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 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 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 shoulder immobilizer (20) includes a semi-rigid or rigid orthosis, in the form of an arm support (22), which supports the upper arm, elbow, forearm and wrist of a patient. A bolster (24) is positioned between the patient and the arm support (22). A body strap (26) extends around the patient and attaches to the arm support (22) and/or the bolster (24), holding the arm support and bolster in position against the body of the patient. In embodiments, the shoulder immobilizer (20) may utilize a shoulder strap (28), but such a shoulder strap is not necessary for shoulder immobilization of the patient.

Abstract: An orthosis, and components thereof, that may be used as a shoulder brace for immobilization of the arm and shoulder joint may comprise components that may allow for abduction, internal/external rotation and allow for flexion and extension simultaneously. Methods of using the brace and methods of using the brace and treating shoulder injuries are similarly provided.

Abstract: Systems and methods provide air or gas-based temperature-controlled medical devices. The systems and methods may be applied to provide therapy to a patient suffering orthopedic or other injuries. Air or other gas is temperature-controlled and adjusted to meet a patient's physical needs and delivered the patient therapy site through a temperature regulated system including a therapeutic orthopedic wrap. Feedback mechanisms allow the caregiver or the patient to adjust the temperature of the gas. Other fluids may also be used. The systems and methods permit use of electrotherapy for enhanced therapy and injury recovery.

Abstract: A cold therapy device is provided. The device includes a fluid tank configured to hold a cooling fluid. The device includes a lid configured to seal an opening in the fluid tank. The device includes a temperature indicator configured to provide an indication of a temperature of the cooling fluid. The device includes a heat-conductive probe. The heat-conductive probe includes a first portion configured to be immersed in the cooling fluid or disposed in direct physical contact with the fluid tank. The heat-conductive probe includes a second portion in physical contact with the temperature indicator and configured to conduct heat between the first portion of the heat-conductive probe and the temperature indicator. A method of using the cold therapy device and a method of manufacturing the cold therapy device are also provided.

Abstract: Systems, methods, and devices are described for providing a brace having an inflation control. 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 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: Systems, methods, and devices are described for providing a brace having an inflation control. 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: Orthopedic braces and associated methods are described for treatment of lower back injuries and chronic back pain. An orthopedic brace may include a pair of back panels, a pair of front panels, and a closure system. A lateral end of each front panel is releasably coupleable to a lateral end of each back panel at a desired angle. A ventral end of each front panel includes an attachment provision configured to allow one of the front panels to releasably attach to the other of the front panels generally over an abdomen of a wearer. The brace also includes a pocket on the ventral end of at least one of the front panels, the pocket configured to temporarily receive a hand of the wearer to aid in donning the orthopedic brace.

Abstract: A unitized cast system for immobilizing and supporting a body part. The unitized casting system includes a first inner layer for padding and dissipating heat against the patient's skin. A second layer is formed from a thermoformable structural material such as perforated plastic. A protective third outer layer is provided to provide insulation for the second layer. These three layers are formed together to form a unitized cast system that is easily formed and applied to the patient.

Abstract: A hinged ankle brace having a semi-rigid ankle cuff and a semi-rigid foot bed rotatably connected by a medial hinge and a lateral hinge provides enhanced stability and support to a wearer's ankle. The medial hinge of the ankle brace may be higher than the lateral hinge to accurately replicate the bending motion of an ankle. The ankle brace also includes ratchetably interconnected semi-rigid straps. These semi-rigid straps provide a semi-rigid structure encircling the ankle of a wearer for enhanced support. The ratchet mechanism may include a curved window that enables angular adjustment of the ratcheting straps. The ankle brace may also include a soft inner liner and a soft outer sleeve. The outer sleeve is configured to provide compression to the semi-rigid shell, which in turn provides additional compression to the ankle. The semi-rigid foot bed may include posterior extensions that cup and support the wearer's heel, and a posterior cut-out portion that receives the wearer's heel.

Abstract: Disclosed is a shoulder brace for immobilization of the arm and shoulder joint in neutral abduction/adduction. Methods of using the brace and methods of treating shoulder injuries are similarly provided.

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.