program.

At the absence of any pathology, the input signal will be characterized by some value of the modulation, typical of normal tissues. If focal spot 5 falls into the zone of an impairment hearth 20 and becomes coincident with it, at least one of the parameters of the IR-modulation, received ny photodetectors 9 and 10 (by both or by one of their.} , will change, indicating the presence of the tissue inhomogeneity and of possible pathology. It is a combined recording of the output signal and the changes in the position of focal spot 8 ( via information from scanning block 17) over the investigated area that gives the possibility to localize the impairment hearth and to draw the hearth contour, or in other words, to perform mapping.

To identify the type of the pathology, the focal spot is fixed at the impairment hearth and spectral dependencies of the amplitude of the output signal are recorded, while varying the spectral composition of the illuminating radiation and/or of the optical radiation recorded. In addition, the dependence of the parameters of the IR-radiation modulation on the parameters of the US-beam modulation (pulse duration, the duty circles , power, the ultrasound waves carrying frequency) are recorded with the same aim.

The device for realization of the method in the part that relates to the supplementing the apparatus with the means of the ultrasound beam forming and scanning or the arrangement of US-probe, can be fulfilled with the use of the elements adopted to the ultrasound diagnostics, see [8], for example.

The device (see fig. 4) represents a hermetic frame 21, filled with immersion medium 22, with water free of gases, for example. Ultrasound oscillator 6 connected with the scanning facilities (not shown) is placed at the cavity . Oscillator 6 with the facilities for focal 5 formation can be fulfilled in the form of an electro-acoustical piezo-transformer, supplied with an acoustical lens. The latter can be omitted, in this case a sectioned piezo-transformer is used, each section being connected via a manageable phase-rotor with the generator of the electrical oscillations [13]. In the latter case, controlled moving of the focal spot can be performed both at the axis and at the transversal directions without use of any mechanical scanning mechanisms.

Frame 21 is optically (and acoustically) shut at the front surface with transparent protector 23 made from an organic glass, for example, or from other transparent plastic matherial. Such plastic protectors are widely used in the ultrasound technology, since they are characterized by relatively low decay of ultrasound waves at the frequency of up to 10 MHz. Photodetectors 9, 19 are placed at protector 23 and are fulfilled in the form of one or several sensitive elements 24, turned by their sensitive parts to the free surface of protector 23. They could be arranged in a random manner, however, an uniform distribution over the protector area is mostly used.

In the case, when a sectioned piezo- transformer [13] is used, a local bath with the immersion medium , together with protector 23, can be fulfilled in the form of a solid state sound conducting cable.

Illuminating device 2 capable of moving up and down is fixed at protector 23 side. It is fulfilled in the form of optically transparent plate 26, supplied with an illumination source, an incandescent lamp or light diodes, for example.

In the first case, to provide a wide illuminating beam, lamp 27 is supplied with an optical system which is fulfilled in the form of condenser 28 and changeable filters 29, setting up the necessary radiation spectral range. Instead of filters, a monochromator of any type can be used. The monochromator or filters management is performed by device 18. Inside the body of plate 26, the photodetector are installed, the sensitive elements 24 of the latter being oriented towards the photodetectors placed at the surface of protector 23. The photodetectors, placed both at protector 23 and at plate 26, are coupled to the control block 11, the latter possessing several inputs, each for each photodetector. Block 11 puts up the necessary spectral range of the received radiation with the help of known means: monochromators or changeable filters.

In the second case, when light diodes 30 are used as the IR-radiation sources, they are disposed in such a manner (fig. 5) that both sensitive elements 24 of the photodetectors and light diodes 30 are located at the same side of plate 26. The basis of plate 26 is made to be non-transparent for the IR-radiation, in order to exclude direct illuminating of sensitive elements 24 by light diodes 30, since a working point of the photodetectors can be shifted due to such illumination. A figured form could be given to the working surface of plate 26, so that elements 31 could be properly inserted into it and were capable of correcting the diaphragm of the radiation directionality. As such elements, lens and phocons could be used. The above figured form of the light radiating and the radiation receiving surfaces of plate 26 make it possible to provide sufficiently good light contact of the illuminator with the patient body. To perform the spectral analysis of the pathological inhomogeneity, light diodes 30 are divided into groups with different wavelength of radiation, which are switched on alternatively one after another from each group. These groups are connected with illuminator control block 18, providing a choice of the corresponding light diodes groups.

Plate 26 in the apparatus, working both in the transmitted and reflected (scattered) light, is drawn into basement 21 so that the investigated organ could admit a flat form and a smoothed state. Usual springs could serve as the means of such drawing, as well as pneumatic drivers with a progressive movement, or other known devices of a similar assignment with a smooth action.

For the case, when the anatomic peculiarities or the physical state of a patient do not permit carrying out the investigation in the transmitted light, the invention foresees the possibility of such apparatus construction when an investigated organ, liver for example, is accessible from one side. As shown in fig. 6, in this latter case, the IR-radiation sources - light diodes 30 and sensitive elements 24 of the photodetectors are arranged directly in the body of protector 23 and their disposition can random or uniform, as in the case, shown in fig. 5. The method is realized with the apparatus described in the following manner. Investigated organ, mammary gland, for example, is placed at the protector 23 surface while plate 26 is turned upward. Then the plate is put down and under the action of springs or pneumatic driver the investigated organ admits a flat and smooth form. The system of the IR-radiation illumination (lamp 27 or light diodes 30) is switched on and the corresponding radiation spectrum is set up, that for lamp 27 with the help of filters 29 and that for photodiodes 30 by switching on of the corresponding group at illuminator control block 18. Ultrasound oscillator 6 and driver 16 of the scan system of the US-probe are then switched on. In the case, when during the apparatus action, focal spot 5 of the US-probe turns to be at the zone of an impairment hearth, at least one of the parameters of the modulation of the optical signal recorded by the photodetectors must change. Simultaneously, signals about the US-probe coordinates are received by block 14 from scanning block 17 which permits tp. construct a map of the dependency of the amplitude of optical radiation modulation on the investigated point coordinate. At such a map, the areas differing (by contrast) from the surrounding tissues can be revealed. The set of these data, i.e. the spectral dependence of at least one of the parameters of the modulation of the scattered IR-radiation, the dependency of the latter on the parameters of the ultrasound beam modulation, as well as on the ultrasound carrying frequency at fixed IR- radiation wavelengths, makes it possible to identify the type of the pathology via comparing this data set with similar characteristics for different pathological tissues.

The apparatus realization can be performed both with the help of an analogy means and digital technology. In particular, the signal processing block and the reflecting device can be realized on the basis of a computer [14]. Block 18 of the illuminators control adjusts, after the computer command, the necessary level of the illumination intensity, as well as the spectral composition either for one common radiation source or for each of the separate sources. The principles and the means of such systems construction are well known in technology and are not the subject of the invention. In a similar way, also from the computer, the wavelength of the radiation recorded by the frequency selective photodetectors is set up via block 11 of the illuminator control.

The inventor signature

Claims

REFERENCES

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8. Vartapetjan M.A. et al. Sensor perception. An investigation experience with the help of focused ultrasound, Leningrad, Nauka, 1985 (Russian)

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THE INVENTION FORMULATION

1. A method of optical diagnostics of human body internal organs, based on the illumination of the investigated body or its internal organ with infrared radiation of 0.6 - 1.5 um wavelength range and recording of the radiation parameters at several discrete wavelengths, -d i s t i n g u i s h i n g by an additional application to the investigated body of a focused beam of the amplitude-modulated ultrasound waves, the focal spot of the beam scanning the volume of the body investigated, and recording simultaneously at least one of the parameters of the appearing under these conditions modulation of the transmitted and/or back scattered infrared radiation intensity, the presence and the character of pathology being judged by the value and/or the character of the relative changes in the above mentioned parameters during the scanning process.

2. A method of optical diagnostics of the internal organs as described in claim 1, d i s t i n g u i s h i n g by the use of pulse modulation of the intensity of the ultrasound beam intensity and recording of the amplitude of the infrared radiation modulation, appearing under these conditions.

3. A method of optical diagnostics of the internal organs as described in claims 1, 2 d i s t i n g u i s h i n g by variation of duration of pulses of the modulation of the ultrasound beam intensity, as well as time intervals between the successive pulses, and recording of at least one of the parameters of the transient process of the modulation of the scattered infrared radiation intensity.

4. An apparatus for realization of the method as described in claims 1-3, including a transparent basement for the investigated body,- illuminators and photodetectors placed along the basement opposite sides and a scan system, a block of signal processing and a reflective device d i s t i n g u i s h i n g by an additional inclusion into the apparatus of a focusing ultrasound waves generator, an excitation generator, a modulator, blocks of the illuminator and photodetectors control, an amplifier and a synchronous integrator, the focusing ultrasound waves generator being coupled to the scan system at the transparent basement plane and connected with the excitation generator output, the modulation input of the latter is connected with the modulator output; manageable spectrally selective photodetectors via sequentially coupled photodetector control block, amplifier and synchronous integrator are connected with signal processing and control block, the modulator output is connected with synchronizing input of the synchronous integrator, and the illuminators inputs are coupled to the outputs of the illuminator control block, the synchronizing inputs of the photodetectors and illuminators control blocks being connected with outputs of the signal processing and control block.

5. An apparatus for realization of the method as described in claim 4 d i s t i n g u i s h i n g by the fulfillment of the basement in the form of plates, transparent for infrared and ultrasound radiation, and by arrangement of the photodetectors inside the plates body with their sensitive surfaces being turned towards to each other.

6. An apparatus for realization of the method as described in claims 4,5 d i s t i n g u i s h i n g by arrangement of the photodetectors and radiating elements of the illuminators inside the body of at least one of the plates.

7. An apparatus for realization of the method as described in claims 4-6 d i s t i n g u i s h i n g by arrangement of the focusing ultrasound waves generator inside a camera, formed by the transparent plate of the basement and filled with an immersion medium, the acoustic axis of the generator crossing the plane of the plate.

8. An apparatus for realization of the method as described in claims 4-6 d i s t i n g u i s h i n g by the fulfillment of the ultrasound waves generator in the form of piezo-electrical transformer, the electrodes of the latter being sectioned and coupled via manageable phase-rotators to the generator of excitation, the managing inputs being connected with the signal processing and control block.