Abstract:
An anterior opening spinal orthosis features a sternal plate and/or a bridged pectoral pad set. The sternal plate and/or a bridged pectoral pad set is at least partially supported by a spring biased hinge having an axis of motion perpendicular to a sagittal anterior-posterior midplane. The spring biased hinge is capable of providing a posteriorly directed force against the chest of a patient.

Description:
[0001]     This application is related to U.S. patent application Ser. No. 10/265,287 entitled “Anterior Sternal Thoraco-Lumbosacral Spinal Orthosis,” which is incorporated herein by reference in its entirety. 
     
    
       [0002]     An exemplary aspect of this invention relates to spinal orthosis. More particularly, an exemplary aspect of the invention relates to spinal orthoses and a spring biased hinge mechanism that is capable of providing rigid frame spinal bracing for musculoskeletal injury, disease, or the like, that occurs, for example, in the thoracic, lumbar and sacral spinal regions.  
         [0003]     The anatomy of the spine is usually divided into four major sections: the cervical, thoracic, the lumbar and the sacral. Each section is made up of individual bones called vertebrae with there being 7 cervical vertebrae, 12 thoracic vertebrae, and 5 lumbar vertebrae. In order to relieve pain that can sometimes be associated with back injuries, it may be necessary to temporarily hyperextend the spine by using some type of orthosis.  
         [0004]     According to an exemplary embodiment of the present invention, a spinal orthosis features a semi-resilient material, such as either a homogenous material or a laminate, the laminate having at least one of a shell and a liner, the shell at least partially having at least one layer, for example, a clothing contact surface material, a core, a stiffener and, for example, a strengthening material. The liner can have at least one layer, for example, at least one of a resilient cushion and a dermal contact surface layer.  
         [0005]     A second exemplary embodiment relates to a spinal orthosis featuring a semi-rigid semi-resilient material that can be, for example, a homogenous material or a laminate, with the laminate having at least one of a shell and a liner. The shell can, for example, at least partially have at least one layer of at least one of a clothing contact surface material, a core, a stiffener and a strengthening material. The liner can at least partially include at least one layer of at least of a one resilient cushion and a dermal contact surface layer.  
         [0006]     A third exemplary embodiment includes a spring biased hinge attached to an anterior surface of the orthosis, the spring biased hinge biasing a sternal portion.  
         [0007]     The clothing contact surface can be made of any one or more of a plastic, a metal, an alloy, a cloth, leather, a rubber, a polyethylene, a polypropylene, a polyvinylchloride, a polybuterate, a polystyrene, a polycarbonate, an aluminum, or the like.  
         [0008]     The core can be, for example, made from one or more of a plastic, a metal, an alloy, a cloth, leather, a rubber, a polyethylene, a polypropylene, a polyvinylchloride, a polybuterate, a polystyrene, a polycarbonate, an aluminum, or the like.  
         [0009]     The strengthening material can be made from one or more of a plastic, a metal, an alloy, carbon fibers, glass fibers, plastic fibers, a cloth, leather, a rubber, a polyethylene, a polypropylene, a polyvinylchloride, a polybuterate, a polystyrene, a polycarbonate, an aluminum, or the like.  
         [0010]     The sternal pressure base, hinge and sternal pressure bar can be made from one or more of a plastic, a metal, an alloy, carbon fiber, fiberglass, an aluminum, or the like.  
         [0011]     The stiffener can be, for example, made from one or more of a plastic, a metal, an alloy, a cloth, leather, a rubber, a polyethylene, a polypropylene, a polyvinylchloride, a polybuterate, a polystyrene, a polycarbonate, an aluminum, or the like.  
         [0012]     The resilient cushion can be, for example, made from any one or more of a foam, a plastic foam, a cloth, leather, a rubber foam, a polyethylene foam, a polypropylene foam, a polyvinylchloride foam, a polybuterate foam, or the like.  
         [0013]     The dermal contact surface can be made from any one or more of a plastic, a cloth, leather, a rubber, a polyethylene, a polypropylene, a polyvinylchloride, a polybuterate, a polystyrene, a polycarbonate, or the like, or some combination thereof.  
         [0014]     An exemplary aspect of the invention features a spinal orthosis having an overlap to include at least one inner flap and at least one outer flap, with both the inner and the outer flaps extending in an essentially equivalent distance past a sagittal anterior-posterior midplane. A sternal pad assembly attaches to at least one of the outer flap and inner flap.  
         [0015]     In accordance with another exemplary embodiment, a spinal orthosis features a chest module, such as a sternal plate, or a bridged pectoral pad set, wherein the chest module is at least partially supported by a hinge having an axis of motion perpendicular to a sagittal anterior-posterior midplane.  
         [0016]     Another exemplary aspect of the invention relates to a spinal orthoses having a chest module being either a sternal plate or a bridged pectoral pad set. The chest module attaches via a hinge having an axis of motion perpendicular to the sagittal anterior-posterior midplane, collectively all the axes of motion defining a compound hinge, the compound hinge including a resilient element where the resilient element urges the at least one of the module attachment and the chest plate attachment in a posterior direction against a posterior pressure directing anchor point.  
         [0017]     These and other aspects of the invention will be apparent from the following detailed discussion of the embodiments. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]      FIG. 1  is in perspective view illustrating an exemplary embodiment of the present invention;  
         [0019]      FIG. 2  is an exploded view of the spring biased hinge according to this invention;  
         [0020]      FIG. 3  illustrates a cross-section of the spring biased hinge in an unbiased position;  
         [0021]      FIG. 4  illustrates a cross-section of the spring biased hinge in a biased position;  
         [0022]      FIG. 5  is an environmental view of the orthosis according to this invention; and  
         [0023]      FIG. 6  is a second environmental view of the orthosis according to this invention. 
     
    
     DETAILED DESCRIPTION  
       [0024]      FIG. 1  illustrates an exemplary embodiment of the orthosis module  100 . The orthosis module  100  comprises a torso support portion  101 , a sternal plate  102 , a sternal pressure base  105 , a spring biased hinge  200 , a sternal pressure bar  108 , one or more straps  110 , and one or more adjustable straps  104  with corresponding strap loops  106 .  
         [0025]     While the torso support portion  101  of the orthosis module  100  that comes into contact and surrounds the torso of the patient as illustrated in  FIG. 1  is shown as a substantially unitary structure, it should be appreciated that the torso support portion  101  could comprise multiple sections that are held together by a fastening system, or in general be of any shape or configuration that provides spinal orthosis.  
         [0026]     For example, by utilizing the spring biased hinge, and adhering to basic biomechanical principles, the operation of the orthotic module can be expanded to any specific orthotic function. For example, use is not limited to spinal orthosis. The spring biased hinge and appropriate orthotic support could also be used in upper limb (hand wrist elbow, forearm) bracing and rehabilitation. For example, through the addition of uprights and cuffs with, for example, hook and loop closures, such as Velcro®, the spring biased hinge could be used to assist in reducing flexion or extension contractures at the elbow. The hinge can also be placed proximal to the volar surface, and by adding a distal opponens and a proximal forearm cuff, forces to resist palmarflexion or promote palmarflexion strengthening may be performed by patients.  
         [0027]     The spring biased hinge and appropriate body brace could also be modified and placed anteriorly with a clip or clasp on one end and a calf cuff and upright on the other end of the hinge and be used in dorsiflexion and plantarflexion strengthening exercises. In general, the spring biased hinge and accompanying body braces/supports can be used in any application to include, for example, orthotic, orthopedic and rehabilitation of patients.  
         [0028]     The exemplary orthosis module  100  in  FIG. 1  wraps around a patient and forms an overlap  107  at an anterior face of the orthosis module  100 . The orthosis module  100  can, for example as discussed above, be constructed of a semi-rigid contortable plastic material with, for example, a resilient lining. The overlap  107  in the orthosis module  100  allows adjustment to varying levels of tightness around the patient by the adjusting mechanism comprising the adjustable straps  104  and corresponding strap loops  106 .  
         [0029]     For example, the adjusting mechanism can comprise multiple adjustment straps  104  that attached to the orthosis module  100  on laterally opposite sides of the overlap  107  with one end of each adjustment strap  104  being affixed to the orthosis module  100  and on the other end threaded through a strap loop  106  and folded back onto itself and fixed, for example, through the use of a hook and loop fastening system. The adjustment straps  104  can, for example, alternate in different directions with one end of a first adjustment strap fixed to a first side of the orthosis module and the accompanying strap loop on the opposite side, with the next strap being fixed to the opposite side of the orthosis module  100 , and the strap loop on the opposite side as illustrated in exemplary  FIG. 1 . The number of straps is not limited to three as illustrated, but rather can be varied, based on, for example, the size of the orthosis module, the amount of tightness required, and the like. Likewise, the adjusting mechanism need not be limited to straps and strap loops but could also be made from any one or more of laces, belts and buckles, and the like.  
         [0030]     Furthermore, additional straps can be located on any portion of the orthosis module, such as straps  110 , that can be further used to, for example, tighten a portion of the orthosis module  100 , maintain the position of the orthosis module  100  on a patient, and the like. For example, as illustrated in  FIG. 1 , the straps  110  can be used in an over-the-shoulder type arrangement and fixed to the anterior face of the orthosis module by a fastening mechanism (not shown).  
         [0031]     Also attached to the anterior face of the orthosis module  100  is a sternal pressure base  105  that is affixed, for example, to the anterior face of the orthosis module  100  where the overlap  107  occurs. The sternal pressure base  105  can be attached to the orthosis module  100  by many means including, but not limited to, bolts, screws, rivets, adhesives, clamps, molded interlocks, and the like. Furthermore, it should be appreciated that the sternal pressure base  105  could be integrally formed into the orthosis module  100  and can be fixed to or integrated into either the inner or outer flap.  
         [0032]     The walls of the orthosis module  100  are contoured to exert compression from all sides by creating an increased hydraulic rigidity in a patient&#39;s abdominal section. This abdominal hydraulic rigidity increases the support between the pelvis and the thorax and provides corrective forces. The corrective forces are arranged in a 3-point pressure system, wherein the anterior portion of the orthosis module  100  provides a posteriorly directed force, the sternal plate  102  provides a second posteriorly directed force, and a posterior section of the orthosis module provides an anteriorly directed force.  
         [0033]     Attached to the upper end of the sternal pressure base  105  is a spring biased hinge  200  which is also connected to the sternal plate  102 . As described in greater detail hereinafter, the spring biased hinge  200  is capable of providing a posteriorly directed force due to the spring biased feature as discussed hereinafter. The spring biased hinge  200  is connected to the sternal pressure base  105  and sternal pressure bar  108  by, for example, bolts, screws, rivets, adhesives, clamps, molded interlocks, a friction fit, a mechanical fit, or any other fastening means and/or arrangement that is capable of holding the various components together.  
         [0034]     While the exemplary embodiment illustrated in  FIG. 1  shows the sternal plate  102  as a single component, such as a pad, it is to be appreciated in the sternal plate  102  can be configured, for example, in a wide variety of configurations including but not limited to a plurality of pads. Likewise the shape of the sternal plate(s) can be altered into any shape, including, but not limited to, a circle, oval, square, kidney-shape, or the like. Furthermore, the sternal plate  102  can include padding and is fixed to the external pressure bar by fastening means, such as those discussed in relation to the external pressure base.  
         [0035]      FIG. 2  illustrates in greater detail an exploded view of the hinge  200 . In particular, the exemplary spring biased hinge  200  comprises a sternal pressure base portion  210 , a sternal pressure bar portion  220 , a hinge pin  230 , a nut  240 , a plurality of, for example, set screws  250 , a spring  260 , a ball bearing  270 , and a tension adjustment mechanism  280 . As previously discussed, the sternal pressure base  105  can fit into slot  205  of the sternal pressure base portion  210  and secured, for example, by setscrews  250 . In a similar manner, the sternal pressure bar  106  can be inserted into slot  215  and secured by setscrews  250 . The spring biased hinge  200 , and in particular the external pressure bar portion  220  and external pressure base portion  210  are hingedly connected by means of a hinge pin  230  which is secured by nut the  240 . The spring biased hinged  200  is fixed to the external pressure base  105  in a manner such that the sternal plate  102  opens in a posteriorly directed manner. This spring biased hinge  200  when closed, allows the sternal plate  102  to be substantially parallel to the chest of the patient.  
         [0036]     The tension adjusting mechanism  280 , in cooperation with the spring  260  and ball bearing  270 , provides a bias on the hinge which produces a posteriorly directed force that is applied by the sternal plate  102  to the chest of the patient. As, for example, the tension adjusting mechanism  280  is screwed into the corresponding threaded receiving portion  285 , the spring  260  is placed under greater compressive force which presses the ball bearing  270  against a surface of the sternal pressure bar portion  220  thereby providing the posteriorly directed force.  
         [0037]     As illustrated in greater detail in  FIG. 3 , the spring biased hinge  200  is illustrated in a closed position. In the closed position, the spring biased hinge is held in a substantially linear orientation by means of bump stops  225  and  235 . It should be appreciated that the thickness of the bump stops  225  and  235  can be modified such that, for example, the spring biased hinge, when closed, can be substantially linear, or, for example, adjusted such that the sternal plate  102  is angled slightly toward or away from the patient as appropriate.  
         [0038]     As illustrated in  FIG. 4 , the tension adjusting mechanism  280  has been “tightened” such as to create a greater compressive force on the spring  260  thereby forcing the ball bearing  270  to press against a surface of the sternal pressure bar portion  220  thereby creating the posteriorly directed force. The tightening, in turn, presses the sternal plate against the chest of a patient. As the tension adjusting mechanism  280  is further screwed into the receiving portion  285 , the posteriorly directed force increases.  
         [0039]     As illustrated in the figures, while a coil spring is used is to create the posteriorly directed force, it should be appreciated that other spring mechanisms, such as a flat spring, or the like, could be used with equal success. Furthermore, a “mouse-trap” type spring arrangement could be utilized, for example, wherein the coil portion of the mouse trap type spring surrounds the hinge pin  230 . The spring could then be tensioned by a tensioning mechanism (not shown) that, for example, adjusts a non-helix portion of the spring, thus increasing the posteriorly directed force in a similar manner.  
         [0040]     The spring tension adjusting mechanism is not be limited to the spring and tensioning adjusting screw as shown, but could also include, for example, a pneumatic or hydraulically based system, with, for example, an exterior pump that allows for the posteriorly directed force to be adjusted. More particularly, a cylinder and piston type arrangement could be used in place of the tension adjusting mechanism spring and ball bearing whereby a material, such as a fluid is injected into the cylinder which thereby extends a piston that presses against the surface of the sternal pressure bar  230  and increases the posteriorly directed force.  
         [0041]     It should further be appreciated that the bias mechanism can be interchanged based on, for example, the intended patient use. For example, for use with a child, the spring  260  could be switched for a spring with lesser bias. Alternatively, for example, for a large patient, a larger spring could be used to provide more substantial posteriorly directed force.  
         [0042]      FIGS. 5 and 6  illustrate environmental views of the orthosis module  100 . In particular,  FIG. 5  illustrates the orthosis module  100  where the sternal plate  102  is resting against the patient&#39;s chest and the spring biased hinge  200  is in the closed position.  FIG. 6  illustrates the orthosis module  100  with the spring biased hinge  200  providing a posteriorly directed force which is thereby pressing the sternal plate  102  against the chest of the patient thereby keeping the patient in a more erect position.  
         [0043]     It is, therefore, apparent that there is provided, in accordance with the present invention, an orthosis system. While this invention has been described in conjunction with a number of embodiments, many alternatives, modifications, and variations would be apparent to those of ordinary skill in the applicable arts. Accordingly, all alternatives, modifications, equivalents and variations are intended to be included within the spirit and scope of this invention.