Patent Document

FIELD OF THE INVENTION 
       [0001]    The present invention relates to medical devices and methods useful for improving a person&#39;s ability to grasp and release an object. More specifically, the present invention relates to apparatuses for causing dynamic extension of a finger and/or thumb. 
       BACKGROUND OF THE INVENTION 
       [0002]    Many individuals suffer from a condition known as flexor spasticity which prevents the normal extension of the fingers or thumb. Often caused by a stroke, muscular damage, brain damage, nerve damage or degeneration, a person or individual afflicted with flexor spasticity may have difficulty relaxing the muscles that close the hand and contracting the extensor muscles of the digits and thumb, and as a result, the individual may not be able to fully open his or her hand, and may have difficulty grasping and releasing an object. 
         [0003]    The majority of dynamic extension splints on the market are designed to be used for post-surgical treatment to provide a slow progressive stretch to the flexor tendons, muscles, or other soft tissues as post-surgical treatment. These existing dynamic extension splints contain high profile outriggers and typically use rubber bands, straps, or exposed springs to provide the dynamic extension. These rubber bands frequently break and need replacement. Additionally, the majority of dynamic extension splints are bulky and are not intended for functional, everyday use. Dynamic extension splints are frequently custom made in the clinic, but some may be purchased through hand rehabilitation and durable medical equipment (DME) catalogues, such as the Saeboflex® dynamic finger and thumb extensor splint. Accordingly, it would be an advance in the state of the art to provide a functional, low-profile, dynamic extension splint for biasing an individual&#39;s fingers in an open position to permit the individual to grasp an object and engage in related everyday activities. 
       SUMMARY OF THE INVENTION 
       [0004]    To improve upon the shortcomings of prior art splints, methods and apparatuses useful for treating individuals having flexor spasticity are presented. These methods and apparatuses may be used for treatment or as a supplement to an individual&#39;s active daily life (ADL). Methods of using and constructing the apparatus are presented including techniques for customizing the shape and size of the splint for a particular individual. 
         [0005]    In one of its aspects, the present invention provides, inter alia, a durable, inexpensive, and low-profile solution to designing a splint capable of extending an individual&#39;s fingers. In another of it aspects, the present invention provide splint configurations that do not utilize springs, wires, or rubber bands/straps to create the biasing force required to extend the patient&#39;s finger(s). Rubber bands and springs can break or loose their elasticity over time, and often require frequent adjustments. In addition, should one of these parts break, the device may become inoperable which is inconvenient to the individual. Thus, to increase the durability of the dynamic extension splint, configurations of the present invention are disclosed that do not utilize springs, wires, or rubber straps. 
         [0006]    In yet another of the aspects of the present invention, minimizing the cost of the device is also an important consideration, and the present invention discloses several low-cost configurations. For example, multiple configurations of the present invention may be constructed using only four separate components (not counting any adhesive or fixating materials). Additionally, patient evaluation has demonstrated that wearing bulky splints or braces can be awkward and socially embarrassing. Moreover, the additional height (thickness) of many prior art devices makes maneuvering one&#39;s hand more difficult. To meet these shortcomings a low-profile splint was designed to minimize the impact on the person&#39;s physical and social life. Clinical experimental trials of the dynamic extension splint has shown the splint to be effective in training individuals to grip objects as thin as a piece of paper as well as objects over 3½ inches thick. After the first treatment session many individuals were able to stabilize a cup while filling it with water, hold the edges of a coat while zippering or buttoning it, and even tie a bow. 
         [0007]    In one of its configurations, the present invention provides a dynamic extension splint for biasing a person&#39;s fingers in an open position and having a low-profile configuration. The splint may include a glove having a thumb jacket for positioning the person&#39;s thumb by covering and securing a portion of the thumb. The thumb jacket may have elastic properties which assist with opening the thumb thereby aiding in the grasp and release of an object. Optionally, the glove may include a handwrap for securing the glove to the person&#39;s hand. A platform may also be included for attachment to the glove. The platform may be configured to rest on the dorsum of the hand and may have an outrigger mount portion to which an outrigger is attached. The splint may also include a flexible outrigger for biasing at least two of a person&#39;s fingers in an open position. The flexible outrigger may be mounted to the outrigger mount portion and may extend away from the outrigger mount portion parallel and proximate to the plane of the outrigger mount portion to provide the low-profile configuration of the dynamic extension splint. Two finger extenders may also be provided, each of which may be configured to surround a respective one of the person&#39;s index finger and long finger for biasing the fingers into an extended position. The finger extenders may include an arcuate shape designed to fit snuggly around the person&#39;s fingers. 
         [0008]    In an additional aspect of the present invention, various manufacturing methods for the components of the splint are presented. Additionally, methods for using the splint are disclosed, as well as various methods for customizing the size and shape of the splint for a particular user. Also various methods for selecting a component having specific attributes, such as the rigidity of the rod, are presented. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  schematically illustrates a perspective view of a left-handed splint comprising a glove and an extension assembly. 
           [0010]      FIG. 2  schematically illustrates a perspective fragmentary view of the splint of  FIG. 1  illustrating the extension assembly. 
           [0011]      FIG. 3  schematically illustrates a perspective view of the splint of  FIG. 1  showing the underside of the splint. 
           [0012]      FIG. 4  schematically illustrates a perspective view of the splint of  FIG. 1  showing the underside of the splint with the thumb flap placed in an open position. 
           [0013]      FIG. 5  schematically illustrates a perspective view of the underside of the extension assembly attached to a platform. 
           [0014]      FIG. 6  schematically illustrates a perspective view of the top side of the extension assembly and the platform. 
           [0015]      FIG. 7  schematically illustrates a perspective view of the top side of an alternative configuration of an extension assembly and platform. 
           [0016]      FIG. 8  schematically illustrates a perspective view of the top side of the extension assembly and platform with an optional platform pad attached. 
           [0017]      FIG. 9  schematically illustrates a perspective view of the outrigger without the other components of the splint. 
           [0018]      FIG. 10  schematically illustrates a perspective view of the platform. 
           [0019]      FIG. 11  schematically illustrates a perspective view of a finger extender. 
           [0020]      FIG. 12  schematically illustrates a perspective view of an alternative configuration of the finger extender. 
           [0021]      FIG. 13  schematically illustrates a top view of the splint mounted on the person&#39;s left hand showing the dorsal side of the hand with the handwrap in an opened position. 
           [0022]      FIG. 14  schematically illustrates a bottom view of the splint mounted on the person&#39;s left hand showing the palmar side of the hand with the handwrap in an opened position. 
           [0023]      FIG. 15  schematically illustrates a top view of the splint mounted on the person&#39;s left hand showing the dorsal side of the hand with the handwrap in a closed position. 
           [0024]      FIG. 16  schematically illustrates a top view of a splint having an alternative configuration of the platform, with the splint mounted on a person&#39;s left hand showing the dorsal side of the hand with the handwrap in a closed position. 
           [0025]      FIG. 17  schematically illustrates a side elevational view of the splint mounted a on person&#39;s left hand showing the side of the hand with the fingers extended. 
           [0026]      FIG. 18  schematically illustrates a side elevational view of the splint mounted on a person&#39;s right hand showing the side of the hand with the index and long finger closed in a tripod grip with the thumb. 
           [0027]      FIG. 19  schematically illustrates a cross-sectional perspective view of an outrigger tension adjustment mechanism. 
           [0028]      FIG. 20  schematically illustrates a cross-sectional side elevational view of the outrigger tension adjustment mechanism of  FIG. 19 . 
           [0029]      FIG. 21  schematically illustrates a cross-sectional side elevational view of another outrigger tension adjustment mechanism. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0030]    Referring now to the figures, wherein like elements are numbered alike throughout, an exemplary low-profile dynamic extension splint in accordance with the present invention, generally designated “ 10 ”, is provided,  FIG. 1 . The dynamic extension splint  10  may comprise a glove  20  and an extension assembly  100  which provide an extension force to bias an individual&#39;s fingers and thumb in an open position, which may be particularly helpful to individuals who suffer from flexor spasticity which prevents the normal extension of the fingers through the DIP (distal interphalangeal) and PIP (proximal interphalangeal) joints,  FIG. 17 . In addition, the dynamic extension splint  10  is sufficiently flexible to allow the individual to bend one or more of their fingers at the knuckle towards the thumb to permit a grip, such as tripod grip, to be formed between the fingers and the thumb,  FIG. 18 . 
         [0031]    Returning to  FIG. 1 , the splint  10  may include various types of structures for covering and supporting the hand. For example, the overall structure of the splint  10  may take the form of a glove  20 , which may include finger coverings, partial finger coverings (like a weightlifting glove), or no finger coverings at all (i.e., a fingerless glove). The glove  20  desirably includes a thumb jacket  32  into which the individual&#39;s thumb is placed and an optional thumb hole  30  at the tip of the thumb jacket  32  through which the tip of the thumb may extend. In addition, the glove  20  may include a handwrap  40  for wrapping around the individual&#39;s hand and may include an optional hook-and-loop strap  260  for attachment to an optional hook-and-loop pad  272  for securing the handwrap  40  to the individual&#39;s hand once the handwrap  40  has been wrapped around the hand. In addition, the glove  20  may optionally include a hook-and-loop pad  270  disposed on a thumb flap  31  for engagement with the underside  33  of the glove  20  once the handwrap  40  has been wrapped around the hand,  FIGS. 2 ,  14 . The glove  20  may be composed of materials such as leather or Gore-Tex™ fabric (a fiber made from polytetrafluoroethylene (PTFE)), for example. Depending on the individual&#39;s condition, a resilient material capable of returning to its initial shape after being deformed may be selected, such as Neoprene® elastomer (a polychloroprene synthetic rubber manufactured by DuPont Performance Elastomers). 
         [0032]    The splint  10  also includes an extension assembly  100  attached to the glove  20  for providing a biasing and extension force to the individual&#39;s fingers. The extension assembly  100  includes one or more finger extenders  200  attached to an outrigger  90  which in turn is attached to a platform  50  attached to the handwrap  40  of the glove  20 ,  FIG. 2 . The outrigger  90  may comprise a rod  91  and a stop  92  disposed at the distal end of the rod  91 , which may be shorter or longer than the fingers of the individual,  FIG. 9 . The rod  91  may be formed from any material having suitable flexibility and resiliency, such as fiberglass or graphite, for example. Typical diameters of the rod  91  can vary from 0.05 to 0.075 inches for fiberglass rods, and from 0.050 to 0.10 inches for graphite rods, for example, but other thicknesses or materials could be used depending on the desired flexibility, rigidity, or resiliency required. 
         [0033]    The extension assembly  100  may be attached to the glove  20  by cooperation between the proximal end of the outrigger rod  90  and the mounting platform  50 ,  FIGS. 2-6 . The mounting platform  50  may be secured to the underside  33  of the glove  20  using any suitable fastening mechanism. For example, a fastener  70 , which may comprise a hook-and-loop fabric, may optionally be attached to the surface of the platform  50  that contacts the underside  33  of the glove  20  to secure the platform  50  to the glove  20 ,  FIG. 10 . The platform  50  may be composed of a semi-rigid resilient material such as a thermoplastic, and may have a soft, resilient platform pad  51  attached to the surface of the platform closest to the individual&#39;s hand to provide a cushion between the platform  50  and the dorsum of the individual&#39;s hand,  FIG. 8 . As used herein, the term “semi-rigid” describes a material capable of being bent but able to return to its shape upon release of the bending force. If the platform  50  is made from Aquaplast® plastic, the material may be shaped by first heating the plastic in hot water and manipulating the plastic while it is warm into the desired configuration. The platform&#39;s thickness may vary depending on the material used and depending on the desired rigidity. Experimentation with differing platform thicknesses has shown that a thickness of about ⅛ inch is sufficient for a platform made of Aquaplast® plastic. The platform  50  may extend along a portion of the width of the hand as shown in  FIG. 15  or may extend the entire width of the hand as shown in  FIG. 16 . Additionally or alternatively, a platform  50  may extend the length of the glove  20  to provide the individual with additional surface area to distribute pressure forces when needed. 
         [0034]    The platform  50  provides an outrigger mount portion  60  to which the outrigger  90  may be attached,  FIG. 5 . In addition, the platform  50  may optionally include a thumb extension portion  80  that slides into the thumb jacket  32  to act as a splint to apply an extension force against the thumb to straighten the thumb. The thumb jacket  32  alone may be sufficiently stiff to bias the individual&#39;s thumb to remain extended. In other cases, the thumb extension  80  may be used to complement the glove&#39;s natural extension force. 
         [0035]    The outrigger  90  may be attached to the platform  50  via a platform fastening material  280  such as an adhesive or any other suitable material,  FIG. 6 . In such a configuration, the fastener  70  may be provided over the platform fastening material  280 ,  FIG. 6 . Additionally, as shown in  FIG. 7 , the outrigger  90  may be sandwiched between the platform  50  and a second platform provided in the form of a platform patch  52 . The platform patch  52  may be bonded, glued, melted, welded or otherwise fixed to the platform  50 . If a thermoplastic patch  52  and platform  50  are used, the two pieces may be heated and melted together to form one thicker platform with the outrigger  90  sandwiched between the platform  50  and platform patch  52 . 
         [0036]    The outrigger  90  may extend away from the platform  50  proximate to the plane of the outrigger mount portion  60  to provide the low-profile configuration of the dynamic extension splint  10 ,  FIG. 19 . A total profile thickness  290  of less than one inch, as measured from the dorsum of the hand upward to the top of the outrigger  90 , provides the wearer with increased dexterity and is less conspicuous to other individuals,  FIG. 19 . One exemplary configuration of a low-profile splint  10  in accordance with the present invention having a total height profile thickness of less than ½ inch can be achieved using Neoprene® elastomer for the glove  20  and Aquaplast® plastic for the platform  50 . 
         [0037]    To prevent discomfort caused by the outrigger  90 , an optional outrigger cushion pad  110  may be attached to the outrigger  90  using a pad fastening material  250 , which may include an adhesive, a tape such as Coban® tape, or any other suitable material. The cushion pad  110  (like the platform pad  51 ) may be composed of soft materials like sponges, cotton, polystyrene (PS), ethylene-vinyl acetate (EVA), or a Durafoam® pad (a closed-cell sponge composed of rubber and plastic foam). 
         [0038]    To prevent flexion of one or both of the interphalangeal joints and to hold the individual&#39;s finger(s) in position relative to the outrigger  90 , one or more finger extenders  200  may be attached to the outrigger  90  using a finger extender bridge  230 . Attaching two finger extenders  200  on either side of the outrigger  90  provides a buddy-splinting configuration in which two adjacent fingers are secured together. The finger extender(s)  200  may be provided in the form of a finger splint, tube, brace, or an Oval-8 splint (a seamless, molded, plastic splint manufactured by 3 Point Products, Stevensville, Md.) The finger extender  200  may include a cradle or a warped circular saddle  210  supporting the palmar side of the individual&#39;s finger(s) and a half ring bridge  220  supporting the dorsal side of the individual&#39;s finger(s). Alternatively, the finger extender  205  may be provided without the half ring bridge  220 ,  FIG. 12 . The finger extender(s) may be sized to fit snuggly around the individual&#39;s fingers. 
         [0039]    To attach the finger extender(s)  200  to the outrigger  90 , the finger extender bridge  230  may include a hole  231  through which the outrigger  90  may pass. The finger extender bridge  230  may be a affixed to the outrigger  90  using materials such as string, adhesive, or thermoplastics such as Aquaplast® plastic (a hard, semi-rigid, resilient plastic made by WFR/Aquaplast Corporation and distributed by Sammons Preston), Aquaflex® plastic (splint casting material made by Roylan), or other suitable materials. For example, in addition to thermoplastics, chemical resins, epoxies, or irradiation plastics may be used. Other examples of suitable thermoplastic materials may include polyacrylates (acrylic), polyoxymethylene, polysulfone (PSU), polycarbonate (PC), and polyvinyl chloride (PVC). The finger extender(s)  200  may be slidably attached to the outrigger  90  to permit the finger extender(s)  200  to move along the outrigger  90  when the outrigger bends  90 . In this regard, the outrigger  90  may be slid through the hole  231  in the finger extender bridge  230 . To help prevent the finger extender(s)  200  from sliding off the distal end of the outrigger  90 , a plastic or rubber stop  92  may be added to the distal tip of the outrigger  90 . In addition for configurations of the dynamic extension splint  10  that have a plurality of finger extenders  200 , it may be desirable to fix the finger extenders  200  together via a fastening material to improve their mechanical rigidity, such as Coban® tape (an elastic, self-adhesive tape made by Nexcare and 3M), a thermoplastic, or other fastening material. 
         [0040]    In use, when donning the dynamic extension splint  10 , the individual opens the glove  20  by moving the thumb opening flap  31  away from the handwrap  40  (open position,  FIG. 3 ) and sliding his or her thumb into the thumb jacket  32  and through the thumb opening  30 , thereby placing the dorsum of the hand into contact with platform  50 . Additionally, the individual slides one or more fingers into the finger extender(s)  200  which are connected to the platform via flexible outrigger  90  to prevent flexion along one or more of the interphalangeal joints,  FIGS. 13-19 . As shown in  FIGS. 13-19 , the two finger extenders  200  prevent flexion along both the DIP (distal interphalangeal) and PIP (proximal interphalangeal) joints. The individual may then wrap the handwrap  40  around his or her hand and/or wrist and attach an optional hook-and-loop strap  260  to an optional hook-and-loop pad  272 . Depending on the configuration, the handwrap  40  can be wrapped two or more times around the individual&#39;s wrist, or the glove can be secured by other fastening mechanisms such as Velcro™ fasteners, strings, buttons, zippers, etc. As shown in  FIG. 14 , when a left-handed glove is worn with the palm facing upwards, the outrigger  90  will be positioned to the right of the individual&#39;s left index finger and to the left of the individual&#39;s long finger. When the individual flexes his or her finger(s) the outrigger  90  is curved into an arcuate shape increasing the potential energy of the outrigger,  FIG. 18 . The outrigger  90  applies a force against the user&#39;s fingers through the finger extender(s)  200 . Without the aid of the splint  10 , the affected individual&#39;s fingers and thumb would be partially or completely curled closed (flexed). While wearing the splint, the individuals fingers and thumb remain at least partially open (extended), as would normally be the case for an individual not suffering from flexor spasticity,  FIGS. 17-18 . When the individual flexes the muscles in his or her hand and grasps an object, the outrigger  90  applies a biasing force against the flexion of the individual&#39;s finger(s). The biasing force transmitted to the finger(s) through the finger extender(s)  200  and outrigger  90  allows the individual&#39;s fingers to return to an extended position once flexion forces are sufficiently diminished. 
         [0041]    In the configuration shown in  FIGS. 1-4 , the rod  91  causes the biasing force against the individual&#39;s fingers, which is advantageous over parts like rubber bands, wires, and springs that tend to wear out and break requiring replacement parts. Additionally, using the rod  91  as a source of the biasing force allows for configurations of the dynamic extension splint  10  to be optionally composed of essentially four components: the glove  20 , the platform  50 , the outrigger  90 , and a finger extender  200 . Other configurations having added features may contain additional parts such as: two finger extenders  200 , a platform pad  51 , an outrigger pad  110 , or an thumb extension portion  80 . To adjust the biasing force of the outrigger  90 , the thickness of the outrigger  90  can be modified, or the composition of the outrigger changed  90 . Alternatively, optional outrigger tension adjustment mechanisms  300 ,  400  may be provided to permit adjustment of the tension or biasing force provided by the outrigger,  FIGS. 19-21 . 
         [0042]    For example,  FIGS. 19 and 20  schematically illustrate cross-sectional perspective and side elevational views, respectively, of one exemplary configuration of an outrigger tension adjustment mechanism  300  in accordance with the present invention. The outrigger tension adjustment mechanism  300  may include a housing  310  that may have a generally cylindrical shape. The housing  310  may be attached to the mounting platform  50  of the glove  20  by securing a mounting arm  350  to the mounting platform  50  by any suitable method. For example, the mounting arm  350  may be attached to the mounting platform  50  by any of the methods described above for attaching the outrigger rod  91  to the mounting platform  50 . An L-shaped guide wire  330  may be provided internally to the housing  310  having a distal end  321  that extends upward towards the top of the housing  3   10 . An outrigger rod  391  is provided having a hole through which the distal end  321  of the guide wire  330  extends so that the outrigger rod  391  may be slidably disposed on the guide wire  330 . Thus, when the outrigger tension adjustment mechanism  300  is optionally included on a splint of the present invention, the outrigger rod  391  is not directly attached to the mounting platform  50 . Rather, the outrigger tension adjustment mechanism  300  may be attached to the mounting platform  50  by the mounting arm  350 , and the outrigger rod  391  may be attached to the opposing distal end of the housing  310 . 
         [0043]    A vertically oriented slit  365  is provided at the end of the housing  310  distal to the mounting arm  350  through which the outrigger rod  391  extends to permit the outrigger rod  391  to travel vertically in the slit  365 . The slit  365  may be provided as part of the distal housing end  312  or may be provided as part of a cap  360  fitted onto the distal end  312  of the housing  310 . To regulate the range of vertical motion of the outrigger rod  391 , and thus the biasing force provided by the outrigger rod  391 , a coil spring  320  is provided within the housing  310  and is wound around (or slid over) the guide wire  330 . A tension adjustment screw  340  is provided at the end of the housing  310  proximate the mounting arm  350 , with the shaft of the screw  340  extending internally to the housing  310 . The internal end of the screw  340  contacts the end of the spring  320  furthest from the outrigger rod  391 . As the screw  340  is rotated into the housing  310 , the spring  320  is compressed and rides along the guide wire  330  to provide an upward directed force to bias the outrigger rod  391  towards the top of the housing  310 ,  FIG. 20 . As the screw  340  is rotated further into the housing  310  the upward force provided by the spring  320  on the outrigger rod  391  is increased, which in turn decreases the ability of the outrigger rod  391  to travel in the downward direction within the slit  365 , resulting in an outrigger rod  391  with less mobility, and therefore, an outrigger rod  391  that provides a greater extension force against the fingers of the individual. 
         [0044]    Turning to  FIG. 21 , an additional exemplary configuration of a tension adjustment mechanism  400  in accordance with the present invention is illustrated in cross-sectional side elevational view. The outrigger tension adjustment mechanism  400  may include a housing  410  that may have a generally cylindrical shape. The housing  410  may be attached to the mounting platform  50  of the glove  20  by securing a mounting arm  450  to the mounting platform  50  by the methods described above with regard to the tension adjustment mechanism  300 . An outrigger rod  491  may be attached to the end of the housing  410  distal to the mounting arm  450 . The outrigger rod  491  may optionally be provided in two portions joined together by a hinge  430  to allow the outrigger rod  491  to bend at the hinge  430  in the downward direction towards the individual&#39;s palm. The hinge  430  may be provided along the length of the outrigger rod  491  at a location that would position the hinge  430  over one of the interphalangeal joints. To assist in preventing hyperextension, a pair of hyperextension stops  435  may be provided on the upper surface of the outrigger rod  491  opposing the hinge  430 . 
         [0045]    To adjust the ease with which the outrigger rod  491  may be bent, a tension wire  480  may be provided along the outrigger rod  491  along with a coil spring  420  and tension adjustment screw  440  in the housing  410 . The tension wire  480  may be provided internally to a hollow outrigger rod  491  and secured in place via a stop  482  on the end of the tension wire  480  that abuts an internal wall  492  of the hollow outrigger rod  491 . Alternatively, the tension wire  480  may be provided externally to, and run along the exterior of, the outrigger rod  492 , with the end of the tension wire  480  furthest from the housing  410  secured to the outrigger rod  492  by a screw or other suitable fastening mechanism. In such an alternative configuration, the outrigger rod  492  need not be hollow. 
         [0046]    The distal end  421  of the coil spring  420  may be attached to the proximal end  481  of the tension wire  480  by a crimped metal sleeve  422  or other suitable attachment mechanism. The tension adjustment screw  440  may be provided at the end of the housing  410  proximate the mounting arm  450 , with the shaft of the screw  440  extending internally to the housing  410 . The internal end of the screw  440  may be attached to the end of the spring  420  furthest from the outrigger rod  491 . As the screw  440  is rotated into the housing  410 , the spring  420  is compressed and foreshortened to decrease the force with which the spring  420  pulls on the tension wire  480 . As a screw  440  is rotated further into the housing  410  the pulling force provided by the spring  420  on the tension wire  480  is decreased, which in turn increases the ability of the outrigger rod  491  to bend downwards, resulting in an outrigger rod  491  with increased mobility, and therefore, an outrigger rod  491  that provides a decreased extension force against the fingers of the individual. 
         [0047]    Various methods of making and assembling the components of the functional local profile dynamic extension splint  10  of the present invention are also provided including various methods for selecting appropriate parts for the splint  10 , and for properly fitting the splint  10  to an individual&#39;s hand. Specifically, the methods include steps for: A.) manufacturing the platform  50 ; B.) determining the size of the thumb jacket  32 ; C.) manufacturing the optional thumb extension portion  80  of the platform  50 ; D.) attaching two finger extenders  200  together to form a buddy splint; E.) attaching the finger extender bridge  230  to the finger extender(s)  200 ; F.) attaching the finger extender(s)  200  to the outrigger  90 ; G.) selecting a rod  91  having the appropriate rigidity for use in the dynamic extension splint  10 ; and, H.) attaching a rod  91  having the appropriate rigidity to the platform  50 . 
         [0048]    A.) To manufacture the platform  50  for the functional low-profile dynamic extension splint  10 , draw an outline of the dorsum of the affected hand on a piece of paper or other writing surface. Along the dorsum of the hand, ¼ inch proximal to the knuckle of the index finger, draw a line vertically along the mid-radial border of the second metacarpal to ½ inch proximal to the carpometacarpal (CMC) joint. Draw another vertical line from ¼ inch proximal to the knuckle of the small finger to ½ inch distal to the CMC of the 5 th  metacarpal. Draw a horizontal line on the paper connecting the top of the vertical line ¼ inch below the knuckle of the index finger to the top of the vertical line ¼ inch below the small finger. Draw a horizontal line at the bottom mark ½ inch distal to the CMC of the index finger to the bottom of the line ½ an inch distal to the CMC of the small finger. Cut out the drawing using a scissor or other cutting tool. Trace the drawing using a wax marking pencil or other drawing tool onto a thermoplastic slab. Use a shears or cutting tool to cut out the drawing traced on the thermoplastic slab. Heat the slab in a water tray until the slab becomes transparent; allow the slab to cool to a temperature where the slab will not be able to cause damage to the skin, but will be still playable to mold to the dorsum of the hand, and allow the slab to cool and harden into the platform  50 . If constructing a dynamic extension splint with a platform pad  51 , the method of making the platform may include the following steps. Place the thermoplastic cutout onto the surface of the platform pad. Use a drawing tool to trace the outline of the cutout onto the pad. Cut out the outline traced onto the pad, and secure the pad to the palmar surface of the slab.  FIGS. 4 ,  5 ,  7 ,  8 , and  10  illustrate various configurations of the platform  50  that can be made by this method. 
         [0049]    B.) To determine the size and length of the thumb jacket  32 , begin by positioning the platform  50  on top of the dorsum of the affected hand. Place the glove  20  over the platform  50  and around the hand. Secure the thumb opening  30  around the thumb. Inspect the thumb opening  30  to make sure the distal portion of the thumb opening  30  rests between the IP joint and the thumb tip to block the thumb from over flexing at the IP joint when attempting to make a tripod pinch with the spastic hand. Trim the thumb jacket  32  down to terminate at the point between the PIP joint and thumb tip, if the thumb jacket  32  is too long.  FIGS. 2-4  illustrate an example of a thumb jacket  32  made by this method. 
         [0050]    C.) For certain individuals, the thumb may have residual spasticity even with the thumb jacket  32  equipped. Consequentially, the thumb may abduct past the index and long finger when the individual attempts to close his or her hand. To assist this type of individual, a thumb extension portion  80  of the platform  50  may be used to provide a cooperative extension force with the thumb jacket  32  against the person&#39;s thumb. To manufacture and attach the optional thumb extension portion  80  of the platform  50 , begin by providing an outrigger mount portion  60  of the platform  50  and a slab. The outrigger mount portion  60  and slab may comprise thermoplastics other appropriate materials, such as Aquaplast® plastic, for example. Hold the outrigger mount portion  60  in place on the dorsum of the affected hand. Measure the distance from the web space of the hand to the IP joint of the thumb. Draw a rectangle or oval shaped pattern with a writing tool on the slab, so that the pattern is approximately two inches wide and approximately two inches longer than the distance from the web space to the IP joint of the thumb. Cut out the pattern on the slab with a shears or other cutting tool to form a thumb extension portion  80  of the platform  50  from the slab. Warm the thumb extension portion  80  and warm the dorsum of the outrigger mount portion  60  using a warming pan, splint gun, or other heating tool. Secure the thumb extension portion  80  to the warmed area of the outrigger mount portion  60  to provide the platform  50  and allow the platform  50  to cool.  FIG. 10  illustrates a configuration of a platform made by this process. 
         [0051]    D.) To attach two finger extenders  200  together to form a buddy splint, begin by providing a finger extender  200  sized to block the proximal fold of the PIP joint of the index finger to midway between the distal crease of the DIP joint and the finger tip. Provide a second finger extender  200  sized to block the proximal fold of the PIP joint of the long finger to midway between the distal crease of the DIP and the finger tip. Secure the two extenders  200  together with a fastener such as Coban® tape, a plastic tie, or adhesive. The finger extenders  200  may comprise  3  Points Product&#39;s Oval-8® splint, or other generic finger extenders  200 . 
         [0052]    E.) To attach the finger extender bridge  230  to the finger extender(s)  200 , begin by heating a thermoplastic strip and then wrap the heated strip around a part of the finger extender  200  to form the finger extender bridge  230 . Pinch the sides of the finger extender bridge  230  to flatten the sides of the bridge  230 . Form a hole  231  for the rod  91  to slide through in the middle of the flattened finger extender bridge  230 . Other materials such as wax, resin, fiberglass, plastic, and polymers can be substituted for the thermoplastic strip as appropriate. 
         [0053]    F.) To attach the finger extender(s)  200  to the outrigger  90 , begin by inserting an individual&#39;s finger(s) into a finger extender(s)  200  and insert the individual&#39;s thumb into the thumb opening  30  of the glove  20 . Position the platform  50  with attached rod  91  over the dorsum of the hand. Slide the rod  91  through the hole  231  in the finger extender bridge  230  and optionally mount a stop  92  at the distal end of the rod. 
         [0054]    G.) To select a rod  91  having the appropriate rigidity for use in the dynamic extension splint  10 , begin by positioning the proximal end of the rod  91  on top of the platform  50  so that a portion of the rod  91  is resting on the surface of the platform  50  and the rod  91  is positioned between the metacarpals of two fingers. Place the glove  20  onto the individual&#39;s affected hand thereby covering the platform  50  with the glove  20 . Insert the individual&#39;s fingers into the finger extender(s)  200 . Use a second hand to secure the rod  91  to the platform  50  and have the individual close and open the affected finger(s), and observe whether the individual&#39;s finger(s) open within about ten degrees or less of full extension. If the fingers do not open within about ten degrees or less of full extension, then replace the rod with a more rigid rod and repeat the previous steps. If the individual is not able to fully flex his or her fingers, then replace the rod with a less rigid rod and repeat the previous steps. In some cases, it may be easier to attach the rod  91  to the platform if the platform is marked with a line. In these cases, the following step may be included: draw a line with a wax pencil or other appropriate marking tool on the platform  50 , with the line drawn from the respective location of the MCP joint to the point where the rod  91  will be secured on the platform  50 .  FIG. 2  illustrates a configuration of a rod made by this process. 
         [0055]    H.) To attach the rod  91  having the appropriate rigidity to the platform  50 , begin by providing a thermoplastic slab for attaching the rod  91  to the platform  50 . Heat the thermoplastic slab with a splint pan or other heating element. Use a splint hot gun or other heating tool to warm the section of the platform  50  predetermined to be attached to the rod  91 . Place the proximal end of the outrigger rod along heated section. If a line was made on the platform, align the rod with the previously drawn line, place the heated thermoplastic slab over the rod  91  and attach it to the platform  50 , and allow the platform  50  and thermoplastic slab to cool. If a dynamic extension splint with the optional fastener is being constructed, the additional step of placing the fastener on the palmar side of the platform-thermoplastic slab complex may be performed. Once the rod  91  is attached to the platform  50 , the platform  50  may be inserted inside the glove  20 . If a Neoprene® glove  20  is used and the fastener  70  is a hook-and-loop fastener, the platform  50  may be secured to the Neoprene® by hooking the fastener to the underside  33  of the palmar side of the glove  20 . 
         [0056]    The above methods can be used to construct splints comprising other materials. For example, materials other than thermoplastic may be used for the platform, such as epoxies, resins, or metals. Further, in most cases several methods exist for constructing each configuration of the splint. For example, in the method above one could substitute the step of tracing the outline of the thermoplastic slab, by attaching a picture of the thermoplastic slab onto the platform pad  51 . 
         [0057]    Various alternative configurations and modifications to the methods and apparatuses may be made. Many of the methods presented contain optional steps that may be omitted or modified. In addition to the splints depicted and described in the specification, splints designed to extend all four fingers may be used as well as splints having multiple outriggers. It should therefore be understood that this invention is not limited to the particular embodiments described herein, but is intended to include all changes and modifications that are within the scope and spirit of the invention as set forth in the claims.

Technology Category: 1