GB2445734A - Substance intolerance testing system using multiple frequency substance signature signals - Google Patents

Substance intolerance testing system using multiple frequency substance signature signals Download PDF

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Publication number
GB2445734A
GB2445734A GB0701081A GB0701081A GB2445734A GB 2445734 A GB2445734 A GB 2445734A GB 0701081 A GB0701081 A GB 0701081A GB 0701081 A GB0701081 A GB 0701081A GB 2445734 A GB2445734 A GB 2445734A
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Prior art keywords
substance
stimulation
voltage
frequencies
signature
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GB0701081D0 (en
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Jonathon Mark Griffiths
Huw John Griffiths
Nicholas Purdue
Guy Tritton
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CWM DULAS CORP Ltd
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CWM DULAS CORP Ltd
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Priority to GB0701081A priority Critical patent/GB2445734A/en
Publication of GB0701081D0 publication Critical patent/GB0701081D0/en
Priority to PCT/GB2008/000129 priority patent/WO2008087395A1/en
Publication of GB2445734A publication Critical patent/GB2445734A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/41Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0035Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531Measuring skin impedance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282Holders for multiple electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235Details of waveform analysis
    • A61B5/7253Details of waveform analysis characterised by using transforms
    • A61B5/7257Details of waveform analysis characterised by using transforms using Fourier transforms

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Immunology (AREA)
  • Vascular Medicine (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

An intolerance testing system can automatically determine a person's intolerance of specific substances, primarily specific foodstuffs. The device has a memory for storing data which represents two or more signature frequencies that are characteristic of a particular substance. The device has a stimulation electrodes 12A,B for applying the AC stimulation signal, derived from stored signature frequencies, to the patient's skin. Multiple frequencies may be produced in sequence for a particular substance. An amplifying and filtering circuit is coupled to a sensing electrodes 14A,B to detect a change in sensed body response voltage following application of the substance signal. The device may be self contained and comprise a bracelet or watch device with display 15 and user controls. The substance frequencies may be derived from peaks in the infra-red absorption spectrum of the substance (fig 3) which are then scaled to produce the characteristic frequencies.

Description

INTOLERANCE TESTING DEVICE AND SYSTEM
This invention relates to an intolerance testing device and an intolerance testing system for determining a person's intolerance of specific substances, primarily specific foodstuffs. This invention also relates to a method of testing a person's intolerance of specific substances and to a method of calibrating an intolerance testing device. Furthermore, this invention relates to a method of determining characteristics of a particuLar substance, in particular signature frequencies which are characteristic of a particular substance.
Research has established that the human body responds to electrical signals which are emitted by substances, chemicals and foodstuffs.
It is also known in the prior art that every substance has a characteristic frequency which arises from the inherent vibrational nature of atoms. That frequency can be measured by measuring the nano-voltage of the Hertzian wave as it passes through an object.
It has also been established, through research seeking to explain the properties of acupuncture and related techniques, that those substances to which the human body has intolerance and which stress the body, affect electrical signals generated within the body, and it has been found that such signals may be picked up at acupuncture locations.
The latter property is sometimes referred to as the electrodermal response of the body, and is measured by monitoring changes in electrical parameters of the body, e.g. its electrical resistance in particular regions, when the person is subjected to different compounds. There are on the market a number of so-called bio-resonance systems making use of the electrodermal response to test for food allergies as well as various other ailments and disorders. All of these systems involve the patient being connected to a number of electrodes and tested by a therapist. Typically, the electrodes are applied to the ankles, wrists, and the head. In some cases, the patient holds an electrode to complete the circuit.
In general, intolerance to a particular compound is tested by placing a sample of the compound or a homeopathic trace of the compound in a small vial which is located on a metal plate or in a metal honeycomb forming part of an electrical transmission circuit for applying a stimulation signal via the electrodes. A resultant change in resistance of the body is used to detennine "rejection" or intolerance of the compound.
There are a number of disadvantages with these prior systems. Firstly, the prior systems are bulky and not easily transportable. They thus tend to reside in one place like a health centre. Secondly, they are very expensive, often in the order of thousands of pounds sterling. This means that they are not suitable for purchase by the average consumer. Thirdly, they require a skilled operator to use. The skilled operator will often have to calibrate the machine for each patient and spend some time selecting the acupuncture points. Fourthly, the prior systems tend to use a machine to measure electrical resistance of the body and then intelligently use the machine to determine whether there is a substantial reaction.
These disadvantages give rise to a number of problems, in particular the fact that the body's resistance is considerably affected by surface perspiration (this is well-known in lie detector tests). Measurement of resistance is inherently unreliable and will normally require a skilled operator. For instance, surface perspiration can substantially affect the electroconductivity of the skin and variations in the resistance caused by perspiration can mask any minor variations caused by the adverse reaction of an individual to substances. Furthermore, the measurement of body resistance generally requires a substantial distance between the sensing electrodes. This ensures that actual body resistance is measured and mitigates the effect of changes in resistance due to surface perspiration..
A further problem is that, since the reactivity of the human body changes continually, any such intolerance test is a snapshot in time and, as a result, may not consistently and reliably indicate the overall pattern of intolerances of a patient unless the test is repeated over a period of time. This is expensive and time-consuming.
When a test has been completed, the therapist typically recommends remedial steps, but such advice, although informative and helpful, may raise more questions for the patient than it answers. The cost of a visit to the therapist often has an inhibitory effect on a return visit. Thus, the patient is often left with a snapshot of reactivities, but this is not followed up by either the therapist or the patient which is unsatisfactory for medium to long term patient care.
There is a need for a less expensive, more convenient and more reliable means for testing for intolerances. In particular, there is a need for a device which can be used by an individual without the need for a therapist and which permits ongoing testing and analysis of the intolerance of that individual to particular substances.
UK Patent Application No. 0515122.0, in the name of the present applicant, discloses an intolerance testing device for determining a person's intolerance to specific substances, such as foodstuffs, in which a signature frequency that is characteristic of a substance is stored for a plurality of substances. A signal representative of the frequency is applied to the person and the person's reaction is noted as a change in a sensed body response voltage. No sample or homeopathic trace of the substance is required for satisfactory operation of the device. The entire contents of this application is incorporated herein by reference.
It has now been discovered by the applicant however, that the device and method of the invention of this earlier application can be improved.
In accordance with one aspect of the present invention, there is provided an intolerance testing device for determining a person's intolerance to specific substances comprising storage means for storing a plurality of sets of data, each set of which is representative of two or more signature frequencies that are characteristic of a respective substance, a signal generator and at least one stimulation electrode, the signal generator being configured to apply to the stimulation electrode an alternating stimulation voltage signal, derived from the storage means, at each of the two or. more signature frequencies of a set characteristic of a particular substance, and a reaction sensing arrangement including at least one sensing electrode and an amplifying and filtering circuit coupled to the sensing electrode to detect a change in a sensed body response voltage.
Each set of two or more, and preferably nine, signature frequencies characteristic of a substance provides a unique "fingerprint" of the particular substance that is the subject of the intolerance testing. The refinement of using a plurality of signature frequencies, rather than a single frequency representative of a particular substance, results in the accuracy of the person's response being significantly improved, since the differentiation of the person's response to testing for different substances is enhanced. Furthermore, there is a closer correspondence between the "fingerprint" and the substance it represents, than is the case when a single characteristic frequency is used.
Furthermore, as measurement of the change in the body's natural microvoltage (i.e. the voltage measured between two electrodes of the intolerance testing device) is carried out rather than measurement of a change in resistance or other parameter, the variations in response due to, for example, variations in electrode location on the body, surface perspiration and applied pressure and substantially reduced. As a result, patients can use the device themselves on a day-to-day basis away from a treatment centre or clinic. They may test themselves for tolerance levels of whichever substances they choose, and they may use the device where and when they want to. There is no need for a trained therapist, for instance, to locate acupuncture points and to ensure that suitable and stable testing conditions are maintained.
The stimulation and sensing electrodes are preferably skin contact electrodes and, at least one of the sensing electrodes may be coupled to a voltage measuring circuit for measuring a DC body response voltage signal.
A particularly preferred device in accordance with the invention has a pair of stimulation electrodes and a pair of sensing electrodes which form part of a unitary stimulation and sensing module. For example, the electrodes may be integral with the module or one or more may be on flying leads, for example, for attachment to an arm or a leg. The module contains the signal generator which is coupled to the stimulation electrodes to generate an alternating stimulation voltage therebetween with a peak-to-peak value in the range of from OV to about 6V. The amplifying and filtering circuit is also within the unitary module and is coupled to the sensing electrodes and configured to measure a DC body response voltage, preferably of less than lOOmV between the sensing electrodes.
The module may be in the form of a bracelet, preferably for fitting to an arm or leg, having stimulation and sensing electrodes formed as spaced-apart skin contacts on the inwardly facing surfaces of the bracelet so that when the bracelet is tensioned around the wrist, the electrodes bear against the skin of the patient on both the back (upper or outer) and the front, (lower or inner) side of the wrist.
Advantageously, the bracelet, or wrist unit may consist of four stainless steel pads, which measure 25 mm x 20 mm, and which each have six raised areas which are generally circular and approximately 5 mm in diameter. Two pads may be provided on a top arm of the wrist unit and two on a bottom arm. The two pads on the bottom of the wrist unit are used to stimulate the body with a fingerprint of frequencies corresponding to a particular foodstuff. The voltage is preferably between 0 and 6 volts. The actual voltage used is preferably determined on an individual basis using a calibration process which is carried out each time the device is used as described below. The two pads on the top of the wrist unit are used to read the body's response voltage.
The unitary module preferably further includes the storage means for storing signature frequencies.
Preferably, the signature frequencies correspond to wavenumbers lying within the range from 500 cm' to 2000 cm. Preferably, the signature frequencies lie between 1 and 4 MHz.
Preferably, changes in the body's response voltage signal are measured at the sensing electrode or electrodes and stored in a memory of the device in such a way as to relate them to the corresponding substance that is being tested.
Preferably, the device further comprises a comparator, the comparator configured such that, for each substance being tested for, a change in the body's response voltage signal is compared against predetermined sensitivity criteria. An output is provided via an audio-visual display to indicate the likelihood of sensitivity of the person to the substance characterised by the associated set of signature frequencies.
Preferably, the device is configured to determine the size of the alternating stimulation voltage by means of an automatic calibration process. The automatic calibration process comprising the steps of: (i) stimulating the person with a signal at two or more signature frequencies characteristic of a particular control substance; (ii) measuring the body response voltage of the person; (iii) amplifying the body response voltage to obtain an amplified body response voltage; and (iv) adjusting the stimulating signal voltage and the amplification of the body response voltage incrementally until the amplified body response voltage falls within a predetermined range which is suitable for testing.
Preferably, the predetermined range is between 0.1V and 0.2V. More particularly, the predetermined range is between 0.17 and 0.1 SV. The control substance may be a carrot.
In an alternative aspect, the present invention provides an intolerance testing device for determining a person's intolerance to specific substances, comprising a stimulation circuit arranged to apply an alternating stimulation voltage to at least one or more stimulation electrodes, attached to the person, at a number of signature frequencies from 1 MHz to 4 MHz, and a response measuring circuit for measuring the change in a body response voltage developed across a pair of sensing electrodes, attached to the person, in response to application of the stimulation voltage, the response circuit being arranged to exclude signals at frequencies above 30 Hz.
The present invention further provides an intolerance testing system for S determining a person's intolerance to specific substances, wherein the system comprises a self-contained wearer unit which is configured to be worn by the person being tested and which includes means for connecting to a power supply; stimulation contacts and response sensing contacts; a storage device storing a plurality of data, each set of which consists of two or more signature frequencies that are characteristic of a respective substance; wearer operable control means for initiating a testing procedure; and a display for displaying the result of the testing procedure.
Preferably, the system further comprises a source of electrical signature data external to the wearer unit, and an interface which allows for the transfer of the electrical signature data from the source to the wearer unit in response to a wearer request.
Preferably, the interface allows for the transfer of data from the wearer unit to a remote server.
Preferably, the system is arranged to allow the user to access, on a remote server, a personalised data file which is updated by the wearer unit when it is connected to the remote server and which contains substance intolerance data relating to the user, and which data file links to associated data such as dietary and lifestyle suggestions appropriate to persons who have such substance intolerance.
The present invention also provides a method of testing a person's intolerance of a specific substance, the method comprising generating a stimulation signal as an alternating electrical voltage of at least two or more signature frequencies which are characteristic of a particular substance and applying the stimulation signal to the person's body through at least one skin contact stimulation electrode, measuring a reaction voltage developed by the person's body in response to the stimulation signal by receiving the reaction voltage using at least one skin contact electrode located at position on the person's body spaced from the or each stimulation electrode, and amplifying, filtering and analysing the reaction voltage to produce a test result indicative of an intolerance of a substance when the reaction voltage associated with the substance being tested for meets a S predetermined condition.
Preferably, the substance tested comprises a foodstuft Preferably, the method further comprises the steps of applying the alternating stimulation voltage signal at each frequency to the stimulation electrode successively and for a fixed time period. Each signature frequency of each set is applied for approximately 20 ms with substantially no gap between each application of each frequency.
Preferably, the electrodermal. body response voltage is measured during the period following the application of the alternating stimulation voltage signal for all the signature frequencies characteristic of a substance, and in the absence of any stimulating voltage. The period may be approximately 90 ms.
Preferably, after the electrodermal body response voltage has been measured, no further application of the stimulation signal occurs for at least 410 ms.
In prior systems, calibration and testing of intolerance testing systems is done by a therapist using considerable experience and intuition. With a home use intolerance testing system, that is not possible and represents a considerable deterrent to manufacturing and marketing a home use intolerance testing system.
Furthermore, it has been found that different patients react better to different voltage stimulation levels. Preferably, for optimum sensitivity, each patient has an "optimum stimulation level", substantially below which it is difficult to detect any sensitivity in the patient and substantially above which there is a saturated response which is of little use. At the optimum stimulation level, small increases in the stimulation voltage level will show substantial changes in the body's response voltage at frequencies which represent substances to which that individual is intolerant. It is necessary therefore to automatically determine the optimum stimulation level for each individual.
Thus, in accordance with a further aspect of the present invention, there is provided a method of calibrating an intolerance testing device the device, being for determining a person's intolerance to a substance and comprising a stimulation channel for generating an alternating stimulation signal at a frequency which is characteristic of a control substance and a sensing channel for sensing and processing a detected body response voltage, the sensing channel having a first gain whereby to produce an amplified body response voltage, the method comprising the steps of varying the stimulation signal voltage and said first gain iteratively and applying the stimulation signal at each iteration to the person until the amplified body response voltage of the person falls within a predetermined range.
Preferably, the predetermined range is between O.IV and 0.2V. In particular, the predetermined range may be between 0.17 and 0.1 8V Preferably, in order to calibrate an intolerance testing device for a particular person, a set of frequencies for a particular control substance is used for calibration ("the Calibration Control Substance"). In particular, it has been found that the signature frequencies of carrot is suitable as a Calibration Control Substance.
The voltage of the stimulation signal the gain of the sensing channel are thus varied according to an iterative process so as to obtain a suitable response from the subject. Experimentation has found that an amplified body response voltage signal of the subject between 0.1 7V and 0.1 8V provides an optimum level of response for determining the reactivity of the subject to substances. In a preferred embodiment, the stimulation channel (which preferably comprises a signal generator) outputs a stimulation signal voltage between OV and 6V peak-to-peak. This signal is applied to be individual via stimulation electrodes. The stimulating voltage is set at an initial value ("Initial Control Value A") and the gain of the sensing channel is set at an initial value ("Initial Control Value B").
Using the fingerprint frequencies of the Calibration Control Substance, Initial Control Value A and B, are adjusted either upwards or downwards, as required, until the amplified body response voltage signal falls within an acceptable range i.e. a range which provides a suitable level for testing the reactivities of any individual to a range of substances. An optimum level of response occurs with a body response voltage between 0.1 7V and 0.1 8V. Once the desired response has been achieved, the first phase of calibration is finished. The values of Control Value A and B have now been determined for purpose of testing.
Preferably, the intolerance testing device will then use the value of Control Values A and B which have produced the optimum level of response for the purpose of testing i.e. in the above example, an amplified body response between 0.l7VandO.18V.
Preferably, the second phase of calibration is then carried out to determine the person's general reactivity in the "fingerprint" frequency range. This is achieved by applying a range of selected frequencies to the person under test to measure the person's average reactivity. This second phase is not used to change the value of Control Value A or B but to provide a value which can be used when analysing the results. This value is termed the Individual Control Average.
Preferably, tis is done by stimulating the person under test with a sweep of frequencies which lie in the workable range (1 to 4 MHz) e.g. 1.3 MHz and 3.8 MHz, where each frequency has the same amplitude, in order to determine the person's general reactivity in the "fingerprint" frequency range.
It is known that the position of atoms in chemical bonds between two molecules are not fixed. The molecules vibrate, both stretching and bending. As a result, it is known that particular chemical bonds will absorb electromagnetic radiation at a particular frequency, namely the vibrational frequency. Thus, the 0-H bond will tend to absorb electromagnetic radiation at a wavenumber of 3500 cm This can be converted into a corresponding frequency by frequency = c (the speed of light) x wavenumber.
A complex product such as a foodstuff may be made up of a number of complex molecules. There will exist a variety of chemical structures or group vibrations including C=O, N-H, C-H, 0-H and C-O. Since many molecules will contain the same type of bonds, using frequencies that correspond to vibrational frequencies will not uniquely identify a particular molecule or substance. However, it has been found that there is a "fingerprint" region existing between wavenumbers 500 to 2000 cm where unique patterns of absorbance exist for substances. It is S in this region that absorption peaks of proteins, lipids and complex carbohydrate molecules which are typical of foodstuffs and other complex organic edible compounds lie. In this region, it has been discovered by the applicant that there is a high degree of differentiation of characteristic wavenumbers, and thus frequencies, between different foodstuffs.
By electrically stimulating an individual at a particular voltage using frequencies that correspond to the absorbance peaks in the "fingerprint" region of a particular substance, one can mimic the presence of a particular substance without the need to have that substance at hand.
Thus, in accordance an aspect of the present invention, there is provided a method for determining one or more signature frequencies that are characteristic of a particular substance, the method comprising the steps of: (i) irradiating the substance with infra-red radiati,n; (ii) detennining at least one wavenumber (p) of infra-red radiation which is most intensely absorbed by the substance using infra-red spectroscopy in a region of the electromagnetic spectrum where there is a marked degree of differentiation of absorption between different substances; (iii) converting at least one wavenumber into at least one corresponding absorption frequency using the formula f=cv; (iv) converting at least one absorption frequency into at least one corresponding signature frequency which is suitable for stimulating and provoking a measurable electrodermal response.
Preferably, the wavenurnber region of the electromagnetic spectrum lies between 500cm and 2000cm'.
Preferably, the method used for irradiation and determination of the level of absorption is Fourier Transform Infrared Spectroscopy.
Preferably, the signature frequency lies between 1 and 4 MHz.
Preferably, the ratio of the absorption frequency to the signature frequency is x' :1 where x is a prime number higher than I and y is a whole number whose value is such that the signature frequency lies between 1 to 4 MHz.
S
Preferably, the ratio of absorption frequency to the signature frequency is 3':1.
In accordance with yet another aspect of the present invention, there is provided a method of determining a set of signature frequencies that is characteristic of a substance, preferably a foodstuff, wherein a plurality of absorption peaks of electromagnetic radiation lying within the wavenwnber range of from 500 cm' to 2000 cm' are measured.
In this region, it has been found by the applicant that there is a high degree of differentiation of the absorption peaks of different substances.
Advantageously, Fourier Transform Infrared Spectroscopy is used to identify the absorption peaks of each substance.
Preferably, the absorption frequencies determined by the spectroscopic analysis are scaled, preferably reduced, using aharmonic thereof, to a signature frequency that is at level suitable for safe application to a human body.
Preferably, the characteristic set of frequencies comprises nine frequencies that are representative of a substance.
The applicant has discovered that a particular effective method which gives good results uses Fourier Transform Infrared (FTIR) Spectroscopy. This is a chemically specific analysis technique which uses infrared spectroscopy to identify compounds and constituent groups. Since each molecule absorbs electromagnetic radiation at different frequencies, producing an individual spectrum, FFIR can be used to identify different types of chemical bonds.
Scientists use this spectral information to identify different compounds, much the same way that a fingerprint can identify a person. Using this technology, a database of substance spectra and frequencies can be created.
Preferably, the present invention provides an intolerance testing device which uses signature frequencies of a substance to stimulate a person for testing that person's sensitivity to that substance wherein the signature frequencies have been determined in accordance with the method described above.
The invention will now be described by way of example with reference to the drawings in which:-Figures 1A and lB are perspective views of a wristlet device shown, respectively, fastened and laid out flat; Figure 2 is a block circuit diagram in accordance with an embodiment of the invention.
Figure 3 is a graph showing the absorbance characteristic of white flour; Figure 4a is a graph showing an FTLR interferogram; and Figure 4b is a graph showing the Fast Fourier Transform of the interferograin of Figure 4a.
Referring to Figures IA and 1B, an intolerance testing device in accordance with the invention comprises a wristlet 10 having an enclosure 1OA arid a strap lOB with a buckle IOC. The wristlet 10 has four spaced-apart electrical skin contacts on its inwardly facing surfaces. These four contacts comprise a first pair of stimulation electrodes 12A, 12B on the enclosure bA, positioned to bear against one surface of the wrist, here the back surface i.e. the surface of the wrist adjacent the back of the hand, and a second pair of sensing electrodes 14A, 14B on the strap I OB, positioned so as to be located on the oppositely facing surface of the wrist, here called the front side. In practice, the sensing electrodes are located so as to bear against acupuncture points on the underside of the wrist.
The location of the stimulation electrodes 12A, 12B is not critical, but they are preferably mounted well spaced apart, e.g., 15mm apart or more. Generally, it is preferable that the stimulation electrodes are on or close to the subject's acupuncture points on the wrist as this causes greater sensitivity. The enclosure lOA contains electronic circuitry, and has a display 15, user-operated keys (not shown) and a battery power supply. In fact, this preferred device contains all the necessary circuitry for autonomous operation, i.e., without connection to external power supplies, signal sources or the like. The display 15 indicates, amongst other information, the substance being tested and the level of sensitivity to that substance.
The keys allow the user to control the unit to select substances for which an intolerance is to be tested and to control the tests to be carried out, to store results in a memory within the device, and to switch the device on or off.
Referring to Figure 2, the electronic circuit 20 contained within thwristlet housing 1OA for the operation of the intolerance testing device will now be described.
The circuit 20 comprises an analogue stimulation channel 22 and an analogue sensing channel 24. The stimulation channel 24 comprises an output amplifier 26 which is a voltage controlled amplifier (VCA) optimised for high frequency operation. The output amplifier 26 has a Control Value A which is the value of the output peak-to-peak stimulation voltage. Output amplifier 26 is coupled to an electrode contact 28 via a capacitor 30. The electrode contact 28 is connected to one of the stimulation electrodes 12A, 12B. The other stimulation electrode is connected to ground. Thus, there will be a voltage drop between 12A and 12B.
Electrode contact 28 is electrically isolated for patient safety.
The output amplifier is connected to a direct synthesis frequency generator 32 and a microprocessor unit (MPU) 34. The direct synthesis frequency generator 32 generates frequencies from 1Hz to 30 MHz. The generator 32 is also connected to the MPU 34. The MPU 6 controls the frequency output by generator 32. The MPU 6 controls the generator 32 such that either single frequencies or a sequential basket of frequencies, corresponding to the substances being tested for, is output to amplifier 26.
The sensing channel 24 comprises a pair of electrode contacts 36, 38 which are connected to the sensing electrodes 14A, 14B. The contacts 36, 38 are coupled to differential amplifier 40. The differential amplifier 40 amplifies any difference in voitage appearing across contacts 36, 38. The differential amplifier has a Control Value B which is the gain of the differential amplifier. It is possible to detect common mode noise using amplifier 40. Any detected common mode signal is buffered by buffer amplifier 42 which is connected to amplifier 40 and terminal 44. Terminal 44 can be used to detect other body phenomena such as heart rate. Terminal 44 is connected to a contact electrode which is not shown in Figures 1A and lB.
The output of amplifier 40 is connected to a capacitor filter 46 which is an 8th order switched capacitor filter. The filter 46 is set to filter at all frequencies above 30 MHz. The filter 46 is a very sharp low pass filter such that a 45 Hz signal is 80 to 85 dB below the passband level. Thus, virtually all signals at power line frequencies (i.e. 50 Hz and 60 Hz) are eliminated. The output of filter 46 is connected to a galvanic isolation amplifier 48 which provides electrical isolation from the person being tested.
The amplifiers 40, 42 and 48 and the filter 46 are all supplied with DC power from an isolated power supply which is run off a device power supply (not shown) which ensures complete electrical isolation from the person under test.
The output of the isolation amplifier 48 is connected to voltage controlled amplifier 50. The gain of the amplifier 50 is controlled by the MPU 34. The gain of the amplifier is proportional to the voltage amplified by the MPU 34 and is in the range of 0dB to 40dB. The output of the amplifier 50 is connected to an analogue-to-digital converter (not shown) which is located in the MPU 34. The MPU 34 conducts test result analysis on the signal fed to it by the amplifier 50.
The MPU 34 is also connected to an LCD 52 which corresponds to the display shown in Figure 1A. The MPU 34 is arranged to display operational menus and test results on the LCD 52. The MPU 34 is also attached to a real time clock 54 which enables accurate eventing when testing patients.
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An input/output port 56, is also connected to the MPU 34 to enable the MPU to communicate with a computer, such as a desktop PC, for enhanced testing and analysis.
Calibration of the intolerance testing device will be described Following the description of the calibration process, details of the testing process will be described.
As noted above, the electronic circuit 20 has a stimulating channel 22 which can stimulate the body with a signal having a peak-to-peak voltage between 0 and 6V. The circuit 20 also includes a sensing channel 24 which includes amplifier 40. Amplifier 40 has a variable gain which can be as high as 40dB. Control Value A (voltage of peak-to-peak stimulating signal) is initially set to a value of 3V peak-to-peak and Control Value B (gain of sensing amplifier 40) is set to a value of 20dB. These values are about midway between the extremes of operation for each amplifier.
The Calibration Control Substance is carrot. The nine characteristic signature frequencies of carrot measured by FTIR spectroscopy and applying the formulae described above are 2062961, 2170744, 2305721, 2361123, 2953418, 2765053, 1933019, 3021916 & 2634104 Hz. Calibration is performed at these specific stimulation frequencies and at the peak-to-peak voltage noted above. This is controlled by the MPU 34. Any significant body responses are recorded by the MPU 34 for analysis. The system performs the automatic calibration process as follows: A stimulation signal at each of the nine carrot signature frequencies is applied to the skin of the person under test, on the underside of the wrist for 20 milliseconds one after another, with no gap between applications. As there are nine frequencies, the application of all frequencies takes 180 milliseconds. There is then a 500 millisecond gap before the application of any further signal to electrodes 12A, 12B. This is repeated three times.
The body's response voltage is measured via the sensing electrodes 14A, 14B.
The body's response voltage is measured from the time the stimulation signal is turned off, for a period of 90 milliseconds. During this period of 90 milliseconds 5400 readings are taken and recorded of the voltage between electrodes 14A, 14B. The maximum and minimum readings are recorded, and the difference between the highest voltage and lowest voltage of the 5400 readings is calculated. This is then amplified by the sensing circuitry amplifier to a voltage level which is dependent on the gain. This amplified voltage signal is called the "delta factor".
If the delta factor of that person is below 0.1 7V, the Initial Control Value A is then increased by a set amount and the delta factor then measured again. If the delta factor of that person remains below 0.1 7V, the Initial Control Value B is then increased by a set amount. Conversely, if the delta factor of that person is above 0.1 8V, the Initial Control Value A is decreased by a set amount and the delta factor then measured again. If the delta factor of that person remains above 0. 18V, the Initial Control Value B is then decreased by a set amount. This process of adjustment of on an alternating basis, Control Value A and then Control Value B is done until the delta factor of the individual falls within the range 0.17 to 0.1 8V. This is done automatically.
It has been found that a suitable range for a delta factor for testing is between 0.1 and 0.2 V and in particular is 0.1 69V -0.181 V. Suitable increments/decrements for Control Value B and Control Value B are 0.03V and 0.097dB. The aim is to find a delta factor that permits the subject to be tested for their reactivity to a wide range of substances such that the reactivity is measurable and sufficiently differentiates between those substances which the individual is reactive to and those which the individual is not. If the delta factor is too high one gets a "saturated response" whereby the individual is over-stimulated. If the delta factor is too low the individual will not exhibit a measurable reactivity across the whole range of substances.
Once the delta factor falls in this predetermined range, the first phase of calibration is over. The device has automatically detennined the appropriate RF and IP Gain Control voltage settings for testing.
Once the stimulating voltage (Control Value A) and amplification gain (Control Value B) have been set to produce an appropriate delta factor for the person using the device, an Individual Control Average (ICA) is detennined. The ICA for an individual is the average delta factor for an individual which could be applied during testing. The ICA is determined using the following sweeping method.
The range of possible testing frequencies is 1.3 MHz to 38 M}lz. The ICA is determined by applying a stimulation signal at a number of discrete frequencies across this range.
In the preferred embodiment, a sweep consists of eleven groups of nine frequencies. The individual frequencies are calculated as follows. The range 1.3 MHz to 3.8MHz is divided by 99 (1 lx9) to determine the basic increment. This is 0.0253 MHz ("x"). The first group will consist of nine frequencies which are: 1.3, 1.3+x. 1.3+2x, I.3+3x.. .. 1.3+8x. The second group will consist of nine frequencies as follows -1.3+9x, 1.3+1 Ox 1.3+1 7x and so on. The eleventh group will consist of 1.3+92x, 1.3+93x.. .1.3+98x, 3.8. Thus, the individual is subjected to a stimulation signal at 99 frequencies equally spaced between 1.3 and 3.8 MHz.
For each of the 11 group of frequencies, in ascending order, the following is done:- (i) The stimulation signal is emitted for 20 ms starting with the lowest of the nine frequencies and ending with the highest frequency in that group. After the stimulation signal has been applied at one frequency, there is 2 ms delay before applying the stimulation signal at the next frequency; and (ii) A 500 ms pause occurs after the ninth frequency during which a reading of the individual's reactivity is measured. This measures the response range i.e. the range between the lowest and highest voltage reading from the individual via the sensing electrodes 14A, 14B during this period (the delta factor).
Thus after a sweep, there are 11 readings. The sweep is then done 3 times. The average of the eleven groups in each cycle (SI, S2 and S3) are added together and themselves averaged to give the Individual Control Average. This figure is used for the purpose of analysis of the test results. The formula for the Individual Control Average is as follows: ICA =(S1+S2+S3)/3 where SI = (X1+X2+X3 X4+X5+X6+X7+X8+X9+X1O+XI 1)/il for the first cycle; Xl the delta factor measured for the first nine frequencies; and X2the delta factor measured for the second nine frequencies etc. A running Global Control Average can also be obtained by averaging all historical ICAs. A measure of the individual's level of reactivity to the global reactivity can be obtained by M=ICA/GCA Once calibration is finished, testing can begin. This is done in the same way as the first stage of calibration.
Thus, the device runs a selected test, each test consisting of a number of selected substances. As noted above, each substance has typically nine characteristic frequencies known as its fingerprint. The stimulation signal is applied to the skin, at these frequencies on the underside of the wrist by the stimulation electrodes I 2A, I 2B on the bottom of the wrist unit. The stimulation voltage is applied at the Control Value A and the amplifier in the sensing circuit at Control Value B as selected by the first stage of calibration as described above.
The stimulation signal is applied at each frequency and for 20 milliseconds one after another, with no gap between applications. As there are typically nine frequencies, each substance takes 180 milliseconds to be tested. There is then a 500 millisecond gap before the next substance is tested, and so on until the selected test is finished. This is repeated three times for each substance.
The body's response voltage is then measured via the sensing electrodes 14A, 14B for the first 90 milliseconds of the 500 millisecond gap. A large number of readings are taken, typically over 5000 readings, of the minimum and maximum voltage reading. The difference between the highest and lowest of all these readings is the delta factor and is an indication of the reactivity of that individual to the substance being tested.
Typically, three sweeps will be done. Thus, typically, each substance is tested three times in any one test. The average reading of these three is called the Personal Substance Reactivity (PSR). The PSR gives a raw indication of the reactivity of that individual to the tested substance.
It will be appreciated that the raw results for each substance can then be processed in a number of meaningful ways. For instance, it may be that a particular substance tested tends to provoke a large reactivity in all individuals tested i.e. the human body is essentially intolerant of a particular substance.
Although this information can be of use (for instance, there are plainly substances which the population at large is generally reactive to and should be avoided except in small does), it will often be of more use to measure the relative reactivity of the tested individual to the general reactivity of the population for that substance. Jn this regard, one could use a Global Substance Average which represents the mean (or median) average reactivity of all persons tested to date for a particular substance. One would then compare the subject's reactivity for that substance to the Global Substance Average.
Furthermore, each individual has a particular level of reactivity to electrodermal stimulation. It will usually be necessary to normalise the results of each individual so as to screen out this factor. This can be done by dividing the Individual Control Average by the Global Control Average (as discussed above).
This gives a factor (M) which reflects the individual's general level of reactivity to electrodermal stimulation as compared to the average human's level of reactivity.
One particularly useful algorithm for processing data for a particular substance is as follows: (i) PNSR (Personal Normalised Substance Reactivity)= PSRxM The PSR is nonnalised as against the person's relative reactivity to the population at large to give the Personal Nonnalised Substance Reactivity (ii) GNSA (Global Nornialised Substance Average)-mean average of all PNSR The GNSA represents the mean average reactivity of all persons who have been tested for the particular substance once test results have been normalised to1 take account of the individual's particular level of reactivity (iii) A=PNSR-GNSAJstdevGNSA.
A gives the individual's relative reactivity to the substance tested as against the community of people tested having taken into account the standard deviation of the GNSA. This figure will thus be a negative or positive figure depending on whether the individual is more or less reactive than the population at large to that substance.
In certain cases, despite normalisation, one may find that an individual's results for all substances are, across the board, higher or lower than the population at large. This can be adjusted itself using the following formula: B A-X/stdevX where X is the average value of A for all substances tested for that individual.
If this formula is applied to individuals whose responses are generally, for all substances, in line with the average across the board, B will hardly differ from A. However, if there is a marked difference, the application of such a formula will cause the results to be shifted to the norm. Thus, it is a useful formula to use for all results.
Each test is automatically numbered, named and dated, the results from each test are displayed, saved or printed.
Advice can then given to the individual to eliminate temporarily or permanently the foodstuff from his or her diet or to take other appropriate remedial steps such as rotation of the substance or foodstuff with another foodstuff of which the individual is more tolerant.
The results data can be displayed via appropriate audiovisual equipment (e.g. display 15) on the device itself or on a remote unit. In a preferred embodiment, the device is arranged to interface to communication unit such as a personal computer having an Internet connection. Information gathered by the unit can be analysed by the user and/or additional testing signature frequencies can be downloaded from a remote database. The personal computer may embody a proprietary software package for providing more detailed results than can be displayed on the device itself. The Internet connection allows exchange of data with a specially built database at a remote server. Individuals may then store results from their device in their own confidential health-check files to allow them to monitor not only the test results, but also, for instance, other remedial steps and associated data. In particular, information on the substance which the individual has been identified as having an intolerance may be maintained. It is envisaged that users would pay a periodic fee for such services.
The frequencies which represent absorbance peaks of substances can be determined using Fourier Transform Infrared Spectroscopy (FTIR). FTIR spectrometers are based on the Michelson Interferometer. They work on the basis that an infra red beam passes through a beamsplitter that allows 50% of the beam to be transmitted to a moving mirror and the other 5O% to be reflected to a fixed mirror. On reflection from these mirrors, the beamsplitter recombines the light which is then guided towards the sample. The amount of radiation absorbed by the sample is then guided to the detector.
The interference of light reflecting back from the fixed mirror and the moving mirror results in a constructive interference pattern. An interferogram is recorded at each displacement of the moving mirrors and all frequencies from the source are measured simultaneously. Due to the complexity of the interferogram it is converted to a spectrum through a Fast Fourier Transform calculation. This generates an absorbance spectrum that reveals the intensity of absorbance at each wavenumber that can then be converted into a frequency as set out above.
Typical frequencies are of the order of magnitude 1013 Hz. However, a frequency of iOU Hz cannot be directly applied to the human body as such as it is far too energetic and would end up harming or killing the person under test.
Accordingly, it is necessary, to convert, or scale, such high frequencies into a frequency which is acceptable to the human body ard which is sufficient to provoke a response which is neither a saturated response nor a minimal response, thereby allowing differentiation of the electrodermal reactivity of the person to different foodstuffs, or other products. Furthermore, this frequency must cause the body to perceive the frequency as characteristic of the substance. It has been determined that an acceptable and workable range is 1 to 4MHz.
By experimentation, it has been found that if one considers the original frequency as a harmonic, one can find a fundamental frequency in a range which provokes an acceptable and measurable electrodennal response. The body will perceive this frequency as characteristic (in part) of that substance. In particular, it has been found that if one equates the original absorption frequency as the 315 harmonic of a fundamental frequency, then the fundamental frequency (the signature frequency) gives, upon application to a user a workable electrodermal response range that provides consistent results. Thus using an example of 1745 cm', which converts to a frequency of 5.235 i0' Hz, the signature frequency 5.235 x iO' HzJ 315 = 3647453 Hz (3.65MHz)
S
This is a useable frequency as it falls within the range I to 4 MHz.
Other values for a signature frequency can be used. If, instead of equating the original frequency as the 31 5harmOnic of the fundamental frequency, one could equate the original frequency as the 7X lix 3X 7X etc harmonic of the signature frequency (or prime numbers above this) where x equals a whole number such that, for example, 5.235 xlO'3 /7X gives a frequency falling between 1 to 4 MHz.
Such harmonics have been found to provide a good consistent set of results.
For any given substance, a sufficient number of wavenumbers corresponding to the most intensely absorbed frequencies is measured to ensure that the "fingerprint" is unique to a particular substance. It has been found that taking the nine most intense absorbance peaks in the region 500 to 2000 cm' is an optimum number of frequencies to be used for testing. A peak is defined as a particular wavenumber where adjacent absorbance values are less than its absorbance value. These wavenumbers which represent the "fingerprint" are then converted to a corrected and useable electrodermal signature frequency in accordance with the above equations. Where a substance (e.g. lemon) does not have nine peaks in this fingerprint region, then the maximum number of peaks is taken.
One then has a characteristic "fingerprint" which represents a basket or set of signature frequencies which are unique to a particular substance and, in particular, foodstuffs. This basket of signature frequencies can then be used in the device explained above which emits an electrical signal at a particular voltage and at various frequencies corresponding to the fingerprint of a particular foodstuff. This signal is applied to a person and the body response voltage signal of the body is measured. This is used to determine whether there is an adverse reaction to a particular substance or foodstuff FTJR data can be obtained on any FFIR spectrophotometer, for example one including a Nicolet Continuum microscope coupled to a NEXUS FTIR spectrophotometer, with a 50pin MCT (Mercury Cadmium Telluride) detector cooled with liquid nitrogen. Equipped with a Globar infrared source, one can S record the characteristic frequencies of a particular substance by taking the average of 128 scans, at 4 cm' resolution with a 25pm2 spot size, over a measuring range of 700-4000 cm'. The substance is prepared by a dry casting' method. This method involves grinding a small amount of the sample with a mortar and pestle until a homogenous slurry is produced. For dry samples such as grains, pulses, tea leaves etc., a drop of water was added to hydrate the sample. A very thin film of the slurry is then smeared onto a gold reflective microscope slide and air-dried. A minimum of three different areas of the slurry sample are scanned and displayed as absorbance spectra using Nicolet Omnic Software.
The nine most absorbent wavenuinbers in the range 600-1800 cm are then determined by the software or human examination of the results. Each wavenumber is then converted into a frequency and adjusted to give a frequency which provides an appropriate and useful electrodermal response, as discussed above.
Figure 3 shows an Fourier Transfer Infrared (FTIR) analysis of white flour that has a certain number of peaks in the region 500 to 2000 cm" in the fingerprint region. In certain foodstuffs, such as lemon, which are very simple foodstuffs, there will be less than 9 peaks in the fingerprint region. Lemon only has 3 peaks and one then just takes those 3 peaks.
By way of example, Figure 4a shows a typical interfcrogram obtained by FTIR analysis of a substance, and Figure 4b shows how the complexity of the interferogram has been converted by application of a Fast Fourier Transform, showing the intensity of absorbance of radiation by the substance with reference to wavenumber.
Thus for white flour, for example, the following results are achieved: 1800cm1 ___________ ___________ -Frequency Wavenumber Absorbance 1 2087137 998.9622 1.3096430 2 2098218 1004.2660 1.2669700 3 2247298 1075.6200 0.6941022 4 2396379 1146.9740 0.6061029 2848659 1363.4480 0.4855783 6 2302701 1102.1370 0.4826973 7 2941332 1407.8040 0.4691420 8 3024938 1447.8200 0.4190559 9 3419802 1636.8130 0.3872282 1798040 860. 5925 0.2996129 11 1584491 758.3820 0.2170702 12 1476710 706.7947 0.1876455 13 1461600 699.5628 0.1516798 The nine highest absorbance wavenunibers are chosen and converted into suitable frequencies via the formula discussed earlier in this description.

Claims (47)

1. An intolerance testing device for determining a person's intolerance to specific substances comprising: storage means for storing a plurality of sets of data, each set of which consists of two or more signature frequencies that are characteristic of a respective substance; a signal generator and at least one stimulation electrode, the signal generator being configured to apply to the stimulation electrode an alternating stimulation voltage signal, derived from the storage means, at each of the two or more signature frequencies of a set which is characteristic of a particular substance; and a reaction sensing arrangement including at least one sensing electrode and an amplifying and filtering circuit coupled to the sensing electrode to detect a change in a sensed body response voltage.
2. A device according to Claim 1 wherein the sensing arrangement is configured to measure a DC voltage at the sensing electrode.
3. A device according to Claims 1 or 2, wherein the signature frequencies correspond to wavenumbers lying within the range from 500 cm1 to 2000 cm
4. A device according to any of the preceding claims, wherein the signature frequencies lie between 1 to 4 MHz.
5. A device according to any preceding claim, wherein the number of signature frequencies used for each substance is 9.
6. A device according to any preceding claim, having a pair of stimulation electrodes and a pair of sensing electrodes, wherein the signal generator is coupled to one of the stimulation electrodes to generate a peak-to-peak stimulation voltage between OV and 6V, and wherein the amplifying and filtering circuit is coupled to the sensing electrodes and configured to measure a DC response voltage signal of generally less than 100 mV therebetween.
7. A device according to any preceding claim, wherein the stimulation and S sensing electrodes form part of a unitary stimulation and sensing module.
8. A device according to Claim 7 wherein the module is in the form of a bracelet in which the stimulation and sensing electrodes comprise spaced apart skin contacts.
9. A device according to Claim 8, wherein the skin contacts are arranged such that, when the bracelet is worn on the wrist, the stimulation electrode or electrodes are on the back side of the wrist and the sensing electrode or electrodes are on the front side.
10. A device according to any of Claims 7 to 9, wherein the unitary module includes the storage means, the signal generator and the amplifying and filtering circuitry.
11. A device according to any preceding claim, wherein changes in the body's response voltage signal are measured at the sensing electrode or electrodes and stored in a memory of the device in such a way as to relate them to the corresponding substance that is being tested.
12. A device according to Claim 11, further comprising a comparator, the comparator configured such that, for each substance being tested for, a change in the body's response voltage signal is compared against predetermined sensitivity criteria and an output is provided via an audio-visual display to indicate the likelihood of sensitivity of the person to the substance characterised by the associated set of signature frequencies.
13. A device according to any of Claims I to 12 configured to detennine the size of the alternating stimulation voltage by means of an automatic calibration process.
14. A device according to Claim 13, further arranged to carry ut the automatic calibration process, the process comprising the steps of: (i) stimulating the person with a signal at two or more signature frequencies characteristic of a particular control substance; (ii) measuring the body response voltage of the person; (iii) amplifing the body response voltage to obtain an amplified body response voltage; and (iv) adjusting the stimulating signal voltage and the amplification of the body response voltage incrementally until the amplified body response voltage falls within a predetermined range which is suitable for testing.
15. A device according to Claim 14 wherein the predetennined range is between 0.1V and 0.2V
16. A device according to Claim 15 wherein the predetermined range is between 0.
17 and O.18V 17. A device according to any of Claims 14 to 16 wherein the control substance is carrot.
18. An intolerance testing device for determining a person's intolerance to specific substances, comprising a stimulation circuit arranged to apply an alternating stimulation voltage to at least one or more stimulation electrodes, attached to the person, at a number of signature frequencies from 1 MHz to 4 MHz, and a response measuring circuit for measuring the change in a body response voltage developed across a pair of sensing electrodes, attached to the person, in response to application of the stimulation voltage, the response circuit being arranged to exclude signals at frequencies above 30 Hz.
19. An intolerance testing system for determining a person's intolerance to specific substances, wherein the system comprises a self-contained wearer imit which is configured to be worn by the person being tested and which includes: means for connecting to a power supply; stimulation contacts and response sensing contacts; a storage device storing a plurality of data, each set of which consists of two or more signature frequencies that are characteristic of a respective substance; S wearer operable control means for initiating a testing procedure; and a display for displaying the result of the testing procedure.
20. A system according to Claim 19 wherein the system further comprises a source of electrical signature data external to the wearer unit, and an interface which allows for the transfer of the electrical signature data from the source to the wearer unit in response to a wearer request.
21. A system according to Claim 20 wherein the interface allows for the transfer of data from the wearer unit to a remote server.
22. A system according to Claim 21, arranged to allow the user to access, on a remote server, a personalised data file which is updated by the wearer unit when it is connected to the remote server and which contains substance intolerance data relating to the user, and which data file links to associated data such as dietary and lifestyle suggestions appropriate to persons who have such substance intolerance.
23. A method of testing a person's intolerance of a specific substance comprising generating a stimulation signal as an alternating electrical voltage of at least two or more signature frequencies which are characteristic of a particular substance and applying the stimulation signal to the person's body through at least one skin contact stimulation electrode, measuring a reaction voltage developed by the person's body in response to the stimulation signal by receiving the reaction voltage using at least one skin contact electrode located at position on the person's body spaced from the or each stimulation electrode, and amplifying, filtering and analysing the reaction voltage to produce a test result indicative of an intolerance of a substance when the reaction voltage associated with the substance being tested for meets a predetermined condition.
24. A method according to Claim 23, wherein the substance tested comprises a foodstuff.
25. A method of according to Claims 23 or 24 further comprising the steps of applying the alternating stimulation voltage signal at each frequency to the stimulation electrode successively and for a fixed time period.
26. A method according to Claim 25, wherein each signature frequency of each set is applied for approximately 20 ms with substantially no gap between each application of each frequency.
27. A method according to Claims 25 or 26, wherein the body's response voltage is measured during the period following the application of the alternating stimulation voltage signal for all the signature frequencies characteristic of a substance, and in the absence of any stimulating voltage.
28. A method according to Claim 27, wherein the period is approximately 90 ms.
29. A method according to claim 28 wherein after the electrodermal response has been measured, no further application of the stimulation signal occurs for at least 410 ms.
30. A method of calibrating an intolerance testing device the device, being for determining a person's intolerance to a substance and comprising a stimulation channel for generating an alternating stimulation signal at a frequency which is characteristic of a control substance and a sensing channel for sensing and processing a detected body response voltage, the sensing channel having a first gain whereby to produce an amplified body response voltage, the method comprising the steps of varying the stimulation signal voltage and said first gain iteratively and applying the stimulation signal at each iteration to the person until the amplified body response voltage of the person falls within a predetermined range.
31. A method according to Claim 30 wherein the predetermined range is between 0.1 V and O.2V
32. A method according to Claim 31 wherein the predetermined range is between0.I7andO.18V
33. A method according to any of Claims 30 to 32, wherein the control substance is carrot.
34. A method for determining one or more signature frequencies that are characteristic of a particular substance, the method comprising the following steps of: (i) irradiating the substance with infra-red radiation; (ii) determining at least one wavenumber (v) of infra-red radiation which is most intensely absorbed by the substance using infra-red spectroscopy in a region of the electromagnetic spectrum where there is a marked degree of differentiation of absorption between different substances; (iii) converting the at least one wavenumber into at least one corresponding absorptip frequency using the formula f=cv; (iv) converting the absorption frequency into at least one corresponding signature frequency which is suitable for stimulating and provoking a measurable electrodermal response.
35. A method in according to Claim 34 wherein the wavenumber region of the electromagnetic spectrum lies between 500cm' and 2000cm'.
36. A method in accordance with Claims 34 or 35 wherein the method used for irradiation and determination of the level of absorption is Fourier Transform Infrared Spectroscopy.
37. A method according to any of Claims 34 to 36 wherein the signature frequency lies between 1 and 4 Mhz.
38. A method according to any of Claims 34 to 36 wherein the ratio of the absorption frequency to the signature frequency is x:1 where x is a prime number higher than I and y is a whole number whose value is such that the signature frequency lies between 1 to 4 Mhz.
39. A method according to Claim 38 wherein the ratio of the absorption frequency to the signature frequency is 315: 1.
40. An intolerance testing device which uses signature frequencies of a substance to stimulate a person for testing that person's sensitivity to that substance wherein the signature frequencies have been determined in accordance with the method defined in any of Claims 34 to 39.
41. A method of determining a set of signature frequencies that is characteristic of a substance, preferably a foodstuff, wherein a plurality of absorption peaks of electromagnetic radiation lying within the wavenumber range of from 500 cm' to 2000 cm' are measured.
42. A method according to claim,41, using Fourier Transform Infrared Spectroscopy to identify the absorption peaks.
43. A method according to claim 42, wherein the absorption frequencies determined by the spectroscopic analysis are scaled, preferably reduced, using an harmonic thereof, to a signature frequency that is at level suitable for safe application to a human body.
44. A method according to claim 43, wherein the ratio of the signature frequency to the absorption frequency is 1:3's.
45. A method according to any one of claims 41 to 44, wherein the characteristic set comprises nine frequencies that are representative of the substance.
46. An intolerance testing device constructed and arranged substantially as herein described and shown in the drawings.
47. An intolerance testing system constructed and arranged substantially as herein described and shown in the drawings.
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