Abstract: Devices, systems and methods are provided for treating migraine headaches and other conditions by non-invasive electrical stimulation of nerves and other tissue. A hand-held device includes a housing with a controller having a signal generator, an electrode for delivering electrical signals, and a conductive surface configured as a return path for the electrical signals. In certain implementations, the electrode is repositionable with respect to the housing. The patient can self-apply the hand-held device by pressing it against areas in need of pain relief. The device may include a pressure-sensitive gating switch to control delivery of the stimulation therapy. In certain embodiments, the electrode is a rollerball electrode. The device may include a chamber for retaining and dispensing conductive gel to the therapy site. In certain approaches, the device includes an electrode support for coupling an electrical stimulation system to the head for hands-free electrical stimulation therapy.

Abstract: A dorsal night splint has dynamic adjustable features that allow the patient to adjust the splint while in use to control the stretching of the plantar fascia and Achilles. A semi-rigid flexible frame is included along with a tightening strap that is anchored to the frame and by which the patient can tension the strap and adjust the structure of the frame to fit the patient's desired therapeutic or prophylactic needs.

Abstract: Described herein are systems and devices for providing an orthopedic walking brace having a housing and a sole with a curved distal surface. The housing is configured to encompass and immobilize a patient's ankle against flexion. The distal surface of the sole has a posterior region, a mid region, and an anterior region. The posterior region is configured to lie under a heel portion of the patient's foot, and the mid region is configured to lie under a center portion of the patient's foot. The anterior region is configured to lie under an anterior metatarsal and toe portion of the patient's foot, and has an Anterior-Posterior curvature that increases from a posterior side of the anterior region toward a middle portion of the anterior region and decreases from the middle portion toward an anterior side of the anterior region.

Abstract: A disposable electrical stimulation device and method for providing therapeutic treatment and pain management in a convenient, compact configuration. Electrode size and shape and relative configuration can be varied according to an intended application and use, or a universal configuration can be provided for use on almost any area of the body. The common structure of communicatively coupled dual electrodes including control circuitry and a power source accommodates a range of different sizes, configurations, stimulation treatment intensities, and other physical and electrical characteristics that can be pre-customized and packaged for specific, limited time use. The device can therefore be used in methods of providing therapy, managing pain, and achieving other treatment goals by electrical stimulation.

Abstract: A multi-layered composite material suitable for use in orthopedics includes a foam core layer bonded between two layers of thermoformable polymer material. The thermoformable material is heat formable within a target temperature range allowing for rapid heating and application to a patient such as in the form of a splint. While within the target temperature range, the composite material includes a dwell time sufficiently long to enable proper fitment and adjustment, yet not overly long requiring extended periods of holding the composite material in place. The composite material is very light yet extremely rigid and easily conformable to patients.

Abstract: A device for the treatment of the body of a wearer comprising an orthopedic brace combined with at least one electrically active zone to stimulate the body of the wearer of the brace.

Abstract: Systems, methods, and devices are described for providing a fluid control for an inflation system. The control directs fluid flow from an inflation component to one or more inflatable cells of the brace. The inflatable cells are independently inflated and deflated by the inflation component through the control. The control allows a user to create a fluid path between the inflation component and one of the inflatable cells by positioning the control in an orientation corresponding to the desired inflatable cells. Each inflatable cell is independently inflated and deflated in various orientations of the control.

Abstract: A moldable rigid ankle brace is disclosed. The rigid stabilizing ankle brace includes a heat-moldable multi-layer housing having an opening for receiving a user's ankle, a footplate attached to the housing, and a closure mechanism. The multi-layer housing includes a middle layer, which is substantially stiff at a temperature below about 130° F. and moldable at temperatures between about 130° F. and 275° F. A method of stabilizing an ankle is also disclosed. The method may include providing a rigid stabilizing ankle brace, having a heat-moldable multi-layer housing having an opening for receiving a user's ankle, and a footplate removably attached to said housing, heating the ankle brace to between about 130° F. to about 275° F., and applying said heated ankle brace to the ankle of a patient in need thereof.

Abstract: In various embodiments, the invention disclosed herein provides systems, devices and methods for providing electrical stimulation to a patient. An electrical mechanical interconnection is provided to facilitate user friendly systems and devices. Exemplary therapeutic electrical stimulation devices include a shoe connected mechanically and electrically to a conductor that provides signals for electrical stimulation.

Abstract: A moldable ankle flexible brace is disclosed. The flexible ankle brace may include a heat-moldable, multi-layer leg support portion, a heat-moldable, multi-layer foot support portion, a pair of hinges connecting the leg support portion to the foot support portion, an opening for receiving a user's ankle, and a closure mechanism. The flexible ankle brace may include a middle layer that is substantially stiff at a temperature below about 130° F. and moldable at temperatures above 130° F. Also disclosed is a method of using a flexible ankle brace to treat an ankle. The method may include, for example, heating the brace to above 130° F. placing the heated brace on a patient's ankle and molding the brace to conform to the shape of the patient's ankle.

Abstract: A device and method for carrying out dialysis and stimulation of a patient at the same time, in which an inflatable/deflatable cuff applies the stimulation.

Abstract: Disclosed herein are devices for preventing or treating an injury to an individual. Also provided are devices and methods for alleviating pain or discomfort caused by equipment or other padding or articles of clothing or uniform. The device can include a disposable padded tape having a plurality of force absorbing zones. It can also include an adhesive layer for attaching the device to a body contacting surface.

Abstract: 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.

Abstract: A low-profile electrical connector includes a housing having exterior perimeter sides and top and bottom surfaces, where the bottom surface is configured to extend along a user's body site and the top surface is spaced above the bottom surface. The connector also includes a side-entry guide channel disposed along the bottom surface. The channel includes an opening along the exterior perimeter side that is configured to receive an electrically conductive element. The channel is also configured to guide the electrically conductive element within the housing. The connector includes a receptacle positioned within the housing and forms an electrically conductive interface with the electrically conductive element.

Abstract: A composite material 10 for forming custom fitted orthopedic and other products. The composite material is easily formable when heated to temperatures of about two hundred degrees Fahrenheit for a time of at least six to eight minutes and then is rigid at temperatures of about one hundred thirty degrees. The composite material can be sewn and formed in complex shapes when initially heated to about two hundred degrees. Closure attachments 60 can be secured to the composite material as needed on site rather than at the manufacturing facility. The composite material can be custom fitted to a patient in situ.

Abstract: 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.

Abstract: Devices, systems and methods are provided for treating migraine headaches and other conditions by non-invasive electrical stimulation of nerves and other tissue. A hand-held device includes a housing with a controller having a signal generator, an electrode for delivering electrical signals, and a conductive surface configured as a return path for the electrical signals. In certain implementations, the electrode is repositionable with respect to the housing. The patient can self-apply the hand-held device by pressing it against areas in need of pain relief. The device may include a pressure-sensitive gating switch to control delivery of the stimulation therapy. In certain embodiments, the electrode is a rollerball electrode. The device may include a chamber for retaining and dispensing conductive gel to the therapy site. In certain approaches, the device includes an electrode support for coupling an electrical stimulation system to the head for hands-free electrical stimulation therapy.