 transcutaneous stimulation process and system
专利摘要:
TRANSCUTANEOUS STIMULATION SYSTEM.The present invention relates to a method of treating a tailings evacuation dysfunction, which comprises administering transcutaneous electrical stimulation (TES) to at least one lower and / or sacral pelvic region for a specific treatment regimen. Also disclosed is a system for configuring a stimulation device to deliver transcutaneous electrical stimulation (TES), the system comprising: a computing device that stores or has access to a plurality or TES configurations and comprising a user interface to enable the authorized selection of at least one of the TES configurations for providing TES by the stimulation device according to at least one selected TES configuration and the stimulation device communicatively coupled to the computing device to receive and store those selected by the at least one TES configurations, the stimulation device being of a size to be readily transported in a body and configured to selectively supply current to the external electrode according to one of the TES configurations. 公开号:BR112013022151A2 申请号:R112013022151-8 申请日:2012-03-02 公开日:2020-10-20 发明作者:Bridget Rae Southwell；John Medwyn Hutson；Andre Yi Feng Tan 申请人:Murdoch Childrens Reserch Institute； IPC主号:
专利说明:
Descriptive Report of the Invention Patent for "TRANSCUTANEOUS STIMULATION SYSTEM". The described modalities generally refer to processes and systems for transcutaneous stimulation; More particularly, processes, systems and apparatus for transcutaneous stimulation in one or more of the lumbar, abdominal, lower pelvic and sacral regions are described to treat one or more disorders associated with a body's ability to evacuate waste. BACKGROUND Reference to any prior technique in this specification is not and should not be regarded as, an acknowledgment or any form of suggestion that this prior technique is part of the common general knowledge in any country. Reference in this descriptive report to any previous publication (or information derived therefrom) or to any matter that is known, is not and should not be considered as, an acknowledgment or admission of any form of suggestion that that previous technical publication (or information derived therefrom) or that any known matter is part of the common general knowledge in the field of effort to which this specification refers. The bibliographic details of the publications cited by the author in this specification are collected alphabetically at the end of the specification. The dysfunction of waste disposal can take many forms. For example, urinary incontinence, intestinal incontinence or constipation can occur. There are treatment systems for treating constipation by providing electrical stimulation through electrodes implanted subcutaneously positioned around the lower intestine. The electrical stimulation provided by the use of such electrodes can be used to sequentially activate the muscle fibers around the intestine to force a peristaltic action to occur. However, such treatment systems are undesirably invasive. In addition, although such systems can have an immediate effect in helping to evacuate the intestine, they do not necessarily control the cause of constipation. Fundamentally, this effect has not been described as lasting or having an effect beyond the immediate electrical stimulation time. Untreatable constipation and involuntary elimination of excrement are extremely common in the community, both in young people and the elderly, and the treatments available are generally uncomfortable, can cause distress in society for patients and are a significant sacrifice. health care system. Individuals who suffer from constipation and involuntary excrement elimination, whether young or elderly, may also have psychological problems. In addition, constipation can be a side effect of some kinds of medication, such as opiates. The most laxative therapies are designed to soften the stool or stimulate the intestine by chemicals in the lumen. Patients with chronic or untreatable constipation may have had a failure in other treatment methods including pharmaceutical treatment. Patients on therapies for other illnesses in which constipation is a side effect of medication may not be able to undergo co-administered pharmaceutical treatments for constipation. In such cases, non-invasive, non-drug based treatment methodologies may be desired. Sometimes constipation may not be related to diet or medications and may be due to low motility in the entire colon (Benninga et al., J Pediatr Gastroenterol Nutr., 23: 241-51, 1996; Hutson et al., J Pediatr Surg. , 31: 580-583, 1996). A newly identified disorder, which is known as slow transit constipation (CTS), is not uncommon among children in whom standard medical therapy fails and such children often show signs of colon dysfunction even at birth. (Shin et al., J Pediatr Surg., 37: 1762-1765, 2002). 19593855v1 Previous electrical stimulation involved non-daily stimulation (ie, 12 sessions over a period of 4 weeks) of short periods of time (ie, 20 minutes of treatment) with the use of cross-cutting devices that were developed for physical therapy treatment muscle damage (Clarke et al., J. Pediatr. Surg., 44: 408-412, 2009.) It is desirable to control or improve one or more disadvantages or inconveniences associated with existing treatment systems, methods or regimes or for at least provide a useful alternative to them. SUMMARY Apparatus, devices, methods and systems for non-invasive electrical stimulation are described here to be used specifically for the treatment of constipation and in improved treatment regimens. This treatment may have long-term advantages in some patients with continuous improvement after the treatment period by non-invasive electrical stimulation. Throughout this specification and in the claims that follow, unless the context requires otherwise, the word "understand" and variations such as "understand" and "understanding" will be understood to imply inclusion of a cited whole number or a step or a group of whole numbers or steps but not the exclusion of any other whole number or step or group of whole numbers or steps. Some modalities generally refer to treatment regimes for transcutaneous stimulation. More particularly, processes, devices, apparatus and systems are provided for the treatment of constipation or other waste evacuation dysfunction by administering transcutaneous electrical stimulation to at least one lumbar and / or abdominal region over a period of time. on a daily basis or in more than 12 sessions over a 4 week period. The electrical stimulus can alternatively or additionally be administered to a lower and / or sacral pelvic region. Reference to "more than 12 sessions" includes from approximately 19593855v1 to approximately 12 to approximately 100 sessions such as approximately 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 , 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 , 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75 , 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or 100 sessions, for example, or even more. In some modalities, treatment may involve a single treatment session every day or multiple (for example, 2 or 3) treatment sessions per day. Treatment sessions can be for periods of between approximately 10 and approximately 90 minutes or from approximately 20 and approximately 60 minutes. Other time periods include approximately 11, 12, 13, 14, 15, 16, 17, 18, 19, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88 and 89 minutes, for example. In some modalities, the daily electrical stimulus regime (or more than 12 sessions in a 4-week period) can be performed as part of a treatment plan for a longer term, in which the stimulation is performed daily or in more than 12 sessions in a period of 4 weeks during between approximately 2 weeks and 2 to 3 months. This includes periods of approximately 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 weeks, for example. The regimen may also involve repeat treatment for a longer time within periods of approximately 4 months to two years. Such longer term periods include approximately 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 months, for example. Transcutaneous electrical treatment can provide an effect over a longer term of more than 1 day, for example, up to 1 month to 1 year or more. Therefore, the treatment effect lasts beyond the immediate electrical stimulus time. 19593855v1 In some modalities, where daily treatment (or of more than 12 treatment sessions in a 4-week period) is anticipated, for ease of administration, the treatment device is such that it can be used at home without supervision of a trained professional during the daily treatment regimen (or more than 12 sessions in a period of 4 weeks). Stimulation can be performed using one to ten electrodes, for example, placed on the lower abdominal and / or lower frontal areas. The electrodes can be additionally or alternatively placed over the lower pelvic and / or sacral regions, including the buttocks or other tissue overlying or adjacent to the ilium, to excite or modulate the nerves and other tissues around the rectum, including the rectum -sigmoid. In particular embodiments, an even number of electrodes is employed in a spaced pair arrangement. Alternatively, one, three, five or more electrodes can be employed. In some embodiments, one to ten or more electrodes can be attached to an apparatus such as a belt. The fixed positioning of the electrodes on a device such as a belt can assist in positioning the electrodes to the lower frontal lumbar and / or abdominal areas and in spacing the electrodes. The electrodes used to provide the electrical stimulus can be provided on a support that can be removably attached, for example, by adhesion, to a desired area of the skin surface to facilitate proper spacing of the electrodes between them. The electrodes can be coupled to and receive a stimulation current from a stimulation device that has a small voltage, source of low current power. A stimulation device can comprise a portable handheld device, for example, which can be operated without the need to be coupled to an external power source. A stimulation device can be configured to be moved on the disposable or rechargeable battery or by another self-sufficient power phone, for example. The power source for a stimulation device can be rechargeable, for example, by coupling it 19593855v1 by means of a transformer to a main power source. A stimulation device can be configured to prevent or minimize the supply of current to the electrodes while a stimulation device is being recharged by a portable power source. A stimulation device may provide or consist of a primitive display, for example, to indicate its on / off state, whether it is in use (ie, providing stimulation signals), an increased usage time display and / or time remaining for use in a particular session. A stimulation device may be configured to prevent electrical stimulation that is provided for a period of time greater than a predetermined total for a period of one day or 24 hours or for more than a period of time greater than one predetermined period (for example, 60, 70, 80 or 90 minutes) in any other session of use. Alternatively, or in addition, the stimulation device may be configured to restrict the total amount of electrical energy supplied to stimulation electrodes during a session of use or during a particular time period. A stimulation device may be free of external mechanisms that can be operated manually, but with a button or a switch to switch on / off and a button or switch to stop / start. In some alternative embodiments, a stimulation device may have external mechanisms that can be operated, for example, to interface with a display for the device, but it may be free of any external mechanisms that can be operated manually to provide energy input for a stimulation device that changes the device's adjustment controls or the parameters according to which electrical stimulus signals are provided. In some modalities, a stimulation device is configured to operate only according to a single set of operating parameters in a given period of time. In some modes, this single set of operating parameters can be replaced 19593855v1 only by another single set of operating parameters that uses a separate electronic configuration interface, but that can be coupled in communication to a device for stimulation. For example, a device for stimulation may be provided with a pre-established set of operating parameters by a device manufacturer and this set of parameters can be subsequently modified by a therapist using authorized software to reconfigure the settings. devices for stimulation over a wired or wireless connection. In other embodiments, a stimulation device may be configurable (for example, by a trained professional using authorized software) with multiple sets of stimulation settings stored for separate use by multiple users. In this way, the user interface of a device for stimulation can be configured to be quite simple and to disallow modification of the settings by the user, to facilitate and in case of an inappropriate use of the device. However, in alternative modalities, a stimulation device may have greater user interface functionality and may allow one of two, three, fourth or more stimulation settings to be selected by a user. In some embodiments, a stimulation device may be preconfigured or configured to provide output signals to stimulation electrodes that are approximately sinusoidal in shape, with a support frequency of approximately 4 kilohertz, a modulated frequency of approximately 80 at 150 hertz and a current intensity of around 5 to around 33 milliamps. Such stimulation signals can be applied to two or four or more electrodes, for example, including two electrodes spaced across the lower frontal abdominal area and two electrodes spaced across the lumbar area, applying stimulation by left interference current. front to the right back and / or the right front to the left back. In some modalities, a stimulation frequency can be selected or configured to take into account the Mass Index 19593855v1 Body (BMI) of the patient, which can be different for a child compared to an adult and also if the patient is at normal weight, overweight, obese or underweight. Some modalities refer to a system to configure a device for stimulation for the application of a transcutaneous electrical stimulus (TES), the system comprising: a device for computing that stores or has access to a large number of TES adjustments and that comprises a user interface to allow an authorized selection of one of the TES settings for providing TES by a pacing device according to a fit and by a pacing device coupled in communication with the computing device to receive and store a selected TES setting, a stimulation device being one size to be easily loaded into a body and configured to selectively supply current to the external electrodes according to a TES setting. In some embodiments, a stimulation device can receive and store multiple TES settings selected for applying TES to multiple users. BRIEF DESCRIPTION OF THE DRAWINGS The modalities will now be described in more detail, for purposes of example, with reference to the accompanying drawings, in which: Figure 1 is a schematic diagram illustrating the use of electrical stimulus to treat an intestinal dysfunction in an kid; Figure 2 is a schematic diagram illustrating the use of electrical stimulation to treat intestinal dysfunction in an adult; Figures 3A, 3B, 3C and 3D are schematic diagrams of an example device for stimulation in different views; Figure 4 is a block diagram of a device for stimulation; Figure 5 is a schematic illustration of software controls for using a stimulation device; 19593855v1 Figure 6 is a block diagram of a system for configuring a device for stimulation; Figure 7 is a graphical representation showing before and after a daily stimulation treatment for 1 month (Rx1) and 2 months (Rx2) in 11 patients: A) Total number of defecations / week, B) Number of days with involuntary excrement elimination and C) Number of days with abdominal pain; Figure 8A is a schematic illustration showing the placement of electrodes in a lower pelvic region on a person's front side; Figure 8B is a schematic representation of placing electrodes in a sacral or lower lumbar region on the person's back; Figure 8C is a schematic plan view showing cross currents between the electrodes in the lower and sacral pelvic region or in the lumbar region; Figure 9A is a schematic illustration showing the placement of multiple frontal electrode pairs; Figure 9B is a schematic illustration showing the placement of multiple posterior electrode pairs and Figure 10 is a schematic diagram of a belt to assist the placement of single or multiple front and rear electrode pairs . DETAILED DESCRIPTION The modalities here refer in general to processes, systems, devices and treatment regimes to treat or allow the treatment of a waste elimination dysfunction, such as, for example, and without limitation, constipation , ileum, urinary incontinence or intestinal incontinence. Such modalities generally involve the application of transcutaneous electrical stimulation (TES) to an abdominal (lumbar) region in the front or back for at least one treatment session per day for consecutive days of a treatment period of at least one week. 19593855v1 TES can alternatively or additionally be applied to the lower pelvic and / or sacral regions, including the buttocks, to excite or modulate the nerves and other tissues around the rectum, including the recto-sigmoid colon. The term "waste evacuation dysfunction" or "waste disposal dysfunction" used in this case is intended to include the dysfunction associated with the processing and / or elimination functions of the body of gastrointestinal and urinary waste, whether or not the processing results in immediate evacuation or elimination of waste from the body. For example, ileum or slow transit of tailings through parts of the intestinal tract to the rectum are considered to be a dysfunction of tailings evacuation in this sense because they affect the process of eliminating the body from that tailings, even if the ileum or the slow transit of tailings = s can be accurately described as a dysfunction that precedes the actual elimination of that tailings. The treatment session can be performed multiple times a day or just once and can be performed for a period of time between approximately 10 and approximately 90 minutes for each session. In some modalities, the treatment session can be between approximately 20 minutes and approximately 60 minutes, preferably closer to 60 minutes, such as 25, 30, 35, 40, 45, 50, 55, 65 or 70 minutes or other intermediate time periods. In some modalities, daily treatments are anticipated for more than 12 sessions in a period of 4 weeks (ie, three sessions per week). For ease of administration, the treatment device is such that it can be used at home without the supervision of a trained healthcare professional during the daily treatment regimen (or more than 3 sessions per week). The treatment term of at least one week can be, for example, between approximately 2 weeks and approximately 3 months. In some modalities, the term of treatment can be between approximately 1 month and approximately 2 months. The treatment term can be repeated during a pro- 19593855v1 lasting from approximately 4 months to approximately 2 years or possibly more, to have the proper treatment program, to teach or train various muscles and / or nerves responsible for the proper function of the affected organs or tissues. Thus, the treatment period can be repeated multiple times during the longest term, with the degree of repetition depending on the physiological response to one or more initial treatment terms. The treatment may have an effect beyond the immediate electrical stimulus time period, which can last 1 day, for example, up to 1 week, 1 month up to a year or beyond the last electrical stimulus time period. In general, as illustrated in Figures 1 and 2 in relation to a child 10 or an adult 60, the electrical stimulus can be supplied to the electrodes 30 positioned on a frontal region of the abdomen 12 (on either side of the navel 11) and / or an abdominal (lumbar) region of the back 14. The electrodes 30 receive electrical stimulus signals through the conductors 32 to which they are attached and transport them to the skin surface of the child 10 or the adult 60 to which they are attached or else positioned conductively against the same. A suitable conductive gel can be used to increase the conductivity of the electrical signals from the electrodes 30 to the body through the skin. In some modalities, four electrodes 30 on the surface can be used, two electrodes 30 being positioned on any side of the navel 11 on the anterior abdominal wall below the costal margin and two electrodes 30 being positioned on the T9-10 paraspinal area to L2. It is intended with the positioning of the electrodes 30, whether four or more than four electrodes 30 are used, to stimulate the nearby colon (including at least part of the ascending colon and the transverse colon) and at least an upper part of the descending colon, which in general is correlated to the abdominal neighborhood of the navel 11. With the positioning of the electrodes 30, it is not intended to particularly affect the sigmoid colon or the distal parts of the descending or straight colon. Thus, although the 19593855v1 positioning of the electrodes 30 is applied to provide stimulation to the parts of the large intestine closest to the costal margin, it is not necessarily the entire large intestine that needs to be stimulated in this way. The lateral spacing of the positions of the navel electrode 11 can be in the vicinity of 1, 2, 5 or 8 to 20 cm, for example, thereby providing a lateral separation between the electrodes 30 of approximately 2, 4, 10 or 15 up to 40 cm. Other lateral spacing within such ranges may be used, where appropriate. The electrodes 30 can be positioned approximately at the level of the navel 11, although some small variation of locations, for example, slightly closer or also to the costal margin, can be used. The electrodes 30 positioned in the paraspinal area can be located substantially directly through the abdomen of the front electrodes 30. In some modalities, the electrodes 30 may be slightly detached from each other vertically or laterally across the pelvis and / or the abdomen. The electrodes 30 can be provided on a support 20 comprising a flexible substrate conveniently positioning the electrodes 30 at a fixed distance from each other to assist in the proper positioning of the electrodes in one or more regions 12, 14. The flexible substrate 20 can comprise adhesive substances on one or more parts of it to facilitate the removable application of electrodes 30 to the skin and the retention of electrodes 30 in a specific selected location. Each support 20 can comprise 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more electrodes 30 in specific spaced relation. Once the electrodes 30 are properly positioned, either with or without the help of a support 20, conductive wires for electrode 32 are used to couple conductors 30 to the respective channels 139a, 139b (Figure 4) of a device for stimulation 100. A stimulation device 100 and its components and aspects are described in more detail below, with reference to Figures 3A, 3B, 3C, 3D and 4. Figure 3A is a schematic plan view of the device vo 100. Figure 3B is an end view of device 100. Figure 19593855v1 3C is a view of the opposite end of the device 100. Figure 3D is a schematic perspective view of the device 100. Figure 4 is a block diagram of the device 100, showing components and a circuit housed in a housing 105 of the device 100. The stimulation device 100 is designed to be simple, portable and lightweight so that it can be worn by a user, possibly within a belt to be carried, while it provides stimulation signals to electrodes 30 while the user performs his activities no more. The portable stimulator device 100 is designed to provide therapeutic electrical stimulation to individuals who suffer from dysfunction. Device 100 applies a specified electrical signal to the patient through a set of electrodes that are placed on the skin surface of the abdomen, lower back, lower pelvis and / or sacral region. The device is designed to be as simple as possible, optionally in combination with a belt to help position the electrode (Figure 10), so that those with relatively little technological sophistication, including children and the elderly, can operate the device without clinical supervision (for example, at home) and with minimal complication. It has been discovered that devices that employ an overly sophisticated user interface are likely to be used in the wrong way, with the result that the patient may experience pain from inappropriate treatment or may not receive the therapeutic benefit. intended treatment. Some modalities of the device 100 thus provide an on / off type of user interface, allowing any selection or reconfiguration of the stimulation adjustments to be carried out by a trained clinician or therapist using external software. Device 100 may be provided with an attached software package for use by a patient or the patient's caregiver on a separate computer system 605 (Figure 6) to facilitate education and instruction for the user. In addition, a separate software may be provided for use by a clinician to allow the clinician to adjust or 19593855v1 modify the settings or functions of the device 100 to further benefit patients. Device 100 is configured to allow its internal software (firmware) to be easily updated. If more effective treatment settings are determined, device 100 can be updated via firmware so that patients can access different treatment regimens or settings. The device 100 is small enough for a small child to carry with it and the design variations may present shapes and colors that are pleasant for the child through variable and also larger plates and covers, buttons marked with Braille alphabet or other buttons tactile and / or display for users with vision or geriatric defects. Measures to provide security for the device may include short circuit protections, isolated charging circuits to prevent energy from being released from transmission lines to a user in the event of device malfunctions and safety device mechanisms. safety in conditional operation (ie the device cannot be operated if electrodes 30 and / or the conductor wires for the conductor wires for electrode 32 are not connected or not connected correctly). Device 100 may have one or more of: 1. Two independent electrical channels 139a, 139b, each of which is capable of delivering a specified current, voltage and characteristic waveform via conductive wires for electrode 32 to the electrodes 30. 2. A display 120 that includes a liquid crystal display (LCD) and / or an LED-based display or other form of display, responsible for the signals received in the display circuit 138 of the microprocessor 130 to present some or all the following information: a. Device ON / OFF status 100. b.The remaining battery life of the device 100. 19593855v1 c. START / STOP status of the electrical stimulus. d. A stopwatch to indicate the elapsed time and / or remaining stimulation for a treatment session. 3. An ON / OFF switch or a button 122 to turn device 100 on or off. 4. A START / STOP switch or a button 124 to turn the electrical stimulus signals on or off. Device 100 may comprise several communication and power supply inputs, including (but not limited to): a. Stimulator electrode sockets 112 - these allow the conductive wires of the electrode and the wires to fit into the device. As a safety device, device 100 can be configured to be non-operable unless the electrode conductor wires and electrodes are correctly fitted and connected. In some modalities, more than two (for example, fourth) sockets 112 and / or more than two (for example, four) interference current channels can be provided to be able to apply interference TES to multiple pairs front and rear electrodes. B. Direct current power supplies socket 114 to supply power to the device and internal battery 142. Power can be converted from transmission lines (110V / 240V 60 / 50Hz) to an adequate direct current voltage by a switched power source (SMPS) or other suitable electrical power converter. ç. A computer interface port 116 (Universal Serial Bus, or other standardized computer interface standardized, wired or wireless) to allow authorized users to add, modify or vary the function of the device, based on the level of authority. d. A reset button (not shown in the figure) that cannot be easily accessed, but that can be accessible, for example, through the battery compartment 140, if the device had to be reset. 19593855v1 e. An integrated speaker (not shown in the figure) to provide audible messages, beeps, alerts or other signals to visually impaired users and younger users. Device 100 can comprise a rigid enclosure 105 to house electronic parts (for example, in PCB 108) and can comprise environmental sealing to industry standards (ie, rubber gaskets over exposed connectors, rubber inside the device to prevent liquids and other foreign material from breaking the device’s casing). Device 100 may also comprise one or more accelerometers to detect and record the movement and / or orientation of device 100, thereby deducing one or more states or situations of use. In addition, device 100 may have means for detecting and recording temperature, for example, using electrodes 30, to deduce additional information regarding the use of device 100. This patient usage information can then be used to assess the patient acceptance of the treatment regimen. The Device 100 may, in some modalities, comprise selection means, such as a button or buttons, selector, touch pad or touch screen, in cooperation with the display 120, to vary the intensity of the TES current to be applied by electrodes 30. This allowable variation can be limited to within a predetermined or pre-adjusted range, for example. In some other modalities, the selection means can be used in combination with multiple personalized stimulation settings (for multiple different people) stored in the device, possibly by a clinician in consultation with people for whom the TES is intended to be used. This may allow a single device 100 to be used in an assembly where multiple users are present, such as in a nursing home or other shared accommodation or in a treatment facility. The physical size or external appearance of the device 100 may vary depending on the target market. He can: 19593855v1 a. Being small enough to fit into a small backpack that a child can easily carry, it can come in a variety of packaging styles and designs to give it a child-friendly look and make it more attractive to young users . B. Be large enough to be handled by geriatric users and present: i. Extra large LCD (or other display) with larger symbols (if a display is provided). ii. Large buttons for easy operation. iii. Braille symbols embedded in various parts of the device and touch buttons to allow users with weak eyes to operate the device. ç. Have a case / plate that can be changed to modify the physical appearance of the device so that the user can adapt to the device's "appearance" (that is, a case that looks like a bunny for small children, a wrapper that looks like a car for a 10 year old boy user, a doll for a 6 year old girl). This housing is completely separate from the internal housing 105 which contains the electronic parts of the device. Device 100 may comprise a battery compartment 140 defined by housing 105 and containing a battery 142 (optionally rechargeable) that can be coupled to an external power source via socket 114. Battery 142 provides a DC voltage, such as 9V, to the power source circuit 134, which supplies power to the various electrical / electronic components of the device 100. The device 100 comprises a combination of programmable and non-programmable circuits, digital or analog, plugged or attached to at least one printed circuit board (PCB) 108. Circuits include, but are not limited to: 1. Signal generating circuits 136 to produce electrical waveforms delivered to channels 139a, 139b. As a safety device, signal generating circuits 136 may have limited current to prevent current overload. 19593855v1 2. An on-board microprocessor system 130, which may comprise a suitable microcontroller, an Application-Specific Integrated Circuit (ASIC) and / or Field-Programmable Integrated Circuit Gate Array (FPGA) ". The microprocessor system 130 has access to sufficient Read-Only Memory (ROM) 0 131 and Random Access Memory (RAM) 132 for facilitate device operation, communication between external devices, firmware update functions and service / maintenance functions The device 100 operates according to the control software (firmware) preprogrammed in ROM 132 to facilitate operation and control the device. 3. Plate load testing circuits (as part of or controlled by, and sensitive to, microprocessor 130) to check that each and all electrodes are connected and in appropriate contact for an electrical charge that is representative of human tissue. 4. Integrated safety aspects to prevent or minimize the application of an unwanted current to the patient. This may include (but is not limited to): a. Isolation of the charging circuit by means of power source circuits 134 to prevent the provision of electrical stimulus during a battery charging operation. b. Safety device measurements provided by the load testing circuits to avoid the provision of current stimulation of the device when an inappropriate electrical connection is detected, for example, when the electrodes are not connected to the conductor wires of the device. electrode, when the conductive wires to the electrode are not connected to device 100 or when the electrodes are incorrectly connected to device 100 or when the electrodes are not connected to a human body. c.Protections against short circuit to avoid or mitigate the application of unwanted current to the patient. 19593855v1 The device software (firmware) and the computer software (to be executed by the 605 computer system) can have three access modes through which three different classes of users can interact with it. These modes are described below and illustrated schematically in Figure 5. Patient Mode: The user can operate the device for therapeutic purposes, but cannot modify, change or eliminate the functions of the device during interaction with the physical device. An exception to this is that the user can vary the function of the device only with an update of the authorized software (firmware) provided by the manufacturer. This update needed to be sufficient tamper-proof to avoid user errors and device corruption. The user can operate the personal computer software to access information or help files to learn how to operate the device 100 or optionally to view usage statistics, for example, but cannot modify, change or eliminate the functions of the device. - active when interacting with device 100 through the personal computer 620 interface (Figure 6). This user-focused software can be provided when the device is purchased by purchase, either as CD software (or as another medium that can be read by the computer) or by downloading it electronically directly from the manufacturer. Clinical Mode: The Clinical user can change the function of the device (in a restricted manner), for example, to select different stimulation settings for device 100 to improve the therapeutic benefit of device 100 to the patient by interaction only with the clinician-user interface module running on the 605 computer system. This may include authorized firmware updates as listed in the Patient Mode section. Software for use on the Personal Computer by the clinician may not be provided with the device, but instead can only be obtained after the clinician has registered with the manufacturer and has been authorized to make limited modifications to the function of the device for therapeutic benefits only. 19593855v1 Technical / Service Mode: An authorized repair agent or a manufacturer / engineer technician can access the program content of the device to facilitate diagnosis and repair functions. This mode allows full / authorized modification for the device's function. The software / firmware is divided into two separate code modules that interact with each other: 1. Software programmed into device 100 (firmware): a. The firmware can be programmed for device 100 at the time of manufacture. The firmware has all three levels of pre-programmed functionality, but the specific functions can be accessed only by the license owners or authorized persons as specified before. 2. Software programmed for use on the 605 computer: a. The software can interact only with its authorized level and with any levels with which they are authorized to interact. For example, Patient Mode on the device can interact only with Patient Mode in the computer software and Technical Mode can interact with both Patient Mode and Clinical Mode. B. The software on the 605 computer makes it easy to update the firmware in an automated way to minimize complications in the upgrade process. This will also provide security verification so that the device cannot be tampered with through this access method. Software and firmware updates may be provided from time to time by the manufacturer when necessary. It is intended to be operated as follows: The user attaches the electrode holder 20 and the electrode blocks 30 (or only the electrode blocks 30 if they are not provided on a holder 20) to the lower front abdomen and the lower back as shown in Figures 1 (child) and 2 (adult). The electrode holder 20 and / or the electrode blocks 30 may additionally or alternatively be attached as shown in Figures 8A to 8C, 9A, 9B and 10. 19593855v1 Lead wires for electrode 32 are connected to all blocks of electrode 30 and then to the correct sockets 112 on the device 100. Alternatively, conductive wires 32 can be supplied to a patient pre-connected to blocks 30 and / or to sockets 112. The user then connects device 100 to the socket using button 122, in response to which device 100 performs a function control on the back side to ensure that all systems are no longer and that electrodes 30 and the lead wires for electrode 32 are connected correctly. During this time, the LCD 120 may present a brief message to the user that the device is starting to function. Once the device 100 is ready, the LCD 120 can show a message or a signal (for example, turn on a green LED) to inform the user that the stimulation is ready to start. A light behind the START / STOP button 124 can light up and flash and the user can then press the START / STOP button 124 to start stimulation. During the application of the current, a counting or timing function performed by the microprocessor 130 can cause the circuits of the display 138 coupled to the display 120 to indicate the remaining stimulation time. If the user wishes to finish applying the current, the user presses the START / STOP button 124. Pressing the ON / OFF button 122 in the ON state will also end the current application and turn off the device switch. 100. Once the current application has ceased, device 100 can indicate on LCD 120 that the current treatment session for the stimulation is complete. If the user does not press the ON / OFF button 122, device 100 can be configured to automatically turn off the switch itself after a period of time specified by the manufacturer to prevent accidental operation and minimize battery consumption. The microprocessor system 130 can control the 19593855v1 device 100 to disallow additional stimulation delivery over a period of several (for example, up to 24) hours, regardless of whether the device 100 is off. For this purpose, microprocessor 130 may comprise an adequate time control function (possibly with a long-term power supply installed) that cannot be interrupted, even with device 100 having its switch off or battery 142 being removed or depleted. This feature can be disabled or absent in the modalities of device 100 configured for use by multiple different users. Device 100 can, in alternative modalities, comprise a greater functionality of the user interface than described above, for example, to allow a user to select some stimulation adjustments, including support frequency, modulated frequency, intensification. current, duration of the treatment session, etc. however, without taking into account the functionality of the user interface device 100, it needed to be operable to provide a stimulation current of less than approximately 40 mA at a support frequency of between approximately 1 kHz and approximately 10 kHz, with a modulated frequency of approximately 20 to approximately 300 Hz. Preferably, device 100 is configured to provide stimulation currents having a magnitude of 33 to 40 mA or less (but greater than zero) at a support frequency of approximately 4 kHz, with a frequency modulated from approximately 80 Hz to 150 Hz. The electrical stimulus can be provided as an electrical interference stimulus, for example, from the front left to the right of the back and / or from the right front to the left of the back. In some modalities, because the electric current is applied transcutaneously to the individual, the amount of electrical stimulus to be released to an individual may vary from individual to individual based on the Body Mass Index (BMI) ) and / or waist circumference and / or weight. For example, the optimal energy for the electrical stimulus needed for a normal weight child would be less than 19593855v1 for an obese child. An algorithm to determine the required electrical stimulus energy, for example, based on age, BMI, weight or circumference around the waist, can be included in the device's firmware, along with parameters of the operation to allow the specific parameters of the electrical stimulus are initially adjusted by the clinician who is responsible for the treatment or by another professional trained in medicine. A specific dysfunction for the treatment of which some modalities are considered adequate is slow transit constipation (CTS). However, the described modalities can be applied to treat several other dysfunctions of waste evacuation, such as other types of constipation, incontinence, irritable bowel syndrome (IBS) and ileum, for example. In some embodiments, the stimulation device 100 can be coupled to the computer system 605, as shown in Figure 6. In the illustrated arrangement, the computer system 605 and the stimulation device 100 are part of a system 100 to facilitate the configuration of device 100 and / or to facilitate communication between the device for stimulation 100 and the computer system 605 or a network 630 to which the computer system 605 is attached. The computer system 605 can comprise a desktop computer (desktop), a portable computer (laptop) or a manual computing device that has a 610 processor, 615 memory and 620 user interface. The 610 processor can comprise more than one processing device and has access to 615 memory which comprises volatile and non-volatile storage to perform program functions as described in this case. The 620 user interface comprises no more peripheral devices and / or user interface functionality to facilitate user interface with the 605 computer system and may include appropriate display related software in addition to the normal display screen, keyboard, mouse, screen touch sensitive and / or stylus etc. The computer system 605 comprises an input / output port 655 for communication over a wired or wireless connection 660 19593855v1 with port 116 for pacing device 100, thereby allowing processor 610 to reconfigure (to the extent allowed) or interface with the pacing device 100. Ports 116 and 655 can adopt a common configuration, for example, according to the standardized universal serial bus (USB) or may have patented non-standard port / communication configurations. Computer system 605 can be a computer system used by a patient to interface with the pacing device 100, for example, to communicate with (or even charged using USB power, for example) pacing device 100. Alternatively , the 605 computer system can be a computing device used by a clinician, such as a therapy specialist, to select one or a few configuration settings stored locally on the 605 system or accessible to the 605 system (for example, on network 630), from among possible multiple selections to be used to configure or reconfigure device 100 pacing settings. The software that can be operated on system 605 to perform such device reset 100 can be stored in memory 615 and can be executed by the 610 processor. Such software can be downloaded from a remote location on a 630 network in response and properly accredited or authenticated suitable for the clinician to use such a reconfiguration program. Alternatively, the computer system 605 can be a computer used by a technician or manufacturer to interface with device 100 when necessary, for example, to provide initial or predetermined pacing adjustments. In some modalities, electrodes 30 may be positioned in regions closer to the anus, for example, in a lower anterior pelvic area and in a posterior sacral or lower lumbar region, as illustrated in Figures 8A and 8B. It is believed that such positioning of the electrode helps in the treatment of anorectal retention (RA) as evidenced by the information described in Example 3 below. Apart from the lower positioning of the electrodes 30, such modalities use the device 100 in combination 19593855v1 tion with conductors 32 and electrodes 30 in the same manner as described above. As shown in Figures 8A to 8C, the lower positioning of electrodes 30 is intended to excite or modulate the nerves and tissues around the rectosigmoid colon to aid in the evacuation of fecal matter that accumulates in the intestine. distal thick of the near colon (ie, through the descending colon of the sigmoid colon and the rectum). Figure 8C illustrates schematically how the interference crossing currents are arranged between the left and right of the back (X to X) and between the right and left of the back (Y to Y). The anterior electrodes 30 are positioned between approximately 1 and approximately 10 cm separated laterally in relation to the vertical central line of the navel 11 in an inferior pelvic area that does not extend down to the genitalia and does not extend to the groin. The lateral separation of the electrodes 30 in some modalities may be less than the modalities described above in relation to Figures 1 and 2. On the rear side illustrated in Figure 8B, the electrodes 30 can be placed approximately over the dimples that are commonly visible on top of the inner part of the buttocks, generally corresponding to a lower or sacral lumbar region that is above or adjacent to the parts of the sacrum or iliac. The lateral spacing of the rear electrodes can therefore be between approximately 1 cm and approximately 10 cm, for example. Optionally, the posterior electrodes 30 may be positioned slightly above the upper extension of the sacrum or iliac in order to reduce the likelihood that the electrical current will be directed through the bones of the sacrum and the iliac while the interference current is passed between the anterior and posterior electrodes 30. Some modalities may employ more than two pairs of electrodes, such as four pairs illustrated in Figures 9A and 9B. In such modalities, the positions of the electrode illustrated in Figures 1, 2, 8A and 8B can be combined, with two pairs of electrode 810, 812 laterally and vertically spaced in the anterior abdominal (810) and lower pelvic areas 19593855v1 or (812). In addition, on the back side, two pairs of electrodes 816, 818 are laterally and vertically spaced in relation to the backbone. The lower pair of posterior electrodes (818) can be positioned just above the buttocks on either side of the backbone or in a lower position that is above the inner upper part of the buttocks overlying or adjacent to the sacrum or iliac. The upper pair (816) of electrodes 30 can be generally positioned in opposition to the corresponding upper anterior pair (810) of electrodes 30 so as to be located in a para-spinal area on each lateral side of the T9- lumbar vertebrae 10 to L2. In the modalities as illustrated in Figures 9A and 9B, electrodes 30 can be operated in two upper pairs and in two lower pairs to apply interference current stimulation in sequence with each other simultaneously. In some embodiments, the interference current can be applied between the opposite upper and lower electrodes. For example, the stimulation current can be applied between a posterior lower electrode 30 and an anterior upper electrode diagonally opposite 30 and optionally also an inferior anterior electrode diagonally opposite 30. The upper electrode pairs needed to be located below the costal margin 802 and in general to be positioned to excite or modulate the ascending, transverse and descending colon parts, while the lower electrode pairs 30 needed to be so general positioned above the anus and genitals in order to excite or modulate the rectum and thus help in the treatment of anorectal retention. The upper and lower two pairs of electrodes for stimulation 30 are believed to be likely to have a combined positive treatment effect for parts of the large intestine that affects evacuation dysfunction, including the nearby colon as well as the parts of the distal large intestine of the nearby colon, such as the sigmoid colon and the rectum. Referring now to Figure 10, a structure is illustrated schematically containing an electrode that can be worn in the example of a 910 belt arrangement. The 910 belt supports two pairs of anterior 30 electrodes and two more pairs of posterior electrodes 30 (which do not appear in the figure) to provide TES using interference current interference current applied by device 100 using conductors 32. Conductors 32 are at least partially supported by belt 910 and are preferably through cords or strings through at least part of the 910 belt or parts of it. The belt 910 may comprise means of transport, such as a ball, a bag, a frame or a fastening mechanism, to support and transport the device 100 while the patient is moving. Although belt 910 is illustrated as having electrodes 30 positioned to provide TES in the manner described in relation to Figures 9A and 9B, belt 910 may instead contain a single anterior pair (810/812) and a single posterior pair (816 / 818) of electrodes for placement in the regions as illustrated in Figures 1, 2, 8A and 8B. In other embodiments, belt 910 may comprise a selectable array of internal electrode connection positions by which electrode 30 is affixed to the five and is in electrical communication with conductors 32 in any of the position arrangements. In this way, one or more of a pair of electrodes 30 can be supplied previously and one or more of a pair of electrodes 30 can be supplied to a selected position or positions later in accordance with with the desired treatment regimen prescribed by a medical professional. Once the appropriate positions of the electrodes 30 on the belt 910 have been selected by the medical professional, patient 10, 60 can simply place the electrodes 30 in the correct position on their skin for each treatment session using the 910 belt on the same position in relation to the patient's own anatomy. The belt 910 can be suitably flexible and can be adjusted and removed by suitable coupling means, for example, such as a side flap 920 which has means for tightening 925, such as a hook or hook and loop fasteners, buttons or buckles. The 910 belt can be 19593855v1 formed from one or more individual or composite layers of flexible fabric (optionally at least partially elastic), which includes, for example, leather, Lycra, Spandex, cotton, nylon, plastic or other suitable fabric, for provide a structure that can be used to support device 100, conductors 32 and electrodes 30. Belt 910 can generally be permeable or impermeable fluid. Preferably, the 910 belt is made of one or more machine washable materials. The 910 belt is preferably designed to be worn with reasonable comfort under normal clothing so that a patient wearing the 910 belt can walk normally using the TES under the clothing. When self-administering the treatment prescribed by the medical professional, each patient can be directed to follow instructions in particular for the care of the electrodes and their placement to maximize the effective application of the TES. Modifications to the described modalities can be apparent to those skilled in the art, without departing from the spirit and scope of the described modalities. It is intended that the modalities described are therefore exemplary and not limiting when considered in the context of the appended claims. Studies involving some of the described modalities are presented by the following non-limiting Examples. EXAMPLE 1 Daily transcutaneous electrical stimulation increases defecation in children with slow traffic constipation. Patient Groups In the middle of a randomized control experiment (Clark et al., 2009 supra) (RCT) transcutaneous electrical stimulus testing (TES), battery operated machines became available, thereby allowing stimulation by parents at home. Eleven children (6M / 5F, with an average age of 14, aged 12-18 years) with slow traffic constipation that they completed, the RCT study, however, had relapsed or without an increase in defecation, were offered the opportunity to try the machine for a 19593855v1 pediatrician (11 ± 5 months after the experiment with TES). These children all had chronic constipation and involuntary elimination of excrement for a minimum of two years before the RCT and failed to respond significantly to the TES in the experiment, as well as to medical treatments such as dietary changes, oral and rectal laxatives. All eleven children underwent a radio-nuclear transit study to show slow transit in the transverse colon. However, it was discovered that a child had normal colon traffic and was excluded from the experiment with TES. The latter still had treatment with TES but there was no improvement, so it was included in this study. Another child had more severe symptoms requiring a stoma in the appendix and his constipation and involuntary excrement elimination were controlled with anti-grid washes every 2-3 days (King et al., J. Pediatr. Surg., 40: 1935-1940, 2005). Stimulation Scheme The parents of the children were trained to use the battery operated interference stimulation machine (EPM IF 4160, Fuji Dynamics, Hong Kong) by the physiotherapist in the experiment. Stimulation was performed and monitored by parents at the residence (1 hour daily for a minimum of 2 months). Interference treatments applied a support frequency of 4 kHz, a beating frequency of 80-150 Hz with an intensity of <33mAmp. Two adhesive electrodes with 3 cm2 were placed on the anterior abdominal wall below the costal margin of the children and two other electrodes placed on the posterior abdominal wall between T9 and L2 on each side. The current from the electrodes was crossed diagonally from the front to the back to ensure that a stimulation current from each electrode crossed over the inside of the child's abdomen. Outcome Measures The number of spontaneous defecations and "sit", the number of antegrade washings with enema or medication and the number of incidents of involuntary excreta disposal were recorded daily in 19593855v1 a specially designed continence diary. The diary was kept for one month before and for two months during electrical stimulation. A (a) frequency of defecation, (b) frequency of involuntary excreta elimination and (c) frequency of abdominal pain episodes per month were compared using ANOVA with post-test analysis and paired t-tests (with two ends ). P values <0.05 were considered statistically significant. Results Figure 7 is a graphical representation that shows: A) Total number of defecations / week, B) Number of days with involuntary excrement elimination and C) Number of days with abdominal pain. The diaries were evaluated daily for 1 month before stimulation (Pre Rx) and during the first month (Rx 1) and the second month (Rx 2) of stimulation performed daily at the residence. Statistically analyze by paired t-test. There are no adverse events or complaints of discomfort reported by the children. All patients tolerated stimulation well at home. a) Defecation As shown in Table 1, defecation increased in nine of the eleven children. There was a significant increase (p = 0.008) in total defecation per week (mean SD, 2.5 ± 2.1 vs 6.7 ± 4.4) (Figure 7A). Five of the eleven patients had less than three defecations / week in the baseline period and all of them had no more defecation episodes (> 3 / week) during stimulation. Six children experienced an increase in spontaneous defecation (Table 1) and three experienced an increase in defecation during sitting times trained in the toilet. One child had no increase in total defecation but there was a marked increase in spontaneous defecation, that is, variations in sitting times for spontaneous defecation (urgency of defecation followed by the child performing defecation in the toilet). 19593855v1 b) Involuntary excrement elimination There was a qualitative decrease in four of the eleven children, however this was not statistically significant (3.8 ± 1.6 vs 1.1 ± 0.5 epidodes / week) (p = 0 , 1) (Figure 7B). In the baseline period, involuntary excreta elimination was frequent in 3/11 children (Table 1). This was reduced to low episodes during stimulation in all three children. The patient with a stoma in the appendix had his unintentional excrement elimination controlled by antegrade enemas and therefore there was no recorded involuntary excrement elimination. c) Pain Daily stimulation did not affect abdominal pain (0.97 ± 1.8 vs 1.03 ± 2.0 episodes / week, p = 0.7) (Figure 7C). This study found that the use of a battery-operated machine was safe for the application of interference TES in the home environment. In addition, a daily stimulation of one hour per session for ≥ 1 month caused a significant increase in total defecation episodes / week, with no adverse effects. Fundamentally, this improvement in intestinal function occurred in patients who had experienced only a marginal or temporary improvement after stimulation three times a week in the newly conducted randomly controlled experiment (Clark et al., J. Pediatr. Surg., 43: 320-324, 2008). In the formal experiment, TES was provided for 20 minutes in each treatment session, three times a week, so that the total duration of therapy was one hour per week. When the experiment was designed, the optimal parameters (if any) were unknown and were therefore selected with arbitrary criteria. Because they have shown a statistical improvement in transit times (Clark et al., 2009 supra), colon manometry for 24 hours (King et al., Am. J. Gastroenterol., 103: 2083-2091, 2008) and quality of life (Clark et al., 2008 supra) in the experiment, the current study aimed to find out if a more frequent TES treatment could further improve function. 19593855v1 Daily TES at the residence allowed children in this pilot study to receive 7 hours of treatment per week (compared to 1 hour per week in the formal experiment), which improved their total intestinal function in defecation frequency. Interestingly, this was one of the few parameters that was not improved in the randomized placebo-controlled experiment, despite increased colon transit and peristaltic activity. The reason for this difference is unknown, but it may be that TES three times a week causes more traffic near the colon, but without altering the rectal evacuation. The children then needed to learn how to normally defecate to take advantage of this increased contractility near the colon. In this pilot study, better defecation may have occurred because more time had passed since the experiment and patients were more able to learn how to empty their colon under conscious control. Another possibility is that the longer period of time and frequency of treatment from one hour to 7 hours a week provided a much more substantial stimulus to the colon's function, allowing not only faster transit but also more effective evacuation. There was concern that the electrical stimulus could increase the involuntary elimination of excrement, but this did not occur. A daily stimulation showed a qualitative reduction in the frequency of involuntary excreta elimination, but this was not statistically significant. Although it was necessary that more patients be tested, it is considered that this qualitative improvement was likely to be important. The frequency of abdominal pain, which is thought to be caused by peristaltic movement, has also been measured and this is not changed by daily TES. TES has been tested only in very limited studies in children, outside the controlled experiment described here, so its place in the constipation therapy archive is unknown. The initial pilot study with TES used sophisticated machines connected to the power grid and operated by a licensed licensed physiotherapist (Chase et al., J. Gastroenterol. Hepatol., 20: 1054-1061, 2005). This extends this and demonstrates that a simpler machine with a rechargeable battery 19593855v1 9 volts is adequate to provide the necessary stimulation and can even provide superior effects to the intestine. The RCT has shown that TES is significantly more effective than a placebo. Therefore, longer duration and frequency of treatment times with TES is an advantage. In the group of children being treated for slow transit constipation by transcutaneous electrical stimulation using a battery operated interference stimulation device (EPM IF 4160, Fuji Dynamics, Hong Kong), it was discovered during the follow-up of a patient that there were some efficiency problems in the treatment that arise from the wrong or inappropriate use of the device. The Fuji Dynamics device has a relatively large number of buttons to be pressed and many settings for stimulation and options to choose from. In one case, the relative was confused about which buttons he would press to obtain the appropriate settings for the treatment (with the need to press 6 buttons). This family member was also illiterate and the written instructions for use were essentially useless, which led to a practical demonstration of the use of the device that is necessary to confirm that the family member is obtaining correct adjustments for stimulation. It was also discovered that the patient or family member would commonly forget to press the buttons to achieve the essential adjustments for treatment. In one case, a patient went through the treatment period without adjusting a stimulation frequency, resulting in the application of inadequate stimulation and the patient did not experience any improvement in symptoms. In younger children, it has been found that they tend to play with the buttons on the device. The Fuji Dynamics device used in the experiment did not have any locking characteristics to avoid inappropriate modification by the user of the device settings. One child experienced acute pain in both legs after varying the stimulation settings on the device. 19593855v1 EXAMPLE 2 Benefits of long-term TES treatment In a follow-up study in patients who had been incorporated into a TES experiment, it was observed that there was a continuous improvement in patients after the time of using TES. There are a total of 105 patients who were included in therapy with transcutaneous electrical (interference) stimulus (Table 2). They comprise 66 male patients and 39 female patients. The age of the patients is in the range of 6 - 18 years, with an average age of 11.5 years. All of these patients were selected for treatment after having been diagnosed with slow traffic constipation using a nuclear traffic study. There are different stages of development of the transcutaneous electrical stimulus, resulting from the TIC TOC to TENS experiment and the stimulation therapy at home. All patients were asked to complete continence diaries and age-appropriate PedsQL questionnaires after selection for the experiment and as the outline for follow-up during and after treatment. In the TIC TOC experiment, at 6 months of follow-up, of the 39 patients with the data analyzed when completing the experiment, 20 patients answered the research questionnaires. Sixteen of the 20 patients had ≥ 3 episodes of defecation per week for 6 months after treatment. After 12 months of follow-up, 13 answered the research questionnaire. Eleven of the 13 patients had ≥ 3 episodes of defecation per week. Regarding the involuntary excreta elimination, at 6 months of follow-up, 14 of the 23 who responded did not present involuntary excreta elimination. After 12 months of follow-up, 6 out of 11 responded that they did not have an involuntary excrement elimination. There was a total improvement in patients with slow traffic constipation treated by transcutaneous interference therapy. In the most recent therapy of stimulation therapy at home, one patient had complete resolution of abdominal pain, two times 19593855v1 zes increase in defecation and 3.7 times improvement in involuntary excrement elimination in one month follow-up. The stimulation regimes described in Examples 1, 2 and 3 were also used in direct stimulation of the pelvic floor or the area around the perineum or perianum. EXAMPLE 3 There are 4 children currently using the anorectal retention (RA) protocol to treat chronic constipation, the results of which are shown in Table 3. The position of the electrodes 30 is shown and described above in relation to Figures 8A to 8C. The stipulated TES treatment regimen and adjustments were the same as for the other Examples, including that the treatments last approximately 60 minutes every day over a period of several weeks or several months. Table 3 Children with chronic constipation using the AR protocol. Gender Age Clinical diagnosis- Current status positions used (February 25, 2011 electrode constipation co) Chronic 1 Male 9 STC Protocol constipation, AR develop- Clinically better after 6 slow transit (STC) reversed (palpable fecaloma- remained well (deliverable) 6 months later. view performed by telephone 22 of used AR Protocol. February 2011). No faecomal anymore. 2 Male 4 STC STC protocol for 6 Greater sense of urgency in months. The repetition of the bass with reduced use of laxative study of the traffic presented (interview conducted by telephone sat AR. Protocol AR 22 February 2011) started in December 2010. 3 Male 6 STC + Retention Used STC protocol Clinically improved with anorectal (RA) for 4 months before more regular bowel actions. switch to the AR protocol. It remained the same (telephone interview in February 22, 2011). 4 Female 6 AR Fecaloma palpable. Starts- Still waiting for a response by the AR protocol in 17 of the family's call. September 2010. 19593855v1 As these preliminary data indicate in Table 3, treatment with TES that uses interference current applied to the lower pelvic and sacral regions is effective to treat an evacuation dysfunction in the rectosigmoid colon. This has been shown to be effective as a procedure performed after treatment at the highest electrode positions for CTS. The indication is that this lower electrode positioning can be used as a supplementary or independent procedure to the upper electrode positioning. If the treatment procedure with the lower electrodes is supplementary to the treatment with upper electrodes, this can be carried out simultaneously or in sequence. Those skilled in the art will find that the invention described herein is susceptible to variations and modifications other than those specifically described. It must be understood that the invention includes all such variations and modifications. The invention also includes all stages, characteristics, compositions and all compounds cited or indicated in this specification, individually or collectively and any and all combinations of any two or more of said stages or characteristics. 19593855v1 Table 1 Days with involuntary elimination of excrement - Defecation / week mentos / week Days with pain / week Stomach of appendix study Sex Before IFT 1 IFT 2 Change Before IFT 1 IFT 2 Before IFT 1 IFT 2 With stoma in the appendix F Not Slow 0 12 14 1/2 Seated & Spontaneous Positions 0 3 0 0 1 0 F Not Slow 0 4 NA ↑ Seated Positions 0 1 NA 3 0 NA F Not Slow 1 3 NA ↑ Spontaneous 6 1 NA 5 5 NA F No Slow 3 11 11 ↑ seating positions 7 3 3 0 1 1 37/39 F Not Slow 7 10 12 ↑ Spontaneous 2 0 0 0 2 0 M Not Slow 1 4 3 ↑ Spontaneous 0 0 0 1 3 4 M Not Slow 2 6 6 ↑ Spontaneous 3 5 3 0 1 1 M Not Slow 3 2 4 ↑ spontaneous 0 0 0 0 0 0 M No Slow 4 2 3 1/2 sitting & spontaneous positions 4 4 3 0 2 1 ppendix M Yes Slow 3 5 9 ↑ spontaneous 0 0 0 0 0 0 0 With Normal Traffic M Not Normal 4 12 NA ↑ seating positions 7 2 NA 2 0 NA ND: No Data C: NRPortbl DOCS DLA 19593855_1.DOC - 10/25/13 Table 2 TIC TOC Started with 60 patients; 39 patients available for analysis and follow-up. Monitoring periods from 1 year to 2 years. 21 patients were excluded from the study. GENDER NUMBER (N) MALE 21 FEMALE 18 AGE IN THE 7 - 18 YEARS RANGE, AVERAGE AGE OF 11.8 YEARS (OF THE 39 PATIENTS INCLUDED IN THE FINAL ANALYSIS). GENDER NUMBER (N) MALE 39 FEMALE 21 AGE IN THE 6 - 18 YEAR OLD RANGE, AVERAGE AGE OF 12.3 YEARS (OF THE 60 PATIENTS AT THE START OF THE STUDY) YOU HAVE GENDER NUMBER (N) MALE 5 FEMALE 5 AGE IN THE 5 - 16 YEARS RANGE, AVERAGE AGE OF 9.3 YEARS. FOLLOW-UP PATIENTS FROM 6 MONTHS TO 1 YEAR 1st STIMULATION THERAPY IN RESIDENCE GENDER NUMBER (N) MALE 6 FEMALE 5 AGE IN THE 9 - 15 YEAR OLD RANGE, AVERAGE AGE OF 12 YEARS. MONITORING PATIENTS FROM 6 MONTHS TO 1 YEAR. 19593855v1 2nd STIMULATION THERAPY IN RESIDENCE GENDER NUMBER (N) MALE 16 FEMALE 8 AGE IN THE 4 -16 YEARS RANGE. AVERAGE AGE of 10.3 YEARS MONITORING PATIENTS FROM 0-5 MONTHS. BIBLIOGRAPHY Benninga et al., J Pediatr Gastroenterol Nutr., 23: 241-51, 1996 Chase et al., J. Gastroenterol. Hepatol., 20: 1054-1061, 2005 Clark et al., J. Pediatr. Surg., 43: 320-324, 2008 Clark et al., J. Pediatr. Surg., 44: 408-412, 2009 Hutson et al., J Pediatr Surg., 31: 580-583, 1996 King et al., J. Pediatr. Surg., 40: 1935-1940, 2005 King et al., Am. J. Gastroenterol., 103: 2083-2091, 2008 Shin et al., J Pediatr Surg., 37: 1762-1765, 2002
权利要求:
Claims (15) [1] 1. Transcutaneous stimulation system configured to treat a waste evacuation dysfunction, comprising: at least four electrodes (30) comprising a first 5 pair of electrodes (30) and a second pair of electrodes (30) ; a stimulation device (100) configured to provide electrical stimulus signals to at least four electrodes (30) for a treatment regimen of at least one treatment period per day for a treatment period of at least one week, in which electrical stimulus signals are provided to administer transcutaneous electrical stimulus (TES) and in which TES comprises interferential electrical stimulus; characterized by the fact that the first pair of electrodes (30) is configured to be positioned one on each side of the spine or sacrum in the sacral region and a second pair of electrodes (30) is configured to be positioned laterally through the lower pelvic region; and in which the electrical stimulation device (100) comprises a means of assessing patient acceptance of the treatment regimen based on information collected and stored in the stimulation device related to the patient's use of the stimulation device. [2] 2. System according to claim 1, characterized by the fact that the stimulation device (100) is configured to have a single set of stored stimulation settings that control the provision of electrical stimulus signals. [3] 3. System, according to claim 2, characterized by the fact that a device for stimulation (100) is free of controls that can be operated by the user that allow modification of the stimulation adjustments. [4] System according to any one of claims 1 to 3, characterized in that the stimulation device (100) comprises a port attachable to an external computing device to allow modification of the stimulation settings. [5] 5. System according to any one of claims 1 to 4, characterized by the fact that the stimulation device (100) stores a limited set of selectable stimulation settings that control the provision of electrical stimulus signals. [6] 6. System according to any one of claims 1 to 5 5, characterized by the fact that at least four electrodes (30) comprise a first pair of electrodes (30) configured to be positioned one on each side of the navel and a second pair of electrodes (30) configured to be positioned in a para-spinal area on each side of the lumbar vertebrae T9-10 to L2. [7] System according to any one of claims 1 to 6, characterized by the fact that at least one electrode is transported on a support substrate capable of being adhered to the skin by an adhesive that can be released manually. [8] 8. System according to claim 7, characterized by the fact that the support substrate contains at least two electrodes (30) spaced at a substantially fixed distance through the substrate. [9] System according to any one of claims 1 to 6, characterized in that it also comprises a structure that can be used to carry a device for stimulation (100) and to assist in positioning at least one electrode on the skin . [10] 10. System, according to claim 9, characterized by the fact that the conductors that electrically couple a stimulation device (100) to at least one electrode are supported by the structure that can be used. [11] 11. System according to claim 10, characterized by the fact that the conductors pass at least partially through the structure that can be used. [12] 12. System according to any of claims 1 to 11, characterized in that the structure that can be used comprises a belt. [13] 13. System according to any one of claims 1 to 12, characterized in that a device for stimulation (100) it comprises at least one accelerometer to detect at least one of movement and orientation of a device for stimulation (100). [14] 14. System according to any one of claims 1 to 13, characterized in that the stimulation device (100) 5 comprises a microcontroller that has a timing function and is configured to disallow an additional administration of electrical stimulus during a period after the provision of electrical stimulus. [15] 15. System according to any one of claims 1 to 14, characterized by the fact that the information collected and stored in the stimulation device regarding the patient's use of the stimulation device comprises the temperature detected by means of at least four electrodes ( 30).
类似技术:
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同族专利:
公开号 | 公开日 US20190083783A1|2019-03-21| RU2013144203A|2015-04-10| US10080892B2|2018-09-25| NZ614757A|2015-08-28| US20140148871A1|2014-05-29| JP6212395B2|2017-10-11| MX343839B|2016-11-24| EP2680921B1|2017-04-19| JP2014511240A|2014-05-15| SG193306A1|2013-10-30| RU2609459C2|2017-02-01| EP2680921A1|2014-01-08| MX2013010008A|2014-02-28| MY161168A|2017-04-14| ZA201306573B|2015-03-25| CA2828479A1|2012-09-07| US20170348526A1|2017-12-07| WO2012116407A1|2012-09-07| US9789308B2|2017-10-17| EP2680921A4|2014-09-10| KR20140007456A|2014-01-17| AU2012222866B2|2014-04-24| CN103492024B|2016-02-10| CN103492024A|2014-01-01| AU2012222866A1|2013-04-18|
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法律状态:
2020-10-27| B15I| Others concerning applications: loss of priority|Free format text: PERDA DA PRIORIDADE US 61/448,378 REIVINDICADA NO PCT/AU2012/000212, CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 167O, ITEM 28 DO ATO NORMATIVO 128/97 E NO ART. 29 DA RESOLUCAO INPI-PR 77/2013. ESTA PERDA SE DEU PELO FATO DE O DEPOSITANTE CONSTANTE DA PETICAO DE REQUERIMENTO DO PEDIDO PCT SER DISTINTO DAQUELES QUE DEPOSITARAM A PRIORIDADE REIVINDICADA E NAO APRESENTOU DOCUMENTO DE CESSAO REGULARIZADO DENTRO DO PRAZO DE 60 DIAS A CONTAR DA DATA DA PUBLICACAO DA EXIGENCIA, CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 166O, ITEM 27 DO ATO NORMATIVO 128/97 E NO ART. 28 DA RESOLUCAO INPI-PR 77/2013. | 2020-11-03| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|Free format text: REFERENTE A 8A ANUIDADE. | 2021-02-23| B08K| Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]|Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2600 DE 03-11-2020 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013. | 2021-11-23| B350| Update of information on the portal [chapter 15.35 patent gazette]|
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