Systems and methods for therapeutic electrical stimulation

A patch for a therapeutic electrical stimulation device includes a shoe connected to the first side of the patch, the shoe including a body extending in a longitudinal direction from a first end to a second end, and having first and second surfaces, the first end of the shoe defining at least two ports, and the first surface of the shoe defining a connection member. The patch also includes at least one conductor positioned in the ports of the first end of the shoe. The shoe is configured for sliding insertion into a receptacle defined by a controller so that the conductor is connected to the controller to deliver electrical current from the controller, through the conductor, and to the electrodes, and the connection member is at least partially captured by a detent defined by the controller in the receptacle to retain the shoe within the receptacle.

BACKGROUND

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.

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.

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.

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.

SUMMARY

In general terms, this disclosure is directed to therapeutic electrical stimulation. One aspect is a therapeutic electrical stimulation device comprising a controller, the controller including 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; and a patch arranged to convey the electrical signals from the controller, the patch including a shoe, an insulating layer, and electrodes, wherein the shoe is removably connected to the controller at the receptacle, wherein the shoe is electrically coupled to the conductor, and wherein the electrodes are electrically coupled to the shoe.

Another aspect is a 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 electrically coupled to the electrical signal generator to receive the electrical signal, the receptacle arranged and configured to receive a portion of a patch to electrically couple a portion of the patch with the conductor.

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.

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.

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.

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.

DETAILED DESCRIPTION

Referring now toFIG. 1, an example therapeutic electrical stimulation device10is shown. In this example, device10is a transcutaneous electrical nerve stimulation (“TENS”) device. Device10includes controller11and shoe13. Controller11is a device that generates electrical impulses and supplies the electrical impulses to shoe13. Shoe13receives the electrical impulses from controller11and supplies the electrical impulses to a therapeutic location, such as the skin of a patient.

As shown inFIGS. 2-5, controller11includes an outer protective shell formed of upper housing12and lower housing14. Upper and lower housings12,14are made of any suitable material such as plastic, metal, or the like. A lower edge of upper housing12is configured to be connected with an upper edge of lower housing14. In some embodiments, a fastener is used to connect upper housing12to lower housing14. Examples of suitable fasteners include adhesive, screws, latching mechanisms, and other known fasteners. In other embodiments, upper housing12is directly connected to lower housing14, such as by welding or over molding.

Upper and lower housings12,14act together to enclose battery26and electrical circuitry27. As a result, upper and lower housings12,14provide protection to the enclosed components from contact with other objects that could otherwise damage the components. In some embodiments, upper and lower housings12,14are water resistant to protect enclosed components from water or other fluids. Some embodiments of upper and lower housing12,14are completely sealed to resist most or all fluid, gas, or particle intrusion. Some embodiments are hermetically sealed.

Battery26is a power source that provides electrical power to controller11. In some embodiments, battery26is a rechargeable battery such as a lithium-ion battery. Battery26can be charged by connecting controller11to 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 controller11does not include battery26, but rather includes a different power source such as a capacitor.

Lower housing14includes a controller receptacle24that is arranged and configured to receive a portion42of shoe13. In some embodiments, lower housing14and portions of electrical circuitry27are uniquely arranged and configured to mate with portion42and resist mating with other show configurations. In addition, a railway28is positioned within controller receptacle24to receive complementary structure on portion42. These features are 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 controller11. On the other hand, the keyed receptacle is also used in some embodiments to allow connection of controller11with various types of patches or other devices if desired.

In the example shown, the electrical circuitry27includes a PCB board29with a plurality of pins31extending therefrom. Pins31are sized to be received in receptacles formed in corresponding portion42of the shoe13to create an electrical connection between controller11and shoe13, as described below.

Upper housing12includes a member22that moves into and out of controller receptacle24to capture and release corresponding structure on the42of the shoe13. As described further below, as portion42is inserted into controller receptacle24, member22engages structure on portion42to couple portion42to controller11. To release portion42, the user depresses member22to disengage member22from portion42. Portion42of shoe13can then be pulled out of controller receptacle24.

In one embodiment, controller11includes a user interface having a power button20and amplitude adjustment buttons16and18. When power button20is first depressed, the controller turns ON and begins generating therapeutic electrical signals. When power button20is depressed again, the controller turns OFF and stops generating the therapeutic electrical signals.

While the controller11is ON, amplitude adjustment buttons16and18are used to adjust the amplitude of the generated therapeutic electrical signals accordingly. Amplitude adjustment button16provides an input to increase (“+”) the amplitude of the therapeutic electrical signals. Amplitude adjustment button18provides an input to decrease (“−”) the amplitude of the therapeutic electrical signals.

Referring now toFIGS. 6-8, shoe13is shown in greater detail. In the example shown, shoe13includes portion42and a base44. Also typically included, but not shown, is a patch with an insulating layer (see, e.g., insulating layer122described below). Portion42is configured to engage with a receptacle (shown inFIGS. 9 and 10) of controller11. Portion42is a connector used to physically and electrically connect shoe13with controller11.

Electrodes46,48extend from portion42. Electrodes46,48are 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 (not show, but see adhesive layer128described below) is typically applied to one side of shoe13to allow shoe13to be securely, yet removably, adhered to the skin. Some embodiments of shoe13include additional layers.

During stimulation, controller11typically generates a voltage potential between electrodes46,48such 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 shoe13.

To make electrical connection between shoe13and controller11, portion42includes a plurality of electrical receptacles50on a front face52of portion42. Electrical receptacles50are sized to receive pins31of controller11when portion42is fully inserted into connector receptacle24(seeFIGS. 9 and 10). This creates an electrical connection between controller11and shoe13and allows controller11to deliver electrical stimulation therapy through electrodes46,48to the patient.

Referring now toFIGS. 9 and 10, shoe13is coupled to controller11. In this position, pins31of controller11are inserted into receptacles50of portion42to create an electrical connection therebetween.

In addition, railway28of controller11is received in channel54of portion42and allows portion42to be slid along railway28as portion42is inserted into controller receptacle24. The engagement of railway28and channel54fixes the position of controller11and shoe13in a direction Y so that shoe13cannot be moved out of controller receptacle24in the direction Y.

Further, lip23of member22of controller11is engaged by clip member56of portion42. The engagement of lip23and clip member56fixes the position of controller11and shoe13in a second dimension so that shoe13cannot be moved in a direction X out of controller receptacle24. When the user wants to remove portion42from controller receptacle24, the user depresses member22in the direction Y so that lip23clears clip member56. Portion42thereupon be slid along railway28in direction X out of receptacle24.

Other configurations can be used to maintain the portion42in the receptacle24. For example, in another embodiment, a knob or knurl can be formed on the portion42that engages or is seated with a detent within the receptacle when fully inserted. When the portion42is removed, the knob or knurl flexes slightly to bend away from the detent so that the portion can be removed. Other configurations are possible.

In some examples described herein, shoe13is connected to a patch to deliver therapy to the user. In other examples, shoe13is connected to other structures to: (i) deliver therapy; (ii) charge controller11; and/or (iii) program controller11.

For example, referring now toFIG. 11, shoe13is electrically connected to a structure60. As described below, shoe13can be connected to a plurality of different structures so that controller11can be coupled thereto.

In some examples, structure60is an apparatus that can be used to deliver therapy to the user. For example, as described below, structure60can be a patch (e.g., patch104) that is attached to the skin to deliver therapy. In other examples, structure60is 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 shoes13can be located along the best so that one or more controllers11can be coupled to the shoes13to deliver therapy at desired locations along the belt. For example, the belt can include a single shoe13for one controller11, and can include a plurality of electrodes that are spaced along the belt to delivery therapy along an entire surface for the patient. In other examples, structure60is a brace or cast (e.g., air cast, knee brace, or back brace) with built-in electrodes that allow controller11to be connected to the shoe and delivery therapy to the desired area.

In some embodiments, structure60is electrical components that are used to provide power so that controller11can be connected to shoe13to charge battery26in controller11. For example, in one embodiment, structure60is a docking station, such as docking station1300described below. In other examples, structure60is an electrical power transformer that can be plugged into a typical wall outlet or an automobile outlet to provide power to charge battery26. In other examples, controller11can also include an auxiliary charging port, such as a USB or micro-USB port, which can be used to charge controller11. In yet other examples, controller11can include on-board recharge capabilities, such as solar panels or inductive coupling technologies.

In yet other examples, structure60is electrical circuitry that can be used to program controller11. In some embodiments, controller11includes computer readable media, such as RAM or ROM. In one embodiment, controller11includes flash memory that can be rewritten with new therapy programs to enhance the functionality of controller11.

In such examples, structure60can be a docking station, such as docking station1300described below. In other examples, structure60can be a component in a care giver's office that allows the care giver to modify or enhance the therapies that can be provided by controller11.

In this example, device100is a transcutaneous electrical nerve stimulation (“TENS”) device. Device100includes controller102and patch104. Controller102is a device that generates electrical impulses and supplies the electrical impulses to patch104. Patch104receives the electrical impulses from controller102and supplies the electrical impulses to a therapeutic location, such as the skin of a patient.

In one embodiment, controller102includes a user interface having a power button110and amplitude adjustment buttons112and114. When power button110is first depressed, the controller turns ON and begins generating therapeutic electrical signals. When power button110is depressed again, the controller turns OFF and stops generating the therapeutic electrical signals.

While the controller102is ON, amplitude adjustment buttons112and114are used to adjust the amplitude of the generated therapeutic electrical signals accordingly. Amplitude adjustment button112provides an input to increase the amplitude of the therapeutic electrical signals. Amplitude adjustment button114provides an input to decrease the amplitude of the therapeutic electrical signals.

Patch104is typically applied to the skin of a patient. The electrical signals are conducted from the controller to the skin by patch104. Patch104includes a shoe120(shown inFIG. 13), an insulating layer122, and conductive electrodes124and126. Shoe120is connected to one side of insulating layer122, and is configured to engage with a receptacle (shown inFIG. 14) of controller102. Shoe120is a connector used to physically and electrically connect patch104with controller102.

Electrodes124and126(shown more clearly inFIG. 13) are located adjacent insulating layer122on a side opposite shoe120. 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 layer128is typically applied to one side of patch104to allow patch104to be securely, yet removably, adhered to the skin. Some embodiments of patch104include additional layers.

During stimulation, controller102typically generates a voltage potential between electrodes124and126such 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 patch104.

In some embodiments, buttons110,112, and114are arranged with a unique tactile arrangement. For example, buttons110,112, and114are arranged at one end of controller102and protrude out from the housing of controller102. 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's upper arm, the patient can feel controller102through the shirt and locate protruding buttons110,112, and114. Due to the unique arrangement of buttons110,112, and114, the user is able to identify each button, and select from them accordingly. Other embodiments include additional tactile elements. For example, in some embodiments buttons110,112, and114include an elevated identifier, such as a line, square, arrow, dot, circle, or Braille character. In other embodiments, buttons110,112, and114each 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.

Controller102includes an outer protective shell formed of upper housing202and lower housing210. Upper and lower housings202and210are made of any suitable material such as plastic, metal, or the like. A lower edge of upper housing202is configured to be connected with an upper edge of lower housing210. In some embodiments, a fastener is used to connect upper housing202to lower housing210. Examples of suitable fasteners include adhesive, screws, latching mechanisms, and other known fasteners. In other embodiments, upper housing202is directly connected to lower housing210, such as by welding or over molding.

Upper and lower housings202and210act together to enclose battery204and electrical circuitry208and to at least partially enclose user input devices206. As a result, upper and lower housings202and210provide protection to the enclosed components from contact with other objects that could otherwise damage the components. In some embodiments, upper and lower housings202and210are water resistant to protect enclosed components from water or other fluids. Some embodiments of upper and lower housing202and210are completely sealed to resist most or all fluid, gas, or particle intrusion. Some embodiments are hermetically sealed.

Lower housing210includes a controller receptacle211that is arranged and configured to receive shoe120of patch104. In some embodiments, lower housing210and portions of electrical circuitry208are uniquely arranged and configured to mate with shoe120and 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 controller102. On the other hand, the keyed receptacle is also used in some embodiments to allow connection of controller102with various types of patches or other devices if desired.

Battery204is a power source that provides electrical power to controller102. In some embodiments, battery204is a rechargeable battery such as a lithium-ion battery. Battery204can be charged by connecting controller102to 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 controller102does not include battery204, but rather includes a different power source such as a capacitor.

User input devices206receive input from a user to cause controller102to adjust an operational mode of the device100. User input devices206include power button110and amplitude adjustment buttons112and114. User input devices206are arranged such that a portion of buttons110,112, and114protrude through upper housing202. A user provides input to controller102by momentarily depressing one of buttons110,112, and114. When the button is depressed, the force is transferred through user input device206to a switch of electrical circuitry208. The switch closes to make an electrical connection and causes current flow within electrical circuitry208. The electrical circuitry208responds to adjust the appropriate operational mode of controller102.

Electrical circuitry208typically 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 shoe120. Examples of electrical circuitry208are described in more detail herein. In some embodiments, electrical circuitry208includes sensors that receive electrical signals from patch104. In some embodiments the electrical circuitry is activated between output pulses to monitor the patient. Some embodiments of controller102further include sensor electronics that monitor patch104to 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 controller102. In some embodiments, the electronics monitor for changes in impedance between electrodes. In another embodiment, electrical circuitry208also includes activity monitoring, such as with an accelerometer.

Patch104is a device that transfers electrical impulses from controller102to a therapeutic location on a patient, such as the patient's skin. Patch104includes shoe120, insulating layer212, electrodes124and126, and adhesive layer128.

Shoe120is arranged and configured to engage with controller102, such as through controller receptacle211. In some embodiments, shoe120includes a unique configuration that is designed to mate only with controller receptacle211and to resist connection with other receptacles or devices. This 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 patch104. On the other hand, the keyed shoe is also used in some embodiments to allow patch104to be connected with various types of controller102. Shoe120includes conductors that conduct electrical signals between controller102and electrodes124and126.

Patch104includes insulating layer212. Insulating layer212is connected to patch104by any suitable fastening mechanism, such as adhesive, screws, nails, or other known fasteners. In other embodiments, insulating layer212and shoe120are formed of a unitary piece, such as by molding. Conductors from shoe120pass from shoe120, through insulating layer212, and are connected to electrodes124and126.

In some embodiments, insulating layer212is a primary structural layer of patch104. Insulating layer212also electrically insulates a side of patch104. In this way, if insulating layer212comes into contact with a conductive object (e.g., the hand of the patient or another electronic device), insulating layer212prevents or at least resists the electrical conduction between electrodes124and126and the conductive object. Inadvertent electrical shocks and unintended electrical connections are thereby reduced or entirely prevented.

Electrodes124and126are electrical conductors that are used to introduce electrical signals to a therapeutic location of a patient, such as on to the patient's skin. Electrodes124and126are electrically connected to conductors that pass through shoe120. In some embodiments electrodes124and126are generally disk-shaped to distribute the electrical signals across a relatively large area of skin. In other embodiments, electrodes124and126are of a variety of other shapes including ring-shaped, circular, elliptical, serpentine, comb-shaped, or other desired shape.

Patch104is connected to the skin of a patient with adhesive layer128. In some embodiments, adhesive layer128is applied across an entire surface of patch104, including across electrodes124and126. In such embodiments, adhesive layer128is electrically conductive. In other embodiments, adhesive layer128is applied to the surface of patch104, but not on the regions of electrodes124and126. Other adhesive layer arrangements are used in other embodiments.

FIGS. 14-16illustrate an exemplary method of connecting a controller102to a patch104of a therapeutic electrical stimulation device100.FIGS. 14-16are right side cross-sectional views of device100.FIG. 14illustrates controller102disconnected from patch104.

FIG. 15illustrates controller102arranged in a first position over patch104.FIG. 16illustrates controller102arranged in a second position and connected with patch104. A method of disconnecting controller102from patch104is the reverse of that described herein.

Before connecting controller102with patch104, patch104is typically applied to a desired therapeutic location on the patient (not shown inFIG. 14) such that shoe120extends from patch104in a direction generally away from the therapeutic location.

The process of connecting controller102with patch104begins as illustrated inFIG. 14, such that controller102is arranged such that controller receptacle211is in line with shoe120. Controller102is also oriented such that rear side301of shoe120is facing toward the rear side302of receptacle211. In some embodiments, shoe120in receptacle211is shaped such that shoe120can only be inserted into receptacle211in a single orientation. In other embodiments, shoe120can be inserted within receptacle211in multiple orientations, but can only be fully engaged (as shown inFIG. 16) if shoe120and receptacle211are properly oriented.

Once properly oriented, controller102is moved toward patch104in the direction of arrow A1, such that shoe120enters receptacle211as shown inFIG. 15. Controller102is then advanced in the direction of arrow A2. This movement of controller102causes shoe120to engage with controller102as shown inFIG. 16. In particular, electrical circuitry208makes electrical contact with conductors of shoe120to electrically connect electrodes of patch104with electrical circuitry208.

Electrical connectors are used to electrically connect conductors of shoe120with electrical circuitry208. In one embodiments, male and female plug-type connectors are included as part of shoe120and electrical circuitry208. 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.

As described above,FIGS. 14-16illustrate a two-step method of connecting patch104and controller102. The first step involves moving controller102in the direction of arrow A1, and the second step involves moving controller102in the direction of arrow A2. This method of connection is partially a result of the “L-shape” of shoe120. Shoe120has a first portion304that extends generally normal to a surface of insulating layer212, and a second portion306that extends at generally a right-angle to the first portion304.

One of the benefits of this shape of shoe120is that it resists unintentional disengagement of controller102from patch104, once controller102is properly connected (as shown inFIG. 16). For example, if a force is applied to controller102in a direction opposite arrow A1, the second portion of shoe120resists disengagement of controller102from patch104. Sideways forces (e.g., forces normal to arrow A1and arrow A2) are also resisted, as well as a force in the direction of arrow A2. A force in the direction opposite arrow A2will result in disconnection of shoe120from electrical circuitry208. However, shoe120will still provide support to receptacle211unless controller102is arranged vertically below patch104. This allows the user to manually grasp controller102before it becomes completely disconnected from patch120and reconnect controller102, if desired. If controller102is arranged vertically below patch104, then gravity will tend to pull controller102away from patch104.

In another embodiment, shoe120has a generally linear shape (not shown inFIGS. 14-16), such that shoe120is plugged directly into controller102in a single step, namely the insertion of shoe120into receptacle211. In this embodiment, electrical circuitry208includes an electrical connector that is in line with the path of entry of shoe120into receptacle211or directly surrounds the point of entry.

In another possible embodiment, shoe120has an “L-shape” but receptacle211is arranged on a side of controller102. In this embodiment, connection of controller102with patch104is accomplished in a single step-insertion of a second portion of shoe104into the side receptacle.

Some embodiments of shoe120and receptacle211are arranged and configured to safely disconnect from each other upon the application of a sufficient force. If the user bumps device100on another object, for example, it is preferred that controller102electrically disconnects from patch104before patch104becomes disengaged from the patient. Shoe120and receptacle211are designed to remain connected unless a sufficient force is applied to controller102and before the force becomes large enough to disconnect patch104from the patient.

InFIG. 17, shoe120is shown in the fully connected position, such as shown inFIG. 16. When in this position, electrical connectors of shoe120mate with electrical connectors610of electrical circuitry208. Circuit board traces on or within circuit board602communicate electrical signals between electrical components604and shoe120.

Some embodiments of electrical circuitry208include transformer606. In some embodiments (such as shown inFIG. 13), the transformer is mounted on a surface of the circuit board. To reduce space consumed by transformer606, some embodiments include a hole in circuit board602. Transformer606is inserted within the hole to reduce the overall distance that transformer606extends above circuit board602. This allows upper and lower housing202and210to have a reduced profile.

Some embodiments include one or more status indicators608. Status indicators inform a user of the operational status of device100and can come in the form of visual, audible, and/or tactile indicators. Examples of suitable status indicators608include a light, an LED, a liquid crystal or other type of display, a speaker, a buzzer, and a vibrator. Status indicators608are used in some embodiments to show whether device100is ON or OFF. In other embodiments, status indicators608communicate 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 indicators608are 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).

FIG. 18is a block diagram of an exemplary electrical schematic for controller102. Controller102includes power supply700, pulse generator702, power switch704, amplitude adjustment switches706, and output708.

Power supply700provides electrical power to controller102. In some embodiments, power supply700includes a battery and also includes power filtering and/or voltage adjustment circuitry. Power supply700is electrically coupled to power switch704and to pulse generator702. Power switch704receives input from a user through power button110(e.g., shown inFIG. 12) and operates with power supply700to turn controller1020N or OFF.

Pulse generator702generates therapeutic electrical signals. Pulse generator702is electrically coupled to output708and provides the electrical signals to output708. In turn, output708is electrically coupled to patch electrodes to deliver the electrical signals to the therapeutic location of the patient. Amplitude adjustment switches706are electrically coupled to pulse generator702and receive input from the user through amplitude adjustment buttons112and114(e.g., shown inFIG. 12). Amplitude adjustment switches706operate with pulse generator702to adjust the intensity of the electrical signals sent to output708.

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 generator702are simple modulated pulse (SMP) signals. Other configurations and electrical signals are possible.

FIG. 19is an electrical schematic of an exemplary circuit for controller102. Controller102includes power supply800, pulse generator802, power switch804, amplitude adjustment switch806, and output808. Power supply800includes battery812, thermistor814, step up converter816, and other electrical components. Power supply800is electrically coupled to supply power to pulse generator802. In addition, power supply804is electrically coupled to connector block820that is used to supply power to power supply800to charge battery812.

In this example, battery812is 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. Thermistor814is electrically coupled between battery812and connector block820and is used to detect the temperature of battery812to ensure that battery812is not overheated while recharging. Power switch804is used to turn controller1020N or OFF. In one embodiment, switch804is a single pole double throw (SPDT) switch, as shown. Power supply800also includes step up converter816. Step up converter816operates to increase the voltage of power from battery812to 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.

Pulse generator802receives power from power supply800and generates a therapeutic electrical signal. The therapeutic electrical signal is provided to by pulse generator802to output808. Pulse generator802includes amplitude adjustment switch806. In this embodiment, amplitude adjustment switch806is a potentiometer. When the potentiometer is adjusted, intensity of the electrical signal generated by pulse generator802is increased or decreased accordingly.

In this example, pulse generator802includes first and second timers830and832as well as additional circuitry as shown. In one embodiment, both timers830and832are the TS556 low-power dual CMOS timer, distributed by STMicroelectronics, with headquarters in Geneva, Switzerland.

Pulse generator802also includes output stage840. Output stage840includes MOSFET842and transformer844. Output stage840acts to increase the output voltage of the electrical signal before sending the electrical signal to output808.

FIG. 20is a block diagram of another exemplary electrical schematic for controller102. In this embodiment, controller102is formed from primarily digital circuitry. Controller102includes power supply902, battery904, controller processor906, power switch908, amplitude adjustment switches910, data communication device912, data storage device914, output stage916, and output918. Controller102can be connected to external power source920, such as to charge battery904. In one embodiment, external power source920is a home or commercial power supply, such as available through an electrical power outlet. In another embodiment, external power source920is an vehicle power supply, such as accessible through a 12V receptacle.

During normal operation, power supply902receives power from battery904. Power supply902converts the battery power to a desired voltage before supplying the power to other components of controller102. Power supply902also includes battery charger930. Battery charger930receives power from an external power supply and operates to recharge battery904.

Control processor906controls the operation of controller102. Control processor906is powered by power supply902. Control processor906also generates electrical signals that are provided to output stage916.

Control processor906is electrically coupled to power switch908and amplitude adjustment switches910. Control processor906monitors the state of power switch908. When control processor906detects that the state of power switch908has changed, control processor906turns controller1020N or OFF accordingly. Control processor906also monitors the state of amplitude adjustment switches910. When control processor906detects that the state of amplitude adjustment switches910has changed, control processor906increases or decreases the intensity of electrical signals provided to output stage916accordingly.

Control processor906includes memory932. Firmware934is stored in memory932. Firmware934includes software commands that are executed by control processor906and defines logical operations performed by control processor906.

In some embodiments, controller102includes a data communication device912. 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.

Data communication device912can be used to send and receive data with another device. For example, data communication device912can be used to download different firmware934to alter the operation of control processor906. Data communication device912can also be used to upload data to another device. For example, control processor906stores a therapy log in data storage device914. The control processor906can be used to upload the therapy log to an external device by sending the data log to data communication device912.

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 device914is part of memory932.

When controller102is ON, control processor906generates therapeutic electrical signals, and provides those signals to output stage916. Output stage916converts and filters the electrical signals, and then provides the electrical signals to output918. Output918is electrically coupled to a patch that delivers electrical signals to the patient.

FIG. 21is an electrical schematic of another exemplary circuit for controller102. In this embodiment, controller102includes a control processor1006that controls the operation of controller102. In this embodiment, controller102is made from primarily digital circuitry. Controller102includes power supply1002, battery1004, control processor1006, power switch1008, amplitude adjustment switches1010, output stage1016, and output1018. Controller102can also be connected to external power source1020, such as to charge battery1004.

In this embodiment, power supply1002includes a lithium-ion charge management controller1030and a step up converter1032, as well as other electrical components as shown. An example of a suitable lithium-ion charge management controller1030is 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.

Battery1004provides power to power supply1002. In this example, battery1004is a lithium-ion 3.7V battery. Power supply1002can also be connected to external power source1020, such as a 5V DC power source. External power source1020provides power to power supply1002that enables power supply1002to recharge battery1004. In some embodiments, battery1004includes a thermistor to monitor the temperature of battery1004during charging.

Control processor1006controls the operation of controller102. One example of a suitable control processor1006is 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 processor1006may 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.

Control processor1006is electrically coupled to power switch1008and amplitude adjustment switches1010. Power switch1008provides signals to control processor1006that cause control processor1006to alternate controller102between ON and OFF states accordingly. Amplitude adjustment switches1010instruct control processor1006to adjust the intensity of the electrical signals generated by controller102. Electrical signals generated by control processor1006are passed to output stage1016.

Output stage1016converts the electrical signals received from control processor1006to an appropriate form and then provides the electrical signals to output1018. In this example, output stage1016includes MOSFET1042and transformer1044. Other embodiments do not include transformer1044, but rather use a flyback converter or other converter to generate an appropriate output signal.

FIG. 22is a top perspective view of another exemplary embodiment of patch104. Patch104includes insulating layer212and shoe120. Shoe120is connected to a surface of insulating layer212. In this embodiment, shoe120includes wires1101and1103that are electrically coupled to conductors within shoe120. Wires1101and1103are also connected at an opposite end to patches1102and1104.

In one embodiment, patch104includes one or more electrodes, such as shown inFIG. 13, and an adhesive layer that allows patch104to be connected to a patient or other device. In another embodiment, patch104does not include an electrode, but rather passes electrical signals through wires1101and1103to patches1102and1104. Patches1102and1104include one or more electrodes and can be adhered to the patient such as with an adhesive layer. The electrodes of patches1102and1104direct the electrical signals to desired therapeutic locations of the patient.

Other embodiments include any number of wires1101and1103and any number of patches1102and1104(e.g., one patch, two patches, three patches, four patches, five patches, etc.) as desired for a particular therapy. Shoe120includes an appropriate number of electrical conductors that can provide multiple electrical conduction channels for communicating electrical signals between controller102(such as shown inFIG. 12) and the patches. In some embodiments, wires1101and1103are formed adjacent to or within insulating layers to provide additional protection to the wires from damage. In some embodiments, wires1101and1103are other types of electrical conductors.

In other examples, multiple electrode sites can be positioned in a patch104. For example, a quad-patch can be formed with an insulating layer have four lobes, with each lob having an electrode for delivery of therapy. Other configurations are possible.

In some embodiments, patches104,1102, and1104do not include an adhesive layer, but rather 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. Some further examples are illustrated inFIG. 23.

FIG. 12schematically illustrates some of the possible applications and configurations of therapeutic electrical stimulation device100.FIG. 23illustrates a patient1200including a front profile (left) and a rear profile (right).

One application of device100is to reduce joint pain or to reduce swelling in a joint. For example, device100is integrated into elbow brace1202, hip support1204, knee braces1206and1208, shoulder brace1210, glove1212, back support1214, and sock1216to provide relief from pain or swelling at the respective location. This illustrates that device100can be used to treat symptoms at the patient's elbow, hip, knee, shoulder, wrist, hand, fingers, back, ankle, foot, or any other joint in the body.

Alternatively, embodiments of device100are directly adhered to the desired therapeutic location, such as shoulder1220, as described herein.

Another application of device100is to reduce muscle or other tissue pain at any desired therapeutic location on the body. For example, device100is adhered to thigh1222of patient1200.

Another application of device100is to stimulate wound healing. For example, device100can be placed on or adjacent to wound1224(shown on the rear left thigh of patient1200). Some embodiments of device100act as electronic adhesive bandage to promote wound healing and reduce pain associated with wound1224. Some embodiments of device100include controller102and patch104(such as shown inFIG. 12) as a single non-separable unit.

Furthermore, alternate patch configurations (such as shown inFIG. 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).

In some embodiments, multiple devices100are in data communication with each other to synchronize therapies provided by each respective device. For example, wireless communication devices (e.g.,912shown inFIG. 20) are used to communicate between two or more devices100.

In some embodiments, device100is configured to provide interferential therapy, such as to treat pain originating within tissues deeper within the body than a typical TENS device.

Some embodiments of device100are configured for drug delivery. Such embodiments typically include a drug reservoir (such as absorbent pads) within patch104(e.g., shown inFIG. 13). Iontophoresis is then used to propel the drug (such as medication or bioactive-agents) transdermally by repulsive electromotive forces generated by controller102. 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.

Other therapies can also be delivered. For example, controller100can 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.

FIG. 24is a perspective view of an exemplary docking station1300. Docking station1300includes housing1302including multiple slots1304,1306, and1308and status indicators1310associated with each slot.

Each slot of the docking station1300is arranged and configured to receive a controller102of a therapeutic electrical stimulation device100, such that multiple controllers102can be connected with docking station1300at any time. However, some embodiments of docking station1300include only a single slot1304or other port for connection to a single controller102. Other embodiments include any number of slots as desired.

Docking station1300includes an electrical connector similar to shoe120, such as shown inFIGS. 3-5. When device100is inserted into docking station1300, shoe120engages with receptacle211, such as shown inFIGS. 14-16. In this way, docking station1300is electrically coupled to controller102.

In this example, docking station1300performs two primary functions. The first function of docking station1300is to recharge the battery of controller102. To do so, docking station1300is typically electrically coupled to a power source such as an electrical wall outlet. Docking station1300converts the power from the electrical wall outlet to an appropriate form and then provides the power to the power supply (e.g.,902shown inFIG. 20) of controller102.

The second function of docking station1300is to communicate data between controller102and a communication network. Controller102can send to docking station1300and can receive data from docking station1300. This function is described in more detail with reference toFIG. 25.

Some embodiments of docking station1300provide only one of these functions. Other embodiments provide additional features and functionality. For example, some embodiments of docking station1300allow multiple devices100to communicate with each other when connected with docking station1300. In other examples, docking station1300is also configured to communicate with one or more computers accessible through a network, as described below.

Docking station1300includes status indicators1310associated with each slot of docking station1300. In this example, status indicators1310include a data communication indicator and a charging indicator. The data communication indicator is a light emitting diode (LED) that illuminates when the docking station1300is communicating with the respective controller102. The charging indicator is an LED that illuminates when docking station1300is charging the respective controller102. Other embodiments include additional status indicators1310. 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).

Docking station1300is not limited to connection with a single type of controller102. Multiple types of controllers102can be connected with docking station1300at any one time, if desired. For example, controllers102include 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.

In some examples, docking station1300is configured to be used at a patient's home, such as in a bathroom or kitchen. Docking station1300can include multiple stations for charging different types of devices, as well as drawers and other conveniences that allow docking station1300to be used for multiple purposes.

FIG. 25is a block diagram of an exemplary system for communicating across communication network1400involving therapeutic electrical stimulation devices. The system includes devices102,1402, and1404. Devices102are in data communication with docking station1300, such as shown inFIG. 24. Device1402includes a wireless communication device and device1404includes a wired network communication device. The system also includes server1406, caregiver computing system1408, and patient computing system1410. Server1406includes database1412and Web server1414. System also includes wireless router1416.

Communication network1400is a data communication network that communicates data signals between devices. In this example, communication network1400is in data communication with docking station1300, device1402, device1404, server1406, caregiver computing system1408, patient computing system1410, and wireless router1416. Docking station1300is in data communication with devices102. Wireless router1416is in data communication with device1404. Examples of communication network1400include the Internet, a local area network, an intranet, and other communication networks.

In some embodiments, devices102,1402, and1404store, in memory, data relating to therapy delivery or other operational characteristics of the respective devices. Communication network1400can be used to communicate that data to another device. For example, the data is transferred to patient computing system1410or to caregiver computing system1408. 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 network1400can also be used to communicate data from devices102,1402, and1404to server1406. Server1406stores the data in patient record1420.

In some embodiments, server1406includes Web server1414. Web server1414includes caregiver interface1430patient interface1432. Additional interfaces are provided in some embodiments to third parties, such as an insurance company. Web server1414generates web pages that are communicated across communication network1400using 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. The webpage data is transferred across communication network1400and received by computing system1408and computing system1410. A browser operating on respective computing system reads the webpage data and displays the webpage to the user.

Caregiver interface1430generates a webpage intended for use by a caregiver. The caregiver interface1430allows the caregiver to access patient records1420and generates reports or graphs to assist the caregiver in analyzing data from patient records1420. In addition, caregiver interface1430provides technical or medical suggestions to the caregiver. In some embodiments, caregiver interface1430also allows the caregiver to request adjustments to an operational mode of a device102,1402, or1404. The operational mode adjustments are then communicated from server1406to the device, and the device makes the appropriate mode adjustments.

Patient interface1432generates a webpage intended for use by a patient. In one example, patient interface1432allows the patient to access patient records1420and generates reports or graphs that assist the patient in analyzing data from patient records1420. Patient interface1432provides instructions to assist the patient with uploading data from device102,1402, or1404to patient records1420. Instructions or other educational information is also provided by patient interface1432, if desired.

In some embodiments, database1412includes firmware repository1422. Firmware repository1422includes data instructions that define the logical operation of a controller102(e.g. firmware934shown inFIG. 20). Firmware repository1422is 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 repository1422. The firmware is then communicated to the appropriate devices102,1402, or1404. The communication of new firmware versions can be either automatically distributed, or provided as an option to a patient or caregiver through interfaces1430and1432. In some embodiments, patient interface1432requires that a patient agree to pay for an upgraded firmware version before the firmware is made available for installation on a device.

In another embodiment, firmware repository1422includes different firmware algorithms. Each firmware algorithm is specifically tailored to provide a specific therapy when executed by devices102,1402,1404or 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.

For example, a patient may first obtain a TENS device including a patch shown inFIG. 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 system1410to access patient interface1432. 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 interface1432and 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 controller102are customizable to provide multiple different therapies.

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.

In some embodiments, controllers11,100include graphical user interfaces that allow the user to control the controllers11,100and 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.

In other examples, a separate device is used to control the controllers11,100. This device can communicate with the controllers11,100through wired or wireless means (e.g., Wifi, Bluetooth). For example, a docking station (e.g., docking station1300described above) can include a user interface that is programmed to control the therapy provided by controllers11,100. The docking station can communicate wirelessly with controllers11,100.

In some examples, controllers11,100can include additional functionality, such as open lead detection. If a lead looses contact with a surface that is being delivered therapy, controllers11,100are programmed to detect the open lead and to modify therapy appropriately until the lead again makes contact. For example, controllers11,100can 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.

In other examples, controllers11,100are programmed to sense feedback from the user and modify therapy accordingly. For example, controllers11,100can be programmed to sense electromyographic biofeedback based on muscle activity and regulate therapy accordingly. In other examples, controllers11,100are 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.

In some examples, the user can provide specific feedback as well. For example, the user can set pain thresholds that controllers11,100are programmed to remember. In other examples, the pain thresholds can be set automatically by controllers11,100by monitoring capacitance levels.

In yet other examples, controllers11,100can 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. Controllers11,100can 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's body.

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.