WO2011106225A2

WO2011106225A2 - Apparatus and method for treatment of pain with body impedance analyzer

Info

Publication number: WO2011106225A2
Application number: PCT/US2011/025162
Authority: WO
Inventors: John Crosson; David Weinkle
Original assignee: Newlife Sciences Llc
Priority date: 2010-02-26
Filing date: 2011-02-17
Publication date: 2011-09-01
Also published as: WO2011106225A3

Abstract

A patient treatment unit and method analyzes and treats pain in tissues by applying an electrical pulse train to the affected tissue. The impedance of the affected tissue is measured, and the measured impedance is correlated to a level of pain in the patient. The pulse train is further applied in response to the measured impedance to reduce the patient's pain. The patient treatment unit includes a probe stimulus generator that outputs the pulse train. The treatment unit also includes a pair of probes for contacting the patient's body and receiving the pulse train. The unit further includes a body impedance analysis circuit that senses voltage and current via the probes when the probes are contacting the patient and observe the impedance. A monitor is electrically coupled to the body impedance analysis circuit and provides an indication of the measured impedance indicative of the patient's level of pain.

Description

APPARATUS AND METHOD FOR TREATMENT OF PAIN

WITH BODY IMPEDANCE ANALYZER

FIELD OF THE PRESENT DISCLOSURE

[0001] The present disclosure relates to a patient treatment unit and method for analyzing and treating pain in human or animal tissues. More particularly, aspects of the present disclosure relate to an apparatus and method for evaluating and treating chronic or acute pain with a dual-probe patient treatment unit (PTU).

BACKGROUND

[0002] Electrical stimulation may be used for pain management. One such therapy is transcutaneous electrical nerve stimulation (TENS) therapy, which provides short-term pain relief. Electrical nerve stimulation and electrothermal therapy may also be used to relieve pain associated with various conditions, including back pain. Additionally, intradiscal electrothermal therapy (IDET) is a treatment option for patients with low back pain resulting from intervertebral disc problems.

[0003] Pain is typically attributable to a stimulus on nerve endings, which transmits signal impulses to the brain. This type of pain is referred to as nociceptive pain, a somatic sensation of pain, where a patient is made aware of potential tissue damage by neural processes encoding and processing noxious stimuli. The sensation is initiated by nociceptors that detect mechanical, thermal, or chemical changes above a pain threshold. Once stimulated, a nociceptor transmits a signal within the central nervous system through neurons. Each neuron transmits impulse information about the stimulus on the nerve endings along portions of the central nervous system transmission pathway.

[0004] Non-nociceptive pain is referred to as neuropathic pain or neuralgia.

Neuralgia is pain produced by a change in neurological structure or function. Unlike nociceptive pain, neuralgia exists with no continuous nociceptive input. That is, neuralgia may develop without any actual impending tissue damage. Neuralgia may involve a disease of the nervous system, including an underlying disease process or injury, or from

inflammation, infection, and compression or physical irritation of a nerve. Neuralgia is a form of chronic pain and can be extremely difficult to diagnose and treat.

[0005] Pain sensations may be gated naturally, such as when pain sensation is inhibited by activation of large diameter afferent neurons activated by vibration, such as when someone burns their hand, and it is involuntarily shaken in response. Transcutaneous electrical nerve stimulation also employs this technique by applying electrical nerve stimulating impulses from an external stimulator to reduce transmission of pain signals to the brain.

[0006] Transcutaneous electrical nerve stimulation (TENS) therapy may be used to treat both nociceptor pain and neuralgia. In TENS therapy, an electrical current is applied through the skin near the source of pain. The current is often delivered via electrodes. The current from the electrodes stimulates nerves in the affected area and sends signals to the brain that activate receptors in the central nervous system to reduce normal pain perception.

[0007] In Textbook of Pain (Butler & Tanner Ltd., 3^rd Ed. 1994, pp. 59-62), authors

Melzack and Walls proposed a gate theory to describe the manner in which transcutaneous electrical nerve stimulation devices interfere with pain. Melzack and Walls suggest that TENS devices generate an artificial abnormal noise on the neural pathways that are shared with the pain fibers conducting the real pain impulses. When the transmission of pain impulses from that region of the body are received by the central nervous system, the impulses are "gated." That is, the transmission of the pain impulses is altered, changed, or modulated in the central nervous system by the artificial signals. As the central nervous system receives the barrage of signals from the stimulated region of the body, a neurological circuit closes a gate and stops relaying the pain impulses to the brain.

[0008] Gating is affected by the degree of activity in the large diameter and the small diameter nerve fibers. Nerve transmissions carried by large nerve fibers travel more quickly than nerve transmissions carried by small nerve fibers. As such, transcutaneous electrical nerve stimulation to large nerve fibers travel to the brain more quickly and are more powerful than pain impulses carried by smaller nerve fibers. Thus, the transcutaneous electrical impulses often arrive at the brain sooner than the pain nerve impulses, and the sensation of the large nerves overrides and blocks out the sensations from the smaller pain nerves. That is, impulses along the larger fibers tend to block pain transmission (close the gates) and more activity in the smaller fibers tends to facilitate transmission (open the gates). The gating mechanism in the spinal cord is affected by descending impulses from the brain. Large fibers may activate specific cognitive processes in the brain, which then influence the gate by downward (descending) impulse transmission. [0009] Another theory regarding the pain reducing effect of transcutaneous electrical nerve stimulation devices is based on the understanding of serotonin and other chemical neurotransmitters that participate in the pain and the pain reduction processes in the central nervous system. Transcutaneous electrical nerve stimulation devices produce their effects by activating opioid receptors in the central nervous system. For example, high frequency transcutaneous electrical nerve stimulation activates delta-opioid receptors both in the spinal cord and supraspinally in the medulla, while low frequency transcutaneous electrical nerve stimulation activates mu-opioid receptors both in the spinal cord and supraspinally. Further high frequency transcutaneous electrical nerve stimulation reduces excitation of central neurons that transmit nociceptive information, reduces release of excitatory neurotransmitters such as glutamate, and increases the release of inhibitory neurotransmitters, including GABA, in the spinal cord, and activates muscarinic receptors centrally to produce analgesia. Low frequency TENS also releases serotonin and activates serotonin receptors in the spinal cord, releases GABA, and activates muscarinic receptors to reduce excitability of nociceptive neurons in the spinal cord.

[0010] By applying an electrical field to nervous system tissue, electrical stimulation can effectively reduce or mask certain types of pain transmitted from regions of the body. Pain perception may be inhibited by the applied electrical signals interfering with nerve transmission pathways carrying a pain transmission.

[0011] However, electrical stimulation intended to manage or control a pain condition may inadvertently interfere with other nerve transmission pathways in adjacent nervous tissue. Because neuro stimulation devices must apply electrical energy across a wide variety of tissues and fluids, the amount of stimulation energy needed to provide the desired amount of pain relief is difficult to precisely control. As such, increasing amounts of energy may be required to ensure sufficient stimulation energy reaches the desired stimulation area.

However, as the applied stimulation energy increases, so does the likelihood of damage of surrounding tissue, structures, or neural pathways.

[0012] To provide pain relief, the targeted tissue must be stimulated, but the applied electrical energy should be properly controlled, and the amount and duration of energy applied to surrounding or otherwise non-targeted tissue must be minimized or eliminated. An improperly controlled electric pulse may not only be ineffective in controlling or managing pain, but it may inadvertently interfere with the proper neural pathways of adjacent spinal nervous tissue.

SUMMARY

[0013] A system and method in accordance with the present disclosure delivers stimulation energy to a patient precisely and accurately and avoids many of the pitfalls of conventional systems.

[0014] A patient treatment unit and method in accordance with the present disclosure analyzes and treats pain in human or animal tissues by applying an electrical pulse train to the affected tissue. The impedance of the affected tissue is measured, and the measured impedance is correlated to a level of pain in the patient. While monitoring the impedance, an additional pulse train is further applied and manipulated based upon the monitored impedance to reduce the patient's pain. The patient treatment unit includes a probe stimulus generator that outputs an electrical pulse train sequence or other specific electrical waveforms. The probe stimulus generator controls the pulse frequency and the pulse width of the electrical pulse train. The pulse width and carrier current can be varied to control the intensity of the electrical pulse train. The electrical pulse sequence output by the probe stimulus generator can includes a stimulus profile that is based upon the surface and tissue impedance of the patient or can be a modified electrical pulse train based on the impedance response of the tissue of the patient. Of course, other waveforms can also be used depending upon the desired frequency (which can range from 4kHz to 20kHz in a non-limiting example), pulse width, carrier current, waveform polarity, and intensity.

[0015] The treatment unit also includes a pair of electrically conductive probes for receiving the electrical pulse train and applying the pulse train to the patient' s body. The probes are electrically coupled to the probe stimulus generator to receive the sequence of electrical pulses. The system and method of the present disclosure enables treatment of wide ranges and types of patients using a patient treatment unit capable of delivering higher power pulse trains and more accurately reading the impedance measurements over a wide range of patient body types and tissue types.

[0016] The patient treatment unit further includes a body impedance analysis circuit that senses voltage and current via the probes when the probes are contacting the patient. The sensed voltage and current provides a means to measure the impedance of the examined tissue and to vary the position of the applied electrical pulse train, the frequency of the pulse train, the pulse width, the carrier current, and the like, as treatment progresses and the applied waveforms reduce the patient's pain. The treatment unit also includes a monitor that is electrically coupled to the body impedance analysis circuit that provides an audio, visual, or other indication of the impedance, the sensed voltage, or the sensed current indicative of the patient's level of pain. In this fashion, the body impedance analysis circuit can be used to measure surface and tissue impedance of the patient using the sensed voltage or current from the probes. The body impedance analysis circuit can also be used to measure the electrical phase of the voltage and current sensed from the probes and can include a filtering circuit in which waveform ripples in the sensed voltage or current are corrected. The monitor device can include an audio output with a frequency cut off volume that provides an indication of the sensed voltage or current or a visual indication of the determined impedance.

[0017] The body impedance analysis circuit of the present disclosure accurately and effectively measures voltage, current, and impedance using the probes. The body impedance analysis circuit employs electrical components with strict material tolerances that provide accurate impedance measurements over a wide range of patients, thereby enabling treatment planning and pain treatment of a patients with many body types and impedances. The body impedance analysis circuit, in concert with a stable electrical pulse train provided by the probe stimulus generator that supplies stable waveforms with non- varying pulse amplitudes, pulse widths, and pulse frequencies, enabling accurate measurements that are less susceptible to electrical noise and frequency drift. The electrical pulse width, amplitude, and frequency can be controlled by a physician or other trained operator. As a result, the pain treatments can be carried out safely and effectively. Conventional transcutaneous electrical nerve stimulation devices were often susceptible to electrical noise and drift, which made it difficult for a physician or other care giver to properly determine the length and effectiveness of the treatment. Accurate waveform transmission and impedance measurements provided by a system and method of the present disclosure enable safe and effective treatment.

[0018] Additionally, a patient treatment unit in accordance with the present disclosure can include a treatment counter circuit that detects and tracks an elapsed treatment time indicative of the time the primary probe is receiving the sequence of electrical pulses. The treatment counter circuit can be used to measure and track treatments for regulatory and insurance compliance and to ensure treatment efficacy and patient safety. Likewise, the patient treatment unit can also include a coil sense circuit that evaluates the presence of a probe connection and enables the probe stimulus generator when the probes are connected to the body impedance analysis circuit. The coils sense circuit can ensure that no electrical pulse train is generated when the probes are not properly connected.

[0019] The patient treatment unit in accordance with the present disclosure can further include a wall wart power supply circuit that provides a stable and regulated 12 volt DC power source to the patient treatment unit. The probe stimulus generator can provide a handshaking signal to the power supply circuit to check for a stable and regulated 12 volt DC power source. If the power supply voltages or currents are outside a specified acceptable range, the probe stimulus generator will not be enabled, and no treatment can commence. A visual or other indication of the status of the power source can be displayed using LEDs on the patient treatment unit or by an audio or other indication.

[0020] Further, the treatment unit can also include a treatment area selection circuit that is used to select a narrow treatment area using a "direct" setting, or a diffused treatment area using an "indirect" treatment area setting. The electrical pulse train can then be applied to the selected affected treatment area in a narrow space or in a wider physical space via the probes. In the direct setting, the electrical current passing through the probes has a first polarity (e.g., positive), and in the indirect setting, the polarity of the current is reversed (e.g., negative).

[0021] The treatment unit also includes a response level circuit that is used to measure and indicate the conductivity between the probes. Also, the patient treatment unit can further include an intensity adjustment circuit that is used to measure and indicate and adjust the intensity of the electrical pulses. The intensity of the electrical pulses can be adjusted by adjusting a carrier current or the pulse width or the amplitude of the electrical pulse train. The patient treatment unit can also include a programming and debugging circuit that is used to configure the patient treatment unit and to debug processing errors in the patient treatment unit.

[0022] The patient treatment unit in accordance with the present disclosure uses electrical pulse trains to temporarily reduce chronic intractable pain. The treatment unit can also be used as an adjunctive treatment in the management of post-surgical and posttraumatic acute pain. The patient treatment unit in accordance with the present disclosure is a symptomatic treatment device, and as such, suppresses the sensation of pain that can otherwise signal potential tissue damage.

[0023] These and other advantages, aspects, and features of the present disclosure will become more apparent from the following detailed description of embodiments and implementations of the present disclosure when viewed in conjunction with the

accompanying drawings. The present disclosure is also capable of other embodiments and different embodiments, and details can be modified in various respects without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and descriptions below are to be regarded as illustrative in nature, and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The accompanying drawings illustrate an embodiment of the present disclosure and depict the above-mentioned and other features of this disclosure and the manner of attaining them. In the drawings:

[0025] FIGURE 1 is a functional block diagram illustrating a patient treatment unit in accordance with the present disclosure.

[0026] FIGURE 2 is a top view illustration of a patient treatment unit in accordance with the present disclosure.

[0027] FIGURES 3A-3D illustrate a primary treatment probe in various treatment positions and intensity levels in accordance with the present disclosure.

[0028] FIGURE 4A is an illustration of the initial device settings of a patient treatment unit in accordance with the present disclosure.

[0029] FIGURE 4B is an illustration of the algorithmic evaluation code of a patient treatment unit in accordance with the present disclosure.

[0030] FIGURES 5A - 5B show exemplary waveforms of a voltage across the probes when no load (e.g., patient's body) is present across the probes and when a load (e.g., patient's body) is present across the probes in accordance with a specific aspect of the present disclosure. [0031] FIGURES 6A-6B are process flow diagrams outlining a method of analyzing and treating pain using a patient treatment unit in accordance with the present disclosure.

DETAILED DESCRIPTION

[0032] The following detailed description refers to the accompanying drawings and to certain preferred embodiments, but the detailed description does not limit the aspects of the present disclosure. The scope of the present disclosure is defined by the appended claims and equivalents as it will be apparent to those of skill in the art that various features, variations, and modifications can be included or excluded based upon the requirements of a particular use.

[0033] The patient treatment unit sends an electrical pulse train to the patient's tissues via the primary and secondary probes to provide nerve stimulation to relieve the patient's pain. The patient treatment unit in accordance with the present disclosure receives impedance measurements from a patient's tissues using primary and secondary probes. As the electrical pulse train is applied, the impedance measurements are monitored. A drop in impedance is indicative of less resistance. The lower impedance measurements have been correlated to lower perceived levels of pain that patients experience. The patient treatment unit in accordance with the present disclosure receives impedance information from the patient's tissues, including the body's cellular network. By monitoring the received impedance information as additional electrical pulse trains are applied as pain treatment, the system and method of the present disclosure assesses and treats pain experienced by the patient's tissues and other physical structures.

[0034] In assessing and treating pain, the system and method of the present disclosure applies electrical pulse trains at the site of pain, at the tissue abnormality, or upon selected nervous system trigger points or motor points. These trigger or motor points can also coincide with acupuncture or pressure points of the body. An electrical pulse train is transmitted into the tissue and encounters the inherent impedance signature produced by the tissue or subject matter under study. The impedance information is generated by this initial analysis and measurement and can be used as a baseline measurement to plan and evaluate treatment.

[0035] In addition to evaluating and characterizing a patient's degree of pain, the system and method of the present disclosure is also used to provide therapeutic action to alleviate the pain. The patient treatment unit can provide neural stimulation to alleviate pain, reduce healing time, and upon suitable repetition of therapy, result in long-term improved pain management of the afflicted area.

[0036] Pain is reduced or eliminated by means of the electrical pulse train effect on nociceptive afferent neurons, which are sensitive to electrical stimuli as well as noxious stimuli including thermal, mechanical, and chemical stimuli as described above.

[0037] An electrical device and method for analyzing and treating abnormality of human and animal tissues includes means for delivering an electrical pulse train having an output voltage in the approximate range of 50-60 volts and a peak pulse amplitude of 190 volts. The means for delivering the electrical pulse train provide a pulse rate range of 1-490 pulses per second in a low frequency mode and a pulse rate range of 4,000 to 20,000 pulses per second in a high frequency mode, and a pulse duration range of 370-600 microseconds in the low frequency mode and 9-20 microseconds in the high frequency mode. Additionally, the means for delivering the electrical pulse train provide a maximum output current of 8.9 milliamps and a maximum charge per pulse of 7 microcoulombs. The electrical pulse train can include complex wave forms with variable frequency, variable pulse width, and AC- coupled or DC rectangular pulses.

[0038] The system also includes means for detecting and measuring impedance of the patients' tissues and subjecting the tissues to an electrical pulse train. The system further includes means for generating and applying an electrical pulse train to the tissues to reduce or nullify pain impulse signals perceived by patients.

[0039] As outlined above, a patient treatment unit in accordance with the present disclosure analyzes and treats pain in human or animal tissues by applying an electrical pulse train to the affected tissue. The impedance of the affected tissue is measured, and the measured impedance is correlated to a level of pain in the patient. While monitoring the impedance, an additional pulse train is further applied and manipulated based upon the measured impedance to reduce the patient's pain. The additional pulse train is frequency or amplitude modulated with the carrier pulse train to produce a modulated pulse train having multiple amplitude or frequency components.

[0040] FIGURE 1 shows a functional block diagram illustrating a patient treatment unit 100 in accordance with the present disclosure. The patient treatment unit 100 includes a probe stimulus generator 101 (also shown schematically in FIGURE 7) that outputs an electrical pulse train sequence. The probe stimulus generator 101 controls the pulse frequency, the pulse width, and the polarity of the electrical pulse train. The pulse width can and the carrier current be varied to control the intensity of the electrical pulse train.

Additionally, the probe stimulus generator outputs an electrical pulse train that is a clean waveform, largely free of electrical noise by using rigid electrical component tolerances in a carrier waveform generation circuit. Short leads and traces are provided between the components and close to the ground plane and circuits are simplified to mitigate the effect of electrical noise on the probe outputs. For example, the carrier waveform frequency can be set using a carrier adjustment in combination with a capacitor. This RC circuit can be adjusted to produce the desired carrier frequency of the electrical pulse train. The RC circuit values provide a stable waveform, largely free of electrical noise. Similarly, once the carrier frequency is set, the waveform is not susceptible to frequency drift.

[0041] The probe stimulus generator 101 can use a number of different electrical pulse train configurations, depending upon the treatment at hand. For example, a number of different waveforms of variable amplitude can be selected. For example, a basic square wave with a pulse width of 0.24 milliseconds and a pulse rate of 440 pulses per second with a pulse amplitude of 100 volts can be selected to treat lower back pain. In addition, the filtering of the electrical pulse train eliminates error signals that often manifest as waveform ripples.

[0042] As shown by outline OL in FIGURE 1, a number of the circuits 121, 107, 101,

121, 129, 109 can be physically mounted and manufactured on a single printed circuit board to reduce electrical noise between components and circuits. The printed circuit board (PCB) can be a multi-layer printed circuit board to further reduce ambient electrical noise and to generate a clean and error-free pulse train. The traces on the PCB are short and can be close to the ground plane of the PCB to suppress the effects of electrical noise.

[0043] The probe stimulus generator 101 also includes internal monitor functions to ensure the safety and performance of patient treatment unit 100. For example, the probe stimulus generator 101 monitors and checks power supply voltage from the power supply circuit 121 as well as a coil sense indication from the coils sense circuit 117 that the probes 103, 105 are properly connected across a proper tissue or patient. Further, the treatment counter 115 provides a handshake signal indicating a ready condition that must be detected by the probe stimulus generator 101 before a pulse train can be applied to a tissue. The probe stimulus generator 101 will not output the sequence of electrical pulses until the power supply handshake, the coils sense handshake, and the treatment counter handshake signals all indicate that these circuits 121, 117, 115 are in a ready condition.

[0044] The treatment unit also includes a pair of probes 103, 105 for receiving the electrical pulse train and applying the pulse train to the patient' s body. The pair of probes includes a primary probe 103 and a secondary probe 105 that are both electrically coupled to the probe stimulus generator 101 to receive the sequence of electrical pulses.

[0045] The primary probe 103 includes a treatment switch 333 shown in FIGURES

3A-3D that, when in a back position as shown in FIGURE 3A, causes the relative

conductivity between primary probe 103 and secondary probe 105 in a "measurement" mode to be read. In the measurement mode, a small amplitude current is applied between the probes 103, 105 to measure the impedance of the tissue to be examined. Voltage and current can be sensed and measured, and impedance readings are calculated. In the measurement mode, the treatment switch 333 activates contact level display 214 to provide a visual indication of the conductivity and impedance of the tissue under examination. When pushed forward, the treatment switch 333 activates treatment by completing a coil sense circuit 117 that enables probe stimulus generator 101 to generate an electrical pulse train output to treat the tissue under examination. When switched to the treatment mode, the probe stimulus generator 101 receives a handshake signal from the treatment counter 115. In this fashion, probe stimulus generator 101 can provide output current to the probes 103, 105 in the form of the electrical pulse train when the treatment counter 115 is in the circuit. The probe stimulus generator 101 also checks the power supply circuit 121 to ensure that proper power is provided prior to enabling output current in the form of an electrical pulse train. If the power is not adequate, or if the treatment counter 115 does not shake hands, the stimulus generator 101 is precluded from outputting the electrical pulse train. The various handshake checks are made by a handshake controller. When the patient treatment unit 100 is in the treatment mode, the impedance between the probes (and therefore the impedance of the tissue under examination) is shown in contact level display 214. Additionally, the primary probe 103 includes an intensity dial 344 shown in FIGURE 3B that controls the intensity of treatment. At the onset of treatment, the intensity dial 344 should be turned toward the back of the probe at its minimum setting. The intensity dial 344 is then turned forward toward the front of the probe 103 until the patient feels the carrier current, but is not uncomfortable. [0046] The patient treatment unit 100 further includes a body impedance analysis

(BIA) circuit 107 that senses voltage and current via the probes 103, 105 when the probes 103, 105 are contacting the patient. The sensed voltage and current provide a means to measure the impedance of the examined tissue and to vary the position of the applied electrical pulse train, the frequency of the pulse train, the pulse width, the carrier current, and the like. As indicated above with regard to the probe stimulus generator 101, by setting an accurate frequency, amplitude, and pulse width of the electrical pulse waveform, the body impedance analysis circuit 107 can determine an accurate impedance measurement of the examined tissue. Changes in impedance can be measured causally based upon the applied treatment rather than ascribed to any drift in the carrier waveform frequency or electrical noise.

[0047] The treatment unit 100 also includes a monitor circuit 109 that is electrically coupled to the body impedance analysis circuit 107 and provides an audio, visual, or other indication of the impedance, the sensed voltage, or the sensed current indicative of the patient's level of pain. The body impedance analysis circuit 107 can also simultaneously sense voltage and current associated with skin and tissue measurements as well as convert sensed readings to characterize other properties of the measured tissue such as conductivity, impedance, and the like. The indication can be provided by a speaker 111, a display monitor (not shown), or another indicator. In this fashion, the body impedance analysis circuit 107 can be used to measure surface and tissue impedance of the patient using the sensed voltage or current from the probes 103, 105 and indicated to a physician or other operator. The body impedance analysis circuit 107 can also be used to measure the electrical phase of the voltage and current sensed from the probes 103, 105 and can include a filtering circuit 113 in which waveform ripples in the sensed voltage or current are corrected. The display driver 135 can be used to illuminate LEDs 137, 139 to provide an indication of the sensitivity of the probe measurement. Of course, other visual or audio methods of indication can be used as well. The monitor circuit 109 can include an audio output to speaker 111 that includes a frequency cut off volume to provide an indication of the sensed voltage or current or a visual indication of the determined impedance.

[0048] Additionally, the patient treatment unit 100 can include a treatment counter circuit 115 that detects and tracks an elapsed treatment time indicative of the time the primary probe 103 is receiving the sequence of electrical pulses. The treatment counter circuit 115 can be used to measure and track treatments for regulatory and insurance compliance and to ensure patient safety. A visual indication of the treatment time can be presented using display 133, or an algorithmic evaluation code (AEC) indicative of the treatment time as shown in FIGURE 4A. Patient compliance with treatment is a medical concern regardless of the form of treatment. Patients must follow through with the prescribed treatments to ensure efficacy and to facilitate recovery. If a patient avoids treatment or takes part in the treatment in a manner not prescribed, the patient' s noncompliance masks any effects of the treatment. This leads to great uncertainty as to the effectiveness of the prescribed therapy and whether the current level of treatment is appropriate, or if it is in need of adjustment or

discontinuation. Patients are often unwilling to admit they are non-compliant, and when a treatment is difficult or painful, patients can choose to forgo or avoid the treatment despite proven therapeutic benefits. Misuse of the treatment weakens the economic and therapeutic incentives for health care providers and insurance companies to fund or cover the costs of the treatment.

[0049] To ensure compliance for both medical outcomes and insurance requirements, the patient treatment unit 101 includes algorithmic evaluation code display 216 as a compliance monitoring tool. The algorithmic evaluation code display 216 tracks and displays the treatment time or an indication of the treatment time during which an electrical pulse train is applied to the affected patient tissues. The algorithmic evaluation code (treatment) counter 115 runs continuously as long as the patient treatment unit 100 is in a treatment mode and thereby tracks actual treatment time. Each time the patient treatment unit 100 is powered on, the current software revision can be illuminated in the algorithmic evaluation code field display 216. The software version number remains illuminated until the patient treatment unit 100 is turned off or until the treatment is activated by pushing forward the treatment switch 333 on the primary probe 103 as shown in FIGURES 3A-3D and described below with regard to FIGURES 6A-6B. Once the treatment switch 333 is activated and treatment begins, the treatment counter 115 will take over the algorithmic evaluation code display 216, and the code display 216 will track the timed elapsed using hexadecimal numbers, decimal numbers, or another count indicator. The algorithmic evaluation code display 216 will continue to count as long as the primary probe 103 remains in treatment mode. Once the treatment switch 333 is deactivated (that is, the patient treatment unit is returned to the measurement mode), the algorithmic evaluation code 216 will stop incrementing but will remain visible. Algorithmic evaluation code display 216 will not increment until the treatment switch 333 on primary probe 103 is once again moved forward to re-start additional treatment. At that time, the algorithmic evaluation code display 216 will again continue to increment. With each patient treatment session, the starting value for algorithmic evaluation code display 216 must be noted upon commencement of the treatment session and at the end of the treatment session, the end value on the algorithmic evaluation code display 216 must be noted. These values should be recorded in the patient's file to track treatment times and compliance.

[0050] Likewise, the patient treatment unit 100 can also include a coil sense circuit

117 that evaluates the presence of a probe connection and enables the probe stimulus generator 101 when the probes 103, 105 are connected to the body impedance analysis circuit 107. The coils sense circuit 117 ensures that no electrical pulse train is generated when the probes 103, 105 are not properly connected.

[0051] The patient treatment unit 100 can further include a wall wart power supply

119 and a power supply circuit 121 that provides a stable and regulated 12 volt DC power source to the patient treatment unit 100. The stable and regulated power source helps provide an electrical pulse train free from ambient electrical noise. Further, the patient treatment unit employing a wall wart power supply 119 and a power supply 121 of the present disclosure is less susceptible to fluctuations in AC input power typically provided by convenience outlets and other conventional power receptacles. The wall wart power supply 119 and the power supply circuit 121 promote treatment efficacy and lower treatment costs by eliminating the need to replace batteries during treatment or at other inopportune times as can be the case with conventional systems.

[0052] Likewise, the wall wart power supply 119 and the power supply circuit 121 eliminate the need to monitor battery power and to make adjustments to power output once the overall power level of the battery source has dropped beneath a threshold power level. By employing the wall wart power supply 119 and the power supply circuit 121, the output signal (electrical pulse train) of the patient treatment unit is less susceptible to fluctuations following power disruptions, defective operations, or operator misuse.

[0053] The patient treatment unit 100 can also include a programming and debugging circuit 123 that is used to configure the patient treatment unit 100 and to debug processing errors in the patient treatment unit 100. The programming and debugging circuit 123 can be integral hardware to patient treatment unit 100 or can be deployed via an external input/output connection 125 to accommodate a laptop computer or other computing device that can provide input commands and receive output commands to program, analyze, and process computer instructions used to carry out a method of the present disclosure using patient treatment unit 100. The programming and debugging circuit 123 can also be used to update the computer program instructions used to carry out a method of the present disclosure.

[0054] Further, the patient treatment unit 100 can also include a treatment area selection circuit 127 that is used to select a narrow treatment area using a "direct" setting (positive polarity), or a diffused treatment area using an "indirect" treatment area setting (negative polarity). By toggling from "direct" to "indirect" modes, the polarity of the pulse train created between the primary and the secondary probes is reversed. The electrical pulse train can then be applied to the selected affected treatment area in a narrow space or in a wider physical space via the probes 103, 105.

[0055] The treatment unit 100 also includes a response level circuit 131 that is used to measure and indicate the conductivity or impedance between the probes 103, 105. Also, the patient treatment unit 100 can further include an intensity adjustment circuit 129 that is used to measure, indicate, and adjust the intensity of the electrical pulses. The intensity of the electrical pulses can be varied by adjusting a carrier current or the pulse width of the electrical pulse train using the intensity dial 344 shown in FIGURE 3D.

[0056] Exemplary electrical output specifications of patient treatment unit 100 are shown below in Table 1 :

Power Supply 115 VAC, 60 Hz

12 volt, DC output

Maximum Power Consumption 21 W

Output voltage Range of normal use: 50-60 V

Peak pulse amplitude: 190 V

Pulse Rate 1-490 and 4,000-20,000 Pulses/second, +6%

Pulse Duration 370-600 microseconds (low frequency); 9-20

microseconds (high frequency) Output Current (maximum) 8.9 milliamps

Maximum charge per pulse 7 micro coulombs

Wave Form Complex pulse trains: variable frequency, variable pulse width, AC-coupled rectangular pulse

Table 1

[0057] FIGURES 5A-5B show exemplary output waveforms of a patient treatment unit 100 in accordance with the present disclosure. FIGURES 5A-5B illustrate a number of impedance, power, and frequency relationships. For example, FIGURE 5A shows a frequency response using a 1 ΜΩ maximum impedance. The output waveform varies depending on the load as shown in FIGURE 5B. That is, FIGURE 5B shows voltage versus time when a load (such as the patient's body) is present across the probes. Changes in load affect both pulse duration and maximum pulse frequency. For example, a maximum pulse rate frequency can be in a range of 490 Hz +6% from 500 ohms to 1 ΜΩ. Lower impedances can have lower maximum pulse rates, while pulse width can be fixed for a given impedance. For example, a pulse width can be 0.74 milliseconds at 500 ohms and can be 0.24

milliseconds at 1 ΜΩ.

[0058] FIGURES 6A-6C illustrate an example method 600 to control pain using the patient treatment unit 100 in accordance with the present disclosure. In block 601, a physician or other licensed operator makes the patient treatment unit 100 ready for use by preparing the initial device settings. As illustrated in FIGURE 2 and in FIGURE 4A, the initial device settings include the volume, tone, intensity, sensitivity, tone cut-off, and carrier. The volume knob 402 is used to adjust the volume of the sound indicators from monitor circuit 109. The tone knob 404 adjusts the frequency of an audible tone that is used to communicate the level of conductivity between the probes to ensure proper probe contact with the patient's skin. The intensity knob 406 controls the carrier voltage.

Sensitivity/baseline calibration knob 412 adjusts the conductivity of the patient treatment unit. The tone cut-off knob 410 adjusts the response level at which an auditory signal will be heard. The carrier knob 408 controls the frequency of the carrier wave. Initially, the volume knob 402 is set to level of 5, and the tone knob 404 is set to a level of 0. Additionally, the intensity knob 406 is set to a level of 10, and the sensitivity/baseline calibration knob 412 is set to a level of 5. Likewise, the tone cutoff knob 410 is set to a level of 0, and the carrier knob 408 is set to a level of 10. The frequency selector switch 219 controls whether the pulses outputted by the probes are low frequency (e.g., between 1 and 490 Hz) or high frequency (e.g., between 4kHz and 20kHz).

[0059] Returning to FIGURE 6 A, in block 601 the pain is characterized. For example, in conjunction with a patient history and examination results, the patient can characterize the location and severity of the pain. The patient can describe his or her pain in order to determine the scope and size of the problem and to establish a baseline measure of the perceived pain. The patient can point out the precise location of the most intense source of discomfort. For example, the patient can use a single finger to point at and touch the exact center of the pain point. Similarly, the physician or clinician can palpate the general area until the patient confirms the exact location of the most intense pain-related trigger point. The physician or clinician can continue to palpate the area to find a secondary trigger point. Once the location of the pain is identified and characterized, in step 605 the physician or clinician notes the displayed algorithmic evaluation code prior to beginning the treatment as discussed above and shown in FIGURE 4B.

[0060] Impedance readings are used to determine the condition of the tissue under examination. A reduction in impedance during or after treatment indicates the treatment is reducing the level of pain perceived by the patient. The patient treatment unit of the present disclosure makes impedance readings in the measurement mode. Periodically during treatment, the probes are switched from the treatment mode to the measurement mode to determine the effectiveness of the treatment. If the impedance measurement is lower than the initial measure, the treatment can be deemed to be effective. If the periodic impedance measurements are not lower during treatment, treatment can be continued. Additionally, the patient treatment unit of the present disclosure can be configured to regularly switch to measurement mode during treatment to provide an ongoing, periodic display of the tissue impedance.

[0061] In block 607, the physician or clinician ensures that primary treatment probe

103 is set to the "measurement" mode, where the treatment switch 333 is placed in the back position as shown in FIGURE 3A. Additionally, the physician or clinician can select the polarity of the current applied to the probes using a switch 218 shown in FIGURE 2. The physician or clinician places the primary treatment probe 103 on the primary pain-related trigger point and the secondary treatment probe 105 on the secondary pain-related trigger point and notes the reading on the contact level display 214 as also shown in FIGURE 2. The physician or clinician adjusts the sensitivity knob 412 until a reading of, for example, 7 is achieved on the contact level display 214. A typical body impedance when a gel is applied to the area to be treated is about 20,000 Ohms.

[0062] In block 609, if a reading of, for example, 7 (on a scale of 20) cannot be achieved initially, the contact between the patient's skin and the probes 103, 105 can be inadequate, and the physician or clinician can clean the patient's skin at the pain related trigger points in step 611. For example, the physician or clinician can clean the patient's skin with an isopropyl alcohol swab and return to step 607 to place the probes 103, 105 firmly into the patient' s skin and, if a reading of 7 still cannot be achieved, the physician or clinician can move the probes to an adjacent point on the patient's skin where a contact display reading of 7 can be achieved.

[0063] Once a contact display reading of at least 7 is achieved, in block 611 the physician or clinician turns the probe intensity dial 344 fully toward the back of the probe 103 indicative of minimum intensity. In block 613, the physician or clinician pushes the treatment switch 333 forward on the primary treatment probe as shown in FIGURE 3C to select the treatment mode.

[0064] In step 615, the physician or clinician begins to adjust the intensity dial 344 forward on the primary treatment probe 103 as shown in FIGURE 3C. As indicated above, the intensity of the electrical pulse train can be controlled by increasing or decreasing the pulse width, or by increasing or decreasing the carrier current. As the physician or clinician gradually increases the intensity of the electrical pulse train, the physician or clinician monitors the patient until the patient begins to feel the carrier current. The carrier current can feel like a tingly, or prickly sensation.

[0065] In step 617, the physician or clinician asks the patient to indicate when the intensity is strong and can reach the point of discomfort. Although higher intensity provides further pain relief, the patient should not experience significant discomfort. In step 619, the physician or clinician incrementally reduces the intensity of the pulse train, and returns to step 615 to optimize the intensity of the pulse train to just before the point where the intensity level has reached the maximum intensity level in which the patient remains comfortable. In step 621, the physician or clinician notes the impedance measurement of the area to be treated. The treatment then continues in step 623 for approximately 30 seconds. It is possible during treatment that the patient will begin to feel the treatment more strongly. If this occurs in step 625, the physician or clinician can use the intensity dial 344 on the primary treatment probe 103 to reduce the intensity of the electrical pulse train to a comfortable level.

[0066] After treating the affected tissue area for approximately 30 seconds, in block

627, the physician or clinician notes the impedance measurement of the treated area. Once noted, the physician stops treatment in step 629 by pushing the treatment switch 333 back on the primary treatment probe 103 as shown in FIGURE 3D to stop the treatment and to take the probe 103 out of treatment mode. The physician or clinician then asks the patient to reassess his or her pain.

[0067] If pain remains in block 631, the physician or clinician continues to treat the pain in block 633 and moves to the next set of pain trigger points and repeats blocks 615 to 631. If the pain is remediated, or if the pain is insignificant after treatment, or if further progress in ameliorating the pain can not be made, the physician or clinician notes the impedance measurement in block 635, notes the algorithmic evaluation code in block 637, and ends the treatment.

[0068] The systems and methods of the present disclosure can be used to treat conditions such as, for example, arthritis, post surgical pain, post surgical reduction of swelling, inflammation and bruising, Osgood Schlater Disease, treatment of organ transplant patients for the purpose of reducing organ rejection, adhesive capsilitus, MS, ALS, motor neuron disease, reduction of keloid scarring treatment of skin graft sites for better

vascularization and better chance of successful graft improvement of circulation and oxygen saturation in compromised tissue and limbs, limb and digit reattachment for better chance of successful graft, improvement and normalization of conductivity in infarcted cardiac tissue, joint inflammation and injuries, fibromyalgia, reflex sympathetic dystrophy, neuralgia, peripheral neuropathy, macular degeneration, wounds and scleroderma. However, a library of tissue profiles and conductivity measurements can be employed in the system to develop a separate library of profiles for each patient as well as a baseline of healthy tissue types.

[0069] While the present disclosures have been described in connection with a number of exemplary embodiments and implementations, they are not so limited, but rather cover various modifications, and equivalent arrangements, which fall within the purview of the claims that follow.

Claims

What is claimed is:

1. A patient treatment unit for analyzing and treating pain in human or animal tissues, the treatment unit comprising:

a probe stimulus generator circuit that outputs a sequence of electrical pulses, the electrical pulses having a pulse width and a pulse frequency, the probe stimulus generator controlling the pulse frequency and the pulse width of the electrical pulses, wherein the pulse frequency is selectable up to 20kHz;

a primary probe and a secondary probe for contacting a body of a patient and electrically coupled to the probe stimulus generator to receive the sequence of electrical pulses;

a body impedance analysis circuit that senses voltage or current via the probes when the probes are contacting the body of the patient; and

a monitor device electrically coupled to the body impedance analysis circuit that provides an indication of the sensed voltage or current.

2. The patient treatment unit of claim 1 further comprising:

a treatment counter circuit that detects and tracks an elapsed treatment time indicative of the time the primary probe is receiving the sequence of electrical pulses.

3. The patient treatment unit of claim 2, wherein the treatment counter circuit is electrically coupled to the probe stimulus generator circuit and includes a handshake circuit that enables output of the sequence of electrical pulses from the probe stimulus generator when the treatment counter circuit is in a ready condition.

4. The patient treatment unit of claim 1, wherein the pulse width of the electrical pulses is in a range of substantially 0.24 - 0.74 milliseconds.

5. The patient treatment unit of claim 1, wherein the pulse frequency of the electrical pulses is in a range of substantially 1-490 Hz +6% with 500 ohms to 1 mega-ohm of resistance across the probes.

6. The patient treatment unit of claim 1, wherein the monitor device electrically coupled to the body impedance analysis circuit includes an audio output with a frequency cut off volume that provides an indication of the sensed voltage or current.

7. The patient treatment unit of claim 1 further comprising: a coil sense circuit that evaluates the presence of a probe connection and enables the probe stimulus generator when the probes are connected to the body impedance analysis circuit.

8. The patient treatment unit of claim 1 further comprising:

a wall wart power supply circuit that provides a 12 volt DC power source to the patient treatment unit.

9. The patient treatment unit of claim 8, wherein the power supply circuit is electrically coupled to the probe stimulus generator circuit and includes a handshake circuit that enables output of the sequence of electrical pulses from the probe stimulus generator when the power supply circuit is in a ready condition.

10. The patient treatment unit of claim 1 further comprising:

a programming and debugging circuit that is used to configure the patient treatment unit and to debug processing errors in the patient treatment unit.

11. The patient treatment unit of claim 1 further comprising:

a treatment area selection circuit that is used to select a narrow treatment area or a diffused treatment area.

12. The patient treatment unit of claim 1 further comprising:

a response level circuit that is used to measure and indicate the conductivity between the probes.

13. The patient treatment unit of claim 1 further comprising:

an intensity adjustment circuit that is used to measure and indicate and adjust the intensity of the electrical pulses.

14. The patient treatment unit of claim 13, wherein the intensity of the electrical pulses is adjusted by adjusting a carrier current.

15. The patient treatment unit of claim 14, wherein the maximum current output of the probe stimulus generator circuit is 8.9 milliamps.

16. The patient treatment unit of claim 1, wherein the maximum charge of the electrical pulses is 7 micro-coulombs.

17. The patient treatment unit of claim 1, wherein the body impedance analysis circuit measures surface and tissue impedance of the patient using the sensed voltage or current from the probes.

18. The patient treatment unit of claim 17, wherein the sequence of electrical pulses output by the probe stimulus generator includes a stimulus profile that is based upon the surface and tissue impedance of the tissue of the patient.

19. The patient treatment unit of claim 18, wherein the stimulus profile is an inverse wave form of the impedance response of the tissue impedance of the tissue of the patient.

20. The patient treatment unit of claim 1, wherein the body impedance analysis circuit measures electrical phase of the voltage and current sensed from the probes.

21. The patient treatment unit of claim 1, wherein the body impedance analysis circuit includes a filtering circuit in which waveform ripples in the sensed voltage or current are corrected.