Abstract:
An individual custom orthodic device for application to a limb of a mammal includes an inner sleeve for disposition on the limb, reinforcing strands fixed to the sleeve, and an outer sleeve fixed to and disposed around the inner sleeve. The inner and outer sleeve define therebetween a space in which a curable resin is disposed. upon curing of the resin, the device is hardened and is conformed to the limb.

Description:
FIELD OF THE INVENTION  
         [0001]    The invention relates to orthotic devices of the type applied to the limbs of mammals and is directed more particularly to an individualized custom device which closely conforms to the limb of a patient.  
         BACKGROUND OF THE INVENTION  
         [0002]    Injuries, particularly ankle injuries, to workers and athletes are common. Often the injuries are slight or moderate sprains of ankle ligaments. However slight, such injuries can be debilitating, rendering continued work afoot, or any athletic activity, quite painful.  
           [0003]    In efforts to prevent such injuries and, when the injuries occur, to permit rapid return of an injured patient to the work place or athletic field, support devices have been devised, particularly ankle supports, which range from completely taping the ankle and foot to the application of rigid side support members, often with a rigid stirrup portion extending beneath the foot. The former is expensive, time consuming, and labor intensive. The latter usually is ill-fitting and uncomfortable, and often includes the use of a number of straps which must be manually connected together with a proper amount of tension.  
           [0004]    There is a need for an orthotic support device which can be applied to an ankle or other affected body area without the use of straps, or the like, and which provides a close, comfortable fit.  
           [0005]    Accordingly, an object of the invention is to provide an orthotic device which can be closely conformed to an ankle and foot, or other body area, and which provides required support to afford protection from injury or, if injury has already occurred, to afford comfortable support to the injured body area.  
           [0006]    A further object of the invention is to provide such a device which can be applied to the patient by the patient, and which takes little time to apply, conform and fix to the body.  
         SUMMARY OF THE INVENTION  
         [0007]    With the above and other objects in view, as will hereinafter appear, a feature of the present invention is the provision of an orthotic device for application to a limb of a mammal, the device comprising a sleeve for disposition on the limb, reinforcing strands fixed to the sleeve, and a curable layer of resin disposed on the sleeve and the strands. Upon curing of the resin, the device is conformed to the limb and contains the reinforcing strands therein.  
           [0008]    In accordance with a further feature of the invention, there is provided an orthotic device for application to a limb of a mammal, the device comprising an inner sleeve for disposition on the limb, reinforcing strands fixed to the sleeve, an outer sleeve fixed to and disposed around the inner sleeve, the inner and outer sleeves defining a space therebetween. A curable resin is disposed in the space, such that upon curing of the resin the device is conformed to the limb.  
           [0009]    In accordance with a further feature of the invention, there is provided a method for forming a custom orthotic device, the method comprising the steps of providing a sleeve of elastomeric material, tacking reinforcing fiber strands to the sleeve, positioning the sleeve around a limb of a mammal, applying a layer of curable resin on the sleeve and over the reinforcing strands, and curing the resin, whereby the resin is made to harden conforming to the limb.  
           [0010]    In accordance with a still further feature of the invention, there is provided a method for forming a custom orthotic device, the method comprising the steps of providing an inner sleeve of elastomeric material, tacking reinforcing fiber strands to the sleeve, fixing an outer sleeve of elastomeric material onto and around the inner sleeve such that the inner and outer sleeves define a space therebetween, positioning the device thus formed around a limb of a mammal, injecting curable liquid resin into the space, and curing the resin, whereby to harden the resin conforming to the limb.  
           [0011]    The above and other features of the invention, including various novel details of construction and combinations of parts and method steps, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular devices and methods embodying the invention are shown by way of illustration only and not as limitations of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]    Reference is made to the accompanying drawings in which are shown illustrative embodiments of the invention, from which its novel features and advantages will be apparent.  
         [0013]    In the drawings:  
         [0014]    [0014]FIG. 1 is a plan view of one form of a panel for forming a sleeve portion of an orthotic device, with reinforcing strands fixed thereto;  
         [0015]    [0015]FIG. 2 is a perspective view of the panel of FIG. 1 with edges thereof joined together to form a sleeve portion, with additional reinforcing strands fixed thereto;  
         [0016]    [0016]FIG. 2A is similar to FIG. 2, but is an illustration of an alternative embodiment of the sleeve portion;  
         [0017]    [0017]FIG. 3 is a perspective view of an orthotic device comprising the sleeve portion and reinforcing strands of FIG. 2 covered with a resinous material;  
         [0018]    [0018]FIG. 4 is a perspective view of the orthotic device of FIG. 3 subjected to a heat or ultra violet source to cure the resin, to provide one form of the orthotic device illustrative of an embodiment of the invention;  
         [0019]    [0019]FIG. 5 is a plan view of one form of an outer panel for forming an outer sleeve portion of an alternative orthotic device;  
         [0020]    [0020]FIG. 6 is a perspective view of the outer panel of FIG. 5 with edges thereof joined together to form an outer sleeve portion which is fitted over the-device of FIG. 2;  
         [0021]    [0021]FIG. 7 is a perspective view illustrating injection of a resin material into a gap defined by the inner and outer sleeves; and  
         [0022]    [0022]FIG. 8 is a perspective view similar to FIG. 4 but showing the orthotic device of FIG. 7 subjected to the heat or ultra violet source to cure the resin to provide another form of orthotic device. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    Referring to FIG. 1, it will be seen that for formation of the orthotic device presented herein, there is provided a panel  20  from which is formed an inner sleeve  22  (FIG. 2). The panel  20  is configured to provide inner sleeve instep hems  24  and Achilles hems  26 . The hems  24  are joined together, as by sewing, to interconnect the hems  24  along an inseam line  28 . Similarly, the hems  26  are joined together to interconnect the hems  26  along an Achilles line  30 . Alternatively, the hems  24 ,  26  may be provided with strips of hermaphroditic fastener material for quick and easy joining.  
         [0024]    The panel  20  is provided with reinforcing strands  32  of material which renders the strands readily bendable but inelastic axially. This property enables the strands  32  to protect against excessive flexing of a joint, by bending to conform to anatomy but not extending axially, that is, refraining from extending in directions in which the device should not yield. The strands  32  may be applied to the panel  20  before the hems  24 ,  26  are joined together to form the sleeve  22 . The strands  32  are tacked to the panel  20 , as by stapling or sewing at selected points, such as at ends thereof along end tack lines  34 , and preferably a central tack line  36 . A figure-eight strand  38  may be applied to the sleeve  22  (FIG. 2) and may be tacked to the sleeve in a central area  40  of the figure-eight.  
         [0025]    The panel  20 , and therefore the sleeve  22 , is of an elastomeric material. Materials found appropriate include latex, nitril, vinyl, and apparel fabric including an elastane fiber. The reinforcing strands are of a material which provides the aforesaid attributes of being bendable but axially inelastic. Materials found appropriate include glass fibers, carbon fibers, and Kevlar® fibers.  
         [0026]    The sleeve  22  is then fitted onto the appropriate body part of the patient. In the illustrations, the body part for which the orthotic device is formed is a human foot and ankle.  
         [0027]    The sleeve  22  and strands  32 ,  38  are then coated, as by spraying or painting, with a layer of resinous curable material to provide an outer coating  42  (FIG. 3).  
         [0028]    The device as shown in FIG. 3 is then subjected to a curing operation, such as the application of heat, to cure the covering  42 . The covering  42  may be cured chemically, or by ultraviolet light, or by a common heater or ultra violet light source  44 , the latter two alternatives being shown diagrammatically in FIG. 4, as an example.  
         [0029]    As the covering  42  cures, it forms a rigid device closely conforming to the shape to which it is applied and is supportive of that body area. The tacking of the strands  32  to the sleeve  22  serve to keep the strands in place during application of the resinous material. The strands are attached to the resin along their entire lengths, providing supporting strength to the resinous material.  
         [0030]    The resinous material of the outer covering  42  may be selected from a number of materials found to perform appropriately. The materials known to be acceptable include curable epoxy, acrylates (such as urethane acrylate, 2-phenoxyethyl acrylate, di-trimethylopropane tetraacrylate, dipentaerythritol pentaacrylate), urethane (including two component urethane and two component urethane elastromers), silicone, copolymers thereof and polymer alloys thereof, and thermoplastics with glass transition temperatures in a range of 120-160° F. In a preferred embodiment, the resinous material comprises a polymer exhibiting a cure time of about five minutes or less.  
         [0031]    If desired, the panel  20  and reinforcing strands  32  may be provided in an integrated fashion. For example, if the panel  20  is of a fabric material, the strands  32  may be woven into the fabric; if the panel  20  is of latex, or the like, the strands may be embedded therein. The integrated panel and strands appear much the same as the panel and strands tacked thereon, as shown in FIGS. 1 and 2.  
         [0032]    In an alternative embodiment, and particularly for use to prevent injury, the strands may be omitted. In this embodiment, the covering  42  is deposited on the sleeve  22 , as shown in FIG. 3, but without reinforcing strands integrated with, or attached to, the sleeve  22 . Again, curing of the covering  42  serves to harden the device and conform the device to the substrate body part.  
         [0033]    In another alternative embodiment, the sleeve  22  may be formed by the sleeve material in tape form 20′ (FIG. 2A) and then coated with the covering  42 , as shown in FIG. 3.  
         [0034]    In a further alternative embodiment, there is provided a second panel  50  (FIG. 5) provided with hems  52 ,  54 , similar to the hems  24 ,  26 . The second panel  50  is of a size slightly larger than that of the panel  20 , such that the second panel  50  can be fitted and joined together, similarly to the first panel  50 , over the device shown in FIG. 2. That is, the panel  50  is fitted over the inner sleeve  22  and strands  32 ,  38  to form an outer sleeve  56  over the inner sleeve  22 . The two sleeves  22 ,  56  define a space  58  therebetween.  
         [0035]    As shown in FIG. 7, the space  58  is closed at ends  60 ,  62 ,  64  and the space  58  is filled, as by injection by a syringe  66 , with the aforementioned resinous material, which in this embodiment constitutes a middle layer  68  of a laminar structure, rather than the outer covering  42  heretofore described.  
         [0036]    If a two part material is used for the middle layer  68 , such as two-component urethanes or two component urethane elastomers, the injection device may comprise a self-mixing liquid polymer injector. In such instances, the outer sleeve  56  may be provided with one or more one-way valves (not shown).  
         [0037]    The assembly as shown in FIG. 7 is then subjected to heat or ultra violet light (FIG. 8) in the same manner as the previously described device  46 , illustrated in FIG. 4. Upon curing of the resinous material, the middle layer  68  hardens and the inner and outer elastomeric sleeves  22 ,  58 , permit the device to assume a configuration conforming to the foot and ankle upon which the device is mounted. The finished device is about ⅛ inch in thickness and therefore not a hindrance when used to protect against injury.  
         [0038]    There is thus provided an orthotic device which can be closely conformed to a body area of a patient and which provides required support to either prevent injury or protect a previously injured area. Further, the device can be applied by the patient and cured in little time without the assistance of others.  
         [0039]    It will be understood that many additional changes in the details, materials, steps and arrangement of parts, which have been herein described and illustrated in order to explain the nature of the invention, may be made by those skilled in the art within the principles and scope of the invention as expressed in the appended claims.