Abstract:
A device and method for releasably connecting together two elements, such as two orthotic devices, or two elements of an orthotic device is provided. A quick connect apparatus and method of use is disclosed that quickly and easily enables a user to attach and detach two devices or two elements of a device, such as the elements of an orthosis or a prosthetic. An example device that may easily be converted back and forth between an ankle-foot orthosis and a knee-ankle-foot orthosis is disclosed, along with steps for making and using same.

Description:
BACKGROUND  
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates to a device and method for releasably connecting together two elements, such as two orthotic devices, or two elements of an orthotic device. More particularly, the invention relates to a quick connect apparatus that quickly and easily enables a user to attach and detach two devices or two elements of a device, such as the elements of a knee-ankle-foot orthosis. 
         [0003]    2. Background of the Invention 
         [0004]    Orthotic devices traditionally have been utilized to aid in supporting, guiding and limiting the range of motion of different joints in the human body, or in the case of prosthetic devices, to replace missing body joints and limbs or portions thereof. For example, if natural joints such as knees or ankles are congenitally impaired or become impaired due to disease or injury, an orthosis may be used to support the joints, and guide and limit their range of motion. Orthotic devices typically comprise one or more orthotic supporting members that support a limb or part of a limb, such as for example a foot, a leg, or a lower or upper portion of a leg. When more than one orthotic supporting member is used the members are typically connected with orthotic metal bars that may form a pivoting mechanical orthotic joint across, for example, the knee, elbow, wrist, hip, ankle, spine, torso or neck of a patient. Such orthotic metal bars are typically mounted on opposite sides of the orthotic supporting members and cannot usually be detached except by an orthotist using fabrication techniques. Orthotic devices are often custom fit specifically for an individual patient, such as by contouring orthotic supporting members and orthotic metal bars to a plaster mold of a patient&#39;s anatomy. Examples of such procedures are described in U.S. Pat. No. 6,171,535, the teachings of which are incorporated herein by reference. 
         [0005]    In some cases a patient no longer needs part of their orthotic device, for instance where a patient with a knee-ankle-foot orthosis improves and requires only an ankle-foot orthosis. Alternatively, a patient with an ankle-foot orthosis may occasionally or temporarily need a knee-ankle-foot orthosis, for instance for certain physical activities. However, when orthotic metal bars are permanently or semi-permanently attached to the orthotic supporting members to create, for instance, a knee-ankle-foot orthosis, it is difficult and time consuming for the orthotist to later remove the various orthotic supporting members from the orthotic device. Because in the past they were not easily modified, patients have often required separate knee-ankle-foot and ankle-foot orthoses. 
         [0006]    U.S. Pat. Nos. 6,129,689 and 6,736,567 to Dibello, both entitled Quick Connect Apparatus And Method For Orthotic And Prosthetics Devices, the teachings of which are incorporated herein by reference, are generally directed to a device for releasably connecting orthotic metal bars to orthotic supporting members. Each Dibello device includes two plate members attachable to different orthotic elements, and a slider plate that is movable between a first released position and a second locked position. The Dibello device also may include a stop to secure the slider plate in the locked position. While the Dibello device should theoretically be usable to allow a patient to releasably connect orthotic supporting members to his or her orthotic device, in practice the Dibello device has proven very difficult and tedious to implement and use, because it requires precise, simultaneous, three-dimensional alignment of complicated plate members. Specifically, two Dibello plate members must each be separately attached to orthosis metal bars, and then precisely aligned and connected with corresponding plate members attached to opposite sides of an orthotic supporting member. Such alignment and connection of the Dibello plate members is in practice very difficult even for a professional orthotist, due to the misalignment and dimensional variation inherent in custom fabrication, as well as normal flexing and deformation of the metal bars and polymer supporting members. 
         [0007]    A need remains for a device and method of quickly and reliably attaching and detaching orthotic members to and from an orthotic device that can be performed easily, for instance by a patient. A need also exists for such a device and method allowing easy connection of orthotic members that is sturdy and reliable for the user of an orthotic device and will not inadvertently disconnect when the orthotic device is in use. 
       SUMMARY  
       [0008]    For purposes of the present invention, the terms “orthotic elements” and “appliance elements” refer to orthotic bars, orthotic straps, cuffs or bands, prosthetic limbs or any other members which are desired to be connected in an orthotic or prosthetic device. Also as used herein, the term “appliance” shall mean an orthosis or orthotic device or a prosthesis or prosthetic device. 
         [0009]    One aspect of the present invention relates to a quick connect device adapted to be affixed to a first element of an appliance for releasably connecting the first element of the appliance to a second element of the appliance, wherein the quick connect device comprises one or more engagement members that are drivable back and forth between a retracted position and an extended position by actuation of an actuatable member from a first position and a second position, the one or more engagement members being adapted to engage the second element of the appliance and connect the second element of the appliance to the first element of the appliance when the quick connect device is affixed to the first element of the appliance and the second element of the appliance is positioned adjacent the first element of the appliance and the actuatable member is actuated from the first position to the second position, where the one or more engagement members are further adapted to disengage the second element of the appliance and disconnect the second element of the appliance from the first element of the appliance when the actuatable member is then actuated from the second position to the first position. Alternatively, the quick connect device may comprise no fewer than two engagement members. 
         [0010]    In accordance with one aspect of the invention the quick connect device may comprise a cam member adapted to drive the one or more engagement members back and forth between their retracted and extended positions when the actuatable member is actuated back and forth between its first position and second positions. The actuatable member may be adapted to drive the cam member back and forth between a lesser lift position and a greater lift position when the actuatable member is actuated back and forth between its first position and second positions. 
         [0011]    Additionally, the quick connect device may comprise means to releasably lock the engagement members in an extended position. 
         [0012]    One aspect of the present invention relates to an appliance with releasably connectable first and second elements, the appliance comprising a quick connect device affixed to the first element of the appliance for releasably connecting the first element of the appliance to the second element of the appliance, the quick connect device including one or more engagement members that are drivable back and forth between a retracted position and an extended position by actuation of an actuatable member from a first position and a second position, the one or more engagement members being releasably engagable with the second element of the appliance to connect the second element of the appliance to the first element of the appliance when the second element of the appliance is positioned adjacent the first element of the appliance and the actuatable member is actuated from the first position to the second position, the one or more engagement members being disengagable from the second element of the appliance to disconnect the second element of the appliance from the first element of the appliance when the actuatable member is actuated from the second position to the first position. 
         [0013]    In accordance with one aspect of the invention the appliance may comprise a knee-ankle-foot orthosis. 
         [0014]    In accordance with one aspect of the invention the first element of the appliance may be part of an ankle-foot orthosis. 
         [0015]    In accordance with one aspect of the invention the appliance may comprise a prosthetic device. 
         [0016]    One aspect of the present invention relates to a method of releasably connecting first and second elements of an appliance, the method comprising affixing a quick connect device to the first element of the appliance for releasably connecting the first element of the appliance to the second element of the appliance, the quick connect device including one or more engagement members that are drivable back and forth between a retracted position and an extended position by actuation of an actuatable member from a first position and a second position, the one or more engagement members being releasably engagable with the second element of the appliance to connect the second element of the appliance to the first element of the appliance when the second element of the appliance is positioned adjacent the first element of the appliance and the actuatable member is actuated from the first position to the second position, the one or more engagement members being disengagable from the second element of the appliance to disconnect the second element of the appliance from the first element of the appliance when the actuatable member is actuated from the second position to the first position; positioning the actuatable member such that the one or more engagement members are in the retracted position; and positioning the second element of the appliance adjacent the first element of the appliance and releasably connecting the first and second elements of the appliance by positioning the actuatable member such that the one or more engagement members are in the extended position and engaging the second element of the appliance. 
         [0017]    In accordance with one aspect of the invention the method of releasably connecting first and second elements of an appliance further may further comprise the step of disconnecting the second element of the appliance from the first element of the appliance by positioning the actuatable member such that the one or more engagement members are in the retracted position and disengaged from the second element of the appliance. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0018]      FIG. 1  is a perspective view of an example prior art ankle-foot orthosis (“AFO”) with an ankle joint; 
           [0019]      FIG. 2  is a perspective view of an example prior art ankle-foot orthosis (“AFO”) without an ankle joint; 
           [0020]      FIG. 3  is a perspective view of an example prior art knee-ankle-foot orthosis (“KAFO”) without an ankle joint; 
           [0021]      FIG. 4  is a perspective view of an example appliance according to the present invention showing the quick connect device in the unlocked position; 
           [0022]      FIG. 5  is a perspective view of the example appliance of  FIG. 4  showing the quick connect device in the locked position; 
           [0023]      FIG. 6  is a perspective exploded view of an example quick connect device mechanism according to the present invention; 
           [0024]      FIG. 7  is a series of views of an example cam member of the example quick connect device mechanism of  FIG. 6 , with  FIG. 7-1  being a top perspective view,  FIG. 7-2  being a bottom perspective view,  FIG. 7-3  being a top view,  FIG. 7-4  being a side view, and  FIG. 7-5  being a bottom view thereof; 
           [0025]      FIG. 8  is a series of views of an example actuatable member of the example quick connect device mechanism of  FIG. 6 , with  FIG. 8-1  being a bottom perspective view,  FIG. 8-2  being a top perspective view,  FIG. 8-3  being a bottom view,  FIG. 8-4  being a side view, and  FIG. 8-5  being a top view thereof; 
           [0026]      FIG. 9  is a series of views of example engagement members of the example quick connect device mechanism of  FIG. 6 , with  FIG. 9-1  being a bottom perspective view of a left-side engagement member,  FIG. 9-2  being a bottom perspective view of a right-side engagement member,  FIG. 9-3  being a side view of the member of  FIG. 9-2 ,  FIG. 9-4  being a bottom view of the member of  FIG. 9-2 , and  FIG. 9-5  being an end view of the member of  FIG. 9-2 ; 
           [0027]      FIG. 10  is a series of views of an example housing member of the example quick connect device mechanism of  FIG. 6 , with  FIG. 10-1  being a top perspective view,  FIG. 10-2  being a bottom perspective view,  FIG. 10-3  being a top view,  FIG. 10-4  being a side view, and  FIG. 10-5  being a bottom view thereof; 
           [0028]      FIG. 11  is a series of views of an example housing cover member of the example quick connect device mechanism of  FIG. 6 , with  FIG. 11-1  being a top perspective view,  FIG. 11-2  being a bottom perspective view,  FIG. 11-3  being a top view,  FIG. 11-4  being a side view, and  FIG. 11-5  being a bottom view thereof; 
           [0029]      FIG. 12  is a series of views of the example quick connect device mechanism of  FIG. 6 , with  FIG. 12-1  being a top perspective view showing the engagement members in a retracted position, and  FIG. 12-2  being a top perspective view thereof showing the engagement members in an extended position. 
       
    
    
     DETAILED DESCRIPTION  
       [0030]    While the quick-connect apparatus and method described below will be described with respect to ankle-foot and knee-ankle-foot orthoses, the principles will apply to other appliances as well. 
         [0031]    Referring to  FIG. 1 , an example prior art ankle-foot orthosis  10  (“AFO”) is shown including a foot support element  12 , a calf support element  14 , and an ankle joint  16 . Alternatively, an ankle-foot orthosis  20  can be one-piece or otherwise omit an ankle joint, as shown in  FIG. 2 . Orthoses such as an ankle-foot orthosis typically include one or more straps  22 . Other example straps are shown in more detail in U.S. Pat. No. 7,018,352, all the teachings of which are incorporated herein by reference. 
         [0032]      FIG. 3  depicts an example prior art knee-ankle-foot orthosis  30  (“KAFO”), comprising a one-piece ankle-foot orthosis  20  connected to a thigh support member  32  by metal bars  34  that are permanently or semi-permanently affixed to first and second sides of orthosis  20  and support member  32  by fasteners  36  and over-lamination areas  38 , which at least partially encapsulate the metal bars  34 . Straps  22  for holding a patient&#39;s leg (not shown) into the orthosis  30  are also depicted. The metal bars  34  may include joints  39  on each side to allow the ankle-foot orthosis  20  to pivot in a controlled manner relative to the thigh support member  32 , as is known in the art. 
         [0033]    An example embodiment  40  will now be discussed with reference to  FIGS. 4 ,  5 ,  6 ,  10  and  12 . As an example first element of an appliance,  FIG. 4  depicts a one-piece ankle-foot orthosis member  20  with an example quick connect device mechanism  60  (shown in  FIGS. 6 and 12 ) attached to and at least partially encapsulated in the body of orthosis member  20  at location  42 , for instance by over-lamination. In one embodiment the example quick connect device mechanism  60  is completely encapsulated in the body of orthosis member  20  at location  42 , except openings are provided to allow a user to access actuatable member  80  and to allow engagement members  90  to be extended from retracted positions  FIG. 12-1  to extended positions  FIG. 12-2 . Alternatively, an example quick connect device mechanism  60  can be attached to orthosis member  20  with glue, fasteners, or any other suitable fastening means at or near location  42 , instead of or in addition to encapsulation in the body of the orthosis member  20 . In one embodiment the example quick connect device mechanism  60  is positioned on or in the orthosis member  20  at or near location  42  with the bottom  110  of the housing  100  positioned toward the leg (not shown) of the wearer of the orthosis member  20 , with the actuatable member  80  positioned away from the leg of the wearer, and with the tapered portion  102  of the housing  100  positioned upward to provide an outer profile decreasing in size as it extends upward toward the back of the wearer&#39;s knee. When so oriented the tapered portion  102  may provide additional clearance with respect to seating in which the orthosis wearer may sit. Alternatively the various elements of a quick connect device can be positioned in any suitable location and orientation. 
         [0034]    Also shown in  FIG. 4  is a second element of an appliance, in this example a calf support element  46 . Calf support element  46  may be connected to thigh support element  32  by orthotic metal bars  34  that may include joints  39 , as described above with respect to prior art connections of orthotic metal bars to other orthotic elements. In the example shown, calf support element  46  is contoured to be placed against and fit closely around the upper exterior of ankle-foot orthosis member  20 . In this example calf support element  46  includes a receiver portion  44  adapted to fit around the example quick connect device mechanism  60 . The receiver portion  44  may include an opening to allow a user to access actuatable member  80  when calf support element  46  is placed against ankle-foot orthosis member  20  as shown in  FIG. 5 . The receiver portion  44  may further include recesses, detents, or openings adapted to receive and engage engagement members  90  when calf support element  46  is placed against ankle-foot orthosis member  20  as shown in  FIG. 5  and engagement members  90  are extended from retracted positions  FIG. 12-1  to extended positions  FIG. 12-2  as explained herein. While the above embodiment is described with an example quick connect device mechanism  60  attached to orthosis member  20  and engaging calf support element  46  at receiver portion  44 , in an alternative embodiment a quick connect device could be attached to calf support element  46  and adapted to engage orthosis member  20 . 
         [0035]      FIG. 5  depicts the first appliance element  20  and second appliance element  46  of  FIG. 4  attached to form a knee-ankle-foot orthosis  40 ′. This attachment can easily be accomplished by a user, such as a patient wearing the appliance or any other person, by placing the calf support element  46  against ankle-foot orthosis member  20  as shown in  FIG. 5 , and causing engagement members  90  to be extended from retracted positions  FIG. 12-1  to extended positions  FIG. 12-2 , thereby engaging engagement members  90  with corresponding and adjacent receiver portion  44  of calf support element  46 . Engagement members  90  can be caused to be extended from retracted positions  FIG. 12-1  to extended positions  FIG. 12-2  by actuating actuatable member  80  of quick connect device  60  as discussed below. Knee-ankle-foot orthosis  40 ′ can then easily be changed back to a stand-alone ankle-foot orthosis  20  by actuating actuatable member  80  of quick connect device  60  to cause engagement members  90  to be retracted from extended positions  FIG. 12-2  to retracted positions  FIG. 12-1 , and removing first appliance element  20  from second appliance element  46 . 
         [0036]    The components of an example quick connect device  60  will now be described.  FIG. 6  depicts an exploded view of an example quick connect device  60 , including housing  100  and housing bottom  110  encompassing and supporting cam member  70 , actuatable member  80 , and engagement members  90 . As shown in  FIG. 7 , example cam member  70  includes a rack of gear teeth  72  , an interface surface  74  that interfaces with actuatable member  80 , a pilot slot  75  that interfaces with actuatable member  80 , and cam grooves  76  and cam ridges  78  that interface with engagement members  90 ,  92 . When assembled as shown in quick connect device  60 , cam member  70  interfaces with and is driven by example actuatable member  80  shown in  FIG. 8 . Example actuatable member  80  includes a pinion of gear teeth  82  that are adapted to mesh with cam member gear teeth  72 , a shoulder  84  that interfaces with and is axially restrained in one direction by inner surface  104  of housing  100  (shown in  FIG. 10 ), a pilot protrusion  85  that interfaces with and is located by pilot slot  75  in cam member  70 , and a slot  86  adapted to interface with a flat screw driver, or a coin, such as a penny, nickel, dime, or quarter. Slot  86  could alternatively be replaced by any suitable structure, such as, for example, an external hex shape to be driven by a wrench, or a phillips-style interface, or a torx-style interface, or an allen-style interface. Example actuatable member  80  further includes an outer-diameter bearing surface  88  which interfaces with and is located by inner-diameter bearing surface  108  in housing  100 . Example quick connect device  60  further includes left and right, or first side and second side, engagement members  90  and  92  as shown in  FIG. 9 . Left and right, or first side and second side, engagement members  90  and  92  are in this example mirror images of each other; accordingly, their features will be described with respect to right, or second side engagement member  92 . Engagement members  90 ,  92  include engagement surfaces  94  that slidably interface with and are located by surfaces  106  of housing  100  and surfaces  114  of housing bottom  110 . Engagement surfaces  94  are further adapted to engage receiver portion  44  of calf support element  46 , for instance by having holes (not shown) in receiver portion  44  dimensionally corresponding to engagement members  90 ,  92  as located by surfaces  106  of housing  100  and surfaces  114  of housing bottom  110  when first appliance element  20  and second appliance element  46  of  FIG. 4  are attached to form a knee-ankle-foot orthosis  40 ′ as shown in  FIG. 5 . Engagement members  90 ,  92  may further include grooves  95  that interface with and catch on surfaces  106  of housing  100  and surfaces  114  of housing bottom  110  when engagement members  90 ,  92  are in extended positions  FIG. 12-2 . This interface of grooves  95  with housing  100  and housing bottom  110  creates a locking effect, effectively locking the engagement members  90 ,  92  in extended positions  FIG. 12-2  such that first appliance element  20  does not inadvertently disconnect from appliance element  46  of  FIG. 4 . This locking effect may be overcome, and the mechanism un-locked, by applying extra force to actuatable member  80 , to pop surfaces  106  and  114  out of grooves  95 . Engagement members  90 ,  92  include engagement slots  96  and engagement ridges  98  that slidably interface with corresponding cam ridges  78  and cam grooves  76 , respectively, of cam member  70 . As shown in  FIG. 10 , example housing  100  includes a top surface  101 , a tapered surface  102  that tapers away from top surface  101 , a raised boss  103  extending upward from the top surface  101  and designed to extend through overlamination material at least partially encapsulating connecting device  60  and connecting it to first appliance element  20 , an inner surface  104 , surfaces  106  to guide and engage members  90 ,  92 , bottom edges  107 , and an inner-diameter bearing surface  108  for locating and interfacing with actuatable member  80 . Example housing bottom  110  is shown in  FIG. 11 , and snap-fits between bottom edges  107  of housing  100 , and includes a bottom surface  112 , a top surface  113 , surfaces  114  on ears  116  to guide and engage members  90 ,  92 , and a pilot hole or recess  115  to engage and locate pilot protrusion  85  of actuatable member  80 . The various components of quick connect device  60  discussed above may each be made from any suitable material, such as nylon 6/6 or any other suitable polymer or metal, and may be formed by any combination of machining, plastic injection molding, compression molding, vacuum molding, or any other suitable manufacturing process. 
         [0037]    Operation of example quick connect device mechanism  60  will now be described. A user actuates actuatable member  80  by rotating it, for instance by engaging a screw driver or a coin in slot  86 . In other example mechanisms actuatable member  80  may be replaced by one or more switches, latches, buttons, levers, or any suitable mechanism adapted to drive one or more engagement members  90 ,  92 . While two engagement members  90 ,  92  are shown in this example, in other embodiments one engagement member may be used, or three or more engagement members may be used. When actuatable member  80  is rotated in a first or second rotational direction, gear teeth  82  drive cam member gear teeth  72 , slidably translating cam member  70  in a first or second axial direction within housing  100 . When cam member  70  is translated in a first or second axial direction, engagement slots  96  and engagement ridges  98  of engagement members  90 ,  92  slidably interface with corresponding axially angled cam ridges  78  and cam grooves  76 , respectively, of cam member  70 , which then vary between lesser and greater lifts as cam member  70  is translated axially, and which cause engagement surfaces  94  of engagement members  90 ,  92  to slide past surfaces  106  of housing  100  and surfaces  114  of housing bottom  110  a distance corresponding to the change in lift of the cam member  70 . When actuatable member  80  is rotated in a first rotational direction, engagement surfaces  94  of engagement members  90 ,  92  slide past surfaces  106  of housing  100  and surfaces  114  of housing bottom  110  and extend to an extended position as shown in  FIG. 12-2 . When fully extended or sufficiently extended, grooves  95  in engagement members  90 ,  92  engage with surfaces  106  of housing  100  and surfaces  114  of housing bottom  110 , locking the mechanism in the extended position as shown in  FIG. 12-2 . Engagement members  90 ,  92  may then be retracted by rotating actuatable member  80  in a second rotational direction, first applying sufficient force to disengage surfaces  106  of housing  100  and surfaces  114  of housing bottom  110  from grooves  95 , and then causing engagement surfaces  94  of engagement members  90 ,  92  to slide past surfaces  106  of housing  100  and surfaces  114  of housing bottom  110  to a retracted position as shown in  FIG. 12-1 . 
         [0038]    An example fabrication technique will now be discussed. A KAFO (Knee Ankle Foot Orthosis) cast or mold is created based on the shape of a patient&#39;s limb and may be fully modified and screened to the practitioner&#39;s expectations. Once a cast or mold is made, locate an area on the mold corresponding to where the quick connect device mechanism  60  will be located and trace with an indelible pencil, approximately three inches distal from the fibular head. An orthotist may use judgment on pediatric applications as they may vary. Using a flat sure form make a flat surface (using indelible marks as guide) on which to place the quick connect device mechanism  60  (screen smooth after satisfied with the way the box sits on the mold). Once the mold is fully shaped, seal it to reduce moisture, then place a nylon covering, such as nylon leg hosiery, over the mold. Later when a vacuum is applied, the vacuum will be communicated between the fibers and through the openings in the nylon material. Next, use plastic such as a trash bag to wrap and seal the nylon-covered upper thigh area of the KAFO, from the top just passed the knee center. Seal the ends of plastic material to the nylon with black electrical tape, covering several inches of nylon with the tape, and seal the other end of the plastic material to a vacuum source. Apply a small amount of spray adhesive to the nylon material where the quick connect device mechanism  60  will be placed, and place the quick connect device mechanism  60  there. Heat up 1/16 inch thick polyethylene, at least 7 inch by 7 inch in size, in an oven until it becomes substantially transparent, for instance about 18 minutes at 350 degrees Fahrenheit. Then remove the heated polyethylene from the oven and stretch it over the area on the mold where the quick connect device mechanism  60  is placed. The heated polyethylene may contact the quick connect device mechanism  60 , the nylon, the mold, and the black electrical tape, but may not touch the plastic bag material. The polyethylene may be stretched around the mold until it thins down to approximately 1/32 inch thick, and it should be compressed together to form an air-tight enclosure around the mold. Apply a strong vacuum to the interior of the plastic bag, which vacuum is then communicated through the nylon hosiery, under the electrical tape, and under the heated polyethylene that encloses the mold. The vacuum will then suck the heated polyethylene tightly to the nylon hosiery-covered mold, over and encapsulating the quick connect device mechanism  60 . After the material cools somewhat but while it is still hot to the touch, use a razor blade to cut the polyethylene away from the locations of engagement members  90 ,  92  so that they may extend as shown in  FIG. 12-2 , and grind away the polyethylene material covering the actuatable member  80  so that it may be actuated. After the material cools to substantially room temperature, the foregoing steps are repeated by heating, stretching, and vacuum-forming a second layer of polyethylene over the first layer of polyethylene at the location of the quick connect device mechanism  60 , while the engagement members  90 ,  92  are extended as shown in  FIG. 12-2 . This will form the corresponding engagement areas for engagement members  90 ,  92  in the second layer of polyethylene. The second layer of polyethylene material covering the actuatable member  80  must also be ground away so that it may be actuated. In the present example discussed herein, the first layer of polyethylene will form the ankle-foot orthosis  20 , including protrusion  42  encapsulating quick connect device mechanism  60 , and the second layer of polyethylene will form calf support element  46  including receiver portion  44  form-fitted to fit around protrusion  42  ankle-foot orthosis  20 . After the material cools, excess material is cut away and typical orthosis hardware is added as is known in the art to produce an appliance as shown in  FIGS. 4 and 5 . 
         [0039]    While the foregoing invention has been described with reference to its preferred embodiments, various alterations and modifications will occur to those skilled in the art. All such alterations and modifications are intended to fall within the scopes of the appended claims.