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US 2022/0175588 A1Published application
Thermoformable orthosis apparatus and method of use
AssigneeFastForm Research Ltd.
InventorDavid Sheehan
Life of this patent
Estimating the term…
Abstract
An improved thermoformable orthosis apparatus for being selectively formed and applied and removed having offset zipper closures on two shell members for improved hinging and opening and access for initial application and forming when malleable and for removing and reinstalling when hardened.
Claims23
A thermoformable orthosis apparatus for being selectively placed on a lower leg and foot of a patient, the apparatus comprising:
- a thermoformable first shell member and an opposed thermoformable second shell member formed as a mirror-image of the first shell member, such that the first and second shell members are symmetrical, the first shell member having a first upper end and an opposite first lower end, further having a first shell member outer surface and an opposite first shell member inner surface, and further having a lengthwise first front edge and an opposite lengthwise first back edge, the first front edge and the first back edge each spanning between the first upper end and the first lower end, and the second shell member having a second upper end and an opposite second lower end, further having a second shell member outer surface and an opposite second shell member inner surface, and further having a lengthwise second front edge and an opposite lengthwise second back edge, the second front edge and the second back edge each spanning between the second upper end and the second lower end;
- a front zipper assembly joined to and selectively closing the respective first and second front edges as by a front first zipper strip affixed along the first front edge and a front second zipper strip affixed along the second front edge, the front first zipper strip affixed to both the first shell member outer surface and the first shell member inner surface along the first front edge and the front second zipper strip applied to both the second shell member outer surface and the second shell member inner surface along the second front edge for improved retention of the front zipper assembly along the first and second front edges of the respective first and second shell members, whereby the first and second front edges may be fully or partially separated through selective operation of the front zipper assembly, the front zipper assembly configured to be selectively positioned across the top of the foot and up the front of the lower leg;
- and
- a back zipper assembly joined to and selectively closing the respective first and second back edges as by a back first zipper strip affixed along the first back edge and a back second zipper strip affixed along the second back edge, the back first zipper strip affixed to both the first shell member outer surface and the first shell member inner surface along the first back edge and the back second zipper strip applied to both the second shell member outer surface and the second shell member inner surface along the second back edge for improved retention of the back zipper assembly along the first and second back edges of the respective first and second shell members, whereby the first and second back edges may be fully or partially separated through selective operation of the back zipper assembly, the back zipper assembly configured to be selectively positioned over and around the toes, across the bottom of the foot, around the heel, and up the back of the lower leg, the back zipper assembly thus being longer than the front zipper assembly;
- whereby heat activation of the apparatus allows for conformable placement of the first and second shell members about the lower leg and foot of the patient that is to be immobilized;
- whereby selective closure of the front and back zipper assemblies joins the first and second shell members along the respective first and second front and back edges to install the apparatus about the lower leg and foot of the patient;
- whereby cooling of the apparatus causes the first and second shell members to set conforming to the lower leg and foot of the patient, advantageously the front and back zipper assemblies thereby simultaneously conforming to the lower leg and foot of the patient;
- and
- whereby selective opening of one or both of the front and back zipper assemblies separates the first and second shell members along one or both of the respective first and second front and back edges to uninstall and allow removal of the apparatus from the lower leg and foot of the patient, at least a portion of one of the front and back zipper assemblies allowing for selective hinging of the set first and second shell members about the portion of one of the front and back zipper assemblies for ease of removal and replacement of the apparatus in use.
6 more elements
A thermoformable orthosis apparatus comprising:
- a thermoformable first shell member and an opposed thermoformable second shell member formed as a mirror-image of the first shell member, such that the first and second shell members are symmetrical, the first shell member having a first front edge and an opposite first back edge, and the second shell member having a second front edge and an opposite second back edge, the first and second shell members further comprising aperture regions configured for providing increased stretchability during heat activation and forming of the apparatus and increased breathability during setting and use of the apparatus;
- a front zipper assembly joined to and selectively closing the respective first and second front edges as by a front first zipper strip affixed at the first front edge and a front second zipper strip affixed at the second front edge;
- a back zipper assembly joined to and selectively closing the respective first and second back edges as by a back first zipper strip affixed at the first back edge and a back second zipper strip affixed at the second back edge, a distal end of the back zipper assembly extending distally beyond the first and second shell members at a lower end of the apparatus;
- and
- an inflation bladder configured to be selectively positioned between the first and second shell members and the body part of the patient, the inflation bladder comprising an inflation bladder body and an inflation line in fluid communication with the inflation bladder body, the inflation line passing through an aperture of the aperture regions formed in the first and second shell members;
- whereby heat activation of the apparatus allows for conformable placement of the first and second shell members and the toe box about the inflation bladder body and a body part of a patient that is to be immobilized;
- whereby selective closure of the front and back zipper assemblies joins the first and second shell members along the respective first and second front and back edges to install the apparatus about the body part of the patient and selective pivoting of the toe box about the lower end of the apparatus positions the toe box in a curved configuration over the lower end, during heat activation and forming the adjustability of the toe box enabling a single apparatus to accommodate a range of foot sizes and the insertion of the inflation bladder body between the body part of the patient and the first and second shell members thereby providing additional padding and selectively increased or decreased volume within the apparatus for the body part such as to account for increased or decreased swelling without having to heat and in any way reform the orthosis apparatus once set;
- whereby cooling of the apparatus causes the first and second shell members and the toe box to set conforming to the body part of the patient;
- whereby selective inflation or deflation of the inflation bladder body via the inflation line allows for volumetric adjustment between the body part and the first and second shell members of the apparatus;
- whereby selective pivoting of the toe box opens the lower end of the apparatus;
- and
- whereby selective opening of one or both of the front and back zipper assemblies separates the first and second shell members along one or both of the respective first and second front and back edges to uninstall and allow removal of the apparatus from the body part of the patient, at least a portion of one of the front and back zipper assemblies allowing for selective hinging of the set first and second shell members for ease of removal and replacement of the apparatus in use.
9 more elements
A thermoformable orthosis apparatus comprising:
- a thermoformable first shell member and an opposed thermoformable second shell member formed as a mirror-image of the first shell member, such that the first and second shell members are symmetrical, the first shell member having a first front edge and an opposite first back edge, and the second shell member having a second front edge and an opposite second back edge;
- a front zipper assembly joined to and selectively closing the respective first and second front edges as by a front first zipper strip affixed at the first front edge and a front second zipper strip affixed at the second front edge;
- a back zipper assembly joined to and selectively closing the respective first and second back edges as by a back first zipper strip affixed at the first back edge and a back second zipper strip affixed at the second back edge;
- an insole having an upper surface and an opposite lower surface and being selectively positionable within the apparatus between the first and second shell members such that the upper surface is facing toward the upper end of the apparatus;
- and
- a rocker extending away from the lower surface of the insole and being selectively repositionable on the lower surface, the rocker thus being positioned between the insole and the first and second shell members at a desired location along the insole;
- whereby heat activation of the apparatus allows for conformable placement of the first and second shell members about a body part of a patient that is to be immobilized;
- whereby selective closure of the front and back zipper assemblies joins the first and second shell members along the respective first and second front and back edges to install the apparatus about the body part of the patient;
- whereby the rocker positioned on the lower surface of the insole forms a corresponding bottom rocker feature in the first and second shell members of the apparatus when the rocker and the insole are together inserted within the apparatus and the shell members are heat activated and formable, the bottom rocker feature thereby being effectively formed in the apparatus from the inside thereof as by the incorporation of the rocker with the insole;
- whereby cooling of the apparatus causes the first and second shell members to set conforming to the body part of the patient and as to the bottom rocker feature conforming to the rocker;
- whereby the bottom rocker feature contributes to plantar pressure offloading within the apparatus during use;
- and
- whereby selective opening of one or both of the front and back zipper assemblies separates the first and second shell members along one or both of the respective first and second front and back edges to uninstall and allow removal of the apparatus from the body part of the patient, at least a portion of one of the front and back zipper assemblies allowing for selective hinging of the set first and second shell members for ease of removal and replacement of the apparatus in use.
10 more elements
Dependencies are inferred from the claim text.