DIAGNOSTIC SYSTEM

FIELD OF THE INVENTION

This invention relates to devices for measuring resistance on the skin of a patient, in particular for the purpose of non-invasive diagnosis of actual and potential pathological phenomena.

BACKGROUND OF THE INVENTION

It is known that there are points on the skin of the human body at which the electric resistance may be different from that of the surrounding area, for example as a result of some actual or potential pathological phenomena. It has been found that each one of these points can be related to a particular organ of the body.

The points of the body at which the electrical resistance is measured on the skin are referred to as Biologically Active Points (hereinafter BAPs, or BAP in singular). It has been found that for each organ there is one pair of BAPs (one each on corresponding point on both sides of the body) that represents it and provides an average value of electrical resistance therefor. Figs. IA and IB illustrate the locations of BAPs.

In US 6,934,581, the entire contents of which are incorporated herein by reference, the inventor of the present invention describes in detail a method for utilizing source-points, announcement points, sympathetic points and energy reference points for assessing the physiological condition of a diagnosed person.

Briefly, according to US 6,934,581, a number of BAPs are selected and the skin resistance at those points is measured twice to form two sets of results. The first set of measurement results includes the skin resistance at the BAPs without stimulating these points, whereas the second set comprises measurement results of skin resistance at the same BAPs after stimulating the body (the stimulation will be described below). Then, a normal corridor is conventionally used (sometimes referred to as a universal corridor), and if both a specific result from the first set of measurements (i.e., before applying stimulation to the BAPs) and a corresponding result from the second set of measurements (i.e., after stimulating the organism) fall outside the normal corridor, these two specific results indicate the presence of a disease in the related organ. However, if one of the results in one of the two sets of measurements falls inside the normal corridor, then if the corresponding result from the other set of measurements falls outside the universal corridor, it is considered a false disease indication and is therefore disregarded. In other words, if there is a measurement result, either from the first or from the second set of measurements, that exceeds the universal corridor (hereinafter, "a meaningful result"), which can potentially indicate an infected organ, this meaningful result might be rendered useless by a corresponding result from the other set of measurements should the latter result He within the universal corridor. A measurement result that lies within the normal corridor may be referred to as "concealed result".

According to US 6,934,581, two sets of measurements are compared, e.g., by superimposing them on one another, for example on a computer monitor, and diagnostic conclusions are reached based on the comparison. However, in some cases, one or more of the measured values, which can belong to the first, second or both sets of measurements, become concealed after being superimposed on one another, because the concealed measurement resides entirely within the

universal corridor. In such cases, no decisive medical decision can be made with respect to the organ whose BAP measurement value is concealed.

The stimulations may be the type referred to as "electropunctural stimulation" or "under-load probing", or transcutaneous electrical nerve stimulation (hereinafter "TENS"). It is known the stimulation is particularly effective when applied to BAPs E36 on the legs and GI4 on the hands, as their stimulation makes all systems in the body more active simultaneously, and are thus referred to as "general influence points". E36 is located on the hands at the middle point of the metacarpalis II bone, on the prominence of the 1 ^st m. inter ossei dorsalis, slightly towards the side of the index, and GI4 is located on the legs fingers-widths below the kneecap, and one finger-width lateral to the crista tibiae anterior. The locations of these points are illustrated in Fig. 1C.

Electrical stimulation is generally applied by increasing a current applied to the skin, usually from 0 through a maximum of about 25 mA, until a sensation of tingling is felt by the user. At this level of stimulation, a stimulation countdown timer is initiated.

The purpose of the stimulation is to make some the patient's system of homeostasis more active. Homeostasis is the system which regulates the production and the action (influence) on the target organs of hormones, enzymes, amines. It regulates the blood circulation, the immune system's functioning, nerve-muscle connections, and metabolic processes. The doctrine of homeostasis is at the basis of conventional ideas about man's normal and pathological physiology; it constitutes its main section. In other words, homeostasis is the state of all the processes of the organism being balanced. When homeostasis is disturbed, it is an indication that a disease has set in.

The system of homeostasis reacts to a certain extent to all the external and internal influences, like changes in the weather, acclimatizing, physical or psychological stress, alcohol consumption, food consumption, intake of

medicine, physiotherapy, any organ's pathology, etc. Under the influence of electropunctural stimulation, defensive response reactions of the homeostasis system become active.

In WO 2005/117522, the entire contents of which are incorporated herein by reference, the inventor of the present invention discloses a method of modifying the corridor such as to make concealed measurements available to a therapist, to allow him to consider every measurement and, thus, to obtain more accurate conclusions regarding problematic organs of the monitored person.

SUMMARY OF THE INVENTION According to one aspect of the present invention, there is provided a device for measuring electrical resistance on a patient's skin by applying an electrical signal thereto at least one first BAP before and after electrical stimulation, which may be transcutaneous electrical nerve stimulation (hereinafter "TENS"), of at least one second BAP, the device comprising: (a) at least one active electrode adapted to contact said first BAP and to apply thereto the electrical signal;

(b) at least one dual-purpose electrode, adapted to operate in a grounding mode of operation when said electrical signal is applied by the active electrode to the first BAP, and a stimulating mode for performing said stimulation to the second BAP; and

(c) a controller adapted to control the dual-purpose electrode to switch between the grounding and stimulating modes of operation.

The device may further comprise a signal generator for providing the stimulation and a connection to electrical ground; the controller is adapted to selectively electrically connect the dual-purpose electrode to one of the signal generator and the connection to electrical ground to switch between the grounding and stimulating modes of operation. The controller thus selectively

connects one or more of the dual-purpose electrodes to electrical ground in the grounding mode of operation, and to a stimulation-generator of the machine in the stimulating mode of operation.

Each of the dual-purpose electrodes may be in the form of a pad detachably attachable to the patient's skin and connected to the controller via an electric cable. The pad is adapted, in its stimulating mode, to apply the stimulation. The stimulation may be between 0 and 25 _x mA, and may be in the form of a pulsed current of a frequency substantially in the range of 75 to

125 Hz, for example substantially 100 Hz. The pulses may be rectangular pulses, and may have a voltage in the range of 3 to 5 volts.

The stimulation may be performed by all dual-purpose electrodes simultaneously, or sequentially.

The electrical signal may be between 0 and 20 microamperes. According to one embodiment, the device comprises four dual-purpose electrodes, for attachment to corresponding four second BAPs which may be E36 on the left leg, E36 on the right leg, GI4 on the left hand, and GI4 on the right hand.

The controller may be adapted to control the dual-purpose electrodes so that: (a) when an electrical signal is applied to a first BAP located on the left arm or hand of the patient, the dual-purpose electrode attached to a second BAP on the right hand (e.g., GI4) is in a grounding mode of operation;

(b) when an electrical signal is applied to a first BAP located on the right arm or hand of the patient, the dual-purpose electrode attached to a second BAP on the left hand (e.g., GI4) is in a grounding mode of operation;

(c) when an electrical signal is applied to a first BAP located on the left leg or foot of the patient, the dual-purpose electrode attached to a second BAP on the right leg (e.g., E36) is in a grounding mode of operation; and (d) when an electrical signal is applied to a first BAP located on the right leg or foot of the patient, the dual-purpose electrode attached to a second BAP on the left leg (e.g., E36) is in a grounding mode of operation.

The active electrode may be a handheld probe. Alternatively, each one may be in the form of a pad detachably attachable to the patient's skin. The device may comprise a number of these pads, and each pad may comprise an indicium indicating a corresponding first BAP.

The device may further comprise a speaker. It may provide an audible indication, via the speaker, of an expected BAP (i.e., announcing to the user the point on the patient's skin to which an electrical signal should next be applied).

The device may be adapted to draw a diagnostic conclusion from the calculated resistances. The diagnostic conclusion may be selected from the group comprising:

(a) whether one or more organs is undergoing an acute process; (b) whether one or more organs is undergoing a chronic process; and

(c) the state of a physiological system.

The device may further be adapted to be connected to an external processing unit. It may be adapted to receive commands and/or transfer data to the external processing unit. The external processing unit comprises a printer, the device being adapted to issue print commands.

According to another aspect of the present invention, there is provided a method for measuring electrical resistance on a patient's skin by applying an

electrical signal thereto at a set of first BAPs before and after electrical stimulation of at least one second BAP, the method comprising the steps of:

(a) providing a device as described above;

(b) attaching each dual-purpose electrode to a second BAP on the patient's skin;

(c) taking a set of first measurements at each of the BAPs of the set of first BAPs, the measurement at each BAP being taken as follows: i) contacting the BAP with the active electrode; ii) the active electrode producing said electrical signal; and iii) the device calculating the electrical resistance between the active electrode and at least one of the dual-purpose electrodes in a grounding mode of operation;

(d) perfoπning electrical stimulation by the dual-purpose electrodes;

(e) taking a set of second measurements at each of the BAPs of the set of first BAPs ₅ the measurement at each first BAP being taken as follows: i) contacting the BAP with the active electrode; ii) the active electrode producing said electrical signal; and iii) the device calculating the electrical resistance between the active electrode and at least one of the dual-purpose electrodes in a grounding mode of operation;

The stimulation, which may be TENS stimulation, may be between 0 and 25 mA, and may be in the form of a pulsed current of a frequency substantially in the range of 75 to 125 Hz, for example substantially 100 Hz. The pulses may be rectangular pulses, and may have a voltage in the range of 3 to 5 volts.

The second BAPs may be E36 on the left leg, E36 on the right leg, GI4 on the left hand, and GI4 on the right hand.

The stimulation may be performed by all dual-purpose electrodes simultaneously, or sequentially.

The electrical signal may be between 0 and 20 microamperes. The controller may connect the dual-purpose electrodes to electrical ground in the grounding mode of operation as follows:

(a) when an electrical signal is applied to a first BAP located on the left arm or hand of the patient, the dual-purpose electrode attached to a second BAP on the right hand (e.g., GI4) is in a grounding mode of operation; (b) when an electrical signal is applied to a first BAP located on the right arm or hand of the patient, the dual-purpose electrode attached to a second BAP on the left hand (e.g., GI4) is in a grounding mode of operation;

(c) when an electrical signal is applied to a first BAP located on the left leg or foot of the patient, the dual-purpose electrode attached to a second BAP on the right leg (e.g., E36) is in a grounding mode of operation; and

(d) when an electrical signal is applied to a first BAP located on the right leg or foot of the patient, the dual-purpose electrode attached to a second BAP on the left leg (e.g., E36) is in a grounding mode of operation.

The set of first BAPs may comprise BAPs selected from the group comprising P9 left, P9 right, MC7 left, MC7 right, C7 left, C7 right, IG4 left, IG4 right, TR4 left, TR4 right, GI5 left, GI5 right, RP3 left, RP3 right, F3 left, F3 right, R3 left, R3 right, V65 left, V65 right, VB40 left, VB40 right, E42 left, and

E42 right, and it may comprise all 24.

The device may further draw a diagnostic conclusion from the calculated electrical resistances. The diagnostic conclusion may be selected from the group comprising:

(a) whether one or more organs is undergoing an acute process; (b) whether one or more organs is undergoing a chronic process; and

(c) the state of a physiological system.

The electrical signals may each be between 0 and 20 microampere.

The device may comprise a number of active electrodes, each active electrode being in the form of a pad detachably attachable to the patient's skin, the number of active electrodes being equal to the number of first BAPs. Each active electrode may comprise an indicium indicating a corresponding first BAP.

The device may be connected to an external processing unit. The external processing unit may issue commands to the device, and/or the device may transfer data to the external processing unit. For example, the external processing unit may be a computer, and it may store the patient's information, or transfer it to an external database for storage. In addition, the external processing unit may comprise a printer, the device issuing print commands.

It will be understood that while the term user typically refers to the person administering the diagnostic procedure, and the term patient typically refers to the person to whom the diagnostic procedure is being administered, it is within the scope of the present invention that the patient administers the procedure to himself, i.e., he assumes the roles of both the user and the patient, for example, if a doctor wishes to perform a diagnosis on himself using the device according to the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carried out in practice, an embodiment will now be described, by way of a non-limiting example only, with reference to the accompanying drawings, in which: Fig. IA lists the measuring BAPs;

Fig. IB illustrates the locations of the BAPs listed in Fig. IA;

Fig. 1C illustrates the locations of the BAPs which are general influence points on a human;

Fig. 2A is schematic view of an example of the device for drawing diagnostic conclusions according to the present invention;

Fig. 2B is a schematic view of another example of the device for drawing diagnostic conclusions according to the present invention;

Fig. 2C is a block diagram of the device illustrated in Fig. 2A, showing interconnections among its elements; Fig. 3 is a closeup schematic view of an active electrode of the device illustrated in Fig. 2A; and

Fig. 4 is a flowchart illustrating a typical use of the device to reach a diagnostic conclusion.

DETAILED DESCRIPTION OF EMBODIMENTS Figs. 2A through 2C illustrate a device, generally indicated at 10, according to the present invention, for drawing a diagnostic conclusion for a patient. The device comprises a main housing 12, a signal system 13 adapted to deliver an electrical signal, a stimulation system 7 adapted for selectively delivering a stimulation to the patient or constituting an electrical ground, and a user interface 18. A processing unit 15, in communication with each of the above, is provided within the housing. The signal system 13 comprises at least one active electrode 14 connected to an electrical signal generator 11. The active

electrode 14 may be in the form of an electrode probe, as illustrated in Fig. 2A, or in the form of a plurality of pads detachably attachable to the patient's skin, as illustrated in Fig. 2B. The stimulation system 7 comprises a stimulation generator 8, a controller 9, and four dual-purpose electrodes 16. As seen in Fig. 2C ₅ the controller 9 is electrically connected both the stimulation generator 8 and to electrical ground. In addition, the device 12 may comprise a removable media reader/writer 17, such as a disk drive, and an external data interface 19, such as a data port.

The device 10 is adapted to operate in one of two operative states. In the first operative state, the device allows a user to measure the electrical resistance on a point or points of a patient's skin. In this state, the dual-purpose electrodes 16 are in their grounding mode of operation, wherein the controller 9 selectively connects one of the dual-purpose electrodes 16 to electrical ground. In this way, when the active electrode 14 contacts a BAP on the patient's skin, the resistance across the body may be accurately measured. In the second operative state of the device 10, the device provides a TENS stimulation to the patient via the dual- purpose electrodes. In this state, the dual-purpose electrodes are in their stimulating state of operation, wherein the controller connects the dual-purpose electrodes to the stimulation generator 8, either simultaneously or sequentially. As seen in Fig. 3, the active electrode 14, according to the embodiment illustrated in Fig. 2A, comprises a wand 20, adapted to be held by the user. The wand is connected to the housing via a cable 22 attached at a distal end thereof, and comprises a metallic tip 24, electrically connected with the cable 22, at a proximal end thereof. A retractable tip cover 26 (shown in a partially retracted position) is provided, so that the tip 24 may be protected when the device 10 is not in use. A slide 28 is provided to control the tip cover 26. The slide 28 may be spring-loaded, in order to ensure that the tip cover 26 remains closed when the device 10 is not in use. In addition, indicator lights 30 are provided, for example

to indicate power or operative state of the device, whether the active electrode 14 is ready, to indicate an error, etc.

The active electrodes 14, according to the embodiment illustrated in Fig. 2B, may in the form of any known type of electrode pads, such as those which are detachably attachable to a patient's skin. They may each be attached to the housing 12 via an individual cable, as shown, or several cables may be attached to the housing (for example, one associated with each limb), with individual active electrodes branching out therefrom. In addition, as seen in Fig. 2B, each pad may comprise an indicium 5 indicating the BAP o which it corresponds. The indicium may be, for example, the name of the BAP. An illustration of where it is on the body, or a reference numeral, in which case a reference table (not shown) may also be provided. It will be noted that while eight active electrodes 14 are illustrated in Fig. 2B, this is a non-limiting example only, and any appropriate number of active electrodes may be provided according to this embodiment. For example, if the electrical signal is to be delivered to 24 BAPs, then 24 active electrodes 14 may be provided.

The dual-purpose electrodes 16 may be any known type of electrode, such as a pad detachably attachable to a patient's skin. They may each be attached to the housing 12 via an individual cable, as shown, or two cables attached to the housing may branch into four cable ends, to each of which a dual-purpose electrode is connected. The dual-purpose electrodes are adapted, during the first operative state of the device 10, to be passive, i.e., to be electrically grounded, and during the second operative state of the device to be active, i.e., to provide the stimulation, as described above. The user interface 18 comprises buttons 32, indicator lights 34, and a speaker 36. The buttons 32 may be used, for example, to turn the device 10 on and off, to reset the device, such as in the event of an error, and/or to start a new diagnostic test. The indicator lights 34 may indicate the operative state or general

state (i.e., warming up, resetting, etc.) of the device 10, whether or not it is on, or if an error has occurred. The speaker 36 is adapted to provide audible instructions to the user, such as to announce the next BAP to which an electrical signal should be applied (this will become clear below in the discussion of the use of the device), if and what type of error has occurred, etc.

The processing unit 15 is adapted to control the overall functionality of the device 10, such as controlling the timing and strength of electrical signals via the electrical signal generator 11, determining the operative state of the device via the controller 9, regulating the strength of the TENS stimulation, controlling announcements via the speaker 36, etc. In addition, it draws diagnostic conclusions from the measurements taken using the dual-purpose electrodes.

This may be accomplished using the device of the present invention and employing the methods described in US 6,934,581 and/or in WO 2005/117522.

In operation, as illustrated in Fig. 4, the dual-purpose electrodes are attached to 4 points on the patient's body, E36 on the right and left legs, and GI4 on the right and left hands. These points are known in the art as being BAPs at which electrical stimulation may be applied. At this stage, the device 10 is in its fist operative state, i.e., the dual-purpose electrodes 16 are electrically grounded.

A set of first BAPs is selected, and the skin resistance at each first BAP is measured. These BAPs would usually be six left hand zones Hl through H6, six right hand zones Hl through H6, six left leg zones Fl through F6, and six right leg zones Fl through F6 (these zones are described and illustrated in Figs. A! and IB).

According to the embodiment illustrated in Fig. 2A, this is done by contacting the tip 24 of the active electrode 14 to each of the BAPs, at which point the processing unit 15 directs the signal system 13 to generate a non- harmful but measurable electrical signal or pulse. The device 10 may instruct the

user as to when each BAP is to be contacted. The processing unit 15 determines and stores the resistance at each BAP as described above.

According to the embodiment illustrated in Fig. 2B, the active electrodes 14 are attached to several or all of the BAPs, after which the processing unit 15 directs the signal system 13 to generate a non-harmful but measurable electrical signal or pulse in each of the active electrodes 14, either simultaneously on each of six limb zones (i.e., six left hand zones Hl through H6, then six right hand zones Hl through H6, then six left leg zones Fl through F6, then six right leg zones Fl through F6) or sequentially. According to either embodiment, at the same time, the processing unit 15 directs the stimulation system 7, via the controller 9, to connect one of the dual-purpose electrodes 16 to electrical ground. The dual-purpose electrode 16 which is to be connected to ground is selected based on the BAP at which the active electrode is generating the electrical signal 14: if the BAP is on the left hand, then GI4 on the right hand is connected to electrical ground, and vice-versa, and if the BAP is on the left leg, then E36 on the right leg is connected to electrical ground, and vice-versa. The current measured at the dual-purpose electrodes 16 thus indicates the resistance of the organ represented by the BAP being contacted.

The above measurement is carried out at all the BAPs of the set, whereby a first set of measurement results is obtained. Subsequently, the device 10 enters its second operative state, wherein stimulation is applied to the patient. In the second operative state of the device, the controller 9 connects the dual-purpose electrodes 16 to the stimulation generator as described above, thus stimulating the patient. The controller 9 may connect all of the dual-purpose electrodes 16 to the stimulation generator 8 concurrently, or it may do so sequentially. During this state, the active electrode or electrodes 14 need not supply any electrical signal.

After the stimulations, the device 10 enters its first operative state again, and the measurements are carried out again in the same manner as described

above, whereby a second set of measurement results is obtained. The processing unit 15 draws diagnostic conclusions about the patient from the two sets of measurement results. For example, for each set of measurements, the average resistance is calculated. A normal corridor for each average resistance is defined according to any known method. If the device 10 is connected to an external processing unit such as a computer, this may be graphically shown. For each measurement of the first set, the processing unit 15 determines whether or not it falls within the normal corridor of the first set. If it falls outside the normal corridor, the processing unit 15 checks the corresponding measurement of the second set (i.e., the measurement of the resistance taken after stimulation at the same BAP), to determine if it falls within the normal corridor of the second set. If it does, then the processing unit 15 disregards the first measurement. If it does not, then the processing unit 15 draws a diagnostic conclusion about the organ corresponding to the BAP. If it the measurement falls above the normal corridor, the processing unit 15 determines that the corresponding organ is undergoing an acute process; if it falls below the normal corridor, the processing unit 15 determines that the corresponding organ is undergoing a chronic process.

The removable media reader/writer 17 may be any appropriate device known in the art, such as a floppy disk drive, a CD or DVD reader/writer, memory card reader/writer, or a port to receive an external storage device, such as a removable USB drive. The device may transfer the diagnostic conclusions on such a removable media for storage. In addition, the device 10 may be adapted to receive upgrades thereby stored on removable media.

The external data interface 19 may be one or more ports adapted to receive therein cables for connecting the device 10 to an external processing unit, such as a computer on which diagnostic software has been loaded. The external data interface 19 may supplement or replace the removable media reader/writer 17, i.e., all data transfers can be done to/from an external processing unit, and

storage can be accomplished via its removable media reader/writer. In addition, software loaded on the external processing unit may take over some of the functions of the processing unit 15, i.e., determining which BAP is to be measured next, drawing the diagnostic conclusions, etc. All communication with the external processing unit is coordinated by the processing unit 15.

In addition, the external processing unit may be a printer. The device would therefore be adapted to issue commands to print the results.

Those skilled in the art to which this invention pertains will readily appreciate that numerous changes, variations and modifications can be made without departing from the scope of the invention mutatis mutandis.