Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/328—Applying electric currents by contact electrodes alternating or intermittent currents for improving the appearance of the skin, e.g. facial toning or wrinkle treatment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
  • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
  • A61N1/36071—Pain

Definitions

• This invention relates generally to a device for providing an electrical signal to a patient. More particu larly, this invention relates to a device for producing accurate, particularly complex intermittent electrical waveforms. Still more particularly, this invention relates to an apparatus of the type which comprises means for delivering a programmed prescriptive electrical signal to patient by direct application of the prescribed signal via electrodes placed or. one or more selected points of the ea or the mastoid process or, in the alternative, by radio transmission of a controlling signal to enable a radio receiver located at the point or points of application to receive the prescribed signal.
• Means are provided for monitoring the signal applied t the patient and comparing it with the prescribed charac ⁇ teristics for noting discrepancies and correcting the applied signal. The differences noted are used to correct the original output of the delivery device.
• Stored data representative of the application of a signal to the patien -2- are analyzed and used to improve subsequent programs for application to that patient.
• the signals are applied to contact points chosen because of their known affinity for changing endogenous concentrations of neurotransmitters and neuromodulators in the brain.
• the signals are applied and controlled as the impedance of the patient at the applied points changes during the procedure.
• the patient is a conductive medium.
• the signal waveform parameters that are prescribed and con ⁇ trolled in their delivery to the patient are frequencies, positive and negative voltage amplitudes, positive and negative current amplitudes, net charge delivered in any pulse, the duration of each particular pulse, the number of pulses in each packet, the time or pauses between adjacent packets of pulses, the number of packets in each train, the time between trains of packets of pulses, and the number of trains in the prescription.
• Such synthesized pulses trains eliminate, to the greatest extent possible., depolarization or hyperpolarization of the nerve sheath and conditioning of the patient, while providing the maximum opportunity for accurate selectable stimulation of the communication proto ⁇ cols of the brain.
• transcutaneous electrical nerve stimulation has been used for applying a signal voltage to a patient by electrodes placed at the site of local pain.
• TENS transcutaneous electrical nerve stimulation
• the resulting afferent sensory signals compete with the pain signals produced by the human, resulting in analgesia.
• PINS percutaneous induced neurcstimulation
• Still another analgesic technique involves the use of implanted deep brain probes (DBP) wherein electrodes are inserted directly into the brain so that when voltage is applied, analgesia results.
• DBP deep brain probes
• the TENS and PINS processes induce essen ⁇ tially the same mechanism within the human organism. It is known that pain induces electrical signals which are trans ⁇ mitted to the brain through the spinal chord by a com ⁇ bination of electrical conduction and chemical diffusion where the pain signals are interpreted at the brain because of the activities they induce in certain cells. In the TENS and PINS applications, the pain signals are effectively diluted because of the competition induced with the afferent sensor signals produced by the TENS and PINS processes. The dilution of the pain signals effectively relieves the extremity of the pain interpreted by the brain.
• the DBP process is completely different.
• the electrical signals applied directly to the peri-aqueductual grey space within the brain induce addi ⁇ tional secretion of beta-endorphins which act to inhibit the reception of the pain signal at the interpretive end (the Raphe nuclear cells) .
• the pain signal is blocked from reaching a destination within the brain where it is normally interpreted and analgesia results.
• the DBP processes are unsatisfactory because they require invasive techniques and are generally limited to terminal patients with extraordinary, intractable pain. It is desirable to utilize the pain relieving mechan ⁇ ism of the DBP process without the disadvantages of its invasive application.
• Dr. Ifor D. Capel which shows generally that for a se of unique frequencies, the transcranial voltage induces th secretion of beta-endorphins in the brain and leads to th same kind of analgesia as DBP processes.
• Dr. Capel has al shown that a different set of frequencies is effective fo treating the pain associated with withdrawal, as well as treating the physiological symptoms associated with with ⁇ drawal.
• Such efforts are the subject of co-pending Unite States patent application Serial No. 626,335, filed June 2 1984, the disclosure of which is incorporated by reference
• Dr. Capel has explored some effects of electrical signals on the mechanisms for neurotransmissio within the brain.
• the effect of habituating drugs on brai chemistry and cellular activity is such that both stimulan and depressants cause debilitating effects on such neuro activity which lead to long-lasting physical change and ultimately to deterioration of the cell affected.
• the debilitating effect can be reversed counteract the effect of drugs at the cellular level.
• 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 of addictive drugs.
• it is another general object of this invention provide a device with the capability of providing prescrip ⁇ tive therapeutic voltage signals of duration, amplitude, frequency, pulse width, and intermittency according to the teachings of Dr. Capel, as well as to extend these teaching with the applicant's research.
• a number of analog devices for producing waveforms suitable for the application of the TENS and PINS processes are known. However, such devices do not produce signals which are sufficiently reproducible, controllable and accurate to be merchandized as a reliable medical device. More critically, analog circuitry cannot match the diversit of waveforms producible with digital electronics, the facility for incorporating patient feedback to . modify the signal and the speed with which these processes can be conducted using digital electronic means.
• a method and apparatus comprises means for developing and generating a reliable, reproducible, program-controlled, prescriptive electrical waveform, havi a desired therapeutic and alagesic effect.
• the system according to the apparatus comprises a development statio and a control unit for developing and storing a prescripti waveform of the type described, available for insertion in a personal delivery instrument (PDI) .
• PDI personal delivery instrument
• the personal delivery instrument comprises means for receiving and storing the developed prescriptive waveform from the control unit for delivery of an accurately-controlled waveform to the pa ⁇ tient.
• the PDI includes a central processing unit, having ROM and a RAM for programming a voltage source powered by battery, to provide the desired waveform transcranially t the head of a patient.
• Means are provided for monitoring the signal applied to the patient, comparing it with the prescribed signal characteristic stored according to the prescription from the control unit and by noting discrep ⁇ ancies, correcting the applied signals.
• the signal actual applied to the patient can be recorded.
• any differences from the prescription in the signal actually delivered to the patient are also recorded for subsequent use in analyzing and improving subsequent prescriptive programs for application to that patient and others.
• the actually .delivered signal will be affected by the change over time of the impedance of the patient and, therefore, not corrected, the applied signal will drift away from th prescriptive signal.
• the actually delivered signal can also b used as a feedback signal to continuously correct the sign applied to the patient back to the intended prescriptive signal.
• the PDI includes components for accurately controllin each of the parameters of a train of pulses and for adjust ing the signals so that the net voltage charge applied to the patient is zero.
• a set of pulses is referred to as a packet and a train is a set of packets.
• the definition of the waveform includes:
• the pulse frequency or frequencies, f. since t prescription may include pulses delivered at more than on frequency, where f. is the frequency of the pulses in th ith packet;
• the instrument is capable of delivering a prescriptive programmed waveform defined by the set of parameters noted above, i.e.
• th prescription may include packets and pulses at different frequencies, where the packets may have different amplitud and pulse widths.
• the method according to the invention is also disclose discussing a number of internal tests and verifications for security and monitoring.
• Means are provided for delivering the signals from the PDI to the patient by leads from a machine attached to the pinnae, ear lobe, mastoid process, or to other contact points chosen because of their affinity for changing endogenous concentrations of neurotransmitters or neuromodulators.
• Electrode design and placement on different parts of the ears are important features in the overall system. Placement of the electrodes so that the positive pole is on the motor-dominant side of the patient is necessary to achieve optimum result.
• the electrode must be sharp enough to deliver a high -areal current density but not so sharp that it will penetrate the skin. The placement is critical
• the electrodes must be placed in contact with points on the ears which have been tested and display locally greatest electrical conductivity, and in the general location on the ear to stimulate one of the selected major cranial nerves innervating the ears.
• An alternative means for delivery are provided by using radio transmission of the signal from a separate computerized controller-transmitter, containing the pa ⁇ tient's program for a particular prescriptive waveform, wit the reception means worn by the patient.
• the patient receiver will decode the signal and output the prescribed waveform.
• Fig. 1 is a block diagram of the system, including th personal delivery instrument for applying prescriptive signals transcranially to a patient according to the invention
• Fig. 2A is a generalized waveform for illustrating th parameters controlled by the device in Fig. 1 for achievin an accurate prescription for transmission to a patient an for analysis showing a typical wave packet i of pulses;
• Fig. 2B is a similar generalized waveform of a typica train of packets j;
• Fig. 2C shows a similar generalized .waveform of a typical prescription of trains J;
• Fig. 2D is a chart of the parameters of the prescrip ⁇ tion delivered by the instrument.
• Fig. 3 is a more complex waveform of the type-hereto fore applied to a patient capable of being analyzed by th system according to the invention
• Fig. 4 is a drawing similar to Fig. 3 showing the us of the device in analyzing the waveform of the type of Fig 3;
• Fig. 5 is an exemplary program sequence for inputtin the prescriptive waveform from the control unit to the PDI;
• Fig. 6 is an exemplary program sequence for monitorin the prescriptive waveform delivered from the PDI to a patient
• Fig. 7 is a representative drawing showing the applica ⁇ tion of the prescriptive waveform to the Shen Men acupoint of a patient
• Figs. 8A-8C are block diagrams showing several modes of transmitting the prescriptive waveform to a patient
• Fig. 9 is a more detailed functional block diagram of the personal delivery instrument of the type shown in Fig.
• Fig. 10 is a more detailed functional block diagram of a controlled signal generator unit of the PDI
• Fig. 11 is a general block diagram illustrating the use of a monitor for changing the applied signal delivered to a patient
• Fig. 12 is a graph of an alternate applied signal current level as applied to a patient
• Fig. 13 is a graphical analysis of the electrochemical effects created by two different prescriptions in accordance with the present invention.
• Fig. 14 is a graphical comparison of two different trains in accordance with the present invention and their resulting effects
• Fig. 15 is an application switching connection scheme for applying a prescriptive signal in an alternate process in accordance with the invention.
• Fig. 16 is an alternate switching connection scheme for applying a prescriptive signal in yet another alternate process in accordance with the invention.
• Fig. 17 is yet another alternate switching connection scheme for applying one or more prescriptive signals in still another alternate process in accordance with the invention.
• Fig. 18 is a block diagram of the monitoring and corrective feedback scheme for use with multiple applied prescriptive signals. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• a transcranial electrical nerve stimulator 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 amelioration of pain or assistance in ameliorating stress or anxiety relate 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.
• the PDI 16 when programmed with the prescriptive electrical waveform, is used to provide current signals transcranially to the head 21 of a patient either by direct connection 22, as shown in Fig.
• control unit 18 is usable by medical personnel to program the required 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.
• the prescriptive waveforms having the extended thera ⁇ Commissionic effects are disclosed in detail in the above-mentioned pending patent application of Ifor D. Capel while other signal prescriptions have been known to inves ⁇ tigators for research on patients or animals in developing acceptable prescriptions. It is contemplated that the device according to the invention is capable of delivering any of such prescriptive waveforms to a patient, upon identification of the parameters of the waveform, includin their sequence.
• the PDI 16 includes a delivery control unit 24 havin central processing unit 25, a ROM 26, and a RAM 27 for precisely programming the operation of a pulse electrica source 28 connected to a power source 28a to provide th desired waveform on a output lead 22 connected to the he of the patient.
• Monitoring means 29 are provided for monitoring th signal applied to the patient and comparing it in the delivery control unit 24 with the prescribed characterist stored therein from the control unit 18 for noting discre ancies and correcting the applied signals.
• the differenc noted are used to correct the original signal output of t personal delivery instrument (PDI) 16 for storing data accurately representative of the actual application of signal to the patient for analysis, to develop subsequen prescriptive programs, and to improve existing prescripti programs for application either to that patient or others returning the stored data on an output to the control un 18 for interfacing on lead 31 with the development stati 20.
• a developed or modified prescriptiv program prepared at the development station 20 may be transferred by the interface 19 to the control unit 18, to a plurality of such control units located at a number locations, such as hospitals.
• the control unit 18 also operates with respect to t PDI 16 to perform a number of additional functions. Th control unit 18 thus may reset the PDI 16 to prepare it f reception of a new prescriptive program, interrogate fo current operational conditions and errors, perform appro priate internal verifications, communicate selected appli tions to the PDI in simple or encrypted format, verify t correct receipt of the prescriptive program by the PDI 1 communicate a current time, a and request statistics fro the PDI 16. -13 -
• the PDI 16 after communication of series of instructions from the control unit 18, outputs a 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 PD 16 may also be programmed to provide either a low frequenc or a high frequency sequence wave modulation to the output pulse, acting to turn on or off the output pulse so that th 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).
• a 146805 CMO 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 operationa amplifiers to generate the output signal, and CMOS LSI logic.
• the control unit 18, for compatibility, may utiliz a 16 bit computer with floppy discs to store the program sequence parameters to insure media compatibility with the development station 20.
• the development station may com ⁇ prise 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 prescrip ⁇ tion.
• Figs. 2A-2D illustrate a generalized depiction of an electrical waveform for analyzing a train of pulses comprising a plurality of irregularly spaced packets of pulses wherein the pulses in each packet are also controlled.
• the PDI 16 includes a pulse profile controller which produces a waveform, the components of which are shown respectively in Figs. 2A, 2B and 2C.
• the pulse frequency f. may vary either within packet i or between adjacent packets so that the prescrip tive waveform includes a specification of the pulse fre ⁇ quency or frequencies f. , where f. is the frequency of th pulses in the i packet.
• the PDI 1 delivers a pulse having a positive pulse amplitude A . fo each pulse in each packet of each train forming the pre ⁇ scription. While Fig. 2A shows positive and negative puls A , A , of approximately the same respective amplitudes, t
• the PD 16 produces a waveform which includes a specification of t positive pulse duration S . for each pulse in each packet each train forming the prescription, and the negative puls duration S . for each pulse in each packet of each train forming the prescription, and the negative pulse duration S . for each pulse in each packet of each train forming th prescription, as well as the number of pulses in each packet, n..
• the PDI 16 also delivers a train of packets i of pulses of the type shown in Fig. 2A.
• the PDI 16 thus also controls the respective times between th delivery of adjacent packets where the time between the first packet and the second packet, for example, is noted ..t ⁇ so that for a generalized case, the instrument deliver packets at the time .. ..t. for packet i.
• the instrument 16 also delivers prescription of trains J of packets i where the time betwee adjacent trains is controlled according to the generalize expression / ⁇ i x T., where the time between respective adjacent trains during the prescription by vary.
• the entir prescription includes M trains and N packets in the pre ⁇ scriptive train j.
• the instrument is capable of delivering a prescriptive program waveform defined by the parameters shown in Fig. 2D under the conditions wherein the product ApSp is equal to AnSn t deliver a zero net charge.
• Such synthesized pulse trains eliminate to the extent possible a polarization demyelination of the nerve sheath o the patient, conditioning the patient, and provide the investigator the maximum opportunity for accurate simulatio of the communication protocols of the brain of the patient.
• Fig. 3 is a more complex waveform which may also be analyzed according to the application of the techniques o the invention. Because the prior art devices for applying TENS signals to patients tended to output a signal-like tha shown in Fig. 3, this particular waveform is of special interest to investigators.
• Such a waveform 33 can be analyzed by the instrument o the invention by inputting it or a reproduction of the waveform to the monitoring means 29 to produce a program fo determining by approximation its constituents as shown in Fig. 4.
• the investigator has a common basis for comparison of new prescriptions with former applications.
• Fig. 5 is a program for transferring the signal pre ⁇ scription from the control unit 18 to the PDI 16.
• the patient identification such as name and cod number
• the patient identification is input to the control until 18 and a brief description and other identifying data concerning the patient profile are input in steps 36 and 37.
• the patien code is checked for accuracy against a user identificationio for security in step 39 and, if incorrect, the prescriptio will not be loaded from the control unit 18 into the PDI 1 and the program returns to the input step 36. If correct, the treatment code is input in sequence 38 containing the prescription for a precise wave train to be applied to t patient.
• more than one prescription is provided by sequentially inputting the frequency, the amplitude A , of the positive pulse, the sequence S . of positive pulse, the amplitude A . of the negative pulse, the duration S . of the negative pulse in steps 40, 41, 4
• steps 45 the product of A .S is calculated and the product Am.Sni. is calculated, the calculated products are compared to provide a net zero current, and a correction signal is input in step 45a.
• An appropria final check may be made at step 52 to insure complete delivery of all prescriptive components, if desired.
• Fig. 6 is a block diagram of a representative sequen for checking and correcting the prescriptive delivery.
• the system commanded in step 57 to perform sequence of internal delivery service checks of the batte in sequence 58, of the RAM in sequence 59, of any other appropriate components 59a, and of the circuit by monitor the circuit using test voltages in step 60.
• the prescriptive wave train stored in accordance w Fig. 5 is initiated in step 62 and the delivery of that prescription is monitored at predetermined intervals by sequentially interrogating at intervals Q the components o 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 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 he control unit 18 and for use a the development station 20 for analysis.
• Fig. 7 shows a portion of the ear of a patient illus ⁇ trating the application of the electrodes 22 to selected contact points on the ear of a patient.
• electrical signals or other processes were delivered to a patient by direct application of the prescribed voltage through electrodes placed on selected elements of the ear o the mastoid process.
• the precisely controlled prescriptive electrical signals according to the invention are applied to selected points of the ear having optimal conductivity. These contact points are chosen because of their known affinity for changing endogenous concentrations of neurotransmitters or neuromodulators in the brain.
• the application of th;e_ prescriptive signals at these points optimizes 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.
• Fig. 8A contemplates a delivery control unit 24' miniaturized to be worn by the patient or further miniaturized to become a part of a non-invasive application appearing similar to a hearing aid or eyeglasses with enlarged ear lobes.
• the control unit 18' similar to control unit 18, is connected to a RF transmitter 102 for transmitting all of the signals for loading and applying the prescriptiv waveforms to the unit for rece tion by an RF receiver 104 connected to the delivery control unit 24'.
• the delivery control unit 24' may be loaded and the prescriptive electrical signal delivered at the patient.
• Such radio transmission may require additional security coding to prevent erasing a preloaded delivery control unit 24'.
• the delivery control unit 24' may comprise a cassette or cartridge preloaded with the prescriptive electrical signal from a control unit 18' to b activated by a secured RF transmitted signal. Either of th foregoing embodiments permits a patient significant increas in freedom of movement while undergoing treatment.
• Fig. 8B is representative of an embodiment wherein a control unit 18' and a delivery control unit 24' operate as described in connection with Fig. 1 but where the prescrip ⁇ tive waveform is transmitted by an RF transmitter 102' to b received by an RF receiver 104' at the patient in a suitabl patient device 105, such an ear piece or radio receiver.
• the RF transmitter/receiver pair may comprise a pair of transceivers suitably secured for two-way communication of the transmitted and monitored data.
• Fig. 8C is similar to Fi ⁇ B wherein the patient device is an implant 105a to illustrate an embodiment wherein the prescriptive waveform is radio transmitted to a implanted receiver at the patient to achieve the desired therapeutic effects.
• Fig. 9 is a functional block diagram of the PDI 16 according to its presently preferred embodiment for incor ⁇ poration in a portable desk top unit.
• the princi ⁇ ples of the invention may be embodied in a device sized to be protable with the patient as in Figs. 8A-8C while receiv ⁇ ing the applied signal characteristics, such as discussed in connection with such illustrations.
• the embodiment of Fig. 9 is designed to provide tire electrical signal characteristics of the type described, t power requirements, memory requirements, display, key boar connectors and operational requirements 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 illiamp peak outpu current programmable throughout the range of zero to maxim current with limitations on the maximum output current fo patient safety.
• the frequencies of the pulses are provide in a range of 0.5 hz to 500 hz with a one percent deviatio or less from optimum throughout the range of primary inter est in implementing the waveform prescription according t the aforementioned identified patent application of Ifor D Capel.
• the frequency range and pulse shape are programmab and provided with a 100 microsecond sampling interval, fr example.
• the modulating wave may" be provided in a suitable range, f example, 5.0 Khz -to 100 Khz for high frequency modulation whereas low frequency modulation of the output current pul is selectable in predetermined time increments, such as 0. minutes, up to 20 minutes, on an on/off basis.
• the ramp time exhibited by the wave pulses i.e., the tim lapse necessary to change from zero to the programmed outp current
• the unit is designed to meet load characteristics approximately 200,000 ohms in parallel with a 0.10 microfarad capacitance.
• the unit is preferably powered b an internal dual power supply having a battery and a backu to insure data retention in the case of power failure. data retention feature is also provided as will be dis ⁇ cussed.
• the internal clock is accurate to 0. percent.
• the display is preferably a one digit LED displa capable of generating numbers zero to nine while the key ⁇ board is preferably a one button unit.
• the speaker for emitting audible warning signals, may generate audio signa as desired, for example, form two seconds to five minute increments.
• Connections of the PDI 16 to the patient are provided by conventional plugs and jacks and, as described, the unit is capable of a self-test sequence, a main line sequence, and data monitoring storage sequencing. As described, the unit is capable of generating current pulse of defined amplitude and duration, with high frequency and low frequency modulation ranging from .05 hz to 500 hz according to the program stored therein according to the waveform prescription discussed in connection with Figs. 2A-2C and 5. The self-diagnostic sequence for the unit ha been discussed in connection with Fig. 6.
• the unit is intended for operation over a five hour period so that current pulses on the order of or less than 25 micro ⁇ amperes provided to a 200,000 ohms load require a 0.1 watt signal (because of the unique parameters of the waveforms) permitting selection of a battery source to meet the operat ing parameters.
• the PDI 16 comprises a plurality of functional modules.
• the controller 80 provide for the timing and control of all of the units and acts as an interface between any two modules.
• the display numeric module 81 is used as a status indicator, while the keyboar module 82 is used to command data input to establish the program sequence described in connection with Fig. 5.
• the alarm module 83 may be actuated as described in connection with Fig. 6 to obtain operator attention, as described in connection with step 61.
• the alarm module not only functions as an alarm, but also monitors the time between activities and the starting and stopping time to associate the data generation with the status of the patient.
• the program 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 wel as the results of the tests and signal schedule in the dat storage module 85.
• the battery indicator module 86 monitors the condition of the battery source in the system to provide an indicatio when the battery needs charging, while the Input/Output por module 87 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 created according to the discussions of Figs. 1 and 3 by the program sequence.
• the PDI as shown in Fig. 9 is capable of performing program scheduling, signal generation, self-testing, data output, and battery charging or changing. Each of these modes have been described in connection with Figs. 1-8C above.
• 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 interface betwee different modules.
• 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 t 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 generate 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 91.
• 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 opera ⁇ tional amplifiers to generate a electrical differential at the output.
• a bipolar signal from the operational amplifiers can generate current flowing in either direction through the electrodes 22, connected to terminals El and E2.
• the binary numbers are selected to generate the pulse or inverse current signal with an 8 bit resolution.
• the micropr cessor control unit selects the binary number determined the software.
• Input/output module 87 controls all of the input an output activity of the PDI.
• the output comprises plurality of signal channels for output of status informa tion and input of programming sequencing, two of which ar dedicated to the use of electrodes and another of which i for recharging, if a recharge cable battery is selected.
• FIG. 11 a simplified block diagram an apparatus for delivering a prescriptive signal to a hum patient 100 is shown.
• the system comprises generally a control computer 102 and a delivery system 104, both of which can be substantially identical to similar devices previously described.
• Monitor 106 shown in Fig. 11 is connected to contact points of the patient so as to actual monitor a plurality of the parameters of the signal as th are applied to the patient. Specifically, the voltage, current and frequency parameters are monitored. As men ⁇ tioned above, one preferred frequency is approximately 10 Hz, the preferred voltage is in the range of 1 to 4 volts and the current is in the size range of approximately 10-1 microamperes.
• Fig. 12 illustrates that the current level is reduced from maximum at the onset of treatment to a minimum at the end o the treatment.
• the feedback mechanism of voltage, current and frequency which was discussed with reference to Fig. 1 are compatible to support the application of current at a the reduction level over a period of time.
• a typical number of pulses in a packet is 256.
• the typical positive cycle of the pulse is about six times the amplitude of the negative cycle of the pulse.
• eac frequency or repetition rate of pulses relates favorably t a unique ratio of pulses per packet and pauses between packets to achieve optimal results.
• a packet of a burst of pulses all of the same width, exhibiting a zero net charge characteris tic and constant in frequency as previously described differs in making an effect on the patient merely because the pauses between packets in the train are different.
• Thi is illustrated for achieving a first effect and a second effect as shown in Fig. 14.
• Electrode design has progressed to the point where molds can be made of th contour of the individual patient's pinnae.
• Contact elec trodes are embedded in the molds with locations that correspond to the contact point or points on the skin of t ear that show the greatest electrical conductivity.
• Thes points as previously mentioned are those points selected because of their known affinity for changing the endogeno concentrations of neurotransmitters and neuromodulators i the brain.
• the molds can be removed and reinserted many times and the electrodes will return to the correct conta point positions. Molds can be made to accommodate multip electrodes to access more than one contact point simul ⁇ taneously, if desired.
• a given prescription A 108 can be appli through switch 110 so as to be applied to a first pair o contact points 112 to achieve a first effect or alternate to a second pair of contact points 114 for accomplishing desired second effect.
• Fig. 16 illustrates the capability of switching betwe a prescription A having a first pulse frequency provided memory device 116 and a second prescription B having a pul frequency at a second frequency stored in a control devic 118.
• Prescription A for causing a first effect can be applied through switch 120 to a first pair of contact poin or alternately through switch 120 to a second pair of contact points to cause a second effect on the patient.
• prescription B can be selected from devi 118 through switch 122 to be applied to the first pair o contact points or alternately to the second pair of conta points.
• switches 120 and 122 can be electronic switches that cycle on a time shared basis between the two positions with each set of contacts at the respective switches.
• the prescription delivery system is desirably capable of gen ⁇ erating each different waveform, outputting them to the appropriate electrode pair and monitoring the output so as to maintain the parameters within the limits of accuracy required.
• the simplified block diagram shown in Fig. 17 accomplishes this.
• the prescrip ⁇ tion delivery system 124 produces up to four different electrical prescriptions through an appropriate switching combination 126 so as to apply the prescriptions simultan ⁇ eously or in sequence to four electrode pairs 128.
• Each of thesfe electrode pairs is appropriately monitored by monitor ⁇ ing device 130, the output of which is fed back to the prescription delivery system.
• Fig. 18 illustrates the effect of the feedback mechan ⁇ ism for correcting the signals delivered to the patient.
• Storing means 130 including controlling means 132, is connected to the delivery means 134, including at least two signal sources 136 and 138. As mentioned above, it is common for there to be up to four signal sources in an actual delivering means 134.
• the output from signal source 136 and signal source 138 are initially determined by the prescriptive input from controlling means 132 which is applied to patient 140.
• the output from the patient is detected by voltage, current, frequency (V,I,F) monitor 142 for the first signal and by V,I,F monitor 144 for the second signal.
• the feedback from these respective monitors are applied to comparison means 146 and 148, respectively, in the delivering means.
• each of the prescriptions is delivered to the patient within the prescribed parameters o the prescription at all times.

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• 1987
  • 1987-06-10 AU AU77089/87A patent/AU601203B2/en not_active Ceased
  • 1987-06-10 EP EP87904754A patent/EP0272318A1/en not_active Withdrawn
  • 1987-06-10 BR BR8707351A patent/BR8707351A/pt not_active Application Discontinuation
  • 1987-06-10 WO PCT/US1987/001438 patent/WO1987007511A2/en not_active Application Discontinuation
  • 1987-06-12 CA CA000539498A patent/CA1310069C/en not_active Expired - Lifetime
• 1988
  • 1988-02-15 DK DK076088A patent/DK76088A/da not_active Application Discontinuation
  • 1988-02-15 FI FI880696A patent/FI880696A0/fi not_active Application Discontinuation
  • 1988-02-16 KR KR1019880700187A patent/KR880701121A/ko not_active Application Discontinuation

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