Systems and methods for delivering pulsed current to biological tissue - Patents.com

Abstract

A patient treatment unit for delivering non-invasive pulsed energy as a therapy signal to biological tissue using a probe stimulus generator circuit configured to output a series of DC electrical pulses at a controlled pulse frequency of approximately 20 kHz, with the pulse voltage defined by the variable supply voltage of the probe stimulus generator circuit. The unit includes a primary probe and a secondary probe for contacting the body, an intensity adjustment circuit configured to control the variable supply voltage, and an electronic timer display configured to display elapsed time in decimal minutes and seconds format. The current of the pulses ranges from 0.1 to 2 mA while the probes are in contact with the body. The operating output voltage across the probes while conducting the therapy signal does not exceed a maximum operating output voltage of 165 VDC while the probes are in contact with the body.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. § 119 to and the benefit of U.S. Provisional Patent Application No. 62 / 860,678, entitled “System And Method For Delivering Pulsed Electric Current To Living Tissue,” filed June 12, 2019, which is incorporated by reference in its entirety.

[0002] The present invention relates generally to a device unit and method for the treatment of pain, and more particularly to delivering pulsed electrical or electromagnetic energy in a non-invasive, patient-specific manner. [Background technology]

[0003] Over the past 12 years, perhaps over 10,000 patients have been treated with the treatment unit to relieve pain. These treatments include a diverse range of patients, i.e., young, elderly, and those in between, and both male and female. The patients have a variety of health conditions, ranging from very fit (e.g., professional athletes) to deconditioned and frail. The patients typically have a very extensive medical history, including sports and other acute injuries, long-standing chronic problems, in some cases lasting 15 years or more, and symptoms that are a by-product of recently completed surgery.

[0004] The original goal of these treatments and related techniques was to reduce or eliminate people's pain, which has been accomplished to some extent. However, one problem associated with these previous treatments is that, although they have a cumulative effect, it takes many treatments, sometimes of long duration, to achieve some form of sustained pain relief. Often, as many as 15-20 treatments are required over many weeks, with each individual treatment lasting 30 minutes or more. Because sustained results require many treatments and a significant time commitment from the patient, the number and duration of such treatments (3-5 weeks) is an obstacle to the patient's commitment to continue coming for treatment, which in turn is a major disincentive to high sustained results.

[0005] Yet another problem with current treatment units is that they do not display the elapsed treatment time for a particular treatment site, session time, which is resettable for each treatment site, or in a form that is understandable by a layperson. Without a meaningful timer to show these times in a form that a layperson can understand, this can greatly reduce patient outcomes during treatment.

[0006] Yet another problem with current treatments is that the wide range of options for adjusting the frequency of the treatment current and the nearly unlimited ways in which a treatment provider can place a treatment probe on a patient's body generate infinite permutations and combinations of treatments, many or most of which are suboptimal and produce less effective results. Moreover, these suboptimal treatment choices made by treatment providers often only result in temporary pain relief, rather than curing the underlying condition and / or long-term pain relief. With approximately 24% of patients not having significant pain relief, the opportunity for more carefully considered or more precise therapy, both in terms of electromotive configuration and probe placement, would reduce the number of patients for whom therapy has not worked.

[0007] Thus, there is a great need to provide more precise treatment units and related methods in optimizing the opportunities offered by the present technology, not only to provide lasting pain relief, but also to cure and / or prevent or reduce the above and other problems. Summary of the Invention [Means for solving the problem]

[0008] The term embodiment and similar terms are intended to broadly refer to all of the subject matter of the present disclosure and the following claims. Statements containing these terms are understood not to limit the subject matter described herein, nor to limit the meaning or scope of the following claims. The embodiments of the present disclosure encompassed herein are defined by the following claims, not this summary. This summary is a high-level overview of various aspects of the present disclosure, and introduces some of the concepts that are further described in the Detailed Description section below. This summary is not intended to identify key or essential features of the claimed subject matter. This summary is also not intended to be used alone to determine the scope of the claimed subject matter. The subject matter should be understood by reference to appropriate portions of the entire specification of this disclosure, any or all drawings, and each claim.

[0009] According to an embodiment of the present disclosure, a method of treating pain or inflammation or wounds in a patient to reduce or treat pain or inflammation or wounds is disclosed, the method comprising the steps of initiating a first treatment cycle using a patient treatment unit, the first treatment cycle comprising placing a first conductor and a second conductor at a first site and a second site on biological tissue of a human or animal body in an area exhibiting pain or inflammation or wounds, the first conductor having a conductive tip, the first conductor and the second conductor being electrically coupled to a patient treatment unit having a first timer display configured to display a resettable timer, and, while the tips are in contact with the biological tissue, placing a small amount of the conductive tip and a small amount of the second conductor at a first site and a second site on the biological tissue of a human or animal body in an area exhibiting pain or inflammation or wounds. applying a strong pressure to at least the first conductor; and delivering electrical energy to the tissue through the first conductor and the second conductor in the form of a treatment signal supplied by a patient treatment unit, the treatment signal including a pulse train of DC pulses having a pulse frequency in the range of 18 to 22 kilohertz (kHz), a pulse current of 0.1 milliamps (mA) to 6.0 mA, and a pulse voltage that is dependent on a variable supply voltage supplied to a probe stimulation generator circuit and provides a maximum pulse voltage of approximately 165 volts direct current (DC) (VDC).

[0010] The method further includes, during a first treatment cycle, monitoring the elapsed time of the first treatment cycle with a timer that starts at the beginning of the first treatment cycle and ends when delivery of electrical energy is discontinued to terminate the first treatment cycle, ending the first treatment cycle and stopping the timer, and initiating a second treatment cycle, the second treatment cycle including holding or placing the first conductor at a first site or a new site on the body while applying strong pressure to at least one of the first conductor or the second conductor, holding the first conductor stationary during at least a portion of the second treatment cycle or moving the first conductor along the body during at least a portion of the second treatment cycle while delivering electrical energy through the body and maintaining the strong pressure on the first conductor, and monitoring the elapsed time of the second treatment cycle with a timer that restarts when the second treatment cycle is initiated. The method includes ending the second treatment cycle.

[0011] The first treatment cycle lasts for 2-5 minutes and the second treatment cycle has the same or a different duration relative to the first treatment cycle. The second treatment cycle lasts for a shorter duration relative to the first treatment cycle. The first treatment cycle further includes monitoring body impedance or conductivity and, in response to no change being observed during the first treatment cycle, maintaining the first conductor at the same site for the second treatment cycle. The first treatment cycle includes moving the first conductor during at least a portion of the first treatment cycle. The first treatment cycle includes moving the second conductor toward or away from the first conductor during at least a portion of the first treatment cycle.

[0012] The same firm pressure is applied to the first conductor and to the second conductor during at least one of the first treatment cycle or the second treatment cycle. The firm pressure comprises an applied weight of 0.05 to 10 pounds. The timer is displayed in decimal minutes and seconds format.

[0013] Terminating the first treatment cycle is performed by withdrawing at least one of the first conductor or the second conductor from the body to interrupt the delivery of electrical energy through the body, or by selecting a switch on the first conductor or on the second conductor or on the patient treatment unit to stop the delivery of electrical energy regardless of whether the first conductor and the second conductor are in contact with the body.

[0014] Positioning the first conductor includes positioning the first conductor in a generally orthogonal orientation relative to a body surface, the body surface corresponding to a finger, knee, shoulder, hip, joint, or nerve of the body, and positioning the first conductor includes positioning the first conductor at an approximately 45 degree angle relative to a muscle of the body.

[0015] The first treatment cycle includes moving the first conductor during at least a portion of the first treatment cycle, where moving the first conductor includes moving the first conductor around a muscle to treat a muscle trigger point of the body while maintaining the first conductor at an angle of approximately 45 degrees relative to the body. The first treatment cycle includes moving the first conductor during at least a portion of the first treatment cycle, where the conductive tip is rounded and has a ¼ inch diameter. The second conductor includes a conductive tip that is rounded and has a ¼ inch diameter.

[0016] The method can further include repeating the first treatment cycle or the second treatment cycle one or more times to accumulate a total elapsed treatment time, wherein the total elapsed treatment time does not exceed 10 minutes, and wherein the first treatment cycle or the second treatment cycle does not exceed 4 minutes.

[0017] The total elapsed time is not more than 8 minutes. The method herein can be used to treat pain or inflammation or wounds in humans or animals. The wound can include diabetic wounds, ulcers, infections, incisions, or incisional wounds.

[0018] According to another embodiment of the present disclosure, a method of treating pain or inflammation or wounds in a patient to reduce or eliminate the pain or inflammation or wounds is disclosed. The method includes initiating a treatment cycle by placing a first conductor and a second conductor on biological tissue of a human or animal body in an area exhibiting pain or inflammation or wounding, the first conductor having a rounded tip that is conductive, the first conductor and the second conductor being electrically coupled to a patient treatment unit having a first timer display configured to display a resettable activation timer; applying a firm pressure to at least the first conductor while the rounded tip is pressed against the biological tissue; and delivering electrical energy to the tissue through the first conductor and the second conductor in the form of a treatment signal supplied by the patient treatment unit, the treatment signal including a pulse train of direct current (DC) pulses having a pulse frequency in the range of 18 to 22 kilohertz (kHz), a pulse current of 0.1 milliamps (mA) to 6 mA, and a pulse voltage that is dependent on a variable supply voltage supplied to a probe stimulation generator circuit, the variable supply voltage providing a maximum pulse voltage of approximately 165 volts DC (VDC).

[0019] The method includes moving at least a first conductor along the body in a direction that the pain signal traverses the body while maintaining hard pressure on the first conductor as electrical energy is delivered through the body, monitoring the elapsed time of treatment with an operating timer that begins from the start of delivery of electrical energy through the conductor, and in response to the elapsed time having lasted a first duration, stopping the timer, retrieving the at least first conductor, placing the at least first conductor at the same or a new site on the body and applying hard pressure thereto, and resetting the timer.

[0020] Positioning the first conductor includes positioning the first conductor in a generally perpendicular orientation relative to a body surface. The body surface corresponds to a finger, knee, shoulder, hip, joint, or nerve of the body. The second conductor has a rounded tip that is conductive and is held stationary on the body while the first conductor is moved. The second conductor has a rounded tip that is conductive, and the method further includes moving the second conductor along the same direction as the first conductor or in a different direction than the first conductor is moved while maintaining a hard pressure on the second conductor. The hard pressure is in the range of 0.5 lbs / in2 to 150 lbs / in2.

[0021] The method can further include repeating the treatment cycle one or more additional times, such that the total elapsed treatment time does not exceed 10 minutes, the total elapsed treatment time does not exceed 8 minutes, the total elapsed treatment time does not exceed 6 minutes, and the duration of the treatment cycle does not exceed 4 minutes.

[0022] The method may further include repeating the treatment cycle one or more additional times until the patient subjectively reports a reduction in pain or until an objective impedance measurement obtained in the patient's treatment area drops below a threshold. The reduction in pain is at least 50% after the repetitions. The reduction in pain is at least 70% after the repetitions. The threshold objective impedance measurement is 20% of the impedance measurement at the beginning of the first duration. In response to placing at least the first conductor at the same or new site, the method may further include moving the first conductor along the body while applying firm pressure thereto.

[0023] Placing the first conductor includes placing the first conductor at approximately a 45 degree angle relative to a muscle of the body. In response to placing at least the first conductor at the same or new site, the method can include moving the first conductor along the body while applying firm pressure thereto, and moving the first conductor includes moving the first conductor around the muscle to treat a muscle trigger point of the body while maintaining the first conductor at approximately a 45 degree angle relative to the body.

[0024] The method may be performed while the human or animal is awake and alert and is not taking any medication that affects the human or animal's state of consciousness, and the human or animal is in a prone or sitting position at all times during the method.

[0025] According to yet another embodiment of the present disclosure, a patient treatment unit or device is intended to deliver non-invasive pulsed energy to biological tissue. The patient treatment unit includes a probe stimulus generator circuit configured to output a series of direct current (DC) electrical pulses as a treatment signal. The DC electrical pulses are output at a controlled pulse frequency of about 20 kilohertz (kHz) and have a pulse voltage defined by a variable supply voltage of the probe stimulus generator circuit. The patient treatment unit further includes a primary probe having a rounded tip configured to contact a human or animal body. The primary probe is electrically coupled to the probe stimulus generator circuit to receive the DC electrical pulses. The patient treatment unit further includes a secondary probe configured to contact the body. The secondary probe is electrically coupled to the probe stimulus generator circuit to complete an electrical circuit with the primary probe through the body. The patient treatment unit further includes an intensity adjustment circuit configured to control the variable supply voltage, the intensity adjustment circuit including setting the variable supply voltage to a predetermined starting voltage upon activation of the probe stimulus generator circuit. The patient treatment unit includes an electronic timer display configured to display elapsed time in a human understandable format of minutes and seconds in decimal. The elapsed time begins with each activation of the probe stimulus generator circuit and runs until the corresponding deactivation of the probe stimulus generator circuit. The current of the DC electrical pulse is in the range of 0.1 milliamps (mA) to 6 mA or 8.9 mA while the primary and secondary probes are in contact with the body. The operating output voltage across the primary and secondary probes while conducting the therapy signal does not exceed a maximum operating output voltage in the range of 150 to 165 volts DC (VDC) while the primary and secondary probes are in contact with the body. As used herein, the terms probe, conductor, and electrode may be used interchangeably. The patient treatment unit may include a primary conductor having an elongated body and a rounded tip configured to contact a human or animal body, the primary conductor being electrically coupled to a probe stimulus generator circuit to receive DC electrical pulses. The patient treatment unit may include a secondary conductor configured to contact the body and electrically coupled to the probe stimulus generator circuit to complete an electrical circuit with the primary conductor through the body. The patient treatment unit further includes a pressure sensor in the primary conductor configured to output a pressure applied to the rounded tip, the pressure sensor measuring a pressure of at least 0.5 lbs / in. 2 ~150lbs / in 2 The pressure sensor may be configured to measure the pressure at the rounded tip of the pressure sensor.

[0026] According to another embodiment of the present disclosure, a method for treating pain in a patient is aimed at reducing or eliminating the pain. The method includes applying a hard pressure with a first probe and a second probe to the patient's biological tissue in an area where pain is exhibited. The method further includes causing electrical energy to be delivered to the tissue in the form of a therapeutic signal through the probes. The therapeutic signal includes a pulse train of direct current (DC) pulses having a pulse frequency of about 20 kilohertz (kHz), a pulse current of 0.1 milliamps (mA) to 2.5 mA or 6 mA or 8.9 mA for a defined range of load impedances (e.g., derived from the range of human children and adults), and a pulse voltage that depends on a variable supply voltage provided to a probe stimulus generator circuit. The variable supply voltage provides a maximum pulse voltage of about 165 volts DC (VDC). While maintaining the hard pressure on the probes, the method further includes moving the probe along the patient's biological tissue in a direction in which the pain signal traverses the patient's body. The method further includes retrieving the probes and moving the probes to the same or a new site on the patient. The method further includes repeating the moving and withdrawing steps one or more times until the patient subjectively reports a reduction in pain or until an objective impedance measurement obtained in the patient's treatment area drops below a threshold. The method further includes tracking the elapsed time of treatment by starting at each activation of a treatment mode and stopping at each corresponding deactivation of the treatment. The method further includes displaying the elapsed time of treatment in the form of minutes and seconds.

[0027] According to yet another embodiment of the present disclosure, the patient treatment unit includes a probe stimulus generator circuit that generates a therapy signal during active operation. The therapy signal includes a pulse train of direct current (DC) pulses having a pulse frequency of about 20 kilohertz (kHz), a pulse current of 0.1 milliamps (mA) to 2.5 mA or 6 mA or 8.9 mA for a defined range of load impedances, and a pulse voltage that depends on a variable supply voltage provided to the probe stimulus generator circuit. The variable supply voltage provides a maximum pulse voltage of about 165 Volts DC (VDC). The patient treatment unit further includes a pair of conductive probes coupled to the probe stimulus generator circuit. The pair of conductive probes are for conducting the therapy signal through the body of a human or animal patient via non-invasive contact with the patient's skin as a load impedance. The patient treatment unit further includes a mode control circuit configured to activate and deactivate a therapy mode of the patient treatment unit in response to an operator input. The therapy mode is characterized by active operation of the probe stimulus generator circuit. The patient treatment unit further includes an intensity adjustment circuit configured to control the variable supply voltage to initiate each activation of the treatment mode at a predetermined starting voltage. The patient treatment unit further includes a visual display unit configured to display an elapsed time of the treatment by starting at each activation of the treatment mode and stopping at each corresponding deactivation of the treatment, the elapsed time of the treatment being displayed in the form of minutes and seconds.

[0028] The above summary is not intended to represent each embodiment or every aspect of the present disclosure. Rather, the foregoing summary merely provides some examples of some of the novel aspects and features described herein. The above features and advantages of the present disclosure, as well as other features and advantages, will be readily apparent from the following detailed description of exemplary embodiments and modes for carrying out the concepts and aspects of the present disclosure, when considered in conjunction with the accompanying drawings and the appended claims. Additional aspects of the present disclosure will be apparent to those skilled in the art in view of the detailed description of the various embodiments made with reference to the drawings, a brief description of which is provided below.

[0029] The present disclosure and its advantages and advantages will be better understood from the following description of exemplary embodiments with reference to the accompanying drawings, which depict only exemplary embodiments and therefore should not be considered as limitations on the various embodiments or the claims. [Brief description of the drawings]

[0030] [Figure 1] FIG. 2 is a functional block diagram illustrating circuit components of a patient treatment unit according to aspects of the present disclosure. [Figure 2A] FIG. 2 is a front view of the patient treatment unit of FIG. 1. [Figure 2B] 2 illustrates a primary probe of the patient treatment unit of FIG. 1, according to one embodiment. [Figure 2C] 2 illustrates a secondary probe of the patient treatment unit of FIG. 1, according to one embodiment. [Figure 3A] 13A-13C show another embodiment of a primary probe switch in a rear position for various treatment positions and intensity levels. [Figure 3B] FIG. 3B is a view of the primary probe of FIG. 3A with the switch in the rearward position, with the intensity dial facing the rearward position. [Figure 3C] FIG. 3B is a diagram of the primary treatment probe of FIG. 3A with the switch in the forward position, with the intensity dial facing the forward position. [Figure 3D] FIG. 3B is a view of the primary treatment probe of FIG. 3A with the intensity dial in the forward position and the switch in the rearward position. [Figure 4] FIG. 2 is a circuit diagram of a waveform generator of the patient treatment unit of FIG. 1. [Figure 5A] FIG. 1 is a process flow diagram outlining a method for analyzing and treating pain using a patient treatment unit. [Figure 5B] 5B is a continuation of the process flow diagram of FIG. 5A. [Figure 5C] 5C is a continuation of the process flow diagram of FIG. 5B. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to be limited to the particular forms disclosed. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

[0032] Various embodiments are described with reference to the accompanying drawings, in which like reference numerals are used throughout the drawings to designate similar or equivalent elements. The drawings are not drawn to scale and are provided merely to illustrate the present disclosure. Several aspects of the present disclosure are described below with reference to illustrative example applications. It should be understood that numerous specific details, relationships, and methods are shown to provide a thorough understanding of the present disclosure. However, one skilled in the art will readily recognize that the present disclosure can be practiced without one or more of the specific details, or with other methods. In other instances, well-known structures or operations have not been shown in detail to avoid obscuring the present disclosure. Various embodiments are not limited by the illustrated ordering of acts or events, as some acts may occur in different orders and / or simultaneously with other acts or events. Furthermore, not all illustrated acts or events are required to practice a method according to the present disclosure.

[0033] For example, elements and limitations disclosed in the Abstract, Summary, and Detailed Description sections, but not explicitly recited in the claims, should not be incorporated into the claims, either singularly or collectively, by implication, inference, or otherwise. For purposes of the detailed description of the present invention, the singular includes the plural and vice versa, unless otherwise noted. The word "including" means "including but not limited to." Furthermore, approximation words such as "about," "approximately," "substantially," "approximately," "generally," and the like, may be used herein to mean "at," "near," "approximately," "within 3-5% of," or "within acceptable manufacturing tolerances," or any logical combination thereof.

[0034] Non-invasive drug-free treatment and amelioration of pain is an effort that many have attempted to address through a myriad of therapeutic methods and means of stimulation. One area of ​​focus is the application of electrical energy directly to the skin of a person being treated for a pain condition through the tip of a metal probe that delivers a specific form of energy to the tissue. One early effort using a metal probe tip placed in direct contact with the skin was described in U.S. Pat. No. 8,064,988, which disclosed a very wide range of billion frequencies ranging from 1 Hertz (Hz) to 1 Gigahertz (GHz), along with magnetic flux densities ranging from 0.1 Gauss to 4 Tessa (or 40,000 Gauss) or 400,000 Gauss, and pulse widths of 0.34 milliseconds (ms) to 0.74 ms. Only one specific low frequency was disclosed, in the range of 1 Hz to 490 Hz. Later, for example, in U.S. Pat. No. 10,085,670, in addition to the low frequency range of 1 to 490 Hz, an additional specific frequency range of 4 kilohertz (kHz) to 20 kHz was disclosed. A machine with a frequency selector was disclosed, allowing the operator to switch between low and high frequency ranges to vary the frequency applied through the probe. Although this latter patent reduced the range of frequencies from 1 billion, those skilled in the art, of course, still continued to experiment in the range above 16,500 Hz, using many of the other electrical parameters (amplitude, pulse width, duty cycle, energy content) disclosed in these patents. Furthermore, no quantification of pressure was disclosed in U.S. Pat. No. 8,064,988, nor was there any recognition that pressure and specific electrical properties would be particularly effective in reducing pain over very short periods of time (e.g., less than 10 minutes). There was no instruction as to how long the probe with the applied energy should be placed on the patient, nor any recognition that the angle at which the probe is placed on the body makes a significant difference to pain reduction. It was not recognized whether moving one or more probes was effective in reducing pain.

[0035] Since then, according to the present disclosure, it has been discovered, with surprising results, that at least one specific frequency range centered around 20 kHz (plus or minus 10%), in combination with additional electrical parameters, is particularly effective in reducing or in many cases completely eliminating certain types of pain, including certain types of chronic pain. It has also been found that strong pressure, as described below, must be applied to at least one of the probes to which energy is applied, that the angle of the primary probe can be important depending on the area being treated (e.g., joint vs. muscle), that moving at least the primary probe can be used to "chase the pain," and that there can be a point where recovery is compromised by over-applying energy to the area being treated for an extended period of time. These and other insights, combined, result in a surprising and dramatic reduction in pain and even inflammation, and can also be used in wound treatment to shorten wound healing times and reduce pain around the wound site. Wounds that can be healed using the devices and methods disclosed herein include diabetic wounds, ulcers, infections, incisions, and incisional wounds.

[0036] Treatment times are dramatically reduced, with subjective reports of patients experiencing substantial pain reduction after just one application of probe-delivered electrical energy centered at about 20 kHz or in the range of about 18-22 kHz, with many reporting no pain after a single treatment application lasting only a few minutes. Additionally, in accordance with the present disclosure, it has been discovered that specific loading pressures, placements, and / or movements of the electrical probe during treatment application can also enhance efficacy of treatment and substantially reduce treatment times. As a result, treatment times are reduced from many hours to just a few minutes, and within treatment windows lasting only a few minutes or even 8 or 10 minutes or less, the operator of the probe needs to be guided by some visual cue as to when to move the probe or how long the probe is applying energy to a stationary site on the skin. Some patients have reported a 100% reduction in pain, i.e., complete absence of pain, within less than 8 minutes of the treatment methods disclosed herein, despite starting at 10 out of 10 before treatment.

[0037] A treatment timer circuit was disclosed in U.S. Patent No. 10,085,670 that displayed the elapsed time in hexadecimal and was used in conjunction with an algorithmic evaluation code display 216 to ensure "compliance with both medical outcomes and insurance requirements." At the start of each patient treatment session, a hexadecimal algorithmic evaluation code (AEC) had to be noted and recorded in the patient's file. This AEC code was never reset and was expressed as a hexadecimal number instead of a decimal number, representing the total cumulative treatment time that the proprietary treatment unit had been used. The use of hexadecimal numbers (e.g., AE01) made it difficult for the operator to understand how many seconds had elapsed between one treatment and another, and unless the caregiver was familiar with hexadecimal numbers, the AEC counter would not have conveyed any meaningful information to the caregiver. Additionally, because the timer was not reset, the caregiver operator had to write down or remember the treatment time from one therapy application to another. This can lead to overtreatment, inconsistent treatment times, caregiver-operator confusion, and operators simply ignoring the AEC codes, resulting in overall suboptimal treatment efficacy and, at times, overtreatment of areas with reduced or counterproductive benefit.

[0038] In accordance with the present disclosure, it has been identified that certain treatment protocols provide particularly effective results and that timing is a critical element of such protocols. The discovery that the use of treatment frequencies in the range of 18 kHz to 22 kHz increases efficacy and concomitantly reduces the required duration of treatment makes timing even more important. In addition, the discovery that probe application of DC pulses centered at a frequency of approximately 20 kHz is highly effective in treating certain pain conditions, resulting in complete pain relief within just a few minutes of a single application of treatment has proven advantageous to clearly inform the caregiver of how much treatment time has elapsed since the delivery of electrical energy to the patient to ensure that the probe is manipulated on the patient's skin in an optimal manner and at an optimal time. Additionally, the timer can be used as a training tool to assist novice operators in using the device and manipulating the probe to deliver the most effective treatment strategy to the pain or inflammation or wound in situ. Because treatment times using the therapeutic methods herein are very short in duration (e.g., 1-4 minutes from the start of delivery of electrical energy through the body to the cessation of delivery of electrical energy), a timer indicating the elapsed time from the start of delivery of electrical energy is important to notify the caregiver when to stop delivering energy and / or move one or both probes to a new site.

[0039] In addition to the characteristics of the energy applied to the body, the pressure applied to the body while the energy is being delivered through the conductors is also important in the efficacy of treating pain and reducing treatment time. Because the energy is applied through the conductors that contact the body of the patient being treated, a range of strong pressure must be applied to at least one of the conductors.

[0040] Conventional TENS electrodes that adhere to the patient's body apply negligible pressure to the body. A typical TENS electrode weighs approximately 0.0055 lbs, and other than the surface tension applied by the adhesive, there is negligible pressure applied to the patient's skin while energy is being delivered through the TENS patch. It has been found that pressure needs to be applied to the conductor while energy is being applied through it. Too little pressure significantly reduces the efficacy of the treatment. Too much pressure can cause the patient to feel uncomfortable without simultaneously increasing efficacy. The amount of pressure that can be applied for optimal efficacy also depends on the outer dimensions of the tip of the electrode or conductor that contacts the body. Considering the range of bodies to which the embodiments of the present disclosure may be applied, the minimum pressure, expressed as weight, that would be applied to the conductor while in contact with a person's body while delivering electrical energy as disclosed in the present disclosure is 0.05 lbs (pounds), assuming a hemispherical or rounded tip on an elongated probe with a diameter of 0.25 inches. The maximum pressure should not exceed 10-15 lbs at the same probe tip. With larger (tip surface area) probe tips, a higher maximum weight or pressure may be tolerated by most patients (e.g., closer to 15 lbs or more), and with smaller (tip surface area) probe tips, a lower maximum weight or pressure may be tolerated (e.g., closer to 10 lbs).

[0041] However, for different configurations of the conductor tip that contacts the body, a higher upper limit pressure may be applied, for example 16 lbs, depending on the size and weight of the person. The acceptable pressure ranges contemplated herein on the surface of the conductor tip or end that contacts the body are expressed herein as pounds per square inch (PSI), assuming a contact surface area corresponding to a circular area having a diameter of 0.25 inches.

[0042] Using a weight range of 0.05 lbs to 15 lbs, the allowable pressure range (expressed as PSI) in one embodiment is a minimum of 0.5 lbs / in 2 ~Up to 150lbs / in 2(or it can be 0.05lbs to 15lbs). In addition, 0.5 lbs / in 2 is 0.345N / cm 2 Also, 150lbs / in 2 is 103.421N / cm 2 It is. In another embodiment, the minimum PSI is 0.6 lbs / in 2 ~10lbs / in 2 (or any value between 0.06 lbs and 1 lbs). In yet other embodiments, the minimum PSI is 0.6 lbs / in 2 ~15lbs / in 2 (or any value between 0.06 lbs and 1.5 lbs). In yet other embodiments, the minimum PSI is 0.6 lbs / in 2 ~20lbs / in 2 (or any value between 0.06 lbs and 2 lbs). In yet other embodiments, the minimum PSI is 0.6 lbs / in 2 ~25lbs / in 2 (or any value between 0.06 lbs and 2.5 lbs). In yet other embodiments, the minimum PSI is 0.6 lbs / in 2 ~30lbs / in 2 (or any value between 0.06 lbs and 3 lbs). In yet another embodiment, the minimum PSI is 0.6 lbs / in 2 ~35lbs / in 2 (or any value between 0.06 lbs and 3.5 lbs). In yet another embodiment, the minimum PSI is 0.6 lbs / in 2 ~40lbs / in 2 (or any value between 0.06 lbs and 4 lbs). In another embodiment, the minimum PSI is 0.6 lbs / in 2 ~45lbs / in 2(or any value between 0.06 lbs and 4.5 lbs). The minimum pressure threshold depends on one or more of the shape and outer dimensions of the end face of the conductor that contacts the body, the area being treated, the size of the patient being treated, the thickness of the tissue the conductor contacts, and the age of the patient. In some embodiments, the maximum PSI is 100 or 110 or 120 or 130 or 140 lbs / in. 2 Assuming the diameter of the tip of the primary probe is ¼ inch, the maximum weight applied to the tip when pressed against the body is 10 or 11 or 12 or 13 or 14 or 15 pounds. As used herein, the term “strong pressure” refers to any operating conductor pressure range within any minimum and maximum amounts disclosed herein, whether expressed as weight (e.g., pounds, kilograms, or equivalent), or pressure (e.g., pounds or kilograms per square inch or per square centimeter or equivalent), or any other measure in which pressure (compressive force) is quantified. These pressure amounts assume the probe is placed orthogonally relative to the surface of the tissue being treated, although the present disclosure expressly contemplates that angles of 45 to 90 degrees may be used depending on the area being treated. Even when the primary probe is held against the body with strong pressure at an angle other than 90 degrees, it is important to maintain strong pressure on the probe while the tip is in contact with the body and energy from the probe is being delivered into the body. In some embodiments, when energy is being delivered to the body, approximately the same intensity pressure is applied to both probes 103, 105, while in other embodiments, different intensity pressure values ​​may be applied to the probes 103, 105. Because the pressure on the probes partially measures the depth to which the energy penetrates the tissue, the pressure on the probes can be adjusted independently to locate pain within the tissue.

[0043] The present disclosure is also useful in wound treatment, and therefore when applying the conductors to a wound, light pressure should be used to avoid discomfort to the patient, but the maximum pressure that the patient can comfortably tolerate without causing further damage or injury to the wound should be applied. For ease of discussion, the range of pressures applied to the patient's body by the conductors or probes or electrodes may be referred to herein as the working conductor pressure range. Stated differently, pressures within the working conductor pressure range are considered to be strong pressures as used herein. Pressures below the working conductor pressure range are considered to be light pressures, and pressures above the working conductor pressure range are considered to be overpressures. In all applications herein, strong pressures should be applied to at least one of the conductors through which energy is being delivered to the patient's body being treated. In one particular application, weights applied to the conductor tips in the range of 0.1 lbs to 4 lbs, or 1 to 40 lbs / in using a ¼ inch hemispherical rounded probe tip may be used. 2 Pressures of (PSI) have been found to be effective in treating a wide range of conditions, but not all, and relatively non-sensitive treatment areas (for example, the top of the foot is particularly sensitive and lighter pressure should be used there so as not to cause discomfort to the patient being treated). Weight pressures in this range are effective in a wide range of treatment applications and areas, but not all.

[0044] In general, one aspect of the present disclosure relates to a treatment unit or device for delivering non-invasive, optimized, patient-specific pulsed electromagnetic energy while applying pressure within the working conductor pressure range, which not only eliminates or reduces acute or chronic pain, but also further heals the patient's body. The treatment unit and associated methods first and foremost actually improve the underlying condition that is causing the pain. Rather than simply interrupting the transmission of pain signals, the treatment actually alters the underlying physiology, thereby repairing the pain-inducing condition. In some treatment applications, it is believed that a combination of pressure within the working conductor pressure range and application of pulsed DC energy having a frequency centered around 18-22 kHz optimally reduces pain in the shortest amount of time. These realizations only came after performing thousands of treatments and seeking real-time patient feedback using a variety of different electrical energies and pressures over many years. Other considerations include the starting site of the initial location of the electrodes or conductors on the body and how one of those conductors is moved along the body, which depends on the site of pain and type of pain (e.g., tennis elbow vs. ankle sprain), the time the conductors are held in one position, the angle of one or both conductors relative to the tissue, and the total treatment time during a treatment session (e.g., a treatment session ends when there is a period of at least 60 minutes during which no energy is applied to treat the patient, and a new treatment session begins when at least 60 minutes have passed since the last application of energy to the patient during treatment).

[0045] Several differences, including those mentioned above, distinguish the treatment unit and method of the present disclosure from previous treatments. These differences allow the disclosed technology to go beyond strict pain relief to healing the body. For example, one difference relates to broadening the purpose of treatment from stopping pain to curing the underlying condition. The change in the purpose of treatment has a significant impact on which body part the treatment is applied to. Instead of simply treating at the source where the patient perceives the pain to be emanating, the treatment of the present invention focuses on the site where the underlying condition is occurring and treats that particular body part. In many cases, the present disclosure requires multiple sites to be treated. This has implications regarding how long each site needs to be treated, which requires a timer (human understandable) built into the treatment unit to help the treatment provider deliver the most effective treatment in an efficient manner.

[0046] The disclosed treatment unit delivers pulsed electromagnetic energy non-invasively to affected areas of a patient. The treatment unit can reduce both acute and chronic pain and, with appropriate follow-up treatment, provide long-term pain relief. The electrical current delivered by the treatment unit is defined by a novel set of parameters that have been thoroughly developed, refined, and researched. Within the configuration of the processing unit are certain characteristics of electromagnetic current delivery that distinguish the processing unit from other current generating devices, including one or more of: (1) a specific frequency of approximately 20 kHz; (2) a specific DC current in the range of 0.1-2 mA or 0.1-6 mA or 0.1-8.9 mA; (3) a maximum operating output voltage of 165 Volts Direct Current (VDC); (4) the use of direct and alternating current; (5) at least one movable probe or electrode or conductor as the delivery mechanism for electrical energy; (6) the angle of the movable conductor; (7) the pressure applied to the body by the movable conductor while electrical energy is being delivered through the movable conductor; and (8) two human readable timers indicating the elapsed time that energy has been applied to the body (resettable) and a lifetime timer (non-resettable) indicating the cumulative time energy has been delivered by the treatment unit within its lifetime.

[0047] The importance of the frequency of the pulsed current (especially direct current) cannot be overstated. At this higher frequency, both the current perception threshold and the withdrawal threshold increase significantly. It is possible to employ significantly higher intensities, up to 165 volts (V), since the patient can easily tolerate this high level of intensity in most cases without feeling any sensation. This is the opposite of lower frequency electrotherapy, which can be painful and difficult for the patient to tolerate, limiting the intensity that can be utilized. The lack of discomfort from the higher frequency of the disclosed treatment unit allows the treatment provider to use the full strength of the treatment of the treatment unit, which improves efficacy. The full strength also allows for shorter treatment times to be effective. And at higher frequencies, the treatment unit utilizes very rapid and short pulses to keep the volumetric delivery of energy per pulse low, thus improving patient safety.

[0048] The high frequency current of the treatment unit plays a key role in its ability to deliver current non-invasively, and even penetrate the epidermis to reach deep within the patient's tissue. The skin itself has a very high level of resistance, which can make it difficult for electromagnetic therapy to be delivered beyond the skin and deep within the patient. The high impedance of the skin can be attributed to the lipids in the stratum corneum. However, high frequency current with sufficient voltage and short pulse length can generate "pores" in the skin lipid bilayer and create transdermal channels to the depths of the tissue. For example, the 20 kHz carrier frequency of a treatment unit with a 50V output meets these criteria. Furthermore, in some cases, the high frequency and short pulse width of the treatment unit allows the body's tissue to act as a kind of capacitor. This increased capacitance results in the palliative effects of the treatment unit lasting long after the treatment has ended.

[0049] The 20kHz frequency capability of the treatment unit is extremely beneficial. In fact, with currents of approximately 20kHz (e.g., plus or minus 2kHz), complete nerve block is achievable, which is not seen with other frequencies. The 20kHz ±2Hz frequency, like those used in the treatment unit, affects voltage-controlled gates and second messenger triggers, triggering a myriad of other beneficial biological effects. At the same time, this 20kHz frequency makes the current virtually undetectable to the patient, allowing the shorter pulses to safely deliver the higher voltage levels that can be used in treatment, producing better results than other electromagnetic therapies.

[0050] The treatment unit further utilizes pulsed direct current to deliver polarity effects, unlike the majority of electrotherapy devices that generally use alternating current. Direct current has proven to be particularly beneficial for skeletal and neurological conditions, as well as wound healing. In fact, direct current can promote peripheral nerve regeneration, and in post-operative patients, promote the recovery of nerve function, contributing to a better healing process. Prior art has disclosed DC current, but has not appreciated the combination of energy characteristics disclosed herein, which provides the most effective pain treatment in a surprisingly short time.

[0051] When tissue is damaged, as in the case of a surgical incision, an electrical potential is created between healthy and damaged tissue. This and other evidence suggests that wound healing may be controlled in part by electrical signals, and thus that electrical therapy may affect wound healing. Many clinical studies over the past 25 years have found that electrical stimulation leads to accelerated wound healing. The results of many investigations show that the healing rate is approximately twice as high in electrically treated patients. Direct current is a common theme throughout the studies of these investigations. The polarity effect between the anode and cathode appears to have a particular effect on tissue. Low-intensity direct current may reduce the time required for superficial wound healing by 1.5 to 2.5 times compared to wounds not subjected to such treatment. This form of current may promote hydration, increase the number of growth factor receptors, increase the rate of collagen formation, stimulate the proliferation of fibroblasts and granulation tissue, and / or reduce the number of mast cells in the damaged area.

[0052] AC current appears to be more common in other electrotherapy products than DC, which makes the use of DC in a treatment unit unique, and as previous research has shown, the use of DC has many positive aspects in the overall therapy, making pulsed DC a key contributor to the effectiveness of the treatment unit and how it functions.

[0053] Actively administered probes or electrodes can be manually manipulated on and along the body, but create significant differences in the treatment units, which provide a separate delivery method through the use of a stainless steel hemispherical-tipped probe. The caregiver ultimately administers the treatment using the probe as the delivery mechanism, which allows for a more focused, dense current to be delivered directly to the affected area while applying pressure within the working conductor pressure range. Research has shown that current density is important, finding that the naturally high resistance of the skin can impair electromagnetic therapy unless the density is sufficient and the frequency of the current is high enough to pass easily through the skin.

[0054] In contrast to the disclosed probe, the majority of electrotherapeutic treatments utilize large electrode pads that are adhered to the patient in a stationary state, despite the importance of current density and its correlation with the probe as a delivery mechanism. The pads themselves, due to their large surface area and paper-thin depth, can generate a less dense and more diffuse signal, making effective penetration of the skin more difficult, reducing the intensity of the current delivered to the affected area, and ultimately resulting in the usual failure to obtain significant therapy. Furthermore, the mobility or non-stationarity of the disclosed probe vs. stationary pad allows the caregiver to cover more areas and "follow the pain" as described herein while still using high-density current. This movement allows the treatment provider to flush out of the area any underlying edema or inflammation that is highly correlated with pain. Movement also reduces the risk of static electrodes being placed in the wrong or suboptimal locations, which can thereby compromise treatment.

[0055] In alternative embodiments, a small diameter (high density) pad is used instead of or in addition to the disclosed probe. For example, in one embodiment, the small diameter pad is approximately the same size as the disclosed probe tip. For example, a small diameter pad can be used with one probe, where the pad can be fixed or adhered to the patient and the probe can be moved to treat pain at the same time. The conductor providing the return energy can be stationary or both conductors can be movable, preferably independently of each other, depending on the treatment application.

[0056] The disclosed electromagnetic therapy using a treatment unit has emerged as an excellent treatment option for many painful conditions where unwanted or unregulated generation of nerve impulses is a major disabling factor. Existing alternative treatments, including pharmacological and chemical treatments, or surgery, all have significant drawbacks, including their lack of consistent success. The disclosed electromagnetic therapy can induce ion concentrations and cellular changes comparable to traditional pharmacological nerve blocks, making it an effective alternative. The disclosed electromagnetic therapy also offers a high degree of safety and predictability.

[0057] In summary, a treatment unit is an electrical therapy that reduces and / or eliminates pain. Its closest frame of reference is an electrical version of a nerve block. A treatment unit is non-invasive and provides immediate feedback to the patient. Additionally, a treatment unit has no known side effects and can be used as frequently as needed. A treatment unit may reboot the nerves in the affected area to restore normal impulses, thereby providing proper neural control to the cells involved. If the impulses can be reset, painful symptoms can be reduced or completely eliminated. By targeting the nerves that arguably control all bodily processes, there is a cascading effect that not only promotes the release of the body's natural opiates, but also improves vascular response, which is likely responsible for the objective and immediate improvement in swelling commonly seen with treatment via a treatment unit. A treatment unit uses pulsed electromagnetic energy delivered to the patient via direct current through the treatment unit's probe delivery system at a carrier frequency much higher than almost all other common electrical therapies.

[0058] Clinical studies have demonstrated that treatment with higher frequencies results in improved outcomes, including a reduction in the number of treatments required. A draft of the study is entitled "A Clinical Study of the MediPhysics Pain Treatment System for the Treatment of Chronic and Acute Pain" (December 2005) by Frank L. Greenway. For example, using lower frequencies, it took 12 treatments (3 treatments per week) over a 4-week period to adequately treat a patient's pain. Using lower frequencies, 41% of patients achieved greater than 70% pain reduction over 12 treatments, 33% of patients achieved 20-70% pain reduction, and 26% of patients achieved little or no pain relief (less than 20% relief). Using lower frequencies, each individual treatment resulted in an average of 52% improvement from pre-treatment to post-treatment.

[0059] In contrast, recent data from high frequency studies show that using high frequencies, such as the approximately 20 kHz frequency of the present disclosure, most patients require three or fewer treatments, with an average of only 3.6 treatments. Each treatment resulted in an average of 72% pain reduction (vs. 52% improvement at lower frequencies). All patients experienced a pain reduction of 78% or more over the entire course of treatment (vs. 41% achieving over 70% at lower frequencies), with 84% of patients achieving a complete (100%) reduction in pain. In another study in which chronic testicular pain was treated, the average number of treatments required was only 3.2 treatments per patient, and those patients averaged a 58% reduction in pain with only 3.2 treatments.

[0060] Comparing the above results between the low frequency in the clinical study and the high frequency in the high frequency study, it is clear that the higher frequency reduces the number of treatments per patient and greatly improves efficacy: the amount of energy the patient is exposed to per pulse is actually less (making the treatment safer and better tolerated), but the total amount of energy delivered to the site of pain is actually more due to the higher frequency.

[0061] According to the above unique features, the treatment unit delivers electrical pulses to the patient's tissue via the primary and secondary probes to provide neurostimulation to relieve the patient's pain. The treatment unit receives impedance measurements from the patient's tissue using the primary and secondary probes. As the electrical pulses are applied, the impedance measurements are monitored, with a drop in impedance indicating less resistance. Lower impedance measurements correlate with a lower perceived level of pain experienced by the patient. The treatment unit receives impedance information from the patient's tissue, including the body's cellular network, and by monitoring the impedance information received as additional electrical pulses are applied as pain treatment, the treatment unit system and method assesses and treats pain experienced by the patient's tissue and other body structures. To be clear, the inventive aspects of the present disclosure are not focused on the high frequency range as the only point of novelty, but rather it is a combination of the insights disclosed herein gained over many years of thousands of treatments, and feedback from dozens of patients.

[0062] In assessing and treating pain, the treatment unit applies an electrical pulse train to the site of pain, tissue abnormality, or selected nervous system trigger or motor points. These trigger or motor points may also coincide with acupuncture or pressure points on the body. When the electrical pulse train is transmitted to the tissue, it encounters a unique impedance signature generated by the tissue or object under investigation. Impedance information is generated by this initial analysis and measurement and may be used as a baseline measurement for planning and evaluating treatment. Because the impedance measurement is objective, it may serve as an objective indicator of pain reduction and may be used to complement or verify the patient's subjective pain assessment. From the start of pain treatment to the end of the pain treatment session, which may include multiple cycles of energy applied through the conductor, the reduction in impedance may be at least 10% or 20% or 30% or 40% or more compared to the start of the pain treatment session. In other words, when the energy is first applied through the probe, if the impedance drops below 80% or 70% or 60% of its original value, it may be concluded that the treatment was successful and reduced the level of pain. These measurements can be used as a check against the patient's subjective report of the level of pain. In some embodiments, objective impedance measurements can be used as an indicator of insurance fraud, such as when a patient reports a subjective level of pain that is much greater than the objective norm. Note that an increase in conductivity is another facet of impedance. That is, instead of a reduction in impedance as an indicator of efficacy, an increase in conductivity indicates the same improvement. The terms reduction or decrease in resistivity or impedance mean the same thing as an increase in conductivity. The conductivity level display 212 shown in FIG. 2A is monitored by the caregiver. If the meter shown on the display 212 represents electrical conductivity, the meter increases or rises as conductivity improves. If the meter shown on the display 212 represents body impedance, the meter decreases or falls as impedance falls.In either case, the caregiver can monitor the meter changes to determine when to stop applying energy during a particular treatment cycle. As described herein, if no meter movement is observed after applying energy to the body, for example, three minutes, the caregiver can decide to continue applying energy during that treatment cycle for a longer duration, for example, one additional minute, while monitoring the meter changes displayed on the display 212. Similar to the elapsed treatment time display, the conductivity level display 212 also provides an important visual aid for the caregiver to understand the length of time that energy is being applied through the probe and the effectiveness of a particular energy delivery strategy during a particular treatment cycle. The rapid changes in the meter displayed on the display 212 also allow the caregiver to stop applying energy through the body sooner than the caregiver anticipated, allowing the caregiver to focus on other areas of the body and reducing overall treatment time.

[0063] In addition to assessing and characterizing the degree of pain in the patient, the treatment unit provides a therapeutic action to suppress pain. The treatment unit further provides nerve stimulation to suppress pain and reduce healing time, which, when appropriately repeated, can lead to long-term improved pain management of the affected area. Pain is reduced or eliminated by the effect of electrical pulse trains on nociceptive afferent neurons, which are sensitive to noxious stimuli, including electrical, thermal, mechanical, and chemical stimuli, as described above.

[0064] 1, a functional block diagram illustrates an exemplary embodiment of a treatment unit in the form of a patient treatment unit 100 including a probe stimulus generator circuit 101 for outputting a series of DC electrical pulses as a treatment signal at a controlled pulse frequency of approximately 20 kHz (plus or minus 10%). The probe stimulus generator circuit 101 outputs DC electrical pulses at a pulse voltage defined by a variable supply voltage.

[0065] The probe stimulus generator circuit 101 further controls the pulse frequency, pulse width, and polarity of the electrical pulse train. In addition, the probe stimulus generator circuit 101 outputs an electrical pulse train that is a clean waveform with little electrical noise by using tight electrical component tolerances in the carrier waveform generator circuit. For example, the carrier waveform frequency can be set using a carrier adjustment circuit in combination with a capacitor. This RC circuit can be adjusted to generate the desired carrier frequency of the electrical pulse train. The RC circuit values ​​provide a stable waveform and little electrical noise.

[0066] The probe stimulus generator circuit 101 may use several different electrical pulse train configurations depending on the treatment at hand, but according to the specific parameters disclosed above. For example, several different waveforms of variable amplitude may be selected to treat back pain, such as a basic square wave with a pulse width of 9-20us or 14us, a pulse rate of 20,000 pulses / sec, and a pulse amplitude of 100V. Optionally, filtering of the electrical pulse train removes error signals that often appear as waveform ripple.

[0067] The patient treatment unit 100 further includes a primary probe 103 and a secondary probe 105 coupled to the probe stimulus generator circuit 101. As shown in FIG. 2B below, the primary probe 103 has a rounded tip configured to contact the human or animal body and an elongated (dielectric) body with a diameter sufficient to be grasped or grasped or held by a human hand. The elongated shape helps to manipulate the primary probe 103 over the human or animal skin while maintaining a strong pressure on it during application of electrical energy through the probes 103, 105. The primary probe 103 is electrically coupled to the probe stimulus generator circuit 101 to receive DC electrical pulses. The secondary probe 105 is also configured to contact the human or animal body and is electrically coupled to the probe stimulus generator circuit 101 to complete an electrical circuit with the primary probe 103 through the human or animal body. The secondary probe 105 can be a stationary conductor, such as one that is glued to the body, such that only the primary probe 103 is movable. This configuration would allow a patient to, for example, self-administer therapy via the primary probe 103 while maintaining the stationary probe 105 at a fixed site on the body. The primary probe 103 and / or secondary probe 105 may optionally include a pressure sensor therein, such as a pressure transducer 262 (see FIG. 2B ), configured to sense pressure applied to the end of the probe 103 / 105. Optionally, the probe stimulus generator circuit 101 may be configured to require a threshold pressure detected via the pressure transducer before outputting DC electrical pulses through the primary probe 103. Similarly, the probe stimulus generator circuit 101 may be configured to terminate outputting DC electrical pulses through the primary probe 103 when the pressure detected by the pressure transducer falls below a threshold. The threshold may be any value in the lower range of the operating conductor pressure range, for example, 0.5 lbs / in 2and the threshold can be adjusted based on the area being treated and the nature of the pain being treated. For example, if the area being treated is near or on a bone or sensitive area, a lower pressure threshold can be set, while if the area being treated is the thigh or a less sensitive area, a higher pressure threshold can be set.

[0068] The current of the DC electrical pulse is in the range of 0.1-2 mA or 0.1-6 mA or 0.1-8.9 mA while the probes 103, 105 are in contact with the body. The operating output voltage across the probes 103, 105 while conducting the therapy signal does not exceed a maximum operating output voltage of 165 VDC while the probes 103, 105 are in contact with the body.

[0069] The treatment unit 100 includes one or more of a body impedance analysis circuit 107, a monitoring circuit 109, an audio speaker 111, a mode control circuit 115, an optional sensing circuit 117, a power supply circuit 121, an optional programming and debugging circuit 123, an external input / output connection interface 125, an optional treatment area selection circuit 127, an intensity adjustment circuit 129, a display driver 135, a primary timer 136, and a secondary timer 138. The unit is powered by an external AC adapter power supply 119, which provides DC power to the power supply circuit 121. In this embodiment, as shown by the schematic OL of FIG. 1, several circuits 121, 107, 101, 121, 129, 109 are physically mounted and fabricated on a single printed circuit board to reduce electrical noise between components and circuits. The printed circuit board may be a multi-layer printed circuit board to further reduce ambient electrical noise and generate clean, error-free pulse trains. As described below, additional useful data may be provided to the clinician via the interface module 150. The pair of probes 103 and 105 receive and apply electrical pulse trains to the patient's body.

[0070] The probe stimulus generator circuit 101 also includes internal monitoring functions to ensure the safety and performance of the patient treatment unit 100. For example, the probe stimulus generator circuit 101 monitors and checks the power supply voltage from the power supply circuit 121 and, optionally, the coil sense indication from the sense circuit 117 that the probes 103, 105 are properly connected across the appropriate tissue or patient. In addition, the mode control circuit 115 provides a handshake signal indicating a ready state that must be detected by the probe stimulus generator circuit 101 before a pulse train can be applied to the tissue. The probe stimulus generator circuit 101 can optionally include a level shift circuit that can be used to vary the carrier current and shift the current and voltage limit circuits. The probe stimulus generator circuit 101 will not output a train of electrical pulses until the power supply handshake signal, optionally the sense handshake signal (if present), and the treatment counter handshake signal all indicate that these circuits 121, 117, 115 are in a ready state.

[0071] Referring to FIG. 2A, the outer casing of the patient treatment unit 100 has a front with several controls including a carrier knob 200, a sensitivity or calibration knob 202, a baseline calibration knob 204, a power indicator light 206, a treatment time display 208, a frequency button 210, and a conductivity level display 212. The carrier knob 200 controls the frequency of the carrier wave, and the sensitivity / calibration knob 202 adjusts the magnitude of change in conductivity level. The baseline calibration knob 204 adjusts the conductivity measurement range of the patient treatment unit 100, and the power indicator light 206 indicates that the patient treatment unit 100 is powered on when the light 206 is illuminated. The treatment time display 208 provides a means to track the duration of each patient's treatment, and the frequency button 210 sets the output frequency range, e.g., switching between high and low frequencies. The conductivity level display 212 indicates the conductivity between the probes, which is used to track the progress made during treatment, and operates on a scale of 1 to 20, for example. The display 212 also shows resistivity or impedance due to its inverse relationship to conductivity. The display 212 can alternatively be configured to show impedance, in which case a reduction in the meter displayed on 212 represents a reduction in impedance (and a corresponding reduction in pain or effectiveness of treatment).

[0072] More importantly, the treatment time display 208 includes at least one of two timer displays that show (a) the total elapsed time or total number of treatments performed using the patient treatment unit 100 via a total treatment timer display, and / or (b) a resettable session time via an elapsed treatment timer display. The total treatment timer is not reset, as it tracks the total time on the machine across all treatment sessions and / or the total number of treatment sessions performed using the machine. This is particularly important to provide accountability for maintaining an accurate record of total usage of the patient treatment unit 100 and to track and improve treatment efficacy. The elapsed treatment timer display measures the time elapsed each time a treatment mode is engaged and disengaged, but typically represents a portion of a treatment session at a particular site of the body, and is reset to zero before a new treatment is started. The elapsed treatment timer display restarts each time a new treatment is started. A manual reset button (not shown) is provided to allow the elapsed treatment timer to be manually reset, if desired, or the elapsed treatment timer display can be configured to automatically reset when the probes 103, 105 begin delivering energy through the body again.

[0073] According to one embodiment, the treatment time display 208 is an electronic timer display configured to display the elapsed time in a decimal format of minutes and seconds. Alternatively, the timer can be visually represented to immediately tell the operator how much time has elapsed in an amount of time familiar to the operator. For example, instead of decimal numbers, a meter graphic or dial graphic can be displayed to indicate the elapsed time. The timer display herein is understandable to a layperson, unlike the AEC code described above. Hexadecimal numbers are understandable to those familiar with computer technology, but are unfamiliar to, for example, an unskilled layperson. It is important for the operator to see in real time how much time has elapsed as energy is being delivered through the probe. The elapsed time starts with each activation of the probe stimulus generator circuit 101 and runs until the corresponding deactivation of the probe stimulus generator circuit 101. A treatment visit for a particular patient can be considered as a treatment duration or session after at least 60 minutes or more have elapsed before the next application of energy to the patient's body. The treatment duration may include many applications of energy to the body at the same or different sites, but with a short period between non-application of energy to the body and the next application of energy (e.g., enough time for the operator to move one or both probes to a new site). If more than 60 minutes have passed since the last application of energy, the treatment session ends at the time of the last application of energy to the body. Because the treatment time using embodiments of the present disclosure is very short compared to the treatment time using prior art treatment approaches, it is important for the operator to have a human readable timer that displays the time that has elapsed since the application of energy to the body. Overtreatment may be unproductive and result in reduced efficacy or no substantial improvement in pain reduction. The continuous, uninterrupted delivery of electrical energy through the body via the conductors is referred to herein as a treatment cycle. A treatment session may include multiple treatment cycles, such as when the conductors are moved one or more times.A treatment visit for a given patient may include multiple treatment sessions (which, in turn, may include one or more treatment cycles) but will end more than 60 minutes after the last application of electrical energy through that patient's body.

[0074] 2B, the primary probe 103 is coupled to the casing of the patient treatment unit 100 by respective cables and plugged into a primary probe socket located on the side of the casing. The primary probe 103, according to one embodiment, has a treatment switch 233 and a probe intensity dial (or wheel) 234. The treatment switch 233 is a binary treatment switch that, when pressed towards the probe tip 235, places the patient treatment unit 100 in treatment mode. Optionally, the probe tip 235 is rounded. Conversely, when the treatment switch 233 is pressed away from the probe tip 235, it places the patient treatment unit 100 in measurement mode. The intensity dial 234 increases the current intensity when dialed (or rotated) towards the probe tip 235 and decreases the current intensity when dialed away from the probe tip 235.

[0075] In an alternative exemplary embodiment that functions consistent with this disclosure of the patient treatment unit 100, the treatment switch 233 is removed entirely and the probe intensity dial 234 is replaced with a similar looking dial that actually moves to a locked position when dialed all the way away from the probe tip 235. This alternative probe intensity dial effectively performs the functions of both the treatment switch 233 and the probe intensity dial 234 described above. When dialed all the way away from the probe tip 235, the alternative probe intensity dial is positioned in a "locked" position and measurement mode is enabled. When the alternative probe intensity dial is dialed towards the probe tip 235 and moved from its initial "locked" position, the treatment mode is turned on and the current intensity increases as the alternative probe intensity dial continues to be dialed towards the probe tip 235. The advantage of the alternative probe intensity is that it provides an easier and more efficient way to switch between measurement and treatment modes.

[0076] That is, the probe intensity dial 234 is a manual setting for incrementing the variable supply voltage to a desired variable treatment voltage. The probe intensity dial 234, according to one exemplary embodiment, is in the form of a detent wheel. The detent wheel 234 is rotatable toward.

[0077] 2C, the secondary probes 105 have respective probe tips 236 but lack any switches or dials. The secondary probes 105 are coupled to the casing of the patient treatment unit 100 by respective cables and plug into secondary probe sockets located on the sides of the casing.

[0078] 3A-3D, the primary probe 103 includes a treatment switch 333 that, when in the rearward position as shown in FIG. 3A, reads the relative conductivity between the primary probe 103 and the secondary probe 105 in a "measure" mode. In the measurement mode, a small amplitude current is applied between the probe 103 and the probe 105 to measure the impedance of the tissue under test. The voltage and current may be sensed and measured periodically, and an impedance reading is calculated periodically. In the measurement mode, the treatment switch 333 activates the conductivity (or contact) level indicator 212 of FIG. 2A to provide a visual indication of the conductivity and impedance of the tissue under test. When pressed forward as shown in FIG. 3B, the treatment switch 333 activates treatment by completing a sensing circuit 117 that enables the probe stimulus generator circuit 101 to generate an electrical pulse train output to treat the tissue under test. When switched to the treatment mode, the probe stimulus generator circuit 101 receives a handshake signal from the mode control circuit 115. In this manner, the probe stimulus generator circuit 101 provides output voltages in the form of electrical pulse trains to the probes 103 and 105 when the mode control circuit 115 enables a handshake signal.

[0079] The probe stimulus generator circuit 101 also checks the power supply circuit 121 to ensure that adequate power is being supplied before enabling output current in the form of an electrical pulse train. If the power is not adequate or if the mode control circuit 115 does not handshake, the stimulus generator 101 will be prevented from outputting the electrical pulse train. Various handshaking checks are performed by the handshaking controller. When the patient treatment unit 100 is in measurement mode, the impedance between the probes (and therefore the impedance of the tissue under test) is shown on the conductivity level display 212 of FIG. 2A. The LED display of the conductivity level display 212 of FIG. 2A remains illuminated during measurement mode. In addition, the primary probe 103 includes an intensity dial 344, shown in FIG. 3B, which controls the intensity of the treatment. At the start of treatment, the intensity dial 344 is turned towards the rear of the probe at its minimum setting, as shown in FIG. 3B. Then, as shown in Figures 3C and 3D, the intensity dial 344 is turned forward toward the front of the probe 103 until the carrier current is felt by the patient but not uncomfortable.

[0080] The mode control circuit 115 detects and tracks elapsed treatment time, which indicates the time that the primary probe 103 has been delivering a series of electrical pulses. The mode control circuit 115 is used to measure and track treatment for regulatory and payment compliance, to ensure patient safety, and for other health or business reasons. A visual indication of the treatment is presented on the primary and secondary timer displays in accordance with the applicable disclosures presented above.

[0081] Patient compliance with treatment is a medical concern regardless of the form of treatment. Patients need to continue prescribed treatment to see efficacy and promote recovery. Patient noncompliance masks the effectiveness of treatment if patients avoid treatment or participate in treatment in a non-prescribed way. This leads to great uncertainty regarding the effectiveness of the prescribed therapy, whether the current level of treatment is adequate, or whether it requires adjustment or discontinuation. Patients are often unwilling to admit that they are noncompliant, and if treatment is difficult or painful, patients may choose to discontinue or avoid treatment despite proven therapeutic benefit. Treatment misuse weakens the economic and therapeutic incentives for health care providers and insurance companies to fund or cover the cost of treatment.

[0082] After the treatment switch 333 is activated and treatment begins, the mode control circuit 115 starts a timer that is displayed on the display, which will visually track the elapsed time in minutes and seconds. The display will continue to count as long as the primary probe 103 remains in treatment mode. When the treatment switch 333 is deactivated (i.e., the patient treatment unit is returned to measurement mode), the appropriate display will stop incrementing but remain visible. The display will reset to zero and begin showing the elapsed time when the treatment switch 333 on the primary probe 103 is again moved forward to resume additional treatment. At that point, the display will again continue to increment. Instead of decimal minutes and seconds, the display may show a bar or line graph, a pie chart, an hourglass or sand timer graphic, a clock graphic, or a similar graphic to indicate to a layperson how much time has passed since the start of treatment in a manner that is understandable to a layperson. The idea here is to clearly communicate the elapsed time to a lay clinician or caregiver, rather than obscuring or confusing the layperson, so that the caregiver can keep track of the minutes and optionally seconds that have elapsed since the start of energy application in the treatment mode of the patient treatment unit.

[0083] 1, optional sensing circuit 117 is an option that evaluates for the presence of a probe connection and enables the probe stimulus generator circuit 101 when the probe 103, 105 is connected to the body impedance analysis circuit 107. The sensing circuit 117 ensures that no electrical pulse trains are generated when the probe 103, 105 is not properly connected. The AC adapter power supply 119 and power supply circuit 121 provide a stable, regulated 12 volt DC power source to the patient treatment unit 100. The stable, regulated power source helps to provide an electrical pulse train free of ambient electrical noise.

[0084] A response level circuit 131 measures and indicates the conductivity or impedance between the probes 103 and 105. An intensity adjustment circuit 129 is used to adjust the intensity of the electrical pulses. The intensity of the electrical pulses can be varied or changed by adjusting the current using the intensity dial 344 shown in FIG. 3D.

[0085] The intensity adjustment circuit 129 is further configured to control the variable supply voltage, including setting the variable supply voltage to a predetermined starting voltage upon activation of the probe stimulus generator circuit 101. The predetermined starting voltage is generally a low voltage selected to avoid an initial painful response (or "zapping") by the patient. After initial contact is made between the probe 103, 105 and the body, the predetermined starting voltage is changed to a variable treatment voltage as required by each individual custom application. Thus, after activation of the probe stimulus generator circuit 101, the predetermined starting voltage continues to be increased up to the treatment voltage as the treatment progresses, and may vary over the course of treatment. The increase in current is accomplished manually (such as via the probe intensity dial 234) or automatically.

[0086] 4, an exemplary pulse forming circuit 400 isolates the high voltage that may be included in the probe stimulus generator circuit 101 to the probes 103 and 105. The pulse forming circuit 400 isolates the high voltage from the low voltage control circuit to produce a cleaner waveform with better pulse shape without ringing. The resulting unipolar waveform output promotes unidirectional ion flow, producing a better net effect. The pulse forming circuit 400 includes a high voltage generator 402, a high voltage output circuit 404, and a low voltage output control circuit 406.

[0087] The high voltage generator 402 includes a step-up transformer 410, a pair of MOSFETs 412 and 414, and a D flip-flop 416. A center tap input 418 is coupled to a control MOSFET 420, which is coupled to a DC voltage source such as the power supply circuit 121. A higher clock frequency allows a smaller transformer to be used. The output voltage from the high voltage generator 402 is a function of the center tap voltage coupled to the control MOSFET 420 and the turns ratio (primary turns to secondary turns) of the transformer winding.

[0088] The low voltage output control circuit includes an inverter 444, AND gates 446 and 448, and output MOSFETs 450 and 452. The other inputs of AND gates 446 and 448 are driven by a pulse width modulated control signal from control input 442. The pulse width control signal times the output pulses at what frequency and how long they are applied. The electrical output specifications are as described above with reference to the parameters of the processing unit. In addition, exemplary output waveforms of the patient treatment unit 100 and other optional features are shown in U.S. Patent No. 10,085,670, entitled "Apparatus And Method For Treatment Of Pain With Body Impedance Analyzer," issued on October 2, 2018, and incorporated herein by reference in its entirety.

[0089] 5A-5C, a method is directed to reducing or eliminating pain using a patient treatment unit 100. As shown in FIG. 5A, the patient treatment unit is first prepared at step 500. At step 502, the device is powered on, a frequency band is selected, and the intensity wheel on the primary probe is ensured to be in the off state. At step 504, the patient characterizes the location and severity of the pain. In response to the patient's input, at step 506, the sensitivity is set to the appropriate setting, the probe is placed at the treatment site, and the baseline calibration is adjusted. At step 508, if a conductance level reading of 7 is not achieved, then at step 510, the sensitivity is adjusted and a conductance level reading of 7 is achieved.

[0090] Referring to FIG. 5B, if a conductivity level reading of 7 is achieved, the method proceeds to "1B" in step 512 by rotating the intensity wheel on the primary probe to ON. This means that the therapy mode is now enabled. In step 514, the method rotates the intensity wheel on the primary probe to increase the intensity of the current or continue to adjust otherwise. In step 516, if the patient indicates that the intensity is not too strong, the affected area is treated for 3 minutes in step 518. If the patient indicates that the intensity is too strong in step 516, the intensity of the current is reduced in step 528 until the patient is comfortable. In step 520, the intensity wheel is rotated on the primary probe until it clocks off. The therapy mode is now turned off and the measurement mode is now enabled.

[0091] If, in step 522, the measured conductivity level reading is not 3 lights higher than before, then in step 526, the same site is treated for another minute with a pressure within the operating conductor pressure range disclosed herein. The intensity wheel on the primary probe is rotated until it stops to re-enable the measurement mode. If, in step 522, the conductivity level reading still indicates that it is not 3 lights higher than before, then in step 526, the same site is treated again. If, in step 522, the conductivity level reading is 3 lights higher than before, then in step 524, a determination is made whether the patient indicates that he or she is in significantly less pain. If the answer is no, then in step 526, the same site is treated again for 1 minute. If the answer is yes, then the method continues (as shown in FIG. 5C) to determine whether there is another treatment site for the patient's condition.

[0092] Referring to FIG. 5C, in step 530, a determination is made whether there is another treatment site for the patient's condition. If the answer is yes, in step 536, the primary and secondary probes are moved to the next treatment site and the method generally repeats the steps illustrated and described above with reference to element Z of FIG. 5B. If there is no other treatment site for the patient's condition, in step 532, the patient's pain is checked while moving (if appropriate). If the patient does not have substantially pain, in step 540, treatment is stopped. If the patient has substantially pain but it is determined that the patient would not benefit from additional treatment as determined in step 538, treatment is discontinued. If the patient has substantially pain and it is determined that the patient would benefit from additional treatment as determined in step 538, the method proceeds to step 536 for another treatment site and the method generally repeats the steps illustrated and described above with reference to element Z of FIG. 5B.

[0093] As mentioned above, the therapeutic methods disclosed herein can be applied to treat wounds, including chronic wounds such as incisions, punctures, and ulcers, diabetic wounds, non-healing surgical wounds, and puncture wounds.These therapies can be combined with negative pressure wound therapy (NPWT), pressure dressings, and / or topical medications.The methods and therapeutic devices disclosed herein have been used to treat diabetic foot ulcers, bedsores, and venous stasis ulcers.One chronic wound patient who had been suffering from chronic pain for many years was healed within weeks using the therapeutic methods disclosed herein after enduring many years of non-healing.

[0094] Treatment Examples According to an exemplary treatment, the two probes are "held" and "kept" approximately 1-2 inches apart, depending on the person's height, and maintained on the body at a pressure within the working conductor pressure range disclosed herein. The probes are held adjacent to one another in-line and moved up and down in unison from time to time along a particular treatment area while maintaining pressure within the working conductor pressure range. For example, if treatment is directed at a tendon, the probes are held in line with the tendon and moved straight up and down in unison along the line of the tendon. The probes are lined up along the edges of the tendon and current is applied between the edges.

[0095] According to a specific tendon example, the tendon beneath the patella is tracked to maintain the same equidistant distance for each probe to the edge of each tendon, with the probes in line with each other, as the probes are moved up and down in unison for approximately 3-4 minutes. Slowly moving continuously up and down along (but not across) the fibers of the tendon has shown greater results than moving side to side along or across the tendon, while maintaining pressure on the probe within the operating conductor pressure range disclosed herein.

[0096] According to another specific tendon example, the Achilles tendon in the ankle joint is generally smaller than the patellar tendon in the knee joint. Therefore, the two probes cannot be positioned as in the above example. In the case of the Achilles tendon, the probes are placed vertically (e.g., about 90 degrees or perpendicular from the surface of the skin) about 1-2 inches apart from each other. They are then moved slowly along the entire length of the tendon for 3-4 minutes with pressures within the working conductor pressure ranges disclosed herein. This technique is also effective in treating pain along the peroneus longus tendon (also known as the peroneus tendon) and tibialis posterior tendon. Both of these tendons are very small, therefore, vertical placement of the probes allows for constant contact of the tendons throughout treatment. In some cases, there may be one significant area of ​​pain along any one of these tendons. This small area can be addressed by holding the secondary probe stationary about 1 inch away from it, and then moving the primary probe directly above / below and medial / lateral to this small area for about 1-2 minutes with pressures within the working conductor pressure ranges disclosed herein.

[0097] According to another example treatment, the treatment area of ​​the lumbar spine (e.g., L4 / L5 or S1 / S2) is associated with sciatica. The probes are held stationary at the spine with pressure within the working conductor pressure range disclosed herein and moved in unison down the spinal muscles into the piriformis muscle. The nerve from the spine is energized from the same nerve line, reactivating the nerve. Thus, the treatment awakens the nerve and reactivates it through the treatment of the muscle.

[0098] According to yet another example of treatment, the treatment area is the elbow and treatment is directed to ulnar nerve entrapment or ulnar inflammation. A groove is formed in the nerve on the inside of the elbow, with paralysis in the third, fourth, and half of the fifth finger of the hand. A probe is employed and gullyed at the site where the ulnar nerve is located. The probe is held in the gully for about one minute with pressure within the working conductor pressure range disclosed herein, and then lowered toward the wrist or finger. A similar approach is applied when treating pain associated with the carpal tunnel.

[0099] Generally, treatment is customized based on the specific area being treated. For example, as mentioned above, treatment of nerves (which function similarly to guitar strings) is different from treatment of muscles (which are flexible and can be felt more easily). When treating nerves, the probe is moved over the root canal and directly over the nerve while maintaining pressure on the probe within the operating conductor pressure range disclosed herein. In addition, treatment of ligaments requires smaller or more subtle movements of the probe, while treatment of muscles or nerves requires larger or global movements. During treatment, the skin whitens and then reddens based on the inflow of blood circulation. According to one embodiment, treatment focuses on an area like looking through the cone of a coin to see where the blood flow is flowing.

[0100] The above treatment examples are in stark contrast to conventional treatment methods, which typically involve placing a static pad in one location for 5-30 minutes and then removing the static pad to terminate treatment. These pads also do not provide pressure to the skin within the operating conductor pressure ranges disclosed herein.

[0101] According to another example treatment, inflammation is treated by moving a probe towards the heart. For example, when treating knee inflammation, the patient's leg is elevated and the probes are placed around the knee joint. Slow, continuous movement of the probes begins below where the inflammation (or swelling) is located. The probes are placed on either side of the knee joint and moved upwards towards the patient's hip joint (towards the heart). Movement is slow and meticulous around the joint. The spacing between the probes is kept approximately 1 to 1.5 inches apart.

[0102] The angle of attack or positioning of the probe relative to the body part being treated is relevant and varies based on the type of body part being treated. For example, when treating joints, it is beneficial to position the probe vertically. As a specific example, if the movement is to the finger, knee, hip, or around the hip joint, the probe is positioned perpendicular to the respective joint with really good contact between the probe and the joint. Otherwise, if the probe is angled away from a perpendicular orientation to the joint being treated, current crowding is minimized. Similar perpendicularity is beneficial when the treatment involves nerves.

[0103] When treating a muscle, the probe is angled close to 45 degrees to the muscle being treated. The movement of the probe circles the muscle, capturing all angles of the muscle to treat the muscle's trigger points.

[0104] The pressure applied by the probe while energy is being applied through it should be within the working conductor pressure range disclosed herein so that skin indentation is generally achieved. Keeping in mind that the tip of the probe is a small rounded hemisphere, the pressure applied should be firm and the patient should feel it but not feel pain from it. Once the trigger point is reached, more pressure is applied (e.g., at the hip joint or piriformis muscle). However, if the movement is over a ligament or generally a bony area, less pressure is applied to avoid or reduce discomfort.

[0105] Typically, the current applied between the probes is moved across (rather than along) the problem area. For example, when treating chronic neck or back pain (e.g., stenosis or arthritis), the probes are positioned on either side of the spine and held in a pattern at different levels for 1-2 minutes. In another example, the probes are moved back and forth over the shoulder or buttocks. In contrast, when treating the knee joint, the movement is along the side of the knee joint, treating the anterior and posterior of the knee joint separately.

[0106] Treatment results show that nerves, tendons, and muscles show significant improvements in physical symptoms (e.g., reduction in pain associated with sciatica). Surprising beneficial results are achieved, for example, in the treatment of sciatica in elderly patients. Other surprising beneficial results are associated with ankle treatment, showing a significant reduction in the treatment required, for example, a patient who required 15 treatments with conventional methods now requires only 3-8 treatments with the treatment units and methods disclosed herein. Still other surprising beneficial results are associated with nerve, tendon, and muscle treatment. Tendon treatment, in particular, has provided "wow" results. After tendon treatment, some patients have canceled previously scheduled surgeries. Thus, tendon treatment is extremely effective.

[0107] Knowing the anatomy and the nuances of that anatomy is useful to provide appropriate movement of the probe when treating a particular body part. As mentioned above, movement of the probe is useful when performed in a specific manner that is beneficial and customized to the part being treated. Thus, precise individual treatment for a particular condition and patient is beneficial when appropriate movement is performed using an independently movable probe. In certain applications, stationary techniques may work individually or in conjunction with moving techniques.

[0108] Human patient case studies Several specific patient treatments are described below, where the electrical characteristics are the same for each patient. All patients were treated at maximum intensity for each patient using DC pulsed current of 20,000 Hertz. All patients were alert, awake, unsedated, and in a sitting or prone position during treatment. No other pain relief or state of consciousness altering therapies, such as analgesics, were used during any of these non-drug, non-opioid treatments. Probe pressures were within the operating conductor pressure range disclosed herein. The results are a significant improvement compared to the results of previous methods, e.g., (a) more patients obtained pain relief and (b) more pain relief was achieved by each patient. Overall, patients received an average of 3.6 treatments each, with each treatment achieving an average of 72% pain relief per single treatment. 99% of patients achieved 70% or greater pain relief over the entire course of treatment. These results are a significant improvement when compared to the clinical study described above, where patients averaged 7.8 treatments each, with each treatment achieving an average of 52% pain relief for each single treatment, and 41% achieving 70% or greater pain relief over the entire course of treatment. Thus, the data below demonstrates that the results of the treatment of the present invention are a significant improvement over previous treatments, with the number of treatments required being reduced by half. In addition, the time required for each treatment was reduced by approximately 30-50% on average. The following acronyms refer to separate actual human patients on whom the following treatments were administered. Many other actual human patients were tested, but these actual treatments are summarized below as examples of different treatments that treated different patient complaints and resulted in different therapeutic improvements and benefits.

[0109] LS- This patient had R Achilles tendinitis. Patient LS was seen by a physician and scheduled to undergo surgical debridement of the tendon. In this patient's case, the probe was held at the insertion site on the calcaneus for 4 minutes while maintaining probe pressure against the skin within the working conductor pressure range disclosed herein. The probe was then moved upward along the tendon, holding the tip perpendicular to the tendon. The probe was slowly moved upward through the tendon for 2 minutes. The most swollen tender spot was then located. The secondary probe was held stationary while the primary probe was moved up and down along the tendon with pressure within the working conductor pressure range disclosed herein. The primary probe was moved side to side to provide a cross friction motion across the tendon. The final spot treated was the tendon insertion to the gastrocnemius. This spot was held at this spot for 4 minutes with pressure within the working conductor pressure range disclosed herein. This patient underwent 7 treatments. Before treatment began, the pain was a 9 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain), and when treatment ended, the pain was zero - a 100% reduction in pain, which has not been achieved with traditional approaches.

[0110] JH - This patient had lateral knee pain and was painful to squat. A trigger point was found in the vastus lateralis and the probe was held for 2 minutes at a pressure within the working conductor pressure range disclosed herein. Probes were then placed bilaterally and slowly worked along the vastus lateralis, along the entire length of the muscle from the origin to the tendon insertion. This patient underwent 4 treatments. Before treatment began, the pain was 5 on a scale of 0-10 (0 being no pain and 10 being the highest level of pain) and when treatment ended, the pain was zero. 100% pain reduction.

[0111] MM-This patient had peroneus longus tendonitis and Achilles tendonitis. Treatment began at the origin of the peroneus longus and the probe was held for 2 minutes at a pressure within the working conductor pressure range disclosed herein. The probe was then aligned and moved along the entire length of the peroneus longus and peroneus brevis muscles. The probe was moved slowly for 4 minutes at a pressure within the working conductor pressure range disclosed herein. When the lateral malleolus was reached, the secondary probe was held stationary and the primary probe was moved. This technique was used all the way to the fifth metatarsal tendon insertion. This patient underwent two treatments. Before treatment began, the pain was a 6 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain) and when treatment ended, the pain was zero. 100% pain reduction.

[0112] JOH - This patient had acute onset of shin splints while running the previous day. A trigger point was found at the posterior tibial muscle and the probe was held at this point for 2 minutes with pressure within the working conductor pressure range disclosed herein. The probe was slowly moved downwards over the entire length of the posterior tibial tendon to the arch of the foot for a total of 4 minutes with pressure within the working conductor pressure range disclosed herein. This patient underwent 2 treatments. Before treatment began, the pain was an 8 on a scale of 0-10 (0 being no pain and 10 being the highest level of pain) and when treatment was completed, the pain was zero. 100% pain reduction.

[0113] BM-This was a post-operative knee reconstruction patient. He had significant knee pain and swelling. The tip of the probe was held perpendicular to the leg, starting at the calf, and the probe was moved slowly towards the heart, holding the probe about 1.5 inches apart on each side while maintaining pressure on the probe within the working conductor pressure range disclosed herein. This was done for about 4 minutes while moving the entire knee. The probe was then held over the knee joint (posterior) near the top of the gastrocnemius and the medial and lateral femoral condyles. This patient underwent 11 treatments. Before treatment began, the pain was a 9 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain) and when treatment was completed, the pain was zero. 100% pain reduction.

[0114] MG-This was a patient with R sciatica. The right side at L3 / L4 / L5 / S1 was treated. Then L4 / L5 was traced and the probe slowly moved to the gluteus medius trigger point and held there for 2 minutes with pressure within the working conductor pressure range disclosed herein. The probe was then moved back to L4 / L5 / S1 and then slowly moved to the piriformis. The probe was held at the piriformis trigger point for 2 minutes and then slowly moved down to the ischial tuberosity. The probe was held there for 2 minutes and then moved medially and laterally for 2 minutes with pressure within the working conductor pressure range disclosed herein. The probe was then slowly moved down the hamstring (2 minutes total) and held on the biceps femoris trigger point for 2 minutes with pressure within the working conductor pressure range disclosed herein. This patient underwent 6 treatments. Before treatment began, the pain was 8 on a scale of 0-10 (0 being no pain and 10 being the highest level of pain) and when treatment ended, the pain was zero. 100% pain reduction.

[0115] EB- This patient had thumb pain along the extensor pollicis brevis and abductor pollicis longus tendons. The secondary probe was held stationary and the primary probe was moved along these tendons for 2 minutes each with pressures within the working conductor pressure ranges disclosed herein. The tendons were too small to actuate both probes along the tendons. The probes were held stationary for 2 minutes at the CMC joint and wrist joint with pressures within the working conductor pressure ranges disclosed herein. The patient only received one treatment. Before treatment began, the patient had pain of 6 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain) and when treatment was over, the pain was zero. 100% pain reduction.

[0116] OH- This patient was a soccer player with pain along the peroneal tendon and calf pain. Trigger points were found at the peroneus longus and peroneus brevis. The probe was held there for 2 minutes each, with pressure within the working conductor pressure range disclosed herein. The probe was then aligned along the peroneal tendon and moved along its entire length around the lateral malleolus to the tendon insertion at the base of the 5th metatarsal. This movement lasted a total of 4 minutes. This patient underwent 2 treatments. Before treatment began, the pain was 6 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain), and when treatment ended, the pain was zero. 100% pain reduction.

[0117] JW - This male patient had a R hip flexor strain. This was a collegiate semi-professional soccer player. Treatment began with the R ASIS and held there for 2 minutes with pressure within the working conductor pressure range disclosed herein. The trigger point of the rectus femoris was found and the patient's leg was gently extended over the side of the treatment table. The probe was then lined up side to side and moved slowly downwards to the knee. This was also done over the sartorius muscle and tendon, but here the patient flexed the knee and rotated the hip outward. This patient underwent one treatment. Before treatment began the pain was a 5 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain) and when treatment ended the pain was zero. 100% pain reduction.

[0118] JW - This female patient was a 40 year old runner who had been in pain for 9 months and had been going to two chiropractors. She was unable to run but was attempting to train for a marathon. The patient suffered from pain in the left hip. Treatment was started at L5 and the probe was held there for 2 minutes with pressure within the working conductor pressure range disclosed herein. The probe was then moved to S1 for 2 minutes and then to S2 for 2 minutes. From S2, the probe was slowly moved along the piriformis muscle from the sacrum to the greater trochanter of the femur. The probe was moved slowly for approximately 4 minutes. A trigger point was found at the piriformis muscle and held there for 2 minutes with pressure within the working conductor pressure range disclosed herein. This patient underwent one treatment. Before treatment began, the pain was an 8 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain) and when treatment ended, the pain was zero. 100% pain reduction.

[0119] JB - This patient had cervical radiculopathy. Symptoms were those of a C7 radiculopathy. The patient experienced pain in the upper arm and back of the wrist, numbness and tingling in the back of the arm and in the middle finger of the right hand. The probe was held at C5 / C6 / C7 / C8 for 2 minutes each. The probe was then placed on either side of C6 and C7 for 1 minute each. The probe was slowly moved from C6 down the neck to the UT, held for 2 minutes, then moved to the levator scapulae and held for 2 minutes at a pressure within the working conductor pressure range disclosed herein. The probe was then slowly moved to the infraspinatus, down the deltoid to the triceps, and finally to the wrist extensor. This treatment took approximately 8 minutes. This patient underwent 5 treatments. Before treatment began, the pain was a 9 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain) and when treatment ended, the pain was zero. 100% pain reduction.

[0120] FB- This patient had radicular low back pain with symptoms at L4 / L5. The probe was held on the right side of the spine at these levels for 2 minutes, then for 1 minute on either side with pressure within the working conductor pressure range disclosed herein. Symptoms were also felt in the buttocks and legs. The probe was moved to trace from the spinal segment to the gluteus medius, piriformis, hamstrings, and peroneus. Treatment took approximately 10 minutes. Movement was slow while pressure on the probe was maintained within the working conductor pressure range disclosed herein. This patient underwent one treatment. Before treatment began, the pain was 10 on a scale of 0 to 10 (0 being no pain and 10 being the highest level of pain), and when treatment ended, the pain was 2. 80% pain reduction.

[0121] Although various embodiments of the present disclosure have been described above, it should be understood that they are presented by way of example and not limitation. Numerous changes to the disclosed embodiments can be made in accordance with the disclosure herein without departing from the spirit or scope of the disclosure. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described embodiments. Rather, the scope of the present disclosure should be defined in accordance with the following claims and their equivalents.

[0122] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. Furthermore, to the extent that "including," "include," "having," "has," "with," or variations thereof are used in either the detailed description and / or claims, such terms are intended to be inclusive in the same manner as "comprising."

[0123] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly defined as such.

Claims

1. 1. A patient treatment unit for delivering non-invasive pulsed energy to biological tissue, the patient treatment unit comprising: a probe stimulus generator circuit configured to output a train of electrical pulses as a therapy signal at a controlled pulse frequency of 18-22 kHz, the electrical pulses having a pulse voltage as a variable supply voltage; a primary conductor having a rounded tip configured to contact a human or animal body and an elongated body, the primary conductor being electrically coupled to the probe stimulus generator circuit to receive the electrical pulses; a secondary conductor configured to contact the body and electrically coupled to the probe stimulus generator circuit to complete an electrical circuit with the primary conductor through the body; an intensity adjustment circuit configured to manually or automatically adjust an intensity of the variable supply voltage, the patient treatment unit having a treatment mode in which the electrical pulses are provided to the primary conductor and the secondary conductor, the intensity adjustment circuit setting the variable supply voltage to a predetermined starting voltage upon activation of the treatment mode; a first electronic timer display configured to display an elapsed time, the elapsed time starting with each activation of the treatment mode and stopping with each deactivation of the treatment mode; the current of the electrical pulse is in the range of 0.1 to 2 mA while the primary and secondary conductors are in contact with the body; the variable supply voltage of the electrical pulse does not exceed 165V while the primary and secondary conductors are in contact with the body; The primary conductor has a resistance of 0.345 N / cm ２ ~103.421N / cm ２ and the primary conductor is configured to contact a region of the human or animal body at an angle of 45 to 90 degrees; the patient treatment unit further comprising a pressure sensor in the primary conductor configured to output a pressure applied to the rounded tip, the pressure sensor configured to measure a pressure at the rounded tip of at least 0.345 N / cm 2 to 103.421 N / cm 2 . Patient care unit.

2. 10. The patient treatment unit of claim 1, further comprising a second electronic timer display configured to display a total accumulated time that the probe stimulus generator circuit has delivered the therapy signal since the first time the therapy mode is activated.

3. 10. The patient treatment unit of claim 1, wherein the intensity adjustment circuit is further configured to increase the variable supply voltage from the predetermined starting voltage to a variable treatment voltage after the activation of the treatment mode.

4. 4. The patient treatment unit of claim 3, wherein the primary conductor includes a dial as a manual setting for increasing the variable supply voltage to the variable treatment voltage.

5. 5. The patient treatment unit of claim 4, wherein the dial is a detent wheel.

6. The patient treatment unit of claim 5 , wherein the detent wheel has a locked position in which a measurement mode is enabled.

7. 7. The patient treatment unit of claim 6, wherein the detent wheel is rotatable toward the rounded tip of the primary conductor away from the locked position.

8. 8. The patient treatment unit of claim 7, wherein when the detent wheel is rotated away from the locked position, the measurement mode is disengaged and the treatment mode is enabled.

9. 8. The patient treatment unit of claim 7, wherein the current of the electrical pulse increases as the detent wheel rotates away from the locked position.

10. 6. The patient treatment unit of claim 5, wherein the detent wheel is the only manual setting on the primary conductor.

11. 4. The patient treatment unit of claim 3, wherein the variable supply voltage automatically varies between the predetermined starting voltage and the variable treatment voltage.

12. 10. The patient treatment unit of claim 1, further comprising an outer casing in which the probe stimulus generator circuitry, the intensity adjustment circuitry, and the electronic timer display are enclosed.

13. 1. A patient care unit comprising: a probe stimulus generator circuit for generating, during active operation of a therapy mode, a therapy signal including electrical pulses having a pulse frequency of 18-20 kHz, a pulse current of 0.1-8.9 mA in a defined range of load impedance, and a pulse voltage as a variable supply voltage, the variable supply voltage not exceeding 165 V; a pair of conductive probes coupled to the probe stimulus generator circuit for conducting the therapy signal through a human or animal patient's body as the load impedance via non-invasive contact with the patient's skin, wherein in the therapy mode, the electrical pulses are provided to the pair of conductive probes; a mode control circuit configured to activate and deactivate the treatment modes in response to an operator input; an intensity adjustment circuit configured to control the variable supply voltage to set the variable supply voltage to a predetermined starting voltage upon activation of the treatment mode; a visual display unit configured to display an elapsed time of treatment in the form of minutes and seconds, said elapsed time starting with each activation of said treatment mode and stopping with each deactivation of said treatment mode; The pair of conductive probes includes a primary probe, the primary probe having a resistance of 0.345 N / cm ２ ~103.421N / cm ２ and said primary probe is configured to contact a region of said human or animal patient's body at an angle of 45 to 90 degrees; the primary probe has a rounded tip configured to contact the human or animal body; the patient treatment unit further comprising a pressure sensor within the primary probe configured to output a pressure applied to the rounded tip, the pressure sensor configured to measure a pressure at the rounded tip between at least 0.345 N / cm 2 and 103.421 N / cm 2 . Patient care unit.

14. 14. The patient treatment unit of claim 13, wherein the variable supply voltage varies between the predetermined starting voltage and a variable treatment voltage, the predetermined starting voltage being lower than the variable treatment voltage.

15. 15. The patient treatment unit of claim 14, further comprising a detent wheel on one of the pair of conductive probes, the detent wheel rotatable to activate and deactivate the therapy mode.

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