Patent Document

RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 12/276,068 filed on Nov. 21, 2008, and entitled “Systems and Method for Therapeutic Electrical Stimulation” and claims the benefit of U.S. Provisional Application No. 61/019,489 filed on Jan. 7, 2008 entitled “Systems and Method for Therapeutic Electrical Stimulation,” the entirety of which are hereby incorporated by reference. 
     
    
     BACKGROUND 
       [0002]    Low-power electrical stimulation has been found to have various therapeutic uses. One example of low-power electrical stimulation is transcutaneous electrical nerve stimulation (“TENS”). TENS devices typically operate by generating low-power electrical impulses that are supplied to the skin of a patient through electrodes. The electrical impulses have been found to diminish or completely relieve pain previously felt by a patient. 
         [0003]    There are two primary theories for the effectiveness of TENS devices. The first theory is the Gate Control Theory. In this theory, the mild electrical stimulation is thought to relieve pain in a similar way as when an injured area is manually rubbed. Rubbing acts to mask the pain from the injury. Similarly, when electrical impulses pass through the skin they pass through portions of the peripheral nervous system. The electrical impulses reduce the transmission of pain messages, thereby diminishing or completely relieving pain. 
         [0004]    A second theory is the Endorphin Release Theory. This theory states that the electrical impulses from the TENS device cause mild to moderate muscle twitching in the body. The body responds to the muscle twitching by producing natural pain relievers called endorphins, thereby diminishing or completely relieving the pain. 
         [0005]    In addition to TENS, electrical stimulation has also been found to be useful for other therapies. Examples include edema reduction, wound healing, iontophoresis drug delivery, muscle stimulation, and interferential current therapy. 
         [0006]    Currently available TENS devices are subject to several drawbacks that impair their usability for a patient. For example, some devices are bulky and have many wires that get tangled or in the way of the user. The wiring and bulky housings of some current TENS devices can also be obtrusive and embarrassing for a user to wear in public. In addition, many devices are complex and lack a simple, user-friendly connection mechanism between controller and electrodes to allow a user to easily connect or disconnect the device. The drawbacks of current TENS devices prevent a user from seamlessly integrating electrical stimulation therapy into their everyday lives. 
       SUMMARY 
       [0007]    In general terms, this disclosure is directed to therapeutic electrical stimulation and addresses various shortcomings with currently available electrical stimulation technologies. In one aspect, the systems, devices and methods disclosed herein provide improved usability of electrical stimulation devices. Certain embodiments of the present disclosure provide a therapeutic electrical stimulation device that is user friendly and easy to wear, comprising a controller for providing electrical signals for electrical stimulation of the patient and an electro mechanical intermediate connector arranged to convey the electrical signals from the controller to the patient. The controller includes a power source, an electrical signal generator, and a receptacle, wherein the electrical signal generator is electrically coupled to the power source, and wherein the electrical signal generator generates electrical signals that are provided to a conductor associated with the receptacle. In certain embodiments, the electro mechanical connector is an interconnecting patch. An exemplary patch includes a shoe, an insulating layer, and electrodes, wherein the shoe is removably mechanically connected to the controller at the receptacle, the shoe is electrically coupled to the conductor at the receptacle, and the electrodes are electrically coupled to the shoe. 
         [0008]    Another aspect is a more user friendly controller for a therapeutic electrical stimulation device, the controller comprising a power source including a rechargeable battery; an electrical signal generator powered by the power source and generating an electrical signal, and a receptacle including at least one conductor. The conductor is electrically coupled to the electrical signal generator to receive the electrical signal. The receptacle is arranged and configured to receive a portion of an electro mechanical interconnecting patch to electrically couple a portion of the patch with the conductor. 
         [0009]    Yet another aspect is a patch for a therapeutic electrical stimulation device, the patch comprising an insulating layer having a first side and a second side; a shoe connected to the first side of the patch and including at least two conductors, wherein the shoe is configured for insertion into a receptacle of a controller of the therapeutic electrical stimulation device; at least two electrodes adjacent the second side of the patch, wherein each conductor is electrically coupled to one of the electrodes; and an adhesive layer connected to the second side of the insulating layer. 
         [0010]    A further aspect is a method of connecting a patch with a controller of a therapeutic electrical stimulation device, the method comprising advancing the controller in a first direction toward that patch to insert a shoe of the patch into a receptacle of the controller; and advancing the controller in a second direction to cause the controller to engage with the shoe. 
         [0011]    Another aspect is a method of adjusting the operation of a therapeutic electrical stimulation device, the method comprising operating the therapeutic electrical stimulation device in a first mode by executing a first firmware algorithm; downloading a second firmware algorithm; installing the second firmware algorithm onto the therapeutic electrical stimulation device; and executing the second firmware algorithm to operate the therapeutic electrical stimulation device in a second mode. 
         [0012]    A further aspect is a docking station comprising a housing; a slot in the housing arranged and configured to receive a therapeutic electrical stimulation device; a power source for supplying power to a therapeutic electrical stimulation device to recharge a battery; and a data communication device for communicating between the therapeutic electrical stimulation device and a communication network. 
         [0013]    In one aspect a system is provided for delivering therapeutic electrical stimulation. The system includes a patient interface component, a controller component that provides signals for electrical stimulation, and an intermediate electro-mechanical connection component positioned between the patient interface component and the controller component. The intermediate component matingly engages with the controller component and includes conducting lines that interface with leads in the controller component to provide electrical communication between the patient interface and the controller component. Each component has a useful life that is determined either, by the device supplier, government regulation, or by natural wear and tear of the component itself. In certain embodiments, the useful life of the component is predetermined prior to initial use or sale of the component, and it is replaced upon expiration of the useful life. In some implementations, the predetermined useful life coincides with a period established by regulatory or other administrative authority by paying for or reimbursing for such component. In some embodiments, such predetermined useful life is shorter than the period in which the component becomes physically worn out or inoperable. 
         [0014]    In certain embodiments, the patient interface component has a useful life that is shorter than the useful life of the intermediate component, and the intermediate component has a useful life that is shorter than that of the controller component. In certain embodiments, the controller component has a useful life of about five years, the intermediate component is a multiuse component having a useful life of about six months or less, and the interface component is a single use disposable. 
         [0015]    In one aspect, the system provides an electro-mechanical interface between the patient and an electro stimulation source. In certain embodiments, the interface has disposable and reusable component. In certain implementations, the electromechanical interface is formed from at least two disposable components, with each having a useful life of different length than that of the other. In some embodiments, the system provides a disposable patient contact layer, a disposable/reusable intermediate module, and a reusable controller. 
         [0016]    A further aspect is a garment that carries the components and is adapted to position the patient interface component against the patient. 
         [0017]    Yet another aspect is a controller component that has a receptacle with a least one conductor, the conductor is electrically coupled to an electrical signal generator to receive the electrical signal. The receptacle is configured to receive a portion of the intermediate component to electrically couple a portion of the intermediate component with the conductor. 
         [0018]    In another aspect, the intermediate component is a patch, the patch comprising a shoe connected to at least one insulating layer and including at least one conductor, wherein the shoe is configured for insertion into the receptacle of the controller component. 
         [0019]    This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used in any way as to limit the scope of the claimed subject matter. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  is a perspective top view of an example therapeutic electrical stimulation device. 
           [0021]      FIG. 2  is a perspective top view of the controller of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0022]      FIG. 3  is a top plan view of the controller of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0023]      FIG. 4  is a front view of the controller of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0024]      FIG. 5  is an exploded perspective view of the controller of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0025]      FIG. 6  is a perspective top view of a shoe of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0026]      FIG. 7  is a side plan view of a shoe of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0027]      FIG. 8A  is an exploded perspective view of a shoe of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0028]      FIG. 8B  is a front view of a shoe of the therapeutic electrical stimulation device shown in  FIG. 1   
           [0029]      FIG. 9  is a perspective view of the therapeutic electrical stimulation device shown in  FIG. 1 . 
           [0030]      FIG. 10A  is a side cross-sectional view of the therapeutic electrical stimulation device before connection. 
           [0031]      FIG. 10B  is a side cross-sectional view of the therapeutic electrical stimulation device shown in  FIG. 9  after connection. 
           [0032]      FIG. 11  is a block diagram of an example shoe of the therapeutic electrical stimulation device shown in  FIG. 1  attached to a generic structure. 
           [0033]      FIG. 12  is a perspective top view of another example therapeutic electrical stimulation device. 
           [0034]      FIG. 13  is an exploded perspective view of the therapeutic electrical stimulation device shown in  FIG. 12 . 
           [0035]      FIG. 14  is a right side cross-sectional view of the device shown in  FIG. 12 , including a controller that is disconnected from a patch. 
           [0036]      FIG. 15  is a right side cross-sectional view of the device shown in  FIG. 14  with the controller being arranged over the patch. 
           [0037]      FIG. 16  is a right side cross-sectional view of the device shown in  FIG. 14  with the controller being connected with the patch. 
           [0038]      FIG. 17  is a perspective top view of the device shown in  FIG. 12  in a partially assembled configuration. 
           [0039]      FIG. 18  is a block diagram of an electrical schematic for the controller shown in  FIG. 14 . 
           [0040]      FIG. 19  is an electrical schematic of an exemplary circuit for the controller shown in  FIG. 14 . 
           [0041]      FIG. 20  is another block diagram of an electrical schematic for the controller shown in  FIG. 14 . 
           [0042]      FIG. 21  is another electrical schematic of an exemplary circuit for the controller shown in  FIG. 14 . 
           [0043]      FIG. 22  is a top perspective view of another embodiment of a patch. 
           [0044]      FIG. 23A  is a schematic illustration of possible applications and configurations for the device shown in  FIG. 12  and  FIG. 1 . 
           [0045]      FIG. 23B  is an exploded perspective view of an exemplary implementation of the devices shown in  FIG. 23A . 
           [0046]      FIG. 23C  is a side cross sectional view of a possible configuration for the devices shown in  FIG. 23A . 
           [0047]      FIG. 23D  is a perspective view of a possible configuration for the devices shown in  FIG. 23A . 
           [0048]      FIG. 24  is a perspective view of an exemplary docking station. 
           [0049]      FIG. 25  is a block diagram of an exemplary system for communicating across a communication network including the device shown in  FIG. 12 . 
       
    
    
     DETAILED DESCRIPTION 
       [0050]    Various embodiments will be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims attached hereto. Additionally, any examples set forth in this specification are not intended to be limiting and merely set forth some of the many possible embodiments for the appended claims. 
         [0051]    Referring now to  FIG. 1 , an example therapeutic electrical stimulation device  10  is shown. In this example, device  10  is a transcutaneous electrical nerve stimulation (“TENS”) device. Device  10  includes controller  11  and an electro-mechanical connecting shoe  13 . Controller  11  generates electrical impulses and supplies the electrical impulses to shoe  13 . The connector shoe  13  receives the electrical impulses from controller  11  and supplies the electrical impulses to a conductive layer or directly to a therapeutic location, such as the skin of a patient. Examples of electrical signals which may be used by controller  11  are described in more detail in U.S. Pat. No. 4,922,908, the teachings of which are incorporated herein by reference. 
         [0052]    As shown in  FIGS. 2-5 , controller  11  includes an outer protective shell formed of upper housing  12  and lower housing  14 . Upper and lower housings  12 ,  14  are made of any suitable material such as plastic, metal, or the like. A lower edge of upper housing  12  is configured to be connected with an upper edge of lower housing  14 . In some embodiments, a fastener is used to connect upper housing  12  to lower housing  14 . Examples of suitable fasteners include adhesive, screws, latching mechanisms, and other known fasteners. In other embodiments, upper housing  12  is directly connected to lower housing  14 , such as by welding or over molding. 
         [0053]    Upper and lower housings  12 ,  14  act together to enclose battery  26  and electrical circuitry  29 . As a result, upper and lower housings  12 ,  14  provide protection to the enclosed components from contact with other objects that could otherwise damage the components. In some embodiments, upper and lower housings  12 ,  14  are water resistant to protect enclosed components from water or other fluids. Some embodiments of upper and lower housing  12 ,  14  are completely sealed to resist most or all fluid, gas, or particle intrusion. Some embodiments are hermetically sealed. 
         [0054]    Battery  26  is a power source that provides electrical power to controller  11 . In some embodiments, battery  26  is a rechargeable battery such as a lithium-ion battery. Battery  26  can be charged by connecting controller  11  to a battery charger, as described further below. One example of a battery charger is a docking station described in more detail herein. Inductive charging is used in some embodiments. In other embodiments, other rechargeable batteries are used, such as a nickel cadmium battery, a nickel metal hydride battery, or a rechargeable alkaline battery. Yet other embodiments include non-rechargeable, disposable batteries, such as alkaline batteries, or other known batteries. An alternate embodiment of controller  11  does not include battery  26 , but rather includes a different power source such as a capacitor. 
         [0055]    Lower housing  14  includes a controller receptacle  24  that is arranged and configured to receive a portion  42  of shoe  13 . In some embodiments, lower housing  14  and portions of electrical circuitry  28  are uniquely arranged and configured to mate with portion  42  and resist mating with other shoe configurations. In addition, a railway platform  28  is positioned within controller receptacle  24  to fit with complementary surfaces on portion  42  to matingly engage with receptacle  24 , as described more fully below. This mating engagement foul&#39;s a keyed receptacle. One benefit of a keyed receptacle is that it can be used to resist connection with inappropriate patches or other devices, such as to resist connection with a patch that would be incompatible with controller  11 . On the other hand, the keyed receptacle is also used in some embodiments to allow connection of controller  11  with various types of patches or other devices if desired. 
         [0056]    In the example shown, the electrical circuitry  28  includes a PCB board  29  with a plurality of pins  31  extending therefrom. Pins  31  are sized to be received in receptacles formed in corresponding portion  42  of the shoe  13  to create an electrical connection between controller  11  and shoe  13 , as described below. 
         [0057]    Upper housing  12  includes a member  22  that moves into and out of controller receptacle  24  to capture and release corresponding structure  42  of the shoe  13 . As described further below, as portion  42  is inserted into controller receptacle  24 , and member  22  engages structure  56  on portion  42  to couple portion  42  to controller  11 . To release portion  42 , the user depresses member  22  to disengage member  22  from portion  56 . Portion  42  of shoe  13  can then be pulled out of controller receptacle  24 . 
         [0058]    In one embodiment, controller  11  includes an on-board user interface having a power button  20  and amplitude adjustment buttons  16  and  18 . When power button  20  is first depressed, the controller turns ON and begins generating therapeutic electrical signals. When power button  20  is depressed again, the controller turns OFF and stops generating the therapeutic electrical signals. 
         [0059]    While the controller  11  is ON, amplitude adjustment buttons  16  and  18  are used to adjust the amplitude of the generated therapeutic electrical signals accordingly. Amplitude adjustment button  16  provides an input to increase (“+”) the amplitude of the therapeutic electrical signals. Amplitude adjustment button  18  provides an input to decrease (“−”) the amplitude of the therapeutic electrical signals. 
         [0060]    Referring now to  FIGS. 6-8B , the shoe  13 , with sides  42   a  and  42   b , is shown in greater detail. In the example shown, shoe  13  includes upper portion  42  and a base  44 , having sides  44   a  and  44   b . As shown, upper portion  42   a  is mounted to base portion  44   a , and upper portion  442   b  is mounted to base portion  44   b . Also typically included, but not shown, is an insulating layer (see, e.g., insulating layer  122  described below). During sliding insertion, portion  42  is configured to engage with a receptacle  24  (shown in  FIGS. 9 and 10 ) of controller  11 , as previously described. Portion  42  is a plastic or other suitable structure used to physically and electrically connect shoe  13  with controller  11 . 
         [0061]    The shoe  13  includes two symmetric halves  13   a  and  13   b  that allow insertion of an electrical connector  51  inside, as shown in  FIG. 8A . The electrical connector may be any suitable electrical connection device, such as a FCI connector. The electrical connector  51  fits snugly inside of shoe  13  within the two halves. The electrical connector  51  may be fastened inside of the shoe  13  using glue, ultrasonic welding, or other available techniques. 
         [0062]    One or more electrodes (such as electrodes  124  and  126  in  FIG. 13  or electrodes  1502  in  FIGS. 23B and 23D ) are connected to shoe  13 . When the electrodes are applied to a patient, they provide an electrical connection with the skin of the patient to supply electrical pulses to a desired therapeutic location, such as on the patient&#39;s skin. Exemplary electrodes are made of one or more sheets of electrically conductive material (e.g., conductive polymer or stainless steel). In some embodiments, the electrodes are generally disk-shaped to distribute the electrical signals across a relatively large area of skin. In other embodiments, the electrodes are of a variety of other shapes including ring-shaped, circular, elliptical, serpentine, comb-shaped, or other desired shape. 
         [0063]    In operation, the electrodes are connected to the shoe  13  and ultimately to the controller using electrode lead wires  46 ,  48 , which extend from shoe  13  and connect to the electrical connector  51 . The connection of lead wires to the shoe and the electrodes is done using any appropriate connection mechanism (e.g., metal crimp, solder, etc.). 
         [0064]    In certain embodiments, lead wire  46  connects to the shoe  13  through electrical connector  51  and to signal pin  31   a  in receptacle  50   a . Lead wire  48  connects to the shoe  13  through electrical connector  51  and to ground pin  31   b  in receptacle  50   b . Lead wire  46  and  48  connect to separate electrodes no that during stimulation, a voltage potential is generated between the electrodes and current enters the skin through one electrode, passes through the skin, and then returns through the other electrode. 
         [0065]    A disposable, conducting adhesive layer (e.g., adhesive layer  128  and  1504  described below) is applied to one side of electrodes  124 ,  126  and  1502  to allow the electrodes to be securely, yet removably, adhered to the skin and to permit the electrical signals to flow from the controller  11  to the patient. In some embodiments, adhesive layers  128  and  1504  are applied across an entire surface of electrodes  124 ,  126  and  1502 . In other embodiments, adhesive layers  128  and  1504  are electrically connected to the shoe, but not to the regions of electrodes  124 ,  126  and  1502 . Other adhesive layer arrangements are used in other embodiments. Exemplary adhesive layers are made of an electrically conductive material such as an electrogel or hydrogel (e.g., UltraStim Self-Adhering Neurostimulation Electrodes made by Axelgaard Manufacturing Co.). The adhesive layer is preferably disposed of after one use, but may reused for multiple applications. Some embodiments of shoe  13  include additional layers. 
         [0066]    During stimulation, controller  11  generates a voltage potential between electrode lead wires  46 ,  48  such that the current enters the skin through one wire, passes through the skin, and then returns through the other wire. Some embodiments provide a plurality of electrodes. In some implementations, the polarity of the electrodes is alternated during a therapy. In some embodiments a skin preparation product, such as a conductive gel, is applied to the skin prior to application of shoe  13 . 
         [0067]    To make electrical connection between shoe  13  and controller  11 , portion  42  includes a plurality of receptacles  50   a - 50   c  on a front face  52  of portion  42 . The receptacles are part of connector  51  (e.g., FCI connector) housed inside of shoe  13 . The three electrical receptacles  50   a - 50   c  are assigned various functions such as providing an electrical signal, connection to ground, and battery charging connection. The electrical receptacles  50   a - 50   c  are sized to receive pins  31   a - 31   c , respectively, of controller  11  when portion  42  is fully inserted into connector receptacle  24  (see  FIGS. 9 and 10 ), and provide a location where the pins  31   a  and  31   b  connect with the lead wires  46  and  48 , respectively. As shown, pins  31  extend generally parallel to the railway platform  28 . 
         [0068]    Fitting pins  31  into receptacles  50  creates an electrical connection between controller  11  and shoe  13  and allows controller  11  to deliver electrical stimulation therapy through electrode lines  46 ,  48  to the patient. In particular, as shown, receptacle  50   a  receives the electrical signal pin  31   a  and receptacle  50   b  receives the ground pin  31   b , which combine to form the electrical connection between the shoe  13  and the controller  11 . Receptacle  50   c  receives the battery charging pin  31   c . It will be appreciated that when the shoe  13  and the controller  11  are mated together for operation, the battery charging pin  31   c  sits within the receptacle  50   c  but does not electrically connect. As discussed below, the controller  11  may be disengaged from the shoe  13  after patient therapy and connected to a battery charging station. 
         [0069]    The mechanical connection between the shoe  13  and controller  11  is further shown in  FIGS. 6-10B . With reference to  FIG. 6 , shoe  13  includes portion  42  that defines a channel  54  sized to receive railway platform  28  of controller  11  when portion  42  is inserted into controller receptacle  24 . Railway platform  28  slides inside channel  54  below portion  42  and above the bottom surface defining channel  54 , fitting in a ‘U’ shape around portion  55  of shoe  13 . Also, portion  42  includes a clip member  56  sized to engage a detent or lip  23  of member  22  of controller  11  when portion  42  is fully inserted into controller receptacle  24  to retain portion  42  within receptacle  24 . In certain embodiments, when clip member  56  engages the lip  23  of member  22  the connection creates an affirmative “click” sound, indicating that shoe  13  is connected to controller  11 . In addition, the base  44  of the shoe includes two side flanges  44   a  and  44   b . As the shoe  13  slides into connection with the controller  11 , the base flanges  44   a  and  44   b  slide under and at least partially abut respective side portions  8   a  and  8   b  of the controller  11 . 
         [0070]    Referring now to  FIGS. 9 and 10B , the coupling between shoe  13  and controller  11  also occurs as pins  31  of controller  11  are inserted into receptacles  50  of portion  42  of shoe  13 . 
         [0071]    The process of connecting shoe  13  and controller  11  begins as shown in  FIG. 10A  which depicts the controller  11  and shoe  13  detached and in position to be coupled. By moving shoe  13  in the direction X (i.e., in the direction of the arrow toward controller  11 ), they can be coupled as shown in  FIGS. 9 and 10B . 
         [0072]    When coupled, railway  28  of controller  11  is received in channel  54  of portion  42  and allows portion  42  to be slid along railway  28  as portion  42  is inserted into controller receptacle  24 . Additionally, railway  28  fits around portion  55  of shoe  13 . The engagement of railway  28  and channel  54  fixes the position of controller  11  and shoe  13  in a direction Y so that shoe  13  cannot be moved out of controller receptacle  24  in the direction Y. 
         [0073]    Further, lip  23  of member  22  of controller  11  is engaged by clip member  56  of portion  42 . The engagement of lip  23  and clip member  56  fixes the position of controller  11  and shoe  13  in a second dimension so that shoe  13  cannot be moved in a direction X out of controller receptacle  24 . When the user wants to remove portion  42  from controller receptacle  24 , the user depresses member  22  in the direction Y so that lip  23  clears clip member  56 . Portion  42  thereupon be slid along railway  28  in direction X out of receptacle  24 . Flanges  44   a  and  44   b  engage portions  8   a  and  8   b , as described above. 
         [0074]    Other configurations can be used to maintain the portion  42  in the receptacle  24 . For example, in another embodiment, a knob or knurl can be formed on the portion  42  that engages or is seated with a detent within the receptacle when fully inserted. When the portion  42  is removed, the knob or knurl flexes slightly to bend away from the detent so that the portion can be removed. Other configurations are possible. 
         [0075]    In some examples described herein, shoe  13  is connected to a garment to deliver therapy to the user. The is made by stitching, gluing or embedding the shoe  13  in a laminate layer. In other examples, shoe  13  is connected to other structures to deliver therapy; charge controller  11 ; and/or program controller  11 . 
         [0076]    For example, referring now to  FIG. 11 , shoe  13  is electrically connected to a structure  60 . As described below, shoe  13  can be connected to a plurality of different structures so that controller  11  can be coupled thereto. 
         [0077]    In some examples, structure  60  is an apparatus that can be used to deliver therapy to the user. For example, as described below, structure  60  can be a patch (e.g., patch  104 ) or an electrode that is attached to the skin to deliver therapy. In other examples, structure  60  is a garment such as a belt that is worn around certain anatomy of a patient, such as the waist, arm, or leg. One or more shoes  13  can be located along the belt so that one or more controllers  11  can be coupled to the shoes  13  to deliver therapy at desired locations along the belt. For example, the belt can include a single shoe  13  for one controller  11 , and can include a plurality of electrodes that are spaced along the belt to deliver therapy along an entire surface for the patient.  FIG. 23D  shows an example of a belt including a shoe  13  with base  44  electrically connected to electrodes  1502 . Electrodes  1502  may be placed in any position along the belt and in any pattern suitable to provide therapy to a user. There may be an array of four electrodes, as shown in  FIG. 23D , or there may be more or fewer electrodes provided as necessary. In addition, multiple shoes  13 , may be placed on the belt of  FIG. 23D . In other examples, structure  60  is a brace or cast (e.g., air cast, knee brace, or back brace) with built-in electrodes that allow controller  11  to be connected to the shoe and delivery therapy to the desired area. 
         [0078]    In some embodiments, structure  60  is electrical components that are used to provide power so that controller  11  can be connected to shoe  13  to charge battery  26  in controller  11 . For example, in one embodiment, structure  60  is a docking station, such as docking station  1300  described below. In other examples, structure  60  is an electrical power transformer that can be plugged into a typical wall outlet or an automobile outlet to provide power to charge battery  26 . In other examples, controller  11  can also include an auxiliary charging port, such as a USB or micro-USB port, which can be used to charge controller  11 . In yet other examples, controller  11  can include on-board recharge capabilities, such as solar panels or inductive coupling technologies. 
         [0079]    In yet other examples, structure  60  is electrical circuitry that can be used to program controller  11 . In some embodiments, controller  11  includes computer readable media, such as RAM or ROM. In one embodiment, controller  11  includes flash memory that can be rewritten with new therapy programs to enhance the functionality of controller  11 . 
         [0080]    In such examples, structure  60  can be a docking station, such as docking station  1300  described below. In other examples, structure  60  can be a component in a care giver&#39;s office that allows the care giver to modify or enhance the therapies that can be provided by controller  11 . In other examples structure  60  can be connected to a LAN or have an Internet or phone connection. 
         [0081]    Referring now to  FIG. 12 , another example therapeutic electrical stimulation device  100  is shown. Device  100  is similar to device  10  described above, except that device  100  is configured differently. In the example of  FIG. 12 , device  100  is a transcutaneous electrical nerve stimulation (“TENS”) device. Device  100  includes controller  102  and patch  104 , similar to those described above. Controller  102  is a device that generates electrical impulses and supplies the electrical impulses to patch  104 . Patch  104  receives the electrical impulses from controller  102  and supplies the electrical impulses to a therapeutic location, such as the skin of a patient. 
         [0082]    In one embodiment, controller  102  includes a user interface having a power button  110  and amplitude adjustment buttons  112  and  114 . When power button  110  is first depressed, the controller turns ON and begins generating therapeutic electrical signals. When power button  110  is depressed again, the controller turns OFF and stops generating the therapeutic electrical signals. 
         [0083]    While the controller  102  is ON, amplitude adjustment buttons  112  and  114  are used to adjust the amplitude of the generated therapeutic electrical signals accordingly. Amplitude adjustment button  112  provides an input to increase the amplitude of the therapeutic electrical signals. Amplitude adjustment button  114  provides an input to decrease the amplitude of the therapeutic electrical signals. 
         [0084]    Patch  104  is typically applied to the skin of a patient. The electrical signals are conducted from the controller to the skin by patch  104 . Patch  104  includes a shoe  120  (shown in  FIG. 13 ), an insulating layer  122 , and conductive electrodes  124  and  126 . Shoe  120  is connected to one side of insulating layer  122 , and is configured to engage with a receptacle (shown in  FIG. 14 ) of controller  102 . Shoe  120  is a connector used to physically and electrically connect patch  104  with controller  102 . 
         [0085]    Electrodes  124  and  126  (shown more clearly in  FIG. 13 ) are located adjacent insulating layer  122  on a side opposite shoe  120 . The electrodes are typically a sheet of electrically conductive material that, when applied to a patient, provides an electrical connection with the skin of the patient to supply electrical pulses to a desired therapeutic location. An adhesive layer  128  is typically applied to one side of patch  104  to allow patch  104  to be securely, yet removably, adhered to the skin. Some embodiments of patch  104  include additional layers. 
         [0086]    During stimulation, controller  102  typically generates a voltage potential between electrodes  124  and  126  such that current enters the skin through one electrode, passes through the skin, and then returns through the other electrode. Some embodiments alternate the polarity of the electrodes during a therapy. In some embodiments a skin preparation product, such as a conductive gel, is applied to the skin prior to application of patch  104 . 
         [0087]    In some embodiments, buttons  110 ,  112 , and  114  are arranged with a unique tactile arrangement. For example, buttons  110 ,  112 , and  114  are arranged at one end of controller  102  and protrude out from the housing of controller  102 . The tactile arrangement allows the device to be controlled by the patient or caregiver even if the device is hidden from view under clothing or in a non-visible location, such as on the back. If, for example, the device is located under a shirt on the patient&#39;s upper arm, the patient can feel controller  102  through the shirt and locate protruding buttons  110 ,  112 , and  114 . Due to the unique arrangement of buttons  110 ,  112 , and  114 , the user is able to identify each button, and select from them accordingly. Other embodiments include additional tactile elements. For example, in some embodiments buttons  110 ,  112 , and  114  include an elevated identifier, such as a line, square, arrow, dot, circle, or Braille character. In other embodiments, buttons  110 ,  112 , and  114  each include a unique shape, such as a square, triangle, circle, oval, rectangle, arrow, or other desired shape. In yet other embodiments, buttons are located on different locations of the housing, such as on the sides or bottom of the housing. 
         [0088]      FIG. 13  is an exploded perspective view exemplary therapeutic electrical stimulation device  100 . Device  100  includes controller  102  and patch  104 . Controller  102  includes upper housing  202 , battery  204 , user input devices  206 , electrical circuitry  208 , and lower housing  210 . Patch  104  includes shoe  120 , insulating layer  212 , electrodes  124  and  126 , and adhesive layer  128 . 
         [0089]    Controller  102  includes an outer protective shell formed of upper housing  202  and lower housing  210 . Upper and lower housings  202  and  210  are made of any suitable material such as plastic, metal, or the like. A lower edge of upper housing  202  is configured to be connected with an upper edge of lower housing  210 . In some embodiments, a fastener is used to connect upper housing  202  to lower housing  210 . Examples of suitable fasteners include adhesive, screws, latching mechanisms, and other known fasteners. In other embodiments, upper housing  202  is directly connected to lower housing  210 , such as by welding or over molding. 
         [0090]    Upper and lower housings  202  and  210  act together to enclose battery  204  and electrical circuitry  208  and to at least partially enclose user input devices  206 . As a result, upper and lower housings  202  and  210  provide protection to the enclosed components from contact with other objects that could otherwise damage the components. In some embodiments, upper and lower housings  202  and  210  are water resistant to protect enclosed components from water or other fluids. Some embodiments of upper and lower housing  202  and  210  are completely sealed to resist most or all fluid, gas, or particle intrusion. Some embodiments are hermetically sealed. 
         [0091]    Lower housing  210  includes a controller receptacle  211  that is arranged and configured to receive shoe  120  of patch  104 . In some embodiments, lower housing  210  and portions of electrical circuitry  208  are uniquely arranged and configured to mate with shoe  120  and resist mating with other shoe configurations. This is sometimes referred to as a keyed receptacle. One benefit of a keyed receptacle is that it can be used to resist connection with inappropriate patches or other devices, such as to resist connection with a patch that would be incompatible with controller  102 . On the other hand, the keyed receptacle is also used in some embodiments to allow connection of controller  102  with various types of patches or other devices if desired. 
         [0092]    Battery  204  is a power source that provides electrical power to controller  102 . In some embodiments, battery  204  is a rechargeable battery such as a lithium-ion battery. Battery  204  can be charged by connecting controller  102  to a battery charger. One example of a battery charger is a docking station described in more detail herein. Inductive charging is used in some embodiments. In other embodiments, other rechargeable batteries are used, such as a nickel cadmium battery, a nickel metal hydride battery, or a rechargeable alkaline battery. Yet other embodiments include non-rechargeable, disposable batteries, such as alkaline batteries, or other known batteries. An alternate embodiment of controller  102  does not include battery  204 , but rather includes a different power source such as a capacitor. 
         [0093]    User input devices  206  receive input from a user to cause controller  102  to adjust an operational mode of the device  100 . Different operational modes may be used to provide different types of therapy, such as therapy to treat edema or to provide drug delivery. A more thorough description of how operational modes work can be found in U.S. Pat. No. 5,961,542 which is incorporated herein by reference. User input devices  206  include power button  110  and amplitude adjustment buttons  112  and  114 . User input devices  206  are arranged such that a portion of buttons  110 ,  112 , and  114  protrude through upper housing  202 . A user provides input to controller  102  by momentarily depressing one of buttons  110 ,  112 , and  114 . When the button is depressed, the force is transferred through user input device  206  to a switch of electrical circuitry  208 . The switch closes to make an electrical connection and causes current flow within electrical circuitry  208 . The electrical circuitry  208  responds to adjust the appropriate operational mode of controller  102 . 
         [0094]    Electrical circuitry  208  typically includes a circuit board and a plurality of electrical circuits such as a power supply circuit, pulse generator circuit, and electrical contacts for electrical connection with conductors of shoe  120 . Examples of electrical circuitry  208  are described in more detail herein. In some embodiments, electrical circuitry  208  includes sensors that receive electrical signals from patch  104 . In some embodiments the electrical circuitry is activated between output pulses to monitor the patient. Some embodiments of controller  102  further include sensor electronics that monitor patch  104  to be sure that patch has not become partially or fully disconnected from the patient. If the patch does become disconnected, the electronics deactivate delivery of therapeutic electrical signals from controller  102 . A more detailed description of how a patch connection can be monitored is found in U.S. Patent Application Publication No. 2004/0015212, which is incorporated herein by reference. In some embodiments, the electronics monitor for changes in impedance between electrodes. In another embodiment, electrical circuitry  208  also includes activity monitoring, such as with an accelerometer. With activity monitoring, feedback control is used to increase electrical stimulation level in response to activity level. 
         [0095]    Patch  104  is a device that transfers electrical impulses from controller  102  to a therapeutic location on a patient, such as the patient&#39;s skin. Patch  104  includes shoe  120 , insulating layer  212 , electrodes  124  and  126 , and adhesive layer  128 . 
         [0096]    Shoe  120  is arranged and configured to engage with controller  102 , such as through controller receptacle  211 . In some embodiments, shoe  120  includes a unique configuration that is designed to mate only with controller receptacle  211  and to resist connection with other receptacles or devices. The unique configuration is sometimes referred to as a keyed shoe. One benefit of a keyed shoe is that it can be used to resist connection with inappropriate controllers or other devices, such as to resist connection with a controller that would be incompatible with patch  104 . This may be done by creating a unique shoe configuration with a particular two or three dimensional shape that fits snugly within controller receptacle  211 . Thus, controller receptacles and shoes that do not have a matching two or three dimensional shape cannot be connected. On the other hand, the keyed shoe is also used in some embodiments to allow patch  104  to be connected with various types of controller  102 . In this case, the shoe may be designed with a two or three dimensional shape that fits into multiple controller receptacles. Shoe  120  includes conductors that conduct electrical signals between controller  102  and electrodes  124  and  126 . 
         [0097]    Patch  104  includes insulating layer  212 . Insulating layer  212  is connected to patch  104  by any suitable fastening mechanism, such as adhesive, screws, nails, or other known fasteners. In other embodiments, insulating layer  212  and shoe  120  are formed of a unitary piece, such as by molding. Conductors from shoe  120  pass from shoe  120 , through insulating layer  212 , and are connected to electrodes  124  and  126 . 
         [0098]    In some embodiments, insulating layer  212  is a primary structural layer of patch  104 . Insulating layer  212  also electrically insulates a side of patch  104 . In this way, if insulating layer  212  comes into contact with a conductive object (e.g., the hand of the patient or another electronic device), insulating layer  212  prevents or at least resists the electrical conduction between electrodes  124  and  126  and the conductive object. Inadvertent electrical shocks and unintended electrical connections are thereby reduced or entirely prevented. 
         [0099]    Electrodes  124  and  126  are electrical conductors that are used to introduce electrical signals to a therapeutic location of a patient, such as on to the patient&#39;s skin. Electrodes  124  and  126  are electrically connected to conductors that pass through shoe  120 . In some embodiments electrodes  124  and  126  are generally disk-shaped to distribute the electrical signals across a relatively large area of skin. In other embodiments, electrodes  124  and  126  are of a variety of other shapes including ring-shaped, circular, elliptical, serpentine, comb-shaped, or other desired shape. 
         [0100]    Patch  104  is connected to the skin of a patient with adhesive layer  128 . In some embodiments, adhesive layer  128  is applied across an entire surface of patch  104 , including across electrodes  124  and  126 . In such embodiments, adhesive layer  128  is electrically conductive. In other embodiments, adhesive layer  128  is applied to the surface of patch  104 , but not on the regions of electrodes  124  and  126 . Other adhesive layer arrangements are used in other embodiments. 
         [0101]      FIGS. 14-16  illustrate an exemplary method of connecting a controller  102  to a patch  104  of a therapeutic electrical stimulation device  100 .  FIGS. 14-16  are right side cross-sectional views of device  100 .  FIG. 14  illustrates controller  102  disconnected from patch  104 .  FIG. 15  illustrates controller  102  arranged in a first position over patch  104 .  FIG. 16  illustrates controller  102  arranged in a second position and connected with patch  104 . A method of disconnecting controller  102  from patch  104  is the reverse of that described herein. 
         [0102]    Before connecting controller  102  with patch  104 , patch  104  is typically applied to a desired therapeutic location on the patient (not shown in  FIG. 14 ) such that shoe  120  extends from patch  104  in a direction generally away from the therapeutic location. 
         [0103]    The process of connecting controller  102  with patch  104  begins as illustrated in  FIG. 14 , such that controller  102  is arranged such that controller receptacle  211  is in line with shoe  120 . Controller  102  is also oriented such that rear side  301  of shoe  120  is facing toward the rear side  302  of receptacle  211 . In some embodiments, shoe  120  in receptacle  211  is shaped such that shoe  120  can only be inserted into receptacle  211  in a single orientation. In other embodiments, shoe  120  can be inserted within receptacle  211  in multiple orientations, but can only be fully engaged (as shown in  FIG. 16 ) if shoe  120  and receptacle  211  are properly oriented. 
         [0104]    Once properly oriented, controller  102  is moved toward patch  104  in the direction of arrow A 1 , such that shoe  120  enters receptacle  211  as shown in  FIG. 15 . Controller  102  is then advanced in the direction of arrow A 2 . This movement of controller  102  causes shoe  120  to engage with controller  102  as shown in  FIG. 16 . In particular, electrical circuitry  208  makes electrical contact with conductors of shoe  120  to electrically connect electrodes of patch  104  with electrical circuitry  208 . 
         [0105]    Electrical connectors are used to electrically connect conductors of shoe  120  with electrical circuitry  208 . In one embodiment, male and female plug-type connectors are included as part of shoe  120  and electrical circuitry  208 . In another embodiment, surface conductors are used to connect with protruding electrical contacts, such as used in Universal Serial Bus (USB) connectors and for connecting memory cards with memory slots. Other electrical connectors are used in other embodiments. 
         [0106]    As described above,  FIGS. 14-16  illustrate a two-step method of connecting patch  104  and controller  102 . The first step involves moving controller  102  in the direction of arrow A 1 , and the second step involves moving controller  102  in the direction of arrow A 2 . This method of connection is partially a result of the “L-shape” of shoe  120 . Shoe  120  has a first portion  304  that extends generally normal to a surface of insulating layer  212 , and a second portion  306  that extends at generally a right-angle to the first portion  304 . 
         [0107]    One of the benefits of this shape of shoe  120  is that it resists unintentional disengagement of controller  102  from patch  104 , once controller  102  is properly connected (as shown in  FIG. 16 ). For example, if a force is applied to controller  102  in a direction opposite arrow A 1 , the second portion of shoe  120  resists disengagement of controller  102  from patch  104 . Sideways forces (e.g., forces normal to arrow A 1  and arrow A 2 ) are also resisted, as well as a force in the direction of arrow A 2 . A force in the direction opposite arrow A 2  will result in disconnection of shoe  120  from electrical circuitry  208 . However, shoe  120  will still provide support to receptacle  211  unless controller  102  is arranged vertically below patch  104 . This allows the user to manually grasp controller  102  before it becomes completely disconnected from patch  120  and reconnect controller  102 , if desired. If controller  102  is arranged vertically below patch  104 , then gravity will tend to pull controller  102  away from patch  104 . 
         [0108]    In another embodiment, shoe  120  has a generally linear shape (not shown in  FIGS. 14-16 ), such that shoe  120  is plugged directly into controller  102  in a single step, namely the insertion of shoe  120  into receptacle  211 . In this embodiment, electrical circuitry  208  includes an electrical connector that is in line with the path of entry of shoe  120  into receptacle  211  or directly surrounds the point of entry. 
         [0109]    In another possible embodiment, shoe  120  has an “L-shape” but receptacle  211  is arranged on a side of controller  102 . In this embodiment, connection of controller  102  with patch  104  is accomplished in a single step—insertion of a second portion of shoe  104  into the side receptacle. 
         [0110]    Some embodiments of shoe  120  and receptacle  211  are arranged and configured to safely disconnect from each other upon the application of a sufficient force. If the user bumps device  100  on another object, for example, it is preferred that controller  102  electrically disconnects from patch  104  before patch  104  becomes disengaged from the patient. Shoe  120  and receptacle  211  are designed to remain connected unless a sufficient force is applied to controller  102  and before the force becomes large enough to disconnect patch  104  from the patient. 
         [0111]      FIG. 17  is a perspective top view of an exemplary embodiment of partially assembled device  100 . In this figure, upper housing  202  and battery  204  (shown in  FIG. 13 ) are removed. Device  100  includes controller  102  and patch  104 . Controller  102  includes user input device  206  and electrical circuitry  208 . Electrical circuitry  208  includes circuit board  602  and electronic components  604 . Electrical components  604  include transformer  606 , status indicator  608 , and electrical connector  610 . 
         [0112]    In  FIG. 17 , shoe  120  is shown in the fully connected position, such as shown in  FIG. 16 . When in this position, electrical connectors of shoe  120  mate with electrical connectors  610  of electrical circuitry  208 . Circuit board traces on or within circuit board  602  communicate electrical signals between electrical components  604  and shoe  120 . 
         [0113]    Some embodiments of electrical circuitry  208  include transformer  606 . In some embodiments (such as shown in  FIG. 13 ), the transformer is mounted on a surface of the circuit board. To reduce space consumed by transformer  606 , some embodiments include a hole in circuit board  602 . Transformer  606  is inserted within the hole to reduce the overall distance that transformer  606  extends above circuit board  602 . This allows upper and lower housing  202  and  210  to have a reduced profile. Some embodiments include a receptacle in the circuit board (e.g., circuit board  29  of  FIG. 5 ) to accept a component such as portion  42  of shoe  13 . This allows the allows pins  31  of circuit board  29  to extend into the space created by connector receptacle  24 . 
         [0114]    Some embodiments include one or more status indicators  608 . Status indicators inform a user of the operational status of device  100  and can come in the form of visual, audible, and/or tactile indicators. Examples of suitable status indicators  608  include a light, an LED, a liquid crystal or other type of display, a speaker, a buzzer, and a vibrator. Status indicators  608  are used in some embodiments to show whether device  100  is ON or OFF. In other embodiments, status indicators  608  communicate an operational mode, such as a type of therapy being provided, or a change in operational mode, such as an increase or decrease in amplitude. In yet other embodiments, status indicators  608  are used to show battery power status (e.g., full power, percentage of full power, or low on power/in need of charge), or charging status (e.g., charging or fully charged). Other indicators are used in other possible embodiments. Speakers, buzzers, and vibrators are particularly useful for those with certain disabilities or impairments and also for communication when the device is located in an area that is not easily visible (e.g., on the back of a patient). 
         [0115]      FIG. 18  is a block diagram of an exemplary electrical schematic for controller  102 . Controller  102  includes power supply  700 , pulse generator  702 , power switch  704 , amplitude adjustment switches  706 , and output  708 . 
         [0116]    Power supply  700  provides electrical power to controller  102 . In some embodiments, power supply  700  includes a battery and also includes power filtering and/or voltage adjustment circuitry. Power supply  700  is electrically coupled to power switch  704  and to pulse generator  702 . Power switch  704  receives input from a user through power button  110  (e.g., shown in  FIG. 12 ) and operates with power supply  700  to turn controller  102  ON or OFF. 
         [0117]    Pulse generator  702  generates therapeutic electrical signals. Pulse generator  702  is electrically coupled to output  708  and provides the electrical signals to output  708 . In turn, output  708  is electrically coupled to patch electrodes to deliver the electrical signals to the therapeutic location of the patient. Amplitude adjustment switches  706  are electrically coupled to pulse generator  702  and receive input from the user through amplitude adjustment buttons  112  and  114  (e.g., shown in  FIG. 12 ). Amplitude adjustment switches  706  operate with pulse generator  702  to adjust the intensity of the electrical signals sent to output  708 . 
         [0118]    Some examples of suitable pulse generators are described in U.S. Pat. Nos. 4,887,603 and 4,922,908, both by Morawetz et al. and titled MEDICAL STIMULATOR WITH STIMULATION SIGNAL CHARACTERISTICS MODULATED AS A FUNCTION OF STIMULATION SIGNAL FREQUENCY, the disclosure of which is hereby incorporated by reference in its entirety. In some embodiments, the electrical signals generated by pulse generator  702  are simple modulated pulse (SMP) signals. Other configurations and electrical signals are possible. 
         [0119]      FIG. 19  is an electrical schematic of an exemplary circuit for controller  102 . Controller  102  includes power supply  800 , pulse generator  802 , power switch  804 , amplitude adjustment switch  806 , and output  808 . Power supply  800  includes battery  812 , thermistor  814 , step up converter  816 , and other electrical components. Power supply  800  is electrically coupled to supply power to pulse generator  802 . In addition, power supply  804  is electrically coupled to connector block  820  that is used to supply power to power supply  800  to charge battery  812 . 
         [0120]    In this example, battery  812  is a lithium-ion battery having a voltage of about 3.7 to 4.2 volts, although other battery types and voltages are used in other embodiments. Thermistor  814  is electrically coupled between battery  812  and connector block  820  and is used to detect the temperature of battery  812  to ensure that battery  812  is not overheated while recharging. Power switch  804  is used to turn controller  102  ON or OFF. Power switch  804  may be easily controlled, for example, by user control  110 . In one embodiment, switch  804  is a single pole double throw (SPDT) switch, as shown. Power supply  800  also includes step up converter  816 . Step up converter  816  operates to increase the voltage of power from battery  812  to a desired voltage. One suitable step up converter is the LTC3401 micropower synchronous boost converter that is distributed by Linear Technology Corporation, with headquarters in Milpitas, Calif. 
         [0121]    Pulse generator  802  receives power from power supply  700  and generates a therapeutic electrical signal. The therapeutic electrical signal is provided by pulse generator  802  to output  808 . Pulse generator  802  includes amplitude adjustment switch  806 . Amplitude adjustment switch  806  may be easily controlled, for example, by user controls  112  and  114 . In this embodiment, amplitude adjustment switch  806  is a potentiometer. When the potentiometer is adjusted, intensity of the electrical signal generated by pulse generator  802  is increased or decreased accordingly. 
         [0122]    In this example, pulse generator  802  includes first and second timers  830  and  832  as well as additional circuitry as shown. In one embodiment, both timers  830  and  832  are the TS556 low-power dual CMOS timer, distributed by STMicroelectronics, with headquarters in Geneva, Switzerland. 
         [0123]    Pulse generator  802  also includes output stage  840 . Output stage  840  includes MOSFET  842  and transformer  844 . Output stage  840  acts to increase the output voltage of the electrical signal before sending the electrical signal to output  808 . 
         [0124]      FIG. 20  is a block diagram of another exemplary electrical schematic for controller  102 . In this embodiment, controller  102  is formed from primarily digital circuitry. Controller  102  includes power supply  902 , battery  904 , controller processor  906 , power switch  108 , amplitude adjustment switches  910 , data communication device  912 , data storage device  914 , output stage  916 , and output  918 . Controller  102  is connected to external power source  920 , to charge battery  904 . In one embodiment, external power source  920  is a home or commercial power supply, such as available through an electrical power outlet. In another embodiment, external power source  920  is an vehicle power supply, such as accessible through a 12V receptacle. 
         [0125]    During normal operation, power supply  902  receives power from battery  904 . Power supply  902  converts the battery power to a desired voltage before supplying the power to other components of controller  102 . Power supply  902  also includes battery charger  930 . Battery charger  930  receives power from an external power supply and operates to recharge battery  904 . 
         [0126]    Control processor  906  controls the operation of controller  102 . Control processor  906  is powered by power supply  902 . Control processor  906  also generates electrical signals that are provided to output stage  916 . 
         [0127]    Control processor  906  is electrically coupled to power switch  908  and amplitude adjustment switches  910 . Control processor  906  monitors the state of power switch  908 . When control processor  906  detects that the state of power switch  908  has changed, control processor  906  turns controller  102  ON or OFF accordingly. Control processor  906  also monitors the state of amplitude adjustment switches  910 . When control processor  906  detects that the state of amplitude adjustment switches  910  has changed, control processor  906  increases or decreases the intensity of electrical signals provided to output stage  916  accordingly. 
         [0128]    Control processor  906  includes memory  932 . Firmware  934  is stored in memory  932 . Firmware  934  includes software commands and algorithms that are executed by control processor  906  and defines logical operations performed by control processor  906 . The software commands and algorithms in firmware  932  may be used to operate the electrical stimulation device in a desired mode, such as a mode that provides transcutaneous electrical nerve stimulation therapy. In certain embodiments, controller  102  includes a data communication device  912 . Data communication devices include wired or wireless communication devices, such as serial bus communication devices (e.g., a Universal Serial Bus communication devices), local area networking communication devices (e.g., an Ethernet communication device), a modem, a wireless area networking communication device (e.g., an 802.11x communication device), a wireless personal area networking device (e.g., a Bluetooth™ communication device or other communication device. 
         [0129]    Data communication device  912  can be used to send and receive data with another device. For example, data communication device  912  can be used to download different firmware  934  to the controller  102  to alter the operation of control processor  906 , and operate the therapeutic electrical stimulation device in a desired mode, such as a mode that provides iontophoresis therapy. In certain embodiments, a firmware algorithm must be purchased before it can be downloaded by a user. In certain embodiments, the a user must access a patient interface of a web server or other similar interface before downloading a firmware algorithm. Data communication device  912  can also be used to upload data to another device. For example, control processor  906  stores a therapy log in data storage device  914 . The control processor  906  can be used to upload the therapy log to an external device by sending the data log to data communication device  912 . 
         [0130]    Data storage device is a device capable of storing data, such as a memory card or other known data storage device. In some embodiments, data storage device  914  is part of memory  932 . 
         [0131]    When controller  102  is ON, control processor  906  generates therapeutic electrical signals, and provides those signals to output stage  916 . Output stage  916  converts and filters the electrical signals, and then provides the electrical signals to output  918 . Output  918  is electrically coupled to a patch that delivers electrical signals to the patient. 
         [0132]      FIG. 21  is an electrical schematic of another exemplary circuit for controller  102 . In this embodiment, controller  102  includes a control processor  1006  that controls the operation of controller  102 . In this embodiment, controller  102  is made from primarily digital circuitry. Controller  102  includes power supply  1002 , battery  1004 , control processor  1006 , power switch  1008 , amplitude adjustment switches  1010 , output stage  1016 , and output  1018 . Controller  102  can also be connected to external power source  1020 , such as to charge battery  1004 . 
         [0133]    In this embodiment, power supply  1002  includes a lithium-ion charge management controller  1030  and a step up converter  1032 , as well as other electrical components as shown. An example of a suitable lithium-ion charge management controller  1030  is the MCP73833 stand-alone linear lithium-ion charge management controller manufactured by Microchip Technology Inc., of Chandler, Ariz. An example of a suitable step up converter is the LTC3401 micropower synchronous boost converter. 
         [0134]    Battery  1004  provides power to power supply  1002 . In this example, battery  1004  is a lithium-ion 3.7V battery. Power supply  1002  can also be connected to external power source  1020 , such as a 5V DC power source. External power source  1020  provides power to power supply  1002  that enables power supply  1002  to recharge battery  1004 . In some embodiments, battery  1004  includes a thermistor to monitor the temperature of battery  1004  during charging. 
         [0135]    Control processor  1006  controls the operation of controller  102 . One example of a suitable control processor  1006  is the ATtiny44 8-bit microcontroller manufactured by Amtel Corporation, located in San Jose, Calif. Alternatively, various other processing devices may also be used including other microprocessors, central processing units (CPUs), microcontrollers, programmable logic devices, field programmable gate arrays, digital signal processing (DSP) devices, and the like. Control processor  1006  may be of any general variety such as reduced instruction set computing (RISC) devices, complex instruction set computing devices (CISC), or specially designed processing devices such as an application-specific integrated circuit (ASIC) device. 
         [0136]    Control processor  1006  is electrically coupled to power switch  1008  and amplitude adjustment switches  1010 . Power switch  1008  provides signals to control processor  1006  that cause control processor  1006  to alternate controller  102  between ON and OFF states accordingly. Amplitude adjustment switches  1010  instruct control processor  1006  to adjust the intensity of the electrical signals generated by controller  102 . Electrical signals generated by control processor  1006  are passed to output stage  1016 . 
         [0137]    Output stage  1016  converts the electrical signals received from control processor  1006  to an appropriate form and then provides the electrical signals to output  1018 . In this example, output stage  1016  includes MOSFET  1042  and transformer  1044 . Other embodiments do not include transformer  1044 , but rather use a flyback converter or other converter to generate an appropriate output signal. 
         [0138]      FIG. 22  is a top perspective view of another exemplary embodiment of patch  104 . Patch  104  includes insulating layer  212  and shoe  120 . Shoe  120  is connected to a surface of insulating layer  212 . In this embodiment, shoe  120  includes wires  1101  and  1103  that are electrically coupled to conductors within shoe  120 . The wires  1101  and  1103  may be connected to conductors within shoe  120  using a metal crimp or other suitable method of electrical connection. Wires  1101  and  1103  are also connected at an opposite end to patches  1102  and  1104 . Patches  1102  and  1104  may include electrodes such as a conducting polymer material. Patch  104  may be used in a garment or medical device such as the belt depicted in  FIGS. 23  A-D. 
         [0139]    In one embodiment, patch  104  includes one or more electrodes, such as shown in  FIG. 13 , and an adhesive layer that allows patch  104  to be connected to a patient or other device. In another embodiment, patch  104  does not include an electrode, but rather passes electrical signals through wires  1101  and  1103  to separate patches  1102  and  1104 . Patches  1102  and  1104  include an insulating layer and one or more electrodes, but do not include a shoe. Instead, patches  1102  and  1104  receive electrical signals from the shoe included in patch  104 . Patches  1102  and  1104  can be adhered to the patient such as with an adhesive layer. The electrodes of patches  1102  and  1104  direct the electrical signals to desired therapeutic locations of the patient. 
         [0140]    Other embodiments include any number of wires  1101  and  1103  and any number of patches  1102  and  1104  (e.g., one patch, two patches, three patches, four patches, five patches, etc.) as desired for a particular therapy. Shoe  120  includes an appropriate number of electrical conductors that can provide multiple electrical conduction channels for communicating electrical signals between controller  102  (such as shown in  FIG. 12 ) and the patches. In some embodiments, wires  1101  and  1103  are formed adjacent to or within insulating layers to provide additional protection to the wires from damage. In some embodiments, wires  1101  and  1103  are other types of electrical conductors. In other examples, multiple electrode sites can be positioned in a patch  104 . For example, a quad-patch can be formed with an insulating layer having four lobes, with each lobe having an electrode for delivery of therapy, as described below with respect to  FIG. 23D . Other configurations are possible. 
         [0141]    In some embodiments, patches  104 ,  1102 , and  1104  are held in place by a band, strap, brace, built, garment, active wear, or other suitable supporting object. For example, patches can be formed integral with a supporting object or inserted within a pocket or recess of a supporting object. Some embodiments include integrated hot or cold packs. The connection to a supporting object may be made by stitching, gluing, snapping, velcroing, embedding in a laminate layer or any other possible way to connect one or more of elements  1101 ,  1103 ,  104 ,  1102  and  1104  to a supporting material. In embodiments where one or more of elements  1101 ,  1103 ,  104 ,  1102  and  1104  are formed integral with a supporting object, they may be washed or cleaned (e.g., in a washing machine, soap and water, dry cleaned, etc.) along with the supporting object. Some further examples are illustrated in  FIG. 23A . 
         [0142]      FIG. 23A  schematically illustrates some of the possible applications and configurations of therapeutic electrical stimulation device  100 .  FIG. 23A  illustrates a patient  1200  including a front profile (left) and a rear profile (right). 
         [0143]    One application of device  100  is to reduce joint pain or to reduce swelling in a joint. For example, device  100  is integrated into elbow brace  1202 , hip support  1204 , knee braces  1206  and  1208 , shoulder brace  1210 , glove  1212 , back support  1214 , and sock  1216  to provide relief from pain or swelling at the respective location. This illustrates that device  100  can be used to treat symptoms at the patient&#39;s elbow, hip, knee, shoulder, wrist, hand, fingers, back, ankle, foot, or any other joint in the body. 
         [0144]    Alternatively, embodiments of device  100  are directly adhered to the desired therapeutic location, such as shoulder  1220 , as described herein. 
         [0145]    Another application of device  100  is to reduce muscle or other tissue pain at any desired therapeutic location on the body. For example, device  100  is adhered to thigh  1222  of patient  1200 . 
         [0146]    Another application of device  100  is to stimulate wound healing. For example, device  100  can be placed on or adjacent to wound  1224  (shown on the rear left thigh of patient  1200 ). Some embodiments of device  100  act as electronic adhesive bandage to promote wound healing and reduce pain associated with wound  1224 . Some embodiments of device  100  include controller  102  and patch  104  (such as shown in  FIG. 12 ) as a single non-separable unit. 
         [0147]    Furthermore, alternate patch configurations (such as shown in  FIG. 22 ) can be used to supply therapeutic electrical signals to multiple locations of the body (e.g., a back and hip) or to multiple regions of the same body part (e.g., opposite sides of the knee or top and bottom of the foot). 
         [0148]      FIGS. 23B and 23C  show an example of how a therapeutic stimulation device, such as device  100 , may be configured to provide therapy to as user (e.g., as depicted in  FIG. 23A ). In  FIG. 23B , shoe  13  is attached to a garment  2602 . The shoe  13  may be attached to garment  2062  in a variety of ways, for example it may be stitched or glued to the garment or embedded in a laminate layer. 
         [0149]    The garment  2062  may be any type of garment or medical device such as clothing or elbow brace  1202 , hip support  1204 , knee braces  1206  and  1208 , shoulder brace  1210 , glove  1212 , back support  1214 , and sock  1216 . The garment  2602  is connected to one or more electrodes  1502  positioned adjacent the garment and electrically connected to lead wire  46 . One or more electrodes  1502  may be placed in various positions on the garment  2602  (e.g., the layout shown in  FIG. 23D ). The electrodes  1502  may be wired and connected electrically in various patterns and orders and to one or more different shoes  13 . For example, two of the electrodes  1502  (right) of  FIG. 23D  are electrically connected to each other but not to the electrodes  1502  (left). The variance in electrode patterns and electrical connections allows for the ability to create various stimulation schemes for therapy. The electrodes are made of a conductive polymer, stainless steel or other suitable material, and may be integrated within the garment or connected to the outside of the garment by sewing, gluing, velcroing or other suitable attachment schemes. 
         [0150]    In certain embodiments, stainless steel snaps (male connector) are stamped through the garment and are thereby securely connected to the garment. The snaps are electrically conductive and allow for an electrode (female connector) to mechanically and electrically connect to the male snaps and become secured to the garment. The male snaps are connected to leads wires  46  and  48 , which are electrically connected to the shoe  13 . Snap connectors for electrodes are described in more detail in U.S. Pat. No. 6,438,428 which is incorporated herein by reference. 
         [0151]    As shown in  FIGS. 23B and 23C , the base  44  of shoe  13  and one or more of the lead wires  46  are positioned between layers of the garment  2602 . This allows the wires  46  to be hidden and shielded from the user. The base  44  physically holds the shoe  13  within the garment to create a connection between the garment and the shoe. The top of shoe  13  is exposed on the outside of garment  2602 , to allow connection to controller  11 . In certain embodiments, shoe  13 , lead wires  46 , and electrode  1502  remain attached as a unit, while the controller  11  may be frequently detached and reused for other applications with other shoes or at a different times with the same shoe. In this example, the shoe  13 , lead wires  46 , and electrode  1502  elements may all be washed or cleaned together. Typically, the garment including the shoe, wire, and electrodes are used for about 6 months before being disposed and replaced. 
         [0152]    In certain embodiments, the electrode  1502  connects directly to a user  1506  by sitting directly on top of the skin. In other embodiments, an adhesive layer  1504  is affixed to electrode  1502  and the adhesive layer affixes the electrode to the patient. The adhesive layer  1504  is a conductor to allow current to pass from the electrode  1502  to the patient  1506 . The adhesive layer  1504  may be sticky on both sides so that a more reliable electrical and mechanical connection is made with the skin of a user. In certain embodiments only one side of the adhesive layer  1504  is sticky, and one side (e.g., the exposed side) of the electrode  1502  is sticky. Typically the adhesive layer  1504  is used only once before being disposed, though it may be reused multiple times. 
         [0153]    In some embodiments, multiple devices  100  are in data communication with each other to synchronize therapies provided by each respective device. For example, wireless communication devices (e.g.,  912  shown in  FIG. 20 ) are used to communicate between two or more devices  100 . 
         [0154]    In some embodiments, device  100  is configured to provide interferential therapy, such as to treat pain originating within tissues deeper within the body than a typical TENS device. 
         [0155]    Some embodiments of device  100  are configured for drug delivery. Such embodiments typically include a drug reservoir (such as absorbent pads) within patch  104  (e.g., shown in  FIG. 13 ). Iontophoresis is then used to propel the drug (such as medication or bioactive-agents) transdermally by repulsive electromotive forces generated by controller  102 . An example of a suitable device for iontophoresis is described in U.S. Pat. No. 6,167,302 by Philippe Millot, titled DEVICE FOR TRANSCUTANEOUS ADMINISTRATION OF MEDICATIONS USING IONTOPHORESIS, the disclosure of which is hereby incorporated by reference in its entirety. 
         [0156]    Other therapies can also be delivered. For example, controller  100  can be programmed to deliver microcurrent. Such microcurrent can be a constant voltage that is delivered for wound healing purposes. Other therapies can be delivered to address pain, edema, drop-foot, and other abnormalities. 
         [0157]    The components of the therapeutic electrical stimulation devices, such as device  10  and garment  2602 , are manufactured to be disposable and replaced after the useful life of such components has expired. Useful life of a component can be defined, for example, by number of uses of the particular component, the lifetime of a component before wearing out, time established by the manufacturer, time available between reimbursements by Medicare or Medicaid (or other similar programs), or other similar standards. In certain embodiments, the controller is provided with a manufacturer-imposed useful life of about 5 years, such that upon the expiration of such 5 years, a replacement controller is made available to the patient. During its useful life, the controller may be reused for multiple applications on various different garments and with several different shoes  13 . In certain embodiments, the garment, such as shown in  FIG. 23A-D , including shoe  13  and patch  104 , is provided with a manufacturer imposed useful life of about 6 months or less. In certain embodiments, the adhesive layer (e.g. adhesive layer  128 ) is provided with manufacturer imposed useful life of one application or use, though it may be reused multiple times. In certain embodiments, a user uses a certain number of adhesives (e.g., a package of 10) on a monthly basis. 
         [0158]    In certain embodiments, the useful life of the component is predetermined prior to initial use or sale of the component, and it is replaced upon expiration of the useful life. In some implementations, the predetermined useful life coincides with a period established by regulatory or other administrative authority by paying for or reimbursing for such component. In some embodiments, such predetermined useful life is shorter than the period in which the component becomes physically worn out or inoperable. 
         [0159]      FIG. 24  is a perspective view of an exemplary docking station  1300 . Docking station  1300  includes housing  1302  including multiple slots  1304 ,  1306 , and  1308  and status indicators  1310  associated with each slot. 
         [0160]    Each slot of the docking station  1300  is arranged and configured to receive a controller  102  of a therapeutic electrical stimulation device  100 , such that multiple controllers  102  can be connected with docking station  1300  at any time. However, some embodiments of docking station  1300  include only a single slot  1304  or other port for connection to a single controller  102 . Other embodiments include any number of slots as desired. 
         [0161]    Docking station  1300  includes an electrical connector similar to connector  51  in shoe  13 , such as shown in  FIGS. 8A and 8B . When device  100  is inserted into docking station  1300 , shoe  120  engages with receptacle  211 , such as described with respect to  FIGS. 14-16 . When the shoe  120  engages with receptacle  211 , pins  31   a - 31   c  combine with receptacle  211  to form an electrical connection. When device  100  is coupled with docking station  1300 , data is transferred through pin  31   a  to the docking station  1300  through an abutting connector wire inside the station  1300 , similar to the connection formed when pin  31   a  joins wire  46 , as shown in  FIG. 10B . A ground connection is similarly made through pin  31   b , and the battery in controller  102  is charged through pin  31   c.    
         [0162]    In this example, docking station  1300  performs two primary functions. The first function of docking station  1300  is to recharge the battery of controller  102 . To do so, docking station  1300  is typically electrically coupled to a power source such as an electrical wall outlet. Docking station  1300  converts the power from the electrical wall outlet to an appropriate form and then provides the power to the power supply (e.g.,  902  shown in  FIG. 20 ) of controller  102 . 
         [0163]    The second function of docking station  1300  is to communicate data between controller  102  and a communication network. Controller  102  can send data to docking station  1300  and can receive data from docking station  1300 . This function is described in more detail with reference to  FIG. 25 . 
         [0164]    Some embodiments of docking station  1300  provide only one of these functions. Other embodiments provide additional features and functionality. For example, some embodiments of docking station  1300  allow multiple devices  100  to communicate with each other when connected with docking station  1300 . In other examples, docking station  1300  is also configured to communicate with one or more computers accessible through a network, as described below. This allows for interactive data sharing between devices in order to promote, for example, greater efficiency in hospitals. Connection to the docking station  1300  allows nurses to keep a record of pain management for patients, and thereby increase the quality of care. 
         [0165]    Docking station  1300  includes status indicators  1310  associated with each slot of docking station  1300 . In this example, status indicators  1310  include a data communication indicator and a charging indicator. The data communication indicator is a light emitting diode (LED) that illuminates when the docking station  1300  is communicating with the respective controller  102 . The charging indicator is an LED that illuminates when docking station  1300  is charging the respective controller  102 . Other embodiments include additional status indicators  1310 . Other types of status indicators include audible status indicators (e.g., speakers, buzzers, alarms, and the like) and visible status indicators (e.g., lights, liquid crystal displays, display screens, and the like). 
         [0166]    Docking station  1300  is not limited to connection with a single type of controller  102 . Multiple types of controllers  102  can be connected with docking station  1300  at any one time, if desired. For example, controllers  102  include a TENS device, an iontophoresis device, a muscle stimulation device (e.g., a neuromuscular electrical stimulation (NMES) device), a wound healing device, an interferential device, or other devices. 
         [0167]    In some examples, docking station  1300  is configured to be used at a patient&#39;s home, such as in a bathroom or kitchen. Docking station  1300  can include multiple stations for charging different types of devices, as well as drawers and other conveniences that allow docking station  1300  to be used for multiple purposes. 
         [0168]      FIG. 25  is a block diagram of an exemplary system for communicating across communication network  1400  involving therapeutic electrical stimulation devices. The system includes devices  102 ,  1402 , and  1404 . Devices  102  are in data communication with docking station  1300 , such as shown in  FIG. 24 . Device  1402  includes a wireless communication device and device  1404  includes a wired network communication device. The system also includes server  1406 , caregiver computing system  1408 , and patient computing system  1410 . Server  1406  includes database  1412  and Web server  1414 . System also includes wireless router  1416 . 
         [0169]    Communication network  1400  is a data communication network that communicates data signals between devices. In this example, communication network  1400  is in data communication with docking station  1300 , device  1402 , device  1404 , server  1406 , caregiver computing system  1408 , patient computing system  1410 , and wireless router  1416 . Docking station  1300  is in data communication with devices  102 . Wireless router  1416  is in data communication with device  1404 . Examples of communication network  1400  include the Internet, a local area network, an intranet, and other communication networks. 
         [0170]    In some embodiments, devices  102 ,  1402 , and  1404  store, in memory, data relating to therapy delivery or other operational characteristics of the respective devices. Communication network  1400  can be used to communicate that data to another device. For example, the data is transferred to patient computing system  1410  or to caregiver computing system  1408 . Once the data has been transferred to the computing system, the data is stored for review and analysis by the patient or the caregiver. Communication network  1400  can also be used to communicate data from devices  102 ,  1402 , and  1404  to server  1406 . Server  1406  stores the data in patient record  1420 . 
         [0171]    In some embodiments, server  1406  includes Web server  1414 . Web server  1414  includes caregiver interface  1430  patient interface  1432 . Additional interfaces are provided in some embodiments to third parties, such as an insurance company. Web server  1414  generates web pages that are communicated across communication network  1400  using a standard communication protocol. An example of such a protocol is hypertext transfer protocol. The webpage data is arranged in a standard form, such as hypertext markup language. Thew data is transferred across communication network  1400  and received by computing system  1408  and computing system  1410 . A browser operating on respective computing system reads the webpage data and displays the webpage to the user. 
         [0172]    Caregiver interface  1430  generates a webpage intended for use by a caregiver. The caregiver interface  1430  allows the caregiver to access patient records  1420  and generates reports or graphs to assist the caregiver in analyzing data from patient records  1420 . In addition, caregiver interface  1430  provides technical or medical suggestions to the caregiver. In some embodiments, caregiver interface  1430  also allows the caregiver to request adjustments to an operational mode of a device  102 ,  1402 , or  1404 . The operational mode adjustments are then communicated from server  1406  to the device, and the device makes the appropriate mode adjustments. 
         [0173]    Patient interface  1432  generates a webpage intended for use by a patient. In one example, patient interface  1432  allows the patient to access patient records  1420  and generates reports or graphs that assist the patient in analyzing data from patient records  1420 . Patient interface  1432  provides instructions to assist the patient with uploading data from device  102 ,  1402 , or  1404  to patient records  1420 . Instructions or other educational information is also provided by patient interface  1432 , if desired. 
         [0174]    In some embodiments, database  1412  includes firmware repository  1422 . Firmware repository  1422  includes data instructions that define the logical operation of a controller  102  (e.g. firmware  934  shown in  FIG. 20 ). Firmware repository  1422  is used in some embodiments to store various versions of firmware. For example, when a new firmware version is created, the developer stores the new version of firmware in the firmware repository  1422 . The firmware is then communicated to the appropriate devices  102 ,  1402 , or  1404 . The communication of new firmware versions can be either automatically distributed, or provided as an option to a patient or caregiver through interfaces  1430  and  1432 . In some embodiments, patient interface  1432  requires that a patient agree to pay for an upgraded firmware version before the firmware is made available for installation on a device. 
         [0175]    In another embodiment, firmware repository  1422  includes different firmware algorithms. Each firmware algorithm is specifically tailored to provide a specific therapy when executed by devices  102 ,  1402 ,  1404  or to be used with a particular hardware configuration. Examples of therapies defined by separate firmware algorithms include TENS, interferential therapy, edema therapy, muscle stimulation, iontophoresis therapy, and other therapies. A different firmware algorithm can also be specifically tailored for particular hardware configurations, such as for particular electrode numbers or configurations, for particular data communication devices, for different docking stations, or to accommodate other differences in hardware configuration. 
         [0176]    For example, a patient may first obtain a TENS device including a patch shown in  FIG. 12 . The device includes a first firmware type that defines an algorithm appropriate for TENS therapy. Later, the patient desires to upgrade the device to cause the device to operate as an iontophoresis device. To do so, the patient uses patient computing system  1410  to access patient interface  1432 . The patient selects a new firmware algorithm that is designed for iontophoresis therapy. The patient purchases and downloads the firmware associated with the iontophoresis therapy and loads the firmware onto the device. If necessary, an appropriate patch can be purchased through patient interface  1432  and delivered to the patient. The patch is then connected to the device controller and the new firmware algorithm is executed. The firmware causes the device to provide the desired iontophoresis therapy. In this way, some embodiments of controller  102  are customizable to provide multiple different therapies. 
         [0177]    In another embodiment, firmware is specially tailored for providing a therapy to a particular part of the body. As a result, separate firmware algorithms are available for the treatment of separate body parts and conditions associated with those body parts. Such firmware algorithms can be obtained by downloaded, as described above. 
         [0178]    In some embodiments, controllers  11 ,  100  include graphical user interfaces that allow the user to control the controllers  11 ,  100  and the therapy provided thereby. For example, the controllers can include built-in displays that are used to present the user interfaces. The user interfaces have home pages that allow the user to control various aspects of the controller, such as turning the device on and off, the type of therapy provided, and the intensity of the therapy. 
         [0179]    In other examples, a separate device is used to control the controllers  11 ,  100 . This device can communicate with the controllers  11 ,  100  through wired or wireless means (e.g., Wifi, Bluetooth). For example, a docking station (e.g., docking station  1300  described above) can include a user interface that is programmed to control the therapy provided by controllers  11 ,  100 . The docking station can communicate wirelessly with controllers  11 ,  100 . 
         [0180]    In some examples, controllers  11 ,  100  can include additional functionality, such as open lead detection. If a lead looses contact with a surface that is being delivered therapy, controllers  11 ,  100  are programmed to detect the open lead and to modify therapy appropriately until the lead again makes contact. For example, controllers  11 ,  100  can be programmed to shut down therapy that is delivered to the open lead and to issue an alarm so that the user can replace the lead. 
         [0181]    In other examples, controllers  11 ,  100  are programmed to sense feedback from the user and modify therapy accordingly. For example, controllers  11 ,  100  can be programmed to sense electromyographic biofeedback based on muscle activity and regulate therapy accordingly. In other examples, controllers  11 ,  100  are programmed to sense impedance and deliver therapy accordingly. In other examples, other biofeedback such as heart rate or activity levels can also be monitored. Other configurations are possible. 
         [0182]    In some examples, the user can provide specific feedback as well. For example, the user can set pain thresholds that controllers  11 ,  100  are programmed to remember. In other examples, the pain thresholds can be set automatically by controllers  11 ,  100  by monitoring capacitance levels. 
         [0183]    In yet other examples, controllers  11 ,  100  can include accelerometers and/or gyroscopes that can be used to measure orientation and activity level of the patient. For example, therapy can be adjusted based on the orientation of the patient (e.g., lying down or upright), as well as activity level. Controllers  11 ,  100  can be programmed to adjust therapy over a specific time. In yet other examples, multiple controllers can be used, and the controllers can be programmed to communicate with each other to synchronize the therapy that is delivered to the user, thereby forming a body area network. This network can be formed through wireless communication and/or conductive communication through the patient&#39;s body. 
         [0184]    The number of delivery channels can be modified (e.g., 2 channel vs. 4 channel) to modify the type and intensity of therapy. Also, devices can be connected in series to deliver an increase in therapy intensity or increase the area treated. 
         [0185]    The various embodiments described above are provided by way of illustration only and should not be construed to limit the claims attached hereto. Those skilled in the art will readily recognize various modifications and changes that may be made without following the example embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the disclosure.

Technology Category: 1