Interferometric therapy device to correct beat selection

JP7638052B2Active Publication Date: 2025-03-03ローズドナルドエイ
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Patent Information

Application Number
JP2022549599
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-02-20
Filing Date
2021-02-18
Publication Date
2025-03-03
Estimated Expiration
2041-02-18

AI Technical Summary

Benefits of technology

【0008】 測定温度に何らかの増大をもたらすようなビート周波数の範囲及び電極パターンを選択した後、ビート周波数は、ガイドとして皮膚のインピーダンスの測定値を使用して狭める。例えば、ビート周波数の範囲が1~10であり、わずかなプラスの温度の増大、例えば華氏0.5度の増大を認めた場合、患者に適用するビートの範囲を4~8ビートに狭め、皮膚のインピーダンスが以前の選択から増加したかどうかを決定できる。一方の意味では、狭めた範囲のビート周波数は、第1の範囲の範囲内に完全にあるが、もう一方の意味では、狭めた範囲のビート周波数は、第1の範囲に重なる。ビート周波数の範囲を狭める試みは、範囲の上端又は下端がより効果的であり、元の範囲の一部及び隣接する範囲の一部とを含むビート周波数範囲の選択につながることを示す。即ち、第2の範囲は、第1の範囲の一端を超えて拡張できる。皮膚のインピーダンスは、短期間に増大し、次に、皮膚のインピーダンスは、長期間に減少するようである。皮膚のインピーダンスを追跡する利点は、ほぼ瞬時に結果が得られることである。このことは、治療を行っている間に治療強度を増減することも可能にする。皮膚のインピーダンスが一時的に増大する場合、範囲は、5~6ビートに更に狭め、効果を決定するためにこの工程を繰り返す。

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Abstract

Electrical interference techniques are used to determine viable treatment parameters, which are then used to administer treatment to the patient. A range of beat frequencies is applied to the patient and an index of autonomic nervous system activity is measured. Once a certain degree of autonomic nervous system activity is detected, subsequent tests can be performed using overlapping ranges of frequencies, narrower ranges of frequencies, or a single range to attempt to fine-tune the response to autonomic nervous system activity. A garment with a series of electrode sites thereon can be used for those with limited training to accurately place the electrodes on the patient's body. Treatment can be administered while the patient is sleeping.
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Description

[Technical field]

[0001] This application is based in part on Provisional Application No. 62 / 979,350, filed February 20, 2020, the disclosure of which is incorporated herein by reference and priority is claimed to such application.

[0002] The present invention relates to improved techniques for implementing interferometric therapy approaches, and more particularly to techniques that modify beat frequency selection, simplify and improve electrode placement, and deliver interferometric therapy while the patient is sleeping. [Background technology]

[0003] There are various treatment approaches that incorporate the application of electricity to a patient's body. One of these approaches is called interferometric therapy, which is described in some detail in U.S. Patent Nos. 5,995,873, 6,826,429, 8,515,551, 9,061,145, and 9,333,348, the disclosures of which are incorporated herein by reference. The basic approach is to apply electrodes to various locations on the body and deliver electrical pulses through the electrodes. Typically, two, three, or four pairs of electrodes are used in interferometric therapy. Each electrode is often placed adjacent to a nerve ending, acupuncture point, or reflexology point on the patient's foot or hand. Interferometric therapy involves delivering a carrier frequency and a beat frequency through the electrodes. The result is a stream of pulses that are delivered to the nerve endings. While current approaches use a carrier frequency and a beat frequency to generate a beat that is the difference between the carrier frequency and the beat frequency, interferometric therapy as used herein consists of utilizing beats or pulses rather than generating them.

[0004] The effectiveness of interferometric therapy is measured in any suitable manner. One simple and effective approach to measure short term success is to measure the temperature of the patient's hands, feet or fingers. An increase in measured temperature is a surrogate for increased blood circulation and is related to the effectiveness of the interferometric technique. The measurement for long term success is naturally the reduction in pain or illness suffered by the patient. Long term success is the goal, but to reach that goal short term success comes first.

[0005] The problem is to select a combination of electrode placement and beat frequency that delivers an effective treatment. There are tens of thousands of combinations of electrode placement and beat frequency for use in planning electrical interference wave treatment. Some consistent combinations of electrode placement and beat frequency are better than others. Experimentation is required to determine viable electrode placement and beat frequency because the measured response varies from patient to patient and from time to time for the same patient. If a combination of electrode placement and one range of beat frequencies does not achieve an increase in temperature response, the electrode placement is changed or the range of beat frequencies is changed. This process is repeated until a satisfactory response is obtained. Selection of acceptable combinations of electrode patterns and beat frequencies is complicated by the vast number of electrode placements and beat frequencies, resulting in inconsistent selections and inconsistent patient responses to the same selections of electrode placement and beat frequency. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 5,995,873 [Patent Document 2] U.S. Patent No. 6,826,429 [Patent Document 3] U.S. Patent No. 8,515,551 [Patent Document 4] U.S. Patent No. 9,061,145 [Patent Document 5] U.S. Patent No. 9,333,348 Summary of the Invention [Means for solving the problem]

[0007] The disclosed technique involves adjusting the selection of beat frequency in response to another parameter that varies in a different manner than the commonly used parameter that is a surrogate for the effectiveness of an electrical interferometric treatment regimen. The commonly used parameter is skin temperature, which is a surrogate for increased blood flow and is one measure of the effectiveness of an interferometric treatment regimen. The other parameter is skin impedance, or any other indicator of autonomic activity. Skin impedance is measured in any suitable manner, such as that disclosed in the article entitled "Skin Impedance Measurements Using Simple and Compound Electrodes" by EJ Woo et al., Med. & Bio. Eng. & Comput., 1992, pp. 97-102.

[0008] After selecting a beat frequency range and electrode pattern that results in some increase in measured temperature, the beat frequency is narrowed using the skin impedance measurement as a guide. For example, if the beat frequency range is 1-10 and a small positive temperature increase is noted, e.g., an increase of 0.5 degrees Fahrenheit, the range of beats applied to the patient can be narrowed to 4-8 beats to determine if the skin impedance has increased from the previous selection. In one sense, the narrowed range of beat frequencies is entirely within the first range, while in another sense, the narrowed range of beat frequencies overlaps the first range. Attempts to narrow the range of beat frequencies show that the upper or lower ends of the range are more effective, leading to the selection of a beat frequency range that includes part of the original range and part of an adjacent range. That is, the second range can be extended beyond one end of the first range. It appears that the skin impedance increases for a short period of time, and then the skin impedance decreases for a long period of time. The advantage of tracking the skin impedance is that results are nearly instantaneous. This also allows the treatment intensity to be increased or decreased while the treatment is being administered. If skin impedance temporarily increases, the range is further narrowed to 5-6 beats and the process repeated to determine the effect.

[0009] When testing or treatment is performed by the patient or a less trained caregiver, electrode placement is often ad-hoc, and so it may be desirable to provide a guide or template that can be used to properly place the electrodes. This can be accomplished by a garment worn by the patient, the garment having indicia designating the desired electrode locations. Because there are a large number of possible electrode sites, many different garments can be provided, or many different patterns can be utilized to convey the desired electrode placement to the garment.

[0010] For some patients, it may be desirable to perform treatment while the patient is asleep, which has the advantage of allowing for longer treatments, or different treatments at once even while the device is already working to heal the body.

[0011] It is an object of the present invention to provide a technique for narrowing the selection of beat frequencies in electrical coherence therapy methods.

[0012] It is a further object of the present invention to provide an approach that narrows the selection of beat frequencies by incorporating input from two or more indices of autonomic nervous system activity.

[0013] Another object of the present invention is to provide a guide or template for accurate placement of electrodes.

[0014] A more specific object of the present invention is to provide a garment having indicia thereon which indicate where electrodes should be placed.

[0015] It is a further object of the present invention to provide a method and apparatus for treating a sleeping patient.

[0016] Other objects and advantages of the present invention will become apparent as the present specification proceeds, with reference to the accompanying drawings and appended claims. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a schematic diagram of an interferometric treatment device deployed on a patient. [Figure 2a] 1 is a graph of skin impedance over time showing improved interference wave response. [Figure 2b] 1 is a graph of skin impedance over time showing no improvement in response to interferometric therapy. [Diagram 3] FIG. 1 is a front view of a pair of pants having markings thereon indicating the location of one preferred electrode. [Figure 4] FIG. 4 is a partial rear view of the pants of FIG. 3. [Diagram 5] 13 is a photograph of another garment useful as a guide for placing electrodes. [Figure 6]FIG. 6 is a rear view of the knee brace shown in FIG. 5, showing the knee brace being worn by a patient and illustrating the locations of electrode placement in one general electrode pattern. [Figure 7] FIG. 7 is a front view similar to FIG. 6, showing the location of electrodes in one general electrode pattern. [Figure 8] FIG. 1 is a diagram of a device for performing interference testing and treatment while the patient is sleeping. [Figure 9] FIG. 9 is a schematic diagram of the electrode assembly of FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] 1, a patient 10 rests on an electrical interference therapy device 12 inside a housing 14. The electrical interference therapy device 12 can include a more or less conventional therapy module 16, such as those available from Alan Neuromedical Technologies LLC of The Woodlands, Texas, for a more complete description of which please see Alan Neuromedical Technologies LLC.

[0019] A wide variety of parameters can be used to monitor the autonomic nervous system and thus determine the effect of interferometric therapy on the patient. These parameters may include skin impedance or resistivity, circumferential skin temperature, pulse rate, blood pressure, iris pupil diameter, respiration rate, blood oxygen level, or any other indicator of autonomic nervous system function as described in U.S. Pat. No. 8,515,551. Measuring skin temperature has proven to be an advantageous choice since it is unambiguous, reliable, and easy to determine with commercially available sensors. Temperature may be taken at any suitable location, but the fingers and toes have proven easy and effective. Alternatively, any other indicator of autonomic nervous system function may be used as the primary parameter, such as skin impedance or resistivity, pulse rate, blood pressure, iris pupil diameter, respiration rate, blood oxygen level, or any other indicator of autonomic nervous system function. The secondary parameter used to fine-tune the selection of the beat frequency may be different from the primary parameter and may be another indicator of autonomic nervous system function, preferably one that does not closely mimic the response of the primary parameter. It may be .

[0020] When finger temperature is used as the primary parameter, the sensor(s) 18, 20 may preferably be finger temperature sensors incorporated into a spring-loaded clip that may be attached to the fingers or toes on one or both sides of the patient 10. The sensors 18, 20 may be connected by wires 22, 24 to a module 28 in the housing 14. The module 28 may be a data processor that records the temperature sensing from the sensors 18, 20, stores the values ​​in a memory module 30, controls the treatment module 16 or otherwise operates the device 12, and may transmit any data, stored or unstored, to a suitable storage location such as the cloud. Other sensors are equally effective and may be more effective under some conditions. Temperature sensors sewn into clothing are particularly desirable when the patient is receiving treatment while sleeping or performing daily activities. Similarly, wires embedded in the clothing or braided wires woven into the clothing are suitable.

[0021] The housing 14 may include a series of receptacles 32, 33, 34, 35 capable of receiving jacks 36, 37, 38, 39 of insulated wire pairs 40, 41, 42, 43 which lead to electrode pairs 44, 44', 45, 45', 46, 46', 47, 47'. A suitable display 48 provides indications such as values ​​from the sensors 18, 20, carrier frequency, pulse frequency or frequency range tested, time and date of treatment, as well as other desired information such as treatment intensity, patient data, time remaining until end of treatment, time elapsed between particular test cycles, results of a test sequence, and whether it is time to change electrodes. The device 12 may be battery powered, allowing treatment while the patient sleeps or by wearing the unit during the day.

[0022] Standard commercially available electro-interferometric therapy devices have either a fixed carrier frequency or a minimally selectively variable carrier frequency. For primarily historical reasons, these frequencies have traditionally been 1850 Hz and 2850 Hz in the Sympathetic Therapy System from Dynatronics, Inc., or 4000 Hz in devices commercially available from Rehabilicare Corporation of St. Paul, Minnesota.

[0023] The device 12 may include a selection actuator 50 and an up / down actuator 52, 54. In prior art devices, the intensity can only be set at the beginning of a treatment. An advantage of the current approach is that the data processor module 28 can change the intensity of the pulses delivered through the electrodes during the course of a treatment plan in response to the number of pulses to be delivered, the time of treatment elapsed, the patient's preferences, the response to the treatment as measured by one of the parameters, etc. The module 28 can provide other functions. For example, the electrodes 44, 44', 46, 46' do not provide good sensing indefinitely. The module 28 can perform tests to determine whether to replace the electrodes, count the number of treatments or parameter determination tests, and display a message to replace the electrodes on the screen 48. In response to such a message, the selection actuator 50 can be pressed to send a message to the module 28 that the electrodes have been changed or to change the electrodes. The device 12 may also include a timer function, the time and duration of the treatment, and / or capture of the treatment parameters. The device 12 may also include an on-off switch 56. The device 12 is preferably battery powered, which allows the patient to receive treatment while sleeping, or, if the device 12 is small enough, while walking, driving, or performing daily activities.

[0024] The carrier and beat frequencies used in the selection of treatment parameters can be selected by actuators 50, 52, 54 or can be provided as default selections by software in processor 28. Experience has shown that the majority of desirable beat frequencies are between 1-150 beats per second (bps), although current commercially available devices utilize only 1-80 beats per second. In an attempt to find an effective beat frequency within a reasonable time frame, this range is subdivided into subdivisions of 1-150 Hz, typically 1-10 bps, 11-20 bps, 21-30 bps, 31-40 bps, etc. Experience has shown that of at least one carrier frequency that is the most focused on, some subdivision provides the most desirable beat frequency.

[0025] If it is desired to increase the treatment intensity, either at the start of treatment or during treatment as described above, in response to the processor module 28, the increase actuator 52 is depressed. Thus, it can be seen that the device 12 includes circuitry for delivering therapeutic electrical energy to the patient's body, and more particularly, subcircuitry for modifying the carrier frequency, beat frequency and / or magnitude of the alternating current energy.

[0026] The electrodes are attached to the patient's skin or clothing as described below; that is, the electrodes are self-adhesive. The location of the electrodes on the patient establishes an electrical circuit within the patient. As shown in FIG. 1, in one electrode pattern, one electrode 44 is placed adjacent to the end or terminal end of the right medial plantar nerve L5, and its matching electrode or paired counterpart 44' is placed adjacent to the end or terminal end of the left sural nerve S1 below the left talus (lateral malleolus), thereby establishing a first electrical circuit within the patient. The terms L5, S1, etc., used herein are standard medical terms for the nerves in the human leg. The electrode pattern of FIG. 1 is shown in U.S. Pat. No. 5,995,873, which is incorporated herein by reference for a more complete description. There are hundreds or thousands of possible electrode patterns using various numbers of electrode pairs. In addition to the L5, S1 pattern, a preferred approach is to use four additional electrodes for a total of eight electrodes. The additional electrodes are: L4 , S2, L5-L4 pattern, etc. Those skilled in the art will appreciate that this description is representative of a commercially available electrical interference therapy device available from Alan Neuromedical Technologies LLC of The Woodlands, Texas.

[0027] Two of the indices of autonomic nervous system activity are used together to adjust the selection of the beat frequency. For example, if skin temperature is used as a primary indicator for the effectiveness of interferometric therapy, skin impedance or resistance can be used as a secondary indicator and the beat selection can be modified by adjusting the beat selection from one range to a narrower range or from a wider range or to a number. For example, in a test to determine an effective combination of electrode placement and beat frequency, one can start with a given electrode placement and a range of beat frequencies. A normal or initial setting for the beat frequencies is 1-10. After achieving some temperature response, the beat frequency can be narrowed in response to readings from a skin impedance or resistance sensor 58 connected to the unit 12 by a wire or communication link 60. These adjustments can be made preferably by software in the module 28 or manually by the user. The impedance sensor 58 is preferably near a set of electrodes, for example on the same hand, foot or limb. Over time, the response to interferometric therapy as measured by skin temperature tracks the response as measured by skin impedance. The advantage of using skin impedance is that the onset of changes in skin impedance can be measured in seconds, whereas the onset of changes in skin temperature take minutes to measure. Thus, an adjustment to the beat frequency is narrowed in response to the skin impedance, and if the narrowed range results in an improved response, the skin impedance will increase for a short period of time, verified after a few minutes by an increase in skin temperature. This process of narrowing the beat frequency range can be repeated again to modify the skin temperature response. For example, for a default beat frequency range of 1-10 beats / sec, a first narrowed range can be 2-8 beats / sec, a second narrowed range can be 4-6 beats / sec, and a third narrowed range can be 4.5-5.5 beats / sec.

[0028] The situation in electro-interferometric therapy is to find a combination of electrode placement and beat frequency that results in an adequate temperature response. In the past, this has typically been done by changing the placement of the electrodes or changing the beat selection from a default range of 1-10 to a range of 11-20, 21-30, etc. In contrast, in some approaches of the present invention, the concept is to find a temperature response that may be insufficient and then attempt to fine-tune the beat frequency in response to another parameter such as skin resistivity or impedance. Impedance as used herein is defined as resistance, impedance, or resistance and impedance.

[0029] There are many possible variations in the generation of beat frequencies. For example, a current standard approach to the selection of beat frequencies between 1 and 10 beats per second is to apply the beats in a pattern, e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, and then repeat. For 11 to 20 beats per second, the current standard pattern is 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, and then repeat. Similarly, the limited beat frequency range may be any suitable pattern, e.g., 4, 5, 6, 7, 7, 6, 5, 4, in the case where the results from the sensor 58 indicate a range of 4 to 7 or 9, 10, 11, 12, as testing indicates that the more desirable beat frequency ranges overlap the standard segments. These patterns are standard, but the patterns used in carrying out the disclosed treatments may be of any suitable representation.

[0030] There are some situations where the most effective treatment is in a fairly narrow temperature range. This means that there are situations where there is too little or too much temperature response. For example, many patients with complex regional pain syndrome and erythromelalgia can be better treated with a temperature response in the range of 1-2 degrees Fahrenheit. Thus, while the preferred technique for lowering the temperature response is to reduce the treatment intensity by reducing the magnitude of the carrier frequency and beat frequency, one advantage of the present invention is to reduce the temperature response by fine-tuning the beat frequency and widening the range of the beat frequency to overlap the original range of the beat frequency. This means that the range of the second beat frequency extends beyond the original range. This is in contrast to current thinking that considers a temperature response of 1-3 degrees Fahrenheit to be most desirable. Thus, the beat frequency can be modified in an attempt to increase or decrease the perceived temperature response.

[0031] What constitutes a sufficient temperature response is explained in some detail in U.S. Patent No. 9,061,145, to which reference is made for a more complete understanding of sufficient and insufficient temperature responses. If the temperature response is sufficient, patient treatment continues either automatically in response to commands by data processor 28 or manually in response to commands by the patient or caregiver.

[0032] Various parameters of effect include skin impedance, skin resistivity, circumferential skin temperature, pulse rate, blood pressure, iris pupil diameter, respiration rate, blood oxygen level, or any other indicator of autonomic nervous system function. These parameters do not provide the same response to the same combination of electrode placement and beat frequency, and in other cases do not have the same characteristics, such as cost, ease of use, reliability, repeatability, relative lack of ambiguity, etc. As disclosed above, a viable parameter combination is circumferential skin temperature and skin impedance or resistivity, which has the advantages of low cost, reliable relative clear skin temperature, and rapid response to skin impedance or resistivity. Other combinations of parameters are viable and have some of their advantages, because other combinations of parameters have different responses to the same interferometric wave treatment, different response times, different costs, different ease of use, and other differences.

[0033] FIG. 2a shows a graph of skin impedance versus time, showing an initial short period in which the skin impedance decreases, followed by an extended period in which the skin impedance increases. This type of response typically indicates an improved response to interference therapy. FIG. 2b shows a graph of skin impedance versus time, showing no change in skin impedance and therefore no change in response to interference therapy. The time interval depicted in FIG. 2a is typically on the order of less than a minute. Since skin impedance moves more rapidly than skin temperature, but skin temperature tracks skin impedance within minutes, it may be advantageous to wait until skin temperature corroborates the skin impedance measurement before modifying the beat frequency range. In some situations, the adjustment of the beat frequency range is made in response to skin impedance, and in other situations, in response to skin temperature.

[0034] 3 and 4, a garment or pant 62 of fabric 64 is shown having a series of sites or locations 66 on which electrodes are to be placed in a commonly used electrode pattern. The sites 66 are applied to the fabric 64 of the garment in any suitable manner. As shown, the electrode pattern is a commonly effective eight electrode pattern. This illustrated pattern is merely an example, and many different patterns using different numbers of electrodes are feasible. The electrodes 44, 44', 46, 46' may be applied directly to the fabric 64 of the garment 62, or the locations 66 may comprise holes in the fabric 64, with a cord attached around the holes so that the electrodes may be applied directly to the patient's skin, as will become apparent below.

[0035] The electrode pattern on the garment 62 is conveniently shown as being coded so that the markings 68 at sites 66 correspond to the same numbers on the electrodes or electrode wires shown in Figure 1. Any suitable technique may be used.

[0036] 5-7, one commonly used electrode pattern is shown incorporated into a knee brace 70, providing another example of a garment that can be used to place the electrodes in the appropriate locations. The knee brace 70 includes an opening 72 that rests over the wearer's kneecap, thereby allowing the brace to be placed in a repeatable position. Electrodes 74, 76, 78 are sewn into the brace 70 on the front of the knee brace, and electrodes 80, 82 are sewn on the back, with suitable wires or communication links (not shown) providing connection from the electrodes to the module 28. Alternatively, markings may be provided on the brace 70 to indicate electrode placement. Similar Velcro® wraps could be used on the hand using the thumb as an anatomical landmark, or on the foot and ankle using the talus as an anatomical landmark, allowing accurate placement of the wrap. The electrode pattern on the knee brace 70 is conveniently shown to be coded, so that the markings 84 at the electrode sites correspond to the same numbers on the electrodes or electrode wires shown in FIG. 1. Any suitable technique may be used.

[0037] 8-9, there is shown another electrical interference wave system 86 that looks quite different from that of FIG. 1 but operates in a similar manner. The system 86 includes a control module 88 that can be located on the patient's bedside table and on one or more body worn garments 90. The control module 88 can be battery powered or conventionally powered through a household electrical connection. The body worn garment can be part of the garment as shown in FIGS. 3-7, with electrode assemblies 92 attached at designated locations and with a suitable primary sensor 94, such as a skin thermometer, and a suitable secondary sensor 96, such as a skin impedance sensor. Alternatively or additionally, the body worn garment can include a glove or wrist band 98, with electrode assemblies 100 and a primary sensor 102 attached, and with a secondary sensor 104, such as a skin impedance sensor. The control module 88 and garments 90, 98 may include a wireless communication system 106 to enable the control module 88 to transmit wireless signals to the electrode assemblies 90, 98 and receive information from the sensors 94, 96, 102, 104. Additionally, the system 86 includes a communication system 108 in communication with a receiver to store the data received from the sensors 94, 96, 102, 104 and other suitable information for later viewing by the patient or medical personnel. Currently, the cloud is the preferred location for storing data, although this storage location is dependent on future developments.

[0038] An exemplary electrode assembly 92 is shown in more detail in FIG. 9 and includes a circuit 110 including a battery 112, a wirelessly operated on-off switch 114, a beat generator 116 that delivers pulses to electrodes 118 in communication with the patient's skin, and a near-field communication device 120. The circuit 110 further includes a primary sensor 122 that detects an autonomic nervous system response, and a secondary sensor 124 that adjusts the range of beat frequencies in response to a secondary indicator of the autonomic system response. As in the embodiment of FIG. 1, the primary sensor 122 is a skin temperature sensor and the secondary sensor 124 is a skin impedance sensor. The control module 88 adjusts the range of beat frequencies applied by the electrodes 118 in response to information from the secondary sensor 124.

[0039] An important advantage of the system of Figures 8-9 is the ability to treat the patient while asleep. This not only allows for longer treatment times, but also allows for the application of different treatments. It may be preferable for the lower body garment to be placed on the patient's knees or feet, and the upper body garments 90, 98 to be placed on the patient's hands or wrists. The lower body treatment is followed by the upper body treatment. The module 88 then turns off the electrode assemblies 92, 100, and after a suitable wait, the upper and lower body treatments are repeated.

[0040] Lower and upper body treatments tend to produce more of some neuropeptides and less of others. When combined, the lower and upper body treatments overcome each other's deficiencies and combine to produce a good combination. One approach that may be preferred is to perform upper and lower body treatments while the patient is asleep, thus allowing time for multiple approaches. One approach is to perform upper and lower body treatments, and then perform another upper and lower body treatment after a delay of several hours. Another approach is to perform testing midway through treatment by adjusting the beat frequency again and determining whether the response from the primary and / or secondary sensors indicates improvement.

[0041] Operation of the system 86 begins when the patient places the garments 90, 98 in the proper location to place the electrodes at the desired sites. The control module 88 includes some mechanism that turns on and determines if the patient is asleep. This mechanism could simply be a timer, a more sophisticated head mounted device for use in sleep clinics, or an intermediary such as a motion sensor equipped with software that understands that the patient is not moving much. The system 86 turns on and the sleep discriminator detects when the patient is asleep. The module 88 then sends a signal to the beat generator 116 to send a range of beat frequencies to the electrodes 118, detects the response from the sensors 122, 124, and adjusts the range of beat frequencies accordingly.

[0042] In good health, the same fingers on the left and right hands will show a temperature variation of less than 1 degree Fahrenheit, whatever the ambient temperature. Colder hands are usually due to a predominance of norepinephrine, which reduces blood flow to cold hands. Interferometric therapy often normalizes the left / right difference, and is the patient's documented improvement.

[0043] While the present invention has been disclosed and described in a preferred form and with a certain degree of detail, it is to be understood that the present disclosure of the preferred form is by way of example only, and that numerous changes in the details of operation and the combination and arrangement of parts may be employed without departing from the scope and spirit of the invention.

Claims

1. A device configured to deliver electrical interference wave therapy, the device comprising: a series of electrodes configured for application to a patient; and a system configured to deliver a first range of beat frequencies through the electrodes; the system is configured to measure an effect of the beat frequencies in the first range by measuring a first parameter of autonomic nervous system activity to determine a level of autonomic nervous system activity at the first range of beat frequencies; The system is configured to deliver beat frequencies in a second range of beat frequencies, the second range being shorter than the first range and including at least some beats within the first range; the system is configured to measure an effect of the beat frequency in the second range by measuring a second parameter of autonomic nervous system activity during delivery of the beat frequency in the second range, the second parameter being different from the first parameter; The device, wherein the second parameter is an index that is measured at a different rate than the first parameter.

2. 2. The device of claim 1, wherein the second range of beat frequencies is within the first range of beat frequencies.

3. 2. The device of claim 1, wherein the second range of beat frequencies extends beyond one end of the first range of beat frequencies.

4. The device of claim 1 , wherein the first parameter is skin temperature and the second parameter is skin impedance.

5. 2. The device of claim 1, wherein the second range of beat frequencies is a single value.

6. 10. The device of claim 1, further comprising a first set of garments configured to be attached to the patient's lower extremities and a second set of garments configured to be attached to the patient's upper extremities, the electrodes attached to the garments and configured to receive an interference wave beat, and the system configured to transmit the beat frequency to the first set of garments and the second set of garments.

7. 2. The device of claim 1, wherein the first range of beat frequencies is a subdivision of 1 to 150 Hz.

8. 2. The device of claim 1, wherein the first parameter and the second parameter are selected from skin impedance, skin resistivity, circumferential skin temperature, pulse rate, blood pressure, iris pupil diameter, respiration rate and blood oxygen level.

9. A device configured to deliver electrical interference wave therapy, the device comprising: a series of electrodes configured for application to a patient; and a system configured to deliver a first range of beat frequencies through the electrodes; the system is configured to measure an effect of the beat frequencies in the first range by measuring a first parameter of autonomic nervous system activity to determine a level of autonomic nervous system activity at the first range of beat frequencies; The device, wherein the system is configured to deliver beat frequencies in a second range of beat frequencies, the second range being shorter than the first range and including at least some beats within the first range.

10. 10. The device of claim 9, wherein the second range of beat frequencies lies entirely within the first range of beat frequencies.

11. 10. The device of claim 9, wherein the second range of beat frequencies extends beyond one end of the first range of beat frequencies.

12. 10. The device of claim 9, wherein the system is configured to adjust the range of beat frequencies emitted in response to a second parameter.

13. 13. The device of claim 12, wherein the first parameter and the second parameter are selected from skin impedance, skin resistivity, circumferential skin temperature, pulse rate, blood pressure, iris pupil diameter, respiration rate and blood oxygen level.

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