JP2015528371A - Optimal treatment parameter judgment method - Google Patents

Abstract

The diagnostic device of the interferometric electrotherapy regime applies different pulse frequencies in one selection of electrode placement and determines the blood flow in response to changes in the pulse frequency to determine the optimal or operable set of parameters. Determine change. The device includes a series of tests and an electronic storage device that records the results and a communication link. The communication link allows the professional caregiver to determine whether the parameters made at a location away from the professional office, such as the patient's residence, have been done correctly. . The communication link also allows the specialist to determine whether the treatment was performed and performed correctly. [Selection] Figure 1

Description

  The present invention relates to a method and apparatus for determining effective treatment parameters in an electrical interference wave system.

  Patent Document 1 filed on March 14, 2006 (the disclosure of which is incorporated by reference) transmits information on various pulse signals and electrode positions, and the patient's response to the applied treatment. Discloses a method for determining better treatment parameters in interferometric wave type electrotherapy. By making an expert judgment while changing these treatment parameters, a treatment parameter set effective for treatment of a disease manifested in a patient can be obtained.

  A disclosure having some relation to the present invention can be found in Patent Documents 2-16 shown below.

US patent application Ser. No. 11 / 374,903 U.S. Pat. No. 4,505,275 US Pat. No. 6,016,447 US Pat. No. 6,154,675 US Pat. No. 6,698,921 US Patent Application Publication No. 20020003832 US Patent Application Publication No. 20070150029 US Patent Application Publication No. 201000063544 US Patent Application Publication No. 2011006226 US Patent Application Publication No. 20100211135 US Patent Application Publication No. 2012022844 US Patent Application Publication No. 201110105916 US Patent Application Publication No. 201110106216 US Patent Application Publication No. 2011012974 US Patent Application Publication No. 20110231836 US Patent Application Publication No. 201110313488

  By obtaining more effective treatment parameters and shortening the judgment time of the treatment parameters, even if the skill level of the required personnel is not so high, depending on the patient himself or the caregiver of the patient, the effect It is an object of the present invention to determine typical treatment parameters.

For this reason, the software is designed to obtain better treatment parameters, and when a patient response is input, determine whether the patient feels blood flow improvement in response to applying a series of treatment parameters A function as a series of logic circuits for outputting results is provided.
As one broad application of the method disclosed below, an expert first treats a patient in a specialized environment that obtains a first set of treatment parameters and transmits information about the first treatment to the patient, The patient or the caregiver then performs many subsequent treatments at a location other than the professional office, such as the patient's residence. Thereafter, a new set of treatment parameters is preferably obtained using the same device and software for treatment through the device.

  The hardware and software automatically obtains the patient's response to a set of treatment parameters and includes information about this response along with the treatment parameters, when and how the treatment parameters were determined, and other appropriate information. Usually, it is stored in an electronic storage medium. Similarly, time and parameters used for treatment may be stored. A communication link may be provided to allow an expert to check whether the treatment parameters have been properly selected. Similarly, the communication link can be used by an expert to check whether the treatment was actually performed and in a manner consistent with best practice and at such times. .

It is a flowchart of the automated parameter selection method. 1 is a schematic diagram of a diagnostic system combined with a drawing to apply electrodes to a patient accordingly. FIG. It is a figure of a fingertip temperature sensor. 1 is a schematic diagram of one embodiment of a communication link. FIG. FIG. 6 is a schematic diagram of another embodiment of the disclosed method.

  In practice of the disclosed method, electrical energy in the form of electrical interference pulse waves is transmitted to the patient's body. These treatment signals result in patient changes that can be monitored by the disclosed devices. In other words, the effect of the electrical interference pulse wave is monitored by one or more sensors that detect the function or aspect of the autonomic nervous system. The detected patient change is then used to change the output of the treatment unit and / or the placement of the electrodes used by the treatment device. In other words, the results of the test are used to determine a preferred method of treating the patient by adjusting the therapy device in response to the results.

  Healthy life forms can be quickly adjusted for many external effects due to sufficient sympathetic response. When the relevant factor disappears, parasympathetic activity increases, thereby balancing the overall autonomic activity. It has been found that a great many people have an overactive sympathetic nervous system, that is, the sympathetic nervous system overwhelms or predominates the parasympathetic nervous system. This can have many effects, some of which are controversial, but many are not. In general, overactive sympathetic nervous systems are associated with type 1 and type 2 diabetes, fibromyalgia as disclosed in US patent application Ser. No. 11 / 326,230, filed Jan. 5, 2006. Tend to cause or exacerbate various symptoms or illnesses, such as, bipolar disorder, endometriosis, hypertension, other illnesses, or those disclosed in US Pat. No. 5,995,873 It is in.

  A wide variety of methods may be used to monitor the autonomic nervous system and thereby determine the effect of interferometric treatment on the patient. The preferred method is fingertip temperature monitoring, due to the relative response being relatively fast, easy to measure and relatively clear. Alternatively or in addition, other signs of the autonomic nervous system, such as skin resistance, pulse rate, blood pressure, iris pupil diameter, respiratory rate, for fingertip temperature monitoring Or any other indicator of autonomic nervous system function may be monitored.

  As shown in FIGS. 1 and 2, a patient 10 is connected to an interferometric electrotherapy device 12 inside a housing 14. Interferometric electrotherapy device 12 is referred to in a more complete description later in this specification, although it is described in Dynatronics, Inc. In fact, it may include a conventional treatment module 16 commercially available from (Salt Lake City, Utah). The response of the patient 10 is monitored by one or more sensors 18, 20 which are preferably digital temperature sensors incorporated in spring-loaded clips that can be attached to the fingers or toes on each side of the patient. Each sensor 18, 20 can be connected to a module 28 inside the housing 14 via wires 22, 24. The module 28 records the temperature detection results from the sensors 18, 20, stores the value of the detection results in the memory module 30, controls the treatment module 16 and operates the device 12 differently. It may be. In some embodiments, the memory module 30 can be removed from the housing 14 for the purposes described below.

  The housing 14 may include a pair of receptacles 32, 34 capable of receiving jacks 36, 38 of a pair of insulated wires 40, 42 connected to a pair of electrodes 44, 44 'and 46, 46', respectively. A suitable display 48 includes the output values output by the sensors 18, 20; the carrier frequency; the pulse frequency to be tested; the date and time of the treatment; the intensity of the treatment; the time remaining until the end of the treatment; As a result of the test sequence, a reading value such as any other desired information such as whether or not to replace the electrode is displayed.

  Standard commercially available interferometric electrotherapy devices have a constant carrier frequency or a minimally selectable carrier frequency. Mainly for historical reasons, these frequencies are conventionally known from Dynatronics, Inc. 1850 Hz and 2850 Hz for the sympathetic treatment system from St. Paul, Minnesota, and 4000 Hz for the device marketed by Rehabicale Corporation (St. Paul, Minnesota). In this device, the carrier frequency can be either constant or variable.

  Device 12 may include a selection actuator 50 and up / down actuators 52, 54. It may be desirable to increase the intensity of the electrical pulse. If the actuator 52 increases the strength, the actuator 52 may be manually pressed, and the strength value may be displayed on the screen 48. When the desired intensity value is displayed on the screen 48, the selection actuator 50 may be depressed to instruct the module 28 to increase the intensity to the selected value. Module 28 may provide other functions. For example, the electrodes 44, 44 ', 46, 46' do not provide infinitely good detection. Module 28 may perform a test to determine the need for electrode replacement and counts the number of treatments or parameter determination trials performed and displays on screen 48 to replace the electrodes. A message may be displayed. In response to such a message, the selection actuator 50 may be depressed to send a message to the module 28 that the electrode has changed or will be changed. The device 12 may also include timer functions, treatment time and duration, and / or acquisition of treatment parameters. The device 12 may include an on / off switch 56.

  The carrier frequency and beat frequency used in the selection of treatment parameters may be selected by actuators 50, 52, 54, or a default selection may be provided by software within processor 28. Experience has shown that the majority of desirable beat frequencies are 1-150 beats / second (bps), but currently commercially available devices use only 1-80 beats / second. This range is divided into smaller segments so as to find the most desirable beat frequency in a reasonable time frame. Experience has shown that some of the segments, one or more carrier frequencies with the most effort, provide the most desirable beat frequency.

  If an increase in treatment intensity is desired, the increase actuator 52 is depressed. If a reduction in treatment intensity is desired, the lower actuator 54 is depressed. Accordingly, the device 12 comprises circuitry for transmitting therapeutic electrical energy to the patient's body, and more specifically comprises sub-circuits that alter the carrier frequency, beat frequency, and / or AC type energy amplitude. I understand that.

  The first thing that may be done is to stabilize the temperature of the patient's fingertips or to ensure that the temperature of the patient's fingertips is stable. Since the temperature of a patient's finger often changes in response to room temperature, it is desirable to prevent the temperature of the patient's fingertip from reacting to room temperature. This can be achieved by measuring the initial temperature of the patient's fingertip and determining whether the temperature changes over time. After a short specific period, for example, after 1 minute, the first temperature and the subsequent temperature are compared to determine whether the fingertip temperature is stable. A preferred parameter set is that when the fingertip temperature changes less than 1 ° F. within 1 minute, the processor 28 determines the temperature stability and the acquisition of treatment parameters continues according to FIG.

  The electrodes are conventionally attached to the patient's skin, i.e. may be self-adhesive. The position of the electrodes on the patient's body establishes an electrical circuit in the patient's body. As shown in FIG. 1, in one method, one electrode 44 is placed adjacent to the end or end of the right medial plantar nerve L5 and its corresponding electrode or counterpart 44 'is placed on the left talus ( Is located adjacent to the end or end of the left gastrocnemius nerve S1, under the outer palae, thereby establishing or forming a first circuit 58 in the patient's body. As used herein, reference symbols L5, S1, etc. are standard medical terms for nerves. One skilled in the art will recognize L5 as a nerve that extends away from the fifth lumbar vertebra and S1 as a nerve that extends away from the first sacral vertebra.

  An electrode pattern as shown and described in FIG. 2 is shown in US Pat. No. 5,995,873. It will be appreciated that there are hundreds or thousands of possible electrode patterns. In addition to the L5-S1 pattern described above, a preferred approach may be to use an additional four electrodes, for a total of eight electrodes. The additional electrodes may be placed in any suitable manner, such as in an L4-S2, L5-L4 pattern, or at a needle treatment site on the foot.

  One skilled in the art will recognize that the terminal end of the right medial plantar nerve L5 is located approximately on the thumb ball of the foot, on the bottom surface of the right foot. The terminal end of the left gastrocnemius nerve S1 is located below the left talus (the external capsule). Another electrode 46 is placed adjacent to the end of the right sural nerve S1, and its corresponding electrode or counterpart 46 'is placed adjacent to the end of the left medial plantar nerve L5, thereby causing the patient's A second circuit 60 is established in the body. When device 12 is turned on, electrical energy is transmitted through circuits 58, 60. One skilled in the art will recognize that the medial plantar nerve L5 and sural nerve S1 terminate adjacent to the spinal column near the adjacent vertebra in the area connecting to the lumbar sympathetic ganglion.

  Other arrangements of electrodes for stimulating other nerves are within the scope of the present invention and are shown in US Pat. No. 5,995,873. Because there are thousands of potential electrode placements, you can begin acquiring treatment parameters by choosing one placement that experience has shown to often provide effective treatment desirable.

  Please refer to FIG. FIG. 3 shows a preferred temperature sensor 18 of the type available from Minnesota Wire Company (Saint Paul, Minnesota). The sensor 18 may include a pair of clip sections 62 and 64 that are connected to rotate about a shaft 66. A spring (not shown) biases sections 62 and 64 together. An infrared temperature sensor (not shown) or other suitable temperature measuring device is incorporated into one or the other of the clip sections 62, 64. Alternatively, an infrared sensor (not shown) may be exposed in the housing 14 and the patient simply places his fingertip on the housing 14.

  Initially, the patient is not exposed to the carrier frequency (s) or beat frequency (s) for a short time, typically about 5 minutes, in order to allow the thermistor to maintain the temperature balance of the finger. The patient then begins with a different beat to determine the effective, optimal, or ideal combination of parameters that produce the desired effect on the autonomic nervous system, thereby determining the preferred treatment regimen. It is subjected to a series of tests using the frequency. This uses one of the carrier frequencies while sensing and recording the temperature measured by the sensors 18, 20, and transmits a series of pulses in a first range, such as 1-10 pulses / second. Can be achieved. The order of transmitting the pulses may be any suitable method. The standard interferometric module 16 generates beat sweeps in this range with the following repeating pattern: That is, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, which change every second. The temperature of the fingertip may be recorded continuously or at any suitable interval, for example 1 minute. Table I shows hypothetical temperature patterns performed on a woman with an original left hand fingertip temperature of 71.2 degrees Fahrenheit and an original right hand fingertip temperature of 72.6 degrees Fahrenheit.

  The purpose of this trial is to determine a parameter that results in a significant increase in finger temperature based on the assumption that this is a substitute for improved blood circulation. Table I shows a situation where the temperature of the subject's fingertip increased by about 0.3 ° F. in 3 minutes. Since this suggests a minimal increase in blood circulation, the software of the processor module 28 concludes that there is no effect of the selected pulse beat frequency and electrode placement.

  The module 28 therefore stores information related to the trial in the memory module 30, for example, the serial number of the device 12, the date and time of the trial, the treatment test, and all of the data generated during the execution is stored in the memory module 30.

  If the temperature response from the first trial is not satisfactory, as in Table I, where the finger temperature increase can be less than 1 ° Fahrenheit, the second trial is given, for example, 11-20 beats / second. You may start with a different pulse frequency. This process is repeated until a temperature increase above some minimum value of at least 1 ° F. is obtained, preferably within a few minutes, such as 3 or 4 minutes, or until some maximum range is reached. If the trial is unsuccessful after trying each 10 pulse range to the highest range, a message appears on the display 48 to try a different electrode pattern and / or a different carrier frequency. This process is repeated until a satisfactory temperature rise is obtained. All of the trial parameters and trial results are stored in the memory module 30.

  On a display 48 after a successful attempt to determine a parameter indicative of substantially improved blood flow, i.e., the temperature response exceeds a predetermined threshold, such as a temperature increase of 1 ° Fahrenheit in minutes. In response to the message or automatically, the selected treatment signal may be sent to the patient. A patient, caregiver, or specialist may instruct device 12 to apply therapy by pressing selection actuator 50. After testing all of the available beat frequency arrays, if none of the combinations can produce enough thermistor temperature rise to show sufficient circulation, then the highest raised beat frequency combination is treated Used for. At the end of the treatment, a message appears on the display 48 saying “new protocol needed” or other similar message to advise the clinician or patient that a different electrode placement is needed. Alternatively, in situations where the patient or caregiver makes these trials at a location remote from the specialist facility, the message content may contact the specialist to determine another electrode pattern, or It may be pointed out that a reference book or database is used to determine another electrode pattern.

  The memory module 30 provides significant advantages. There are situations in which a patient or caregiver attempts to determine suitable parameters, and then sends a treatment signal at a location away from the professional office, such as the patient's residence. In this situation, it is highly desirable to have the ability to review trial procedures and results. In the case of a removable memory module, the module 30 is removed and placed in the computer 68, and the data from the module 30 is transmitted from the computer 68 to the professional office 72 through the communication link 70. The data may be read and browsed by storing in the computer 74 (FIG. 4). In this way, the expert can determine whether or not an attempt has been made to determine the parameters from a location remote from the patient and has been performed accurately. Obviously, if an attempt to determine a parameter was made incorrectly or not at all, this can be determined by an expert and appropriate steps made to accurately determine the parameter. It is difficult to exaggerate the importance of this advantage. It will be apparent that the communication link 64 can be of any suitable type, such as with an internet connection.

  The communication link 70 also stores treatment information and parameter acquisition information in the memory module 30 so that the specialist can determine whether, when and how treatment has been performed. Enable review. Therefore, treatment information and parameter information can be transmitted to an expert.

  Please refer to FIG. FIG. 5 shows an interferometric treatment module 78, a processor module 80 having all of the functions of the processor 28, and a communication module 82 that provides a direct communication link 84 with the computer 86 of the professional office 88. Another embodiment of an interferometric device 76 comprising is shown. The communication link 84 may be of any suitable type such as a mobile phone, internet connection, etc. It can be seen that the interferometric device 76 transmits parameter determination information and treatment information to the computer 86 so that it can be reviewed for accuracy and timeliness.

  Although the present invention has been disclosed and described in its preferred form to a certain degree of specificity, the present disclosure in the preferred form is only an example, and many changes in operational details and combinations and component arrangements are patented below. It will be understood that this may be done without departing from the spirit and scope of the invention as claimed.

The electrodes are conventionally attached to the patient's skin, i.e. may be self-adhesive. The position of the electrodes on the patient's body establishes an electrical circuit in the patient's body. As shown in FIG. 2 , in one method, one electrode 44 is placed adjacent to the end or end of the right medial plantar nerve L5, and the corresponding electrode or counterpart 44 'is placed on the left talus ( Is located adjacent to the end or end of the left gastrocnemius nerve S1, under the outer palae, thereby establishing or forming a first circuit 58 in the patient's body. As used herein, reference symbols L5, S1, etc. are standard medical terms for nerves. One skilled in the art will recognize L5 as a nerve that extends away from the fifth lumbar vertebra and S1 as a nerve that extends away from the first sacral vertebra.

The purpose of this trial is to determine a parameter that results in a significant increase in finger temperature based on the assumption that this is a substitute for improved blood circulation. Table I shows that the temperature of the subject's fingertips is approximately 0. It shows a situation where it has risen by 4 °. Since this suggests a minimal increase in blood circulation, the software of the processor module 28 concludes that there is no effect of the selected pulse beat frequency and electrode placement.

The memory module 30 provides significant advantages. There are situations in which a patient or caregiver attempts to determine suitable parameters, and then sends a treatment signal at a location away from the professional office, such as the patient's residence. In this situation, it is highly desirable to have the ability to review trial procedures and results. In the case of a removable memory module, the module 30 is removed and placed in the computer 68, and the data from the module 30 is transmitted from the computer 68 to the professional office 72 through the communication link 70. The data may be read and browsed by storing in the computer 74 (FIG. 4). In this way, the expert can determine whether or not an attempt has been made to determine the parameters from a location remote from the patient and has been performed accurately. Obviously, if an attempt to determine a parameter was made incorrectly or not at all, this can be determined by an expert and appropriate steps made to accurately determine the parameter. It is difficult to exaggerate the importance of this advantage. It will be apparent that the communication link 70 can be of any suitable type, such as with an internet connection.

Claims (17)

A treatment parameter acquisition method for acquiring a desired treatment parameter related to an interference wave type electrotherapy regimen performed at a first location and a second location separated from each other,
A series of interferometric electric waves including a carrier frequency and a series of different beat frequencies generated by an electrical circuit through the pair of electrodes, each applied to a patient's opposing limbs at the first location. Transmitting a test treatment signal;
Detecting the patient's autonomic nervous system activity in response to each of the series of interferometric electrical test therapy signals at the first location and transmitting an output signal indicative of the response;
Electronically transmitting the output signal and a beat frequency correlated with the output signal to an electronic device at the first location;
At the first location, a treatment parameter is selected from one of the series of interferometric electrical test treatment signals, and the selected treatment parameter is passed through the pair of electrodes according to the selected treatment regimen. Applying to the patient;
Communicating with the electronic device at the second location to determine whether the selected treatment parameter constitutes a preferred treatment regime; and
A treatment parameter acquisition method comprising:   The method of claim 1, wherein the first location includes the patient's residence and the second location includes a specialist office.   The method of claim 1, wherein the electronic device is disposed at the first location.   The method of claim 1, wherein the electronic device is disposed at the second location.   The method of claim 1, further comprising: transmitting the selected treatment parameter and the date and time of application of the preferred treatment regimen to the electronic storage device at the first location.   The method of claim 5, further comprising the step of communicating with the electronic device at the second location to determine whether the preferred treatment regime has been applied.   The method according to claim 1, wherein the determining step includes a step of determining whether or not the selected treatment parameter has a higher output.   The method of claim 1, wherein the detecting step includes a step of detecting a finger temperature.   9. The treatment of claim 8, wherein the determining step includes determining whether the selected treatment parameter results in a finger temperature increase of 1 degree Fahrenheit in less than 4 minutes. Parameter acquisition method. At the first location, after applying a pair of electrodes to the patient and before transmitting a series of interferometric electrical test treatment signals through the pair of electrodes, the temperature of the first finger of the patient is ambient Further comprising the step of equalizing the temperature,
The equalizing step measures the temperature of the patient's finger over time, and starts transmission of the series of interferometric electrical test treatment signals through the pair of electrodes when the rate of change of finger temperature falls below a predetermined value. The treatment parameter acquisition method according to claim 8, further comprising:   The method according to claim 10, wherein the predetermined value is approximately 1 degree Fahrenheit per minute. A diagnostic system for obtaining desirable treatment parameters for an interferometric electrotherapy regimen performed at a first location and a second location separated from each other,
A pair of electrodes each temporarily attached to opposite limbs of a patient, and an electrical circuit for transmitting a series of interferometric electrical test therapy signals including a carrier frequency and a series of different beat frequencies through the pair of electrodes;
A sensor that detects autonomic nervous system activity of the patient in response to each of the series of interferometric electrical test therapy signals and transmits an output signal indicative of the response;
A selector that selects a treatment parameter from one of the series of interferometric electrical test treatment signals and applies the selected treatment parameter to the patient through the pair of electrodes according to a selected treatment regime;
An electronic device for receiving the output signal from the sensor and a beat frequency correlated with the output signal;
Determining from the second location whether the selected treatment parameters obtained at the first location constitute a preferred treatment regimen for communicating with the electronic device to transmit data from the electronic device A communication link to enable,
A diagnostic system comprising:   The diagnostic system of claim 12, wherein the electronic device is in the first location.   The diagnostic system of claim 12, wherein the electronic device is in the second location.   The diagnostic system of claim 12, wherein the sensor includes a finger temperature sensor. Means for equalizing the temperature of the patient's finger before transmitting the series of interferometric electrical test therapy signals through the pair of electrodes;
The means measures the temperature of the patient's finger over time, and starts transmission of the series of interference wave type electrical test treatment signals through the pair of electrodes when the change rate of the finger temperature falls below a predetermined value. The diagnostic system according to claim 15, further comprising:   The diagnostic system according to claim 16, wherein the predetermined value is approximately 1 degree Fahrenheit per minute.

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