Patent Publication Number: US-2021186736-A1

Title: Conformable Orthosis

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This PCT application claims priority to and the benefit of provisional patent application titled “Conformable Orthosis”, application number 201841026261, filed in the Indian Patent Office on 13 Jul. 2018. The specification of the above referenced patent application is incorporated herein by reference in its entirety. 
    
    
     BACKGROUND 
     The apparatus disclosed herein, in general, relates to a medical device, and in particular, relates to a conformable and reconfigurable orthosis. Orthotic supports are dimensionally specific to a patient&#39;s body. For example, casts made of plaster of Paris or casts made of existing types of composites cannot be refitted from one patient to another if they differ in size. Ankle and foot orthosis need to snugly fit to the ankle, calf and foot to be effective. Spinal orthosis supports require to confirm to the shape of the spine to provide effective support. Hence, there is an unmet need for orthotic support devices that are conformable to the abutting body part, and that can be reconfigurable in shape. 
     SUMMARY OF THE INVENTION 
     The apparatus disclosed herein addresses the above recited unmet need for orthotic support that are conformable and reconfigurable. Advantageously, such a conformable and reconfigurable orthosis can be adjusted in shape to accommodate for body swelling. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  illustrates a flat grid conformable and reconfigurable orthosis. 
         FIG. 1B  illustrates the conformable and reconfigurable orthosis wrapped as a three-dimensional support on an arm of a patient. 
         FIG. 2  illustrates an internal structure of the conformable and reconfigurable orthosis. 
         FIG. 3  illustrates the conformable and reconfigurable orthosis used in an ankle and foot orthosis. 
         FIG. 4A  illustrates a front view of the conformable and reconfigurable orthosis used in a spinal orthosis. 
         FIG. 4B  illustrates a side view of the conformable and reconfigurable orthosis used in a spinal orthosis. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1A  illustrates a flat grid conformable and reconfigurable orthosis  101 . The grid is composed of rope like sections. By electrically connecting a lead point  102  to a power source, the heat of internal wiring in the conformable and reconfigurable orthosis  101  softens the conformable and reconfigurable orthosis  101  and allows the conformable and reconfigurable orthosis  101  to be easily wrapped on an arm  103  of a patient as exemplarily illustrated in  FIG. 1B .  FIG. 1B  illustrates the conformable and reconfigurable orthosis  101  wrapped as a support on the arm  103  of the patient. After cooling, the shape of the conformable and reconfigurable orthosis  101  sets to the wrapped form.  FIG. 1B  exemplarily illustrates a wrapping of the conformable and reconfigurable orthosis  101  around the arm  103  of a patient with a hand fracture. 
       FIG. 2  illustrates an internal structure of the conformable and reconfigurable orthosis  101 . The conformable and reconfigurable orthosis  101  comprises a central core metallic wire resistive heating element  101   a , an electrically insulating layer  101   b  such as glass fiber or nylon fiber, a structural layer  101   c  of carbon fiber composites, and a thermal insulation and/or a skin compatible cushioning layer  101   d . For example, a 0.5 mm diameter nichrome wire core is the electrically resistive central core metallic wire resistive heating element  101   a  that is configured to reach a maximum temperature of 180° Celsius based on the input current and the maximum set voltage. The electrically insulating layer  101   b  is a braided glass fiber sleeve. The structural layer  101   c  is a carbon fiber composite with a glass transition temperature or a thermal deformity temperature less than the temperature to which the central core metallic wire resistive heating element  101   a  heats the structural layer  101   c . The carbon fiber composite comprises carbon fiber in a thermoplastic or thermosetting matrix. In an embodiment, a thermoset resin epoxy is used in the structural layer  101   c . The thermal insulation layer  101   d  is a lightweight and thermally insulating layer, for example, a soft polyester fiber that significantly inhibits transfer heat to the patient&#39;s arm  103  exemplarily illustrated in  FIG. 1B .  FIG. 1B  illustrates the conformable and reconfigurable orthosis wrapped as a three-dimensional support on an arm of a patient. Optionally, a thermal insulation cloth may first be laid on the body part, and subsequently removed after the conformable and reconfigurable orthosis  101  has cooled and set into shape. 
     For example, a thin 2 mm thick insulation cloth was placed on a test mannequin hand. The 0.5 mm diameter electrical nicrome wire was electrically charged to rapidly heat it to 180 C within five seconds. Within another five seconds the carbon fiber structural layer  101   c  heated upto 180 C and softened. The heated conformable and reconfigurable orthosis  101  was then placed on the insulation above the mannequin hand and then gently pressed to the contour of the mannequin&#39;s hand. As the carbon fiber structural layer  101   c  heated upto 180 C, it came to the consistency of a flexible rope, very little pressure was needed. Within 10 seconds the gentle pressure was released, the structural layer  101   c  rapidly cooled, and the shape was set for the orthosis. The thermal insulation layer  101   d , acted as a partial heat sink and did not allow transfer of heat to the mannequin hand. The temperature on the mannequin hand did not exceed 45 degree celcius even temporarily for 5 seconds. The 2 mm thick insulation cloth acted as a second level of insulation. In many test cases, there was no need for the thick insulation cloth. The insulation cloth was later easily slid and removed from under the set orthosis. 
       FIG. 3  illustrates the conformable and reconfigurable orthosis  101  used in an ankle and foot orthosis. The following conformable members  301  are embedded within the structure of the ankle and foot orthosis: central core metallic wire resistive heating element  101   a , an electrically insulating layer  101   b  such as glass fiber or nylon fiber, a structural layer  101   c  of carbon fiber composites, and a thermal insulation and/or a skin compatible cushioning layer  101   d.    
       FIG. 4A  illustrates a front view of the conformable and reconfigurable orthosis  101  used in a spinal orthosis.  FIG. 4B  illustrates a side view of the conformable and reconfigurable orthosis  101  used in a spinal orthosis. The following conformable members are embedded within the structure of the spinal orthosis  402 : central core metallic wire resistive heating element  101   a , an electrically insulating layer  101   b  such as glass fiber or nylon fiber, a structural layer  101   c  of carbon fiber composites, and a thermal insulation and/or a skin compatible cushioning layer  101   d . The straps  401  hold the spinal orthosis to the body. 
     The apparatus disclosed herein is applicable for any type of orthotic support, and is not limited to hand orthosis, spinal orthosis and ankle and foot orthosis as exemplified. For example, it can be applied for neck supports, back supports, pelvic supports, wrist supports, shoulder, elbow and knee bracing supports. 
     The foregoing examples have been provided merely for explanation and are in no way to be construed as limiting of the conformable and reconfigurable orthosis  101  disclosed herein. While the conformable and reconfigurable orthosis  101  has been described with reference to various embodiments, it is understood that the words, which have been used herein, are words of description and illustration, rather than words of limitation. Furthermore, although the conformable and reconfigurable orthosis  101  has been described herein with reference to particular means, materials, and embodiments, the conformable and reconfigurable orthosis  101  is not intended to be limited to the particulars disclosed herein; rather, the conformable and reconfigurable orthosis  101  extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims. While multiple embodiments are disclosed, it will be understood by those skilled in the art, having the benefit of the teachings of this specification, that the conformable and reconfigurable orthosis  101  disclosed herein is capable of modifications and other embodiments may be effected and changes may be made thereto, without departing from the scope and spirit of the conformable and reconfigurable orthosis  101  disclosed herein.