System and method for non-invasive real time assessment of cardiovascular blood pressure

Abstract

A system and method for non-invasive medical imaging based measurement and calculation of the cardiovascular pressure is presented, wherein the pressure measurements are performed by means of the image stream processing estimating the volumes of the oscillating traceable regions within the body. The invention is applicable to any part of the body transparent for imaging device capable to produce real-time image series. The image series is then processed to obtain the pressure values within the cardiovascular system. The invention permits to assess non-invasively and in real time the pressure in any part of the heart and large blood vessels, and calculate the major markers of heart failure, cardiomyopathy, ventricular ischemia, infarction and other heart related diseases.

Claims

1. A system and method for providing continuous non-invasive measurements and calculations of the dynamically changing pressures inside a person's body, said system comprising of ultrasound or other medical imaging device connected to an end-user control unit presumably computer or a mobile device, said end-user control unit records an initial image stream {J.sub.i}.sub.i=1, . . . N of cardiovascular movement of a said body from the said imaging device; processes the initial image stream {J.sub.i}.sub.i=1, . . . N generating corresponding T-image {T.sub.i}.sub.i=1, . . . N defined as a chronological union of said initial image stream {J.sub.i}.sub.i=1, . . . N with corresponding time stamps; said control unit then processes the T-Image {T.sub.i}.sub.i=1, . . . N to determine the oscillating traceable regions corresponding to cardiovascular features and records their form changing over time; said oscillating traceable region is defined as a region appearing on most images comprising the T-Image {T.sub.i}.sub.i=1, . . . N and corresponding to the physiological domain where the pressure is measured or calculated; said form changing corresponds to relative changes in the pressure in the said oscillating traceable regions; said relative changes in pressure comprise an independent diagnostic tool; said continuous non-invasive measurements and calculations of the dynamically changing pressures inside a said person's body can be performed at any time or place by directing the said imaging device connected to the said end-user control unit to the region of interest, such as the heart or heart chambers and performing a recording from which the said control unit will produce a calculated relative real-time pressure value series {P(t.sub.i)}.sub.i=1, . . . N; said end-user control unit is able to obtain the absolute pressure values as a function corresponding to the said form changing of the said oscillating traceable region; said function is obtained during either patient personal calibration procedure or using a database comprised of calibration process data for patients with similar physiology; said calibration procedure is performed during clinical catheterization as synchronized, simultaneous measurement of pressure values P.sub.i, i=1, . . . N in the said oscillating traceable region(s) with a penetrating physical pressure measurement sensor(s) connected to a pressure monitor unit and a recording with said imaging device of the said oscillating traceable region; said pressure monitor unit and said imaging device being both controlled by calibration control unit; said calibration control unit is preferably a computer or a mobile device capable of connecting to both said imaging device and said pressure monitor unit connected to at least one pressure measurement sensor; said calibration procedure is followed by calibration process initiated by said calibration control unit. Said process includes, but is not limited to the identification of the said oscillating traceable regions inside the said T-Image recorded during said calibration procedure and fitting their movement to the pressure values P.sub.i in these regions measured by the said penetrating physical pressure measurement sensors and processed by calibration control unit; in presence of the said calibration process, said continuous non-invasive measurements and calculations of the dynamically changing pressures inside a said person's body can be performed at any time or place by directing the said imaging device connected to the said end-user control unit to the same region as during the said calibration procedure and performing a recording which the said control unit will compare against the results of the said calibration process for the said patient and produce a calculated real-time pressure value series {P(t.sub.i)}.sub.i=1, . . . N; in absence of said calibration process, on the basis of the recorded image data for the said person the system is capable to estimate the said pressure using a database comprised of calibration process data for patients with similar physiology.

2. A system of claim 1 for non-invasive measurement and calculation of a pressure inside a body, said system containing an external to the said body medical imaging unit capable of highlighting inner physiological features, preferably an ultrasound unit. Said imaging unit, having at least one transducer, preferably ultrasound transducer, arranged outside said body and radiating the beams into a target area inside said body. Said beams reflecting from said inner physiological features are registered by said imaging unit which performs reverse conversion of said reflected beam into image data. Said imaging unit having at least one communication protocol, wired or wireless, is connected to the said control unit, and transmits the obtained image stream {J.sub.i}.sub.i=1, . . . N in real time, as soon as each said image is registered to the said control unit over the said communication protocol.

3. A system from claim 1 for non-invasive measurement and calculation of a pressure inside a body, said system containing a said calibration control unit, which is preferably a computer or a mobile device with a capability of simultaneous operational connection to the said medical imaging device and said pressure monitor unit connected to at least one said penetrating pressure sensor, and adapted to run a control and calibration software. Said software being configured to provide a graphical user interface (GUI) to register in synchronized, simultaneous manner the said image stream {J.sub.i}.sub.i=1, . . . N from the said medical imaging unit and said measured pressure values P.sub.i from the said penetrating pressure sensor in real time, registering the times t.sub.i for received data, generating said corresponding T-image {T.sub.i}.sub.i=1, . . . N and fitting a pressure calculation model to said measured or estimated pressure values P.sub.i≈P(t.sub.i, {T.sub.i}.sub.i=1, . . . N). The said calibration control unit then transmits the said calculation model to said end-user control unit either directly or through optional connection to cloud service/internet. Optionally, the said calibration control unit may be combined with the medical imaging device from claim 2 and pressure sensors and pressure monitor from claim 1 into a single device.

4. A system from claim 1 for non-invasive measurement and calculation of a pressure inside a body, said system containing a said end-user control unit, which is preferably a computer or a mobile device with a capability of operational connection to the said medical imaging device and adapted to run a control and calculation software. Said software being configured to provide a graphical user interface (GUI) to register the said image stream {J.sub.i}.sub.i=1, . . . N registering the times t.sub.i for received data, generating said corresponding T-image {T.sub.i}.sub.i=1, . . . N and perform estimation of the said pressure as P.sub.i=P(t.sub.i, {T.sub.i}.sub.i=1, . . . N) using the said pressure calculation model received from said calibration control unit. Said end-user control unit may optionally be able to establish a connection to optional cloud service or standalone server to transmit and receive said pressure calculation model. Optionally, the said end-user control unit may be combined with the medical imaging device from claim 2 into a single device.

5. A method from claim 1 for non-invasive measurement and calculation of a pressure inside a body of patient, said method including optional calibration procedure. Said procedure performed on said patient in case of undergoing clinical catheterization for any medical, preferably Cardiological reason. During said catheterization a calibration system is used, which includes: Said calibration control unit from claims 1,3 Said medical imaging device from claims 1,2 Said pressure monitor unit from claim 1 At least one said penetrating pressure sensor from claim 1 The said calibration system is functional when the said medical imaging device and the said pressure monitor with attached said penetrating pressure sensor(s) are connected to the calibration control unit and the said unit is able to send and receive data from both connections. Said calibration procedure includes: early introduction of the said penetrating pressure sensor(s) into the said target oscillating traceable region(s); setting said medical imaging device into operation; providing a user interface, such as a graphical user interface (GUI) including an on-screen image, and displaying, highlighting inner physiological features; establishing a connection between the said calibration control unit, said medical imaging device and the said pressure monitor connected to least one said penetrating pressure sensor; pointing said medical imaging device in a direction to said target oscillating traceable region(s), where pressure measurement sensor(s) is located inside said patient's body, and holding in said position and/or adjusting said direction according to said displayed image until said region is visible on said image; switching the said calibration control unit into a recording mode of operation during which the said calibration control unit will perform a synchronized, simultaneous recording from the said imaging device and the said pressure monitor of the said oscillating traceable region(s) and the said pressure data from said penetrating pressure sensor(s) marking the time of received data; upon finishing the said recording, the calibration control unit will save and process the recorded data as the said image stream {J.sub.i}.sub.i=1, . . . N registering the times t.sub.i for received data, generating said corresponding T-image {T.sub.i}.sub.i=1, . . . N and perform estimation of the said pressure creating a calculation model P.sub.i=P(t.sub.i, {T.sub.i}.sub.i=1, . . . N). The said calibration control unit then transmits the said calculation model to said end-user control unit either directly or through optional connection to cloud service/internet.

6. A method from claim 1 for non-invasive measurement and calculation of a pressure inside a body of patient, said method including the said calculation model from claims 3, 5 which is formed by assessing the size of said target oscillating traceable region(s) from each frame of the said T-image {T.sub.i}.sub.i=1, . . . N creating a set of coordinate parameters {x.sub.j}.sub.j=1, . . . M representing the said oscillating traceable region size and position at each time corresponding to each frame T.sub.i of the said T-image {T.sub.i}.sub.i=1, . . . N and fitting the said measured pressure P.sub.i to a given functional shape P.sub.i=P(t.sub.i, {x.sub.j}.sub.j=1, . . . M.sup.i⊂T.sub.i).

7. A method from claim 1 for non-invasive measurement and calculation of a pressure inside a body of patient, said method including the said continuous measurements and calculations of the dynamically changing pressures inside a said person's body performed at any time or place by directing the said imaging device from claims 1, 2 connected to the said end-user control unit from claims 1, 4 to the same region as during the said calibration procedure and performing a recording which the said end-user control unit will assess the size and form of said target oscillating traceable region(s) from each frame of the said T-image {T.sub.i}.sub.i=1, . . . N1 produced during the said recording, creating a set of coordinate parameters {x.sub.j}.sub.j=1, . . . M representing the said oscillating traceable region size, form and position at each time corresponding to each frame T.sub.i of the said T-image {T.sub.i}.sub.i=1, . . . N1. In case of presence of a calibration process from claim 5 for the current patient or from patients with similar physiological parameters as described in claim 1, the said end-user control unit will compare the said set of coordinate parameters against the resulting model fit from claim 6 of the said calibration process for the said patient and produce an estimate real-time pressure value series P(t.sub.i)=P(t.sub.i, {x.sub.j}.sub.j=1, . . . M.sup.i⊂T.sub.i). In case of absence of the calibration process from claim 5 for the current patient or from patients with similar physiological parameters as described in claim 1, the said end-user control unit will provide an estimate of relative changes in the pressure value series.

8. A system from claim 1 may contain an optional server or cloud service which can receive, store and manage said calculation models, perform calculation in lieu of the said end-user control units and use machine learning tools over stored databases to create models for said patients that had not undergone said calibration procedure using said calibration models created for patients with similar physiological parameters.

9. A calculation model from claim 6 may include, but not limited to using a method of assessing the size of the said target oscillating traceable region(s) by using Characteristic (or Eigen-) Image which is defined as follows: The Characteristic image {I.sub.i}.sub.i=1, . . . N of the said T-image {T.sub.i}.sub.i=1, . . . N is defined as a chronological union of the averages of the rows or other invariants of the initial image series {T.sub.i}.sub.i=1, . . . N across each given depth, in the way that the first pixel-column I.sub.1 (i=1) of the Characteristic image contains the averages over the rows or other invariants of the first image in time, the second pixel-column I.sub.2 (i=2) of the Characteristic image contains the averages over the rows or other invariants of the second image in time, and finally the last pixel-column I.sub.N (i=N) of the Characteristic image contains the averages over the rows or other invariants of the last image in time in the series. The invariants in the Characteristic images can be averages of the columns vertical or horizontal average gradients singular values or eigenvalues of each image packed into the Characteristic image as one matrix Fourier, Wavelet or other generalized decomposition images of the Characteristic images defined above.

10. A calculation model from claim 6 when using the Characteristic Image {I.sub.i}.sub.i=1, . . . N from claim 8 is used to assess the size of said target oscillating traceable region(s) from each frame of the said T-image {T.sub.i}.sub.i=1, . . . N creating a set of coordinate parameters {x.sub.j}.sub.j=1, . . . K representing the said oscillating traceable region size and position at each time corresponding to each column I.sub.i of the said Characteristic Image {I.sub.i}.sub.i=1, . . . N and fitting the said measured pressure P.sub.i to a given functional shape P.sub.i=P(t.sub.i, {x.sub.j}.sub.j=1, . . . K.sup.i⊂I.sub.i).

11. A system from claim 1 for non-invasive measurement and calculation of a pressure inside a body of patient, said system includes software including code segments for providing a data transfer and control connection to said medical imaging device from claims 1,2; providing a data transfer and control connection to said pressure monitor from claim 1; providing on a user interface, such as a graphical user interface (GUI) including an on-screen image, and displaying a data stream {J.sub.i}.sub.i=1, . . . N and further calculation results in said user interface; providing a recording of data stream {J.sub.i}.sub.i=1, . . . N received from the said medical imaging device and said pressure monitor; recording a time of data reception; forming a said time series T-Image {T.sub.i}.sub.i=1, . . . N; creating a said calculation model P.sub.i=P(t.sub.i, {T.sub.i}.sub.i=1, . . . N); using the said calculation model on recorded data of subsequent recordings; storing the data, calculation models for subsequent usage; transmitting and receiving the data and calculation models to/from said cloud storage from claim 8.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0064] The below described embodiments with the references to the accompanying drawings present the features and advantages of the current invention. It has to be noted that being an example of a functional system the following implementation is not limited to mentioned devices/technologies that may be replaced by their similar modalities as long as the said modalities can produce the imaging data and maintain data connections to control units which, in turn, may be any computing devices restricted only by ability to run processing software and provide necessary data connections and user interfaces:

[0065] FIG. 1 depicts a schematic illustration of a blood pressure calibration procedure performed during clinical catheterization. The pressure sensor (101) is located inside the patient's heart or blood vessel (102) introduced by catheter (103) through a subclavian jugular or cephalic vein (104). The sensor is connected to pressure monitor (105), which is, in turn, connected to a computer, serving as the calibration control unit (106). The medical imaging device (107), connected to the calibration control unit (106) by wired or wireless connection (108), is performing a recording (109) of the patient's heart (102) where the sensor (101) is located. The calibration control unit (106) creates a simultaneous recording from both imaging device (107) and pressure monitor (105), synchronizes the data, performs the calculations and sends them to remote cloud or other specialized server (110) for storage or performing calculations.

[0066] FIG. 2 depicts the typical usage procedure of the pressure measurement method. The imaging device (201) connected by wired or wireless connection (202) to end-user control unit (203), in this case a smartphone, as an example, is pointed towards the patient's heart (204), for which the calibration was previously performed and performs a recording (205), sending it to the end-user control unit. The end-user control unit sends the data to the remote cloud server or other specialized server (206), where the calculations are performed based on previously recorded model and their results are displayed to the patient through the end-user control unit.

[0067] FIG. 3 depicts the typical case of usage procedure in presence of previously calibration model for the specific patient, who performs the measurement procedure (301), sending the data to remote cloud or other specialized server (302), which retrieves the stored calibration model (303) and calculates the result according to the said model.

[0068] FIG. 4 depicts the typical case of usage procedure without previous calibration model for the specific patient. The patient performs the recording procedure (401), sending further the data to remote cloud or other specialized server (402), which retrieves the stored calibration models (403) of other patients with similar physiological data (age, weight, height, diagnoses, etc.) and uses machine learning to calculate the result according to said models.

[0069] FIG. 5 depicts a single frame of imaging data of patient's heart (501) as it is received from imaging device displayed as 3d surface.

[0070] FIG. 6 depicts two frames of imaging data of patient's heart showing the difference between data at different time moments (601, 602).

[0071] FIG. 7 depicts the assembled T-Image (701) compiled from imaging data (702) with an appropriate time axis (703).

[0072] FIG. 8 depicts two frames of imaging data (801, 802) in different states of the heart with detected heart contour (803, 804), and the positions and contours of Right Atrium (805, 806), Left Atrium (807, 808), Right Ventricle (809, 810) and Left Ventricle (811, 812).

[0073] FIG. 9 depicts two frames of imaging data (901, 902) with separated contours of Right Atrium (903, 904).

[0074] FIG. 10 depicts the connection between pressure (1001) and state of heart chamber, in this case the Right Atrium (1002).

[0075] FIG. 11 depicts the process of creation of a Characteristic Image. A frame of imaging data (1101) is compressed (1102) using averaging or other invariant method to a single column (1103). In the same manner, the T-Image (1104) containing series of frames and a time axis (1105) is compressed to a Characteristic Image (1106) with number of columns identical to number of frames and the same time axis (1107).

[0076] FIG. 12 depicts the connection between pressure (1201) and the Characteristic Image (1202).

[0077] FIG. 13 depicts the definition of the LVEDP (left ventricular end-diastolic pressure) as seen from the pressure monitor (105). The measurement of LVEDP is made once per cardiac cycle, and is defined as the value of the left ventricular (LV) pressure (1301) at a moment along the time axis (1304) when the onset of isovolumetric contraction is registered (1306) positioned to the right from the peak of QRS complex (1305) on the ECG recording (1303). The onset of isovolumetric contraction of LV is associated with mitral valve closure and corresponds to the time moment when Left Ventricle End-Diastolic Pressure (LVEDP) is measured. The value of the pressure at this moment (1306) is roughly equivalent to the left atrial pressure (LA) (1302) at the same moment.

[0078] FIG. 14 depicts the high frequency algorithmic assessment of the LVEDP from Characteristic Image (1401). The method contains synchronous with T-image acquisition, LV pressure measurement (1403) along the time axis (1405) and the subsequent identification of the LVEDP curve (1404) in the Characteristic image (1402) at the frequency corresponding to the one of imaging device.

DESCRIPTION OF EMBODIMENTS

[0079] Specific embodiments or examples of the invention will now be described with reference to the accompanying drawings. This invention may, however, can be embodied in many different forms and should not be construed as limited to the embodiments demonstrated herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention.

[0080] The present description of the current invention is given with reference to blood vessels or a heart chambers as an example only. It should be born in mind however that the present invention is not limited strictly to a blood vessels or heart chambers, but can be easily adapted to any medium transparent for ultrasound or other waves with the need to measure pressure changes of the liquid flow. Examples include the lymphatic system, bile ducts, urinary ducts, subarachnoid space around the brain and spinal cord (Cerebrospinal fluid), inside or exterior of the lung in the chest wall, etc. for measuring pressures and dynamic progress thereof.

[0081] Alternatively or in addition to ultrasound in order to generate series of images to be analysed for the intra body pressure determination, other systems capable of highlighting inner physiological features and streaming image data in real time, for instance Echo Doppler, Magnetic Resonance Imaging (MRI), or ionizing radiation based imaging systems like Roentgen (X-Ray, Computer tomographic Imaging [CT]) can be provided as medical imaging modalities for generating the input for the pressure determination.

[0082] Additionally, while the present description refers to the usage of 2-dimensional cross-section ultrasound imaging of the investigated chamber as is produced by contemporary sensors, is not limited to it and can be utilized with different modalities that produce several 2-dimensional cross-sections or a full 3-dimensional representation of the investigated chamber.

[0083] In accordance with preferred embodiments a system comprises for example:

[0084] 1) For the Calibration Process (FIG. 1) [0085] a) At least one catheter based blood pressure sensor (101) with analogue or digital data output connected to medical pressure monitor (105). The said sensor is located inside the patient's heart or blood vessel, such as pulmonary artery, (102) introduced, for example, by catheter (103) through a subclavian, jugular or cephalic vein (104). It is assumed, however, that since the calibration procedure is performed during scheduled clinical catheterization for the said patient, the sensor may be already introduced into the problematic region as a part of a procedure, and only its connection to the system through items b) and d) is actually required. [0086] b) Medical pressure monitor with analogue or digital data output combined with optional oscilloscope digitalizing the output and permitting to stream the output data into the calibration control unit, preferably a computer (106). Note that this functionality can be encapsulated inside either pressure monitor or calibration control unit in alternative embodiments. [0087] c) At least one medical imaging device, for example an ultrasound probe (107) with wired or wireless digital output permitting to stream the output data into the computer/information receiving/processing/storage calibration control unit (106). The said probe is pointed to the same body region where the sensor (101) is located. [0088] d) Calibration control unit, preferably a computer or a mobile device equipped with hardware and software permitting synchronization, recording, storage and processing of input data from medical imaging device and medical pressure monitor. The said calibration control unit performs a simultaneous recording preferably of 30-60 seconds in time duration from both medical imaging device and medical pressure monitor.

[0089] 2) For the General (or post-calibration) Usage Process (FIG. 2) [0090] a) At least one medical imaging device, for example an ultrasound probe (201) with wired or wireless digital output permitting to stream the output data into the computer/information receiving/processing/storage end-user control unit (203). [0091] b) End-user control unit (203), preferably a computer or a mobile device equipped with hardware and software permitting recording, storage and processing of input data from medical imaging device.

[0092] 3) Optionally the system includes a remote cloud or other specialized server (110, 206, 302, and 402), operation of which permits both calibration control unit (106) and end-user control unit (203) to store, retrieve and exchange data if internet connection is available, but it is generally possible to transfer of the data by other means, directly between the devices or by physical medium.

[0093] 4) During the Calibration Process, the software, positioned either on the Calibration control unit (106) or on remote cloud or other specialized server (110) processes the recorded data by using the algorithm described in items (7)-(8) and creates and stores a calculation model (303) for calculation of subsequent pressure results from medical imaging device recordings of the previously calibrated patient. This model is transferred directly or via the server to end-user control unit.

[0094] 5) During the General (or post-calibration) Usage Process (FIG. 3, 4) the said calculation model (303) is accessed either locally or on server (302) by end-user control unit to calculate the patient's pressure during the subsequent pressure calculation according to the data recorded by the imaging device (202).

[0095] 6) In absence of previous calibration model for the specific patient (FIG. 4) the patient performs the recording procedure (401), sending further the data to remote cloud or other specialized server (402), which retrieves the stored calibration models (403) of other patients with similar physiological data (age, weight, height, diagnoses, etc.) and uses machine learning to calculate the result according to said models. In this case use of a server is required.

[0096] 7) The data recorded during the Calibration Procedure is processed as follows: [0097] a) The data received from the imaging device decoded into image frames (FIG. 5). The frames may be 2 or 3-dimensional, depending on the imaging technology. [0098] b) Each frame (FIG. 6) is marked with a time at which it was recorded. In this example the difference between frames (601) and (602) is about 0.5 second. [0099] c) T-Image {T.sub.i}.sub.i=1, . . . N (FIG. 7) (701) is formed from the data. It comprises an array of imaging data (702) linked to an appropriate time axis (703). [0100] d) The software determines the physiological features that can be detected in the imaging data (FIG. 8). On the two frames (801, 802) separated in FIG. 8 by 0.5 second the software locates the heart (803, 804), and the positions and contours of Right Atrium (805, 806), Left Atrium (807, 808), Right Ventricle (809, 810) and Left Ventricle (811, 812). [0101] e) If, for example, the sensor during the calibration was located in the Right Atrium (FIG. 9) of the patient's heart, the software separates the Right Atrium (903, 904) on each frame (901, 902). [0102] f) The software then converts the detected contour (903, 904) into a set of coordinates {x.sub.j}, representing the 3d or 2d form of the target region, whichever is provided by the imaging device. This coordinate set may contain any number of point coordinates, depending on the processing power available to the software and image resolution of the imaging device, with at least two (the depths where the target region begins and where it ends) required to make a pressure assessment. [0103] g) The software then compares (FIG. 10) the changes in coordinate sets in each frame (1002) to the changes in pressure measured during calibration (1001) at the same times, and builds a calculation model P(t.sub.i)=P(t.sub.i, {x.sub.j}.sub.j=1, . . . M.sup.i⊂T.sub.i), where P(t.sub.i) is the measured pressure at time t.sub.i of each imaging frame. [0104] h) The said model is stored in the calibration control unit and later transferred to patient's end-user control unit using cloud or other specialized server or directly or by any other means.

[0105] 8) Additionally to the method described above in item (7) a simplified method of processing may be used which comprises of: [0106] a) Conversion of T-Image into a Characteristic Image (FIG. 11). Each frame {T.sub.i}.sub.i=1, . . . N of imaging data (1101) is compressed (1102) using averaging or other invariant method to a single column (1103). In the same manner, the T-Image (1104) containing series of frames and a time axis (1105) is compressed to a Characteristic Image (1106) with number of columns identical to number of frames and the same time axis (1107). [0107] b) In a process similar to item (7(d)-(f)) the software determines the boundaries of the target images on the compressed columns, determining the minimum required two (the depths where the target region begins and where it ends), although using various image processing techniques more information on the region's form may be determined, and creates the calculation model in similar way to item (7(g)). The dependency (FIG. 12) between the sequence of compressed columns (1202) and the synchronized pressure recording (1201) is clearly visible.

[0108] This method enables to greatly increase the speed of processing and reduces the computational power requirements while maintaining enough accuracy given the images are recorded from a similar angle to the calibration.

[0109] 9) During General (or post-calibration) Usage, the patient [0110] a) Uses the imaging device in the same manner as during the calibration to make a recording of a given number of seconds of the same region that was recorded during the calibration. The doctor should provide necessary training for the patient to remember the point to which the imaging device should be directed. [0111] b) The imaging device transmits by wired or wireless connection the image sequence to the end-user control unit. [0112] c) The end-user control unit retrieves the patient's model (if the patient had undergone personal calibration) from internal memory/cloud service/storage medium [0113] d) If the patient did not undergo the personal calibration procedure, the end-user control unit transmits the patient's data such as height, weight, diagnosis, stored in similar way to the cloud service or specialized server. The cloud service or specialized server returns a model created using machine learning based on the database of patients with similar characteristics. [0114] e) The software on end-user control unit then passes the images obtained from the imaging device during the said recording in a manner similar to items (7(d)-(f) or 8), obtaining the coordinate set {x.sub.j}. [0115] f) Using the said coordinate set {x.sub.j} and the model P(t.sub.i)=P(t.sub.i, {x.sub.j}.sub.j=1, . . . M.sup.i⊂T.sub.i), the software calculates it's assessment of pressure and displays it to the user. [0116] g) The software may optionally transmit this assessment to the server, display it to the doctor using doctor's dedicated system and/or show system alerts if it detects abnormal values or patterns.

[0117] 10) Highlighting a diagnostic example, the system is capable of assessment and calculation of LVEDP (Left-Ventricular End-Diastolic Pressure) (FIG. 13) at the imaging device frequency (FIG. 14), by recording a movement of the mitral valve (1402). The method contains the LV pressure measurement (1403) along the time axis (1405) synchronous with T-image {T.sub.i}.sub.i=1, . . . N acquisition and the subsequent identification of the LVEDP curve (1404) in the Characteristic image {I.sub.i}.sub.i=1, . . . N (1402) which in combination with the fitting from items 7,8 above of the said measured pressure P.sub.i to a given functional shape P.sub.i=P(t.sub.i, {x.sub.j}.sub.j=1, . . . K.sup.i⊂I.sub.i) provides the LVEDP pressure assessment at the imaging device frequency. LVEDP is the major marker of the left heart failure (CHF), myocardial infarction, tamponade, aortic regurgitation and others. In the same way the method permits to assess non-invasively during the subsequent Ultrasound recordings of the Right Ventricular (RV) pressure, the RVEDP—right ventricular end-diastolic pressure being the major marker of the right heart failure, cardiomyopathy, RV ischemia and infarction.

[0118] 11) The other real time characteristics which can be measured or estimated using the above method include but not limited to: Left Atrial Pressure (LAP), Right Atrial Pressure (RAP), Left Ventricular Pressure Rise dP/dt.sub.max,L (LVPR), Right Ventricular Pressure Rise dP/dt.sub.max,R (RVPR), Pulmonary Artery Pressure (PAP), Pulmonary Capillary Wedge Pressure (PCWP), Left Ventricular Systolic Pressure (LVSP), Right Ventricular Systolic Pressure (RVSP).

[0119] 12) The system includes software with at least the following capabilities: [0120] a) Both control unit devices may be any computing devices restricted only by ability to run processing software and provide necessary data connections and user interfaces. [0121] b) For the Calibration control unit: [0122] i) Provide a real-time connection for data retrieval from [0123] (1) Medical imaging device [0124] (2) Pressure sensor(s) an/or a Pressure Monitor [0125] ii) Display the images and pressure data acquired from said devices, including image stream for targeting the region of interest [0126] iii) Provide assistance in targeting for the user on user interface [0127] iv) Perform a synchronized data recording of set of arbitrary length [0128] v) Store and transmit the acquired data to readable medium, other devices or cloud server. [0129] vi) Perform analysis and calculation of pressure model based on acquired data. [0130] c) For End-user control unit: [0131] i) Provide a real-time connection for data retrieval from Medical imaging device [0132] ii) Display the images and pressure data acquired from said device, including image stream for targeting the region of interest [0133] iii) Provide assistance in targeting for the user on user interface [0134] iv) Perform a recording of set or arbitrary length [0135] v) Store and transmit the acquired data to readable medium, other devices or cloud server. [0136] vi) Store and retrieve the calculation mode from internal memory, readable medium or the cloud server. [0137] vii) Perform analysis and calculation of pressure based on calculation model and acquired data. [0138] viii) Detect anomalies and display alerts on user interface. [0139] d) For cloud server or dedicated server system: [0140] i) Store and retrieve patient data, recordings, models [0141] ii) Provide patient data to respective doctors including recording results, pressure trends, etc. [0142] iii) Collect and provide cumulative models from patients with similar characteristics for patients without personal calibration [0143] iv) Perform all analysis and calculations of end-user and calibration control units (10(a)(vi), 10(b)(vii)). [0144] v) Provide user interfaces for doctors and patients [0145] vi) Provide connection interfaces for end-user and calibration control units.

[0146] The present invention has been described using a non-limiting detailed description of various embodiments and examples thereof. It should be appreciated that the present invention is not limited by the above-described examples and that one ordinarily skilled in the art can make changes and modifications without deviation from the scope of the invention as will be defined below in the appended claims.

[0147] Below are listed some of the modifications, which are within the scope of invention as defined by the appended claims: [0148] The pressure sensors can be combined with pressure monitor, medical imaging device and calibration control unit into single device. [0149] In the same way medical imaging device can be combined with the End User Control Unit into a single device.

[0150] It should also be appreciated that features disclosed in the foregoing description, and/or in the foregoing drawings and/or following claims both separately and in any combination thereof, be material for realizing the present invention in diverse forms thereof. When used in the following claims, the terms “comprise”, “include”, “have” and their conjugates mean, “including but not limited to”.

[0151] The present invention has been described above with reference to specific examples. However, other embodiments than the above described are equally possible within the scope of the invention. Different method steps than those described above, performing the method by hardware or software, may be provided within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The scope of the invention is only limited by the appended patent claims.