Electro-medical device for use with biologics

专利摘要:
Multifunction portable electronic medical device 10 provides interference current stimulation to enhance bone growth. Two signals are applied to the target site, each of which is formed by two sets of electrode pads. At the point where the signals cross each other, the beat frequency occurs. The beat frequency is the difference between the frequencies of the two signals, the amplitude of which is additional and greater than any of the two signals alone. The depth of the interfering signal is increased by increasing the carrier frequency of the signal. The direction of the interfering signal moves towards a signal with a lower amplitude. To further enhance bone growth, electrical stimulation is used with biological agents. The target site is wide enough to include a plurality of spinal segments.
公开号:KR20040032817A
申请号:KR10-2003-7012807
申请日:2002-07-12
公开日:2004-04-17
发明作者:마이클 비. 맥그로；윌리암 에이. 럭스；윌리암 제이. 캐롤；리차드 엠. 테릴；랜디 알랜 머피
申请人:인터내셔널 리허빌리테이티브 사이언시즈, 아이엔씨.；
IPC主号:

专利说明:

ELECTROL-MEDICAL DEVICE FOR USE WITH BIOLOGICS
[2] With the increasing application of advanced technologies to the medical field, it has become a recent trend to provide as much care as possible as well as complex medical treatments outside the hospital. Such trends have resulted in a quantitative increase in surgery as well as other forms of medical treatment such as rehabilitation services being performed outside hospitals, such as in outpatient or rehabilitation centers, respectively.
[1] The present invention generally relates to a portable electronic medical device. More specifically, the present invention relates to a multifunctional portable electronic medical device that can be programmed to provide any form of electronic medical therapy.
[13] 1 is a perspective view of one exemplary embodiment of a multifunction portable electronic medical device according to the present invention,
[14] 2 is a plan view of the portable electronic medical device of FIG. 1,
[15] 3 is a front view of the portable electronic medical device of FIG. 1,
[16] 4 is a rear view of the multifunction portable electronic medical device of FIG. 1,
[17] 5 is a schematic block diagram of an exemplary multifunction portable electronic medical device according to the present invention,
[18] 6 is a schematic block diagram of an exemplary embodiment of an architecture for a multifunctional portable electronic medical device according to the present invention;
[19] 7 is a state diagram showing the operation of an exemplary control routine of the multifunction portable electronic medical device according to the present invention;
[20] 8A and 8B are schematic circuit diagrams of an exemplary embodiment of a multifunction portable electronic medical device according to the present invention;
[21] 9-39 are flowcharts showing control routines of an exemplary embodiment of a multifunctional portable electronic medical device according to the present invention;
[22] 40 to 150 are views showing an exemplary display screen of the multifunction portable electronic medical device according to the present invention.
[23] 151 is a chart illustrating a diagonal modulation treatment stimulus in accordance with the present invention;
[24] 152 and 153 are charts illustrating R-wave stimulation,
[25] FIG. 154 is a view showing a crossing pattern used for interference intrusions having a deep intrusion depth;
[26] 155 is a view showing a crossing pattern used for interference stimulation with a shallow penetration depth;
[27] 155 and 156 illustrate an arrangement of electrode pads.
[28] Embodiment
[29] Referring now to the accompanying drawings, in which like parts are designated by like reference numerals throughout, FIGS. 1 to 4 illustrate exemplary embodiments of the multifunction portable electronic medical device 10 according to the present invention. The multifunction portable electronic medical device 10 includes a power switch 12, a liquid crystal display (LCD) touch screen 14, and a speaker 26. Each of the components described above, as well as other components to be described below, are embedded in a plastic case or shell 24.
[30] As shown in FIGS. 3 and 4, the case or shell 24 of the exemplary electronic medical device 10 may have an upper piece 24a and a lower portion to make the electronic medical device 10 easier to manufacture. It may be formed as a piece 24b. Four output jacks 16-22 may be provided at the rear of the case of the multifunction portable electronic medical device 10. These four output jacks 16-22 provide separate jacks for each output channel. A jack 28 for connecting the electronic medical device 10 to a battery charger (not shown) may be disposed, for example, on the rear side of the electronic medical device 10.
[31] The electronic medical device 10 may be used in such a manner that the patient manages himself / herself for treatment prescribed by a doctor and / or other health manager. Multifunctional portable electronic medical devices according to the present invention include, but are not limited to, relaxation of muscle spasms, prevention or delay of muscle insolubility atrophy, improvement of local blood circulation in the legs or other limbs of the patient, rehabilitation of the leg muscles or other muscles of the patient, For the treatment of various types of muscles, including stimulation immediately after surgery of the lower leg to prevent venous thrombosis, maintenance or increase of the range of activity of the patient's legs or other limbs, acute pain relief, alleviation and management of chronic pain, and edema and And / or to reduce inflammation and for many other treatments.
[32] A plurality of similar cables (not shown) are used to connect the output jacks 16-22 of the electronic medical device 10 to the patient, such that a standard electrode pad (shown) is in contact with one of the output jacks and the skin of the patient. Not connected). For safety purposes, a pin of cable is inserted into each output jack 16-22 to connect the electrode jacks by the output jacks 16-22.
[33] Exemplary embodiments of the multifunction portable electronic medical device 10 of the present invention are digital devices that provide additional safety devices for users other than those previously described in this section. The electronic medical device 10 provides four isolated channels that can independently treat four separate muscle groups. Each of the four channels has independent output power stages and transformers to separate the channels. The electronic medical device 10 is powered by a battery to provide a portable function. Battery power of the exemplary embodiment is provided by an internal 7.2 volt nickel cadmium or nickel metal hydride battery device, which eliminates the need for the user to monitor and replace the battery. The LCD touch screen 14 provides visual feedback and interface to the user. The circuit of the electronic medical device 10 also includes a speaker 26 that reinforces the audible function of the keystroke action. In addition, each electrically insulated channel has a separate strength control device for independently increasing or decreasing the strength of the channel.
[34] In addition to turning on the electronic medical device 10, the power switch 12 also functions as an off switch to shut off the device. The contraction time and relaxation time of the muscle stimulation mode, the selection of treatment time and the normal / alternate mode have built-in default settings. Interference mode, continuous / variable mode selection, frequency setting, pad selection and treatment time are also default settings. However, these basic settings are easily modified at the time of use according to the instruction or prescription of the user's doctor.
[35] An exemplary embodiment of the electronic medical device 10 of the present invention may be provided with a data storage card 30, details of which are described in US Pat. No. 5,755,745, which is incorporated herein by reference in its entirety. It is more fully shown and described. The structure of the data storage card 30 is used by the patient in the electronic medical device 10 or any other similar type II device used by the patient in an autonomous manner, separated from these devices by the patient, and stored in the usage information. It is sent to the service agency for download and is designed to be replaced with a new data storage card. Typically, a data storage card, such as the data storage card 30 described herein, is designed to hold 30 to 60 days of patient usage information. During use in treatment by a patient, data is stored in the data storage card 30 during the processing period.
[36] 5 is a schematic block diagram of an exemplary embodiment of the multifunction portable electronic medical device 10 of the present invention. This exemplary electronic medical device 10 is powered by a rechargeable 7.2 volt nickel cadmium or nickel hydride battery device 36 as discussed above, which is powered by a standard household current of 110 volts. This supply is recharged by the preferred battery charger 38. As a safety device, the electronic medical device 10 is designed not to operate while the battery device 36 is being charged. A battery monitor circuit 40 is connected between the battery device 36 and the processor 42, so that the processor can display to the user by the LCD 14 under certain harmful battery conditions as described below. have. The processor 42 functions to control and monitor all the functions of the electronic medical device 10.
[37] As shown in FIG. 6, the apparatus is preferably implemented with a processor 42. However, the device may include a programmed microprocessor and any necessary peripheral integrated circuit elements, ASICs or other integrated circuits, hardwired electronic or logic circuits such as separate device circuits, programmable logic devices such as PLDs, DLAs, FPGAs or PALs. And the like may be implemented. In general, any device including a finite state machine capable of implementing the flowcharts shown in FIGS. 9-39 can be used to implement the present invention.
[38] An exemplary embodiment of the portable electronic medical device 10 according to the present invention provides four electrically insulated channels 1-4 that can independently treat four separate muscle groups. Each of the four channels has independent drive devices 80-86. The processor 42 may be programmed to control the drive circuits 80-86 to provide some form of electronic medical treatment. The speaker 26 augments the audible function to the user of the key stroke action using the LCD touch screen 14. Although the detailed description of the present invention refers to an apparatus comprising only four channels, those skilled in the art will understand that the apparatus still forms part of the present invention even if it includes any number of channels.
[39] In operation of the exemplary embodiment, the patient first uses the on / off switch 12 to power up the electronic medical device 10. If the patient does not want to change the set value input into the internal memory 32 of the electronic medical device 10, the electronic medical device 10 is powered up in the preset operating mode. The default setting is normal mode. In such a normal mode, although the intensity of each channel is controlled independently, all four channels of the electronic medical device work simultaneously to provide stimulation pulse trains. This mode of operation allows the patient to independently and independently treat four separate muscle groups simultaneously.
[40] If the patient desires, an additional level of control is provided for the particular situation, which is called an alternating mode of operation. In an alternate mode of operation, channel 1 and channel 2 are operated asynchronously with channel 3 and channel 4. Therefore, when channel 1 and channel 2 are stimulating muscles, channel 3 and channel 4 are off, and channel 3 and channel 4 are stimulating muscle when channel 1 and channel 2 are off. The set on and off times are the same for all four channels in normal mode.
[41] In the interference mode of the exemplary embodiment of the present invention, the continuous operation mode includes two four pad interference channels. In continuous mode, the interference frequency is adjustable from 0 to 200 beats per second. In addition, an amplitude modulation feature is selectable that reduces the amplitude to 50 percent of the value selected by the user over a five second period, returns to the value selected by the user, and repeats this process. In a variable mode of operation, the interference frequency varies during operation. Three variable modes are provided: a low range of 1 to 10 beats per second, a high range of 80 to 150 beats per second, and a wide range of 1 to 150 beats per second. The frequencies in all three ranges change over 10 periods. In both continuous and variable modes, a premixed two pad mode can be selected. In the two-pad operation mode, interference signals are mixed in advance and output through one cable for each channel.
[42] In the pulsed muscle stimulation mode, the electronic medical device 10 according to the present invention generates a biphasic asymmetric balanced pulse pattern of 71 Hz cycle frequency, 100 volt peak and 60 milliampere peak. The primary pulse has a maximum width of 415 microseconds followed by a transformer-coupled exponential decay that returns to the zero base line. Abnormal pulses alternate directions, resulting in a pulse repetition rate of 142 pulses per second. As described above, the patient presses the button 50 to adjust the stimulus intensity. The resulting increase or decrease in stimulus intensity is the result of increasing or decreasing the charge per pulse, approximately equal to the width of the pulse multiplied by the pulse height. Muscle stimulation pulses are ramped on / off to increase the width of the pulse to the desired setting and provide a smooth transition with every muscle contraction.
[43] In the pulsed muscle stimulation mode, a series of repetitive pulses are generated during the contraction cycle. The series of pulses lasts until the end of the contraction cycle. The relaxation cycle does not have any pulses. Contraction and relaxation cycles are repeated until the end of treatment.
[44] In the interference mode, an exemplary embodiment of the electronic medical device 10 according to the present invention generates a symmetrical abnormal sinusoidal pattern having a carrier frequency of less than 20 KHz, preferably about 5 to 20 KHz. An adjustable interference frequency of 5000 to 5200 Hz is provided for a carrier frequency of 5000 Hz. The output current has a peak of 100 milliamps for a 500 Ohm load. The carrier and interfering signals are true sinusoidal symmetric anomaly outputs with zero net charge. The two sinusoids are mixed within the patient's body in four pad mode. In two pad mode, the sine wave is premixed in the electronic medical device so that only one premixed output is generated. Sinusoidal development persists until the end of treatment.
[45] An exemplary embodiment of the electronic medical device 10 may be preset to modulate a sinusoidal output. Two types of modulation are provided. The first type of modulation is frequency modulation. Three modulation ranges can be selected: 1 to 10 beats per second, 80 to 150 beats per second and 1 to 150 beats per second.
[46] Amplitude modulation, which is a second type of modulation, may be selected when the interference frequency remains constant. This type of modulation shifts the amplitude of one output down from a preset value over a five second period to 50 percent of that preset value. The amplitude then returns to its preset value over another five second period. This same amplitude modulation is then repeated for the other outputs, and this process is repeated continuously. In addition to the preferred embodiment, each channel is connected to two pads, and these channels are configured such that the modulation of the first channel is opposite to the modulation for the second channel. That is, as the amplitude on the first channel decreases downward, the amplitude on the second channel returns to a preset value. Amplitude modulation can be performed in both normal and alternating modes of operation.
[47] The load detection circuit 78 shown in FIG. 5 of an exemplary embodiment may be composed of output voltage signals measured across a known load resistance. The signal is amplified and fed back to an analog-to-digital conversion system built into the processor 42, which accurately measures the actual load experienced across the transformer outputs built into each of the four drive circuits 80-86. To be able. With such measurements, the processor 42 can detect both open circuit (ie, no-load condition) and short circuit conditions, such that the processor 42 forms a pulse generating circuit that forms part of the drive circuits 80-86. It can block the control signal to proceed to. Therefore, under open or short circuit conditions, the load detection circuit 78 operates to block the generation of pulses by the electronic medical device 10.
[48] In an exemplary embodiment, a monitoring system 88 is also provided to monitor the processor 42 to ensure that the processor 42 operates and issues instructions. Surveillance system 88 operates using a "counter". When the "counter" reaches some predetermined value, the monitoring system is activated to shut down the processor 42, thereby shutting off the electronic medical device 10. During normal operation, the processor 42 prevents such blocking from occurring by resetting the "counter" of the monitoring system 88 to zero before reaching the maximum counter value. In such a method, if the processor 42 becomes inoperative for some reason, the counter of the surveillance system 88 reaches a maximum predetermined value, thus shutting off the electronic medical device 10.
[49] 6 is a schematic block diagram of an exemplary embodiment of an architecture for an electronic medical device according to the present invention. 6 illustrates an interface between hardware modules and control routine modules. The primary module is the foreground execution module 90. The foreground execution module 90 controls the execution from the start of the device to the interruption. The example module is programmed as a state machine with a control routine that controls the operating state of the device based on input received from the device hardware.
[50] 7 is a state diagram of the exemplary control routine shown in FIGS. 9-39 of an electronic medical device 10 in accordance with the present invention. These control routines corresponding to each state will be described in detail below. The primary module for operating the output channel circuit in pulsed muscle stimulation mode is background pulse generator module 94. It is an independent interrupt driven module 98 that is started by the foreground execution module 90 at startup and performs functions using data supplied by the foreground execution module 90. . The foreground execution module and the real time clock operating frequency are continuously monitored relative to each other to ensure that they do not deviate from tolerances. If they deviate from the tolerance, the electronic medical device 10 blocks all operations.
[51] The example control routine also monitors the load on each channel and shuts off the output for the "no load" detection channel. The control routine also monitors the battery and shuts down its operation before power is insufficient to operate the processor 42.
[52] An exemplary control routine also accumulates treatment data for each channel during the treatment period. At the end of the treatment period, the control routine writes this data to the internal data store 36 prior to blocking the processor. This data is also stored in the data storage card 30 by transferring this data from the internal data storage to the data card during the blocking sequence.
[53] As mentioned above, the primary module for operating the output channel circuit is a pulse generator module that forms part of the drive circuits 80-86. The module is started by the foreground module 90 in the initialization state 92 when the power switch 12 is pressed. The background pulse generator module 94 operates in an independent interrupt driven manner and uses the data provided by the foreground module 90 to perform its functions, which are advanced options or programming states 96. While it was entered.
[54] The battery device 36 of the exemplary embodiment is charged during the quick recharge cycle by the battery charger 38. During the charging cycle, the electronic medical device is in a charged state 104 and cannot operate. The battery monitor 40 and the processor 42 determine the amount of charge required by the battery device 36. If the charge amount of the battery device 36 is low enough, the battery device is charged until the battery voltage begins to show a decline, and then the charging circuit “trickles” so that it can always maintain a fully charged battery. "Switch to charging mode.
[55] The control routine of the exemplary embodiment of the electronic medical device 10 according to the present invention also includes a start treatment channel setting function as a safety device. This safety device prevents the output of the channel from setting above zero at the start of treatment. It ensures that the user does not receive sudden muscle contraction at the start of treatment. Therefore, at the start of treatment, the electronic medical device 10 starts to operate with all channel intensity settings equal to zero. If the pad is removed from the skin during treatment, the electronic medical device 10 automatically resets the channel to zero. If the pad cable is pulled out of the electronic medical device 10 during treatment, the strength of the channel is reset to zero.
[56] In addition to the treatment initiation channel setting safety device, an exemplary embodiment of the electronic medical device 10 according to the present invention also includes a channel increase / decrease limit feature, which includes a channel output. The level is designed so that it can only change one digit at a time. Therefore, when each channel button 50 is pressed, the output controlled by that button changes only in small increments. It ensures that the user's muscle contractions do not suddenly increase or decrease if the button is kept pressed during the treatment.
[57] Another exemplary embodiment of an electronic medical device 10 according to the present invention also includes a monitor designed to continuously monitor the frequency and width of the waveform applied to each pad cable. If the waveform changes from a pattern that is designed to generate, the electronic medical device is automatically shut off. It ensures that the user receives an effective and comfortable treatment that is designed to be provided by the electronic medical device 10.
[58] The patient receives constant and accurate indication information regarding the operation of the electronic medical device 10. First, when the electronic medical device 10 is turned on using the switch 12, the LCD 14 displays basic settings for each of the contraction time, relaxation time, mode, and treatment time. If these are prescription settings for a particular patient using the electronic medical device 10, there is no need to change the settings. Otherwise, the setting value is changed as described later.
[59] 8A and 8B are schematic diagrams of circuitry for an exemplary embodiment of a multifunction electronic medical device according to the present invention. The circuit 200 includes a power circuit 204 that includes a charger connector 206 in communication with a battery charger 208 in communication with a power source 21. The power circuit 204 provides a plurality of outputs 212 that provide power to other portions of the electronic medical device.
[60] The circuit 200 also includes an SRAM 216, a flash memory 218, a real time clock 220, and a memory card 222. The processor 214 may be any type of processor as long as it can execute the control routines mentioned in the flowcharts of FIGS. The processor 214 includes an amplifier 242 that controls the speaker 226, a liquid crystal display 228, a programmable logic device 230, sine wave generators 232 and 234, a digital-to-analog converter 236, and an analog-to-speaker. It is connected to the digital converter 238. The analog-to-digital converter 236 is connected to the microphone 240 via an amplifier 242 and also to the touch screen 244. The digital-to-analog converter provides output gains (270, 272, 274, 276) on four channels. The processor 214 controls the digital-to-analog converter 236 to output a predetermined maximum voltage at these outputs. Outputs 270, 272, 274, 276 provide the inputs of amplifiers 250, 252, 254, 256, respectively.
[61] Processor 214 is also connected to programmable logic device 230 and sine wave generators 232, 234, which are multiplexed by digital multiplexer 246 to digital to analog converter 248. Digital-to-analog converter 248 adjusts the signal levels of amplifiers 250, 252, 254 and 256. Amplifiers 250, 252, 254 and 256 communicate with transformers 278, 280, 282 and 284, respectively. The outputs 282 and 284 of the transformer are provided directly to channel 3 and channel 4, respectively. However, the outputs of transformers 278 and 280 are switched to channels 1 and 2 through switches 286 and 288, respectively. Switches 286 and 288 are solenoids that activate dual bar switches to select outputs from transformers 278 and 280 at high voltage outputs 258 and 260. The circuit 200 also includes load sensing devices 262, 264, 266, and 268, each of which senses the load of the corresponding channels 1-4.
[62] 9 schematically shows a control routine for field upgrade of a system of an exemplary embodiment of the apparatus of the present invention. The control routine of FIG. 9 executes every time the device is powered up. Upon powering up, the control routine begins at step 300 where the control routine initializes the processor. The control routine then continues to step 302, where the control routine determines whether there are bad check sums. If in step 302 the control routine determines that there is a bad checksum, then the control routine continues to step 304. At step 304 the control routine sets an error code, emits three beeps, and continues to step 306. At step 306, the control routine shuts down the device. If at step 302 the control routine determines that there is no erroneous checksum, the control routine continues at step 308. At step 308, the control routine determines whether a program in SRAM 216 should be loaded, based on the specific bytes in the serial port that indicate whether a field upgrade will occur. If in step 308 the control routine determines that what the serial port indicates does not occur, then the control routine continues to step 310. At step 310, the control routine loads the program stored in SRAM 216 and continues to step 312. In step 312, the control routine executes the control routine shown schematically in the flowchart of FIG.
[63] However, if at step 308 the control routine determines that a field upgrade will occur, then the control routine continues to step 314. At step 314, the control routine receives the field upgrade system command and continues to step 316. At step 316, the control routine processes the field upgrade system command and returns to step 314. The control upgrade command may include a command to block the device. In that way, steps 308, 314, and 316 operate as a kind of "boot loader" that allows programs in a kind of SRAM to be modified.
[64] 10 is a flowchart of an initialization control routine of an exemplary apparatus in accordance with the present invention as mentioned in step 312 of FIG. The control routine begins at step 318 where the control routine initializes the hardware and continues to step 320. In step 320, the control routine loads the setting data from the internal flash memory and continues to step 321. At step 321, the control routine sets the state of the device to "start" and continues to step 322. At step 322, the control routine determines whether the error has been stored. If in step 322 it is determined that the error has been stored, the control routine continues to step 324. At step 324, the control routine sets the state to "error" and continues to step 326. However, if in step 322 it is determined that no error has been stored, the control routine continues to step 326. At step 326, the control routine determines whether the device has been improperly shut down. If in step 326 the control routine determines that the device is inappropriate, the control routine continues to step 328. In step 328, the control routine records error 13 and sets the state of the device to " error " and then returns to step 330. However, if it is determined in step 326 that the device has not been improperly shut down, then the control routine continues to step 330.
[65] At step 330, the control routine determines whether the device is in maintenance mode. If it is determined in step 330 that the device is in maintenance mode, then the control routine continues to step 332. At step 332, the control routine initiates a serial port output start message, sets the state of the device to "maintenance" and then continues to step 334. However, if it is determined in step 330 that the device is not in maintenance mode, then the control routine continues to step 334. At step 334, the control routine begins a timed task loop. Constant task loops are control loops for tasks that must be executed at specific time intervals. Examples of such schedule task loops include updating the timeline bar on the touch screen. The control routine then continues to step 336. At step 336, the control routine executes the main execution flowchart as shown in FIG.
[66] 11 shows the main execution control routine of the exemplary apparatus according to the present invention. The control routine begins at step 338, where the control routine determines whether the charger is connected. If it is determined in step 338 that the charger is connected, then the control routine continues to step 340. At step 340, the control routine sets the state of the device to "charge", stops all operations and continues to step 342. However, if at step 338 it is determined that the charger is not connected, then the control routine continues to step 342. At step 342, the control routine determines whether the battery is low. If it is determined in step 342 that the battery is low, then the control routine continues to step 344. At step 344, the control routine saves the current state, sets the state of the device to " low battery, " and then continues to step 346. However, if at step 342 it is determined that the battery is not low, then the control routine continues to step 346.
[67] At step 346, the control routine determines whether the device is off. If it is determined in step 346 that the device is off, then the control routine continues to step 348. At step 348, the control routine saves the current state, sets the state of the device to " off " and then continues to step 350. However, if it is determined in step 346 that the device has not been turned off, then the control routine continues to step 350. At step 350, the control routine resets the counter of the monitoring apparatus and continues to step 352. In step 352, the control routine updates the liquid crystal display 14 and continues to step 354. At step 354, the control routine processes the schedule task that was started at step 334 of FIG. 10 and continues to step 356. At step 356, the control routine determines whether the bytes in the data card are set to the "maintenance mode". If it is determined in step 356 that the byte is set to the "maintenance mode", then the control routine continues to step 358. At step 358, the control routine processes the data received at the RS232 serial port as mentioned in the control routine of FIG. 31 and returns to step 338. However, if it is determined in step 356 that the "maintenance maintenance button" has not been touched, then the control routine continues to step 338.
[68] 12 schematically illustrates an execution interrupt control routine of an exemplary embodiment of an apparatus according to the present invention. An exemplary embodiment of this apparatus works by continuously processing the control routine shown schematically in the flowchart of FIG. However, the control routine of FIG. 11 may be interrupted at predetermined schedules, such as every 1 / 10th of a second, to execute the control routine schematically shown in the flowchart of FIG. 12. Similarly, FIGS. 13-15 show another interrupt for the control routine of FIG. 11.
[69] The second routine of FIG. 12 begins at step 360, where the control routine updates the system clock and continues to step 362. In step 362, the control routine executes a control routine corresponding to the current state. Examples of such control routines are shown in FIGS. 16-39, and are described in detail below. After the appropriate state control routine is executed, control of the apparatus returns to the control routine of FIG. 12, where the control routine continues to step 364. In step 364, the control routine determines whether the screen has been touched. If it is determined in step 364 that the screen has been touched, then the control routine continues to step 366. In step 366, the control routine determines whether the screen has been touched at a position corresponding to the inside of the button on the screen, and determines whether the button has been touched on the touch screen. If it is determined in step 366 that the button has been touched on the screen, then the control routine continues to step 368. At step 368, the control routine executes the function of the touched button and continues to step 370.
[70] However, if it is determined in step 364 that the screen has not been touched, then the control routine continues to step 370. At step 370, the control routine updates the battery level and gas gauge on the display device and continues to step 372. At step 372, the control routine determines whether the foreground execution and the real time clock are matched. If it is determined in step 372 that the clock does not match, then the control routine continues to step 373. In step 373, the control routine logs error "2" and sets the state of the device to "error" and then continues to step 374. However, if it is determined in step 372 that the clock is matched, then the control routine continues to step 374. At step 374, the control routine returns to the continued processing of the control routine shown schematically in FIG.
[71] 13 to 15 schematically show control routines for generating a pulse, receiving / transmitting a character, and transmitting processing, respectively. As described above, the control routines of FIGS. 13-15 interrupt the execution of the control routine shown schematically in the flowchart of FIG. 11 and execute a predetermined schedule. After the control routine is completed, control of the apparatus is returned to the control routine schematically shown in the flowchart of FIG.
[72] Figure 16 schematically illustrates a "start" state control routine in accordance with an exemplary embodiment of the present invention. The control routine begins at step 382, where the control routine displays the "splash" screen shown in FIG. 39 and continues to step 384. In step 384, the control routine determines whether the battery power is sufficient for minimal treatment. If it is determined in step 384 that the battery power is not sufficient for minimal treatment, then the control routine continues to step 386. At step 386, the control routine sets the state of the device to "low battery" and continues to step 388. In step 388, the control routine returns control of the device to the control routine of FIG.
[73] However, if at step 384 it is determined that the battery power is sufficient to provide minimal treatment, then the control routine continues to step 390. At step 390, the control routine determines whether the battery power is sufficient to complete the treatment. If it is determined in step 390 that the battery power is not sufficient for the entire treatment, then the control routine continues to step 392. In step 392, the control routine displays a "low battery charge" screen and continues to step 394, an example of which is shown in FIG. At step 394, the control routine determines whether the "recharge now" button has been touched. If it is determined in step 394 that the "Recharge Now" button has been touched, then the control routine continues to step 396. In step 396, the control routine displays a “how to recharge battery” screen and continues to step 398, an example of such a screen is shown in FIG. In step 398, the control routine returns control of the device to the control routine shown schematically in FIG.
[74] However, if at step 394 it is determined that the "Recharge Now" button has not been touched, then the control routine continues to step 400. In step 400, the control routine determines whether the "start shorter treatment" button has been touched. If it is determined in step 400 that the "Start Shorter Treatment" button has been touched, then the control routine continues to step 402. In step 402, the control routine executes the control routine shown schematically in FIG. 21 and continues to step 404. FIG. In step 404, the second routine starts its segment by executing the control routine shown schematically in FIG. However, if at step 400 it is determined that the "Start Shorter Treatment" button has not been touched, then the control routine continues to step 406. In step 406, the control routine determines whether one minute has elapsed. If it is determined in step 406 that one minute has not elapsed, then the control routine returns to step 394. However, if it is determined in step 406 that one minute has elapsed, then the control routine continues to step 407. In step 407, the control routine turns off the device.
[75] If it is determined in step 390 that the battery power is sufficient to perform the entire treatment, then the control routine continues to step 408. At step 408, the control routine determines whether a flag indicates that the device is being operated by a private owner. If it is determined in step 408 that the individual owner is not operating the device, then the control routine continues to step 410. In step 410 the control routine determines whether the device has been shut down. If it is determined in step 410 that the device has ended, then the control routine continues to step 412. In step 412 the control routine displays a "reset" screen and continues to step 418, one example of which is shown in FIG. At step 418, the control routine determines whether the "rest now" button has been touched.
[76] If it is determined in step 418 that the "Reset Now" button has been touched, then the control routine continues to step 420. At step 420, the control routine displays a “device reset” screen and continues to step 422, one example of which is shown in FIG. At step 422, the control routine determines whether the "accept" button has been touched. If it is determined in step 422 that the "OK" button has not been touched, then the control routine continues to step 424. In step 424 the control routine determines whether one minute has elapsed. If it is determined in step 424 that one minute has not elapsed, then the control routine returns to step 422. However, if it is determined in step 424 that 1 minute has elapsed, then the control routine continues to step 425. At step 425, the control routine turns off the device.
[77] However, if it is determined in step 422 that the "OK" button has been touched, then the control routine continues to step 426. In step 426, the control routine determines whether a valid number has been entered in the "Device Reset" screen. If it is determined in step 426 that a valid number has been entered in the "Device Reset" screen, then the control routine continues to step 428. At step 428, the control routine resets the device and continues to step 430. At step 430, the control routine starts the segment by executing the control routine shown schematically in FIG.
[78] However, if it is determined in step 426 that no valid number has been entered, then the control routine continues to step 438. At step 438, the control routine displays a " invalid entry " screen and continues to step 440, one example of which is shown in FIG. At step 440, the control routine determines whether the "retry" button has been touched. In step 440, if it is determined that the "Retry" button is not touched, then the control routine jumps to step 446. However, if at step 440 it is determined that the "Retry" button has been touched, then the control routine continues to step 442. At step 442, the control routine determines whether the device has been reset three times today. If it is determined in step 442 that the device has been reset three times today, then the control routine continues to step 446. At step 446, the control routine shuts down the device. However, if at step 442 it is determined that the device has not been reset three times today, then the control routine then returns to step 420.
[79] However, in step 418, if it is determined that the "reset now" button has not been touched, then the control routine continues to step 432. In step 432, the control routine determines whether the "remind me next time; start treatment now" button has been touched. In step 432, if it is determined that the "Notify me next time; start treatment now" button has been touched, then the control routine continues to step 434. In step 434, the control routine executes the control routine shown schematically in FIG. 21 and continues to step 435. At step 435, the control routine executes the control routine mentioned in the flowchart of FIG.
[80] However, in step 432, if it is determined that the "Notify me next time; start treatment now" button has not been touched, then the control routine continues to step 436. In step 436, the control routine determines whether one minute has elapsed. If it is determined in step 436 that one minute has not elapsed, then the control routine returns to step 418. However, if it is determined in step 436 that one minute has elapsed, then the control routine continues to step 437. In step 437, the control routine shuts down the device.
[81] However, in step 408, if it is determined that the personal owner is operating the device, then the control routine jumps to step 416. If it is determined in step 414 that the device has not passed the warning date, then the control routine continues to step 416. In step 416, the control routine executes the control routine shown schematically in the flowchart shown in FIG.
[82] 17 is a flowchart schematically illustrating a control routine for a start segment. This flowchart begins at step 448, where the control routine determines whether a data log is sufficient. In step 448, if it is determined that the data log is sufficient, the control routine then continues to step 450. At step 450, the control routine displays an "internal update" screen, one example of which is shown in FIG. However, if it is determined in step 448 that the data log is not sufficient, then the control routine continues to step 452. In step 452, the control routine sets segment data that determines the type of device, operating parameters, and continues to step 454. At step 454, the control routine shows one of the start segment screens and continues to step 456, examples of which are shown in FIGS. 45-48. In step 456, the control routine determines whether one of the " up " buttons on the touch screen has been touched. If it is determined in step 456 that one of the "up" buttons on the screen has been touched, then the control routine continues to step 458. At step 458, the control routine starts the segment timer and pulse generator and continues to step 460. The pulse generator is a background interrupt driven task that generates a pulse for step 628 as described below. At step 460, the control routine displays a " treatment running " screen and continues to step 462, examples of which are shown in FIGS. 49-52. At step 462, the control routine sets the state of the device to "running" and continues to step 463. At step 463, the control routine returns control of the device to the control routine shown schematically in the flowchart of FIG.
[83] However, if at step 456 it is determined that the "up" button has not been touched, then the control routine continues to step 464. In step 464, the control routine determines whether the "options" button has been touched on the touch screen. If it is determined in step 464 that the "Option" button has been touched, then the control routine continues to step 466. At step 466, the control routine executes the control routine shown schematically in the flowchart of FIG. 19 and returns to step 454. However, if it is determined in step 464 that the "Option" button has not been touched, then the control routine continues to step 468. At step 468, the control routine determines whether the "view pads" button has been touched. If it is determined in step 468 that the "View pad" button has been touched, then the control routine continues to step 470.
[84] At step 470, the control routine displays the "Pad View" screen and returns to step 454. An exemplary "pad view" screen is shown in FIGS. 84-120. However, in step 468, if it is determined that the "view pad" button is not touched, then the control routine continues to step 474. At step 474, the control routine determines whether the "help" button has been touched on the touch screen. If it is determined in step 474 that the "help" button has been touched on the touch screen, then the control routine continues to step 476. At step 476, the control routine executes the control routine shown schematically in the flowchart of FIG. 18 and continues to step 454. FIG. However, if at step 474 it is determined that the "help" button has not been touched, then the control routine continues to step 478. At step 478, the control routine determines whether 4 minutes have elapsed. If it is determined in step 478 that 4 minutes have not elapsed, then the control routine returns to step 454. However, if it is determined in step 478 that 4 minutes have elapsed, then the control routine then turns off the device.
[85] 18 is a flowchart schematically showing a control routine for a "help" screen. This flowchart starts at step 480. At step 480, the control routine displays a " help " screen and continues to step 482, one example of which is shown in FIG. In step 482, the control routine determines whether the "done" button has been touched on the touch screen. If it is determined in step 482 that the "Done" button has been touched, then the control routine continues to step 484, where the control routine transfers control back to the control routine invoking the help screen control routine of FIG. However, if it is determined in step 482 that the "Done" button has not been touched, then the control routine continues to step 486.
[86] In step 486, the control routine determines whether the "next" button has been touched on the touch screen. If it is determined in step 486 that the "Next" button has been touched, then the control routine continues to step 488. In step 488, the control routine displays a " help " screen and continues to step 494, one example of such a screen is shown in FIG. In step 494, the control routine determines whether the "Done" button has been touched on the touch screen. If it is determined in step 494 that the "Done" button has been touched, then the control routine continues to step 496. In step 496, the control routine returns control to the control routine that called the help screen control routine of FIG. However, if it is determined in step 494 that the "Done" button has been touched, then the control routine continues to step 498. At step 498, the control routine determines whether the "prior screen" button has been touched on the touch screen. In step 498, if it is determined that the "previous screen" button on the touch screen has been touched, then the control routine returns to step 480. However, in step 498, if it is determined that the "previous screen" button is not touched, then the control routine returns to step 488.
[87] However, if at step 486 it is determined that the "next" button has not been touched, then the control routine continues to step 490. At step 490, the control routine determines whether the "Previous Screen" button has been touched. If it is determined in step 490 that the "Previous Screen" button has not been touched, then the control routine continues to step 492. In step 492, the control routine passes control to the control routine that called the help screen control routine of FIG. However, in step 490, if it is determined that the "previous screen" button has not been touched, then the control routine returns to step 482.
[88] 19 schematically illustrates a control routine for modifying options in accordance with the present invention. The flowchart begins at step 500 displaying a " option " screen with one example shown in FIG. 5 and continues to step 502. FIG. In step 502, the control routine determines whether the "view treatments settings" button has been touched on the touch screen. If it is determined in step 502 that the "View Treatment Settings" button has been touched, then the control routine continues to step 504. At step 504, the control routine displays the “View Treatment Settings” screen, an example of which is shown in FIG. 56 and continues to step 506. At step 506, the control routine determines whether the "previous screen" button has been touched. If it is determined that the "previous screen" button has been touched, then the control routine returns to step 500. However, in step 506, if it is determined that the "previous screen" button is not touched, then the control routine returns to step 504.
[89] However, if at step 502 it is determined that the "View Treatment Setpoints" button is not touched, then the control routine continues to step 508. In step 508, the control routine determines whether the "view pad" button has been touched on the touch screen. If it is determined in step 508 that the "View pad" button has been touched, then the control routine continues to step 510. At step 510, the control routine displays the “pad view” screen, some examples of which are shown in FIGS. 84-120 and continue to step 512. At step 512, the control routine determines whether the "previous screen" button has been touched. In step 512, if it is determined that the "previous screen" button has been touched, then the control routine returns to step 500. However, in step 512, if it is determined that the "previous screen" button is not touched, then control The routine continues to step 510.
[90] However, if at step 508 it is determined that the "view pad" button has not been touched, then the control routine proceeds to step 514. In step 514, the control routine determines whether the "adjust screen contrast" button has been touched on the touch screen. If it is determined in step 514 that the "screen contrast adjustment" button has been touched, then the control routine continues to step 516. In step 516, the control routine displays an " screen contrast adjustment " display screen in which one example is shown in FIG. 57, and continues to step 518. FIG. At step 518, the control routine determines whether one of the " more " or " less " buttons has been touched on the touch screen. If one of the "more" or "less" buttons has been touched, then the control routine continues to step 520. In step 520, the control routine adjusts the contrast of the current display screen according to the increase or decrease request. However, if at step 518 it is determined that neither the "increase" or "decrease" button has been touched, then the control routine continues to step 522. In step 522, the control routine determines whether the "accept" button has been touched.
[91] If it is determined in step 522 that the "OK" button has been touched, then the control routine continues to step 524. In step 524, the control routine sets the contrast for all screens and returns to step 500. However, if at step 522 it is determined that the "OK" button is not touched, then the control routine continues to step 523. In step 523, the control routine checks whether the "previous screen" button was touched on the touch screen. If it is determined in step 523 that the "Previous Screen" button has been touched, then the control routine continues to step 500. However, if it is determined in step 523 that the "previous screen" has not been touched, then the control routine returns to step 516.
[92] In step 514, if it is confirmed that the "screen contrast adjustment" button is not touched, then the control routine continues to step 528. In step 528, the control routine determines whether the "Treatment data, Advanced options" button has been touched. If it is determined in step 528 that the "Treatment Data, Advanced Options" button has been touched, then the control routine continues to step 530. In step 530, the control routine executes the control routine shown schematically in the flowchart of FIG. 20 and returns to step 500. FIG.
[93] However, if at step 528 it is determined that the "Treatment Data, Advanced Options" button is not touched, then the control routine continues to step 532. In step 532, it is determined whether the device is in the start state of the treatment segment. If it is determined in step 532 that the device is in the start state of the segment, then the control routine continues to step 534. In step 534, it is determined whether the "take shorter treatment" button has been touched. If it is determined in step 534 that the "Receive Shorter Treatment" button has been touched, then the control routine continues to step 536. At step 536, the control routine displays a take shorter treatment screen, one example of which is shown in FIG. 59 and executes the control routine shown schematically in FIG. 21 and returns to step 500. FIG. However, if at step 534 it is determined that the "Receive Shorter Treatment" button has not been touched, then the control routine continues to step 538.
[94] If it is determined in step 532 that the device is not in the starting state of the treatment segment, then the control routine continues to step 538. At step 538, the control routine determines whether the "previous screen" button has been touched. If it is determined in step 538 that the "Previous Screen" button has been touched, then the control routine continues to step 540. At step 540, the control routine returns control of the device to the control routine that called the option screen control routine of FIG. 19. However, if it is determined that the "previous screen" button has not been touched, then the control routine returns to step 500.
[95] 20 schematically illustrates a control routine of option sub screens of an example device. This flowchart begins at step 542 where the control routine displays the “treatment plan data” screen, an example of which is shown in FIG. 58, and continues to step 544. In step 544, the control routine determines whether one of the "segment" buttons has been touched on the touch screen. If it is determined in step 544 that one of the "segment" buttons has been touched, then the control routine continues to step 546. At step 546, the control routine updates the display screen to show the selected segment data and returns to step 542. However, if at step 544 it is determined that none of the "segment" buttons have been touched, then the control routine continues to step 548. At step 548, the control routine determines whether the device is in the start state of the segment. If it is determined in step 548 that the device is in the start state of the segment, then the control routine continues to step 550. At step 550, the control routine determines whether the "advanced options" button has been touched. If it is determined in step 550 that the "Advanced Options" button has been touched, then the control routine continues to step 552. In step 552, the control routine executes the advanced option control routine described in detail in the flowchart of FIG. 32 and returns to step 542. FIG. However, in step 550, if it is determined that the "advanced option" button is not touched, then the control routine returns to step 542.
[96] If it is determined in step 548 that the device is in the start state of the segment, then the control routine continues to step 554. At step 554, the control routine determines whether the "previous screen" button has been touched. If it is determined in step 554 that the "Previous Screen" button has been touched, then the control routine continues to step 556. At step 556, the control routine returns control of the device to the control routine that called the option subscreen control routine of FIG. However, if at step 554 it is determined that the "Previous Screen" button has not been touched, then the control routine returns to step 542.
[97] 21 is a flowchart schematically illustrating a control routine for managing shorter treatments. The flowchart begins at step 558 and continues to step 560 where the control routine displays one of the shorter receive treatment screens, one example of which is shown in FIG. 59. At step 560, the control routine determines whether a number has been entered. If it is determined in step 560 that a number has been entered, then the control routine continues to step 562. If it is determined in step 560 that a number has been entered, then the control routine continues to step 562. In step 562, the control routine adds the entered number to the display screen and returns to step 558. However, if it is determined in step 560 that no number is entered, then the control routine continues to step 564. In step 564, the control routine determines whether the "clear" button has been touched on the touch screen. If it is determined in step 564 that the "erase" button has been touched, then the control routine continues to step 566. In step 566, the control routine erases the numeric display and returns to step 558. However, in step 564, if it is determined that the "erase" button is not touched, then the control routine continues to step 568.
[98] In step 568, the control routine determines whether the "start" button has been touched. If it is determined in step 568 that the "start" button has not been touched, then the control routine continues to step 570. In step 570, the control routine determines whether a significant number has been entered. If it is determined in step 570 that the significant digit has been entered, the control routine continues to step 580. At step 580, the control routine returns to step 454 of FIG. 17. However, if it is determined in step 570 that no significant digits have been entered, then the control routine continues to step 572. At step 572, the control routine displays an " invalid entry " screen, one example of which is shown in FIG. At step 574, the control routine determines whether the "Retry" button has been touched on the touch screen. If it is determined in step 574 that the "Retry" button has been touched, then the control routine returns to step 558. However, if at step 574 it is determined that the "Retry" button has not been touched, then the control routine returns to step 572.
[99] However, in step 568, if it is determined that the "start" button is not touched, then the control routine continues to step 576. At step 576, the control routine determines whether the "previous screen" button has been touched. If it is determined in step 576 that the "Previous Screen" button has not been touched, then the control routine continues to step 578. In step 578, the control routine returns control of the device to the control routine that called the progress control routine shown in FIG. However, if at step 576 it is determined that the "Previous Screen" button has not been touched, then the control routine continues to step 558.
[100] 22 is a flowchart schematically showing a control routine for the progress state of the apparatus. The flowchart begins at step 582 where the control routine accumulates segment usage data such as usage time, maximum intensity, and average intensity, and continues to step 584. In step 584, the control routine determines whether the intensity key (up or down button) has been touched on the touch screen. If it is determined in step 584 that the strength key has been touched, then the control routine continues to step 586. At step 586, the control routine changes the intensity set point according to the intensity key and returns to step 584. However, if at step 584 it is determined that the strength key has not been touched, the control routine continues to step 588. In step 588, the control routine determines whether an open or short is detected. If it is determined in step 588 that an open or short has been detected, then the control routine continues to step 590. In step 590, the control routine displays an " show problem screen " in which one example is shown in FIG. 153 and continues to step 591. FIG. In step 591, the control routine determines whether the "continue treatment" button has been touched on the touch screen. If it is determined in step 591 that the "Continue Treatment" button is touched on the touch screen, then the control routine returns to step 584. However, if it is determined in step 591 that the "Continue Treatment" button is not touched on the touch screen, then the control routine returns to step 590.
[101] However, if at step 588 it is determined that no open or short is detected, then the control routine continues to step 592. In step 592, the control routine determines whether the "pause" button has been touched on the touch screen. If it is determined in step 592 that the pause button has been touched, then the control routine continues to step 594. In step 594, the control routine displays the treatment on the “pause” screen, examples of which are shown in FIGS. 60-63 and continue to step 596. In step 596, the control routine determines whether the "resume" button has been touched on the touch screen. If it is determined in step 596 that the "resume" button has been touched, then the control routine continues to step 598.
[102] At step 598, the control routine displays the “resuming treatment” screen, examples of which are shown in FIGS. 64-67, and continue at step 600. FIG. At step 600, the control routine returns the strength of the output on each channel to the strength prior to the pause and continues to step 602. In step 602, the control routine determines whether the "stop automatic increase, manually increase intensities" button has been touched. If it is determined that the "Strength Auto Rise Stop, Manual Rise" button has been touched, then the control routine sets the intensity to the current intensity and returns to step 584. However, if it is determined that the "Strength Auto Rise Stop, Manual Rise" button has not been touched, then the control routine continues to step 604. At step 604, the control routine determines whether the channel strength is equal to the channel strength before the pose. In step 604, if the channel strength is determined to be equal to the channel strength before the pose, then the control routine then returns to step 584. However, if at step 604 it is determined that the channel strength is not equal to the channel strength before the pose, then the control routine then returns to step 598.
[103] However, in step 596, if it is determined that the "resume" button is not touched, then the control routine continues to step 606. At step 606, the control routine determines whether 10 minutes have elapsed. If it is determined in step 606 that 10 minutes have elapsed, then the control routine returns to step 594. However, if it is determined that 10 minutes have elapsed, then the control routine returns to step 594.
[104] However, if at step 592 it is determined that the "stop" key has not been touched, then the control routine continues to step 608. In step 608, the control routine determines whether the "options" button has been touched. If it is determined in step 608 that the "Option" button has not been touched, then the control routine continues to step 610. At step 610, the control routine executes the option screen control routine of FIG. 19 and returns to step 584. FIG.
[105] However, if at step 608 it is determined that the "Option" button has not been touched, then the control routine continues to step 612. At step 612, the control routine determines whether the "help" button has been touched on the touch screen. If it is determined in step 612 that the "help" button has been touched, then the control routine continues to step 614. At step 614, the control routine executes the control routine detailed in the flowchart of FIG. 18 and returns to step 584.
[106] However, if at step 612 it is determined that the "help" button has not been touched, then the control routine continues to step 616. At step 616, the control routine updates the segment clock information and continues to step 618. In step 618, the control routine determines whether a clock error exists. If it is determined in step 618 that a clock error exists, then the control routine continues to step 620. If it is determined in step 618 that a clock error exists, then the control routine logs error 12, sets the state of the device to " error ", and executes the flowchart schematically shown in FIG. Continues. In step 622, the control routine returns control of the device to the control routine that called the progress state control routine of the flowchart of FIG. However, if at step 618 it is determined that no clock error exists, then the control routine continues to step 624. In step 624, the control routine executes a particular task of the apparatus shown in FIGS. 23 and 24, as determined in step 452 of FIG.
[107] 23 schematically illustrates a control routine for an exemplary pulsed muscle stimulation task in accordance with the present invention. This control routine begins at step 626 where the control routine sets the control mode to one of a normal mode and an alternating mode, and continues to step 628. At step 628, the control routine generates a pulse and continues to step 630. At step 630, the control routine provides ramping for the pulses and continues to step 632. At step 632, the control routine limits the increase in intensity based on the user's touch to the rising key on the touch screen to prevent accidental reversal of the pulses and continues to step 633. In step 633, the control routine returns control of the device to the control routine that called the pulsed muscle stimulation treatment control routine of FIG.
[108] 24 is a flowchart schematically illustrating an exemplary control routine for an interfering device task in accordance with the present invention. This control routine begins at step 634 where the control routine sets the control mode to one of a variable mode and a continuous mode and continues to step 636. At step 636, the control routine generates a sine wave and continues to step 638. At step 638, the control routine controls two pad mixing by premixing the interfering signals. At step 640, the control routine controls the frequency modulation and continues to step 642. At step 642, the control routine controls amplitude modulation and continues to step 643, where the control routine returns to the control routine that called the interference treatment control routine of FIG.
[109] 25 is a flowchart schematically showing a control routine for a "segment end" state in accordance with the present invention. The control routine begins at step 644 in which the control routine increments the segment counter and continues to step 646. At step 646, the control routine calculates the segment result and continues to step 648. At step 648, the control routine stores the result therein and continues to step 650. At step 650, the control routine determines whether this is the last segment. If it is determined in step 650 that this is the last segment, then the control routine continues to step 652. At step 652, the control routine displays the “treatment completed” screen, an example of which is shown in FIG. 127 and continues to step 654. At step 654, the control routine sets the state of the device to "stopped" and continues to step 655. In step 655, the control routine determines whether the "OK" button has been touched on the touch screen. If it is determined in step 655 that the "OK" button has been touched, then the control routine continues to step 656. At step 656, the control routine returns control of the device to the control routine that called the segment end state control routine of FIG. However, if it is determined in step 655 that the "OK" button has not been touched, then the control routine returns to step 654.
[110] However, if at step 650 it is determined that this is not the last segment, then the control routine continues to step 658. At step 658, the control routine sets the state of the device to "start segment" and continues to step 660. At step 660, the control routine returns control of the device to the control routine that called the segment end state control routine shown schematically in the flowchart of FIG.
[111] FIG. 26 shows a flowchart schematically illustrating a control routine for an "off" state in accordance with an exemplary embodiment of the present invention. The control routine begins at step 662 where the control routine determines whether the current state is "running." If it is determined in step 662 that the current state is "go", then control routine continues to step 664. At step 664, the control routine sets the state of the device to "stop" and continues to step 668. In step 668, the control routine displays the "Resume Treatment" display screen, for example, shown in FIGS. 64-67, ramping the intensity to a preset intensity for the output and continuing to step 670.
[112] At step 670, the control routine determines whether the "stop automatic increase, manually increase intensities" button has been touched on the touch screen. If it is determined in step 670 that the "Strength Auto Rise Stop, Manual Rise" button has been touched, then the control routine continues to step 671. At step 671, the control routine stops automatic ramping of the output intensity and continues to step 672. However, in step 670, if it is determined that the "Strength auto rise stop, manual rise" button is not touched, then the control routine continues to step 672. At step 672, the control routine sets the state of the device to "go" and continues to step 674. At step 674, the control routine returns control of the device to the control routine that called the off state control routine shown schematically in FIG.
[113] However, if at step 662 it is determined that the current state is not "going", then the control routine continues to step 676. At step 676, the control routine displays the " on / off button pressed " display screen of which an example is shown in FIG. 69, and continues to step 678. FIG. At step 678, the control routine determines whether the "Continue" button has been touched on the touch screen. If it is determined in step 678 that the "Continue" button has been touched, then the control routine continues to step 680. At step 680, the control routine shows a "resuming treatment screen", an example of which is shown in Figures 63-67. However, if at step 678 it is determined that the "Continue" button is not touched, then the control routine continues to step 682. In step 682, the control routine determines whether the "off" button has been touched on the touch screen. If it is determined in step 682 that the "off" button has been touched, then the control routine continues to step 684. At step 684, the control routine sets the state of the device to "stop" and continues to step 686. At step 686, the control routine returns control of the device to the routine that called the off state control routine of FIG.
[114] However, in step 682, if it is determined that the "off" button has not been touched, then the control routine continues to step 688. In step 688, the control routine determines whether one minute has elapsed. If it is determined in step 688 that one minute has not elapsed, then the control routine returns to step 678. However, if it is determined in step 688 that one minute has elapsed, then the control routine shuts off the device.
[115] Figure 27 schematically illustrates a "stop" state control routine in accordance with an exemplary embodiment of the present invention. The control routine begins at step 690 where the zeal routine writes treatment data to the data card 30 and continues to step 692. At step 692, the control routine displays the “how to recharge battery” screen, an example of which is shown in FIG. 41, and continues to step 694. FIG. In step 694, the control routine returns control of the device to the control routine that called the stop state control routine of FIG.
[116] 28 schematically illustrates an "error" state control routine. The control routine starts at step 696 to determine whether there is a preceding error. If it is determined in step 696 that a preceding error exists, then the control routine continues to step 698. At step 698, the control routine records a preceding error and continues to step 700. At step 700, the control routine logs an error and continues to step 702. At step 702, the control routine displays the " problem detected " screen, an example of which is shown in FIG. At step 704, the control routine emits three beeps and continues to step 706.
[117] In step 706, the control routine determines whether two minutes have elapsed. In step 706, if it is determined that two minutes have elapsed, the control routine then shuts down the device. If the system is restarted and the control routine encounters the same error three consecutive times, then the device is shut off and cannot be restarted. However, if it is determined in step 706 that two minutes have not elapsed, the control routine returns to step 696. If it is determined in step 696 that no preceding error has been recorded, then the control routine continues to step 700.
[118] 29 schematically illustrates a "low battery" state control routine of an exemplary embodiment in accordance with the present invention. The control routine begins at step 708, where the control routine determines whether the current state is "going". If it is determined in step 708 that the current state is "go", then control routine continues to step 710. At step 710, the control routine calculates the segment result and continues to step 712. At step 712, the control routine stores the result and continues to step 714. However, if at step 708 it is determined that the current state is not " progress, " then the control routine continues to step 714. At step 714, the control routine displays a " battery empty " screen, an example of which is shown in FIG. 70, and continues to step 716. FIG.
[119] At step 716, the control routine determines whether the "recharge" button has been touched on the touch screen. If it is determined in step 716 that the "recharge" button has been touched, then the control routine continues to step 717. At step 717, the control routine displays the " battery recharging method " screen, an example of which is shown in FIG. However, if at step 716 it is determined that the "recharge" button has not been touched, then the control routine continues to step 718. In step 718, the control routine determines whether two minutes have elapsed. If it is determined in step 718 that two minutes have not elapsed, then the control routine continues to step 719. At step 719, the control routine returns to the control routine that calls the control routine of FIG. However, if it is determined in step 718 that two minutes have elapsed, then the control routine continues to step 720. In step 720, the control routine shuts down the device.
[120] 30 schematically illustrates a "charge" state control routine of an exemplary embodiment according to the present invention. The control routine begins at step 722, where the control routine determines whether the charger voltage is acceptable. If it is determined in step 722 that the charger voltage is unacceptable, then the control routine continues to step 724. In step 724, the control routine displays the " recharging alert " display screen of which an example is shown in FIG. However, if at step 722 the charger voltage is determined to be acceptable, then the control routine continues to step 728.
[121] At step 728, the control routine determines whether the battery temperature is acceptable. If it is determined in step 729 that the battery temperature is unacceptable, then the control routine continues to step 730. At step 730, the control routine displays the " recharge alert " display screen, an example of which is shown in FIG. 72, and returns to step 722. FIG. However, if at step 728 the battery temperature is determined to be acceptable, then the control routine continues to step 734. At step 734, the control routine determines whether the battery is fully charged. If it is determined in step 734 that the battery is fully charged, then the control routine continues to step 736. At step 736, the control routine displays the “battery fully charged” screen, an example of which is shown in FIG. 73, and continues to step 738. FIG. In step 738, the control routine returns control to the control routine that called the charge state control routine shown schematically in the flowchart of FIG. However, if at step 734 it is determined that the battery is not fully charged, then the control routine continues to step 740.
[122] At step 740, the control routine shows the “battery recharge” screen, an example of which is shown in FIG. 74, and continues to step 742. FIG. At step 742, the control routine controls the charging current supplied to the battery and continues to step 743. At step 743, the control routine determines whether the battery is fully charged. If it is determined in step 743 that the battery is fully charged, then the control routine continues to step 745. In step 745, the control routine displays the “Battery Full Charge” screen, an example of which is shown in FIG. 73, and continues to step 747. FIG. At step 747, the control routine returns control of the device to the control routine that called the charge state control routine of FIG.
[123] However, if at step 743 it is determined that the battery is not fully charged, then the control routine continues to step 744. At step 744, the control routine determines whether the battery charge is sufficient for complete treatment. In step 744, if the battery is determined to have sufficient charge for complete treatment, then the control routine continues to step 746. At step 746, the control routine displays a message on the display screen indicating that treatment may begin and returns to step 740. However, if at step 744 it is determined that the battery is not sufficiently charged for complete treatment, then the control routine continues to step 740.
[124] Figure 31 schematically illustrates a "maintenance" state control routine of an exemplary embodiment according to the present invention. The control routine begins at step 749, where the control routine displays the maintenance mode display screen with an example shown in FIG. 154 and continues to step 750. FIG. At step 750, the control routine determines whether a command has been received. If it is determined in step 750 that no command has been received, then the control routine continues to step 752. In step 752, the control routine returns control to the control routine that called the maintenance state control routine shown schematically in FIG. However, at step 750, if it is determined that the command has been received, then the control routine continues to step 754.
[125] In step 754, the control routine determines whether a valid instruction has been entered. If it is determined in step 754 that no valid command has been entered, then the control routine continues to step 756. At step 756, the control routine returns an error string and continues to step 758. At step 758, control of the device returns to the control routine that called the maintenance state control routine of FIG. However, if at step 754 it is determined that a valid command has been received, then the control routine continues to step 760. At step 760, the control routine processes the command and continues to step 762. At step 762, the control routine returns control of the device to the control routine that called the maintenance state control routine shown schematically in FIG.
[126] 32 shows a flowchart schematically illustrating an advanced option control routine of an exemplary embodiment according to the present invention. The control routine begins at step 764, where the control routine displays the " advanced options " display screen with an example shown in FIG. 149 and continues to step 766. At step 766, the control routine determines whether a number has been entered. If it is determined in step 766 that a number has been entered, then the control routine continues to step 768. At step 768, the control routine adds the entered number to the display screen and returns to step 764. However, if it is determined in step 766 that no number is entered, then the control routine continues to step 770.
[127] At step 770, the control routine determines whether the "erase" button has been touched. If it is determined in step 770 that the "Erase" button has been touched, then the control routine continues to step 772. At step 772, the control routine clears the numeric display and returns to step 764. However, in step 770, if it is determined that the "erase" button is not touched on the touch screen, then the control routine continues to step 774. In step 774, the control routine determines whether the "OK" button has been touched on the touch screen. If it is determined in step 774 that the "OK" button has been touched, then the control routine continues to step 782.
[128] In step 782, the control routine determines whether the "previous screen" button has been touched on the touch screen. If it is determined in step 782 that the "Previous Screen" button has been touched, then the control routine continues to step 784. At step 784, the control routine returns to the control routine that called the advanced option control routine of the flowchart of FIG.
[129] However, if at step 774 it is determined that the "OK" button has been touched, then the control routine continues to step 776. In step 776, the control routine determines whether a valid code has been entered. If it is determined in step 776 that no valid code has been entered, then the control routine continues to step 778. At step 778, the control routine displays the " alert-invalid entry " screen with an example shown in FIG. 44 and continues to step 780. At step 780, the control routine determines whether the "Retry" button has been touched on the touch screen. If it is determined in step 780 that the "Retry" button has been touched, then the control routine returns to step 764. However, if at step 780 it is determined that the "retry button" has not been touched, then the control routine returns to step 778.
[130] However, if it is determined in step 776 that a valid code has been entered, then the control routine continues to step 786. At step 786, the control routine displays the “Advanced Options” screen, an example of which is shown in FIG. 75 and continues to step 788. In step 788, the control routine determines whether the "select, create treatment plan" button has been touched on the touch screen. If it is determined in step 788 that the "Create Treatment Plan Selection" button has been touched, then the control routine continues to step 790. In step 790, the control routine passes control to the control routine shown schematically in the flowchart of FIG. 33 and continues to step 791. In step 791, the control routine returns control of the device to the control routine that called the advanced option control routine of FIG. However, if at step 788 it is determined that the "Create Treatment Plan Selection" button is not touched, then the control routine continues to step 792. At step 792, the control routine determines whether the "adjust treatment settings" button has been touched on the touch screen. If it is determined in step 792 that the "Treat Treatment Setpoint" button has been touched, then the control routine continues to step 794. At step 794, the control routine transfers control to the control routine shown schematically in the flowchart of FIG. 35 and continues to step 795. In step 795, the control routine returns control of the device to the control routine that called the advanced option control routine of FIG. However, if at step 792 it is determined that the "Treat Treatment Setpoint" button is not touched on the touch screen, then the control routine continues to step 796. In step 796, the control routine determines whether the "setup mini treatment" button has been touched on the touch screen. If it is determined in step 796 that the "Set Minimum Treatment" button has been touched, then the control routine continues to step 798.
[131] At step 798, the control routine transfers control of the device to the control routine shown schematically in the flowchart of FIG. 39 and continues to step 799. In step 799, the control routine returns control of the device to the control routine that called the advanced option control routine of FIG. However, in step 796, if it is determined that the "Set Minimum Treatment" button is not touched, then the control routine continues to step 800. In step 800, the control routine determines whether the "Start Treatment" button has been touched on the touch screen. If it is determined in step 800 that the "Start Treatment" button has been touched, then the control routine continues to step 802. At step 802, the control routine sets the state of the device to "segment start", transfers control of the device to the control routine shown schematically in the flowchart of FIG. 16, and then continues to step 803. In step 803, the control routine returns control of the device to the control routine that called the advanced option control routine of FIG. However, in step 800, if it is determined that the "start treatment" button is not touched, the control routine returns to step 786.
[132] Figure 33 shows a flowchart schematically illustrating a treatment plan selection control routine of an exemplary embodiment of an apparatus according to the present invention. The control routine begins at step 804, where the control routine displays the “select treatment plan-select type of pain” screen, as shown in FIG. 76, and continues to step 805. In step 805, the control routine may display a “acute pain” button, a “sub-acute pain” button, a “hyper sensitive acute pain” button, and “chronic pain” on a touch screen. (chronic pain) "button determines whether one of the buttons has been touched on the touch screen. If it is determined in step 805 that none of these four buttons have been touched, then the control routine continues to step 807. In step 807, the control routine determines whether the "previous screen" button has been touched on the touch screen. If it is determined in step 807 that the "Previous screen" button has been touched, then the control routine returns to step 804. However, if it is determined in step 807 that the "Previous Screen" button is not touched, then the control routine returns to step 805.
[133] However, if at step 805 it is determined that one of the four buttons has been touched, the control routine continues to step 809. In step 809, the control routine displays the " select treatment plan-select one other indication " display screen of which an example is shown in FIG. 77, and continues to step 811. FIG. In step 811, the control routine includes a "muscle spasms" button, an "increase blood increase" button, a "disuse atrophy" button, a "re-educate muscle" button, It is determined whether one of the "range and motion" button, the "venous thrombosis" button or the "none" button has been touched. If at step 811 any of these buttons are determined to have been touched, then the control routine continues to step 806. However, if it is determined that none of these buttons have been touched, the control routine continues to step 813. In step 813, the control routine determines whether the "previous screen" button has been touched. If it is determined in step 813 that the "Previous Screen" button has been touched, then the control routine continues to step 804. However, in step 813, if it is determined that the "previous screen" button is not touched, the control routine returns to step 809.
[134] In step 806, the control routine sequentially displays the appropriate body part display screens, examples of which are shown in FIGS. 78-82 and 155, and determine pain areas to be treated by requesting and receiving indications from the user. The control routine then continues to step 808. At step 808, the control routine determines whether there are any special questions the device should have answered to further determine the correct pad position. In step 808, if the control routine has a special question, then the control routine continues to step 810. At step 810, the control routine displays the “select treatment plan-answer question” screen, an example of which is shown in FIG. 83, and continues to step 812. At step 812, the control routine receives the user's response to the particular question and continues to step 814. However, if it is determined in step 808 that the device has no special question then the control routine continues to step 814.
[135] At step 814, the control routine displays one of the appropriate pad viewing screens of which examples are shown in FIGS. 84-120 and continue to step 816. FIG. In step 816, the control routine displays an “select treatment plan-select frequency of treatment” screen, an example of which is shown in FIG. 121, and after receiving the treatment frequency selected by the user, proceeds to step 818. Continues. At step 818, the control routine determines an appropriate treatment plan based on pain indications, other indications, and pad position, and continues to step 820. At step 822, the control routine transfers control of the device to the control routine shown schematically in the flowchart shown in FIG. 34 and continues to step 823. In step 823, the control routine returns control of the device to the control routine that called the treatment plan selection control routine of FIG. 33.
[136] 34 shows a flowchart schematically illustrating a treatment plan view control routine according to an exemplary embodiment of the invention. This control routine begins at step 824, where the control routine displays an “select treatment plan-review plan” screen, an example of which is shown in FIG. 122, and continues to step 826. At step 826, the control routine determines whether the "OK" button on the touch screen has been touched. At step 826, if it is determined that the "OK" button has been touched, then the control routine continues to step 828. Step At 828, the control routine returns control of the device to the control routine that called the treatment plan view control routine of Fig. 34. However, if it is determined in step 826 that the "OK" button is not touched, then the control routine then proceeds to step Continue to 830.
[137] At step 830, the control routine determines whether the "adjust plan" button has been touched. If it is determined in step 830 that the "plan adjustment" button has been touched, then the control routine continues to step 832. At step 832, the control routine transfers control of the device to the control routine shown schematically in the flowchart of FIG. 35 and returns to step 824. However, if at step 830 it is determined that the "plan adjustment" button has not been touched, then the control routine continues to step 834. In step 834, the control routine determines whether the "createplan" button has been touched on the touch screen. If it is determined in step 834 that the "generate plan" button has been touched, then the control routine continues to step 836. At step 836, the control routine transfers control of the device to the treatment plan generation control routine shown schematically in the flowchart of FIG. 38 and returns to step 824. However, in step 834, if it is determined that the "generate plan" button is not touched, then the control routine continues to step 838.
[138] If it is determined in step 838 that the "View pad" button has been touched, then the control routine continues to step 840. At step 840, the control routine displays the "Pad view" screen, the example of which is shown in Figures 84-120, and returns to step 824. However, if it is determined that the "view pad" button is not touched, the control routine continues to step 842. At step 842, the control routine determines whether one minute has elapsed. If it is determined in step 842 that one minute has not elapsed, then the control routine returns to step 824. However, at step 842, if it is determined that one minute has elapsed, then the control routine shuts off the device.
[139] 35 is a flowchart schematically illustrating a treatment plan adjustment control routine. The control routine begins at step 844, where the control routine displays, depending on the fitness, the "Treatment Setpoint Adjustment" screen shown in FIG. 123 or the "Generate Treatment Plan" screen shown in FIG. And continue to step 846. In step 846, the control routine determines whether the segment is changing based on whether the segment button on the touch screen is being touched. If it is determined in step 846 that the segment is changing, then the control routine continues to step 848. At step 848, the control routine shows the requested segment and returns to step 846. If it is determined in step 846 that the segment is not changing, the control routine continues to step 850.
[140] In step 850, the control routine determines whether the "Adjust" button on the touch screen has been touched. In step 850, "If it is determined that the adjustment button has been touched, then the control routine continues to step 852. In step 852, the control routine transfers control of the apparatus to the control routine schematically shown in the flowchart of FIG. And if it is determined that the "adjust" button has not been touched, then the control routine continues to step 854. At step 854, the control routine determines whether the "done" button has been touched. If it is determined in step 854 that the "Done" button has been touched, then the control routine continues to step 856. At step 856, the control routine returns to the control routine that called the treatment plan adjustment control routine of FIG. However, if at step 854 it is determined that the "Done" button has not been touched, then the control routine continues to step 855.
[141] At step 855, the control routine determines whether the "previous screen" button has been touched. If it is determined in step 855 that the "Previous Screen" button has been touched, then the control routine returns control of the device to the control routine that invoked the treatment plan adjustment control routine shown schematically in the flowchart of FIG. However, in step 855, if it is determined that the "previous screen" button has not been touched, then the control routine returns to step 846.
[142] 36 shows a flowchart schematically illustrating a segment option adjustment control routine of an exemplary embodiment of the present invention. The control routine begins at step 858, where the control routine displays the “Treat Treatment Setpoint” screen, for example shown in FIGS. 125 and 126, and continues to step 860. At step 860, the control routine determines whether the user has touched one of the "adjust" buttons on the touch screen. If it is determined in step 860 that one of the "adjust buttons" has been touched on the touch screen, then the control routine continues to step 862. At step 862, the control routine transfers control of the device to the setpoint adjustment control routine shown schematically in the flowchart of FIG. 37 and returns to step 858. FIG. However, if at step 860 it is determined that the "adjust" button has not been touched, then the control routine continues to step 864.
[143] In step 864, the control routine determines whether the "OK" button has been touched on the touch screen. If it is determined in step 864 that the "OK" button has been touched, then the control routine continues to step 865. In step 865, the control routine determines whether the "previous screen" button has been touched on the touch screen. If it is determined in step 865 that the "previous screen" button has been touched on the touch screen, then the control routine continues to step 866. However, if at step 865 it is determined that the "Previous Screen" button has not been touched, then the control routine returns to step 860. However, if it is determined in step 864 that the "OK button" has been touched, then the control routine continues to step 866. At step 866, the control routine returns control of the device to the control routine that called the segment option adjustment control routine of FIG. 36.
[144] 37 is a flowchart schematically showing a setpoint option adjustment control routine according to an exemplary embodiment of the present invention. The control routine begins at step 868, where the control routine displays the “Treat Treatment Setpoint” screen, the example of which is shown in FIGS. 127-134 and continues to step 870. In step 870, the control routine determines whether the user has selected a setpoint. If it is determined in step 870 that the setpoint has been selected, the control routine sets the selected setpoint and returns to step 868.
[145] However, if at step 870 it is determined that the set point is not selected, then the control routine continues to step 874. In step 874, the control routine determines whether a setpoint has been entered. If it is determined in step 874 that no set value is entered, then the control routine returns to step 868. However, if it is determined in step 874 that the setpoint has been entered, then the control routine continues to step 876. In step 876, the control routine determines whether a number has been entered. If it is determined in step 876 that a number has been entered, then the control routine continues to step 878. At step 878, the control routine adds the entered number to the display screen and returns to step 868. However, if it is determined in step 876 that no number is entered, then the control routine continues to step 880.
[146] In step 880, the control routine determines whether the "erase" button has been touched on the touch screen. If it is determined in step 880 that the "Erase" button has been touched, then the control routine continues to step 882. In step 882, the control routine erases the number from the display screen and returns to step 868. However, if it is determined in step 880 that the "Erase" button has not been touched on the touch screen, then the control routine continues to step 884. At step 884, the control routine determines whether the " enter " button has been touched on the touch screen. If at step 884 it is determined that the "input" button has not been touched, then the control routine returns to step 868. However, if it is determined in step 884 that the "input" button has been touched on the touch screen, then the control routine continues to step 886. In step 886, the control routine determines whether the input is valid. If it is determined in step 886 that the input is valid, then the control routine continues to step 888. At step 888, the control routine returns control of the device to the control routine that called the setpoint option adjustment control routine of FIG.
[147] However, if at step 886 it is determined that the input is invalid, then the control routine continues to step 890. At step 890, the control routine displays the " invalid input alert " screen, an example of which is shown in FIG. In step 892, the control routine determines whether the "retry" button has been touched on the touch screen. If it is determined that the "Retry" button has not been touched, then the control routine returns to step 890. However, if it is determined in step 892 that the "Retry" button has been touched, then the control routine returns to step 868.
[148] 38 shows a flowchart schematically illustrating the creation of a treatment plan of an exemplary embodiment according to the present invention. The control routine begins at step 894, where the control routine displays an "create treatment plan-select number of segments in plan" screen, for example, shown in FIG. After receiving a user input selection for the number of segments, continue to step 896. In step 896, the control routine displays an “create treatment plan-select treatment type for segment 1” screen, an example of which is shown in FIG. 136, and the treatment type selected from the user. After receipt, the process continues to step 898. At step 898, the control routine displays the "Create Treatment Plan" screen, the examples of which are shown in FIGS. 137 and 138, and continues to step 902. In step 902, the control routine determines whether the "adjust" button has been touched on the display screen. If it is determined in step 902 that the "Adjust" button has been touched, then the control routine continues to step 904. At step 904, the control routine transfers control of the device to the control routine shown schematically in FIG. 37 and returns to step 900. However, if at step 902 it is determined that the "adjust" button has not been touched, then the control routine continues to step 908. At step 908, the control routine determines whether the "OK" button has been touched on the touch screen. If it is determined in step 908 that the "OK" button is not touched, then the control routine continues to step 909.
[149] At step 909, the control routine determines whether the "previous screen" button has been touched. If it is determined in step 909 that the "Previous Screen" button has been touched, then the control routine returns to step 896. However, if at step 909 it is determined that the "previous screen" has not been touched, then the control routine returns to step 902. However, if it is determined in step 908 that the "OK" button has been touched, then the control routine continues to step 906. At step 906, the control routine determines whether the current t segment is the last segment of the treatment plan. If at step 906 it is determined that this is not the last segment of the treatment plan, then the control routine then returns to step 896. However, if at step 906 it is determined that this is the last segment of the treatment plan, then the control routine continues to step 910.
[150] In step 910, the control routine displays an “create treat plan-review pan layout” screen, an example of which is shown in FIG. 150, and continues to FIG. 912. At step 912, the control routine determines whether the "OK" button has been touched on the touch screen. If it is determined in step 912 that the "OK" button has been touched, then the control routine continues to step 914. At step 914, the control routine displays the “treatment plan” screen with an example shown in FIG. 124 and continues to step 918. However, if at step 912 it is determined that the "OK" button is not touched, then the control routine continues to step 916. At step 916, the control routine determines whether the "no pad" screen button has been touched on the touch screen. If it is determined that the "no pad" screen on the touch screen is touched, then the control routine continues to step 917.
[151] In step 917, the control routine determines whether the "previous screen" button has been touched on the touch screen. If it is determined in step 917 that the "previous screen" button has been touched, then the control routine returns to step 900. However, if it is determined in step 917 that the "Previous Screen" button has not been touched, then the control routine returns to step 910. However, if at step 916 it is determined that the "no pad" button has been touched, then the control routine continues to step 914. At step 918, the control routine transfers control of the device to the control routine shown schematically in the flowchart shown in FIG. 35 and continues to step 919. FIG. In step 919, the control routine returns control to the control routine that called the treatment plan generation control routine of FIG.
[152] 39 shows a flowchart schematically illustrating a minimal treatment option control routine of an exemplary embodiment in accordance with the present invention. The control routine begins at step 920, where the control routine displays the “Minimum Treatment Settings” screen with an example shown in FIG. 139 and continues to step 922. At step 922, the control routine determines whether the "increase" or "decrease" button has been touched on the touch screen. If it is determined in step 922 that the "increase" or "decrease" button has not been touched on the touch screen, then the control routine continues to step 924.
[153] At step 924, the control routine adjusts the minimum number of treatments according to the touched "increase" or "decrease" button and returns to step 920. However, if at step 922 it is determined that the "increase" or "decrease" button is not touched, then the control routine continues to step 926. At step 926, the control routine determines whether the "previous screen" button has been touched on the touch screen. If it is determined in step 926 that the "previous screen" has been touched, then the control routine continues to step 928. At step 928, the control routine transfers control of the device back to the control routine that called the minimal treatment option control routine of FIG. 9. However, if at step 926 it is determined that the "Previous Screen" button has not been touched, then the control routine continues to step 930.
[154] In step 930, the control routine determines whether the "Start Treatment" button has been touched. If it is determined in step 930 that the "Start Treatment" button has not been touched, then the control routine returns to step 920. However, if at step 930 it is determined that the "Start Treatment" button has been touched, then the control routine continues to step 932. At step 932, the control routine displays the “Minimum Treatment Segment Start” screen, an example of which is shown in FIGS. 140-143 and continues to step 934. FIG. At step 934, the control routine determines whether the "up" button has been touched on the touch screen. If it is determined in step 934 that the "up" button has not been touched, then the control routine continues to step 942.
[155] In step 942, the control routine determines whether the "set value adjustment" button has been touched on the touch screen. If it is determined in step 942 that the "Set Value Adjustment" button has been touched on the touch screen, then the control routine continues to step 944. At step 944, the control routine transfers control of the device to the control routine shown schematically in the flowchart of FIG. 37, and continues to step 945. At step 945, the control routine returns control of the device to the control routine that called the minimal treatment option control routine of FIG. 39. However, in step 942, if it is determined that the "set value adjustment" button is not touched, then the control routine returns to step 943. In step 943, the control routine determines whether the "previous screen" button has been touched on the touch screen. If it is determined in step 943 that the "Previous Screen" button has been touched, then the control routine returns to step 932. However, if it is determined in step 943 that the "previous screen" button has been touched, then the control routine returns to step 920.
[156] However, if it is determined in step 934 that the "up" button has been touched, then the control routine continues to step 936. At step 936, the control routine displays the " treatment running " screen shown in FIGS. 144-147 and continues to step 938. In step 938, the control routine determines whether the "set value adjustment" button has been touched on the touch screen. If it is determined in step 938 that the "Set value adjustment" button has been touched, then the control routine continues to step 940. At step 940, the control routine transfers control of the device to the control routine shown schematically in the flowchart of FIG. 37 and continues to step 941. At step 941, the control routine returns control of the device to the control routine that called the minimal treatment option control routine of FIG. 39. However, if it is determined that the "set value adjustment" button is not touched, then the control routine continues to step 945.
[157] In step 945, the control routine determines whether the intensity button has been touched on the touch screen. If it is determined in step 945 that the intensity button has been touched, then the control routine continues to step 947, where the control routine changes the intensity setting in accordance with the touched intensity button and returns to step 936. However, if it is determined that the intensity button has not been touched, then the control routine continues to step 946. In step 946, the control routine determines whether the segment is complete. If it is determined in step 946 that the segment is incomplete, then the control routine returns to step 938. However, in step 946, if the segment is determined to be complete, then the control routine continues to step 948.
[158] In step 948, the control routine determines whether this is the last segment of the treatment plan. If at step 948 it is determined that this is not the last segment of the treatment plan, then the control routine returns to step 932. However, if at step 948 it is determined that this is the last step of the treatment plan, then the control routine then returns to step 950. In step 950, the control routine displays the "treatment complete" screen with the example shown in FIG. 68 and continues to step 952, and continues to step 952 after the user presses the "OK" button on the test screen. At step 952, the control routine displays the “battery recharging method” screen, an example of which is shown in FIG. 41, and continues to step 953. At step 953, the control routine returns control of the device to the control routine that called the minimal treatment option control routine of FIG. 39.
[159] While the exemplary embodiment described above has four independent channels, it will be understood that an electronic medical device can have any number of channels, which still fall within the scope of the present invention.
[160] One advantage of electronic medical devices is that they can be programmed to accept various waveforms and display feedback and control information. The various waveforms can be used aberrationally with each other according to the needs of the patient as determined by the physician. Therefore, a plurality of waveforms can be integrated together. The device guides the physician through a question to determine the location of the pad with the proposed electrical stimulation protocol. The device maintains system settings and records of patient use and progress.
[161] Another feature of the preferred embodiment is shown in FIG. 151, which takes advantage of the flexibility of an electronic medical device. Below about 1,000 Hz, the intensity increases with increasing frequency. However, above 1,000 Hz, as the frequency increases, the sensation decreases, so the stimulus threshold increases. Therefore, above 1,000 Hz, greater intensity (amplitude) is needed to generate an action potential at the target treatment site. Lowering the intensity or increasing the frequency puts the user below the stimulus threshold and creates a relaxation time for muscle stimulation.
[162] As shown in FIG. 151, a diagonal therapeutic stimulus is provided that modulates frequency and amplitude to generate an action potential period, a stimulus period, and a non-irritant / relaxation period.
[163] The second waveform treatment shown in FIGS. 152 and 153 is called R-wave stimulation. For R-wave treatment, the stimulation period or "on" time is characterized by the period of electrical activity that generates an action potential, and the "off" or relaxation time is the subthreshold stimulation period that does not generate an action potential. In order to normalize metabolic activity, the relaxation time is a low level subthreshold electrical activity time.
[164] At least two stimulus steps are provided for the R-wave stimulation, both being a muscle stimulus step and an interference step. The first step, or “on” time muscle stimulation step, shown in FIG. 152, utilizes parameter settings that allow action potentials to be generated in nerves or muscles. The second stage or " off " time stimulus interference stage, shown in FIG. 153, uses a parameter setpoint that prevents action potentials from occurring. The second step generates a sinusoidal waveform, which modulates frequency and amplitude to generate an inactive potential period (relaxation step). These modulated output frequencies are spaced from one thousand to several thousand Hz with modulation frequencies from 0 to several hundred Hz.
[165] The first stage parameter setpoint is in the range of 0-1,000 Hz (pulses per second), and the second stage preferably has a parameter setpoint comprising a frequency between 1,000 and 100,000 Hz. The stimulus level in the second stage is set lower than necessary to cause the action potential to occur. “Normalizing” currents at higher frequencies have an effect that is considered essentially biochemistry as it triggers a selective mechanism of activity.
[166] Therefore, the electronic therapy device combines muscle stimulation with interference in the same treatment by using a relaxation period to provide an interference stimulus. After the muscle stimulation contraction period has ended slowly, a short period of dead time may be provided before the start of the interference stimulus. Interference stimulation proceeds during the relaxation time. Following the end of the relaxation time, another delay time interval may be followed before the next muscle stimulus contraction period. The muscle stimulation is preferably extended for about 40 minutes, and the time interval between the muscle stimulation and the interference is about 0.5 seconds, for example, can be adjusted between about 0.2 to 2.0 seconds on the interval selection screen as shown in FIG.
[167] This two-step operation of the electronic therapy device is particularly useful for pain-causing muscle rehabilitation and bone growth. Electronic therapy devices can be used for autonomous use at home or for educational, rehabilitation and other therapeutic purposes in a hospital setting for treatment tailored to the patient.
[168] Muscle stimulation screens (eg, FIGS. 45 and 49) can be used to start, continue, and stop. Since the two pad mode can be braked, the " adjust " button in FIG. 126 is obsolete. In addition, amplitude modulation is also useless. The relaxation time can be changed to the message time (FIG. 125) to distinguish the two stage operations, and only to invoke the normal mode of FIG.
[169] Another embodiment of the present invention is shown in FIG. 154, where a multifunctional portable electronic medical device is used to treat bone growth and osteoporosis. The device can be used, for example, to promote bone growth and osteoporosis treatment in the presence of nonunion in the long bone after spinal fusion surgery.
[170] 154 shows interference currents having an alternating current of fundamental intermediate frequency between about 1,000 and 20,000 Hz applied to the third spine of the patient. The first set of electrode pads 1512, 1524 is connected to a first channel of the electronic medical device 10 to apply a first signal 1510 to the patient. The second set of electrode pads 1522, 1524 is connected to a second channel of the electronic medical device 10 to impart a second signal 1520 to the patient. These electrode pads 1512, 1514, 1522, and 1524 have the interfering current in the third spine forming an intersecting pattern at the treatment target site.
[171] The beat frequency is generated at the point where the currents of the first signal 1510 and the second signal 1520 overlap each other. The beat frequency is additional as the difference between the frequencies of the first signal 1510 and the second signal 1520 and has an amplitude greater than any of these signals alone. The amplitudes of the signals 1510 and 1520 can be modulated to widen the target stimulus area. The present invention can achieve improved directional control and penetration depth for bone growth by using interference currents.
[172] 155 is a diagram of current strength. The modulation depth can vary from 0% to 100% depending on the direction of the current. If the two circuits cross 90 degrees, the resulting maximum amplitude and deepest modulation level are in the middle between the two circuits. As shown, the first electrode circuit has a frequency of X (eg, 5,100 Hz) and the second circuit has a frequency of Y (eg, 5,000 Hz). The first circuit and the second circuit intersect each other 90 degrees. The maximum amplitude and the deepest modulation level are at line A, which is intermediate in the 45 degree diagonal direction between the two circuits. Thus, line A represents the purest beat frequency (100 Hz in this example) and is the preferred point for the spinal cord placement of the user. As the distance changes from the midpoint, the resulting frequency drops in amplitude and purity, as shown in line B of FIG. 155.
[173] The arrangement of electrode pads shown in FIG. 154 can achieve high depth of penetration. In addition, the pads can be positioned as shown in FIG. 156 to obtain a shallower penetration depth and a shallower current pattern. The location of the electrode pads and the required depth of penetration depend on the treatment to be achieved, the results obtained beforehand, and the physician's diagnosis.
[174] Another arrangement of the electrodes is shown in FIG. 157, which illustrates the effective magnetic pole area resulting from the intersection of separate circuits. Union of the plurality of spinal cord segments can be treated according to the position of the electrode and the selected amplitude modulation. The cross shaded pattern represents the resulting beat frequency and may span multiple spinal cord segments as shown.
[175] Thus, the number of vertebral segments stimulated is controlled by the direction and position of the electrode. The area to be stimulated can be increased or decreased by changing the amplitude of each circuit. The amplitude can be modulated in each circuit to increase or decrease the target magnetic pole area. This type of current (ie interference current) provides improved direction control and penetration depth over conventional stimulation devices.
[176] Electrical stimulation is preferably used with biological agents for bone growth to further enhance the treatment of bone. Any suitable biological agent can be used together, with growth factors, bone forming proteins, hyaluronic acid, hydroxyapatite, autologous bone grafts, human allogeneic bone and demineralized bone matrix. Examples of suitable biological agents are described, for example, in US Pat. Nos. 6,034,062, 5,948,428, 5,942,499, 5,916,870, and 5,604,204.
[177] In a preferred embodiment, an electrode pad is used that applies an electrical signal directly to the skin of the patient. However, any suitable signal application device may be used, such as a non-surface mounted device that applies an electromagnetic signal to a patient.
[178] According to a preferred embodiment, each signal 1510, 1520 has a frequency of about 1,000 to 2,000 Hz and an amplitude of 0 to 100 mA. The frequency of each signal 1510, 1520 is selected within the range of about 250 Hz from each other, so the beat frequency is modulated between about 0 to 250 Hz and 1-100 mA. The depth of the interference signals is increased by increasing the carrier frequency of these signals. The direction of the interfering signal moves towards a signal with a lower amplitude.
[3] In order to provide even more cost effective results, the present invention achieves the desired medical results with medical equipment that can be used in the patient's home. When patients use the present invention in their homes, in addition to the cost advantages of providing such care in an outpatient facility, it is also convenient for the patient because they do not have to go to an outpatient facility, and the patient is at their convenience. They can then start their own unsupervised treatment.
[4] The present invention greatly extends the conditions of patients who can be treated in clinics and homes with electronic medical devices. The present invention provides the ability to apply any form of electronic medical treatment. For example, one exemplary embodiment of a multifunctional electronic medical device according to the present invention is programmed to apply pulsed muscle stimulation treatment as well as interference current stimulation and high voltage muscle stimulation. The multifunctional portable electronic medical device of the present invention provides the ability to treat painful muscle conditions with the ability to provide interference current stimulation. The multifunctional portable electronic medical device according to the present invention may be programmed to apply many other forms of electronic medical therapy such as NEMS, TENS, microcurrent, high voltage, constant voltage or pulse width.
[5] The multifunctional electronic medical device of the present invention is easy to use and safe. Further, embodiments of the multifunctional portable electronic medical device according to the present invention may also incorporate a monitor system for capturing and storing information about the use of the device by the patient. By obtaining such usage data, the physician / health care provider who developed and / or prescribes the patient's treatment can confirm that the patient is actually receiving the desired treatment and evaluate the patient's progress. In addition, the guarantor of the cost of treatment can confirm that the patient is actually being treated. Such monitors include all Class II devices as defined in the Food and Drug Administration's Manual, "Classification Names for Medical Devices and In Vitro Diagnostic Products." This is important in connection with portable electronic medical devices, for example as defined in 21 CFR890.5850. The Class II devices are controlled and require prescription by a physician, but do not require high supervision. Therefore, such devices are used personally without any supervision when in use by the patient to whom these devices are prescribed.
[6] Another embodiment of the multifunction portable electronic medical device according to the present invention provides any removable data storage card secured on a guide rail in the multifunction portable electronic medical device, wherein the guide rail includes a removable data storage card. Prevents incorrect insertion into portable electronic medical devices. These guide rails also function to removably secure the data storage card in the correct spot in the portable electronic medical device. In addition, the pins on the pad cable used with the electronic medical device as a safety feature are designed to be large in diameter and cannot fit into a typical home 110 volt. In addition, battery charger cable pins are designed to fit only into battery charger jacks, not channel jacks, which can damage portable electronic medical devices.
[7] Another embodiment of the multifunctional portable electronic medical device according to the present invention takes appropriate measures after determining which of the connections between the pad, the cable and the stimulation device is a failure. The multifunctional portable electronic medical device according to the present invention may be designed such that the channel output level can only be changed in small increments, so that if the button is kept pressed during the treatment, the muscle contraction does not rapidly increase or decrease in the user. To ensure.
[8] Another safety device of an embodiment of a multifunctional portable electronic medical device according to the present invention is to monitor a battery charger such that none of the channels of the portable electronic medical device can provide output to the cable and pad during battery recharge, portable electronic medical Continuously monitoring the frequency and width of the waveform output by the device and taking appropriate measures when the waveform changes from the desired pattern; monitoring the liquid crystal display of the portable electronic medical device and not operating the display properly. Taking the necessary measures and continually monitoring the battery voltage of the portable electronic medical device and taking appropriate action if the amount of voltage supplied to the microprocessor is incorrect.
[9] An exemplary embodiment of the multifunction portable electronic medical device according to the present invention includes an interactive liquid crystal display device (hereinafter, "LCD"). The LCD includes a touch screen so that the user can communicate with and control the device through the screen. The LCD may display to the user buttons that indicate where on the touch screen the user will touch to enter a command. The LCD is also large enough to convey a large amount of information to guide the user of the device. For example, the LCD is large enough to display a diagram that clearly tells the user how to connect the pad to the user's body for treatment.
[10] An exemplary embodiment of a multifunctional portable electronic medical device according to the present invention uses a software based system to provide a plurality of therapeutic capabilities. This device is a finitestate machine that provides specific therapies based on the condition of the device. Each condition has an associated module that controls the device to manage the appropriate treatment.
[11] In another embodiment of the present invention, two types of electrical signals are applied to the target region. Each electrical signal is formed by two sets of electrode pads and arranged to form a beat frequency at the point where these signals cross each other. The beat frequency is the difference between the frequencies of the two signals and is added and has a larger amplitude than any of these signals alone. The depth of the interfering signals is increased by increasing the carrier frequency of these signals. The direction of the interfering signal moves towards a signal of lower amplitude. Electrical stimulation is used in conjunction with biological agents to further improve bone growth.
[12] The present invention, together with the foregoing and other features of the invention, which may become apparent later, will be more clearly understood by reference to the following detailed description of the exemplary embodiments, the claims and the accompanying drawings.
[179] The electronic therapy device of the present invention can be used autonomously at home or in a hospital setting. The device provides treatment tailored to patients for educational, rehabilitation and other clinical purposes.
[180] While the invention has been described in conjunction with the specific embodiments outlined above, many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the above-described exemplary embodiments are not limited to the examples. Many changes may be made within the spirit and scope of the invention.

权利要求:
Claims (23)
[1" claim-type="Currently amended] A portable electronic medical device for promoting bone growth,
A first set of electrode pads for applying a first electrical signal of a first frequency and amplitude to a target site comprising a plurality of spinal cord segments;
A second set of electrode pads for applying a second electrical signal of a second frequency and amplitude to the target site,
And the first electrical signal and the second electrical signal form an interference signal having a beat frequency and further comprise a biological agent to be applied to the target site to promote bone growth.
[2" claim-type="Currently amended] The method of claim 1, wherein the beat frequency is,
And a difference between the first frequency and the second frequency.
[3" claim-type="Currently amended] The method of claim 1, wherein the amplitude of the interference signal,
And the first amplitude and the second amplitude are added together.
[4" claim-type="Currently amended] The portable electronic medical device of claim 1, wherein the biological agent is hyaluronic acid.
[5" claim-type="Currently amended] The portable electronic medical device of claim 1, wherein the biological agent is a bone forming protein.
[6" claim-type="Currently amended] The portable electronic medical device according to claim 1, wherein the direction of the interference signal is controlled by controlling one of the first amplitude and the second amplitude.
[7" claim-type="Currently amended] The portable electronic medical device of claim 6, wherein the interference signal moves toward either the first electrical signal or the second electrical signal as a separate one of the first amplitude and the second amplitude is decreased. .
[8" claim-type="Currently amended] The portable electronic medical device of claim 1, wherein a depth at which the interference signal penetrates a target site is increased by increasing one of the first frequency and the second frequency.
[9" claim-type="Currently amended] The portable electronic medical device of claim 1, wherein the first frequency and the second frequency are about 1,000 to 20,000 Hz.
[10" claim-type="Currently amended] The portable electronic medical device of claim 1, wherein the beat frequency is between 0 and 250 Hz.
[11" claim-type="Currently amended] The portable electronic medical device of claim 1 wherein the beat frequency is at an intersection of the first frequency and the second frequency.
[12" claim-type="Currently amended] A portable electronic medical device that promotes bone growth,
A portable electronic medical device, comprising: a signal applying device for applying an electrical signal to a target site including a plurality of spinal segments; and a biological agent applied to the target site to promote bone growth.
[13" claim-type="Currently amended] 13. The portable electronic medical device according to claim 12, wherein the signal application device comprises a set of electrode pads.
[14" claim-type="Currently amended] 13. The portable electronic medical device according to claim 12, wherein the signal applying device applies an electrical signal directly to the skin of the patient.
[15" claim-type="Currently amended] 13. The portable electronic medical device according to claim 12, wherein the biological agent comprises hyaluronic acid.
[16" claim-type="Currently amended] 13. The portable electronic medical device according to claim 12, wherein the biological agent is a bone forming protein.
[17" claim-type="Currently amended] 13. The portable electronic medical device of claim 12, wherein the electrical signal comprises an interfering electrical signal.
[18" claim-type="Currently amended] 13. The portable electronic medical device according to claim 12, wherein the interfering signal has a beat frequency of 0-250 Hz.
[19" claim-type="Currently amended] As a method of promoting bone growth stimulation,
Applying an electrical signal to a target site comprising a plurality of vertebral segments, and applying a biological agent to the target site.
[20" claim-type="Currently amended] 20. The method of claim 19, wherein said electrical signal is applied by crossing two electrical signals at a target site.
[21" claim-type="Currently amended] 20. The method of claim 19, wherein said biological agent comprises hyaluronic acid.
[22" claim-type="Currently amended] 20. The method of claim 19, wherein said biological agent comprises a bone growth protein.
[23" claim-type="Currently amended] 20. The method of claim 19, wherein said electrical signal comprises an interfering electrical signal.

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US20020016616A1|2002-02-07|

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WO2003008038A1|2003-01-30|

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AU2002318292A2|2003-03-03|

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JP2004537355A|2004-12-16|

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EP1406694A4|2005-09-21|

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EP1406694B1|2008-02-27|

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CA2451104A1|2003-01-30|

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ES2305263T3|2008-11-01|

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EP1406694A1|2004-04-14|

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AU2002318292B2|2007-04-19|

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US6675048B2|2004-01-06|

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DE60225287T2|2009-01-29|

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AU2002318292B9|2007-11-15|

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CA2451104C|2013-10-01|

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AT387241T|2008-03-15|

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JP4176012B2|2008-11-05|

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HK1065266A1|2008-08-01|

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DE60225287D1|2008-04-10|

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AU2002318292B8|2007-05-17|

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WO2003008038A9|2004-04-15|

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KR100856926B1|2008-09-05|

引用文献:

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公开号 | 申请日 | 公开日 | 申请人 | 专利标题

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法律状态:
2001-07-16|Priority to US09/905,159

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2001-07-16|Priority to US09/905,159

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2002-07-12|Application filed by 인터내셔널 리허빌리테이티브 사이언시즈, 아이엔씨.

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2002-07-12|Priority to PCT/US2002/021824

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2004-04-17|Publication of KR20040032817A

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2008-09-05|Application granted

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2008-09-05|Publication of KR100856926B1

优先权:

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申请号 | 申请日 | 专利标题

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US09/905,159|2001-07-16|

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US09/905,159|US6675048B2|2000-05-08|2001-07-16|Electro-medical device for use with biologics|

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PCT/US2002/021824|WO2003008038A1|2001-07-16|2002-07-12|Electro-medical device for use with biologics|