Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
2001-01-30
2002-05-28
Chapman, Jeanette (Department: 3764)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
C602S023000, C602S060000, C602S065000
Reexamination Certificate
active
06394971
ABSTRACT:
The present invention relates generally to orthopedic devices and more particularly to improved ankle braces and supports and the method of their manufacture.
BACKGROUND
The present day market for orthopedic devices offers a number of different ankle products of varying types. The product types vary in many respects and particularly in the amount or degree of stabilization provided. Ankle products range from simple compressive elastic sleeves to rigid, plastic immobilizing braces. The most common ankle product is a lace-up style brace that is indicated for both rehabilitative and preventative use. These braces help medially and laterally stabilize the ankle joint to prevent inversion and eversion (twisting) of the ankle, while still allowing for functional dorsi and plantar flexion. This type of stabilization is typically achieved in traditional ankle braces with metal, plastic or spring type stays, boning or inserts. By stabilizing the medial and lateral sides of the ankle joint, the brace is indicated to prevent further injury and treat strains and 1st, 2
nd
, and 3rd degree ankle sprains. The brace is also employed as a preventative prophylactic to help avoid ankle sprains during activity. Historically, ankle braces with rigid stays or inserts have been utilized for these indications.
However, metal or plastic stays or inserts can dig into the tender tendons that these braces were designed to protect. Additionally, rigid stays and inserts cannot conform to the unique ankle shape to give the intimate support and stabilization necessary.
A sample of prior art patents illustrating some of these devices includes the following:
U.S. Pat. No. 4,724,847, issued Feb. 16, 1988, to Ronald E. Nelson, shows a soft orthopedic ankle support that has a plurality of pockets. Rigid stay members are inserted into the pockets to form a rigid structure that surrounds and immobilizes the ankle. U.S. Pat. No. 4,280,488 shows a similar stay stiffened soft orthopedic ankle support.
U.S. Pat. No. 5,853,380, issued to John J. Miller, Dec. 29, 1998, shows an ankle and foot orthopedic device wherein inner and outer layers of soft plastic materials are assembled in a sandwich around a rigid copolymer plastic stay which cradles the ankle and foot. In fabricating the device the inner layer of plastic material is heated and then wrapped around a plaster mold. The mold is equipped with suction by which the sheet can be sucked down to conform to the shape of the mold. The outer surface of the inner layer is then abraded and the stay is placed over the abraded surface. Once the stay is in place, adhesive is sprayed over the entire exposed surface of the inner layer and the stay. Finally the outer layer of plastic is heated and wrapped around the inner layer and stay, sucked down by the vacuum to conform to the shape of the mold, cooled, and trimmed to shape.
U.S. Pat. No. 5,899,872, issued May 4, 1999 to Robert F. Gilmore, describes a foot and ankle support which includes a soft appliance, somewhat elastic, boot element. The somewhat elastic boot element is tightened by means of spaced flaps secured by hook and loop fasteners. Conventional straps encircle the boot. In another embodiment a rigid brace is applied over the boot and affixed by one or more of the straps.
U.S. Pat. No. 5,069,202, issued Dec. 3, 1991, to Steven D. Prock, shows a stirrup type of ankle brace which includes a foot shell having rigid vertical and horizontal portions hingedly connected. This shell is held onto the ankle and foot of the wearer by straps.
U.S. Pat. No. 3,073,305, issued Jan. 15, 1963, to Ernest R. Biggs, et al., shows an ankle brace including a fabric sleeve fitting along the foot and ankle with a strap arrangement spiraling up the leg, and essentially vertical stays inserted in pockets along the leg part of the sleeve.
U.S. Pat. No. 5,472,414, issued Dec. 5, 1995, to Michael K. Detty, describes a one-size-fits-all ankle brace comprising a base of plush fabric covered neoprene having an upper ankle surrounding portion and an upper pair of mounting straps, and a lower foot surrounding portion with a lower pair of mounting straps. The base member is folded into an ankle and foot encasing position with the upper straps wrapped around the ankle and the leg just above the ankle, and the lower straps wrapped around the ankle arch and instep. Hook and loop fasteners hold the straps in position.
U.S. Pat. No. 6,024,712, issued Feb. 15, 2000, to Joseph M. Inglesias, describes an ankle brace using an inner fabric support which extends around the ankle. An outer plastic exo-support is injection molded into the fabric support to resist motion of the injured ankle in undesired directions. The exo-support has side members extending upwardly from a base to provide stirrup like support.
While the aforementioned prior art ankle braces may be generally suitable for their intended purposes, they nevertheless leave something to be desired from the standpoints of accommodating various sized ankles while supplying sufficient customized support, and ease and economy of manufacture. Thus, a need exists for an ankle brace which fits a range of sizes, which is simple in construction and manufacture, easy to use, and which has means to adjust and customize the support applied by the brace without producing the aforementioned adverse effects of metal or other rigid stays.
OBJECTS OF THE INVENTION
It is a primary object of the invention to eliminate the above described problems and shortcomings of the prior art.
It is another object of the invention to provide an improved ankle support comprising a unique combination of low temperature formable plastic foam and a sewn orthopedic soft appliance, which provides ease of economic manufacture.
It is yet another object of the invention to provide an improved methodology for manufacturing an improved ankle support which is fabricated from a combination of low temperature formable plastic foam and a sewn orthopedic soft appliance.
It is a further object of the invention to provide a combination of a sewn soft ankle brace with a contoured semi-rigid support shell of molded foam to produce a snug fitting orthopedic device which gives improved stabilization of the ankle joint.
It is yet a further object of the invention to provide such a combination orthopedic device in which the shell is molded with a unique shape or configuration that flexes around the ankle to provide medial and lateral stabilization without digging into the skin.
It is another object of the invention to provide such an orthopedic wherein a uniquely J-shaped portion of the shell is supported from a collar on the shell and sewn to an inner sock or sleeve to cradle and support the ankle joint without creating pressure points on the sensitive ankle malleoli.
It is yet another object of the invention to provide an orthopedic of the foregoing type wherein the shell has a leg encircling collar which carries depending stiffeners and has a width sufficient to provide cantilever type tensioning of one or more of such stiffeners against an extremity of a wearer.
It is yet another object of the invention to provide an orthopedic of the foregoing type wherein the shell is of an asymmetric shape to even further avoid the creation of pressure points on the ankle malleoli.
SUMMARY OF THE INVENTION
The present invention is directed to a unique incorporation of the technology of low temperature, formable plastic foam with sewn fabrics in the manufacture of improved orthopedic appliances. Particularly the invention is directed to integration of these two approaches for use in ankle and knee braces.
In sewn orthopedic soft appliances and braces the most common means to obtain the rigidity necessary to stabilize the injured joint is by using metal or plastic strips called “stays”. These stays are actually sewn to the product to prevent movement of the joint. However, in some product applications stays simply cannot conform to the anatomy of the patient to provide the necessary support and immobilization. Additionally, in some cases, stays may be too rigid, too
Machin Rhonda M.
Slautterback Ernest Gerald
Chapman Jeanette
FLA Orthopedics, Inc.
Hamilton Lalita M
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