AU719852B2 - Bioenergetic data collection apparatus - Google Patents

Description

WO 97/24980 PCT/AU96/00841 1 "BIOENERGETIC DATA COLLECTION APPARATUS" FIELD OF THE INVENTION This invention relates to a method and apparatus for the collection of biomedical data. In particular, it relates to a bioenergetic approach to the evaluation of observed cardiovascular response as recorded in terminal tissue, such as the fingertip. The invention finds primary application with humans but may also be applied to animals.

BACKGROUND TO THE INVENTION Biomedical data can be collected using electronic instruments that utilize electromagnetic energy in various ways. A useful summary of known devices and techniques has been presented by Dr. Dennis W Remmington to the Joint Committee Meeting of the Utah State Medical Association and published in July 1990. He summarises the known devices in two categories: instruments which measure passive electrical energy, and instruments which measure response to stimuli.

The first category includes instruments such as the electrocardiograph (ECG), the electroencephalograph (EEG), Chinese electric pulse testing, and Chinese gastrointestinal analysis.

In the second category are instruments that measure response to stimuli, such as galvanic skin response devices, and instruments that measure response to electromagnetic stimuli, such as electromyelography, brain stem audiometry, magnetic resonance imaging (MRI) and electroacupuncture according to Voll (EAV).

The galvanic skin response technique measures the electrical conductance between two electrodes placed on the skin. The patient is then subjected to various stimuli, and any change in skin conductance is recorded. Any stimuli causing increased sweat production will increase the conductance and give a change in the readings, which are usually recorded on a graph.

In the EAV method a low voltage electrical charge is introduced into the body, and the precise level of electric current conducted through the WO 97/24980 PCT/AU96/00841 2 acupuncture points are measured. Information about various organ systems and musculoskeletal regions is obtained by the level of the readings.

The known devices have proven useful to various degrees in providing biomedical data to assist medical practitioners in diagnosis.

However, the majority of the known techniques are invasive and require the application of electric current to the patient. Furthermore, the known techniques are subjective in nature and subject to wide variation in interpretation of indicative measures. A method and apparatus for passively collecting bioenergetic data is desirable.

The collection of bioenergetic data, such as pulse rate, by monitoring of blood movement in the fingertip is known. Common devices for performing this function comprise a red or infrared light source and detector.

The light incident on the fingertip penetrates a small distance into the fingertip and is modulated by absorption in the blood in the capillaries. A portion of the light is reflected or transmitted and this is measured by the detector. Thus the signal from the detector mimics the flow of blood through the fingertip.

These devices are not limited to use at the fingertip or with humans.

Devices for use with animals commonly measure blood movement at the ear lobe, lip or tongue.

The majority of the applications of the device described above are for simple monitoring of pulse rate. In some applications, the signals from the device are analysed in more detail to separately identify the systolic and diastolic pulses.

In recent times the devices have become more sophisticated with the advent of more intense light sources and more sensitive detectors. It is now possible to estimate the partial pressure of oxygen in the body by monitoring absorption of infrared light in the blood and making a number of assumptions. Devices performing this function are generally known as oximeters.

The inventors have found that a great deal more information can be obtained by monitoring blood flow in the fingertip than has previously been WO 97/24980 PCT/AU96/00841 3 realised.

OBJECTOFTHE INVENTION It is an object of the present invention to provide an apparatus for the monitoring and evaluation of observed cardiovascular response.

A further object of the present invention is to provide a method of monitoring and evaluating cardiovascular response.

Further objects will be evident from the following description.

DISCLOSURE OF THE INVENTION In one form, although it need not be the only or indeed the broadest form, the invention resides in an apparatus for the collection of bioenergetic data comprising: monitoring means adapted to produce signals characteristic of blood flow; processing means in signal connection with said monitoring means and adapted to receive and analyse said signals to indicate the bioenergetic status of a body; and display means adapted to display the bioenergetic status so indicated.

In preference the apparatus further comprises an isolation means in signal connection with the monitor means and processing means. The isolation means preferably provides electrical isolation between the monitoring means and the processing means so as to ensure that the relatively high voltages in the processing means cannot be transmitted to a patient through the monitoring means.

In preference the monitoring means comprises an oximeter adapted to monitor blood flow in an extremity, such as a fingertip or ear lobe. The oximeter preferably comprises a light source, detector means and interface means. The detector is preferably a photodiode. The light source may be a light emitting diode (LED) or diode laser emitting infrared or visible radiation. Preferably, there are two light sources, one emitting infrared radiation and one emitting visible radiation. The signals from the detector lobe, lip or tongue.

The majority of the applications of the device described above are for simple monitoring of pulse rate. In some applications, the signals from the device are analysed in more detail to separately identify the systolic and diastolic pulses.

In recent times the devices have become more sophisticated with the advent of more intense light sources and more sensitive detectors. It is now possible to estimate the partial pressure of oxygen in the body by monitoring absorption of infrared light in the blood and making a number of assumptions. Devices performing this function are generally known as oximeters.

The inventors have found that a great deal more information can be obtained by monitoring blood flow in the fingertip than has previously been realised.

OBJECT OF THE INVENTION 0It is an object of the present invention to provide an apparatus for the monitoring and evaluation of observed cardio-vascular response.

6 A further object of the present invention is to provide a method of monitoring and evaluating cardio-vascular response.

25 Further objects will be evident from the following description.

o0 DISCLOSURE OF THE INVENTION In one form, although it need not be the only or indeed the broadest form, the invention resides in an apparatus for the collection of bioenergetic data indicative of bioenergetic status of a body including: optical monitoring means including detector means adapted to detect light, the monitoring means being adapted such that in use the light passes through a part of the body of a patient, the light is thereby affected by the light characteristics of the part of body and modulated by blood flowing within the part of the body, and to produce time-varying signals in response ,to the light detected by the detector means; display means for displaying a trace; processing means in signal connection with the optical monitoring means and the display means for processing the time-varying signals and the processing means being adapted to effect display on the display means of the trace; the apparatus being characterised by: the optical monitoring means producing time-varying signals including high frequency components of the detected light and wherein the high frequency components are above the fundamental systolic pulse and diastolic pulse frequencies; the trace being derived from said time-varying signals and the high frequency components in the time-vary signals may be displayed; and, the high frequency components being indicative of bioenergetic data.

In preference the apparatus further comprises an interface means in signal i:connection between the monitor means and processing means. The interface means preferably provides electrical isolation between the monitoring means and the processing means so as to ensure that the relatively high voltages in the S"processing means cannot be transmitted to a patient through the monitoring means.

The interface means may also translate the signals from the monitoring means into o: a format suitable for the processing means.

"In preference the monitoring means comprises an oximeter adapted to monitor blood flow in an extremity, such as a fingertip or ear lobe. The oximeter preferably comprises a light source, detector means and interface means. The detector is preferably a photodiode. The light source may be a light emitting diode (LED) or diode laser emitting infrared or visible radiation. Preferably, there are two light sources, one emitting infrared radiation and one emitting visible radiation. The signals from the detector are indicative of the nature of the blood flow in the extremity. The interface means performs preliminary processing of the signals from the detector including converting the analogue detector signals to digital signals suitable for the processing means.

WO 97/24980 PCT/AU96/0041 6 FIG 2 is a detailed sketch of an oximeter; FIG 3 is a schematic block diagram of the interface of the apparatus; FIG 4 shows a comparison of the waveform of a healthy person with a not so healthy person; FIG 5 is a trace showing the heart activity and amplitude ratio measurements; FIG 6 is a trace showing an ATP ramp measurement; FIG 7 is a trace showing an expansion of a dichotic notch region; FIG 8 is a trace showing an expansion of a systolic pulse; FIG 9 shows a comparison of a waveform for a patient before and after exposure to a therapeutic magnetic field; FIG 10 is an expanded section of FIG 9; FIG 11 is a comparison of a waveform for a patient before and after exposure to an allergen; FIG 12 is a flowchart of the operation of the apparatus; and FIG 13 is a block diagram of additional modules for the apparatus.

DETAILED DESCRIPTION OF THE DRAWINGS In the drawings, like reference numerals refer to like parts.

Referring now to the drawings in detail there is shown in FIG 1 a block diagram of a bioenergetic data collection apparatus according to a first embodiment. The apparatus comprises a monitor means 1, which in the preferred embodiment is an oximeter comprising a finger probe 2 and interface 3. Signal processing is performed in processing means 4.

Associated with the processing means 4 is a display unit 5 and memory 6.

In the preferred embodiment the processing means 4, display unit 5 and memory 6 together comprise a personal computer 7. The personal computer 7 may conveniently be a laptop computer thereby making the whole apparatus portable.

WO 97/24980 PCT/AU96/00841 7 The interface 3 is in signal connection with an isolation means, such as opto-isolator 8, which is in signal connection with the processing means 4. The interface 3 has its own power supply so the only requirement for connection between the oximeter 3 and personal computer 7 is for the transmittal of signals from the interface 3 to the computer 7 via the optoisolator 8. The opto-isolator 8 primarily provides electrical isolation between the interface 3 and the processing means 4 to avoid any risk of electrical injury to persons using the apparatus.

The operation of the pulse monitor and finger probe are shown in more detail in FIG 2. A commercially available device such as a model 71000A2 pulse oximeter from BCI International may be modified for use in the bioenergetic data collection apparatus. The finger probe comprises an infrared light source 9, a red light source 10 and a detector. 1. In normal operation the oximeter determines SpO 2 and pulse rate by passing two wavelengths of light, one red and one infrared, through body tissue 12 to the photodetector 11. The light sources are pulsed and the photodetector signal is sampled at 120Hz. During measurement, the signal strength resulting from each light source depends on the colour and thickness of the body tissue, the probe placement, the intensity of the light sources, and the absorption of the arterial and venous blood (including the time varying effects of the pulse) in the body tissues.

The oximeter processes these signals, separating the time invariant parameters (tissue thickness, skin colour, light intensity, and venous blood) from the time variant parameters (arterial volume and p0 2 to identify the pulse rate and calculate oxygen saturation. Oxygen saturation calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood.

The signal from the interface 3 is a time varying voltage with fast amplitude changes. The processing means 4 requires signals in a digital form so the interface 3 is required to sample and digitise the signal from the probe 2. Prior art devices have applied a relatively course digitising filter which has resulted in the loss of information rich high frequency components WO 97/24980 PCT/AU96/00841 8 of the signal.

The commercially available oximeter requires two primary modifications for use in the bioenergetic data collection apparatus. Firstly, the output port of the interface 3 is adapted for connection to a standard serial port of a personal computer. Secondly, the bandpass of the interface 3 is modified to allow high frequency components to be transmitted to the processing means. Commercial devices routinely include a band-pass filter to remove high frequency components and thereby obtain a more stable reading of the relatively low frequency pulse rate and SpO 2 values. The interface 3 provides a local readout of pulse and SpO 2 The inventor has found it useful to filter out very low frequency signals that are caused by movement of the patient. Although the filtering can be performed in hardware by modification of the oximeter it is convenient to provide software filtering in the processing means.

A schematic block diagram of the interface 3 is shown in FIG 3. A standard microprocessor kernel 13 is formed by microprocessor 14, RAM and EPROM 16. Communication is provided on address bus 17. A current to voltage converter 18 converts the current output of the detector 11 to a voltage readable by the analogue to digital converter 19. The analogue to digital converter 19 performs a 12-bit conversion and places the digital result on data bus 20. The microprocessor 14 analyses the data to provide the local display and outputs the digital data through serial port 21.

The processing means 4 may be a personal computer programmed to analyze the signals received from the interface 3. The personal computer may conveniently be a laptop computer which facilitates mobility of the apparatus. In the described embodiment the display means 5 is included as the monitor of the personal computer or laptop computer. In an alternative embodiment a purpose built processing means may be packaged into a compact container.

The apparatus may be operated in two main modes. In a first mode the apparatus monitors and collects data on the pulse of a subject. In this mode the apparatus is able to provide data in a form that facilitates diagnosis WO 97/24980 PCT/AU96/00841 9 by a skilled medical practitioner. An example of the graphical data obtainable in this mode is given in FIG 4. Fig 4a shows a pulse trace recorded for a 20 year old male in good physical condition. The systolic 22 and diastolic 23 pulses are well-defined and clean. In contrast, Fig 4b shows a pulse trace for an individual in poor physical condition. The systolic and diastolic traces are poorly defined and very irregular. This trace indicates serious vascular problems.

Further analysis can be conducted on the recorded traces. Fig 5 is a screen dump of a display demonstrating the calculation of heart activity.

The X-axis 24 is marked in seconds and the Y-axis 25 is in arbitrary units.

Identifying information including the date, file number, scale, SpO 2 and pulse rate are printed below the X-axis.

Heart activity is defined as the ratio of heart action to heart rest, which in the figure is calculated by D-B/H-B. The result of the calculation is shown on the screen at 26. The value provides useful information to a physician to aid in diagnosis. An amplitude ratio can also be calculated. The amplitude ratio is defined as C-A/E-A. The result may also be shown on screen.

Fig 6 shows how the apparatus can be used to display and compare the ATP ramp angle. The angle of dotted line 27 can be set by the physician at the ATP ramp angle considered to be ideal for the patient and situation.

The variation of a trace from the ideal angle is immediately evident. In the example of Fig 6 the region 28 is good but the other regions, such as 29, deviate to a small degree. It will be appreciated that the example of Fig 4b would show a marked deviation.

Regions of the pulse trace can be windowed and expanded as demonstrated in Fig 7. In Fig 7 the region around the dichotic notch has been expanded to show the high frequency components. It is generally accepted that this region of the pulse trace is indicative of gastrointestinal tract health. A bowel irritation may be manifest in an increase in high frequency components in this region. If every pulse in the trace shows a 'bump' in the ATP ramp region there is likely to be a colon problem. If the 'bump' is intermittent, the problem is probably with ATP production (eg WO 97/24980 PCT/AU96/00841 fatigue). The apparatus provides a display of this region to assist the physician to make a correct diagnosis.

In Fig 8 the region around the top of the systolic pulse trace is enlarged. The shape of the trace in this region is generally accepted as indicative of the health of the aortic valve. A double peak is bad, whereas a single peak, such as 30, indicates good aortic valve condition. The physician can also obtain an estimate of the volumetric blood flow by measuring the height and width of the systolic pulse. This may also be used to diagnose overall heart condition.

In a second mode the data before a change can be stored in memory 6 and compared with data obtained after the change and an analysis provided. The change may be the application of a therapeutic magnetic field such as could be applied by the device described in United States patent number 5527259. Fig 9 indicates the differences that can be observed before and after the application of therapeutic magnetic fields.

In Fig 9 the entire trace acquired over 30 seconds is shown. The lower trace, trace B, is the first acquired trace prior to application of a therapeutic magnetic field. The full trace is useful for showing pulse trends such as the variation in the pulse baseline 31. It Is clear in the lower trace that there is considerable variation in the baseline. In contrast the baseline 32 in the upper trace is relatively fiat.

The scale can be expanded to highlight a subset of pulses. The first five seconds of the traces in Fig 9 are shown in Fig 10. This mode of display is useful for identifying changes in the pulse shapes as opposed to the pulse trends identified from Fig 9. It is clear from Fig 10 that the 'bumps' 33 evident in the ATP ramp of the lower trace are gone from the upper trace after application of therapeutic magnetic fields.

A comparison between traces can also be made to detect the impact of detrimental influences on the body. One such application is the identification of allergic response. Fig 11 shows a comparison of traces taken without (lower trace) and with (upper trace) allergenic influence. The allergenic influence may be applied by a patient simply holding a vial WO 97/24980 PCT/AU96/00841 11 containing allergenic materials. Kits of allergens can be obtained from homeopathic suppliers such as the Practitioner Test Kit obtainable from Brauer Biotherapies Pty Ltd. Fig 11 clearly shows a disruption of the ATP ramp as indicated by 34a in the lower trace and 34b in the upper trace. This disruption can be used by a physician to diagnose allergic reaction to different allergens.

A flow chart of the operation of the apparatus is shown in Figs 12a, 12b and 12c. An initial set-up routine sets up the apparatus according to parameters selected by the user. These parameters include the communications, display and analysis parameters (such as ATP ramp angle).

The name of the patient is keyed into the apparatus for data storage purposes. If the patient is a new patient a new database is opened. If the program detects the name of an existing patient the historical data for that patient is retrieved.

Once the equipment is set-up and the patient information is entered, data collection is commenced. A sub-routine checks synchronisation between the oximeter and the processing means. If the units are not synchronised or synchronicity is lost, the data collection process is recommenced.

The collected data is high pass filtered, displayed on the display means in real time and stored in a temporary buffer. The pulse rate and SpO 2 values are read from the oximeter interface and displayed. Data collection continues for a timed period or until terminated by the operator.

Upon completion of data collection the patient record number is advanced by one and the data is saved to the patient data base. Notes can be entered by the operator if desired.

Comparative data is then retrieved and displayed on the display means with the recorded data. The comparative data may be previous data from the same or a different patient or may be standard data from a compiled library. The operator is able to make a number of comparisons between the new recorded data and the other data on screen. The waveforms can be WO 97/24980 PCT/AU96/00841 12 shifted or scaled as desired.

The patient records or patient data can be deleted or renamed if required. Certain fragments of the waveforms can be zoomed for calculation of indicative diagnostic values. Indicative diagnostic ratios include the heart activity or time ratio and the amplitude ratio.

The ATP ramp line may be drawn by using a mouse or cursor keys to move a cursor to the start of an ATP ramp. The line is drawn at an angle provided at set-up.

A printer interface is provided in the software so that the waveforms and notes may be printed as required. Help files are also provided to assist users of the apparatus. The help files provide details of operating procedures as well as descriptions of common waveforms.

The apparatus may incorporate additional modules to extend the data collection functions to include a diagnostic capability. Fig 13 is a schematic of the modular nature of the invention. The primary module, as described in detail above, is known by the inventors as the Magnagraph TM 35. An EKG Module 36 may interface to the Magnagraph TM 35 to provide an electrical readout of the heart function which, added to the Magnagraph TM physical and mechanical evaluation, renders a complete and objective profile of the cardiac function. A Pulse Blood Pressure Module 37 provides diastolic, systolic and mean arterial pressure, creating a comprehensive and objective evaluation of the profile of the cardiac function. An Allergy Module 38 provides an objective computer based evaluation and assessment of electrodermal readings of known allergens by registering before and after microvoltage changes in response to allergens.

Previously, the allergen response described earlier could only be interpreted subjectively. The Allergy Module 38 provides objective evaluation by comparing measured waveforms with a library of known responses.

It will be appreciated that the apparatus and method described herein are useful for collecting and displaying bioenergetic data collected from a body. Although the description has been in terms of application to a human WO 97/24980 PCT/AU96/00841 13 body it may equally be applied to animals. It will be further appreciated that the collected data can be analysed to varying degrees to provide information of greater value to a medical practitioner or veterinarian. It should be emphasised that the invention is not a prognostic device but only provides data for further consideration by an appropriately skilled practitioner.

The preferred embodiments described herein are intended to illustrate the principles of the invention, but not to limit its scope. Other embodiments and variations to the preferred embodiments may be evident to those skilled in the art and may be made without departing from the spirit and scope of the invention.

EDITORIAL NOTE FOR APPLICATION 11861/97 THE NEXT PAGE IS PAGE 17

Claims (16)

1. An apparatus for the collection of bioenergetic data indicative of bioenergetic status of a body including: optical monitoring means including detector means adapted to detect light, the monitoring means being adapted such that in use the light passes through a part of the body of a patient, the light is thereby affected by the light characteristics of the part of body and modulated by blood flowing within the part of the body, and to produce time-varying signals in response to the light detected by the detector means; display means for displaying a trace; processing means in signal connection with the optical monitoring means and the display means for processing the time-varying signals and the processing means being adapted to effect display on the display means of So 15 the trace; the apparatus being characterised by: S •"the optical monitoring means producing time-varying signals including high frequency components of the detected light and wherein the high frequency components are above the fundamental systolic pulse and 20 diastolic pulse frequencies; 0*95 the trace being derived from said time-varying signals and the high °o frequency components in the time-varying signals may be displayed; and, S° the high frequency components being indicative of bioenergetic data. 25

2. An apparatus as in claim 1 wherein the processing means processes the time-varying signals to determine bioenergetic data and bioenergetic status, and the °"processing means being adapted to effect display of the determined bioenergetic data and bioenergetic status.

3. An apparatus as in either claim 1 or claim 2 including an isolation means in signal connection with the optical monitoring means and the processing means, said isolation means providing electrical isolation between the monitoring means and the processing means.

4. An apparatus as in any one of the preceding claims wherein the optical monitoring means is applied to an extremity of the body to measures light passing I through the extremity, and includes one or more sources means emitting light being infrared and/or visible radiation, the source means and the detector means 18 being spaced apart and adapted such that in use the light passes through the part of the body.

An apparatus as in claim 4 wherein the detection means is a photodiode, said photodiode producing the time-varying signals and being responsive to light received from said one or more sources means.

6. An apparatus as in either claim 4 or 5 including an interface means connected to the detector means, the interface means performs preliminary processing of the time-varying signals including converting analogue signals from the detector means to digital signals suitable for processing by the processing means.

7. An apparatus as in any one of the preceding claims wherein the processing 15 means is a microprocessor programmed to perform one or more algorithms to *calculate bioenergetic data from the trace and to analyse said bioenergetic data to indicate bioenergetic status. *i

8. An apparatus as in any one of the preceding claims wherein the bioenergetic 20 data includes one or more measurable characteristics chosen from a list including: 0o° "ATP ramp angle, heart activity to rest ration, systolic pulse amplitude variation over time, systolic pulse amplitude to diastolic pulse amplitude ratio, and pulse shape variation. o C 25

9. An apparatus as in any one of the preceding claims wherein the bioenergetic status of the body is indicated according to indicative functions chosen from a list Ci.. including: pulse rate, oxygen saturation in terminal tissue blood flow rate, elasticity of blood vessels, strength and regularity of heart beat, cardiac sufficiency, cardiac valve activity, cardiac or vascular metabolic abnormalities, cell energy change, latent hypertension, myocardium damage, cardiac inflammation, vascular inflammation, allergic response, immune system response changes, pulmonary function variation, cardiac function variation, intestinal bioenergetic reactions by analysis of the pulse waveform trace in conjunction with the bioenergetic data.

10. An apparatus as in any one of the preceding claims wherein the display means is a high resolution video display adapted to display graphical and alphanumeric data. 19

11. An apparatus as in any one of the preceding claims further comprising an allergy module in signal connection with said processing means, said allergy module comprising recording means adapted to record electrodermal readings in the form of before and after microvoltage changes occurring in response to known allergens, and analysis means adapted to provide signals characteristic of allergic reaction to known allergens by analysing said electrodermal readings and performing an objective computer based evaluation and assessment, wherein said processing means analyses said bioenergetic data and said signals characteristic of allergic reaction to indicate bioenergetic status.

12. An apparatus as in any one of the preceding claims further comprising an EKG module in signal connection with said processing means. said EKG module adapted to produce signals characteristic of heart function, wherein said processing means analyses quid bioenergetic data and said signals characteristic of heart 15 function to indicate bioenergetic status. g *g o.

13. An apparatus as in any one of the preceding claims further comprising a pulse blood pressure module in signal connection with said processing means, said pulse blood pressure module adapted to provide signals characteristic of pulse pressure including diastolic, systolic and mean arterial pressure, wherein said processing means analyses said bioenergetic data and said signals characteristic of S pulse pressure to indicate bioenergetic status.

14. An apparatus for the collection of bioenergetic data indicative of bioenergetic status of a body including: S.optical monitoring means producing time-varying signals in response to the light detected by the detector means that has past through and been affected by the light characteristics of a part of body and modulated by blood flowing within the part of the body; display means for displaying a trace; processing means in signal connection with the optical monitoring means and the display means for processing the time-varying signals and the processing means being adapted to effect display on the display means of the trace; the apparatus being characterised by: the optical monitoring means producing time-varying signals including high frequency components of the detected light and wherein the high frequency components are above the fundamental systolic pulse and diastolic pulse frequencies; the trace being derived from said time-varying signals and the high frequency components in the time-varying signals may be displayed; the high frequency components being indicative of bioenergetic data; the processing means extracting bioenergetic data from the time-varying signals and determining bioenergetic status from the bioenergetic data, and the processing means analyses the pulse waveform trace to extract bioenergetic data including one or more of ATP ramp angle, heart activity to rest ration, systolic pulse amplitude variation over time, systolic pulse amplitude to diastolic pulse amplitude ratio, and pulse shape variation; and wherein the apparatus facilitates determination of bioenergetic status of a body including one or more of pulse rate, oxygen saturation in terminal :.oI tissue blood flow rate, elasticity of blood vessels, strength and regularity of 15 heart beat, cardiac sufficiency, cardiac valve activity, cardiac or vascular :metabolic abnormalities, cell energy change, latent hypertension, myocardium damage, cardiac inflammation, vascular inflammation, allergic ~response, immune system response changes, pulmonary function variation, cardiac function variation, intestinal bioenergetic reactions by analysis of the pulse waveform trace in conjunction with the bioenergetic data. e.. o

15. A method of determining bioenergetic status of a body including the steps S. 00 of: transmitting visible and infrared radiation into terminal tissue; .5oo measuring a time-varying signal proportional to visible and infrared radiation transmitted through the terminal tissue and which includes high frequency components of the measured radiation and wherein the high frequency components are above the fundamental systolic pulse and diastolic pulse frequencies; converting the time-varying signal to a digital signal; passing the digital signal to a processing means; processing the digital signal in the processing means to produce a displayable trace; analysing the to obtain bioenergetic data; displaying the displayable trace and bioenergetic data on a display means; and Ranalysing the trace and bioenergetic data to determine bioenergetic status.

16. A method as in claim 15 further including the steps of analysing the traces to provide indicative measures of bioenergetic status. Dated this 7th day of March 2000 LARKACE PTY LTD By their Patent Attorney A.P.T. Patent and Trade Mark Attorneys :0000 a* 0 900 0 a0