CA1315345C - Method and apparatus for delivering a prescriptive electrical signal - Google Patents
Method and apparatus for delivering a prescriptive electrical signalInfo
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- CA1315345C CA1315345C CA000514834A CA514834A CA1315345C CA 1315345 C CA1315345 C CA 1315345C CA 000514834 A CA000514834 A CA 000514834A CA 514834 A CA514834 A CA 514834A CA 1315345 C CA1315345 C CA 1315345C
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- prescriptive
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Abstract
ABSTRACT OF THE DISCLOSURE
An electrical nerve stimulator features a personal delivery unit including a computerized delivery control unit controlling a pulse voltage source to apply a signal to the patient's head either directly by wire leads or indirectly by RF telemetry and controlled by a monitoring means sensing the applied signals; a control unit for transmitting the prescribed signal data to the delivery control unit and a development station for programming control unit.
An electrical nerve stimulator features a personal delivery unit including a computerized delivery control unit controlling a pulse voltage source to apply a signal to the patient's head either directly by wire leads or indirectly by RF telemetry and controlled by a monitoring means sensing the applied signals; a control unit for transmitting the prescribed signal data to the delivery control unit and a development station for programming control unit.
Description
3 ~ ~
METHOD AND APPARATUS FOR DELIVERING
A PRESCRIPTIVE ELEC'rRICAL SIGNAL
Background of the Invention This invention relates generally to a device for providing an electrical signal to a patient. More particularly, this invention relates to a device for producing accuxate, reproducible, program-controlled voltage waveforms, particularly complex intermittent waveforms. Still more particularly, this invention relates to an apparatus of the type which comprises means for delivering a programmed prescriptive electrical sig-nal to a patient by direct application of the prescribed signal via electrodes placed on selected elements of the ear or the mastoid process or, in the alternative, by radio transmission of a controlling signal to enable a radio receiver located at the point of application to receive the prescribed signal.
Means are provided for monitorlng the signal applied to the patient and comparing it with the pre-scribed characteristics for noting discrepancies andcorrecting the applied signal. The differences noted are used to correct the original output of the delivery device. Stoxed data representative of the application of a signal to the patient are analyzed and used to improve subsequent programs for application to that patient.
Preferably, the signals are applied to the Shen Men or similar low impedance acupoint to optimize the impedance match between the system output and the patient as a conductive medium. The waveform is analyzed with respect ~5~
to frequencies, positive and negative voltage ampli-tudes, ~ero net charge, the duration of each particular pulse, the number of pulses in each packet/ the time between adjacent packets oE pulses, the number of packets in each train, the time between adjacent packets of pulses, the time between trains of packets of pulses, and the number of trains of pulses in a prescription. Such synthesized pulse trains eliminate, to the extent pos-sible, depolarization or hyperpolarization and demyeli-nation of the nerve sheath, conditioning the patient, andprovide the maximum opportunity for accurate simulation of the communication protocols of the brain.
In the prior art, processes and devices are known for the application of electrical signals to humans for various purposes. Among these processes, transcutaneous electrical nerve stimulation (TENS) has been used for applying a signal voltage to a patient by electrodes placed at the site of local pain. In the "gate" theory of Wall and Melzack, the resulting afferent sensory ~o signals compete with the pain signals produced by the human, resulting in analgesia.
Another type of electrical stimulation technique known to the art, referred to as percutaneous induced neurostimulation (PINS), has been used to treat intrac table pain following major surgery such as spinal sur-gery, by the application of electrodes implanted beneath the skin and excited by an external power source.
Still another analgesic technique involves the use of implanted deep brain probes (DBP) wherein elec-trodes are inserted directly into the hrain so that whenvoltage is applied, analgesia results~
In general, the TENS and PINS processes induce es-sentially the same mechanism within the human organism.
It is known that pain induces electrical signals which are transmitted to the brain through the spinal cord by a combination of electrical conduction and chemical 11 3~3~
diffusion where the pain signals are interpreted at the brain because oE the activities they induce in certain cells~ In the TENS and PINS applications, the pain signals are effectively diluted because of the compe-tition induced with the afferent sensor signals producedby the TENS and PINS processes~ The dilution of the pain signals effectively relieves the extremity of the pain interpreted by the brain.
On the other hand, the DBP process is completely different. The electrical signals applied directly to the peri-aqueductal grey space within the brain induce additional secretion of beta-endorphins which act to inhibit the reception of the pain signal at the inter-pretive end (the Raphe nuclear cells). In effect, the pain signal is blocked from reaching a destination within the brain where it is normally interpreted and analgesia results.
Cuite clearly, the DBP processes are unsatisfac-tory because they require invasive techniques and are ~0 generally limited to terminal patients with extraordi-nary intractable pain. It is desirable to utilize the pain relieving mechanism of the DBP process without the disadvantages of its invasive appli~ation.
Accordingly, it is a general object of this in-vention as described in the specification to provide adevice for applying a prescription of electrical signals to a patient which stimulate the secretion of beta-endorphins in a manner similar to the DBP process. While the TENS and PINS processes are advantageous in that they are non-invasive, such processes have limited appli-cability because of their limited efficacy. Those pro~
cesses are limited in the degree of analgesia produced, the quality of relief obtained, and the range of appli-cability of the processes to the broad spectrum of varieties of pain. Thus, it is another general object of this invention to provide a device for the application of ~3~3~
such electrical signals which are effeGtive for reliev.ing pain for a wider range of maladies, conditions, and syndromes to a degree not heretofore known in the art.
There have also been attempts to treat stress, obesity, insomnia, and related disorders as well as to treat pain associate~ with withdrawal from the effects of nicotine or other addictive drugs by the use of electrical stimulation.
In this regard, signi~icant research has been conducted by Dr. I~or D. Capel which shows generally that for a set of unique frequenries, the transcranial voltage induces the secrstion of beta-endorphins in the brain and leads to the same kind of analgesia as DBP processes.
Dr. Capel has also shown that a different set of frequencies is e~fective for treating the pain associated with withdrawal, as well a~ treating the physiological symptoms associated with withdrawal. Such effects are the subject of United State~ Patent No~ 4,646,744, which issued on March 3, 1987~
In general, Dr. Cape:L has ~xplored the effect of electrical signals on the mechanisms for neuro-transmission within the brain. The effect of habituating drugs on brain chemistry and cellular activity is such that both stimulants and depressants cause debilitating ef~ects on such neuro activity which lead to long-lasting physical change and ultimately ~o deterioration of the cell affected. By utilizing particularly discovered frequencies related to particular drugs, the debilitating effect can be reversed to counteract the effect of drugs at the cellular level. Thus, the application of the teachings of Dr. Capel are both beneficial and therapeutic as an aid to recovery from addiction, from the standpoint of both relief of pain and attention to the physiological changes associated with withdrawal from the use o~ addictive drugs.
~3~ ~3~
Thus, it i5 another general object of this inven-tion to provide a device with the capability of providing prescriptive therapeutic voltage signals of duxation, amplitude, frequency, modulation, and intermittency ac-cording to the teachings of Dr. Capel.
A number of analogue devices for producing wave-forms suitable for the application of the TENS and PINS
processes are known. In general, these devices rely mainly on the use of resonant tank analogue circuitry.
However, such devices do not produce signals which are sufficiently reproducible, controlled, and accurate to merchandize as a reliable medical device.
Accordingly, it is another general objective of the invention described hereinafter to provide such an instrument which uses a significantly different techno-logy to achieve optimality in the parameters noted above, and as more fully described in the specification.
Still further, it is another general objective of this invention to utilize effectively, to produce an in-strument of the type described, the state of the art indigital circuitry, programming techniques, and micropro-cessing design for use by an investigator and for appli-cation of such signals to a patient.
These and other objectives of the invention will be apparent from a review of the detailed description of the invention which follows.
Brief Summary of_the Invention Directed to achieving the above-mentioned objec-tives and achieving the aims of the invention, a method and apparatus according to the invention comprises means for developing and generating a reliable, reproducible, program-controlled, prescriptive electrical waveform, having a desired therapeutic and analgesic effect. The system according to the apparatus comprises a develop--~5 ment s~ation and a control unit for developing and storing a prescriptive waveform of the type described, ~3~3~
available for insertion into a personal delivery instru-ment (PDI).
The personal delivery instrument, according to the inv~ntion, comprises means for receiving and storing the developed prescriptive waveform from the control unit for delivery of an accurately-controlled waveform to the patient. The PDI includes a central processing unit, having a ROM and a RAM for programming a voltage source powered by a battery, to provide the desired waveform transcranially to the head of a patient. Means are provided for monitoring the signal applied to the patient and comparing it with the prescribed siynal characteristics stored according to the prescription from the control unit and by noting discrepancies, cor-recting the applied signals. The signal actually appliedto the patient and any differences from the prescription are thus xecorded for transmission to the control unit for storing data actually representative of the appli-cation of a prescriptive signal to the patient for subsequent use in analyzing and improving subsequent prescriptive programs for application to that patient or others.
The PDI includes components for accurately con-trolling each of the parameters of a train of pulses and for adjusting the signals so that the net voltage charge applied to the patient is zero. For purposes of this description, a set of pulses is referred to as a packet and a train is a set of packets. Thus, the definition of the waveform includes:
(1) the pulse frequency or frequencies fi, since the prescription may include pulses delivered at more than one frequency, where fi is the frequency of the pulses in the ith packet;
METHOD AND APPARATUS FOR DELIVERING
A PRESCRIPTIVE ELEC'rRICAL SIGNAL
Background of the Invention This invention relates generally to a device for providing an electrical signal to a patient. More particularly, this invention relates to a device for producing accuxate, reproducible, program-controlled voltage waveforms, particularly complex intermittent waveforms. Still more particularly, this invention relates to an apparatus of the type which comprises means for delivering a programmed prescriptive electrical sig-nal to a patient by direct application of the prescribed signal via electrodes placed on selected elements of the ear or the mastoid process or, in the alternative, by radio transmission of a controlling signal to enable a radio receiver located at the point of application to receive the prescribed signal.
Means are provided for monitorlng the signal applied to the patient and comparing it with the pre-scribed characteristics for noting discrepancies andcorrecting the applied signal. The differences noted are used to correct the original output of the delivery device. Stoxed data representative of the application of a signal to the patient are analyzed and used to improve subsequent programs for application to that patient.
Preferably, the signals are applied to the Shen Men or similar low impedance acupoint to optimize the impedance match between the system output and the patient as a conductive medium. The waveform is analyzed with respect ~5~
to frequencies, positive and negative voltage ampli-tudes, ~ero net charge, the duration of each particular pulse, the number of pulses in each packet/ the time between adjacent packets oE pulses, the number of packets in each train, the time between adjacent packets of pulses, the time between trains of packets of pulses, and the number of trains of pulses in a prescription. Such synthesized pulse trains eliminate, to the extent pos-sible, depolarization or hyperpolarization and demyeli-nation of the nerve sheath, conditioning the patient, andprovide the maximum opportunity for accurate simulation of the communication protocols of the brain.
In the prior art, processes and devices are known for the application of electrical signals to humans for various purposes. Among these processes, transcutaneous electrical nerve stimulation (TENS) has been used for applying a signal voltage to a patient by electrodes placed at the site of local pain. In the "gate" theory of Wall and Melzack, the resulting afferent sensory ~o signals compete with the pain signals produced by the human, resulting in analgesia.
Another type of electrical stimulation technique known to the art, referred to as percutaneous induced neurostimulation (PINS), has been used to treat intrac table pain following major surgery such as spinal sur-gery, by the application of electrodes implanted beneath the skin and excited by an external power source.
Still another analgesic technique involves the use of implanted deep brain probes (DBP) wherein elec-trodes are inserted directly into the hrain so that whenvoltage is applied, analgesia results~
In general, the TENS and PINS processes induce es-sentially the same mechanism within the human organism.
It is known that pain induces electrical signals which are transmitted to the brain through the spinal cord by a combination of electrical conduction and chemical 11 3~3~
diffusion where the pain signals are interpreted at the brain because oE the activities they induce in certain cells~ In the TENS and PINS applications, the pain signals are effectively diluted because of the compe-tition induced with the afferent sensor signals producedby the TENS and PINS processes~ The dilution of the pain signals effectively relieves the extremity of the pain interpreted by the brain.
On the other hand, the DBP process is completely different. The electrical signals applied directly to the peri-aqueductal grey space within the brain induce additional secretion of beta-endorphins which act to inhibit the reception of the pain signal at the inter-pretive end (the Raphe nuclear cells). In effect, the pain signal is blocked from reaching a destination within the brain where it is normally interpreted and analgesia results.
Cuite clearly, the DBP processes are unsatisfac-tory because they require invasive techniques and are ~0 generally limited to terminal patients with extraordi-nary intractable pain. It is desirable to utilize the pain relieving mechanism of the DBP process without the disadvantages of its invasive appli~ation.
Accordingly, it is a general object of this in-vention as described in the specification to provide adevice for applying a prescription of electrical signals to a patient which stimulate the secretion of beta-endorphins in a manner similar to the DBP process. While the TENS and PINS processes are advantageous in that they are non-invasive, such processes have limited appli-cability because of their limited efficacy. Those pro~
cesses are limited in the degree of analgesia produced, the quality of relief obtained, and the range of appli-cability of the processes to the broad spectrum of varieties of pain. Thus, it is another general object of this invention to provide a device for the application of ~3~3~
such electrical signals which are effeGtive for reliev.ing pain for a wider range of maladies, conditions, and syndromes to a degree not heretofore known in the art.
There have also been attempts to treat stress, obesity, insomnia, and related disorders as well as to treat pain associate~ with withdrawal from the effects of nicotine or other addictive drugs by the use of electrical stimulation.
In this regard, signi~icant research has been conducted by Dr. I~or D. Capel which shows generally that for a set of unique frequenries, the transcranial voltage induces the secrstion of beta-endorphins in the brain and leads to the same kind of analgesia as DBP processes.
Dr. Capel has also shown that a different set of frequencies is e~fective for treating the pain associated with withdrawal, as well a~ treating the physiological symptoms associated with withdrawal. Such effects are the subject of United State~ Patent No~ 4,646,744, which issued on March 3, 1987~
In general, Dr. Cape:L has ~xplored the effect of electrical signals on the mechanisms for neuro-transmission within the brain. The effect of habituating drugs on brain chemistry and cellular activity is such that both stimulants and depressants cause debilitating ef~ects on such neuro activity which lead to long-lasting physical change and ultimately ~o deterioration of the cell affected. By utilizing particularly discovered frequencies related to particular drugs, the debilitating effect can be reversed to counteract the effect of drugs at the cellular level. Thus, the application of the teachings of Dr. Capel are both beneficial and therapeutic as an aid to recovery from addiction, from the standpoint of both relief of pain and attention to the physiological changes associated with withdrawal from the use o~ addictive drugs.
~3~ ~3~
Thus, it i5 another general object of this inven-tion to provide a device with the capability of providing prescriptive therapeutic voltage signals of duxation, amplitude, frequency, modulation, and intermittency ac-cording to the teachings of Dr. Capel.
A number of analogue devices for producing wave-forms suitable for the application of the TENS and PINS
processes are known. In general, these devices rely mainly on the use of resonant tank analogue circuitry.
However, such devices do not produce signals which are sufficiently reproducible, controlled, and accurate to merchandize as a reliable medical device.
Accordingly, it is another general objective of the invention described hereinafter to provide such an instrument which uses a significantly different techno-logy to achieve optimality in the parameters noted above, and as more fully described in the specification.
Still further, it is another general objective of this invention to utilize effectively, to produce an in-strument of the type described, the state of the art indigital circuitry, programming techniques, and micropro-cessing design for use by an investigator and for appli-cation of such signals to a patient.
These and other objectives of the invention will be apparent from a review of the detailed description of the invention which follows.
Brief Summary of_the Invention Directed to achieving the above-mentioned objec-tives and achieving the aims of the invention, a method and apparatus according to the invention comprises means for developing and generating a reliable, reproducible, program-controlled, prescriptive electrical waveform, having a desired therapeutic and analgesic effect. The system according to the apparatus comprises a develop--~5 ment s~ation and a control unit for developing and storing a prescriptive waveform of the type described, ~3~3~
available for insertion into a personal delivery instru-ment (PDI).
The personal delivery instrument, according to the inv~ntion, comprises means for receiving and storing the developed prescriptive waveform from the control unit for delivery of an accurately-controlled waveform to the patient. The PDI includes a central processing unit, having a ROM and a RAM for programming a voltage source powered by a battery, to provide the desired waveform transcranially to the head of a patient. Means are provided for monitoring the signal applied to the patient and comparing it with the prescribed siynal characteristics stored according to the prescription from the control unit and by noting discrepancies, cor-recting the applied signals. The signal actually appliedto the patient and any differences from the prescription are thus xecorded for transmission to the control unit for storing data actually representative of the appli-cation of a prescriptive signal to the patient for subsequent use in analyzing and improving subsequent prescriptive programs for application to that patient or others.
The PDI includes components for accurately con-trolling each of the parameters of a train of pulses and for adjusting the signals so that the net voltage charge applied to the patient is zero. For purposes of this description, a set of pulses is referred to as a packet and a train is a set of packets. Thus, the definition of the waveform includes:
(1) the pulse frequency or frequencies fi, since the prescription may include pulses delivered at more than one frequency, where fi is the frequency of the pulses in the ith packet;
(2) the positive pulse amplitude Ap for each pulse in each packet of each train forming the prescrip-tion;
~ 3~53~
~ 3~53~
(3) the positive pulse duration Spi for each pulse in each packet of each train forming the prescrip tion;
(4) the negative pulse amplitude Ani for each pulse in each packet of each train forming the prescrip-tion;
(5) the negative pulse duration Sni for each pulse in each packet of each train forming the prescrip-tion;
(6) the number ni Of pulses in packet i;
(7) the time (i-l)ti between packets in the train j;
(8) the number J of trains with i packets;
(9) the number Nj of packets in the train j; and (10) the time (j-i)Tj between the trains in the prescription~ which time may vary between respective adjacent trains during the prescription for J = M trains.
Thus, in the generalized case, the instrument is capable of delivering a prescriptive programmed waveform defined by the set of parameters noted above, i.e.
Rx = (f~ Ap, Sp, An~ Snl n, t, j, N, T) In the foregoing summary, it should be noted that ~he prescription may include packets and pulses at dif-ferent frequencies, where the packets may have different amplitudes and pulse widths. With this generalization, the instrument operates to deliver a zero net current, so that within any one packet, ApSp = AnSn, to achieve a zero net charge. Once Ap and Sp are fixed, the product AnSn is fixed by independently setting An and Sn to meet the equality requirement.
The method according to the invention is also dis-closed discussing a number of internal tests and veri-fications for security and monitoring.
Means are provided for delivering th~ signals from the PDI to the patient by leads from a machine 3 ~ ~
attached to the pinnae, ear lobe, mastoid process, or to the Shen Men or other acupoint. An alternative means for signal delivery, are provided by using radio transmission o~ the signal from a separate computerized controllsr~transmitter, containing the patient's program for a particular prescripkive waveform, with reception means worn by the patient.
The patient receiver will decode the signal and output the prescribed waveform.
Therefore, according to a gen~ral aspect of the invention is defined by an apparatus for delivering a predetermined~ pre-programmed prescriptive signal waveform to a living being, comprising:
means Por receiving said predetermined, pre-programmed prescriptive signal ~rom an external source and storing said signal for delivery to said living being, said prescriptive signal containing a predetermined prescription of parameters of said ~i.gnal;
means for delivering saisl prescriptive signal to said living being upon command, wherein said delivery means include~ means for directly applying said signals transcranially to saicl living being; and means for monitoring the delivered prescriptive signal to produce a signal sequence for u~e in comparing the delivered prescriptive signal to the predeter~ined prescriptive signal.
These and other features of the invention will become apparent from the detailed description of the preferred embodiments taken in conjunction with the accompanying drawings.
Brief_Description of the Drawin~s In the drawings:
Fig. 1 is a block diagram of the components of the system, including the personal delivery instrument Por applying prescriptive signals transcranially to a patient according to the invention;
~3~53~
-8a-Fig. 2 is a generalized waveform for illustrating the parameters controlled by the device for achieving an accurate signal prescription for transmission to a patient and for analysis, where Fig. 2A is a generalized waveform showing a typical wave packet i of pulses, Fig. 2B is a generalized waveform of a typical train o~ packets i; Fig. 2C shows a typical prescription o~ trains J; and F~g. 2D is a chart of the parameters of the prescription delivered by the instrument;
Fig. 3 is a more complex waveform of the type hereto~ore applied to a patient capable of being analyzed by the system according to the invention;
Fig. 4 is a drawing similar to Fig. 3 showing the use of the device in analyzing the waveform of the type of Fig. 3;
Fig. 5 is an exemplary program sequence for inputting the prescriptive wavefo~m from the control unit to the PDI;
Fig. 5 and Fiq. 6 are out: o~ order and appear after Fig. 8~c) in the drawinqs;
,. ~
~ 3 ~
g Fig. 6 is an exemplary program sequence for moni-toxing the prescriptive waveform delivered from the PDI
to a patient;
Fig. 7 is a representative drawing showing the application of the prescriptive waveform to the Shen Men I acupoint of a patient;
Figs. 8A-8C are block diagrams showing several modes of transmitting the prescriptive waveform to a patient;
1~ Fig. 9 is a more detailed functional block diagram of the personal delivery instrument of the type shown in Fig. l; and Fig. 10 is a more detailed functional block dia-gram of a controlled signal generator unit of the PDI.
Detailed Description of the Preferred Embodiment ln Fig. 1, a transcranial electrical nerve stimu lator device and system is generally referred to by the reference numeral 15, for developing and generating a reliable, reproducible program-controlled prescriptive electrical waveform having a therapeutic effect for the amelioration of pain or assistance in ameliorating stress or anxiety related disorders and relieving drug habituation diseases by the transcranial application of the prescriptive electrical waveform to a patient. The system comprises a personal delivery instrument ~PDI~
16, a control unit 18, and a development station 20. l~he PDI lZ, when programmed with the prescriptive electrical waveform, is used to provide current signals trans-cranially to the head 21 of a patient either by direct connection 22, as shown in Fig. 1, or by radio trans-mission to a device worn by the patient or implanted in the patient as shown in Fig. 8. The control unit 18 is usable by medical personnel to program the xequired prescriptive signals in the PDI 16. The development station 20 is used to generate compatible data to the control unit 18 and to analyze the results from the control unit 18 and the PDI 16.
~3~53~
--10'-The prescriptive w~veforms having the extended therapeutic effects are disclosed in detail in the above-mentioned patent of Ifor D. Capel, while other signal prescriptions have been known to investigators for research on patients or animals in developing acceptable prescriptions. It is contemplated that the device according to the invention ls capable of delivering any o~ such prescriptive waveforms to a patient, upon identification of the parameters of the waveform, including their seguence.
Starting with a developsd prescriptive waveform having a desired or intended therapeutic effect for a predetermined disorder stored for retrieval in the control unit 18, or a prescriptive w~ve~orm for research, the program for that programmed waveform is provided by connection between the PDI 16 and the control unit 18 through an interfacing connection 17. The PDI 1~
includes a delivery control unit 24 having a central processing unit 25, a ROM 26, and a RAM 27 for precisely programming the operation of a pulse electrical source 28 connected to a power source 28a to provide the desired wave~orm on an output lead 22 connected to the head 21 of the patient.
Monitoring means 29 are provided for monitoring the signal applied to the patient and comparing it in the del ivery ::ontrol unit 2 4 with the prescribed characteristics stored therein from the control unit 18 for noting discrepancies and correcting tha applied signals. The differences noted are used to correct the original signal output of the personal delivery instrument ~PDI) 16 for storing d~ta accurately representative of the actual application o~ a signal to the patient for analysis, to develop subseguent prescriptive programs, and to improve existing 1311 ~3~5 prescriptive programs ~or application either to that patient or others by returning the ~tored data on an output 30 to the control unit 18 ~or inter-~L31~3~
facing on lead 31 with the development station 20. As isapparent, a developed or modified prescriptive program prepared at the development station 20 may be transferred by the interface 19 to the control unit 18, or to a plurality of such control units located at a number oE
locations, such as hospitals.
The control unit 18 also operates with respect to the PDI 16 to perform a number of additional functions.
The control unit 18 thus may reset the PDI 16 to prepare it for reception of a new prescriptive program, inter-rogate for current operational conditions and errors, perform appropriate internal verifications, communicate selected applications to the PDI in simple or encrypted format, verify the correct receipt of the prescriptive program by the PDI 16, communicate a current time, and request statistics from the PDI 16.
The PDI 16, on the other hand, after communication of a series of instructions from the control unit 18, outputs an electrical signal, the basic component of which is a pulse having a frequency, shape, duration, amplitude, and number, each of which is programmable. It is a feature of the PDI to provide an output where the time average of the current passing between the two output electrodes is zero. The PDI 16 may also be progra~ned to provide either a low frequency or a high frequency sequence wave modulation to the output pulse, acting to turn on or off the output pulse so that the output pulse becomes a modulation envelope for the HF
modulation. The presence and frequency of modulation are also programmed into the device 16, as is the time to traverse from zero to nominal amplitude (i.e. ramp time).
The system 15 has the advantage of using currently available devices. F'or example, for the PDI, a 146805 CMOS microcomputer may comprise the CPU 25, interacting (acting as a signal source) with a byte wide CMOS RAM 27 and EPROM 26, a programmable D/A converter with low power ~3.~3~
operational amplifiers to generate the output signal, and CMOS LSI lo~ic. The control unit 18, for compati-bility, may utilize a 16 bit computer with floppy discs to store the program sequence parameters to insure media compatibility with the development station 20. The J development station may comprise a personal computer compatible with accompanying accessories for utilizing stock software readily available for laboratory analysis and report generation.
A significant feature of the invention resides in its precise control of each of the particular parameters of a wave train applied to a patient according to the prescription.
Fig~ 2, including Figs. 2A-2D, is a generalized lS depiction of an electrical waveform for analyzing a train of pulses comprising a plurality of irxegularly spaced packets of pulses wherein the pulses in each packet are also controlled. Thus, the PDI 16 includes a pulse profile controller which produces a waveform, the com-ponents of which are shown respect:ively in 2~, 2B, and 2C.
As shown in Fig. 2A9 a typical wave packet i of pulses at a frequency fi are shown having a positive amplitude Ap, a negative amplitude An~ a positive pulse duration Sp, and a negative pulse duration Sn, for a representative example of a packet i, where the number n of pulses is three. It should be noted that the pulse frequency fi may vary either within a packet 1 or between adjacent packets so that the prescriptive waveform in-cludes a specification of the pulse frequency or fre quencies fi, where f i is the frequency of the pulses in the i packet.
For a packet i of pulses at a frequency fir the PDI
16 delivers a pulse having a positive pulse amplitude Api for each pulse in each packet of each train forming the prescription. While Fig. 2A shows positive and negative pulses Ap, An~ of approximately the same respective :L3~3.~
amplitudes, the amplitudes may vary between adjacent positive or negative pulses if the prescription so re-quires. Similarly, the PDI 16 produces a waveform which includes a specification of the positive pulse duration SPi for each pulse in each packet of each train Eoxming the prescription, and the negative pulse duration Sni for each pulse in each packet of each train forming the prescription, as well as the number of pulses in each packet, ni-As shown in Fig. 2B, the PDI 16 also clelivers a train i f packets i of pulses of the type shown in Fig.
2A. The PDI 16 thus also controls the respective times between the delivery of adjacent packets where the time between the first packet and the second packet, for example, is noted by 1t2 so that for a generalized case, the instrument delivers packets at the time (i - 13ti for packet 1.
As shown in Fig~ 2C, the instrument 16 also delivers a prescription of trains J of packets i where the time between adjacent trains is controlled according to the generalized expression (J-l)Tj, where the time be-tween respective adjacent trains during the prescription by vary. For the generalized prescription chart shown in Fig. 2D, the entire prescription includes M trains and N
packets in the prescriptive train j. Thus, in the generalized case, the instrument lÇ is capable of de-livering a prescriptive program waveform defined by the parameters shown in Fig. 2D under the conditions wherein the product ApSp is equal to AnSn to deliver zero net charge.
Such synthesized pulse trains eliminate to the extent possible a polarization demyelination of the nerve sheath of the patient conditioning the patient, and provide the investigator the maximum opportunity for accurate simulation of the communication protocalls of the brain of the patient.
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Fig. 3 is a more complex waveEorm which may also be analyzed according to the application of the tech-niques of the invention. Because the prior art devices for applying TENS signals to patients tended to output a signal like that shown in Fig. 3, this particular wave-Eorm is of special interest to investigators.
Such a waveorm 33 can be analyzed by the instru-ment of the invention by inputting it or a reproduction of the waveform to the monitoring means 29 to produce a program for determining by approximation its constitu-ents as shown in Fig. 4. Thus, the investigator has a common basis for comparison of new prescriptions with former app:Lications.
Fig. 5 is a program for transferring the signal prescription from the control unit 18 to the PDI 16. For security, the patient identification, such as name and code number, is input to the control unit 18 and a brief description and other identifying data concerning the patient profile are input in steps 36 and 37. The patient code is checked for accuracy against a user identifi-cation for security in step 39 and, if incorrect, the prescription will not be loaded from the control unit 18 into the PDI 16 and the program returns to the input step 35. If correct, the treatment code is input in sequence 38 containing the prescription for a precise wave train to be applied to the patient. As will be seen, more than one prescription may be applied to a patient. There-after, the prescription is provided by sequentially inputting the fre~uency, the amplitude Ap, of the posi-tive pulse, the sequency Spi of the positive pulse, theamplitude Ani of the negative pulse, and the duration S
of the negative pulse in steps 40, 41J 42, 43, and 44.
Thereafter, in steps 45, the product of ApiSpi is calcu-lated and the product AniSni is calculated, the calcu-lated products are compared to provide a net zero cur-rent, and a correction signal is input in step 45a.
Thereafter, the number ni f pulses in each packet, the number of packets N in the train, the time between packets, the time between trains, and the number of trains in the prescription, along with any other neces-sary parameters and any additional prescriptions fortreatment of the patient in steps 46 to 52 50 that at step 53 the overall voltage prescription has been input to the PDI 16. An appropriate final check may be made at step 52 to insure complete delivery of all prescriptive com-ponents, if desired.
Fig. 6 is a block diagram of a representative se-quence for checking and correcting the prescription delivery. After the device is connected to the patient and appropriate connection confirmed in step 55 and the master clock started in step 56, the system is commanded in step 57 to perform a sequence of internal delivery service checks of the battery in sequence 58, of the RAM
in sequence 59, of any other appropriate components 59a, and of the circuit by monitoring the circuit using test voltages in step 60. Step 55 may include checks on whether the electrodes are open, loose, or closed, sta-tion power delivery is appropriate, and other prelimi-nary confirmation tests. Perfoxmance outside of pre-determined parameters in any of these steps 57-59a in-augurates a corresponding notice signal 58b, 59b, 60b tosignal operator attention in step 61. If the internal delivery service checks are accurate and within accepted norms, the prescriptive wave train stored in accordance with Fig. 5 is in.itiated in step 62 and the delivery of that prescription is monitored at predetermined inter-vals by seguentially interrogating at intervals Q the components of the system in steps 70-74, followed by a clock test in step 75 whereupon a command is given to go to the next packet or train of pulses. If any of the parameters is outside of accepted norms, a correction signal is given and the zero level reset (for zero net 13~3~S
charge) is also periodically provided, preferably after each pulse, especially for low frequency transmission.
If the signals are within accepted norms, the delivered data to the patient are then recorded for subsequent transfer to the control unit 18 and for use at the development station 20 for analysis.
Fig. 7 shows a portion of the ear of a patient illustratlng application of the electrodes 22 to the Shen Men acupoint on the ear of a patient. In the past, electrical signals of other processes were delivered to a patient by direct application of the prescribed voltage through electrodes placed on selected elements of the ear or the mastoid process. Preferably, the precisely con-trolled prescriptive electrical signals according to the invention are applied to the Shen Men or other acupoint of the ear. It is believed that the application of the prescriptive signals at this point will optimize the impedance match between the output of the system 15 and the patient as a conductive medium.
Figs. 8A-8C show alternative modes for providing the prescriptive electrical signal to a patient without direct connection to the unit as at lead 22 in Fig. 1.
Thus r Fig. 8A contemplates a delivery control unit 24' miniaturized to be worn by the patient ox further minia-turized to become a part of a non-invasive application appearing similar to a hearing aid or eyeglasses with enlarged ear lobes. In this embodiment, the control unit 18', similar to the control unit 18, is connected to a RF
transmitter 102 for transmitting all of the si~nals for loading and applying the prescriptive waveforms to the unit for reception by an RF receiver 104 connected to the delivery control unit 24'. Thus, when all of the compo-nents of the delivery control unit 24' are in chip form, the delivery control unit 24' may be loaded and the prescriptive electrical signal delivered at the patient.
Such radio transmission may require additional security 13 L53~5 coding to prevent erasing a preloaded delivery control unit 24'. In a simpler embodiment, the delivery control unit 24' may comprise a cassette or cartridge preloaded with the prescriptive electrical signal from a control 5 unit 18' to be activated by a secured RF transmitted Jsignal. Either of the foregoing embodiments permits a patient significant increase in freedom of movement while undergoing treatment.
Fig. 8B is representative of an embodiment where-10 in a control unit 18' and a delivery control unit 24' operate as described in connection with Fig. 1 but where the prescriptive waveform is transmitted by an RF trans-mittex 102" to be received by an RF receiver 104' at the patient in a suitable patient device 105, such an ear 15 piece or radio receiver.
In either of the embodiments of Figs. 8A and 8B, where monitoring is desired as discussed in connection with Fig. 1, the RF transmitter/receiver pair may com-prise a pair of transceivers suitably secured for two-way 20 communication of the transmitted and monitored data.
Fig. 8C is similar to Fig. 8B wherein the patient device is an implant 105a to illustrate an embodiment wherein the prescriptive waveform is radio transmitted to an implanted receiver at the patient to achieve the 25 desired therapeutic effects.
Fig. 9 is a functional block diagram of the PDI 16 according to its presently preEerred embodiment for incorporation in a portable desk top unit. However, the principles of the invention may be embodied in a device 30 sized to be portable with the patient as in Fig. 8 while receiving the applied signal characteristicsr such as discussed in connection wikh Fig. 8.
The embodiment of Fig. 9 is designed to provide the electrical signal characteristics of the type des-35 cribed, the power requirementsr memory requirements, display, key board, connectors and operational require-~3~3~
ments to achieve the intended purposes of the invention.
The output current pulse characteristics provided by the unit include a zero cumulative current with a positive 35 milliamp peak output current programmable throughout the range of zero to maximum current with limitations on the maximum output current for patient safety, The freguencies of the pulse~ are provided in a range of 0.5 hz to 500 hz with a one percent dev.iation or less from optimum throughout the range of primary in erest in implementing the waveform prescription according to the aforementioned patent. The freguency range and pulse shape are programmabl2 and provided with a 100 microsecond sampling interval, for exampleO Wher~ wave modulation i necessary or desirable, the modulating wave may be provided in a suitable r~nge, for example, 5.0 Khz to 100 Khæ for hi~h ~reguency modulation, whereas low ~raguency modulation of the~ output current pulse i5 selectable in predetermined time increments, such as 0.1 minutes, up to 20 minutes, on an on/off basis.
Pre~erably, the ramp time exhibited by the wave pulses (i.e. the time lapse necessary to change from zero to the programmed output current) is typically 100 microseconds.
The unit exhibit~ load characteristics approximating ~ 0000 ohms in parallel with a 0. 05 microfarad capaoitance. The unit i~; preferably powered by an internal dual power supply having both a battery and a backup to insure data retention in the case of power fallure. A data retention ~eature is also provided as will be discussed. Pre~erably, the internal clock is accurate to 0.1 percent. Th~ display is preferably a one digit LED display capable of generating numbers zero to nine while the keyboaxd is preferably a one button unit.
The speaker, for emitting audible warning signals, may generate audio signals as desired, for example, from two seconds to five minute increments. Connections of the ., 13 1 r~
PDI 16 to the patient are provided by conventional plugs and jac]cs and, as described, the unit is capable of a self-test sequence, a main line sequence, and data moni-toring storage sequencing. As described, the unit is capable of generating current pulses oE defined ampli-tude and duration, with high fre~uency and low frequency modulation ranging from .05 hz to 500 hz according to the program stored therein according to the waveform pre-scription discussed in connection with Figs. 1, 2, and 5.
The self-diagnostic sequence for the unit has been dis-cussed in connection with Fig. 6. Preferably, the unit is intended for operation over a five hour period 50 that current pulses on the order of or less than 10 milliamps provided to a lO K ohms load require a O.l watt signal permitting selection of a battery source to meet the operating parameters.
Thus, as shown in Fig. 9, the PDI 16 comprises a plurality of functional modules. The controller 80 provides for the timing and c~ntrol of all of the units and acts as an in~erface between any two modules. The display numeric module 81 is used as a status indicator, while the keyboard module 82 is used to command data input to inaugurate the program se~uence described in connec-tion with Fig. 5. The alarm module 83 may ~e actuated as described in connection with Fig. 6 to obtain operator attention, as described in connection with step 61.
Thus, the alarm module not only functions as an alarm, but also monitors the time between activities and the start-ing and stopping time to associate the data generation with the status o~ the patient. The proyram storage module 84 and the data storage module 85 respectively store the electrical signal prescription and self test schedule in the program storage module 84 as well as the results of the tests and signal schedule in the data storage module 85.
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The battery indicator module 86 monitors the conditions of the battery source in the system to provide an indication wh~e~ the battery needs changing, while the IO port module ~ outputs the gathered data and receives the inputs of the new program sequences. The signal generator module 87 generates the electrical signal prescription with the signal duration and waveform cre-ated according to the discussions of FigsO 1 and 3 by the program sequence. Thus, the PDI 16 as shown in Fig. 9 is capable of performing program scheduling, signal genera-tion, self-testing, data output, and battery charging or changing. Each of those modes has been described in connection with Figs. 1-8 above.
In particular, the controller 80 may control an 8 bit CMOS microcomputer of a single chip design to permit signal generation at random time intervals and to inter-face between different modules. Thus, the controller 80 may include the CPU, ROM, and RAM capabilities discussed in connection with Fig. 1.
The display module 81 preferably comprises an LCD
character generator driven by a 4 bit word from the micro-processor in the controller 80. That signal is converted to proper format and multiplexed to drive the LCD, as is known in the art. A 32 Khz clock is used to drive the generator. The clock chip preferably contains an on-chip oscillator to yenerate the multilevel waveforms.
The signal generator module 87 is shown in greater detail in Fig. 10. The signal generator comprises an 8 bit D to A converter 90 to obtain the needed voltage levels, connected to operational amplifiers ~1. The microprocessor in the controller 80 will program the D to A unit 90 to provide current at the desired levels. The output levels from the D to A converters is thus fed into the two operational amplifiers to generate a electrical differential at the output. By adjusting the binary number into the D to A converter 90 from the master 3 ~ ~
control unit 80, a bipolar signal from the operational amplifiers can generate current flowing in either direc-tion through the electrodes 22, connected to terminals El and E2. The binary numbers are selected to generate the s pulse or inverse current signal with an 8 bit resolution.
As discussed above, the microprocessor control uni-t selects the binary num~ r determined by the software.
The IO module ~ controls all of the input and output activity of the PDI. Thus, the output comprises a plurality of signal channels for output of status information and input of programming sequencing, two of which are dedicated to the use o~ electrodes and another of which is for recharging, if a recharge cable battery is selected~
The invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The present embodiments are, there-fore, to be considered in all xespects RS illustrative and not restrictive, the scope of the invention being indicated by the claims rather than by the foregoing description and all changes which come within the meaning and range of the equivalents of the claims are therefore intended to be embraced therein.
Thus, in the generalized case, the instrument is capable of delivering a prescriptive programmed waveform defined by the set of parameters noted above, i.e.
Rx = (f~ Ap, Sp, An~ Snl n, t, j, N, T) In the foregoing summary, it should be noted that ~he prescription may include packets and pulses at dif-ferent frequencies, where the packets may have different amplitudes and pulse widths. With this generalization, the instrument operates to deliver a zero net current, so that within any one packet, ApSp = AnSn, to achieve a zero net charge. Once Ap and Sp are fixed, the product AnSn is fixed by independently setting An and Sn to meet the equality requirement.
The method according to the invention is also dis-closed discussing a number of internal tests and veri-fications for security and monitoring.
Means are provided for delivering th~ signals from the PDI to the patient by leads from a machine 3 ~ ~
attached to the pinnae, ear lobe, mastoid process, or to the Shen Men or other acupoint. An alternative means for signal delivery, are provided by using radio transmission o~ the signal from a separate computerized controllsr~transmitter, containing the patient's program for a particular prescripkive waveform, with reception means worn by the patient.
The patient receiver will decode the signal and output the prescribed waveform.
Therefore, according to a gen~ral aspect of the invention is defined by an apparatus for delivering a predetermined~ pre-programmed prescriptive signal waveform to a living being, comprising:
means Por receiving said predetermined, pre-programmed prescriptive signal ~rom an external source and storing said signal for delivery to said living being, said prescriptive signal containing a predetermined prescription of parameters of said ~i.gnal;
means for delivering saisl prescriptive signal to said living being upon command, wherein said delivery means include~ means for directly applying said signals transcranially to saicl living being; and means for monitoring the delivered prescriptive signal to produce a signal sequence for u~e in comparing the delivered prescriptive signal to the predeter~ined prescriptive signal.
These and other features of the invention will become apparent from the detailed description of the preferred embodiments taken in conjunction with the accompanying drawings.
Brief_Description of the Drawin~s In the drawings:
Fig. 1 is a block diagram of the components of the system, including the personal delivery instrument Por applying prescriptive signals transcranially to a patient according to the invention;
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-8a-Fig. 2 is a generalized waveform for illustrating the parameters controlled by the device for achieving an accurate signal prescription for transmission to a patient and for analysis, where Fig. 2A is a generalized waveform showing a typical wave packet i of pulses, Fig. 2B is a generalized waveform of a typical train o~ packets i; Fig. 2C shows a typical prescription o~ trains J; and F~g. 2D is a chart of the parameters of the prescription delivered by the instrument;
Fig. 3 is a more complex waveform of the type hereto~ore applied to a patient capable of being analyzed by the system according to the invention;
Fig. 4 is a drawing similar to Fig. 3 showing the use of the device in analyzing the waveform of the type of Fig. 3;
Fig. 5 is an exemplary program sequence for inputting the prescriptive wavefo~m from the control unit to the PDI;
Fig. 5 and Fiq. 6 are out: o~ order and appear after Fig. 8~c) in the drawinqs;
,. ~
~ 3 ~
g Fig. 6 is an exemplary program sequence for moni-toxing the prescriptive waveform delivered from the PDI
to a patient;
Fig. 7 is a representative drawing showing the application of the prescriptive waveform to the Shen Men I acupoint of a patient;
Figs. 8A-8C are block diagrams showing several modes of transmitting the prescriptive waveform to a patient;
1~ Fig. 9 is a more detailed functional block diagram of the personal delivery instrument of the type shown in Fig. l; and Fig. 10 is a more detailed functional block dia-gram of a controlled signal generator unit of the PDI.
Detailed Description of the Preferred Embodiment ln Fig. 1, a transcranial electrical nerve stimu lator device and system is generally referred to by the reference numeral 15, for developing and generating a reliable, reproducible program-controlled prescriptive electrical waveform having a therapeutic effect for the amelioration of pain or assistance in ameliorating stress or anxiety related disorders and relieving drug habituation diseases by the transcranial application of the prescriptive electrical waveform to a patient. The system comprises a personal delivery instrument ~PDI~
16, a control unit 18, and a development station 20. l~he PDI lZ, when programmed with the prescriptive electrical waveform, is used to provide current signals trans-cranially to the head 21 of a patient either by direct connection 22, as shown in Fig. 1, or by radio trans-mission to a device worn by the patient or implanted in the patient as shown in Fig. 8. The control unit 18 is usable by medical personnel to program the xequired prescriptive signals in the PDI 16. The development station 20 is used to generate compatible data to the control unit 18 and to analyze the results from the control unit 18 and the PDI 16.
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--10'-The prescriptive w~veforms having the extended therapeutic effects are disclosed in detail in the above-mentioned patent of Ifor D. Capel, while other signal prescriptions have been known to investigators for research on patients or animals in developing acceptable prescriptions. It is contemplated that the device according to the invention ls capable of delivering any o~ such prescriptive waveforms to a patient, upon identification of the parameters of the waveform, including their seguence.
Starting with a developsd prescriptive waveform having a desired or intended therapeutic effect for a predetermined disorder stored for retrieval in the control unit 18, or a prescriptive w~ve~orm for research, the program for that programmed waveform is provided by connection between the PDI 16 and the control unit 18 through an interfacing connection 17. The PDI 1~
includes a delivery control unit 24 having a central processing unit 25, a ROM 26, and a RAM 27 for precisely programming the operation of a pulse electrical source 28 connected to a power source 28a to provide the desired wave~orm on an output lead 22 connected to the head 21 of the patient.
Monitoring means 29 are provided for monitoring the signal applied to the patient and comparing it in the del ivery ::ontrol unit 2 4 with the prescribed characteristics stored therein from the control unit 18 for noting discrepancies and correcting tha applied signals. The differences noted are used to correct the original signal output of the personal delivery instrument ~PDI) 16 for storing d~ta accurately representative of the actual application o~ a signal to the patient for analysis, to develop subseguent prescriptive programs, and to improve existing 1311 ~3~5 prescriptive programs ~or application either to that patient or others by returning the ~tored data on an output 30 to the control unit 18 ~or inter-~L31~3~
facing on lead 31 with the development station 20. As isapparent, a developed or modified prescriptive program prepared at the development station 20 may be transferred by the interface 19 to the control unit 18, or to a plurality of such control units located at a number oE
locations, such as hospitals.
The control unit 18 also operates with respect to the PDI 16 to perform a number of additional functions.
The control unit 18 thus may reset the PDI 16 to prepare it for reception of a new prescriptive program, inter-rogate for current operational conditions and errors, perform appropriate internal verifications, communicate selected applications to the PDI in simple or encrypted format, verify the correct receipt of the prescriptive program by the PDI 16, communicate a current time, and request statistics from the PDI 16.
The PDI 16, on the other hand, after communication of a series of instructions from the control unit 18, outputs an electrical signal, the basic component of which is a pulse having a frequency, shape, duration, amplitude, and number, each of which is programmable. It is a feature of the PDI to provide an output where the time average of the current passing between the two output electrodes is zero. The PDI 16 may also be progra~ned to provide either a low frequency or a high frequency sequence wave modulation to the output pulse, acting to turn on or off the output pulse so that the output pulse becomes a modulation envelope for the HF
modulation. The presence and frequency of modulation are also programmed into the device 16, as is the time to traverse from zero to nominal amplitude (i.e. ramp time).
The system 15 has the advantage of using currently available devices. F'or example, for the PDI, a 146805 CMOS microcomputer may comprise the CPU 25, interacting (acting as a signal source) with a byte wide CMOS RAM 27 and EPROM 26, a programmable D/A converter with low power ~3.~3~
operational amplifiers to generate the output signal, and CMOS LSI lo~ic. The control unit 18, for compati-bility, may utilize a 16 bit computer with floppy discs to store the program sequence parameters to insure media compatibility with the development station 20. The J development station may comprise a personal computer compatible with accompanying accessories for utilizing stock software readily available for laboratory analysis and report generation.
A significant feature of the invention resides in its precise control of each of the particular parameters of a wave train applied to a patient according to the prescription.
Fig~ 2, including Figs. 2A-2D, is a generalized lS depiction of an electrical waveform for analyzing a train of pulses comprising a plurality of irxegularly spaced packets of pulses wherein the pulses in each packet are also controlled. Thus, the PDI 16 includes a pulse profile controller which produces a waveform, the com-ponents of which are shown respect:ively in 2~, 2B, and 2C.
As shown in Fig. 2A9 a typical wave packet i of pulses at a frequency fi are shown having a positive amplitude Ap, a negative amplitude An~ a positive pulse duration Sp, and a negative pulse duration Sn, for a representative example of a packet i, where the number n of pulses is three. It should be noted that the pulse frequency fi may vary either within a packet 1 or between adjacent packets so that the prescriptive waveform in-cludes a specification of the pulse frequency or fre quencies fi, where f i is the frequency of the pulses in the i packet.
For a packet i of pulses at a frequency fir the PDI
16 delivers a pulse having a positive pulse amplitude Api for each pulse in each packet of each train forming the prescription. While Fig. 2A shows positive and negative pulses Ap, An~ of approximately the same respective :L3~3.~
amplitudes, the amplitudes may vary between adjacent positive or negative pulses if the prescription so re-quires. Similarly, the PDI 16 produces a waveform which includes a specification of the positive pulse duration SPi for each pulse in each packet of each train Eoxming the prescription, and the negative pulse duration Sni for each pulse in each packet of each train forming the prescription, as well as the number of pulses in each packet, ni-As shown in Fig. 2B, the PDI 16 also clelivers a train i f packets i of pulses of the type shown in Fig.
2A. The PDI 16 thus also controls the respective times between the delivery of adjacent packets where the time between the first packet and the second packet, for example, is noted by 1t2 so that for a generalized case, the instrument delivers packets at the time (i - 13ti for packet 1.
As shown in Fig~ 2C, the instrument 16 also delivers a prescription of trains J of packets i where the time between adjacent trains is controlled according to the generalized expression (J-l)Tj, where the time be-tween respective adjacent trains during the prescription by vary. For the generalized prescription chart shown in Fig. 2D, the entire prescription includes M trains and N
packets in the prescriptive train j. Thus, in the generalized case, the instrument lÇ is capable of de-livering a prescriptive program waveform defined by the parameters shown in Fig. 2D under the conditions wherein the product ApSp is equal to AnSn to deliver zero net charge.
Such synthesized pulse trains eliminate to the extent possible a polarization demyelination of the nerve sheath of the patient conditioning the patient, and provide the investigator the maximum opportunity for accurate simulation of the communication protocalls of the brain of the patient.
~3~3~
Fig. 3 is a more complex waveEorm which may also be analyzed according to the application of the tech-niques of the invention. Because the prior art devices for applying TENS signals to patients tended to output a signal like that shown in Fig. 3, this particular wave-Eorm is of special interest to investigators.
Such a waveorm 33 can be analyzed by the instru-ment of the invention by inputting it or a reproduction of the waveform to the monitoring means 29 to produce a program for determining by approximation its constitu-ents as shown in Fig. 4. Thus, the investigator has a common basis for comparison of new prescriptions with former app:Lications.
Fig. 5 is a program for transferring the signal prescription from the control unit 18 to the PDI 16. For security, the patient identification, such as name and code number, is input to the control unit 18 and a brief description and other identifying data concerning the patient profile are input in steps 36 and 37. The patient code is checked for accuracy against a user identifi-cation for security in step 39 and, if incorrect, the prescription will not be loaded from the control unit 18 into the PDI 16 and the program returns to the input step 35. If correct, the treatment code is input in sequence 38 containing the prescription for a precise wave train to be applied to the patient. As will be seen, more than one prescription may be applied to a patient. There-after, the prescription is provided by sequentially inputting the fre~uency, the amplitude Ap, of the posi-tive pulse, the sequency Spi of the positive pulse, theamplitude Ani of the negative pulse, and the duration S
of the negative pulse in steps 40, 41J 42, 43, and 44.
Thereafter, in steps 45, the product of ApiSpi is calcu-lated and the product AniSni is calculated, the calcu-lated products are compared to provide a net zero cur-rent, and a correction signal is input in step 45a.
Thereafter, the number ni f pulses in each packet, the number of packets N in the train, the time between packets, the time between trains, and the number of trains in the prescription, along with any other neces-sary parameters and any additional prescriptions fortreatment of the patient in steps 46 to 52 50 that at step 53 the overall voltage prescription has been input to the PDI 16. An appropriate final check may be made at step 52 to insure complete delivery of all prescriptive com-ponents, if desired.
Fig. 6 is a block diagram of a representative se-quence for checking and correcting the prescription delivery. After the device is connected to the patient and appropriate connection confirmed in step 55 and the master clock started in step 56, the system is commanded in step 57 to perform a sequence of internal delivery service checks of the battery in sequence 58, of the RAM
in sequence 59, of any other appropriate components 59a, and of the circuit by monitoring the circuit using test voltages in step 60. Step 55 may include checks on whether the electrodes are open, loose, or closed, sta-tion power delivery is appropriate, and other prelimi-nary confirmation tests. Perfoxmance outside of pre-determined parameters in any of these steps 57-59a in-augurates a corresponding notice signal 58b, 59b, 60b tosignal operator attention in step 61. If the internal delivery service checks are accurate and within accepted norms, the prescriptive wave train stored in accordance with Fig. 5 is in.itiated in step 62 and the delivery of that prescription is monitored at predetermined inter-vals by seguentially interrogating at intervals Q the components of the system in steps 70-74, followed by a clock test in step 75 whereupon a command is given to go to the next packet or train of pulses. If any of the parameters is outside of accepted norms, a correction signal is given and the zero level reset (for zero net 13~3~S
charge) is also periodically provided, preferably after each pulse, especially for low frequency transmission.
If the signals are within accepted norms, the delivered data to the patient are then recorded for subsequent transfer to the control unit 18 and for use at the development station 20 for analysis.
Fig. 7 shows a portion of the ear of a patient illustratlng application of the electrodes 22 to the Shen Men acupoint on the ear of a patient. In the past, electrical signals of other processes were delivered to a patient by direct application of the prescribed voltage through electrodes placed on selected elements of the ear or the mastoid process. Preferably, the precisely con-trolled prescriptive electrical signals according to the invention are applied to the Shen Men or other acupoint of the ear. It is believed that the application of the prescriptive signals at this point will optimize the impedance match between the output of the system 15 and the patient as a conductive medium.
Figs. 8A-8C show alternative modes for providing the prescriptive electrical signal to a patient without direct connection to the unit as at lead 22 in Fig. 1.
Thus r Fig. 8A contemplates a delivery control unit 24' miniaturized to be worn by the patient ox further minia-turized to become a part of a non-invasive application appearing similar to a hearing aid or eyeglasses with enlarged ear lobes. In this embodiment, the control unit 18', similar to the control unit 18, is connected to a RF
transmitter 102 for transmitting all of the si~nals for loading and applying the prescriptive waveforms to the unit for reception by an RF receiver 104 connected to the delivery control unit 24'. Thus, when all of the compo-nents of the delivery control unit 24' are in chip form, the delivery control unit 24' may be loaded and the prescriptive electrical signal delivered at the patient.
Such radio transmission may require additional security 13 L53~5 coding to prevent erasing a preloaded delivery control unit 24'. In a simpler embodiment, the delivery control unit 24' may comprise a cassette or cartridge preloaded with the prescriptive electrical signal from a control 5 unit 18' to be activated by a secured RF transmitted Jsignal. Either of the foregoing embodiments permits a patient significant increase in freedom of movement while undergoing treatment.
Fig. 8B is representative of an embodiment where-10 in a control unit 18' and a delivery control unit 24' operate as described in connection with Fig. 1 but where the prescriptive waveform is transmitted by an RF trans-mittex 102" to be received by an RF receiver 104' at the patient in a suitable patient device 105, such an ear 15 piece or radio receiver.
In either of the embodiments of Figs. 8A and 8B, where monitoring is desired as discussed in connection with Fig. 1, the RF transmitter/receiver pair may com-prise a pair of transceivers suitably secured for two-way 20 communication of the transmitted and monitored data.
Fig. 8C is similar to Fig. 8B wherein the patient device is an implant 105a to illustrate an embodiment wherein the prescriptive waveform is radio transmitted to an implanted receiver at the patient to achieve the 25 desired therapeutic effects.
Fig. 9 is a functional block diagram of the PDI 16 according to its presently preEerred embodiment for incorporation in a portable desk top unit. However, the principles of the invention may be embodied in a device 30 sized to be portable with the patient as in Fig. 8 while receiving the applied signal characteristicsr such as discussed in connection wikh Fig. 8.
The embodiment of Fig. 9 is designed to provide the electrical signal characteristics of the type des-35 cribed, the power requirementsr memory requirements, display, key board, connectors and operational require-~3~3~
ments to achieve the intended purposes of the invention.
The output current pulse characteristics provided by the unit include a zero cumulative current with a positive 35 milliamp peak output current programmable throughout the range of zero to maximum current with limitations on the maximum output current for patient safety, The freguencies of the pulse~ are provided in a range of 0.5 hz to 500 hz with a one percent dev.iation or less from optimum throughout the range of primary in erest in implementing the waveform prescription according to the aforementioned patent. The freguency range and pulse shape are programmabl2 and provided with a 100 microsecond sampling interval, for exampleO Wher~ wave modulation i necessary or desirable, the modulating wave may be provided in a suitable r~nge, for example, 5.0 Khz to 100 Khæ for hi~h ~reguency modulation, whereas low ~raguency modulation of the~ output current pulse i5 selectable in predetermined time increments, such as 0.1 minutes, up to 20 minutes, on an on/off basis.
Pre~erably, the ramp time exhibited by the wave pulses (i.e. the time lapse necessary to change from zero to the programmed output current) is typically 100 microseconds.
The unit exhibit~ load characteristics approximating ~ 0000 ohms in parallel with a 0. 05 microfarad capaoitance. The unit i~; preferably powered by an internal dual power supply having both a battery and a backup to insure data retention in the case of power fallure. A data retention ~eature is also provided as will be discussed. Pre~erably, the internal clock is accurate to 0.1 percent. Th~ display is preferably a one digit LED display capable of generating numbers zero to nine while the keyboaxd is preferably a one button unit.
The speaker, for emitting audible warning signals, may generate audio signals as desired, for example, from two seconds to five minute increments. Connections of the ., 13 1 r~
PDI 16 to the patient are provided by conventional plugs and jac]cs and, as described, the unit is capable of a self-test sequence, a main line sequence, and data moni-toring storage sequencing. As described, the unit is capable of generating current pulses oE defined ampli-tude and duration, with high fre~uency and low frequency modulation ranging from .05 hz to 500 hz according to the program stored therein according to the waveform pre-scription discussed in connection with Figs. 1, 2, and 5.
The self-diagnostic sequence for the unit has been dis-cussed in connection with Fig. 6. Preferably, the unit is intended for operation over a five hour period 50 that current pulses on the order of or less than 10 milliamps provided to a lO K ohms load require a O.l watt signal permitting selection of a battery source to meet the operating parameters.
Thus, as shown in Fig. 9, the PDI 16 comprises a plurality of functional modules. The controller 80 provides for the timing and c~ntrol of all of the units and acts as an in~erface between any two modules. The display numeric module 81 is used as a status indicator, while the keyboard module 82 is used to command data input to inaugurate the program se~uence described in connec-tion with Fig. 5. The alarm module 83 may ~e actuated as described in connection with Fig. 6 to obtain operator attention, as described in connection with step 61.
Thus, the alarm module not only functions as an alarm, but also monitors the time between activities and the start-ing and stopping time to associate the data generation with the status o~ the patient. The proyram storage module 84 and the data storage module 85 respectively store the electrical signal prescription and self test schedule in the program storage module 84 as well as the results of the tests and signal schedule in the data storage module 85.
~3~53~
The battery indicator module 86 monitors the conditions of the battery source in the system to provide an indication wh~e~ the battery needs changing, while the IO port module ~ outputs the gathered data and receives the inputs of the new program sequences. The signal generator module 87 generates the electrical signal prescription with the signal duration and waveform cre-ated according to the discussions of FigsO 1 and 3 by the program sequence. Thus, the PDI 16 as shown in Fig. 9 is capable of performing program scheduling, signal genera-tion, self-testing, data output, and battery charging or changing. Each of those modes has been described in connection with Figs. 1-8 above.
In particular, the controller 80 may control an 8 bit CMOS microcomputer of a single chip design to permit signal generation at random time intervals and to inter-face between different modules. Thus, the controller 80 may include the CPU, ROM, and RAM capabilities discussed in connection with Fig. 1.
The display module 81 preferably comprises an LCD
character generator driven by a 4 bit word from the micro-processor in the controller 80. That signal is converted to proper format and multiplexed to drive the LCD, as is known in the art. A 32 Khz clock is used to drive the generator. The clock chip preferably contains an on-chip oscillator to yenerate the multilevel waveforms.
The signal generator module 87 is shown in greater detail in Fig. 10. The signal generator comprises an 8 bit D to A converter 90 to obtain the needed voltage levels, connected to operational amplifiers ~1. The microprocessor in the controller 80 will program the D to A unit 90 to provide current at the desired levels. The output levels from the D to A converters is thus fed into the two operational amplifiers to generate a electrical differential at the output. By adjusting the binary number into the D to A converter 90 from the master 3 ~ ~
control unit 80, a bipolar signal from the operational amplifiers can generate current flowing in either direc-tion through the electrodes 22, connected to terminals El and E2. The binary numbers are selected to generate the s pulse or inverse current signal with an 8 bit resolution.
As discussed above, the microprocessor control uni-t selects the binary num~ r determined by the software.
The IO module ~ controls all of the input and output activity of the PDI. Thus, the output comprises a plurality of signal channels for output of status information and input of programming sequencing, two of which are dedicated to the use o~ electrodes and another of which is for recharging, if a recharge cable battery is selected~
The invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The present embodiments are, there-fore, to be considered in all xespects RS illustrative and not restrictive, the scope of the invention being indicated by the claims rather than by the foregoing description and all changes which come within the meaning and range of the equivalents of the claims are therefore intended to be embraced therein.
Claims (21)
1. An apparatus for delivering a predetermined, pre-programmed prescriptive signal waveform to a living being, comprising:
means for receiving said predetermined, pre-pro-grammed prescriptive signal from an external source and storing said signal for delivery to said living being, said prescriptive signal containing a predetermined pre-scription of parameters of said signal;
means for delivering said prescriptive signal to said living being upon command, wherein said delivery means includes means for directly applying said signals transcranially to said living being; and means for monitoring the delivered prescriptive signal to produce a signal sequence for use in comparing the delivered prescriptive signal to the predetermined prescriptive signal.
means for receiving said predetermined, pre-pro-grammed prescriptive signal from an external source and storing said signal for delivery to said living being, said prescriptive signal containing a predetermined pre-scription of parameters of said signal;
means for delivering said prescriptive signal to said living being upon command, wherein said delivery means includes means for directly applying said signals transcranially to said living being; and means for monitoring the delivered prescriptive signal to produce a signal sequence for use in comparing the delivered prescriptive signal to the predetermined prescriptive signal.
2. The apparatus as set forth in claim 1 wherein said prescriptive signal receiving and storing means includes means for controlling a signal source to produce an electrical signal for delivery to said living being precisely according to the predetermined prescription of parameters prescribed for said signal.
3. The apparatus as set forth in claim 2 wherein said monitoring means cooperates with said prescriptive signal receiving and storing means for comparing the signal delivered with the signal prescribed, so that said receiving and storing means corrects said delivered signal when one or more selected parameters of the delivered signal is outside of predetermined limits for said one or more selected parameters.
4. The apparatus as set forth in claim 1 wherein the parameters of the prescriptive signal include a specification of the amplitude Ap of a positive pulse in a packet i, the duration Sp of said positive pulse, the amplitude An of a negative pulse in the packet i, the duration SO of said negative pulse, said delivering means including means for establishing that the respective products ApSp and AnSn are equal so that a zero net charge is delivered to the living being.
5. The apparatus as set forth in claim 1 wherein the parameters of the prescriptive signal include the prescription Rx = (f, Ap, Sp, An, Sn, t, j, N, T) where:
f = the frequency;
Ab = the voltage amplitude of the positive pulse;
Sn = the duration of each negative pulse;
n = the number of pulses in a packet;
t = the time between packets in a train;
j = the number of trains in packets;
N = the number of packets in the train j; and T = the time between trains.
f = the frequency;
Ab = the voltage amplitude of the positive pulse;
Sn = the duration of each negative pulse;
n = the number of pulses in a packet;
t = the time between packets in a train;
j = the number of trains in packets;
N = the number of packets in the train j; and T = the time between trains.
6. The apparatus as set forth in claim 1 wherein the said prescriptive signal, includes a prescription of a train of packets of pulses, according to the expression Rx (f, Ap, Sp, An, Sn, n, t, j, N, T) where;
f = the frequency;
Ap = the voltage amplitude of the positive pulse;
Sp = the duration of each positive pulse;
Ap = the voltage amplitude of the negative pulse;
Sn = the duration of each negative pulse;
n = the number of pulses in a packet;
t = the time between packets in a train;
j = the number of trains in packets;
N = the number of packets in the train; and T = the time between trains.
f = the frequency;
Ap = the voltage amplitude of the positive pulse;
Sp = the duration of each positive pulse;
Ap = the voltage amplitude of the negative pulse;
Sn = the duration of each negative pulse;
n = the number of pulses in a packet;
t = the time between packets in a train;
j = the number of trains in packets;
N = the number of packets in the train; and T = the time between trains.
7. The apparatus set forth in claim 1 wherein said living being is a human being.
8. The apparatus as set forth in claim 7 wherein said signals are applied to the Shen Men accupoint of said human being.
9. The apparatus as set forth in claim 1 wherein said delivery means includes means for transmitting said signal and means, including a patient device worn by said living being, for receiving said signals.
10. The apparatus as set forth in claim 9 wherein said patient device is an earpiece.
11. The apparatus as set forth in claim 9 wherein said patient device is an implant.
12. The apparatus as set forth in claim 1 wherein said monitoring means includes means for delivering a waveform to said receiving and storing means for analysis.
13. The apparatus as set forth in claim 12 wherein said receiving and storing means includes a central processing unit having a RAM and a ROM for storing instructions to produce said prescriptive signal and for controlling a signal source in circuit with a battery to produce said prescriptive signal for delivery.
14. The apparatus as set forth in claim 13 wherein said signal storage and delivery means includes a control unit for storing said prescriptive programming and acting as an external program source for said delivery means.
15. The apparatus as set forth in claim 14 wherein said control unit includes means for receiving from a signal from said receiving and storing means which is representative of the signals actually delivered.
16. The apparatus as set forth in claim 15 wherein the control unit includes means for receiving and correcting the delivered prescriptive signal.
17. The apparatus as set forth in claim 1 wherein said signal delivery means includes means for applying said signal to a location on the skin of said living being which provides optimal
18. The apparatus as set forth in claim 1 wherein a source of power for said apparatus is a battery.
19. The apparatus as set forth in claim 1 wherein said delivery means includes means for testing selected parameters of said prescriptive signal at predetermined intervals to determine whether said parameters are within accepted limits for those selected parameters respectively.
20. The apparatus as set forth in claim 19 wherein said delivery means further includes means for commanding a correction for those selected parameters which are outside of accepted limits.
21. The apparatus as set forth in claim 19 further including means for monitoring selected functions of said apparatus by inputting test signals.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000514834A CA1315345C (en) | 1986-07-29 | 1986-07-29 | Method and apparatus for delivering a prescriptive electrical signal |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000514834A CA1315345C (en) | 1986-07-29 | 1986-07-29 | Method and apparatus for delivering a prescriptive electrical signal |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1315345C true CA1315345C (en) | 1993-03-30 |
Family
ID=4133644
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000514834A Expired - Fee Related CA1315345C (en) | 1986-07-29 | 1986-07-29 | Method and apparatus for delivering a prescriptive electrical signal |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1315345C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115671551A (en) * | 2023-01-03 | 2023-02-03 | 北京市金华医疗器械研究所 | Control method and device of intermediate frequency pulse therapeutic apparatus and therapeutic apparatus |
-
1986
- 1986-07-29 CA CA000514834A patent/CA1315345C/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115671551A (en) * | 2023-01-03 | 2023-02-03 | 北京市金华医疗器械研究所 | Control method and device of intermediate frequency pulse therapeutic apparatus and therapeutic apparatus |
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