KR20020089481A - Electrical stimulation apparatus and method - Google Patents

Abstract

The present invention relates to an electrical stimulation device and method for providing electrical stimulation to a tissue. The electrical stimulation device includes a base unit 12 and an electrode module 24. The base unit 12 includes a first electrical circuit and a first battery for supplying electrical energy to the electrical circuit and is configured to be portable. The second electrical circuit and the second battery provide a time / date function. The base unit 12 supports an LCD that provides a visual indication of the various functions of the electrical stimulation device. The electrode module is programmable to enable the prescribing physician to set a treatment protocol for the electrical stimulation device.

Description

ELECTRICAL STIMULATION APPARATUS AND METHOD

Various skin injuries resulting from acne and herpes viruses are known to be treatable through the use of electrical stimulation. Many theories have emerged to explain this phenomenon, but there has been no satisfactory explanation as a theoretical basis for why such skin diseases can be successfully treated using electrical stimulation. Despite no explanation, various devices have been developed for delivering electrical stimulation to tissues. For example, US Pat. No. 5,117,826 discloses a device for combined nerve fibers and body stimulation, while US Pat. No. 5,133,352 discloses a method for treating herpes simplex. U.S. Patent No. 4,922,906 discloses a small size low frequency treatment device. U.S. Patent 5,107,835 discloses a therapeutic device for electrotherapy. U.S. Patent 4,913,148 discloses the treatment of herpes simplex as well as herpes simplex I, II. U.S. Patent 5,133,351 discloses a low frequency electrotherapy device.

Each of these devices is derived from the search for a device that can be used for various therapeutic purposes as disclosed in the description of the device and its use. It is clear from the foregoing that it would be beneficial if the electrical stimulation was properly applied to the site requiring treatment. Suitable applications include, for example, predetermining the appropriate voltage, waveform, current, duration of application, etc. of the electrical stimulation. Clearly, each application requires that each of the aforementioned elements of the electrical stimulation be tailored to meet specific requirements for each patient.

In view of the foregoing, it would be an advance in the art to provide pre-programmable electrical stimulation devices and methods to provide each patient with an appropriate electrical stimulation as a function of the disease of the patient to be treated. Providing replaceable electrode modules for the electrical stimulation device will also make advances in the art. It would also be further advances in the art to provide logic circuits for electrode modules to pre-program the electrode modules with predetermined operating parameters for the electrical stimulation device. It would also be further advances in the art to provide electrical stimulation devices that provide both the patient and the treating physician the ability to monitor the treatment process using the electrical stimulation device. Such novel inventions will be described and claimed below.

The present invention relates to electrical stimulation of tissue for the treatment of selected physiological diseases, and more particularly, to an activation key that is preprogrammable to apply a predetermined treatment protocol for a particular physiological disease. Novel electrical stimulation device and method having exchangeable electrode modules acting as).

1 shows the electrical stimulation device of the present invention showing an electrode module prior to engagement with an enclosure.

FIG. 2 is a view illustrating the rear surface of the electrical stimulation apparatus of FIG. 1.

3 is a schematic diagram of a circuit of the electrical stimulation apparatus of FIGS. 1 and 2.

4 is an enlarged view of the LCD screen shown in FIG. 1 showing all the display features of the novel electrical stimulation device.

5 is a display of the LCD screen of FIG. 4 prior to insertion of the electrode module.

6 is a display of an LCD screen prior to initiation of a treatment protocol.

7 is a display of an LCD screen showing the remaining time of treatment cycles during the course of treatment.

8 is a display of an LCD screen upon completion of a treatment cycle.

The present invention is a novel stimulation device and method having a portable enclosure and an replaceable electrode module. The enclosure includes a first electrical circuit and a first battery for operation of the electrical stimulation function. The second electrical circuit and the second battery provide a time / date function. A liquid crystal display (LCD) on the enclosure is coupled to the first and second electrical circuits to provide treatment timers, ON / OFF indicators, battery status indicators, number of remaining treatments available, screen prompts, treatment indicators, treatment cycle indicators. Visually displays each of the various functions of the electrical stimulation device, including a beep generator, visual bar, and time / date display. The electrode module is provided with a programmable probe control logic circuit to allow the electrical stimulation device to be selectively programmed for each particular application.

In practice, the prescribing physician prescribes the appropriate treatment protocol input to the programmable probe control logic circuit of the electrode module. The patient obtains a prescription-filled electrode module and plugs it into a portable enclosure. The preset prescription is here relayed to the first electrical circuit in the enclosure. Ultimately, the electrical stimulation device may make OTC available. Instructions for initiating the treatment protocol are visually displayed on the LCD to inform the patient of the operation of the stimulation device. Importantly, the electrode module is specifically programmed to meet the treatment requirements of each patient during the course of treatment, and as importantly, the electrode module is programmed to stop functioning upon completion of the programmed treatment cycle. The latter function encourages the patient to return to the prescribing physician for further analysis of the patient's condition, allowing the doctor to selectively change the treatment protocol programmed in the electrode module to treat the patient more appropriately. Therefore, the main object of the present invention is to improve the electrical stimulation device.

Another object of the present invention is to improve the method of delivering electrical stimulation.

Another object of the present invention is to provide an electrical stimulation device having a replaceable electrode module.

It is a further object of the present invention to provide a programmable logic circuit in the electrode module.

It is another object of the present invention to provide an LCD on the electrical stimulation device as a source of information about the electrical stimulation device.

Another object of the present invention is to provide the prescribing physician the ability to more closely monitor the use of an electrical stimulation device by a patient.

These and other features of the present invention will become more apparent from the detailed description given in the accompanying drawings and preferred embodiments of the invention.

The invention will be better understood from the following description and the appended claims, taken in conjunction with the drawings, wherein like reference numerals designate like parts.

The electrical stimulation devices and methods herein are designed to provide the prescribing physician the ability to select a specific treatment protocol for a particular disease to be treated using the electrical stimulation. The electrical stimulation device may be provided as a single unit or as a device of two components of a base unit and an electrode module. The latter configuration is preferred for several reasons. The electrode module is disposable for refilling the prescription with another electrode module if hygienic reasons as well as additional treatment are required. This procedure allows the doctor to more closely monitor the patient's use of the electrical stimulation device and allow the doctor to change the prescription as the treatment progresses.

The electrode module is provided with logic circuitry that allows the electrode module to be pre-programmed with instructions for specific treatment parameters. These parameters include dosage (milliampere and microvolt), current profile (normal or pulsed current), waveform, and number of treatments and duration of treatment. Once the prescribed number of treatments have been delivered by the logic circuit, the electrode module is programmed to stop working, so the patient needs to obtain a replacement electrode module that is only available by prescription. By adopting this procedure, the number of patients sharing electrical stimulation devices can be reduced, reducing cross-infection between patients by infected electrodes, as well as allowing doctors to monitor the patient's treatment more closely. Due to the programmability of the electrode module, the physician can selectively prescribe different treatment parameters for the electrical stimulation device as a treatment course for the treatment of acne, herpes injury, wrist joint compression syndrome, psoriasis and the like.

The base unit includes a first battery that provides the ability to manage current dosages for therapeutic functions. The second battery provides electrical energy to the circuitry that controls all of the functions related to the LCD screen, clock, and timer. LCD screen includes clock / alarm, ON / OFF notification, “insert key” notification, battery level indicator, alphanumeric residual dose indicator, current power HI / M / LO meter, “push ACT to Start” notification, dosage Multiple messages can be displayed, such as a blinking circle, a dose bar, and a time / date display indicating delivery.

In operation, pressing the ON / OFF key to turn on the electrical stimulation device activates the system. If the electrode module is not electrically coupled to the base unit, the LCD screen will flash the "INSET KEY" message. Once the key (electrode module) is inserted, messages indicating high, medium, or low, one of HI, M, or LO, respectively, are displayed to indicate the dosage of the dose set by the pre-programmed logic circuit in the electrode module. Mark the level. At the same time, the alphanumeric indicator will once again display the remaining number of treatments, as set by the pre-programmed electrode module. The battery symbol will be displayed to provide a visual indication of the battery status. This battery condition is for a battery that provides a current at the time of administration. If the battery charge is too low, dosing cannot be performed. The "PUSH ACT TO START" display flashes to indicate that the patient should press the ACT button. Once the ACT button is activated, a small circle flashes once every second to indicate that electrical stimulation therapy is being applied to the electrode. At the same time, the alphanumeric display, which was displaying the number of treatments available, changes to the word "GO" to indicate that the electrical stimulation device is in operation. During the treatment, the dose bars are displayed with the vertical bars in a horizontal array. Each vertical bar is then increased once per second until treatment is complete and the dose bar is filled. In addition, short beeps are produced at a rate of four times per second during treatment.

When the treatment cycle is complete, the alphanumeric indicator displays the "OK" character, the blinking circle stops blinking, the dose bar fills up and generates a long beep for one second. After a slight delay, the LCD screen will reset to the initial display.

1 and 2, the novel electrical stimulation device 10 includes an exterior 12 and an electrode module 20. The exterior part 12 is configured to be portable and has an external size comparable to a small pocket calculator, so that the electrical stimulation device 10 is easily portable and readily available whenever needed. Exterior 12 includes LCD 40, ON / OFF switch 42, ACT switch 46, and SET switch 46, the respective functions of which will be described later. The enclosure 12 also includes battery covers 48 and 49 (FIG. 2), each of which allows access to the respective batteries 58 and 66 (FIG. 3) embedded in the enclosure 12. FIG. It is removable.

The electrode module 20 includes a body portion 22 having a base 24 on one side and extending further to form a twin pyramid formed of a first peak 26 and a second peak 27. do. The first peak 26 serves as a support for the first electrode 28, while the second peak 27 serves as a support for the second electrode 29. The first connector 30 extends outward from the base 24 and engages with the second connector 31 (FIG. 2) to serve as an electrical connector for electrically coupling the electrode module 20 to the enclosure 12. do. The partial rim 32 prevents the plurality of connecting pins constituting the first connector 30 from being damaged and provides a reliable mechanism for the electrode module 20 to be engaged in the correct direction with the exterior 12. .

Referring to FIG. 3, a schematic diagram of an electronic circuit of the electrical stimulation device 10 (FIGS. 1 and 2) is shown as a circuit 50, which includes an electronic module circuit 52 and a base circuit 54. The electronic module circuit 52 is mounted in the electrode module 20 (FIGS. 1 and 2) and is electrically coupled with the base circuit 54. The base circuit 54 is mounted in the exterior portion 12 by an electrical contact portion formed between the first connector 30 and the second connector 31. The electronic module circuit 52 consists of a probe control logic circuit 56 electrically coupled to the electrodes 28 and 29. The probe control logic circuit 56 provides the instructions necessary for the operation of the base circuit 54. In particular, the probe control logic circuit 56 is optionally pre-programmed with features such as the type, duration, and number of available treatments of a particular electrode module 20 along with the specific type of electrical stimulation. This feature gives the prescribing physician the ability to closely monitor a particular patient's treatment program. Control over the number of available treatments significantly reduces the likelihood of cross-infection between patients caused by sharing the electrical stimulation device 10, which limits the number of treatments for each prescription pre-programmed in the electrode module 20. Because only is available. The limited number of treatments available provides the prescribing physician the ability to monitor the treatment process more closely by having the patient return to the prescribing doctor regularly, and advantageously, the treatment protocol contained within the memory of the probe control logic circuit 56. Can be changed.

Base circuit 54 includes battery 58, main control logic circuit 60, and current regulator 62. The current regulator 62 and the main control logic circuit 60 provide preset electrical stimuli to the electrodes 28 and 29 as preset in the memory of the probe control logic circuit 56. The second battery 66 drives the LCD driver 64 and the clock circuit 68 to provide a continuous time and date display on the LCD screen 40. The LCD driver 64 provides the necessary electronic processing for providing the predetermined information displayed on the LCD screen 40 as described in detail below.

Referring now to FIG. 4, an LCD screen 40 is shown with all possible displays on its surface. These displays include a horn icon 70; Battery symbol 72; Alphanumeric display 74; INSERT KEY prompt 76; Dosing power indicators 78 such as “Hi”, “M”, “Lo” to indicate high, medium, and low power; PUSH ACT TO START prompt 80; Pulse circle 82; Dose bar 84; And time and date display 86. Each of these features will be described in more detail below with respect to the description of the functions shown in FIGS. 5-8. The time and date display 86 always operates regardless of the state of the electrical stimulation device 10 (FIGS. 1 and 2) and whether or not the electrode module 20 is mounted to the exterior 12. FIG.

Referring now to FIG. 5, an LCD screen 40 is shown upon initial drive of the ON / OFF key 42 (FIG. 1). In this step the battery symbol 72 is displayed with an INSERT KEY prompt 76 instructing the user to electrically couple the electrode module 20 to the enclosure 12. This display is displayed on the LCD screen 40 only occurs when the electrode module 20 is electrically disconnected from the exterior 12 or the ON / OFF switch 42 is driven to the ON position. Otherwise, if the electrode module 20 is coupled to the exterior 12, the LCD screen 40 displays only the time and date when the ON / OFF switch is in the OFF position.

Referring now to FIG. 6, an LCD screen 40 in which the electrode module 20 is electrically coupled to the enclosure 20 and the ON / OFF switch is in the ON position prior to commencement of the treatment process by the electrical stimulation device 10. Display configuration is shown. In particular, as pre-programmed in the probe control logic circuit 52 (FIG. 3), a battery symbol is being displayed to show the state of the battery 58 while the dose power indicator is displayed to indicate the intermediate dose power. (78) is displaying the symbol 'M'. The alphanumeric display 74 displays the number 30, indicating that 30 residual doses are available for the electrical stimulation device 10. This indication is indicated by the presence of REMAINS reminder 75. The PUSH ACT TO START prompt 80 is displayed to alert the user to the next step of the treatment procedure and the pulse circle 82 is displayed as a solid display.

Referring to FIG. 7, the LCD screen 40 is shown immediately after driving the ACT button 44. Here, the pulse circle 82 starts flashing at 1 second intervals or the contrast crosses while the alphanumeric display 74 displays "GO". At the same time, the dose bar 84 begins to fill gradually as the plurality of vertical bars progress from left to right. Each vertical bar represents one second of time in the treatment protocol.

Referring to FIG. 8, the LCD screen 40 is shown immediately after completion of the treatment cycle. Here, the alphanumeric display 74 displays OK to indicate successful completion of the particular treatment cycle using the electrical stimulation device 10. In addition, the pulse circle 8 is a continuous solid color circle and the dose bar 84 completes with a plurality of vertical bars. This display is maintained for a few seconds and an audible sound is emitted as visually indicated by the horn icon 70. After the elapse of the predetermined time, the LCD screen returns to the blank screen except for the time and date display 86.

Way

In practicing the method of the present invention using the electrical stimulation device 10, the prescribing physician provides a prescription to the patient so that the patient can obtain the electrical stimulation device 10. The probe control logic circuit 56 in the electrode module 20 here has all predetermined operating parameters for the pre-programmed electrical stimulation device 10 as prescribed by the physician. These parameters include, for example, the number of treatments, duration, and frequency prescribed, and the electrical characteristics of the electrical stimulation, such as voltage, current, waveform, amplitude, frequency, and the like. Each of these parameters is preset by the prescribing physician to meet specific requirements for treating diagnosed physiological diseases such as acne, herpes simplex, carpal tunnel syndrome, eczema, psoriasis, dermatitis. Advantageously, the probe control logic circuit 50 is selectively programmable to provide the electrode module 20 with specific operating instructions for properly controlling the main control logic circuit 60. Furthermore, since the electrode module 20 is pre-programmed for the treatment of a particular disease of a particular patient, the likelihood that the patient will share the electrical stimulation device 10 with another patient is significantly reduced, thereby preventing cross-infection between the patients. Significantly reduced.

After obtaining the electrical stimulation device 10 having the electrode module 20 and properly programming the probe control logic circuit 56, the patient drives the ON / OFF switch 42. The appropriate prompt is then displayed on the LCD 40. For example, if the electrode module 20 is not electrically coupled to the enclosure 12, more specifically to the base circuit 54, the screen prompt on the LCD 40 may be as shown in FIG. 5. As prompt 76 will display the word "INSERT KEY". Correctly coupling the electrode module 20 to the enclosure 12 changes the LCD screen 40 to a display as shown in FIG. In particular, the alphanumeric display 74 displays "30" indicating that 30 residual treatments remain in the configuration of the electrode module 20 of this example, as shown by the prompt 75 with the word "REMAINS". do. The prompt 80 instructs the patient to press the ACT switch 44 to drive the electrical stimulation device 10. The patient places the electrodes 28 and 29 at the specific site and presses the ACT switch 44 in such a way as to wrap the specific site to be treated with the electrodes 28 and 29. The alphanumeric display 74, which was displaying the number of treatments, changes to the word “GO” and the dose bar 84 begins to fill sequentially with the plurality of vertical bars while the dose indicator 82 is blinking. Each line of dose bar 81 represents an electrical impulse delivered to electrodes 28 and 29 as one electrical impulse with predetermined parameters as described above. Upon completion of the treatment cycle, the dose bar 84 fills horizontally, the dose indicator 82 stops flashing and becomes a solid circle, the alphanumeric display shows the word “OK” and the horn icon 70 Sound is emitted by). The patient then returns the electrical stimulation device 10 to the storage position until the next treatment commences. If desired, the electrode module 20 may be removed from the enclosure 12, but this step would be unnecessary if additional treatment is available therein as determined by programming of the probe logic control circuit 52. The SET switch 46 properly controls the clock circuit 68 to allow the patient to set the time and date display 76.

The invention may be embodied in other specific forms without departing from its spirit and essential features. The described embodiments are to be considered for the purpose of description and not of limitation. Accordingly, the scope of the invention is limited not by the foregoing description but by the appended claims. All modifications included within the scope of the claims are included in the present invention.

Claims (19)

In the electrical stimulation device: An exterior part; Display means on the enclosure for visually displaying the selected information; A first electrical circuit in said enclosure for providing a preselected amount of first electrical energy for said electrical stimulation; A first battery electrically coupled to the first electrical circuit; A second electrical circuit for providing second electrical energy for operating the display means, and a second battery electrically coupled to the second electrical circuit; And An electrode module configured to be selectively coupled to the enclosure and making an electrical connection with the electrical circuit; The electrode module includes a key for driving the first electrical circuit, the key including a probe control logic circuit for providing instructions to the first electrical circuit. The electrical stimulation device of claim 1, wherein the probe control logic circuit comprises pre-programming means for pre-programming the probe control logic circuit with a preselected treatment protocol for the first electrical circuit. The electrical stimulation device of claim 2, wherein the key is configured as a disposable element such that the key can be discarded upon completion of the preselected treatment protocol. The electrical stimulation device according to claim 2, wherein the display means comprises prompt means for prompting a user of the electrical stimulation device to follow the preselected treatment protocol. The electrical stimulation apparatus according to claim 2, wherein the display means comprises treatment status display means for displaying the status of treatment applied by the electrical stimulation apparatus. The electrical stimulation apparatus according to claim 1, wherein the display means comprises battery status display means for displaying the status of the first battery. A device that allows a prescribing physician to selectively direct a predetermined electrical stimulation prescription to a patient's tissue: An exterior configured to be portable; A first electrical circuit in the enclosure; A first battery in the enclosure, operable to deliver electrical energy to the first electrical circuit; An electrode module detachably mounted to the exterior part; A second electrical circuit in the electrode module electrically coupled to the first electrical circuit when the electrode module is mounted to the enclosure; Electrodes on the electrode module extending outwardly from the electrode module to be in contact with the tissue of the patient, the electrodes being electrically connected with the second electrical circuit; And And programming means in said second electrical circuit for enabling said prescribing physician to selectively program said electrode module with a predetermined electrical stimulation prescription for said patient's tissue. 8. The apparatus of claim 7, wherein the enclosure includes display means for displaying information about the predetermined electrical stimulation prescription. 8. The apparatus of claim 7, wherein the displayed information includes the number of treatments in the predetermined prescription remaining in the electrode module. 8. The apparatus of claim 7, wherein the displayed information includes instructions for the patient for killing the electrical stimulation. 8. The apparatus of claim 7, wherein the displayed information includes a state of the first electrical circuit. 8. The apparatus of claim 7, wherein the display means comprises alarm means for reminding the user to use the electrical stimulation device. 8. The apparatus of claim 7, wherein the display means comprises means for displaying an error when the first electrical circuit is driven in the absence of the electrode module. A method for providing electrical stimulation to a tissue, Preparing a first electrical circuit operable to apply the electrical stimulus; Connecting a first battery to said first electrical circuit; Surrounding the first electrical circuit and the first battery with an exterior; Providing an electrode module for applying said electrical stimulation from said first electrical circuit to said tissue; The electrode module is selectively mountable to the enclosure, the pre-programmable means for programming the first electrical circuit when the electrode module is mounted to the enclosure and electrically connected to the first electrical circuit. Including, method. The method of claim 14, wherein said providing comprises selectively programming said pre-programmable means with a predetermined treatment protocol for a patient. The method of claim 15, wherein the selectively programming comprises modifying the treatment protocol for the patient by reprogramming the pre-programmable means. The method of claim 14, wherein the step of enclosing comprises providing a visual display on the enclosure for displaying information about the electrical stimulation. A method for providing a preselected electrical stimulation to a tissue of a patient, the method comprising: Preparing a first electrical circuit comprising a first battery; Surrounding the first electrical circuit with a sheath configured to be portable; Assembling a second electrical circuit comprising programming means for programming itself; Disposing the second electrical circuit in an electrode module; Mounting a pair of electrodes to the electrode module in electrical communication with the second electrical circuit; Programming said programming means in said second electrical circuit with a predetermined treatment protocol for said preselected electrical stimulation; Coupling the second electrical circuit with the first electrical circuit; Driving the first electrical circuit and the second electrical circuit while contacting the tissue with the electrode pair to direct the preselected electrical stimulus to the tissue. 19. The method of claim 18, wherein enclosing comprises providing display means on the enclosure, the display means displaying information about the electrical stimulus.