BR112017023157B1 - HEMODYNAMIC PARAMETER MONITORING SYSTEM (HDP) FOR DIAGNOSING A PATIENT'S HEALTH STATE AND METHOD FOR DIAGNOSING A PATIENT'S HEALTH STATE - Google Patents

Abstract

HEMODYNAMIC PARAMETER MONITORING SYSTEM (HDP) FOR DIAGNOSING A PATIENT'S HEALTH STATE. A hemodynamic parameter (Hdp) monitoring system is provided for diagnosing a health condition of a patient and for establishing Hdp marker values or Hdp surrogate marker values for the purpose of comparing with a patient's Hdp values. An Hdp monitor detects, measures and records Hdp values displayed by the patient during a baseline or non-exposure period and in addition Hdp values displayed by the patient during or after an exposure period during which the patient is exposed to electromagnetic output signals low energy. An electrically driven generator is adapted to be driven to generate said low energy electromagnetic output signals for exposing or applying to the patient such output signals during said period of exposure.

Description

FIELD OF INVENTION

[001] This invention relates to a hemodynamic parameter (Hdp) monitoring system for diagnosis, more particularly involving a monitor capable of detecting and monitoring various specified Hdp values and providing recorded values thereof. The specified Hdp values recorded include values necessary for the purpose of performing diagnostics in terms of the invention.

FUNDAMENTALS OF THE INVENTION AND STATE OF THE ART

[002] Several Hdp monitors are available in the art. Such monitors are generally used to detect and monitor various Hdp values, generally for the purpose of diagnosing a patient's cardiovascular conditions. Hdp measurements performed, usually in conjunction with an electrocardiogram (ECG), may include measurements of stroke volume (SV), stroke index (SI), and cardiac output (CO). Such measurements are indicated for the diagnosis and therapy of patients suffering from cardiac conditions such as heart failure, hypertension, coronary artery disease, pericardial disease, pulmonary obstruction and also renal failure. So-called impedance cardiography (ICG), which involves applying a fixed current (approximately 400 microamperes at 40 kHz) to spaced electrodes, is described in the literature for the purpose of measuring patient current current. This prior art is essentially concerned with ensuring CO measurements and comparisons of the spaced electrode ICG procedure with well-known and regularly used thermodilution (TD) procedures for CO measurement or calculations such as by multiplying the stroke volume (SV ) by heart rate (HR).

[003] The state of the art as discussed above was mentioned because it involves passing current through a patient in the ICG procedure, which procedure, however, is concerned only with trying to guarantee, as well as possible, reliable measurements of values of CO of patients. Also of some interest from a prior art perspective is the mention of direct digital synthesis (DDS) to ensure stable current sources, which technology can also, but not necessarily, be used in a component of the hemodynamic monitoring system of the present invention. . In addition to the possible interest from a prior art perspective, statistical analyzes are revealed through Band-Altman plots of differences between CO measurements provided by different measurement procedures. A Band-Altman plot (Difference plot) is a data plotting method used in analysis between two different trials, popularized in medical statistics by J. Martin Bland and Douglas G. Altman.

[004] The prior art as summarized above is found in J. Fortin et al. / Computers in Biology and Medicine 36 (2006) 1185-1203. This possible interest arises from the present invention involving statistical analyzes and computations related to measurements of a variety of specified Hdp values.

[005] Insofar as the present invention is essentially concerned with the diagnosis of a health condition of a patient, mention is made of the state of the art as represented by the disclosure comprised in the related EP Patent Application No. 08 734 777.9-1652 with an electronic system for influencing cellular functions in a warm-blooded mammalian subject, wherein diagnostic mention is made in the following terms: “The electronic system of the invention is therefore a valuable diagnostic tool for diagnosing the presence or absence and identities of types of tumor cell growths or cancers.” This disclosure, however, does not contemplate or suggest the use of measured Hdp values as a means to diagnose either a type of cancer or indeed another form of a patient's health status.

[006] In terms of the foundations of the present invention, extensive clinical trials carried out with the aid of the electronic system described in the aforementioned EP Patent Application No. 08 734 777.9-1652 led to additional investigations regarding the effects of treatments carried out. These additional investigations included performing multiple measurements of various Hdp values in patients and determining, in terms of the present invention, that such values differ depending on the type of cancer. Such determinations provided basis for proposing a diagnostic procedure based on measured Hdp values to diagnose a specific form of cancer harbored by a patient. These determinations further suggested that virtually any form of an impaired health condition suffered by a patient, including such conditions as viral, parasitic or other pathogenic invasions, organic dysfunctions that cause undesirable components such as toxins to be included in the blood of a patient, drug abuse, poisons, high levels of low-density lipoprotein (LDL) cholesterol, venom from a snake bite and the like, can be diagnosed based on the patient's diagnosis of certain identified measured Hdp values. Furthermore, since it has previously been determined that diseases of the Central Nervous System (CNS) described in EP 0 592 851 A2 can be successfully treated by applying to a patient amplitude modulation (AM) carrier signals modulated at AM frequencies predetermined, it is likely that such conditions can be similarly diagnosed based on certain measured Hdp values. Reference is also made to US Patent No. 5,690,692 which discloses a long list of conditions that can be treated with the aid of accurate bioactive frequencies. A frequency synthesizer is controlled to generate a specific exact frequency or a series of those. A keyboard operated by a user is used to select such frequencies, which in turn leads to a circuit that turns the generated signal on or off within well-defined time intervals. Again, however, influences on Hdp values or their determinations are not considered.

[007] Diagnosis in terms of the present invention can be performed with the aid of certain measured and recorded parameter values, in various patients pre-diagnosed as suffering from an identified poor health state or being in a healthy state, at certain times and during specified periods, as described in greater detail below.

SUMMARY OF THE INVENTION

[008] A hemodynamic parameter (Hdp) monitoring system is provided to diagnose a patient's health condition, to establish Hdp marker values or Hdp surrogate marker values for purposes of comparison with a patient's Hdp values. . An Hdp monitor detects, measures and records Hdp values displayed by the patient during a baseline or non-exposure period and in addition Hdp values displayed by the patient during or after an exposure period during which the patient is exposed to electromagnetic output signals low energy. An electrically powered generator is adapted to be driven to generate said low energy electromagnetic carrier output signals for exposing or applying to the patient such output signals during said period of exposure.

BRIEF DESCRIPTION OF THE DRAWINGS

[009] Figure 1 shows an exemplary circuit block diagram, exemplary of circuits that can be used as the means of varying variable Hdp for applying electromagnetic output signals to a patient in accordance with the present invention.

[0010] Figure 2 shows an exemplary patient during experimental setup for continuous monitoring of hemodynamic parameters before and during exposure to AM RF EMF in accordance with the present invention.

[0011] Figure 3 is an example of eleven hemodynamic parameters measured simultaneously during each heartbeat.

[0012] Figure 4 is a flowchart representing a hemodynamic recording performed continuously during periods of no exposure and exposure in a double blind mode.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0013] The present invention provides a hemodynamic parameter (Hdp) monitoring system for diagnosing a patient's health status. The system comprises a hemodynamic parameter (Hdp) monitor that detects and records various detected Hdp values identified from the patient. The system generally detects various detected Hdp values identified from the patient using electrodes placed in contact with various determined parts of the body. The hemodynamic parameters (Hdp) monitor also comprises a recording means that records the various detected Hdp values identified from the patient. The recording means may utilize any storage device in which the patient's various identified detected Hdp values may be recorded. For the purposes of diagnosing a health condition of a patient, it has been determined for the purposes of diagnostics performed in accordance with the invention, that a variety of Hdp values need to be detected, measured and recorded, which include values of at least following nine Hdp's: • RR interval (interval from the R peak to the next as shown on an electrocardiogram (ECG) (RRI); • heart rate (HR); • systolic blood pressure (sBP); • diastolic blood pressure (dBP); • mean arterial pressure (mBP); • pulse pressure (PP); • stroke volume (SV); • cardiac output (CO); and • total peripheral resistance (TPR).

[0014] The above initial measurements or their values are herein referred to as baseline measurements or baseline Hdp values. In terms of procedure, initial measurements of the above parameters are performed on pre-diagnosed individuals after a period of relaxation, for example approximately 15 minutes, while the patient is lying in a supine position (face and preferably also palms facing up).

[0015] Following the execution of the above initial measurements, pre-diagnosed individuals are exposed to or subjected to the application of a procedure that influences Hdp, involving exposure to or application of selected electromagnetic field (EMF) output signals. The selection of such output signals would generally be based on predetermined output signals to provide beneficial therapeutic effects to multiple individuals or rather to patients pre-diagnosed as having an identified poor health state.

[0016] The aforementioned EMF output signals may be provided by a generating device adapted to generate EMF output signals at certain predetermined amplitude modulation (AM) frequencies. The subjects or patients are most preferably exposed to the output signals or the output signals are applied to patients during heartbeats over a certain period of time, more preferably over the time of at least ten heartbeats of the patient. This procedure would generally be carried out while the patient remains connected or is reconnected to the Hdp monitor of the system of the invention so that Hdp values can be detected and measured during the period of exposure or application. Hdp values can, however, also or alternatively be detected and measured after the period of exposures or applications, in order to determine potentially lasting effects, generally statistically significant therapeutically beneficial effects, of exposures or applications to the patient.

[0017] The above Hdp values measured during or after exposures or applications to pre-diagnosed individuals or patients are herein referred to as post-exposure or Hdp variation values.

[0018] The above procedures, generally when applied to multiple pre-diagnosed patients suffering from an identical form of poor health status, provide both multiple baseline Hdp values and multiple post-exposure Hdp values related to the post-diagnosed form. identified as having a poor health status. These multiple Hdp values, for example for most if not all of the nine parameters listed above, may in general be somewhat scattered values. Consequently, for the purposes of defining representative marker Hdp values, such scattered values should be regularly analyzed by statistical procedures for the purpose of obtaining representative Hdp values for each of the Hdp parameters.

[0019] Conventional statistical procedures may, for example, include the Dixon Q test used to identify and reject abnormal values; a T test to determine whether or not average values of two groups of values are statistically different from each other; Fisher's discriminant analysis, standard deviation measurements and variance values; and principal component analysis (PCA), a statistical procedure that uses an orthogonal transformation to convert a set of observations of possibly correlated variables into a set of values of linearly uncorrelated variables called principal components. The values recorded in this document for Hdp values for various Hdp’s use a PCA of correlated variables to linearly uncorrelated variables (PC’s). Hdp values analyzed by such a statistical procedure serve as markers for so-called surrogate markers used to diagnose an individual's health status (including values for healthy status). Surrogates in the present invention that provide marker values would include numbers of patients pre-diagnosed as being healthy or suffering from an identified form of an impaired health condition, such as an identified form of cancer as mentioned below.

[0020] In line with the above, the Hdp monitoring system of the present invention provides means for establishing and identifying marker values for use in diagnosing a patient's health status. Marker values are called surrogate markers because marker values are determined by the monitoring system following treatments and measurements of Hdp values performed on patients pre-diagnosed as healthy or suffering from a known form of poor health status. . An Hdp monitor as described above is used in conjunction with a generating device adapted to generate EM output signals at certain predetermined amplitude modulation (AM) frequencies to influence at least some of the Hdp values of the Hdp's listed above. The Hdp monitoring system of the invention should therefore include means for detecting and measuring and recording both baseline Hdp values and post-exposure Hdp values of patients.

[0021] The monitoring system of the invention may further comprise stored information that includes surrogate markers as described above and comparison means for comparing representative measured Hdp values with representative surrogate markers as described below to provide the indicated diagnosis of a patient. undergoing diagnosis. Alternatively, the generating device may be adapted to receive baseline and post-exposure Hdp values detected from the Hdp monitor and include such stored information, which may, if desired, be communicated to the Hdp monitor to equip attending medical personnel. with information regarding the indicated diagnosis.

[0022] Representative surrogate markers used for diagnostic purposes, in terms of the present invention, are obtained from computational combinations of information from both representative baseline Hdp measured values and representative post-exposure measured values or Hdp variance. Since the predetermined AM frequencies used to influence Hdp values are different for each health state and post-exposure Hdp values are similarly different, computational combinations to obtain representative surrogate markers for a specified health state require different computations. for example for the purpose of aligning different forms of cancer in a two-group PCA analysis.

[0023] The reliability of marker values obviously depends on the number of pre-diagnosed surrogates included for each type of poor health state examined. Therefore, the incidence of poor health states among populations, more particularly the high incidence of poor health states that are difficult to diagnose, such as Hepatocellular Carcinoma (HCC) or related liver diseases, has received special attention. Similarly, the relatively high incidence of breast cancer has so far also received special attention, as mentioned below.

[0024] Measured post-exposure or Hdp variance values, to the extent that they can be reflected following exposure or application of low-energy AM carrier signals, in terms of the invention, can be compared with Hdp values occurring following exposure to or application to a patient of predetermined values of predetermined AM frequencies to mitigate a cause of a specified poor health condition of a patient. By matching baseline and post-exposure Hdp values on your own, one can both support treatment efficacy by applying said predetermined values of AM frequencies and provide diagnostic indication of the patient's health status. Reference additional scientific details reported, for example, specifically the two forms of cancer diagnoses described below. In this document, mention is made of the patient's diagnosis following the no-exposure baseline period and correlations of patient diagnosis with hemodynamic patterns in five (83.3%) of six male HCC cases, 5 (83.3%) of six female breast cancer cases and six (100%) of six healthy controls (Table 4). Similarly, mention is made of the tumor-specific hemodynamic response pattern during periods of exposure (Table 5).

[0025] The electrically powered generator of AM electromagnetic output signals at certain AM frequencies may comprise a storage device for storing predetermined values of AM frequencies. Such a storage device can be used to control the AM frequencies of the output signals, as described in the aforementioned EP Patent Application No. 08 734 777.9-1652.

[0026] Alternative to or in addition to comprising a storage device as above, the exposure or application of means for inducing variances of Hdp values may comprise a variable AM frequency tuning device for varying the AM frequencies between threshold values lows and highs.

[0027] The time periods of exposing or applying output signals of AM frequencies through a variable frequency tuning device within a wide range of frequencies, e.g., AM frequencies within a range between approx. 0.01 to approximately 150 MHz, may require a short period of time for Hdp values to be varied at any specific frequency value. Therefore, consecutive exposures or applications of sections of the AM frequency range may be necessary for the purpose of identifying AM frequency values at which post-application Hdp value variations actually occur during heartbeats at which Hdp values are detected, measured and recorded by the Hdp monitor.

[0028] The system of the invention includes means for measuring and recording frequencies of output signals for measuring and recording such frequency values at which the frequencies of Hdp variances of at least some of the hemodynamic parameter values are displayed. Similarly, the system includes means of recording Hdp values to record each of the measured values for each of the identified Hdp's, preferably separately from each other, measured and recorded before, during or after the period of time of exposure to or application of the exit signals to the patient.

[0029] An additional component of the hemodynamic parameter monitoring system of the invention, additional to those described above, is an analyzer component that can be integrated or coupled to the recording means to record hemodynamic parameter values before, during or after execution of or exposure of the patient to a cell excitation procedure. The analyzer component may include program-controlled calculation means for performing statistical analyzes of several of the recorded hemodynamic parameter values to obtain representative values for each of the different recorded hemodynamic parameter values, optionally making a determination of relationships between representative hemodynamic parameter values. , and comparing each or both of such representative values or ratios between different values, with representative predetermined values or ratios, predetermined in healthy patients or suffering from or likely to develop an identified impaired health condition. Comparison of calculated representative values to recorded hemodynamic parameter values or ratios, more particularly termed post-excitation hemodynamic parameter variation values, which correspond to predetermined representative hemodynamic parameter values or ratios, leads to providing an indication of a diagnosis of a a patient's health status.

[0030] An analyzing component may, alternatively or additionally be integrated or coupled to the recording means as described above, be located in an analysis center that can perform analyzes based on recorded hemodynamic parameter information received by or communicated to the center.

EXAMPLE 1

[0031] Examples of the nine different Hdp values recorded during 16 consecutive heartbeats are presented below: Table 1: Hemodynamic parameter values recorded

[0032] The values detected and recorded for each of the nine hemodynamic parameters are exemplary of such values exhibited by a single patient.

EXAMPLE 2

[0033] Table 2 below is an example of Principal Component (PC) values, representative of a multiple number of hemodynamic parameter values detected and recorded for each of the nine values of various patients. Representative PC values are divided into three groups: Pressure, Flow and Beat for three groups each of 8 patients, respectively 8 patients with hepatocellular carcinoma (HCC), 8 patients with breast cancer and 8 healthy controls to simplify value comparisons. of PC Hdp among patients with a diagnosis of HCC or breast cancer or healthy controls. Also included in the following Table is reference to the canonical X and Y coordinates obtained by Fisher's discriminant analysis, representative pressure, flow values and Hdp's beats exhibited by patients prior to exposures or applications of AM EM signals. Table 2: Diagnosis based on PC and linear discriminant analyzes of hemodynamic parameters (Hdp)

[0034] It is primarily of interest from the above figures that all patients with a cancer diagnosis, in this example both patients with a diagnosis of HCC and patients with a diagnosis of breast cancer, reflect PC P1 values that are significantly greater than the values of PC P2.

EXAMPLE 3

[0035] Table 3 below is exemplary breakdown by analytical geometry using canonical coordinates and vectors obtained from PC values, representative of multiple numbers of hemodynamic parameter values detected and recorded for each of the nine values of a number of patients . Representative PC values are divided into three groups, Pressure, Flow and Beats for three groups each of patients, respectively with HCC, breast cancer patients and healthy controls. To determine the generalized squared distance for d_groups of values using linear discriminant function of geometric parameters, the distinct group of patients based on their diagnoses is identified. Table 3: Diagnosis based on analysis of hemodynamic parameters (Hdp), linear discriminants and geometry

[0036] With reference to Figure 1, an exemplary circuit block diagram is seen, exemplary of circuits that can be used as the means of varying variable Hdp for applying electromagnetic output signals to a patient. Such exemplary circuits may be provided with connection means for connection to or may be comprised of or integrated into the hemodynamic parameter monitoring system of the invention. Descriptions of each of the blocks in the block diagram or their functions are included to facilitate an understanding of them.

[0037] The block diagram of the electronic circuits of an application system applies RF AM output signals to a patient at predetermined selected AM frequencies. The predetermined selected AM frequencies are controlled by AM frequencies stored in the storage device 52. The stored predetermined AM frequency values are determined separately by biological feedback procedures performed on patients and stored in the storage device 52. Various predetermined selected AM frequencies are applied to a patient as indicated for treatment of patients suffering from one or another form of impaired health status of a patient.

[0038] Extended clinical trials carried out with the help of the above application system led to the discovery that the growth of cancer cells or their proliferation in patients can be inhibited by applying AM output signals at certain well-defined frequencies to patients. Further investigation revealed that AM frequencies for cancer treatment purposes need to be very precisely controlled: Patent applications filed worldwide, such as represented by EP 08 734 777.9 or PCT EP 2008/002 379, International Publication WO 2008/ 116 640 A2, relating to this discovery and research, including the identity of very precise AM frequency values of output signals for identical forms of cancer and a modified system that allows application to a patient of such AM frequency output signals. AM very precisely controlled. Modifications to the system included in EP 08 734 777.9 include a so-called Direct Digital Synthesizer (DDS) that can be combined with the illustrated microprocessor 21.

[0039] The present invention contemplates the use of a device or modified device as described above or indeed other devices described in the art, such as that described in US Patent No. 5,690,692 assigned to Regeneration Technology of Tijuana , Mexico, in combination with a hemodynamic parameter monitoring system capable of detecting and measuring at least the nine hemodynamic parameter values mentioned above. More specifically, such a combination allows detection of hemodynamic parameter values of a patient both before, during or after application to the patient of RF AM electromagnetic signals as described in prior literature or other such signals may be applied to the patient. Of specific interest in this regard is that detected, measured and recorded hemodynamic parameter (Hdp) values differ depending on the health of the patient. For example, as exemplified above, values of detected and recorded hemodynamic parameters differ between patients suffering from different forms of cancer and differ from such values of healthy state patients. Furthermore, it appears that such hemodynamic parameter values are shared, at least to some extent, by patients suffering from the same or a closely related poor health condition. The detected and recorded hemodynamic parameter values consequently offer opportunities to diagnose various forms of an impaired health state of a nature such as mentioned above and also to diagnose healthy states of patients.

[0040] In addition to the combination of the invention as discussed above, modifications to the devices or treatment systems described in prior art disclosures are contemplated in terms of the present invention. More particularly, following determinations of detected and recorded Hdp values made on a wide variety of patients who have been treated with the aid of previous systems, it is considered that the requirements for generating exact specific frequencies or a series of exact programmed frequencies may be replaced or supplemented by a variable frequency tuning device, variable between lower and upper frequency limits, which is activated during a time in which a patient is connected to a hemodynamic parameter monitor of the nature described.

[0041] The availability of such a variable frequency tuning device, in combination with the hemodynamic parameter monitor, would allow the detection of Hdp values required in terms of the invention at different frequency values. Frequency values can be selected from frequency values suggested in terms of previous disclosures to determine the effects on Hdp values or variations thereof. However, such frequency values can be recorded at which Hdp values or variations thereof are of interest. Recorded frequency values may be compared with predetermined frequency values proposed in prior disclosures for treatment of patients in support of their identities or accuracy or may provide information regarding additional frequency values that may provide beneficial therapeutic effects in patients suffering from a condition of poor health.

[0042] The availability of a variable frequency tuning device available to vary the frequency of low energy AM output signals during the exposure time or application of Hdp varying means to a patient is a modification that can be considered to be of practical importance. Therefore, in contrast to treatment devices disclosed in prior literature, the frequencies used for various patient treatments are invariably stored predetermined frequencies. In this regard, the above-mentioned US Patent No. 5,690,692 may be considered to suggest the availability of a frequency tuning device following the disclosure of “...the frequency signal is gradually increased at a predetermined rate from zero to a predetermined level controllable by a user.” In fact, what is being mentioned here is a gradual increase in variable amplitudes of signals and not frequencies of amplitude modulations or simply the frequency at which the described square wave output signals occur. As in other prior literature, US Patent No. 5,690,692 relies on predetermined values of frequencies to perform treatment procedures.

[0043] Referring again to Figure 1, the microprocessor 21 operates as the controller for the application system and is connected to control the various components of the system via the address bus 22, data bus 23 and input/output lines ( I/O) 25. The microprocessor 21 preferably includes internal storage for the operation code, control program and temporary data. Additionally, microprocessor 21 includes internal input/output (I/O) ports and timers. The microprocessor 21 may, for example, be a single-chip 8-bit microcontroller, 8048 or 8051 available from Intel Corporation, 2200 Mission College Boulevard, Santa Clara, California 95054 US. Timing for the microprocessor 21 is provided by the system clock 24 which includes a clock crystal 26 along with capacitors 27 and 28. The system clock 24 may operate at any clock frequency suitable for the specific type of microprocessor used. According to one embodiment, the system clock 24 operates at a clock frequency of 8.0 MHz.

[0044] In general, the microprocessor 21 functions to control the controllable electromagnetic energy generator circuit 29 to produce a desired form of modulated low-energy electromagnetic emission for application to a patient via a probe 13. The controllable generator circuit 29 The controllable generator circuit 29 also includes a modulator AM circuit and power generator 34 that operates to amplitude modulate a carrier signal produced by carrier oscillator 32 on carrier signal line 36, with a modulation signal produced by modulation signal generator circuit 31 on carrier signal line 36. modulation 37. The modulator 34 produces an amplitude modulated carrier signal on the modulated carrier signal line 38, which is then applied to the filter circuit 39. The filter circuit 39 is connected to the probe 13 via the coaxial cable 12 and impedance transformer 14.

[0045] The microprocessor 21 controls the modulation signal generator circuit 31 of the controllable generator circuit 29 via the address bus 22, data bus 23 and I/O lines 25. In particular, the microprocessor 21 selects the form of desired wave stored in the modulation waveform storage device 43 via I/O lines 25. The microprocessor 21 also controls the waveform address generator 41 to produce on the waveform address bus 42 a sequence of addresses that are applied to the modulation signal storage device 43 for the purpose of retrieving the selected modulation signal. The desired modulation signal is retrieved from the waveform lookup table 43 and applied to the modulation signal bus 44 in digital form. The modulation signal bus 44 is applied to the digital-to-analog converter (DAC) 46 which converts the digital modulation signal to analog form. This analog modulation signal is then applied to selective filter 47 which, under control of microprocessor 21, filters the analog modulation signal through the use of a variable filter network including resistor 48 and capacitors 49 and 51 for the purpose of smooth the waveform produced by the DAC 46 on the modulation signal line 20.

[0046] In the present embodiment, the various modulation signal waveforms are stored in the lookup table 43. With a memory of 2 kilobytes, the lookup table 43 can contain up to 8 different modulation signal waveforms. Waveforms that have been used successfully include square waveforms or sine waveforms. Other possible modulation signal waveforms include rectified sine, triangular, and combinations of all of the above.

[0047] In the present embodiment, each modulation signal waveform uses 256 bytes of memory and is retrieved from lookup table 43 through 256 consecutive addresses. The frequency of the modulation signal is controlled by how quickly the waveform is retrieved from lookup table 43. In accordance with the present embodiment, this is accomplished by downloading a control code from microprocessor 21 to programmable counters contained in the address generator. waveforms 41. The output of the programmable counters then drives a ripple counter that generates the 8-bit address sequence on the waveform address bus 42.

[0048] The waveform address generator 41 may, for example, be a uPD65042C programmable timer/counter, available from NEC. The modulation signal storage device or lookup table 43 may, for example, be an Erasable Programmable Electrical Read Only Memory (EEPROM) type 28C16 programmed with the desired waveform table. The digital to analog converter 46 may, for example, be a DAC port, AD557JN sold by Analog Devices, and the selective filter 47 may be a type 4052 multiplexer, sold by National Semiconductor or Harris Semiconductor.

[0049] The specific modulation control information used by the microprocessor 21 to control the operation of the controllable generator circuit 29 in accordance with the present invention is stored in the application storage device 52 or, in terms of the present invention, may be a variable AM frequency tuning device adapted to load interface 16 with AM frequencies between high and low frequency levels. Application storage device 52 may be any storage device capable of storing information for future retrieval. For example, the application storage device 52 may be, for example, a magnetic medium-based storage device such as a card, tape, disk or drum. Alternatively, the application storage device 52 may be a semiconductor memory-based storage device such as an erasable programmable read-only memory (EPROM), an erasable programmable electrical read-only memory (EEPROM), or a non-volatile access memory. random (RAM). Another alternative to the application storage device 52 is a mechanical information storage device such as a punch card, cam, or the like. Yet another alternative to the application storage device 52 is an optical storage device such as a compact disk read-only memory (CD ROM).

[0050] It should be emphasized that although the figures illustrate the microprocessor 21 separate from the application storage device 52, the microprocessor 21 and the application storage device 52 may both be incorporated into a single device, which is loaded into the system. to control the operation of the system as described in this document. In this case, interface 16 would exist between the combination of microprocessor 21 and application storage device 52 and the rest of the system.

[0051] Interface 16 is configured as appropriate for the specific application storage device 52 in use. The interface 16 transforms the control information stored in the application storage device 52 into a usable form for storage within the memory of the microprocessor 21 to allow the microprocessor 21 to control the controllable generator circuit 29 to produce the desired low-power modulated emission. . Interface 16 may directly read information stored in application storage device 52, or may read information through the use of various known communications links. For example, radio frequency, microwave, telephone, or optical-based communications links may be used to transfer information between the interface 16 and the application storage device 52. When the application storage device 52 and the microprocessor 21 are incorporated on the same device, interface 16 is configured to connect microprocessor 21 to the rest of the system.

[0052] The control information stored in the application storage device 52 specifies various controllable parameters of the low-frequency modulated RF electromagnetic emission that is applied to a patient through the probe 13. Such controllable parameters include, for example, the frequency and carrier amplitude, carrier modulation amplitudes and frequencies, emission duration, emission power level, emission duty cycle (i.e., the ratio of on-time to off-time of pulsed emissions during an application) , the application sequence of different modulation frequencies for a specific application, and the total number of treatments and duration of each treatment prescribed for a specific patient.

[0053] For example, the carrier signal and the modulation signal may be selected to drive the probe 13 with an amplitude modulated signal in which the carrier signal includes spectral frequency components below 1 GHz, and preferably between 1 MHz. and 900 MHz, and in which the modulation signal comprises spectral frequency components between 0.1 Hz and 10 kHz, and preferably between 1 Hz and 150 kHz. According to the present invention, one or more modulation frequencies can be sequenced to form the modulation signal.

[0054] As an additional feature, an electromagnetic emission sensor 53 may be provided to detect the presence of electromagnetic emissions at the frequency of the carrier oscillator 32. The emission sensor 53 provides the microprocessor 21 with an indication of whether electromagnetic emissions at the desired frequency are present or not. The microprocessor 21 then takes appropriate action, for example, displaying an error message on the information output display 17, disabling the controllable generator circuit 29, or the like.

[0055] The invention also includes a power sensor 54 that detects the amount of power applied to the patient through the probe 13 compared to the amount of power returned or reflected from the patient. This ratio is indicative of proper use of the system during a therapeutic session. The power sensor 54 applies to the microprocessor 21 via the power detection line 56 an indication of the amount of power applied to the patient through the probe 13 in relation to the amount of power reflected from the patient.

[0056] The indication provided on the power detection line 56 may be digitized and used by the microprocessor 21, for example, to detect and control an applied power level, and to record in the application storage device 52, information regarding current treatments applied. Such information can then be used by a doctor or other clinician to assess compliance and effect of treatment on the patient. Such treatment information may include, for example, the number of treatments applied during a given period of time; the current time and date of each treatment; the number of treatment attempts; treatment compliance (i.e., whether or not the probe was in position during the treatment session); and the cumulative dose of a specific modulation frequency.

[0057] The level of applied power is preferably controlled to cause the specific absorption rate (SAR) of energy absorbed by the patient to be from 1 microwatt per kilogram of tissue to 50 Watts per kilogram of tissue. Preferably, the power level is controlled to cause a SAR of from 100 microwatts per kilogram of tissue to 10 Watts per kilogram of tissue. More preferably, the power level is controlled to provide whole-body average SAR in the range of only 0.2 to 1 mW/kg, with 1 g peak spatial SAR between 150 and 350 mW/kg. These SARs can be in any patient tissue. The system also includes power circuits that include battery and charger circuit 57 and battery voltage change detector 58.

[0058] In that association, the combination or use of a device of the nature described above in conjunction with a hemodynamic parameter monitoring device that allows detection, measurement and recording of at least the nine mentioned parameter values, before, during or after exposure or application of means that influence Hdp, has provided previously unknown methods of diagnosing a patient's health states, additional scientific details concerning, for example, specifically two different forms of cancer diagnoses being provided below.

INTRODUCTION

[0059] The identification of changes in pulse amplitude in patients with a diagnosis of cancer when exposed to low, safe levels of amplitude-modulated 27.12 MHz radiofrequency electromagnetic fields at specific frequencies has been previously reported (Barbault, A. and others. Amplitude-modulated electromagnetic fields for cancer treatment: discovery of tumor-specific frequencies and evaluation of an innovative therapeutic technique. J. Exp. Clin. Cancer Res. 28, 51, doi:10.1186/1756-9966-28- 51 (2009)). The observation that changes in pulse amplitude occur at exactly the same frequencies in patients with the same cancer type led to the hypothesis that each cancer type has a specific frequency signature (Id). In vitro experiments have shown that tumor-specific frequencies have antiproliferative effects on cancer cells, modulate the expression of genes involved in cell migration and invasion, and are capable of disrupting the mitotic spindle (Zimmerman, J. W. et al. cancer is inhibited by specific modulation frequencies. British Journal of Cancer 106, 307-313 (2012)). The clinical activity of these tumor-specific frequencies was evaluated in two separate studies in which patients were treated with intraorally administered AM RF EMF, which were modulated at tumor-specific frequencies. Antitumor activity has been observed in patients with metastatic breast cancer (Barbault, A. et al. (2009)) and advanced Hepatocellular Carcinoma (Costa, F. P. et al. Treatment of Advanced Hepatocellular Carcinoma with Very Low Levels of Amplitude Modulated Electromagnetic Fields. British Journal of Cancer 105, 640-648 (2011)) and stable disease has been observed in patients with other tumor types.

[0060] This study was designed to test the hypothesis that analyzing changes in hemodynamic parameters after exposure to specific tumor frequencies is an innovative non-invasive cancer diagnostic technique.

MATERIALS AND METHODS

[0061] The experimental procedures described below were reviewed and approved by the Hospital Sírio Libanês Review Board (IRB), Rua Dona Adma Jafet, Conj.41/43, São Paulo, SP 01.308-050 Brazil. All patients and healthy subjects enrolled in this study signed an informed consent, which was approved by the IRB. The protocol was registered before enrollment of the first patient: clinicaltrial.gov identified no. NCT 01686412, 87 subjects were screened and 82 subjects were prospectively enrolled. The discovery group consisted of eight patients with a diagnosis of advanced HCC, six patients with a diagnosis of advanced breast cancer, and six healthy controls. The patient's diagnosis and nature of AM RF EMF exposure (HCC-specific, breast cancer-specific, and randomly chosen frequencies) were revealed prior to computational analysis. The validation group consisted of 25 patients with biopsy-proven cancer (11 with advanced HCC and 14 with advanced breast cancer) and 31 healthy controls. The last group consisted of six patients with potentially resectable HCC.

[0062] Three separate groups of patients and healthy controls were analyzed in the study: 1) the discovery group consisted of eight patients with advanced hepatocellular carcinoma, six patients with advanced breast cancer and six healthy controls; 2) the validation group consisted of 25 patients with a cancer diagnosis (14 female patients with advanced breast cancer and 11 male patients with advanced HCC) and 31 healthy controls (18 female and 13 male); 3) six patients (five male and one female) with potentially resectable hepatocellular carcinoma.

Intraoral Administration of AM RF EMF:

[0063] The AM RF EMF device used for this study has been previously described in detail (Costa, F. P. et al., British Journal of Cancer 105, 640-648 (2011)). While patients receiving AM RF EMF treatment are exposed to three daily one-hour treatments, the diagnostic feasibility of administering AM RF EMF was tested during a single 10-minute exposure for the purpose of exposing all subjects once every one of 194 tumor-specific frequencies (HCC-specific and breast cancer-specific), which are each emitted for three seconds. (Barbault, A. et al., J. Exp. Clin. Cancer Res. 28, 51, doi:10.1186/1756-9966-28-51 (2009); Zimmerman, J. W. et al. British Journal of Cancer 106, 307- 313 (2012); Costa, F. P. et al. British Journal of Cancer 105, 640-648 (2011)). Similarly, 194 of the 236 previously recorded randomly chosen frequencies were selected (Zimmerman, J. W. et al. British Journal of Cancer 106, 307-313 (2012) to match the number and duration of exposure of tumor-specific frequencies. Therefore, each subject was exposed to all frequencies included in each of the training programs (HCC-specific, breast cancer-specific and randomly chosen frequencies), i.e., each modulation frequency emitted for three seconds from the lowest to the highest frequency as previously described. ((Barbault, A. et al., J. Exp. Clin. Cancer Res. 28, 51, doi:10.1186/1756-9966-28-51 (2009); Zimmerman, J. W. et al. British Journal of Cancer 106 , 307-313 (2012); Costa, F. P. et al. British Journal of Cancer 105, 640648 (2011)).

Monitoring of Hemodynamic Parameters:

[0064] With reference to Figure 2, an exemplary patient is seen during experimental setup for continuous monitoring of hemodynamic parameters before and during exposure to AM RF EMF. Non-invasive hemodynamic measurement was performed using a Monitor Task Force® (CNSystems Medizintechnik GmbH, version 2.2.12.0, Reininghausstraβe 13, 8020 Graz Austria). Numerical values of heart rate, blood pressure and blood flow are measured by photoplethysmography, pressure cuff and ECG. Hemodynamic parameters are transformed into absolute values for each heartbeat before and during exposure to AM RF EMF. The spoon-shaped antenna for intraoral administration of AM RF EMF was placed in the patient's mouth throughout the experiment. In Figure 2, the Task Force® monitor is labeled 1. The AM RF EMF emitting device is labeled 2. The AM RF EMF emitting device is connected to a coaxial cable, which is connected to the spoon antenna 3 A right arm digital pressure cuff is labeled 4. A digital photoplethysmography is labeled 5. A left arm digital pressure cuff is labeled 6. Electrode cables for ECG and impedance cardiography are provided.

[0065] Numerical values of heart rate variability, blood pressure, baroreceptor sensitivity and blood pressure are measured by digital photoplethysmography and ECG acquired through three adhesive thoracic electrodes for high resolution for RR interval analysis. The digital pressure cuff was placed on the right arm and around the middle phalanx of the third and fourth fingers of the right hand and the other on the left arm between the shoulder and elbow. Blood pressure measurements were transformed into absolute values for each consecutive heartbeat.

[0066] With reference to Figure 3, an example of eleven hemodynamic parameters measured simultaneously during each heartbeat is seen: heart rate (HR), systolic blood pressure (sBP), mean arterial pressure (mBP), diastolic blood pressure (dBP) , total peripheral resistance (TPR), total peripheral resistance index (TPRI), cardiac output (CO), cardiac index (CI), RR interval (RRI), stroke volume (SV), and stroke index (SI). Hemodynamic recording was performed continuously in the supine position before and during AM RF EMF exposure. A total of three million hemodynamic parameters were analyzed in this study.

[0067] Participants kept the spoon-shaped antenna in their mouths throughout the experiment. The three different devices, each programmed with one of the treatment programs (HCC-specific, breast cancer-specific, and randomly chosen frequencies), were connected before the start of each of the AM RF EMF exposure periods. The protocol was conducted in a double-blind mode.

[0068] Referring to Figure 4, hemodynamic recording was performed continuously during no-exposure and exposure periods in a double-blind mode. Periods without exposure were the initial baseline and five-minute rest intervals between RF EMF exposures. During exposure periods, patients received AM RF EMF (HCC-specific, breast cancer-specific, and randomly chosen frequencies).

Computational Analysis:

[0069] Hemodynamic parameters were analyzed according to three factors: diagnosis (HCC, breast cancer, healthy control), gender and recording period (baseline and exposure to HCC-specific, breast cancer-specific and chosen modulation frequencies). randomly).

[0070] The analysis of recorded hemodynamic data was only carried out after patient recruitment was completed. Data analysis began with the discovery group (six healthy controls, six patients with advanced HCC, and six patients with advanced breast cancer). The anticipated outcome of the discovery group's analysis was the creation of specific computational analysis for hepatocellular carcinoma patients, breast cancer patients, and healthy controls. Once the calculations were constructed, data from the validation group were analyzed in a double-blind mode in order to validate the computational analysis.

[0071] The analysis of six patients diagnosed with potentially resectable HCC was carried out after the end of the analysis of the validation group. These patients underwent the same non-invasive measurements of hemodynamic parameters less than 24 hours before surgical resection of HCC and after full recovery within four to six weeks post surgery. Pre and post surgical analysis was performed.

RESULTS Discovery Group Identification of Diagnosis-Based Hemodynamic Patterns Analysis of baseline measurements:

[0072] Analysis of hemodynamic parameters during the baseline period without exposure was significantly different between six healthy male controls, six patients with hepatocellular carcinoma and six female patients with breast cancer in the “Discovery Group” (p<0.0001). Having observed significant differences in hemodynamic parameters between male and female participants and taking into consideration the fact that the first six HCC patients were male, two female HCC patients were transferred from the validation group to the discovery group prior to group analysis. validation.

Discovery of patients’ hemodynamic pattern:

[0073] Analysis of hemodynamic parameters during the baseline period without exposure revealed four different hemodynamic parameters in the discovery group. The patient's diagnosis correlated with hemodynamic pattern in 5 (83.3%) of six cases of male HCC, 5 (83.3%) of six cases of female breast cancer and six (100.0%) of six healthy controls, seen in Table 4. Table 4: Determination of four distinct hemodynamic patterns and their correlations in patients diagnosed with cancer and without cancer in the Discovery Group

Discovery of tumor-specific hemodynamic response pattern during periods of exposure:

[0074] Each AM RF EMF exposure (HCC-specific, breast cancer-specific, and randomly chosen modulation frequencies) could be independently tested by computational analysis. A similar hemodynamic response pattern was observed in six (100.0%) of six patients with HCC, which only occurred during exposure to HCC-specific modulation frequencies, seen in Table 5. Table 5: Identification of specific hemodynamic response pattern of cancer after exposure to AM RF EMF modulated at specific and non-specific frequencies in patients diagnosed with cancer in the Discovery Group

[0075] In patients with breast cancer, the application of a computational analysis identified a similar hemodynamic response pattern in 5 (83.3%) of six cases, which only occurred during exposure to breast cancer-specific modulation frequencies (Table 2). Therefore, in patients with a cancer diagnosis, a tumor-specific hemodynamic response pattern was correctly identified in 11 (91.6%) of 12 exposures to the corresponding tumor-specific modulation frequencies. A tumor-specific hemodynamic response was observed in only one (4%) of 24 exposures to randomly chosen modulation frequencies.

Validation Group and Surgical Group Validation of baseline hemodynamic pattern calculations:

[0076] A correct diagnosis based on baseline hemodynamic pattern was made in 9 (81.8%) of 11 cases of HCC, 12 (85.7%) of 14 cases of breast cancer and 21 (67.7%) of 31 healthy controls, as seen in Table 6: Table 6: Determination of four distinct hemodynamic patterns and their correlation in patients diagnosed with cancer and without cancer in the Validation Group

[0077] Validation of tumor-specific hemodynamic response pattern during exposure to AM RF EMF: The HCC-specific hemodynamic response pattern was identified in 10 (90.0%) of 11 cases of HCC patients (Table 4). Breast cancer-specific hemodynamic response pattern was identified in 12 (85.7%) of 14 female breast cancer patients, as seen in Table 7: Table 7: Identification of cancer-specific hemodynamic response pattern following exposure to AM RF EMF modulated at specific and non-specific frequencies in patients diagnosed with cancer in the Validation Group

[0078] Analysis of female HCC: it was found that female patients with HCC had the same hemodynamic pattern and hemodynamic response pattern to AM RF EMF as male patients with HCC, as seen in Table 8: Table 8: Determination of four distinct hemodynamic patterns and its correlation with diagnosis and determination of cancer-specific hemodynamic response pattern after exposure to AM RF EMF modulated at specific and non-specific frequencies and male and female patients diagnosed with HCC

HCC-specific hemodynamic response pattern before and after surgical resection:

[0079] There was no significant change in hemodynamic patterns during the baseline period without exposure and exposure to randomly chosen and breast cancer-specific modulation frequencies. On the contrary, a significant difference occurred between the pre- and post-resection hemodynamic response pattern during exposure to HCC-specific modulated frequencies in six (100%) of six patients.

Pre-specified analysis and post results:

[0080] The combined analysis of all 74 individuals led to the identification of refined criteria for hemodynamic patterns. These refined criteria result in better characterization of hemodynamic patterns between patients with a cancer diagnosis and healthy controls. Correlation between hemodynamic pattern and patient diagnosis was achieved in 16 (100.0%) of 16 HCC patients, 20 (100.0%) of 20 breast cancer patients and 32 (86.4%) of 37 controls healthy.

[0081] In accordance with the present invention, the identification and characterization of new methods are provided that allow the diagnosis of hepatocellular carcinoma and breast cancer in a double-blind mode based solely on hemodynamic parameters measured before and during RF exposure. 27.12 MHz amplitude modulated EMF at tumor-specific frequencies. These findings could have broad clinical implications for cancer diagnosis.

[0082] Although the invention has been described with specific embodiments, other alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to include all such alternatives, modifications and variations presented within the spirit and scope of the appended claims.

Claims (20)

1. Hemodynamic parameter (Hdp) monitoring system for diagnosing a patient's health status, CHARACTERIZED by comprising: an Hdp monitor that detects and measures, and that includes recording means for recording Hdp values displayed by the patient during a baseline or no-exposure period and Hdp values displayed by the patient during or after an exposure period during which the patient is exposed to radiofrequency (RF) electromagnetic output signals; wherein the monitoring system comprises principal component analysis means for converting a set of observations of possibly correlated Hdp values into a set of linearly uncorrelated variable values called principal components, divided into three groups comprising Pressure, Flow and Beats, such main components being representative of: systolic blood pressure, diastolic blood pressure, mean arterial pressure, stroke volume, cardiac output, total peripheral resistance, RR interval, heart rate, and pulse pressure; and an electrically powered generator adapted to be driven to generate said radio frequency (RF) electromagnetic output signals for exposing or applying to the patient such output signals during said period of exposure; and stored information comprising surrogate markers determined from Hdp values of one or a plurality of surrogate patients pre-diagnosed with poor health and measured during a baseline or no-exposure period and during or after an exposure period during the which the surrogate patient is exposed to radiofrequency (RF) electromagnetic output signals, wherein the surrogate markers are derived through principal component analysis with principal components divided into three groups comprising Pressure, Flow and Beats; whereby comparison of the principal components derived from the patient's Hdp values from the baseline or non-exposure period and from during or after the exposure period with the surrogate markers allows diagnosing the patient's health status. 2. Hdp monitoring system according to claim 1, characterized by the fact that said Hdp monitor is adapted to detect and measure each of said Hdp values and separately record such Hdp values displayed by the patient during both said baseline period without exposure as said Hdp values exhibited by the patient during or after said period of exposure. 3. Hdp monitoring system according to claim 1, characterized by the fact that said Hdp monitor is adapted to repeatedly detect and measure said Hdp values and record such values during a period of time determined by at least ten heartbeats. 4. Hdp monitoring system according to any one of claims 1 to 3, CHARACTERIZED by the fact that the electrically powered generator includes amplitude modulation control means to control the amplitude of radio frequency (RF) electromagnetic output signals and means storage of amplitude modulation (AM) frequencies comprising stored AM frequency values at which AM modulated output signals are generated. 5. Hdp monitoring system, according to claim 4, CHARACTERIZED in that the AM frequency storage means comprises AM frequency values determined to provide the AM modulated output signals with relieving or curative effects on patients with a weakened health status. 6. Hdp monitoring system, according to claim 5, CHARACTERIZED by the fact that the poor health condition is a type or form of cancer. 7. Hdp monitoring system, according to claim 6, CHARACTERIZED by the fact that the type or form of cancer is hepatocellular carcinoma (HCC) or breast cancer. 8. Hemodynamic parameter (Hdp) monitoring system, CHARACTERIZED by the fact that it establishes Hdp marker values or Hdp marker surrogate values for the purpose of comparison with patient Hdp values recorded by a system recording means Hdp monitoring device: an Hdp monitor that detects and measures, and that includes recording means for recording Hdp values displayed by one or a plurality of surrogate patients during a baseline or non-exposure period and in addition Hdp values displayed by patients surrogates during or after an exposure period during which surrogate patients are exposed to radiofrequency (RF) electromagnetic output signals; wherein the monitoring system comprises principal component analysis means for converting a set of observations of possibly correlated Hdp values into a set of linearly uncorrelated variable values called principal components, divided into three groups comprising Pressure, Flow and Beats, such main components being representative of: systolic blood pressure, diastolic blood pressure, mean arterial pressure, stroke volume, cardiac output, total peripheral resistance, RR interval, heart rate, and pulse pressure; and an electrically powered generator adapted to be driven to generate said radio frequency (RF) electromagnetic carrier output signals for exposing or applying to surrogate patients such output signals during said exposure period. 9. The Hdp monitoring system of claim 8, characterized by the fact that said Hdp monitor is adapted to detect and measure each of said Hdp values and separately record such Hdp values displayed by surrogate patients during both said baseline or no-exposure period and said Hdp values exhibited by surrogate patients during or after said exposure period. 10. The Hdp monitoring system of claim 8, characterized by the fact that said Hdp monitor is adapted to repeatedly detect and measure said Hdp values and record such values over a period of time determined by at least ten heartbeats. 11. Hdp monitoring system according to any one of claims 8 to 10, CHARACTERIZED by the fact that the electrically powered generator includes amplitude modulation control means to control the amplitude of the radio frequency (RF) electromagnetic output signals and amplitude modulation (AM) frequency storage means comprising stored AM frequency values at which AM modulated output signals are generated. 12. Hdp monitoring system, according to claim 11, CHARACTERIZED in that the AM frequency storage means comprises AM frequency values determined to provide AM modulated output signals with relieving or curative effects on patients with a weakened health status. 13. Hdp monitoring system, according to claim 12, CHARACTERIZED by the fact that the poor health condition is a type or form of cancer. 14. Hdp monitoring system, according to claim 13, CHARACTERIZED by the fact that the type or form of cancer is hepatocellular carcinoma (HCC) or breast cancer. 15. Hdp monitoring system, according to claim 8, CHARACTERIZED by the fact that said records of Hdp values are subject to real-time analysis of such records by means of an analyzer component integrated or coupled to said recording means included in hdp monitor. 16. Hdp monitoring system, according to claim 8, CHARACTERIZED by the fact that said records of Hdp values are subject to analysis of such records by an analysis center equipped with information relating to records of said Hdp values. 17. Hdp monitoring system according to claim 15, characterized by the fact that said analysis includes the calculation of representative values for each of the recorded Hdp values, optionally making a determination of ratios between different representative Hdp values, and comparing the representative values and/or ratios with predetermined representative values or ratios in patients known to be healthy or predetermined to be suffering from or likely to develop an identified impaired health condition, whereby representative values calculated for recorded Hdp values or ratios that correspond to representative values or predetermined Hdp ratios provide an indication of a diagnosis of a patient's health status. 18. The HDP monitoring system of claim 17 is characterized by the fact that the patient's health condition is suspected or known to involve a form of cancerous cell growth or there is a likelihood of such a form of cell growth cancers develop in a patient. 19. The Hdp monitoring system of claim 18 is characterized by the fact that the patient's health condition is suspected or known to involve a form of cancer cell growth that is hepatocellular carcinoma (HCC) or breast cancer . 20. Method for diagnosing a health condition of a patient, CHARACTERIZED by comprising the steps of detecting and measuring and recording by means of an Hdp monitoring system Hdp values exhibited by a patient and by one or a plurality of surrogate patients ; wherein the Hdp monitoring system comprises principal component analysis means for converting a set of observations of possibly correlated Hdp values into a set of linearly uncorrelated variable values called principal components, divided into three groups comprising Pressure, Flow and Beats , such main components being representative of: systolic blood pressure, diastolic blood pressure, mean arterial pressure, stroke volume, cardiac output, total peripheral resistance, RR interval, heart rate, and pulse pressure; and operating the Hdp monitoring system to cause exposure or application of electromagnetic output signals that influence Hdp values to the patient and one or a plurality of surrogate patients during an exposure period, operating the Hdp monitoring system to record each one of the Hdp values measured for each of said hemodynamic parameters, measured during a period of no exposure and during or after an exposure period of applying said electromagnetic output signals to the patient and one or a plurality of surrogate patients, operate the Hdp monitoring system to analyze the various recorded measured Hdp values to obtain representative Hdp values for each of the recorded Hdp values originating from the patient and one or a plurality of surrogate patients, optionally operating the Hdp monitoring system to making a determination of ratios between different representative Hdp values for each patient and one or a plurality of surrogate patients, and operating the Hdp monitoring system to compare each and/or both of said representative values or ratios of different representative values of the patient, with predetermined representative values or ratios of one or a plurality of surrogate patients pre-diagnosed as being healthy or being in an identified pre-diagnosed poor health state, whereby representative values for recorded Hdp values or ratios that correspond to values Representative or predetermined Hdp ratios of the one or a plurality of surrogate patients provide an indication of a diagnosis of a health state of a patient.