Rigid orthopedic walker boot and related methods

Abstract

A brace includes a lower leg shell configured to wrap around at least a portion of a lower leg of a wearer, a foot shell pivotally coupled to, and configured to rotate in relation to, the lower leg shell, a ROM limiting assembly configured to set upper and lower limits for the desired range of angles of plantarflexion and / or dorsiflexion, and an outer sole assembly hingedly coupled to an anterior edge of the foot shell. The brace is configured to hinge at a ball of the wearer's foot. When worn, the toes and ball of the wearer's foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer's foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion and / or dorsiflexion. A wedge spacer is also provided. Related methods are also provided.

Description

DONJOY.123WO PATENT RIGID ORTHOPEDIC WALKER BOOT AND RELATED METHODS TECHNICAL FIELD

[0001] The present disclosure relates generally to orthopedic bracing devices and related methods. In particular, some implementations may relate to rigid, or semi-rigid, orthopedic walker boots and / or lower leg braces configured to substantially immobilize, and provide comfort to, at least a portion of the lower leg and / or foot of a wearer in each of a plurality of fixed ankle positions of plantar flexion and / or in each of a plurality of fixed range of motion settings, for example, as a part of Achilles’ tendon and / or lower leg bone break rehabilitation. BACKGROUND OF THE INVENTION

[0002] Achilles tendon rehabilitation has previously employed the use of fixed rigid walkers that utilize wedges, disposed inside the walker, to position an ankle joint of a wearer in different degrees of plantar flexion (e.g., -30°, -20°, -10° and 0°). However, such conventional solutions employ frames that are too rigid and shells that are not sufficiently adjustable to the changing position of the ankle joint in various degrees of plantar flexion. This unavoidably and undesirably results in discomfort to the toes and / or lower limb of the wearer disposed in the walker frame, which over time unavoidably and undesirably results in negative impacts to the gait pattern, and attendant knee and hip joint movements, in compensation for the ankle positioning. SUMMARY OF THE INVENTION

[0003] A lower leg brace configured to support a wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion is provided. The brace includes a lower leg shell configured to wrap around at least a posterior and sides of a lower leg of the wearer. The brace includes a foot shell pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell to, thereby, set the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion. The brace includes a range of motion (ROM) limiting assembly coupled to the lower leg shell and configured to set an upper limit and a lower limit for the desired range of angles of plantarflexion and / or dorsiflexion. The brace includes an outer sole assembly hingedly coupled to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace, the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell.DONJOY.123WO PATENT

[0004] In some embodiments the brace further includes a wedge spacer assembly configured to be disposed between the foot shell and the outer sole assembly. The wedge spacer assembly includes a plurality of wedge spacers, and a plurality of locking plates, each configured to lock a wedge spacer to an adjacent wedge spacer or to an underside of the foot shell.

[0005] In some embodiments, each of the plurality of wedge spacers is defined by a first planar surface, and a second surface offset from first surface by a predetermined angle θ1, wherein the second surface includes a first planar portion, and a second planar portion recessed or offset compared to the first planar portion by a thickness of the locking plate, the second planar portion corresponding to a footprint of the locking plates such that, when a locking plate is disposed on the second planar portion, an outward facing surface of the locking plate is coplanar with the first planar portion.

[0006] In some embodiments, the first planar surface of each wedge spacer includes a first protrusion configured to mate with a first recess disposed in the first portion of the second surface of a mating wedge spacer, and a post configured to mate with a second recess disposed in the second portion of the second surface of the mating wedge spacer.

[0007] In some embodiments, the second planar surface of each wedge spacer includes a first recess disposed in the first planar portion and configured to receive a protrusion disposed on the first planar surface of a mating wedge spacer, a first post disposed on the second planar portion and configured to mate with a first aperture in a mating locking plate, a second post disposed on the second planar portion and configured to mate with a first arcuate slot in the mating locking plate, and a second recess disposed in the second planar portion and configured to receive a post disposed on the first planar surface of the mating wedge spacer.

[0008] In some embodiments, each locking plate includes a first aperture configured to receive a first post disposed on the second planar portion of a first mating wedge spacer; a first arcuate slot configured to receive a second post disposed on the second planar portion of the first mating wedge spacer, and a second arcuate slot configured to receive a post disposed on the first planar surface of the first mating wedge spacer therethrough. The is configured to further extend into a mating second recess disposed in the second planar portion of a second mating wedge spacer disposed on an opposite side of the locking plate from the first mating wedge spacer.

[0009] In some embodiments, an outer perimeter of each locking plate has a same outer perimeter as the second portion of the wedge spacers such that, when the locking plate is properly secured to a wedge spacer, the outer perimeter of the locking plate and a mating outer perimeter of the wedge spacer are coextensive.DONJOY.123WO PATENT

[0010] In some embodiments, at least one side of the lower leg shell includes an aperture through which a respective side of the foot shell is pivotally coupled to the lower leg shell, and an arcuate slot adjacent the aperture configured to receive, therethrough, a post extending from the side of the foot shell such that, when the foot shell is rotated with respect to the lower leg shell, the respective post slides along the arcuate slot of the lower leg shell.

[0011] In some embodiments, the ROM-limiting assembly includes a rotatable ROM dial that includes a central aperture configured to receive a rivet that also pivotally couples the foot shell to the lower leg shell, the ROM dial configured to rotate about the central aperture, and at least one arcuate slot configured to receive the post extending from the respective side of the foot shell. An overlap between the arcuate slot of the lower leg shell and the arcuate slot of the ROM dial defines a range of travel through which the post can freely slide and the range of angles of plantarflexion and / or dorsiflexion.

[0012] In some embodiments, the outer sole assembly comprises an outer sole coupled to a soft sole, e.g. comprising EVA or another similarly pliable material. The outer sole assembly is configured to maintain a bottom surface of the soft sole substantially parallel to the ground when the wearer is standing regardless of the degree of plantarflexion and / or dorsiflexion of the wearer’s foot.

[0013] In some embodiments, the soft sole includes an anterior portion configured to support the toes and the ball of the foot of the wearer and being sufficiently flexible to flex during a toe-off phase of a gait of the wearer, thereby providing a natural gait for the wearer during ambulation in the brace, and a posterior portion configured to receive the outer sole.

[0014] In some embodiments, the foot shell comprises at least one hinge aperture and a front edge of the outer sole comprises at least one hinge aperture, each configured to receive a metallic hinge axle therethrough, such that the outer sole assembly is hingedly coupled to the foot shell at the metallic hinge axle.

[0015] In some embodiments, a shin cover is configured to be disposed against an anterior portion of the wearer’s lower leg in any one of a plurality of vertically translated positions that depend on the angle of plantarflexion and / or dorsiflexion of the wearer’s foot. In some embodiments, the shin cover includes a first slot centrally disposed on an upper portion of the shin cover and configured to receive a first strap and a second slot centrally disposed on a lower portion of the shin cover and configured to receive a second strap. In some embodiments, the shin cover includes one or more fasteners disposed on a wearer-facing surface of the shin cover and configured to secure one side of a flexible junction.

[0016] In some embodiments, the brace includes a forefoot cover, separate from the shin cover, configured to be disposed against the wearer’s forefoot. In some embodiments, the forefoot cover includes a slot configured to receive a foot strap, and a living hingeDONJOY.123WO PATENT extending between lateral edges at approximately the midpoint between a front edge and a rear edge of the forefoot cover.

[0017] In some embodiments, the forefoot cover includes one or more fasteners disposed on a wearer-facing surface of the forefoot cover and configured to secure another side of the flexible junction such that the flexible junction elastically couples the shin cover to the forefoot cover.

[0018] In some embodiments, the brace includes an adjustable, inflatable liner configured to provide multiple adjustable zones of pressure and support to different portions of the lower foot of the wearer. In some embodiments, the lower leg shell includes a fluid pump and a rotatable dial configured to select one or more of the multiple adjustable zones portions for selective inflating and / or deflating. The adjustable, inflatable liner includes a first adjustable, inflatable liner portion configured to be disposed against the inner facing surfaces of lower leg shell, and a second adjustable, inflatable liner portion configured to be disposed against the inner facing surface(s) of the shin cover of the forefoot cover.

[0019] In some embodiments, the first adjustable, inflatable liner portion includes one or more of a first lower distal air cell configured to be disposed against a distal portion of one side of the lower leg of the wearer, a second lower distal air cell 184b configured to be disposed against a distal portion of the other side of the lower leg of the wearer, a first upper distal air cell configured to be disposed against a side portion of the one side of the lower leg of the wearer proximal of the ankle, a second upper distal air cell configured to be disposed against a side portion of the other side of the lower leg of the wearer just proximal of the ankle, a lower posterior air cell configured to be disposed against a posterior portion of the lower leg at the ankle of the wearer, and an upper posterior air cell configured to be disposed against the posterior portion of the lower leg at the calf and Achilles tendon. In some embodiments, the posterior air cell has a “U” shape. In some embodiments, the posterior air cell includes two parallel vertical cells configured to be disposed adjacent each side of the Achilles tendon of the wearer. In some embodiments, the brace further includes a toe liner configured to cover the toes and forefoot of the wearer’s foot. The toe liner includes a base portion on which a cushioned insole is disposed, a right flap, a left flap, and a front flap, each configured to be wrapped and / or disposed over the toes and forefoot of the wearer’s foot.

[0020] In some other embodiments, a lower leg brace, configured to support a wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion, is provided. The brace includes: a lower leg shell configured to wrap around at least a posterior and sides of a lower leg of the wearer; a foot shell pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell to, thereby, set the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion; a range of motion (ROM) limiting assembly configured to set an upper limit and a lower limit for rotation of the foot shell in relation to theDONJOY.123WO PATENT lower leg shell; and an outer sole assembly hingedly coupled to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace: the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion.

[0021] In some embodiments of the brace, the ROM-limiting assembly comprises: a post extending from the foot shell and through an arcuate slot in the lower leg shell; an upper adjustable stirrup for setting the upper limit for rotation of foot shell in relation to the lower leg shell; and a lower adjustable stirrup for setting the lower limit for rotation of foot shell in relation to the lower leg shell, wherein: rotating the foot shell to the upper limit causes the post to physically contact the upper adjustable stirrup, thereby, preventing further rotation of the foot shell beyond the upper limit, and rotating the foot shell to the lower limit causes the post to physically contact the lower adjustable stirrup, thereby, preventing further rotation of the foot shell beyond the lower limit.

[0022] In some embodiments of the brace, the upper adjustable stirrup, the lower adjustable stirrup, and the foot shell each rotate about a same axis.

[0023] In some embodiments of the brace, setting the upper limit and the lower limit to a same value cause the ROM limiting assembly to disable rotation of the foot shell in relation to the lower leg shell and lock the foot shell at an amount of plantarflexion corresponding to the value.

[0024] In some embodiments of the brace, the upper adjustable stirrup is configured to rotate up and down along a curved posterior portion of the lower leg shell and the lower adjustable stirrup is configured to rotate up and down along the curved posterior portion of the lower leg shell below the upper adjustable stirrup.

[0025] In some embodiments of the brace, the ROM limiting assembly further comprises: an upper stop configured to secure the upper adjustable stirrup in any one of a plurality of different positions, each corresponding to a different upper limit for the rotation of the foot shell in relation to the lower leg shell; and a lower stop configured to secure the lower adjustable stirrup in any one of a plurality of different positions, each corresponding to a different lower limit for the rotation of the foot shell in relation to the lower leg shell.

[0026] In some embodiments of the brace: the curved posterior portion of the lower leg shell comprises a toothed track (2014); the upper stop comprises at least one tooth configured to be disposed in any one of a plurality of positions along the toothed track; and the lower stop comprises at least one tooth configured to be disposed in any other one of the plurality of positions along the toothed track.DONJOY.123WO PATENT

[0027] In some embodiments of the brace, translating the upper stop away from the upper adjustable stirrup causes the at least one tooth of the upper stop to translate sufficiently to clear the toothed track and allow the upper adjustable stirrup to be aligned with another of the plurality of positions along the toothed track.

[0028] In some embodiments of the brace, the upper adjustable stirrup comprises an upper notch and the lower adjustable stirrup comprises a lower notch such that, when the upper adjustable stirrup is disposed directly against the lower adjustable stirrup, the upper notch is disposed immediately adjacent to the lower notch and the post is immobilized at least partly within the upper notch and at least partly within the lower notch.

[0029] In some embodiments, the brace further includes a wedge spacer assembly configured to be disposed between the foot shell and the outer sole assembly, the wedge spacer assembly comprising: a rail on an underside of the foot shell, the rail having an aperture extending transversely therethrough; a plurality of wedge spacers, each wedge spacer comprising: a first planar surface comprising a rail having an aperture extending transversely therethrough, and a second planar surface offset by a respective one of a plurality of different angles θ1 compared to the first planar surface, the second planar surface comprising a slot configured to slidingly receive: the rail on the underside of the foot shell when the wedge spacer is directly slidingly coupled to the foot shell, and the rail on the first surface of an other wedge spacer of the plurality of wedge spacers when the wedge spacer is directly coupled to the other wedge spacer; and a slot in a top surface of the outer sole assembly configured to slidingly receive: the rail on the underside of the foot shell when none of the plurality of wedge spacers are slidingly coupled to the foot shell, and the rail on a bottom-most wedge spacer that is ultimately slidingly coupled to the foot shell when at least one of the plurality of wedge spacers is ultimately slidingly coupled to the foot shell.

[0030] In some embodiments of the brace, the wedge spacer system further comprises a locking bar disposed within an aperture extending transversely through the outer sole assembly, the locking bar configured to: slidingly extend through the aperture extending transversely through the rail on the underside of the foot shell when none of the plurality of wedge spacers are slidingly coupled to the foot shell, thereby locking the foot shell directly to the outer sole assembly; and slidingly extend through the aperture extending transversely through the rail in the second surface of the bottom-most wedge spacer that is ultimately slidingly coupled to the foot shell when at least one of the plurality of wedge spacers is ultimately slidingly coupled to the foot shell, thereby directly locking the bottom-most wedge spacer to the outer sole assembly.

[0031] In some embodiments of the brace, the aperture extending transversely through the outer sole assembly is formed at least in part by: a first tunnel disposed to a left side of a top surface of the outer sole assembly; and a second tunnel disposed to a right sideDONJOY.123WO PATENT of the top surface of outer sole assembly, wherein a negative space between the first tunnel and the second tunnel forms at least a portion of the slot in the top surface of the outer sole assembly.

[0032] In some embodiments, the brace further include a front cover assembly comprising: a shin cover configured to be disposed against an anterior portion of the wearer’s lower leg; a forefoot cover configured to be disposed against the wearer’s forefoot; and a semi- rigid bridge panel configured to couple with, or be disposed against, at least a portion of each of shin cover and the forefoot cover, thereby securing the shin cover and the forefoot cover to the brace.

[0033] In some embodiments of the brace, the bridge panel comprises at least one of: at least one upper winglet configured to couple with mating features in a distal portion of the shin cover; and at least one lower winglet configured to couple with mating features in a proximal portion of the forefoot cover.

[0034] In some embodiments of the brace, the bridge panel comprises a slot for receiving a tightening strap and the bridge panel is configured to be disposed at least partially over a distal portion of the shin cover and at least partially over a proximal portion of the forefoot cover such that, when the strap is secured through the slot and appropriately tightened, the shin cover and the forefoot cover are each held against the lower leg of the wearer by direct physical pressure exerted by the bridge panel against the shin cover and against the forefoot cover.

[0035] In some embodiments, the brace includes a front cover assembly comprising: a shin cover configured to be disposed against an anterior portion of the wearer’s lower leg; a forefoot cover configured to be disposed against the wearer’s forefoot; an elastomeric sheet coupled between a distal portion of the shin cover and a proximal portion of the forefoot cover; and a rigid bridge panel, comprising: a proximal portion configured to directly contact an outer surface of the shin cover, a distal portion configured to directly contact an outer surface of the forefoot cover, and a convex portion configured to extend between the proximal portion and the distal portion, the convex portion comprising a slot for receiving a tightening strap such that, when the strap is secured through the slot and appropriately tightened, the rigid bridge panel directly contacts the outer surface of the shin cover and the outer surface of the forefoot cover but does not contact the elastomeric sheet or the wearer’s ankle.

[0036] In some embodiments of the brace, the outer sole assembly is configured to maintain a bottom surface of the outer sole assembly sole substantially parallel to the ground when the wearer is standing and the wearer’s foot is disposed at any degree of ankle plantarflexion within the desired range of angles of plantarflexion.

[0037] In some embodiments, a stackable wedge spacer for use in a lower leg brace that is configured to support a wearer’s foot in any of a desired range of angles of plantarflexionDONJOY.123WO PATENT is provided. The stackable wedge spacer includes: a first planar surface comprising a rail extending longitudinally along the first planar surface, the rail configured to be received into a slot in a top surface of an outer sole assembly of the lower leg brace or slidingly received into a slot in another one of the stackable wedge spacers, the rail comprising: an aperture extending transversely through the rail, and flanges extending laterally from each side of an anterior portion of rail, and a second planar surface offset by an angle θ1compared to the first planar surface, the second planar surface comprising a slot configured to slidingly receive a rail of an underside of a foot shell of the lower leg brace or a rail of another one of the stackable wedge spacers, wherein the slot comprises: flanges extending from either side of the slot, and recesses formed between flanges and a bottom of the slot.

[0038] In some embodiments of the stackable wedge spacer, the rail has a first width W5along at least a posterior portion of the rail through which the aperture transversely extends; a width of an anterior portion of the rail increases from the first width W5to a second width W4 along the anterior portion of the rail so as to form the flanges extending from either side of the rail; and the flanges have a thickness than is less than a height of the rail so as to create a negative space between the flanges and the first planar surface of the wedge spacer.

[0039] In some embodiments of the stackable wedge spacer, the flanges of the rail are configured to interlock with the recesses in the slot in the second planar surface of another of the stackable wedge spacers.

[0040] In some embodiments of the stackable wedge spacer: a width W1 of an anterior portion of the slot is nominally larger than the width W4 of the flanges of the rail so as to allow the rail of the underside of the foot shell or the rail of another of the stackable wedge spacers to slide into the slot; a width of the slot posterior of the anterior portion tapers from the width W1to a width W2so as to form the flanges extending from either side of the slot; the width W2is nominally wider than the width W5of the rail so as to allow the rail to slide fully into the slot; the flanges of the slot may have a thickness than is less than a height of the slot, so as to create the recesses between each flange and the bottom of the slot; and the recesses have a height that is greater than a largest thickness of the flanges of the rail so as to allow the rail on another one of the stackable wedge spacers or on the underside of the foot shell of the lower leg brace to slide fully into the slot.

[0041] In some embodiments of the stackable wedge spacer, the aperture extending transversely through the rail of the stackable wedge spacer is configured to receive a locking bar of the lower leg brace therethrough to, thereby, directly lock the stackable wedge spacer to the outer sole assembly of the lower leg brace.

[0042] In some embodiments of the stackable wedge spacer, the offset angle θ1 is any one of 5°, 10°, 15°, 20°, 25° and 30°.DONJOY.123WO PATENT

[0043] In some embodiments of the stackable wedge spacer, the stackable wedge spacer is rigid.

[0044] In some embodiments of the stackable wedge spacer, the stackable wedge spacer is not tearable or trimmable so as to modify any of its shape, size and profile.

[0045] In yet other embodiments a method of manufacturing a lower leg brace configured to support a wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion is provided. The method includes: providing, or otherwise forming, a lower leg shell configured to wrap around at least a posterior and sides of a lower leg of the wearer; pivotally coupling a foot shell to the lower leg shell such that the foot shell is configured to rotate in relation to the lower leg shell for setting the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion; coupling at least one component of a range of motion (ROM) limiting assembly to the brace, the ROM limiting assembly configured to set an upper limit and a lower limit for rotation of the foot shell in relation to the lower leg shell; and hingedly coupling an outer sole assembly to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace: the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion and / or dorsiflexion.

[0046] In some embodiments of the method of manufacture, the lower leg brace is the brace of any prior embodiment, and the method further comprises providing, otherwise forming and / or assembling any one or more components of the brace of the embodiment of the lower leg brace.

[0047] In some embodiments, the method of manufacture further includes providing, otherwise forming, and / or assembling at least one component of a wedge spacer assembly configured to be disposed between the foot shell and the outer sole assembly.

[0048] In some embodiments of the method of manufacture, the wedge spacer assembly is the wedge spacer assembly of any prior embodiment.

[0049] In some other embodiments, a method of utilizing a lower leg brace configured to hinge at a ball of the wearer’s foot and support the wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion is provided. The method includes: disposing a lower leg of the wearer in a lower leg shell of the brace such that: the lower leg shell wraps around at least a posterior and sides of the lower leg, portions of the wearer’s foot proximal of a ball of the foot are disposed on a foot shell that is pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell, and toes and the ball of the wearer’s foot are disposed on an anterior portion of an outer sole assembly that is hingedly coupled to an anterior edge of the foot shell; and adjusting a range of motion (ROM) limiting assembly to setDONJOY.123WO PATENT an upper limit for rotation of the foot shell in relation to the lower leg shell and to set a lower limit for rotation of the foot shell in relation to the lower leg shell.

[0050] In some embodiments of the method of utilization, the lower leg brace is the brace of any prior embodiment.

[0051] In some embodiments, the method of utilization further comprises slidably coupling at least one wedge spacer of a wedge spacer assembly between the foot shell and the outer sole assembly to, thereby, support the wearer’s foot within the desired range of angles of plantarflexion.

[0052] In some embodiments of the method of utilization, the wedge spacer assembly is the wedge spacer assembly of any prior embodiment.

[0053] Other features and aspects of the disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying figures, which illustrate, by way of example, the features in accordance with various embodiments. The summary is not intended to limit the scope of the invention, which is defined solely by the claims attached hereto. BRIEF DESCRIPTION OF DRAWINGS

[0054] The technology disclosed herein, in accordance with one or more various embodiments, is described in detail with reference to the following figures. The figures are provided for purposes of illustration only and merely depict typical or example embodiments of the disclosed technology. These figures are provided to facilitate the reader's understanding of the disclosed technology and shall not be considered limiting of the breadth, scope, or applicability thereof. It should be noted that for clarity and ease of illustration, these figures are not necessarily made to scale.

[0055] FIG.1A illustrates a side view of an orthopedic walking brace for the lower leg, according to example embodiments of the present disclosure;

[0056] FIG.1B illustrates a side view of the orthopedic walking brace of FIG.1A with a spacing wedge disposed therein, according to example embodiments of the present disclosure;

[0057] FIG.1C illustrates a side view of the orthopedic walking brace of FIG.1A with a plurality of spacing wedges disposed therein, according to example embodiments of the present disclosure;

[0058] FIG.2A illustrates a front view of the orthopedic walking brace of FIG.1A;

[0059] FIG.2B illustrates a front view of the orthopedic walking brace of FIG.1B;

[0060] FIG.2C illustrates a front view of the orthopedic walking brace of FIG.1C;

[0061] FIG.3A illustrates a bottom view of the orthopedic walking brace of FIG.1A;

[0062] FIG.3B illustrates a top view of the orthopedic walking brace of FIG.1B;DONJOY.123WO PATENT

[0063] FIG.3C illustrates a top view of the orthopedic walking brace of FIG.1C;

[0064] FIG.4 illustrates an exploded isometric view of the orthopedic walking brace of FIGs.1A-3C, according to example embodiments of the present disclosure;

[0065] FIG. 5 illustrates a lower leg shell of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0066] FIG.6 illustrates a perspective view of a fluid pump of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0067] FIG. 7 illustrates a selection dial for the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0068] FIG. 8 illustrates a fluid manifold for the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0069] FIGs.9-10 illustrate assembly of the components of FIGs.6-8;

[0070] FIG.11A illustrates a foot shell of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0071] FIGs.11B-11C illustrate various view of another foot shell of the brace of FIGs. 1-4, according to other example embodiments;

[0072] FIG.12 illustrates assembly of the foot shell to the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0073] FIG.13 illustrates a perspective view of a wedge spacer of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0074] FIG.14 illustrates a perspective view of a locking plate of the brace of FIGs.1- 4, according to example embodiments of the present disclosure;

[0075] FIG.15 illustrates assembly of the components of FIGs.12-14;

[0076] FIG.16 illustrates an exploded perspective view of a wedge spacer assembly of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0077] FIG. 17 illustrates a perspective view of the wedge spacer assembly of FIG. 16;

[0078] FIGs. 18A-18B and 19-21 illustrate various components of a ROM-limiting assembly of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0079] FIG.22A illustrates assembly of the components of FIGs.18A-21 to form the ROM-limiting assembly of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0080] FIG. 22B illustrates assembly of alternative components that form an alternative embodiment of the ROM-limiting assembly of the brace of FIGs.1-4, according to example embodiments of the present disclosure;DONJOY.123WO PATENT

[0081] FIG. 23A illustrates an outer sole of an outer sole assembly of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0082] FIG.23B illustrates another outer sole of an outer sole assembly of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0083] FIG.24A illustrates a soft sole of the outer sole assembly of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0084] FIG.24B illustrates another soft sole of an outer sole assembly of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0085] FIG.25A illustrates assembly of the components of FIGs.23A and 24A;

[0086] FIG.25B illustrates assembly of the components of FIGs.23B and 24B;

[0087] FIG.26 illustrates further assembly of the components of FIGs.11A, 23A and 24A;

[0088] FIG.27A illustrates a shin cover of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0089] FIG.27B illustrates another shin cover of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0090] FIG. 28 illustrates a forefoot cover of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0091] FIG. 29A illustrates the shin and forefoot covers of FIGs. 27A and 28 assembled into the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0092] FIG.29B illustrates the shin cover of FIG. 27B and a corresponding forefoot cover assembled into an embodiment of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0093] FIGs.30-31 illustrate perspective views of portions of an adjustable, inflatable liner of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0094] FIG.32A illustrates a first portion of the adjustable, inflatable liner of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0095] FIG.32B illustrates an alternative first portion of the adjustable, inflatable liner of the brace of FIGs.1-4, according to example embodiments of the present disclosure;

[0096] FIGs. 33-34 illustrate various views of fasteners for securing the adjustable, inflatable liner of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0097] FIGs. 35-37 illustrate different views of a toe liner of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0098] FIG.38 illustrates a fastener for securing the toe liner of the brace of FIGs.1- 4, according to example embodiments of the present disclosure;DONJOY.123WO PATENT

[0099] FIG. 39 illustrates a strap of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0100] FIG. 40-42 illustrates positions for coupling straps to the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0101] FIG.43 illustrates another view of a brace without straps attached, according to example embodiments of the present disclosure;

[0102] FIG.44A illustrates the brace of FIG.43 with several straps attached, according to example embodiments of the present disclosure;

[0103] FIG. 44B illustrates another brace having the straps of FIG. 44A plus an additional toe tightening strap attached, according to example embodiments of the present disclosure;

[0104] FIGs.45-53 each illustrate an injection molding procedure for forming several components of the brace of FIGs. 1-4, according to example embodiments of the present disclosure;

[0105] FIGs.54A-54B illustrate an alternative brace having a combined ROM-limiting and outer sole assembly, according to example embodiments of the present disclosure;

[0106] FIG. 55 illustrates yet another alternative brace having an alternative ROM- limiting assembly, according to example embodiments of the present disclosure;

[0107] FIGs. 56-57, 58A-58B and 59A-59B illustrate various views of yet another alternative brace having an alternative ROM-limiting assembly, according to example embodiments of the present disclosure;

[0108] FIGs.60A-60E illustrate various views of yet another alternative brace having a combined ROM-limiting and outer sole assembly, according to example embodiments of the present disclosure;

[0109] FIGs.61 and 62A-62C illustrate alternative embodiments of the brace of FIGs. 60A-60E;

[0110] FIG.63A-63K illustrate various views of yet another alternative brace having an alternative ROM-limiting assembly, according to example embodiments of the present disclosure;

[0111] FIGs.64A-64D, 65, 66A-66C and 67A-67C illustrate various views of portions of yet other alternative braces having alternative ROM-limiting assemblies, according to example embodiments of the present disclosure;

[0112] FIG.68 illustrates a perspective view of yet another alternative brace utilizing a wedge spacer system, according to example embodiments of the present disclosure;

[0113] FIG.69A-69B illustrate different views of yet another alternative brace utilizing a wedge spacer system, according to example embodiments of the present disclosure;DONJOY.123WO PATENT

[0114] FIG.70 illustrates a perspective view of yet another alternative brace utilizing a wedge spacer system, according to example embodiments of the present disclosure;

[0115] FIG. 71 illustrates a perspective view of yet another wedge spacer system, according to example embodiments of the present disclosure;

[0116] FIGs.72A-72B illustrate various views of yet another alternative brace utilizing a wedge spacer system, according to example embodiments of the present disclosure;

[0117] FIGs.73A-73B illustrate various views of yet another alternative brace utilizing a wedge spacer system, according to example embodiments of the present disclosure;

[0118] FIGs.74A-74B and 75A-75D illustrate various views of yet another alternative brace utilizing a wedge spacer system, according to example embodiments of the present disclosure;

[0119] FIG.76 illustrates various views of an alternative brace utilizing an alternative outer sole spacing system, according to example embodiments of the present disclosure;

[0120] FIG. 77 illustrates a perspective view of a portion of an alternative brace utilizing an alternative outer sole assembly, according to example embodiments of the present disclosure;

[0121] FIGs. 78A-78B illustrate various views of a portion of an alternative brace utilizing an alternative outer sole assembly, according to example embodiments of the present disclosure;

[0122] FIGs. 79A-79B illustrate various views of a portion of an alternative brace utilizing an alternative outer sole assembly, according to example embodiments of the present disclosure;

[0123] FIGs. 80A-80B illustrate various views of a portion of an alternative brace utilizing an alternative outer sole assembly, according to example embodiments of the present disclosure;

[0124] FIGs. 81A-81B illustrate various views of a portion of an alternative brace utilizing an alternative outer sole assembly, according to example embodiments of the present disclosure;

[0125] FIG. 82 illustrates a perspective view of a portion of an alternative brace utilizing an alternative outer sole assembly, according to example embodiments of the present disclosure;

[0126] FIG.83 illustrates a perspective view of a portion of an alternative ROM-limiting assembly for a brace, according to example embodiments of the present disclosure;

[0127] FIG. 84 illustrates a perspective view of a portion of a brace having an integrated shin / foot cover hingedly coupled to a lower leg shell, according to example embodiments of the present disclosure;DONJOY.123WO PATENT

[0128] FIGs.85A-85B illustrate various views of a brace that opens at the posterior, according to example embodiments of the present disclosure;

[0129] FIGs.86-87 illustrate various braces utilizing reel and lace systems for securing the brace to the wearer, according to example embodiments of the present disclosure;

[0130] FIG.88 illustrates an insole for a brace, according to example embodiments of the present disclosure;

[0131] FIGs.89A-89B illustrate various views of an outer sole for a brace, according to example embodiments of the present disclosure;

[0132] FIG. 90 illustrates a rear right perspective view of a brace and a magnified portion of the brace, according to example embodiments of the present disclosure;

[0133] FIG. 91 illustrates a rear view of the brace of FIG. 90, according to some example embodiments;

[0134] FIG.92 illustrates a left perspective view of a portion of the brace of FIG.90, according to some example embodiments;

[0135] FIG.93 illustrates a left perspective view of a portion of the brace of FIG.90 with a locking bar in an unlocked position, according to some example embodiments;

[0136] FIG.94 illustrates a left perspective view of a portion of the brace of FIG.90, according to some example embodiments;

[0137] FIG.95 illustrates a left perspective view of the brace of FIG.90 along with a magnified portion of the brace, according to example embodiments of the present disclosure;

[0138] FIG.96 illustrates a left perspective view of the brace of FIG.90, according to example embodiments of the present disclosure;

[0139] FIG.97 illustrates a bottom and related side view of a wedge spacer for use in the brace of FIG.90, according to some example embodiments of the present disclosure;

[0140] FIG.98 illustrates a top and related perspective view of the wedge spacer of FIG.97, according to some example embodiments of the present disclosure;

[0141] FIG.99 illustrates a left perspective view of a foot shell of the brace of FIG.90, according to some example embodiments of the present disclosure;

[0142] FIG.100 illustrates the brace of FIG.90 accepting a wedge spacer as in FIGs. 97 and 98, according to some example embodiments of the present disclosure;

[0143] FIG. 101 illustrates the brace of FIG. 90 with the wedge spacer properly installed, according to some example embodiments of the present disclosure;

[0144] FIG.102 illustrates a left perspective view of the brace of FIG.90 accepting a plurality of wedge spacers as in FIGs.97 and 98, according to some example embodiments of the present disclosure;DONJOY.123WO PATENT

[0145] FIG.103 illustrates a right perspective view of the brace of FIG.90 accepting the plurality of wedge spacers as in FIGs. 97 and 98, according to some example embodiments of the present disclosure;

[0146] FIG. 104 illustrates a right perspective view of the brace of FIG.90 with the wedge spacers properly installed and a locking bar in an unlocked position, according to some example embodiments of the present disclosure;

[0147] FIG. 105 illustrates a right perspective view of the brace of FIG.90 with the wedge spacers properly installed and the locking bar in a locked position, according to some example embodiments of the present disclosure;

[0148] FIG.106 illustrates another right perspective view of the brace of FIG.90 with the wedge spacers properly installed, the locking bar in a locked position, and the ROM- limiting assembly disposed at a different ROM setting than that shown in FIG.105, according to some example embodiments of the present disclosure;

[0149] FIG.107 illustrates a perspective view of a front panel assembly for the brace of FIG.90, including a magnified callout of a semi-rigid bridge portion that bridges a shin cover and a forefoot cover of the front panel assembly, according to some example embodiments of the present disclosure;

[0150] FIG. 108 illustrates a cutaway view of another front panel assembly for the brace of FIG.90, including a rigid bridge portion that bridges a shin cover and a forefoot cover of the front panel assembly, according to some example embodiments of the present disclosure;

[0151] FIG.109 illustrates a flowchart for a method of using a brace, according to any embodiment(s) described herein;

[0152] FIG. 110 illustrates a flowchart for a method of manufacture of a brace, according to any embodiment(s) described herein;

[0153] FIG.111 shows knee joint angles in the sagittal plane when wearing a brace, as disclosed herein, in various wedge angle conditions compared to a shoe condition;

[0154] FIG.112 shows knee joint moments in the sagittal plane when wearing a brace, as disclosed herein, in various wedge angle conditions compared to a shoe condition; and

[0155] FIG.113 shows activity of the medial gastrocnemius during a stance phase of a gait cycle when wearing a brace, as disclosed herein, in various wedge angle conditions compared to a shoe condition.

[0156] The figures are not intended to be exhaustive or to limit the invention to the precise form disclosed. It should be understood that the invention can be practiced with modification and alteration, and that the disclosed technology be limited only by the claims and the equivalents thereof.DONJOY.123WO PATENT DETAILED DESCRIPTION OF THE INVENTION

[0157] The present disclosure relates to orthopedic boots, braces and / or walkers. In particular, various embodiments may relate to rigid, semi-rigid, or partially rigid orthopedic boots, braces and / or walkers. While this application and embodiments of boots, braces and / or walkers described herein are not so limited, such orthopedic boots, braces and / or walkers may be utilized to treat sutured Achilles tendon ruptures, ankle fractures, joint replacements, foot fractures, arthrodesis of ankle joints, calcaneus fractures, other lower leg fractures, and / or severe ankle sprains. Moreover, while this disclosure presents a variety of elements of one or more braces, the present disclosure is not limited to only the collection of elements described with respect to any one figure. Rather, this disclosure contemplates the broadest possible arrangement of elements in a brace, for example, a brace comprising any one or more features as described anywhere in this disclosure and / or as illustrated by any drawing herein and / or provided herewith, irrespective of whether or not such a collection of elements was specifically described or illustrated in connection with any particular embodiment of any brace herein.

[0158] In some embodiments, a boot, brace and / or walker according to the present disclosure comprises adjustable air cells configured to immobilize and provide comfort to the lower leg of the wearer. Such a boot, brace and / or walker is configured to mimic a normal gait pattern of the wearer in all three walking phases (heel strike, mid-stance, and toe-off) when the wearer’s ankle joint is immobilized and / or restricted to a desired range of motion in any of a plurality of different positions of plantar flexion. Such a boot, brace and / or walker may comprise an adjustable outer sole assembly configured to dispose the wearer’s ankle in any of the plurality of different positions of plantar flexion (and / or dorsiflexion) to, thereby, provide reduced tension in the Achilles tendon during the rehabilitation process, which may reduce the risk of knee and / or hip injuries. This tension may be incrementally increased by incrementally decreasing the degree of plantar flexion of the wearer’s ankle joint secured within the boot to avoid re-rupture and optimal healing of sutured and / or conservatively treated Achilles tendon injuries. Such a boot, brace and / or walker may also offer an improved shin cover. Such a shin cover may be configured to translate vertically based on the position of plantar flexion. Such a boot, brace and / or walker may also offer an improved heel strike area of the outer sole. Such a boot, brace and / or walker may also be configured to pivot immediately below, at and / or along a same axis or degree of freedom of the ball of the foot of the wearer, rather than at a most-distal tip of the toes of the wearer’s foot. This ability to pivot at the ball of the foot rather than at the most-distal tip of the toes results in a more optimal gait pattern and a more natural toe off phase in each of the different ankle joint positions of plantar flexion.

[0159] Several different embodiments of several different aspects of orthopedic boots, braces and / or walkers are described below in connection with one or more figures. While particular combinations of embodiments are illustrated or described herein, the presentDONJOY.123WO PATENT disclosure is not so limited and also contemplates orthopedic boots, braces and / or walkers having any embodiment of any aspect thereof combined with any embodiment of any other aspect thereof. For example, several different embodiments of a range of motion (ROM) adjustment (or limiting) mechanism of an orthopedic boot, brace and / or walker are disclosed herein. Likewise, several different embodiments of an adjustable outer sole assembly and / or wedge spacer system of an orthopedic boot, brace and / or walker are also disclosed herein. Similarly, several different embodiments of a front closure mechanism and / or assembly of an orthopedic boot, brace and / or walker are further disclosed herein.

[0160] FIGs. 1A-53 illustrate an orthopedic walking brace 100 for a lower leg of a wearer, according to example embodiments of the present disclosure. For example, FIGs.1A- 1C illustrate side views of brace 100 having no (1A), one (1B), or multiple (1C) stackable wedge spacers 151 configured to adjustably dispose an outer sole of brace 100 so as to provide various different desired amounts of plantar flexion of the foot of the wearer disposed within brace 100. FIGs.2A-2C illustrate respective front views of brace 100 as shown in FIGs. 1A-1C. Similarly, FIG.3A illustrates a top view of brace 100 with a foot cover 170 and a shin cover 160 removed, FIG.3B illustrates a top view of brace 100 with foot cover 170 attached but shin cover 170 removed, and FIG.3C illustrates a top view of brace 100 with both foot cover 170 and shin cover 160 attached. FIG.4 illustrates an exploded isometric view of brace 100 of FIGs.1A-3C to more easily view several elements of brace 100. Discussion of several components of brace 100 and / or their assembly then follows in connection with at least FIGs. 5-53.

[0161] Turning to FIG.4 for easy viewing, brace 100 comprises a lower leg shell 110. Lower leg shell 110 is configured to wrap around and provide support for at least a posterior portion of the lower leg of a wearer (e.g., a calf of the wearer). Lower leg shell 110 also functions as a frame for coupling with several components, as will be described in connection with at least one figure below.

[0162] For example, brace 100 comprises a foot shell 130 pivotally coupled to lower leg shell 110. Foot shell 130 is configured to rotate in relation to lower leg shell 110 and, thereby, change and / or establish a desired angle of the wearer’s ankle joint at the malleolus. A distal or anterior edge of foot shell 130 is hingedly coupled to an outer sole assembly 140 such that, when a wearer’s foot is properly disposed in brace 100, the toes and ball of the foot are disposed on a distal or anterior portion of outer sole assembly 140 and portions of the foot proximal or posterior of the ball of the foot are disposed on foot shell 130. Accordingly, brace 100 is configured to hinge at the ball of the foot of the wearer instead of at a most-distal end of the toes of the wearer.DONJOY.123WO PATENT

[0163] To establish or set a desired angle of plantar flexion of the wearer’s foot at the ankle joint, brace 100 comprises a range of motion (ROM) limiting assembly 120. ROM limiting assembly 120 may be disposed on one or both sides of lower leg shell 110 at and surrounding the axis about which foot shell 130 is pivotally coupled to lower leg shell 110. As will be described in more detail in connection with one or more figures below, in one embodiment, ROM limiting assembly 120 may comprise a ROM adjustment wheel 121, a spring 122, a washer 123, a rivet 124 and a cap 125 that, when properly assembled, allow ROM limiting assembly 120 to limit both at least one of an upper limit and a lower limit on the desired angle of plantar flexion of the wearer’s foot at the ankle joint as will be described below in connection with at least FIGs 18A-22A. However, the present disclosure is not so limited and brace 100 is also, or alternatively, contemplated to include an alternative ROM adjustment assembly 120a comprising a slightly different construction, for example, as will be described in connection with FIG.22B. As shown in FIG.4, ROM assembly 120 may comprise a set of the above components disposed on each side of lower leg shell 110 such that, when properly assembled, one set is configured to dictate the upper limit on the desired angle of plantar flexion of the wearer’s foot at the ankle joint, while the other set is configured to dictate the lower limit on the desired angle of plantar flexion of the wearer’s foot at the ankle joint.

[0164] Outer sole assembly 140 comprises an outer sole 142 coupled to a soft sole 144, e.g., comprising EVA or another similarly pliable material. Outer sole assembly 140 is configured to maintain a neutral orientation of the bottom surface of soft sole 144 (e.g., substantially parallel to the ground) when the wearer is standing regardless of the angle of plantar flexion of the wearer’s foot at the ankle joint. As will be described in more detail below, outer sole assembly 140 is configured to receive and / or secure a wedge spacer system 150 between outer sole 142 and an underside of foot shell 130.

[0165] Wedge spacer system 150 comprises one or more wedge spacers 151 that are couplable to one another using one or more locking plates 155, as will be described in more detail below. In combination with ROM limiting system 120, cooperation of wedge spacer system 150 with outer sole assembly 140 and foot shell 130 allows the wearer’s foot to be set, maintained and comfortably supported in any one of a plurality of desired angles of plantar flexion.

[0166] Brace 100 further comprises a shin cover 160 configured to be disposed against an anterior portion of the wearer’s lower leg (e.g., the shin). Lateral edges of shin cover 160 are configured to be disposed snuggly between lower leg shell 110 and the wearer’s lower leg without pinching the skin of the wearer. However, as will be described in connection with at least FIG.27B, the present disclosure is not so limited and brace 100 is also contemplated to use a shin cover 160a, comprising winglets 165a configured to at least partially overlap the outer sides of leg shell 110, rather than being configured to entirely tuck within the inner lateralDONJOY.123WO PATENT surfaces of leg shell 110. As will be described in more detail below, shin cover 160,160a is configured to be secured to lower leg shell 110 at any of a plurality of vertically translated positions with respect to lower leg shell 110, corresponding to and / or depending on the desired angle of plantar flexion of the wearer’s foot, via one or more straps. Such vertical translatability ensures shin cover 160,160a is always properly aligned with and disposed against the lower leg of the wearer and the lower portion of shin cover 160,160a does not dig into the upper surface of the foot at the ankle joint when the foot is secured in any desired degree of plantar flexion.

[0167] Brace 100 further comprises a forefoot cover 170 configured to be disposed over a top surface of the wearer’s toes and distal or anterior part of the foot. In some embodiments, lateral edges of forefoot cover 170 are configured to be disposed snuggly between outer sole assembly 140 and the wearer’s foot without pinching the skin of the wearer. However, the present disclosure is not so limited and brace 100 is also contemplated to use a forefoot cover comprising winglets, similar to winglets 165a of shin cover 160a, configured to at least partially overlap the outer sides of lower leg shell 110 and / or of foot shell 130, rather than being configured to entirely tuck within the inner lateral surfaces thereof. As will be described in more detail below, forefoot cover 170 is configured to be secured to outer sole assembly 140 via one or more straps. In some embodiments, forefoot cover 170 is a separate component from shin cover 160, which provides the necessary relative degrees of freedom for both proper fitting of forefoot cover 170 over the foot of the wearer, and the above- described vertical translatability of shin cover 160.

[0168] As will be described in connection with one or more figures below, brace 100 also comprises an adjustable, inflatable liner having a plurality of individually inflatable (and deflatable) air cells configured to provide multiple adjustable zones of pressure and / or support to various different portions of the lower foot of the wearer while the wearer’s foot is held and secured in any desired degree of plantar flexion. Discussion of several components of brace 100 will now be described in more detail in connection with one or more of FIGs.5-53.

[0169] FIG. 5 illustrates a perspective view of lower leg shell 110 of FIGs. 1A-4. In some embodiments, lower leg shell 110 has an open front, for example, allowing the wearer’s lower leg to be inserted into, and removed from, brace 100 therethrough. Accordingly, when viewed from above, lower leg shell 110 may have a generally “C” shape configured to wrap from one side of the lower leg of the wearer, around the posterior of the lower leg, to the other side of the lower leg of the wearer.

[0170] In some embodiments, lower leg shell 110 may be configured to generally follow the contours of the lower leg of the wearer, for example, being wider at the top, adjacent to where the wearer’s calf would be disposed, tapering to a narrower dimension toward the middle-bottom, adjacent to where the narrowest part of the wearer’s lower leg would beDONJOY.123WO PATENT disposed, and flaring out to a relatively wider dimension again at the bottom, adjacent to where the malleolus of the wearer’s ankle would be disposed. Lower leg shell 110 may comprise a plastic material, such as polypropylene. However, the present disclosure is not so limited and also / alternatively contemplates lower leg shell 110 and / or any other element of brace 100 being manufactured of another material, for example polyamide and / or polyamide + glass fiber. In some embodiments, brace 100 may be offered in a variety of sizes, to accommodate a wider range of sizes of wearers. In some such embodiments, lower leg shell 110 may be manufactured to have different sizes corresponding to different sized braces 100. For example, brace 100 may be manufactured in one or more of an extra-small (XS), small (S), medium (M), large (L) and extra-large (XL) sizes, where an XS brace 100 utilizes a lower leg shell 110 having 88% of the size of the medium brace 100, an S brace 100 utilizes a lower leg shell 110 having 93% of the size of the medium brace 100, an L brace 100 utilizes a lower leg shell 110 having 108% of the size of the medium brace 100 and an XL brace 100 utilizes a lower leg shell 110 having 119% of the size of the medium brace 100.

[0171] In some embodiments, lower leg shell 110 comprises a plurality of windows 111 configured to provide breathability to the lower leg of the user disposed therein. In some embodiments, lower leg shell 110 may further function as a platform for securing other components of brace 100, comprising one or more slots 112 configured to receive one or more straps, and one or more apertures and / or recesses for receiving such other components. For example, lower leg shell 110 may comprise an aperture or recess 113 disposed near a top of lower leg shell 110 and configured to receive a pump for selectively inflating and / or deflating portions the above-mentioned adjustable, inflatable liner. Lower leg shell 110 may comprise an aperture or recess 114 disposed near a middle of lower leg shell 110 and configured to receive a dial and / or a fluid manifold for selectively inflating and / or deflating portions of the above-mentioned adjustable, inflatable liner. In some embodiments, aperture or recess 113 may be on a same side of lower leg shell 110 as aperture or recess 114 so as to ensure easy adjustment of the inflating and / or deflating of the portions of the above-mentioned adjustable, inflatable liner using the same hand of the wearer.

[0172] Lower leg shell 110 may further comprise apertures and / or recesses near a bottom and on each side of lower leg shell 110, configured to receive aspects of ROM limiting assembly 120 therein. More specifically, one side of lower leg shell 110 may comprise a circular aperture 115a configured to rotatably receive a rivet 124, and an arcuate slot 116a configured to slidingly receive a pin or post 131a, 131b of the ROM limiting assembly 120. Similarly, the other side of lower leg shell 110 may comprise another circular aperture 115b configured to rotatably receive another rivet 124, and another arcuate slot 116b configured to slidingly receive another pin of the ROM limiting assembly 120 on the opposite side of brace 100. Accordingly, when the posts of foot shell 130 are disposed in arcuate slots 116a, 116b,DONJOY.123WO PATENT foot shell 130,130a is configured to pivot with respect to lower leg shell 110 about a longitudinal axis extending through both rivets 124 and through apertures 115a, 115b of lower leg shell 110.

[0173] FIG.6 illustrates a perspective view of a fluid pump 181 configured to inflate one or more portions of the for selectively inflating and / or deflating portions of the above- mentioned adjustable, inflatable liner. In some embodiments, fluid pump 181 comprises a deformable hemispherical bulb comprising an elastomeric material such that, when a user compresses the bulb between their fingers (or finger(s) and thumb), a fluid (e.g., air) is forced out of fluid pump 181 for use in selectively inflating and / or deflating portions of the above- mentioned adjustable, inflatable liner.

[0174] FIG.7 illustrates a perspective view of a rotatable dial 182 configured to select one or more portions of the above-mentioned adjustable, inflatable liner for selective inflating and / or deflating. In some embodiments, rotatable dial 182 is substantially hemispherical or dome-shaped. In some embodiments, rotatable dial 182 comprises a plurality of ridges or grooves configured to provide greater grip or tactile control of rotatable dial 182 when gripped by a user.

[0175] In some embodiments, FIG.8 illustrates a perspective view of a fluid manifold 183 comprising one or more input ports 184 and a plurality of output ports 185. Manifold 183 is rotatable and configured to receive fluid from input port(s) 184 and, based on its rotational configuration, direct the fluid to one or more of output ports 185 for selectively inflating and / or deflating one or more portions of the above-mentioned adjustable, inflatable liner.

[0176] As shown in FIG.9, pump 182 is secured to lower leg shell 110 at aperture or recess 113 by gluing or any other suitable securing method. Manifold 183 is secured to lower leg shell 110 at aperture or recess 114 by riveting or any other suitable securing method. And as shown in FIG. 10, rotatable dial 182 is secured to manifold 183 by clipping or any other suitable securing method. Rotation of dial 182 causes rotation of manifold 183 and, thereby, the establishment and / or interruption of one or more pathways for fluid to affect the inflating and / or deflating of the one or more portions of the above-mentioned adjustable, inflatable liner.

[0177] FIG. 11A illustrates a perspective view of foot shell 130, which comprises a footbed 132 and sidewalls 133 extending up from footbed 132 along the sides and rear of footbed 132, thereby forming a cup with an open front and an open top. Foot shell 130 further comprises apertures 135a, 135b configured to receive an axle, rivet or the like, for pivotally coupling foot shell 130 to lower leg shell 110 at apertures 115a, 115b. A longitudinal axis extending through apertures 115a, 115b, 135a, 135b defines a pivoting axis of foot shell 130 with respect to lower leg shell 110. A post 131b extends substantially perpendicularly away from one side of foot shell 130, while a similar post 131a (not shown in FIG. 11A) extends substantially perpendicularly away from the opposite side of foot shell 130. In someDONJOY.123WO PATENT embodiments according to FIG. 11A, posts 131a, 131b comprising a plastic material. However, the present disclosure is not so limited and, in some other embodiments, for example, as shown in connection with FIGs.11B-11C, an alternative foot shell 130a comprises posts 131a, 131b comprising metal to provide an increased structural rigidity to posts 131a, 131b. For example, for foot shell 130a, each of posts 131a, 131b may comprise a metallic post 131c, which may have a substantially identical form factor to that of posts 131a, 131b shown in FIG.11A, except having an aperture configured to receive a protrusion of a backing rivet 131d in a backside thereof or, conversely, comprising a protrusion configured to be received by a mating aperture in backing rivet 131d. Accordingly, in addition to form described for foot shell 130, foot shell 130a may also include apertures 131e through which metallic post 131c interacts with backing rivet 131d on each side of foot shell 130a (see, e.g., FIG.s 11B- 11C).

[0178] In embodiments according to FIG.11A, along a front edge of footbed 132, foot shell 130 comprises a hinge axle 134 configured to hingedly couple with outer sole assembly 140 at approximately the ball of the foot of the wearer and not at the most-distal end of the toes of the wearer. In some embodiments according to FIG.11A, hinge axle 134 is formed as an integral part of foot shell 130, e.g., comprising a plastic material similar and / or the same as posts 131a, 131b. However, the present disclosure is not so limited and, in some other embodiments, for example of foot shell 130a as shown in FIGs.11B-11C and 25B, foot shell 130a comprises one or more hinge apertures and / or grooves 134a configured to receive a metallic axle therethrough to provide an increased structural strength to the hinging joint between foot shell 130a and outer sole assembly 140.

[0179] In some embodiments where brace 100 is manufactured in one or more of an extra-small (XS), small (S), medium (M), large (L) and extra-large (XL) sizes, XS brace 100 may utilize a foot shell having 88% of the size of the medium brace 100, an S brace 100 may utilize a foot shell having 93% of the size of the medium brace 100, an L brace 100 may utilize a foot shell having 108% of the size of the medium brace 100, and an XL brace 100 may utilize a foot shell having 119% of the size of the medium brace 100.

[0180] As shown in FIG.12, when foot shell 130 is pivotally coupled to lower leg shell 110, post 131b is disposed in, and slides along, arcuate slot 116b as foot shell 130 is rotated with respect to lower leg shell 110. And, similarly, post 131a is disposed in, and slides along, arcuate slot 116a as foot shell 130 is rotated with respect to lower leg shell 110.

[0181] Discussion now turns to wedge spacer system 150 in connection with FIGs. 13-17. Wedge spacer system 150 comprises one or more wedge spacers 151 and one or more locking plates 155. In general, each wedge spacer 151 is configured to be secured to an underside of foot shell 130 with the use of a locking plate 155. In specific, as shown in FIG.DONJOY.123WO PATENT 13, each wedge spacer 151 is defined by a first planar surface 152a and a second planar surface 152b that is offset from first planar surface 152a by a predetermined angle θ1(e.g., 10°) so as to intersect first planar surface 152a to form a point or “nose” at a first end of wedge spacer 151 and to increase the distance between first and second planar surfaces 152a, 152b along a length of extension of wedge spacer 151 away from the nose or pointed edge. In some embodiments, to reduce weight and / or the amount of material required to manufacture wedge spacer 151, wedge spacer 151 may comprise a plurality of baffles extending from first planar surface 152a to second planar surface 152b, which thereby define wedge spacer 151 between first and second planar surfaces 152a, 152b.

[0182] As also shown in FIG.13, one surface of wedge spacer 151 (e.g., the bottom surface visible in FIG.13) may comprise two portions, collectively covering the entire area of the one surface of wedge spacer 151, a first portion 153a and a second portion 153b. First portion 153a (e.g., generally indicated by the portions outside the dotted white line in FIG.13) is coextensive and coplanar with first planar surface 152b. Accordingly, where wedge spacer 151 comprises the above-mentioned baffles, such baffles within first portion 153a extend all the way to first planar surface 152b. Second portion 153b corresponds to a footprint or perimeter of locking plate 155 and is coextensive with a third planar surface 152c that is parallel to second surface 152b and offset toward first surface 152a by a distance equal to a thickness of locking plate 155. Accordingly, in operation, locking plate 155 is configured to be secured directly against second portion 153b of wedge spacer 151 such that, when locking plate 155 is so secured, a bottom surface of locking plate 155 (e.g., the side opposite the side shown in FIG.14) is coplanar with second planar surface 152b and, so, with first portion 153a of wedge spacer 151. This specific feature allows a pairing of one wedge spacer 151 and one locking plate 155 to form an integral piece having outer planar wedged surfaces coplanar with first and second planar surfaces 152a, 152b.

[0183] To secure locking plate 155 to wedge spacer 151, wedge spacer 151 comprises a first clip or post 154a and a second clip or post 154b, each disposed at spaced locations on second portion153b. As will be described in more detail below in connection with FIG. 14, first and second posts 154a, 154b are configured to be secured within respective apertures and / or slots of locking plate 155.

[0184] To secure a wedge spacer 151 to a mating wedge spacer 151, wedge spacer 151 also comprises a recess 154d disposed within first portion 153a and a recess 154c disposed within second portion 153b (see, e.g., FIG.13). To provide mating components for recesses 154c and 154d, the opposite surface of wedge spacer 151 (e.g., a surface configured to mate with the surface shown in FIG. 13 of another wedge spacer 151) comprises a protrusion 154e configured to nest within or mate with recess 154d of a mating wedge spacerDONJOY.123WO PATENT 151 and another clip or post 154f configured to mate with recess 154c of the mating wedge spacer 151.

[0185] Turning to locking plate 155, as shown in FIG.14, locking plate 155 has a top surface (shown) and a bottom surface (opposite the side shown). In some embodiments, locking plate 155 has a constant thickness and, so, the top and bottom surfaces are parallel to one another. Locking plate comprise a first aperture 156a configured to receive and / or mate with clip or post 154a, a slot 156b configured to receive and / or mate with clip or post 154b, and a slot 156c through which clip or post 154f of one wedge spacer 151 may extend to mate with recess 154c of a mating wedge spacer 151. In some embodiments, slots 156b and 156c may be arcuate slots, each having a respective radius of curvature equal to a spacing between the slot and aperture 156a. Accordingly, locking plate 155 is configured to be secured and / or locked to a wedge spacer 151 by securing respective components within aperture 156a and slots 156b, 156c and then rotating locking plate 155 sufficiently to secure, by friction and / or interference fit, the component disposed within slot 156c against ridge or ramp 157 disposed on or within the sidewall of slot 156c. An outer perimeter of locking plate 155 also has a same or substantially similar outer perimeter as second portion 153b of wedge spacer 151 such that, when locking plate 155 is properly secured to facing wedge(s) 151, the outer perimeter of locking plate 155 and the mating outer perimeter of facing wedge(s) 155 are coextensive, except for the portion of the outer perimeter of locking plate 155 at which a grip or corrugated edge 158 is disposed and from which grip 158 extends away. This provides a visual and tactile indication of a correct, locked alignment between locking plate 155 and either foot shell 130 or a wedge spacer 151.

[0186] Turning to foot shell 130, to allow securing of wedges 151 to foot shell 130, the underside of foot shell 130 comprises a planar portion 134b defined by a same footprint and / or perimeter as second portion 154b of one of the surfaces of wedge spacer 151. Accordingly, planar portion 134b may be recessed compared to the surrounding and / or remaining portions of the underside of foot shell 130 such that, when locking plate 155 is properly disposed within and secured to planar portion 134b, the bottom-most surface of locking plate 155 is parallel and coextensive with a plane defining the surrounding and / or remaining portions of the underside of foot shell 130, an arrangement that is substantially identical to a same fitting previously described between locking plate 155 and wedge spacer 151. Accordingly, the underside of foot shell 130 also comprises clips or posts 134a, 134b and recesses 134c, 134d, each having identical construction and relative placement as a respective one of clips or posts 154a, 154b and recesses 154c, 154d previously described for wedge(s) 151.

[0187] Accordingly, as shown in FIGs.15-17, a wedge spacer 151 may be secured to the underside of foot shell 130 by mating clips or posts 134a and 134b of the underside of footDONJOY.123WO PATENT shell 130 with recesses 156a and 156b of a locking plate 155, respectively. In such an arrangement, recess 134c in the underside of foot shell 130 is accessible through slot 156c. A wedge spacer 151 may then be secured to the underside of foot shell 130 and to locking plate 155 by mating protrusion 154e of the wedge spacer 151 with recess 134d of the underside of foot shell 130 and mating clip or post 154f of the wedge spacer 151 with recess 134c, through slot 156c of locking plate 155. In this configuration, a first locking plate 155 would be disposed between the underside of foot shell 130 and a first wedge spacer 151 and slightly offset (rotated clockwise) from its locked orientation. As previously mentioned, and as best shown in FIG.14, locking plate 155 comprises a ridge or track 157 disposed on or within the sidewall of slot 156c. Accordingly, rotating locking plate 155 about aperture 156a and clip or post 134a until the outer perimeter of locking plate 155 and the mating outer perimeter of the underside of foot shell 130 are coextensive causes ridge or track 157 to increasingly press against clip or post 154f in a friction and / or interference fit that locks wedge spacer 151 to the underside of foot shell 130.

[0188] Similarly, an additional wedge spacer 151 may be secured to already secured wedge(s) 151 by mating clips or posts 154a and 154b of the already secured wedge with recesses 156a and 156b of another locking plate 155, respectively. In such an arrangement, recess 154c in the already secured wedge is accessible through slot 156c of the another locking plate 155. The additional wedge spacer 151 may then be secured to the already secured wedge spacer 151 and to the second locking plate 155 by mating protrusion 154e of the additional wedge spacer 151 with recess 154d of the already secured wedge spacer 151 and mating clip or post 154f of the additional wedge spacer 151 with recess 154c of the already secured wedge, through slot 156c of the second locking plate 155. In this configuration, the second locking plate 155 would be disposed between the already secured wedge spacer 151 and the additional wedge spacer 151 and slightly offset (rotated clockwise) from its locked orientation. Rotating the second locking plate 155 about its aperture 156a and clip or post 154a of the already secured wedge spacer 151 until the outer perimeter of locking plate 155 and the mating outer perimeter of the already secured wedge spacer 151 are coextensive causes ridge or track 157 of the second locking plate 155 to increasingly press against clip or post 154f of the additional wedge spacer 151 in a friction and / or interference fit that locks the additional wedge spacer 151 to the already secured wedge spacer 151, which is already secured to the underside of foot shell 130. In some embodiments, for example as shown in the exploded view of FIG.16 or the condensed view of FIG.17, multiple wedges 151 may be so secured and locked to the underside of foot shell 130 so as to obtain, in the aggregate, a desired degree of plantarflexion of the wearer’s foot.DONJOY.123WO PATENT

[0189] Discussion now turns to the ROM-limiting assembly 120 of brace 100 in connection with FIGs. 18A-22A. In some embodiments, ROM-limiting assembly 120 may comprise a first assembly disposed on a first side of lower leg shell 110 and a second assembly disposed on a second side, opposite the first side, of lower leg shell 110. In some such embodiments, one of the assemblies is configured to set an upper limit on the range of motion (or flexion) of the ankle joint of the wearer, while the other assembly is configured to set a lower limit on the range of motion (or flexion) of the ankle joint of the wearer. As originally shown in FIG.4, and in some embodiments, each assembly comprises a ROM dial 121 (see, e.g., FIGs.18A, 18B and 22A), a spring 122 (see, e.g., FIG.19 and 22), a washer 123 (see, e.g., FIG.22), a rivet 124 (see, e.g., FIGs.20 and 22) and a cap 125 (see, e.g., FIGs.21-22), assembled as shown in FIG. 22A. While any suitable construction materials are also contemplated, in some embodiments, ROM dial 121 comprises polypropylene (PP) and / or polyamide (PA6), ROM cover 125 comprises polypropylene, rivet 124 comprises polyamide (PA6.6), and spring 122 and washer 123 comprise stainless steel.

[0190] As shown in FIGs.18A-18B, ROM dial 121 may have a circular perimeter. In some embodiments, the perimeter of ROM dial 121 comprises a plurality of ridges to provide increased grip and tactile feedback of the ROM settings to the user. ROM dial 121 comprises a central aperture 121a extending entirely through ROM dial 121. ROM dial 121 additionally comprises at least one arcuate slot 121b. Such slot(s) 121b may have a radius of curvature equal to a distance of separation between slot 121b and aperture 121a. FIG.18B illustrates ROM dial 121 having four arcuate slots 121b spaced about aperture 121a, each at a same distance of separation from aperture 121a. Posts 131a, 131b of foot shell 130,130a are each configured to extend through the respective arcuate slot 116a, 116b of lower leg shell 110. And at least one of arcuate slots 121b of each ROM dial 121 is configured to receive the post 131a, 131b of foot shell 130,130a that extends through the arcuate slot 116a, 116b on that side of lower leg shell 110 (see, e.g., FIG. 22A). As shown in FIG. 22A, for each ROM assembly 120, a rivet 124 is disposed through aperture 135a or 135b of foot shell 130, through aperture 115a or 115b of lower leg shell 110, through the center of the coils of spring 122, through washer 123 and through central aperture 121a of ROM dial 121, clipping onto or securing against an outward surface of ROM dial 121. Accordingly, rivet 124 not only serves as the axle about which foot shell 130 pivots with respect to lower leg shell 110, rivet 124 also serves as the central aligning and retaining element of ROM limiting assembly 120, thereby serving two unrelated and indispensable purposes simultaneously.

[0191] In operation, the overlap between arcuate slot 116a or 116b and the slot 121b of ROM dial 121 in which post 131a or 131b is received defines a range of travel through which post 131a or 131b can freely slide. Since foot shell 130 pivots with respect to lower leg shell 110 about rivet 124, this range of travel also defines the limited range of motion affordedDONJOY.123WO PATENT the ankle or foot of the wearer of brace 100. By providing different orientations of slots 121b in the ROM dials 121 on each side of lower leg shell 110, one assembly 120 may be configured to be set in a range that operates as an upper ROM for the ankle and / or foot of the wearer, and the other assembly 120 may be configured to be set in a range that operates as a lower ROM for the ankle and / or foot of the wearer. Accordingly, by setting left assembly 120 and right assembly 120 at the same orientation, the left and right assemblies, collectively, form a ROM mechanism that restricts range of motion to a single degree of plantarflexion of the foot and / or ankle of the wearer.

[0192] An alternative ROM-limiting assembly 120a of brace 100 is shown in FIG.22B. Assembly 120a may be disposed and / or utilized as previously described for assembly 120 in connection with FIGs.18A-22A, comprising a first assembly disposed on a first side of lower leg shell 110 and a second assembly disposed on a second side, opposite the first side, of lower leg shell 110. In some such embodiments, one of the assemblies is configured to set an upper limit on the range of motion (or flexion) of the ankle joint of the wearer, while the other assembly is configured to set a lower limit on the range of motion (or flexion) of the ankle joint of the wearer.

[0193] As shown in FIG.22B, each assembly may comprise a ROM dial 121c, a spring 122a, a rivet 124a and a locking cap 125a. While any suitable construction materials are also contemplated, in some embodiments, ROM dial 121c comprises polypropylene (PP) and / or polyamide (PA6), locking cover 125a comprises polyamide, rivet 124a comprises POM or polyamide (PA6.6), and spring 122a comprises stainless steel. No washer is required in the design of ROM assembly 120a and prior cap 125 is replaced with locking cap 125a.

[0194] ROM dial 121c may have a circular perimeter. In some embodiments, the perimeter of ROM dial 121c comprises a plurality of ridges to provide increased grip and tactile feedback of the ROM settings to the user. ROM dial 121c comprises central aperture 121a extending entirely through ROM dial 121c. ROM dial 121c additionally comprises at least one arcuate slot 121b (not shown but see, e.g., ROM dial 121c of assembly 120). Such slot(s) 121b may have a radius of curvature equal to a distance of separation between slot 121b and aperture 121a. Posts 131a, 131b of foot shell 130,130a are each configured to extend through the respective arcuate slot 116a, 116b of lower leg shell 110. And at least one of arcuate slots 121b of each ROM dial 121c is configured to receive the post 131a, 131b of foot shell 130,130a that extends through the arcuate slot 116a, 116b on that side of lower leg shell 110 (see, e.g., FIG.22B). For each ROM assembly 120a, a rivet 124a is disposed through aperture 135a or 135b of foot shell 130, through aperture 115a or 115b of lower leg shell 110, through the center of the coils of spring 122a, and through central aperture 121a of ROM dial 121c, clipping onto or securing against an outward surface of ROM dial 121c. Accordingly, rivet 124a not only serves as the axle about which foot shell 130,130a pivots with respect to lower leg shell 110,DONJOY.123WO PATENT rivet 124a also serves as the central aligning and retaining element of ROM limiting assembly 120a, thereby serving two unrelated and indispensable purposes simultaneously.

[0195] In operation, the overlap between arcuate slot 116a or 116b and the slot 121b of ROM dial 121c in which post 131a or 131b is received defines a range of travel through which post 131a or 131b can freely slide. Since foot shell 130,130a pivots with respect to lower leg shell 110 about rivet 124a, this range of travel also defines the limited range of motion afforded the ankle or foot of the wearer of brace 100. By providing different orientations of slots 121b in the ROM dials 121c on each side of lower leg shell 110, one assembly 120a may be configured to be set in a range that operates as an upper ROM for the ankle and / or foot of the wearer, and the other assembly 120a may be configured to be set in a range that operates as a lower ROM for the ankle and / or foot of the wearer. Accordingly, by setting left assembly 120a and right assembly 120a at the same orientation, the left and right assemblies, collectively, form a ROM mechanism that restricts range of motion to a single degree of plantarflexion of the foot and / or ankle of the wearer. Furthermore, the addition and / or utilization of locking cap 125a enables ROM assembly 120a a configuration such that locking cover 125a is turned 90° clockwise to lock ROM assembly 120a in a particular setting, and locking cover 125a is turned 90° counterclockwise to unlock ROM assembly 120a to allow adjustment of the particular ROM setting.

[0196] Discussion now turns to the outer sole assembly 140 of brace 100 in connection with FIGs.23A-26. In some embodiments, outer sole assembly 140 comprises an outer sole 142 coupled to a soft sole 144. While any suitable construction materials are also contemplated, in some embodiments, outer sole 142 may comprise polypropylene (PP), while soft sole 144 may comprise EVA, rubber, or any other similarly pliable material. In yet other embodiments, outer sole 142 may comprise another plastic material and / or composite, e.g., polyamide or polyamide + glass fiber. Outer sole assembly 140 is configured to maintain a neutral orientation of the bottom surface of soft sole 144 (e.g., substantially parallel to the ground) when the wearer is standing regardless of the angle of plantar flexion of the wearer’s foot at the ankle joint. A low height of outer sole assembly 140 limits hip discrepancy in all ankle settings to avoid additional related complications. As shown in FIGs.24A and / or 24B, soft sole 144 is configured to provide an anti-slip and shock absorbent surface. Soft sole 144 comprises an anterior portion 144a and a posterior portion 144b. Alternative views of such soft soles are also shown in the cross-section of FIG.89A and the underside view of FIG.89B

[0197] Anterior portion 144a is configured to support the toes and ball of the foot of the wearer. In some embodiments, anterior portion 144a is sufficiently flexible to flex during the toe-off phase and, thereby, provide a more natural gait for the wearer during ambulation. In some embodiments, to reduce weight, to form the above-mentioned sufficient flexibility,DONJOY.123WO PATENT and / or to reduce an amount of construction material, anterior portion 144a may comprise a plurality of recesses 144c so as to form a plurality of baffles whose edges, together, define an upper surface of anterior portion 144a. Soft sole 144 further comprises sidewalls 144d extending up from the lateral edges or sides of anterior portion 144a. Sidewalls 144d are configured to cooperate with lateral edges of forefoot cover 170. In some embodiments, for example, as shown in FIG. 24B, each of sidewalls 144d may further comprise a slot 144e configured to receive a toe strap 108, for example, as will be described in more detail in connection with FIG.44B.

[0198] Posterior portion 144b is configured to support foot shell 130, which may be pivotally secured at any of a plurality of angles with respect to lower leg shell 110 so as to dispose and support the wearer’s foot in a desired degree of plantarflexion. Posterior portion 144b is also configured to receive outer sole 142 thereon, as shown in FIG.24.

[0199] Outer sole 142 is configured to be secured, via glue and pressure, or any other suitable securing method, to posterior portion 144b of soft sole 144 to form outer sole assembly 140 (see, e.g., FIGs.25A and 26A for combination of outer sole 142 of FIG.23A and soft sole 144 of FIG.24A, and FIG.25B for combination of outer sole 142 of FIG.23B and soft sole 144 of FIG.24B). Accordingly, as shown in FIG.23A, a front edge of outer sole 142 of FIG. 23A includes an engagement feature 142a (e.g., a clip in FIG. 23A) configured to receive hinge axle 134 of foot shell 130 while, as shown in FIG.23B, a front edge of outer sole 142 of FIG. 23B includes engagement feature 142a comprises one or more apertures for receiving a metallic axle (see also, e.g., FIG.25B). As shown in at least FIG.23A, outer sole 142 may also comprises a protrusion 142e and a clip or post 142f, which may be substantially similar to and perform the same functions as protrusion 154e and clip or post 154f of wedge spacer 151. And, as shown in FIG.26, outer sole assembly 140 may be hingedly coupled to foot shell 130 at hinge axle 134 via clip 142a (as for embodiments according to FIGs.23A, 24A and 25A), or at the metallic axle via apertures 142a of outer sole assembly 140 and hinge apertures and / or grooves 134a of foot shell 130a (as for embodiments according to FIGs.23B, 24B and 25B). In this way, brace 100 is configured to hinge at the ball of the foot instead of at a most-distal tip of the toes of the wearer. And this allows better support of the foot (at the ball of the foot) in any desired degree of plantarflexion.

[0200] Discussion now turns to the shin cover 160 and forefoot cover 170 of brace 100 in connection with FIGs. 27A-29B. Shin cover 160 is a separate component from lower leg shell 110. While any suitable construction material is also contemplated, shin cover 160 may comprise polyethylene high density (PEHD). In some embodiments, shin cover 160 is configured to curve from a central line of extension toward the lateral sides 165 of shin cover 160. In some embodiments, for example as shown in FIG. 27A, these lateral sides 165 areDONJOY.123WO PATENT configured to be disposed between lower leg shell 110 and the wearer’s leg when brace 100 is properly secured to the wearer. Accordingly, in such embodiments, lateral sides 165 curve sufficiently to extend posteriorly, substantially perpendicular to that the central line of extension. In some embodiments, shin cover 160a, which may be substantially the same as shin cover 160 except as described herein, lateral sides 165a may be or comprise winglets configured to at least partially overlap the outer sides of leg shell 110, rather than being configured to entirely tuck within the inner surfaces of leg shell 110. In some embodiments, shin cover 160, 160a also flares outward toward a bottom edge so as to more closely track a contour of the front of the lower leg of the wearer at or just above the ankle.

[0201] In some embodiments, shin cover 160,160a comprises a plurality of windows 161 configured to provide breathability to the lower leg of the user disposed therein. In some embodiments, shin cover 160,160a also comprises a first slot or strap retaining feature 162 centrally disposed on an upper portion of shin cover 160 and configured to receive a first strap. In such embodiments, shin cover 160,160a may also comprise a second slot or strap retaining feature 163 centrally disposed on a lower portion of shin cover 160 and configured to receive a second strap. In some embodiments, shin cover 160,160a additionally comprises one or more hooks 164 disposed on an inward facing surface near the bottom edge of shin cover 160. Such hooks 164 may be configured to secure one side of a flexible junction 165 that couples shin cover 160 to forefoot cover 170 (see, e.g., FIG.29A).

[0202] Forefoot cover 170 is also a separate component from lower leg shell 110 and a separate component from shin cover 160. While any suitable construction material is also contemplated, forefoot cover 170 may comprise polyethylene low density (PELD) or, alternatively, polyethylene high density (PEHD). In some embodiments, forefoot cover 170 is configured to curve at the lateral sides of forefoot cover 170 such that these lateral sides are configured to be disposed between sidewalls 144d of anterior portion 144a of soft sole 144 of outer sole assembly 140 and the wearer’s foot when brace 100 is properly secured to the wearer. In some embodiments, forefoot cover 170 comprises a living hinge 175 (or thinner corrugated portion) extending between lateral edges at approximately the midpoint between the front and the rear edges of forefoot cover 170. Living hinge 175 provides an increased degree of flexibility in forefoot cover 170, thereby allowing forefoot cover 170 to more closely conform to the contour of the foot of the wearer, increasing comfort and support.

[0203] In some embodiments, forefoot cover 170 comprises a plurality of windows 171 configured to provide breathability to the foot of the user disposed therein. In some embodiments, forefoot cover 170 also comprises a slot or strap retaining feature 172 centrally disposed on an upper (or posterior) portion of forefoot cover 170 and configured to receive a foot strap. In some embodiments, forefoot cover 170 additionally comprises one or more hooks 174 disposed on an inward facing surface near the rear or proximal edge of forefoot coverDONJOY.123WO PATENT 170. Such hooks 174 may be configured to secure the other side of flexible junction 165 that couples shin cover 160 to forefoot cover 170. For example, as shown in FIG. 29, in some embodiments, flexible junction 165 may comprise an elastic textile material. A first edge or portion 166a of flexible junction 165 may comprise polyurethane (PU) for added support. And a second edge or portion 166b of flexible junction 165 opposite first portion 166a may also comprise polyurethane (PU) for added support. And each of first portion 166a and second portion 166b may have one or more openings or apertures 167a, 167b configured to receive hooks 164 of shin cover 160 or hooks 174 of forefoot cover 170 or, as described below, configured to receive rivets. Accordingly, when brace 100 is properly donned by a wearer, shin cover 160,160a is elastically coupled to forefoot cover 170 by flexible junction 165, thereby maintaining each cover in its appropriate relative position. In some other embodiments, rather than flexible junction 165 being releasably coupled between shin cover 160,160a and forefoot cover 170 via hooks 164, 174 and apertures 167a, 167b, flexible junction 165 may be secured between shin cover 160,160a and forefoot cover 170 utilizing rivets configured to extend through holes in shin cover 160,160a and / or forefoot cover 170.

[0204] In yet other embodiments, shin cover 160,160a and forefoot cover 170 may be flexibly secured to one another via a semi-rigid plastic junction, for example via rivets or, alternatively, via a feature akin to a living hinge, such that shin cover 160,160a and forefoot cover 170 are manufactured as a single, monolithic part.

[0205] Discussion now turns to the adjustable, inflatable liner(s) 180, 190 of brace 100 in connection with FIGs.30-34. Lower leg shell 110 is also configured to house an adjustable, inflatable liner or liners that provide air cells around the foot and lower limb that, in combination with muscle contraction, result in intermittent compression of the lower leg of the wearer, facilitating and accelerating the healing process while avoiding the negative side effects of prolonged immobilization. Configurations of individually inflatable air cells as described herein allow the braces to generate intermittent compression and / or pulsating graduated compression, which has beneficial effects on tissue healing by milking away the edema and helping callus formation, offering a conservative treatment modality for lesions traditionally requiring surgery, such as Achilles tendon tears and / or foot and / or lower leg fractures. Such support can provide patients with more confidence in weight bearing and a greater true and perceived protection compared to conventional walkers, braces or casts leading to faster and stronger bone healing.

[0206] For example, brace 100 may comprise a first adjustable, inflatable liner portion 180 configured to be disposed against the inner facing surfaces of lower leg shell 110 and a second adjustable, inflatable liner portion 190 configured to be disposed against the inner facing surface(s) of shin cover 160 and / or forefoot cover 170. As shown in FIG.32A, first linerDONJOY.123WO PATENT portion 180 comprises a plurality of separate inflatable air cells: a first lower distal air cell 184a configured to be disposed against and / or adjacent to a right side distal portion of the lower leg of the wearer, a second lower distal air cell 184b configured to be disposed against and / or adjacent to a left side distal portion of the lower leg of the wearer, a first upper distal air cell 185a configured to be disposed against and / or adjacent to a right side portion of the lower leg of the wearer just proximal of the ankle of the wearer, a second upper distal air cell 185b configured to be disposed against and / or adjacent to a left side portion of the lower leg of the wearer just proximal of the ankle of the wearer, a lower posterior air cell 186 configured to be disposed around the posterior portion of the lower leg of the wearer about the ankle of the wearer, and an upper posterior air cell 187 configured to be disposed around the posterior portion of the lower leg of the wearer around the calf and Achilles tendon of the wearer. In some embodiments, for example as shown in FIG.32B, posterior air cells 186 and / or 187 may comprise a plurality of windows 189 configured to provide breathability to the foot and lower leg of the wearer. As shown, in some embodiments, windows 189 are vertically oriented so as to allow for milking of edema away from the foot and lower leg of the wearer. Further, the material forming the inner, skin contacting and / or facing surface covering at least air cells 186 and / or 187 may comprise a material configured to optimize moisture evacuation from the skin of the wearer.

[0207] In some embodiments, posterior air cell 186 has a “U” shape (see, e.g., lower right of FIG.32). In some other embodiments, posterior air cell 186 comprises two relatively thin parallel vertical cells configured to be disposed adjacent each side of the Achilles tendon of the wearer. In some embodiments, one or more of these air cells comprises foam therein to maintain a certain form of each air cell, even when the brace is donned and secured to the wearer. In some embodiments, rather than having an air cell about the heel area, or in addition, some embodiments contemplate an air cell 188 configured to be disposed under the wearer’s foot, for example under the foot arch for increased foot stability (see, e.g. lower right of FIG. 32). In some embodiments, air cell 188, when linked to the U-shaped air cell 186, is configured to create an alternative compression on the Achilles tendon, which has beneficial effects on tissue healing by milking away edema.

[0208] In such embodiments, such an air cell may have a shape that is reversible for use with the left and / or right foot. Moreover, utilizing multiple air cells allows for differential compression at different parts of the foot, for example higher compression around the ankle and lower compression up near the calf. As also shown in FIG.32A, in some embodiments, pump 181 (not shown) is coupled to the input port (not shown) of fluid manifold 183 via tubing. Tubing also extends from a first of the output ports 184 to an input of a y-connector and from each of the outputs of the y-connector to respective ones of first distal air cells 184a, 185a. Tubing also extends from a second of the output ports 184 to one end of an elbow connectorDONJOY.123WO PATENT and from the other end of the elbow connector to an input of another y-connector and from each of the outputs of the y-connector to respective ones of second distal air cells 184b, 185b. Tubing also extends from a third of the output ports 184 to an input of yet another y-connector and from each of the outputs of that y-connector to respective ones of posterior air cells 186, 187. In some embodiments, tubing also extends from a fourth output port 184 to an anterior air cell 191 of second liner portion 190 (not shown in FIG.32A). To secure first and second liner portions 180, 190, double sided tape, adhesive and / or hook and loop type fasteners may be utilized to couple first liner portion 180 to lower leg shell 110 and second liner portion 190 to shin cover 160 and forefoot cover 170. For example, as shown in FIGs.33 and 34, upper posterior air cell 187 may be secured to lower leg shell 110 via fastener(s) 189a, lower posterior air cell 186 may be secured to lower leg shell 110 via fastener(s) 189d, distal air cells 185a, 185b may be secured to lower leg shell 110 via fastener(s) 189b, and distal air cells 184a, 184b may be secured to lower leg shell 110 via fastener(s) 189c. Likewise, anterior air cell 191 of second liner portion 190 may be may be secured to shin cover 160 via fastener(s) 199a and to forefoot cover 170 via fastener(s) 199b.

[0209] Discussion now turns to the toe liner 187e and insole 188 of brace 100 in connection with FIGs. 35-38. As shown in FIGs. 35-37, toe liner 187e is configured as a padded textile that covers the extremities of the foot (e.g., the toes and metatarsal area). In some embodiments, liner 187e is also configured for direct skin contact. Accordingly, in some such embodiments, liner 187e is constructed from a material configured to optimize the breathability and moisture evacuation from the skin of the wearer. Toe liner 187e may comprise a base portion 187d on which a cushioned insole 188 is disposed. Insole 188 is also shown in more detail in FIG.88, having a cupped portion configured to receive a heel of the wearer extending into a raised arch support portion for providing increased support to the arch of the wearer. Toe liner 187e also comprises a right flap 187a, a left flap 187b, and a front flap 187c. As shown in FIG.37, in operation, a wearer may place his or her foot on insole 188, wrap one of right or left flaps 187a, 187b over the foot, wrap the other of the right or left flaps 187a, 187b over the first, and toe flap 187c over the top. As shown in FIG.38, an outer surface of toe liner 187e may be secured to the upper surface of soft outer sole 144 utilizing a fastener 189e, which, like the other liner fasteners described, may be double sided adhesive and / or hook and loop type fasteners.

[0210] As used anywhere in this disclosure, the term “insole” refers to a permanent or removable padded insert disposed within the same cavity as the foot of the wearer when the brace is properly donned by the wearer, to provide cushioning and / or “soft” support for the foot of the wearer (e.g., arch support, heel support, ball-of-the-foot support, etc). Such “insoles” are differentiated from any feature being disposed outside the lower leg shell, foot shell or,DONJOY.123WO PATENT generally, outside the same cavity in which the foot of the wearer is disposed. For example, wedge spacers and / or wedge spacer systems as described anywhere in this disclosure, which are disposed outside of any lower leg shell and / or foot shell of the brace, are not considered insoles nor considered as part of any insole. Similarly, no portion of any outer sole assembly as described anywhere in this disclosure, which is also disposed outside of the lower leg shell, foot shell and, generally, outside the same cavity in which the foot of the wearer is disposed, are considered insoles or part of insoles.

[0211] Discussion now turns to straps 102, 104, 106 of brace 100 in connection with FIGs.39-44B. In some embodiments, brace 100 is secured to the wearer utilizing a plurality of straps, for example, a first lower leg strap 102, a second lower leg strap 104, and a foot strap 106 as shown in FIG. 44A. However, the present disclosure is not so limited and, in some other embodiments, brace 100 is secured to the wearer utilizing first lower leg strap 102, second lower leg strap 104, foot strap 106, and an additional toe tightening strap 108, configured to maintain and / or further limit or eliminate toe movement, as shown in FIG.44B.

[0212] Regarding foot strap 106, strap 106 comprises first and second ends 106a, 106b. One of first and second ends 106a, 106b comprises a fastener 106d, such as hook and loop fasteners, while the other of the first and second ends 106a, 106b comprises a D-ring buckle 102c. In operation, strap 102 is configured to pass through slots in foot shell 130 and / or lower leg shell 110 and through slot or strap retaining feature 172 of forefoot cover 170. Fastener 106d end of strap 106 extends through D-ring 106c and doubles back to secure to itself

[0213] Regarding first and second lower leg straps 102, 104, FIGs.40-41 illustrate an embodiment in which, similar to first lower leg strap 102, leg strap 102 comprises first and second ends 102a, 102b. One of first and second ends 102a, 102b comprises a fastener 102d, such as hook and loop fasteners, while the other of the first and second ends 102a, 102b comprises a D-ring buckle 102c. In operation, strap 102 is configured to pass through slots 112a, 112b, 112c, 112d of lower leg shell 110 and through slot or strap retaining feature 162 of shin cover 160. Fastener 102d end of strap 102 extends through D-ring 102c and doubles back to secure to itself.

[0214] Similarly, leg strap 104 comprises first and second ends 104a, 104b. One of first and second ends 104a, 104b comprises a fastener 104d, such as hook and loop fasteners, while the other of the first and second ends 104a, 104b comprises a D-ring buckle 104c. In operation, strap 104 is configured to pass through slots 112e, 112f, 112g, 112h of lower leg shell 110 and through slot or strap retaining feature 163 of shin cover 160. Fastener 104d end of strap 104 extends through D-ring 104c and doubles back to secure to itself. FIG.DONJOY.123WO PATENT 43 illustrates an embodiment of brace 100 without straps 102, 104, 106, while FIG. 44A illustrates brace 100 of FIG.43 including straps 102, 104, 106.

[0215] FIG.44B illustrates brace 100 of FIG.44A further comprising and utilizing toe tightening strap 108. Toe tightening strap may comprise two half-straps 108a, 108b. As shown in FIG.39, a first end of half-strap 108a is riveted or otherwise fixed to one side of soft outer sole at winglet 144d, for example as illustrated in the annotated circles of FIG.39, while the opposite end of half-strap 108a comprises a D-ring 108c. A first end of half-strap 108b is riveted or otherwise fixed to a second side of soft outer sole at the opposite winglet 144d, for example as illustrated in the annotated circles of FIG.39, while a portion at and / or near the opposite end of half-strap 108b comprises a fastener 108d configured to couple the opposite end of half-strap 108b to itself, for example, hook and loop fasteners. In operation, half-strap 108b extends from its first fixed end, over an anterior portion of forefoot cover 170, through D- ring 108C of half-strap 108a, and doubled back to secure to itself utilizing fastener 108d.

[0216] In some embodiments, several components of brace 100 may be injection molded. FIGs. 45-53 illustrate portions of injection molds and their movements for manufacturing lower leg shell 110, foot shell 130, outer sole 142, ROM dial 121, shin cover 160, forefoot cover 170, locking plate 155, and soft sole 144.

[0217] For example, FIG. 45 illustrates mold portions 110a, 110b, 110c and 110d, which may be fit together, generally as shown, to form lower leg shell 110 by injection molding. The directions of arrows having the same color as mold portions 110a, 110b, 110c and 110d in FIG.45 illustrate the direction in which each mold portion is slid to release lower leg shell 110 after injection molding.

[0218] FIG.46 illustrates mold portions 130a, 130b, 130c and 130d, which may be fit together, generally as shown, to form foot shell 130 by injection molding. The directions of arrows having the same color as mold portions 130a, 130b, 130c and 130d in FIG.46 illustrate the direction(s) in which each mold portion is slid to release foot shell 130 after injection molding.

[0219] FIG. 47 illustrates mold portions 142a and 142b, which may be fit together, generally as shown, to form outer sole 142 by injection molding. The directions of arrows having the same color as mold portions 142a and 142b in FIG.47 illustrate the direction(s) in which each mold portion is slid to release outer sole 142 after injection molding.

[0220] FIG. 48 illustrates mold portions 121a and 121b, which may be fit together, generally as shown, to form ROM dial 121 by injection molding. The directions of arrows having the same color as mold portions 121a and 121b in FIG.47 illustrate the direction(s) in which each mold portion is slid to release ROM dial 121 after injection molding.

[0221] FIGs. 49 and 50 illustrate mold portions 160a and 160b, which may be fit together, generally as shown, to form shin cover 160 by injection molding. The directions ofDONJOY.123WO PATENT arrows having the same color as mold portions 160a and 160b in FIGs.49 and 50 illustrate the direction(s) in which each mold portion is slid to release shin cover 160 after injection molding.

[0222] FIG. 51 illustrates mold portions 170a and 170b, which may be fit together, generally as shown, to form forefoot cover 170 by injection molding. The directions of arrows having the same color as mold portions 170a and 170b in FIG.51 illustrates the direction(s) in which each mold portion is slid to release forefoot cover 170 after injection molding.

[0223] FIG. 52 illustrates mold portions 155a and 155b, which may be fit together, generally as shown, to form locking plate 155 by injection molding. The directions of arrows having the same color as mold portions 155a and 155b in FIG.52 illustrates the direction(s) in which each mold portion is slid to release locking plate 155 after injection molding.

[0224] FIG. 53 illustrates mold portions 144a and 144b, which may be fit together, generally as shown, to form soft sole 144 by injection molding. The directions of arrows having the same color as mold portions 144a and 144b in FIG.53 illustrates the direction(s) in which each mold portion is slid to release soft sole 144 after injection molding.

[0225] While the above description and related figures disclose one or more embodiments of brace 100 comprising one or more components, the present disclosure also contemplates additional and / or alternative ways of implementing particular features of such a brace, for example, different ROM-limiting assemblies, different outer sole assemblies, and different configurations for closure of such a brace, e.g., bringing lower leg shell 110 and embodiments of shin and / or forefoot cover(s) together. Several such additional and / or alternative embodiments are described below.

[0226] Additional and / or Alternative Embodiments of Braces and / or Components

[0227] Discussion now turns to several alternative embodiments of different ROM- limiting assemblies for braces as described herein. FIGs.54A and 54B illustrate an alternative embodiment of a brace 200 having a ROM-limiting assembly 220 and outer sole assembly 240 combined into a single assembly and / or apparatus. For example, brace 200 includes a lower leg shell 210, which may be substantially similar to lower leg shell 110 as previously described in connection with brace 100. Lower leg shell 210 comprises a lateral bar 220 fixedly coupled to a side of lower leg shell 210. Lateral bar 220 may extend in an arcuate path of extension substantially vertically along the lateral side of lower leg shell 210. At a most proximal extent of lateral bar 220, lateral bar 220 extends posteriorly. Lateral bar 220 comprises a plurality of apertures 221 disposed along the arcuate path of extension of lateral bar 220 and along its posterior extent.DONJOY.123WO PATENT

[0228] Brace 200 also includes a foot shell 230 pivotally coupled to the distal end of lower leg shell 210, similar to that previously described for foot shell 130 and lower leg shell 110. However, contrary to brace 100, in brace 200, foot shell 230 is hingedly coupled, at a most distal (or anterior) point of foot shell 230, to outer sole 240.

[0229] To simultaneously affect and fully support both the degree of plantar flexion of the wearer’s foot and the angle between foot shell 230 and outer sole 240, brace 200 includes a posterior bar 250 pivotally coupled at a first end 251 to a posterior portion of outer sole 240. Posterior bar 250 comprises a linear slot 252 extending along a length of extension of posterior bar 250. Linear slot 252 is configured to receive a post 231 extending from a side of foot shell 230. Accordingly, when foot shell 230 is pivoted with respect to lower leg shell 210 to increase a degree of plantarflexion of the foot of the wearer, post 231 translates upward (toward the top or proximal end of brace 200) within slot 252. Posterior bar 250 also comprises an arcuate slot 253 disposed at an opposite end of posterior bar 250 from first end 251 and configured to extend approximately perpendicularly to linear slot 252. Arcuate slot 253 is configured to receive an adjustable post 222. While remaining in (e.g., constrained by) arcuate slot 253, adjustable post 222 is configured to be adjustably (and / or removably) disposed within any one of the apertures 221 of lateral bar 220 to, thereby, simultaneously pivotally set and secure foot shell 230 in the appropriate orientation with respect to lower leg shell 210 to affect the desired degree of plantar flexion of the foot of the wearer of brace 200 and hingedly set and secure outer sole 240 in the appropriate orientation with respect to foot shell 230 to ensure a bottom surface of outer sole 240 is substantially parallel to the ground when the wearer is standing with brace 200 properly donned.

[0230] Some advantages of such embodiments include a single integrated adjustment for both range of motion limitation and for orienting of the outer sole with respect to the rest of the brace, for example, a lower leg shell 210. Such braces 200 may be useful for rehabilitating venous pumping to decrease edema and to relieve pain of foot injuries. However, the concept may not be the most intuitive for wearers to use. The open concept between outer sole 240 and the rest of brace 200 also increases the risk of picking up dirt. In addition, depending upon the number of apertures 221 within lateral bar 220, not all desired degrees of plantarflexion may be achievable. Furthermore, posterior bar 250 is sufficiently bulky to increase the risk of accidents and to make wearing pants difficult.

[0231] FIG.55 illustrates an alternative embodiment of a brace 300 having a ROM- limiting assembly 320. For example, brace 300 includes a lower leg shell 310, which may be substantially similar to lower leg shell 110 as previously described in connection with brace 100. A foot shell 330 is pivotally coupled to the distal end of lower leg shell 310, similar to that previously described for foot shell 130 and lower leg shell 110. Similar to ROM-limitingDONJOY.123WO PATENT assembly 120 of brace 100, ROM-limiting assembly 320 is configured to limit a range of motion of the wearer’s ankle joint and / or hold the wearer’s foot in a desired degree of plantarflexion.

[0232] In some embodiments, ROM-limiting assembly 320 comprises a foot arm 331 coupled to foot shell 330 at a first end and to a limiting wheel 322 at a second end. ROM- limiting assembly 320 comprises a cover 324 coupled to lower leg shell 310. Accordingly, foot arm 331 and limiting wheel 322 being fixed to foot shell 330 and cover 324 being fixed to lower leg shell 310, when foot shell 330 is pivoted with respect to lower leg shell 310, foot arm 331 and limiting wheel 322 will rotate with respect to cover 324. Accordingly, an alignment marker on foot arm 331 may align with any one of a plurality of angle or degree markers disposed on cover 324, providing a visual indication of the relative orientation of foot shell 330 with respect to lower leg shell 310.

[0233] Limiting wheel 322 comprises a plurality of recesses along its side perimeter, each configured to receive a blocking pin 323a, 323b. And cover 324 comprises fingers adjacent to the side perimeter of limiting wheel 322. Accordingly, when blocking pins 323a, 323b are placed into the appropriate recesses in the side perimeter of limiting wheel 322, upper and lower limits may be placed on the range of motion of foot shell 330 with respect to lower leg shell 310. In some embodiments, ROM-limiting assembly 320 is disposed on only one side of lower leg shell 310. However, in other embodiments, ROM-limiting assembly 320 is disposed on both sides of lower leg shell 310. In some such embodiments, one assembly 320 is utilized to set the upper limit on the ROM, while the other assembly 320 is utilized to set the lower limit on the ROM.

[0234] Such embodiments are simple to understand and use. However, blocking pins 323a, 323b, being removable, could get lost. In addition, assemblies 320 on both sides of lower leg shell 310 may be sufficiently bulky to increase the risk of accidents in some contexts.

[0235] FIGs.56-59B illustrate alternative embodiments of a brace 400 having a ROM- limiting assembly 420. For example, brace 400 includes a lower leg shell 410 and a foot shell 430, similar to lower leg shell 310 and foot shell 310 of brace 300. Similar to ROM-limiting assembly 320 of brace 300, ROM-limiting assembly 420 is configured to limit a range of motion of the wearer’s ankle joint and / or hold the wearer’s foot in a desired degree of plantarflexion, however, utilizing spring-loaded locking pins 423a, 423b rather than removable locking pins 323a, 323b.

[0236] For example, turning to FIGs.57, 58A and 58B, ROM-limiting assembly 420a comprises a limiting wheel 422 coupled to one of foot shell 430 or lower leg shell 410 and one or more toothed racks 421a, 421b coupled to the other of the foot shell 430 and lower leg shell 410. Accordingly, when foot shell 430 is pivoted with respect to lower leg shell 410, limiting wheel 422 will rotate with respect to limiting racks 421a, 421b within a predetermined range of rotation.DONJOY.123WO PATENT

[0237] In some embodiments, toothed racks 421a, 421b are arcuate, having a radius of curvature equal to a distance of separation to a center 427 of assembly 420a. Locking pins 423a, 423b are coupled to respective toothed carriers 425a, 425b, which are each loaded by springs 428 and configured to travel in a direction toward or away from a center 427 of assembly 420a within respective slots 426a, 426b in limiting wheel 422. Accordingly, at least the portion of carriers 425a, 425b having mating teeth that engage with toothed racks 421a, 421b have a similar arcuate shape. In the engaged condition, teeth of carriers 425a, 425b are engaged with mating teeth of racks 421a, 421b and the range of rotation (or motion) of assembly 420a is limited within upper and lower limits set by the relative orientation of racks 421a, 421b with respect to carriers 425a, 425b.

[0238] In operation, a user may press locking pins 423a, 423b toward center 427 of assembly 420a to push carriers 425a, 425b along slots 426a, 426b and disengage the teeth of carriers 425a, 425b from the teeth of racks 421a, 421b. Locking pins 423a, 423b may then be rotated about center 427 of assembly 420a to adjust the relative orientation of carriers 425a, 425b with respect to racks 421a, 421b and, thereby, set the upper and lower limits on the range of motion of ROM-limiting assembly 420a.

[0239] Another embodiment of ROM-limiting assembly 420b is shown in FIGs.59A- 59B, which employs the use of a cam wheel 426 and spring-loaded feet 428c, 428d on the lateral ends of carriers 425c, 425d themselves, rather than coil springs 428, to engage / disengage teeth of carriers 425c, 425d from teeth of racks 421a, 421b. For example, assembly 420b comprises a similar limiting wheel 422, racks 421a, 421b, and locking pins 423a, 423b as in assembly 420a. Locking pins 423a, 423b are coupled to carriers 425c, 425d, which are substantially similar to carriers 425a, 425b except having spring-loaded feet 428c, 428d disposed at each lateral end configured to press against an inward facing edge of limiting wheel 422 and, thereby, bias the teeth of carriers 425a, 425b away from the teeth of racks 421a, 421b. Accordingly, to maintain these mating teeth in engaged orientations, when portions of cam wheel 426 having a larger radius are disposed against carriers 425a, 425b, carriers 425a, 425b are pressed outward and the mating teeth are engaged. And when cam wheel 426 is rotated such that portions of cam wheel 426 having a relatively smaller radius are disposed against carriers 425a, 425b, spring-loaded feet 428c, 428d urge carriers 425a, 425b inward such that the mating teeth are disengaged from one another. In this disengaged position, locking pins 423a, 423b may be rotated about center 427 so as to adjust the relative orientation of carriers 425c, 425d with respect to racks 421a, 421b and, thereby, set the upper and lower limits on the range of motion of ROM-limiting assembly 420b. Then cam wheel 426 may be rotated again, or back, such that the portions of cam wheel 426 having the larger radius are again disposed against carriers 425a, 425b and carriers 425a, 425b are pressed outward such that the mating teeth are engaged.DONJOY.123WO PATENT

[0240] Such embodiments are simple to understand and use. And, additionally, do not suffer the deficiency of easy loss of removable blocking pins 323a, 323b of assembly 320.

[0241] FIGs. 60A-60E illustrate an alternative embodiment of a brace 500 having a ROM-limiting assembly 520 that, similar to the embodiment of FIGs.54A-54B, integrates the ROM-limiting feature with the outer sole leveling feature into a single adjustment assembly. For example, brace 500 includes a foot shell 530 pivotally coupled to a lower leg shell 510 and an outer sole assembly 540 having a most distal edge hingedly coupled to a most distal edge of foot shell 530.

[0242] As shown in FIG. 60A, brace 500 comprises a lateral bar 520 configured to extend though first and second slots 523a, 523b (e.g., vertical slots) in lower leg shell 510. Lateral bar 520 comprises a plurality of apertures 521 disposed along its length. A first removable post 522a is configured to be disposed in a first of apertures 521, while a second removable post 522b is configured to be disposed in a second of apertures 521. Neither first nor second removable posts 522a, 522b are capable of passing through slots 523a, 523b. Accordingly, when disposed in the desired first and second ones of apertures 521, foot shell 530 may be placed in such an orientation with respect to lower leg shell 510 that a wearer’s foot is either limited to a desired ROM or immobilized in a desired degree of plantarflexion in brace 500. A bottom or distal end of lateral bar 520 is also slidably coupled to, and configured to translate along, a track 552 (e.g., either a bar over which bar 520 translates, or a slot within which bar 520 translates) that is held substantially horizontal by a bracket 250 coupled to outer sole assembly 240 (e.g., to an upper surface of a posterior portion of outer sole assembly 240). Accordingly, as angle “B” in FIG.60A is increased (e.g., as a degree of plantarflexion of the wearers foot is increased), an angle “D” also increases. And, since the increase in the angle “B” causes some degree of anterior movement of lower leg shell 110 with respect to outer sole assembly 240, with slots 523a, 523b holding lateral bar 520 in a substantially vertical orientation, lateral bar 520 is urged and / or translated in the anterior direction along track 552. FIGs.60B-60E illustrate brace 500 with removable post 522a, 522b disposed in different pairs of apertures 521 of lateral bar 520 so as to place a wearer’s foot in each of a plurality of different degrees of plantarflexion (e.g., +10°, -10°, -20°, -30°).

[0243] FIG.61 illustrates a version of brace 500 having an arrangement of lateral bar 520, slots 523a, 523b bracket 550 with slot 552 on each side of brace 500.

[0244] FIGs. 62A-62C illustrates another version of brace 500 having a bracket 550 with slot 552 on each side of brace 500 but having a modified lateral bar 520, having a first portion 520a configured to extend vertically along a central posterior part of lower leg shell 510 and through first and second slots 523a, 523b disposed on, and spaced along, the central posterior part of lower leg shell 510. Just as with brace 500 in FIGs.60A-60E, removable posts 522a, 522b are disposed in pairs of the apertures 521 disposed in first portion 520a of modifiedDONJOY.123WO PATENT lateral bar 520 to restrict the range of motion of foot shell 530 with respect to lower leg shell 510. As shown in FIGs.62A-62C, first portion 520a of modified lateral bar 520 extends to form second portion 520b, which extends laterally around a first side of lower leg shell 510 and then vertically down to slide within a track 552 of a bracket 550 on the first side of outer sole assembly 540. First portion 520a of modified lateral bar 520 also extends in the opposite direction to form third portion 520c, which extends laterally around a second side of lower leg shell 510 and then vertically down to slide within a track 552 of a bracket 550 on the second side of outer sole assembly 540. Embodiments according to FIGs.62A-62C provide the same benefits of embodiments of FIG. 61 from fewer components, especially fewer removable and / or adjustable components, thereby simplifying operation and function of this brace 500 of FIGs.62A-62C compared to that of FIG.61.

[0245] FIGs. 63A-63K illustrate yet another embodiment of a brace 600 having a ROM-limiting assembly 620 similar to assembly 120 of FIGs.1A-4. For example, just as with brace 100 and assembly 120, lower leg shell 610 comprises apertures 615a, 615b (b not shown) and arcuate slots 116a, 116b (b not shown), with posts 631a, 631b (b not shown) configured to slide within corresponding slots 116a, 116b. A ROM dial 621 disposed on the assembly 620 on each side of brace 600 comprises a central post 621a and at least one arcuate slot 621b. Slot 621b may have a radius of curvature equal to a distance of separation between slot 621b and aperture 621a. Posts 631a, 631b of foot shell 630 are each configured to extend through the respective arcuate slot 616a, 616b of lower leg shell 610 and the arcuate slot 621b of each ROM dial 621 is configured to receive the post 631a, 631b of foot shell 630 that extends through the arcuate slot 616a, 616b on that side of lower leg shell 610. One ROM dial 621 adjusts the upper limit on the range of motion of assembly 620 and the other ROM dial 621 adjusts the lower limit on the range of motion of assembly 620. A functional aspect of this is illustrated in FIG.64F, where arcuate slots 621b of each ROM dial 621 are shown overlapped with arcuate slots 116a, 116b of lower leg shell 610. The portion where all such arcuate slots overlap one another defines the range within which ROM assembly 620 will restrict pivoting of foot shell 630 with respect to lower leg shell 610. FIG.63G illustrates brace 600 with ROM-limiting assembly 620 having upper and lower limits set at various different angles (e.g., 0 / 0, -10 / -10, -20 / -20, -30 / -30, -20 / -30, 0 / -30).

[0246] FIGs. 63H-63K illustrate various proposals for markings for ROM-limiting assembly 620. For example, in some embodiments according to FIG.63H, ROM dial 621 may include an indication of upper stop or lower stop, for example, “Upper Stop” or “Lower Stop,” as well as numerical indicators of the degree settings at which dial 621 may be set along an outer portion of dial 621. A tick mark is also shown on an immediately adjacent portion of lower leg shell 610 to indicate which numerical indicator of the degree settings is currently the correct indicator. FIG. 63I illustrates markings identical to those of FIG. 63H but further including aDONJOY.123WO PATENT pictorial representation of the brace with a dot on the ankle joint of the representation to indicate the adjustment pertains to the ankle joint of the brace. FIG.63J illustrates markings identical to those shown in FIG.63I, however, excluding the indication of upper stop or lower stop, for example, “Upper Stop” or “Lower Stop.” FIG.63K illustrates alternative markings in which the tick mark is disposed at an edge of lower leg shell 610 immediately adjacent foot shell 630, and the numerical indicators of the degree settings at which dial 621 may be set are disposed along a portion of foot shell 630 immediately adjacent that edge of lower leg shell 610.

[0247] FIGs.64A-67C illustrate yet another set of embodiments of a brace 700 having a ROM-limiting assembly 720 that utilizes one more rows of slidable blocking pins 723a, 723b disposed in respective slots disposed on just one, or alternatively on both sides, of brace 700. For example, just as with brace 100 and assembly 120, lower leg shell 710 comprises apertures (not shown) and arcuate slots (not shown), with posts 731a, 731b (see, e.g., FIG. 65, though 731b not shown) configured to slide within those corresponding slots.

[0248] FIG.64A illustrates an embodiment where assembly 720 has first and second rows of slidable blocking pins 723a, 723b (one row for setting the upper ROM limit and the other for setting the lower ROM limit) disposed in a separate assembly from lower leg shell 710. FIG.64B illustrates an embodiment where assembly 720 has the same first and second rows of slidable blocking pins 723a, 723b but integrally disposed in lower leg shell 710. FIG. 64C illustrates an identical embodiment to that shown in FIG.64B, however, further including first and second lockable sliders 725a, 725b for locking first and second rows of slidable blocking pins 723a, 723b, respectively, in their current configuration. FIG.64D illustrates an embodiment where assembly 720 has only one of the first and second rows of slidable blocking pins 723a, 723b disposed on one side of lower leg shell 710 and the other of first and second rows of slidable blocking pins 723a, 723b disposed on the other side of lower leg shell 710.

[0249] FIG.65 illustrates a cutaway view of an example embodiment of assembly 720 according to any of FIGs.64A-64D. For example, whether utilizing just one or both of first and second rows of slidable blocking pins 723a, 723b on a side of lower leg shell 710, assembly 720 comprises an arcuate slot 721b. Arcuate slot 721b may be coextensive with a slot 716a, 716b in lower leg shell 710 through which post 731a, 731b of foot shell 730 extends. Accordingly, as shown in FIG. 65, post 731a, 731b of foot shell 730 is configured to extend through slot 716a, 716b and into arcuate slot 721b of assembly 720. To set an upper limit on a ROM of assembly 720, one or more or the blocking pins 723a in the first row may be slid down within their respective slots or channels such that the pin(s) protrude into arcuate slot 721b. Similarly, to set a lower limit on a ROM of assembly 720, one or more or the blocking pins 723b in the second row may be slid up within their respective slots or channels such thatDONJOY.123WO PATENT the pin(s) protrude into arcuate slot 721b. In this way, post(s) 731a, 731b may be restricted to translate (or to reside immobilized) between protruding blocking pins.

[0250] FIGs. 66A-66C illustrate various proposals for markings for embodiments of ROM-limiting assembly 720 having only one of first and second rows of blocking pins 723a, 723b on a side. For example, in embodiments according to FIG. 66A, ROM assembly 720 may include a pictorial representation of the brace with a dot on the ankle joint of the representation adjacent to the row of blocking pins 723a or 724b to indicate the adjustment pertains to the ankle joint of the brace. In embodiments according to FIG.66B, ROM assembly 720 may include an indication of upper stop or lower stop, for example, “Upper Stop” or “Lower Stop” adjacent to the row of blocking pins 723a or 724b. In embodiments according to FIG. 66C, ROM assembly 720 includes the markings of both FIGs.66A and 66B.

[0251] FIGs. 67A-67C illustrate various proposals for markings for embodiments of ROM-limiting assembly 720 having both of the first and second rows of blocking pins 723a, 723b on a same side. For example, in embodiments according to FIG.67A, ROM assembly 720 may include a pictorial representation of the brace with a dot on the ankle joint of the representation adjacent to each row of blocking pins 723a, 724b to indicate the adjustment pertains to the ankle joint of the brace. In embodiments according to FIG.67B, ROM assembly 720 may include indications of upper stop and lower stop, for example, “Upper Stop” and “Lower Stop” adjacent to each row of blocking pins 723a, 724b. In embodiments according to FIG.67C, ROM assembly 720 includes the markings of both FIGs.67A and 67B.

[0252] FIG.83 illustrates yet another embodiment for a ROM-limiting assembly 1620 for use in a brace 1600. Brace 1600 may comprise a lower leg shell 1610 substantially as described for any lower leg shell in this disclosure except as differently described here. Lower leg shell 1610 is pivotally coupled, at a distal end, to a foot shell 1630 substantially as described for any foot shell in this disclosure except as differently described here. Lower leg shell 1610 comprises a bar 1631 extending laterally between most distal edges of lower leg shell 1610. As shown in FIG. 83, bar 1631 is configured to extend underneath a posterior portion of the underside of foot shell 1630. An underside of foot shell 1630 comprises a recess 1621 having a plurality of equally spaced notches 1622 disposed in parallel sidewalls of recess 1621. In some embodiments, recess 1621 is rectangular shaped except for the additional notches 1622. Brace 1600 comprises a carrier 1625 having a plurality of protrusions 1626 extending from parallel sides of carrier 1625. Carrier 1625 is configured to fit within recess 1621 in any one of a plurality of different orientations where protrusions 1626 fit within two adjacent notches 1622 of recess 1621. Carrier 1625 also comprises a vice 1627 configured to receive bar 1631 therein. Carrier 1625 also comprises a plurality of screws that, when turned, open or close vice 1627, thereby, respectively releasing or locking vice 1627 around bar 1631. As shown in FIG.83, a desired degree of plantarflexion of the wearer’s foot (and orientationDONJOY.123WO PATENT of foot shell 1630 with respect to lower leg shell 1610) may be achieved by orienting foot shell 1630 with respect to lower leg shell 1610 as desired and placing carrier 1625 in recess 1621 so protrusions 1626 fit within the appropriate adjacent notches 1622 in recess 1621 such that bar 1631 is received in vice 1627. Turning screws 1628 then closes vice 1627 around bar 1631, locking brace 1600 in a configuration providing a desired degree of plantarflexion of the wearer’s foot (and orientation of foot shell 1630 with respect to lower leg shell 1610). As illustrated, such angles may be set in increments, for example increments of 10° between - 30° and +30°.

[0253] Discussion now turns to several alternative embodiments of wedge spacer assemblies for braces as described anywhere herein. For example, FIG.68 illustrates a brace 800 having a lower leg shell 810, foot shell 830 and outer sole assembly 840 substantially similar to any corresponding lower leg shell, foot shell and / or outer shole assembly as described anywhere in this disclosure, however, an underside of lower leg shell 810 and of foot shell 830 and a top surface of outer sole assembly 840 being specifically shaped and configured to receive a complementary shaped spacer wedge or wedge assembly 850 therebetween to, thereby, support lower leg shell 810 and of foot shell 830 arranged to provide the desired degree of plantarflexion to the foot of the wearer.

[0254] For example, as shown in FIGs.69A-69B, a wedge spacer assembly 850 may comprise one or more stackable wedge spacers 851. Each wedge spacer 851 may comprise a substantially planar bottom surface, except for a most posterior portion, which extends at an upward angle compared to the otherwise substantially planar bottom surface. Each wedge spacer 851 may also comprise a substantially planar top surface, except for a most posterior portion, which extends at an upward angle compared to the otherwise substantially planar top surface to form a ramp and / or lip 851a. This lip 851a and top surface are configured to mate with a complementary shaped bottom surface of either lower leg shell 810 and foot shell 830 or of a mating wedge spacer 851. The most posterior portions of the top and bottom surfaces of wedge spacer 851 extending at the above-described upward angle forms a ramp-like surface at the posterior end of each wedge spacer 851 that functions to hold, force and / or maintain the wedge spacer 851 in a fully anterior position in the spacing between lower leg shell 810 and foot shell 830 on the top and outer sole assembly 840 on the bottom. In some embodiments, the substantially planar top surface of wedge spacer 851 may further comprise a protrusion 851c configured to mate with the substantially planar bottom surface of a mating wedge 851 and / or of leg shell 810 or of foot shell 830. As also shown in FIG. 69B, wedge spacer 851 may comprise a plurality of recesses (e.g., hexagonally-shaped) disposed therein and / or therethrough (from the top surface to the bottom surface) in order to reduce a weight of and / or to reduce an amount of material required to construct wedge spacer 951.DONJOY.123WO PATENT

[0255] As another example, as shown in FIG.70, a wedge spacer assembly 850 may comprise one or more stackable wedge spacers 851 that, similarly, comprise a substantially planar bottom surface, except for the most posterior portion, which extends at an upward angle compared to the otherwise substantially planar bottom surface, and a substantially planar top surface, except for the most posterior portion, which extends at an upward angle compared to the otherwise substantially planar top surface to form the ramp and / or lip 851a configured to mate with the most posterior portion of the bottom surface of a mating wedge spacer 851 or of the bottom surface of lower leg shell 810. In some embodiments, the substantially planar top surface of wedge spacer 851 may further comprise a plurality of Lego-like circular, and in some embodiments tapering, protrusions 851d configured to mate with complementary shaped circular, and in some cases tapering, recesses 851e disposed in the substantially planar bottom surface of a mating wedge 851 and / or of leg shell 810 or foot shell 830.

[0256] As another example, as shown in FIG.71, a wedge spacer 851 may comprise a substantially planar bottom surface and a substantially planar top surface. The planar top surface comprises an aperture 851f having a specially-shaped cross section. Such an assembly 850 also comprises a locking post 859 comprising a bottom 859b having a shape complementary to the specially-shaped cross section of aperture 851f and a top having a protrusion 859a extending therefrom. In operation, bottom 859b of locking post 859 is inserted into aperture 851f and locking post 859 is rotated 90 degrees to, thereby, lock locking post 859 into aperture 851f. The bottom surface of wedge spacer 851 comprises a recess (not shown) having a shape complementary to that of protrusion 859a of locking post 859. Accordingly, when another wedge spacer 851 is stacked on a first wedge spacer 851 having locking post 859 appropriate installed therein, the protrusion 859a of locking post 859 of the first wedge spacer 851 fits into the mating recess in the bottom surface of the second wedge spacer 951, thereby securing the first and second wedge spacers 851 to one another. Once the desired number of wedge spacers 851 are stacked and secured to one another, the wedge spacer assembly 850 may be installed into the spacing between foot shell 830 and lower leg shell 810 on the top and outer sole assembly 840 on the bottom. Alternatively, each wedge spacer 851 and installed locking post 859 pair may be incrementally installed into either the bottom surface of foot shell 830 and lower leg shell 810 or into the top surface of outer sole assembly 840.

[0257] As another example, as shown in FIGs.72A-72B, a brace 900 may comprise a lower leg shell 910, foot shell 930 and outer sole assembly 940 substantially similar to that of brace 800 except as described differently below. A most distal central portion of lower leg shell 910 comprises an aperture 911 configured to receive a holding pin 951d for securing one or more wedge spacers 951 to brace 900 as shown in FIG.72A.DONJOY.123WO PATENT

[0258] For example, as shown in FIG. 72B, wedge spacer 951 may comprise a substantially planar bottom surface and a substantially planar top surface. In some embodiments, these surfaces meet at a nose of the wedge spacer 951 and diverge from one another by approximately 10°. Therefore, 3 such stacked wedge spacers 951 may offer an aggregate wedge angle of approximately 30°.

[0259] The planar top surface comprises a post 951a disposed centrally adjacent the posterior edge of the top surface. The planar bottom surface (and bottom surface of lower leg shell 910) each comprise a corresponding recess (not shown) having a complementary shape to that of post 951a, thereby allowing a nested fit between mating wedge spacers 951 and between the topmost wedge spacer 951 and lower leg shell 910. Post 951a comprises an aperture 951b through which holding pin 951d may be received to lock one or more wedge spacers 951 to a lower leg shell 910. The top surface of wedge spacer 951 also comprises a pair of brackets 951c configured to receive and hold a mating wedge spacer 951 therebetween when the wedge spacers 951 are properly mated.

[0260] As another example, as shown in FIGs.73A-73B, a brace 1000 may comprise a lower leg shell 1010, foot shell 1030 and outer sole assembly 1040 substantially similar to that of brace 800 except as described differently below. A most distal central portion of lower leg shell 1010 comprises a buckle 1011 configured to grasp and secure a bracket 1051a disposed centrally on a posterior side of a wedge spacer 1051. Similar to the wedge spacer 851 of FIG.71, wedge as shown in the cross-section of FIG.73B, spacer 1051 may comprise an aperture similar to aperture 851f configured to receive a locking post 1059 similar to locking post 859 as well as a mating aperture on the bottom surface thereof similar to that described for wedge spacer 851.

[0261] FIGs. 74A-75D illustrate brace 1100, similar to brace 1000, with a slightly different wedge spacer assembly 1150. As shown in FIG.74A, a posterior side of outer sole assembly 1140 may also comprise a bracket 1140a similar to bracket 1151a of wedge spacer 1151 from FIGs. 73A-73B, thereby allowing buckle 1111 to be secured directly to bracket 1140a of outer sole assembly 1140 when no spacers are utilized. And when one or more wedge spacers 1151 are utilized, buckle 1111 may be secured to bracket 1151a of the topmost wedge spacer 1151.

[0262] Turning to wedge spacers 1151 and FIGs. 75A-75D, wedge spacer 1151 comprises a substantially planar top surface and a substantially planar bottom surface, both surfaces meeting at a tip or “nose” of wedge spacer 1151 and being rotated, or offset, with respect to one another by approximately 10°. Accordingly, stacking 3 wedge spacers 1151 provides an aggregate wedge angle of approximately 30°. In some embodiments, wedge spacer 1151 comprises a plurality of recesses 1151b (e.g., hexagonally-shaped recesses) disposed therein and / or therethrough (from the top surface to the bottom surface) in order toDONJOY.123WO PATENT reduce a weight of and / or to reduce an amount of material required to construct wedge spacer 1151. Wedge spacer 1151 further comprises a slot 1151d disposed adjacent and parallel to the substantially planar top surface, slot 1151d extending from a posterior surface of wedge spacer inward toward the nose of wedge spacer 1151. In some embodiments, slot 1151d is a T-shaped slot, or an upside down T-shaped slot for example, configured to receive a complementary-shaped protrusion of a bottom surface of a mating wedge spacer 1151. Accordingly, the substantially planar bottom surface comprises such a complementary-shaped protrusion 1151c configured to slidingly engage with slot 1151d of a mating wedge spacer 1151, or with a similarly-shaped slot 1140c disposed adjacent and parallel to a top surface of outer sole assembly 1140. In some embodiments, protrusion 1151c comprises a T-beam form (or half of an I-beam form). FIG.75C illustrates a cutaway view of a plurality of wedge spacers 1151 stacked to for a 3-spacer assembly 1150, while FIG.75D illustrates a view of the stacked plurality of wedge spacers 1151 of FIG.75C from above.

[0263] Discussion now turns to various alternative embodiments of an outer sole assembly and / or associated solutions for protecting the open space between the elevated lower leg and foot shells and such outer sole assemblies. FIG. 76 illustrates a brace 1200 having a lower leg shell 1210 similar or identical to that previously described anywhere in this disclosure except as described differently below. Brace 1200 includes a foot shell 1230 pivotally coupled to a distal end of lower leg shell 1210. A most-distal, or most anterior, end of foot shell 1230 is hingedly coupled to a most-distal, or most anterior, end of an outer sole assembly 1240. Rather than having a ROM-limiting assembly disposed at the pivoting axis between foot shell 1230 and lower leg shell 1210, as shown in FIG.76, brace 1200 comprises a ROM-limiting assembly 1220 disposed underneath foot shell 1230 and lower leg shell 1210 and above outer sole assembly 1240. Rather than utilizing a wedge spacer assembly to support a spacing between foot shell 1230 and lower leg shell 1210 and outer sole assembly 1240, brace 1200 maintains this space as open, instead comprising a posterior bar 1250 fixedly coupled to a posterior side of outer sole assembly 1240 and configured to slide within a complementary slot 1211 disposed on a posterior side of lower leg shell 1210. As shown in FIG.76, brace 1200 further comprises a locking clip 1255 disposed on slot 1211. In operation, pulling locking clip 1255 out or away from brace 1200 unlocks posterior bar 1250 from slot 1211. Rotating locking clip 1255 by 90° frees posterior bar 1250 to slide within slot 1211. While locking clip 1255 is in this unlocked and free configuration, posterior bar 1250 may be slid within slot 1211 so as to rotate foot shell 1230 with respect to lower leg shell 1210 to provide the desired degree (or range of degrees) of plantarflexion of the foot of the wearer. Once the appropriate orientations of foot shell 1230 with respect to lower leg shell 1210 and foot shell 1230 with respect to outer sole assembly 1240 are obtained, locking clip 1255 may be rotatedDONJOY.123WO PATENT back 90° to restrict the ability of posterior bar 1250 to slid within slot 1211 and then push locking clip 1255 toward brace 1200 to lock posterior bar 1250 within slot 1211. As shown in FIG. 76, opening the angle between foot shell 1230 and outer sole assembly 1240 allows access to the buttons of ROM-limiting assembly 1220.

[0264] FIG. 77 illustrates an alternative lightweight, compact embodiment of a foot shell 1330 and outer sole assembly 1340, according to some example embodiments. For example, foot shell 1330 is configured to receive the entire foot of the wearer. The anterior portion of an underside of foot shell 1330 comprises a curved, or cammed, surface 1331 extending substantially from a portion of foot shell 1330 configured to be directly under the ball of the foot of the wearer to the front edge of foot shell 1330. An outer sole blade 1342 is adjustably, pivotally coupled to an underside of foot shell 1330 directly under a position where the ball of the foot of the wearer is configured to rest. For example, to support a desired degree of plantarflexion of the foot of the wearer, outer sole blade 1342 may be adjusted and fixed about a hinge or pivot point 1334 to as to extend away from hinge 1334 at an angle related to the desired degree of plantarflexion. In some embodiments, outer sole blade 1342 comprises a metal, such as stainless steel or titanium. In other embodiments, outer sole blade 1342 may comprise a high-density plastic, or carbon fiber for added strength.

[0265] FIGs. 78A-78B illustrate side and partial perspective views of a brace 1400 having a foot shell and outer sole assembly similar to that of FIG.77. For example, as shown in FIG.78A, brace 1400 comprises a lower leg shell 1410 substantially as previously described anywhere in this disclosure. Foot shell 1430 is pivotally coupled to a distal end of lower leg shell 1410. The anterior portion of an underside of foot shell 1430 comprises a curved, or cammed, surface 1431 extending substantially from a portion of foot shell 1430 configured to be directly under the ball of the foot of the wearer to the front edge of foot shell 1430. An outer sole blade 1442 is adjustably, pivotally coupled to an underside of foot shell 1430 directly under a position where the ball of the foot of the wearer is configured to rest. For example, to support a desired degree of plantarflexion of the foot of the wearer, outer sole blade 1442 may be adjusted and fixed about a hinge or pivot point 1434 to as to extend away from hinge 1434 at an angle related to the desired degree of plantarflexion. In some embodiments, outer sole blade 1442 comprises a metal, such as stainless steel or titanium. In other embodiments, outer sole blade 1442 may comprise a high-density plastic, or carbon fiber for added strength. In some embodiments, for example as shown in FIG. 78B, blade 1442 may comprise an “S” shaped curvature as it extends away from hinge 1434, for example bowing upward from hinge 1434, then curving to bow downward and finally curving back up.

[0266] However, such embodiments result in an open space between the underside of foot shell 1430 and blade 1442 or any such outer sole assembly in general. Accordingly,DONJOY.123WO PATENT FIGs.79A-81B illustrate various concepts for protecting such an open space from entry of dirt and / or other foreign matter.

[0267] FIGs. 79A-79B illustrate brace 1400 where lower leg shell 1410 further comprises a hook 1412 centrally extending from a posterior, distal end of lower leg shell 1410. Hook 1412 is configured to partially block a posterior opening between lower leg shell 1410 and foot shell 1430 and provide an impediment to any foreign object or matter from entering brace through such a posterior opening or open space.

[0268] FIGs. 80A-80B illustrate a portion of brace 1400 wherein brace 1400 further comprises an elastomeric member or sheet 1450 fixed between an underside of foot shell 1430 and a posterior edge of blade 1442. When so fixed, elastomeric sheet 1450 blocks the primary potential posterior entry point for foreign matter between the underside of foot shell 1430 and blade 1442a.

[0269] FIGs. 81A-81B illustrate a portion of brace 1400 wherein brace 1400 further comprises an elastomeric spacer 1550 disposed between an underside of foot shell 1430 and a posterior edge of blade 1442. Elastomeric spacer 1550 comprises a plurality of spaced elastomeric baffles 1551, each configured to bend and distort as the weight of the wearer exerted on brace 1400 causes blade 1442 to flex toward foot shell 1430. By displacing the open space between the underside of foot shell 1430 and blade 1442a, elastomeric spacer 1550 prevents foreign matter from entering the open space.

[0270] Turning to FIG.82, embodiments of a brace as contemplated by this disclosure need not comprise an outer sole blade or any other foot shell / outer sole assembly that results in an open space therebetween whatsoever. For example, a brace may comprise a foot shell 1530 as shown in FIG.82, an anterior portion of an underside of which may include a curved, or cammed, outer under surface 1531 extending from a front edge of foot shell 1530 approximately half way to a posterior edge of foot shell 1530. The remaining posterior portion of the underside of foot shell 1530 may be configured to receive any of a plurality of differently sized posterior outer sole components 1540a, 1540b, which may each have a same sized front face (e.g., so as to ensure all such components match up flush with a mating posterior surface of surface 1531) but may have a different shaped outer sole so as to provide a substantially horizontal outer sole bottom surface when the wearer is standing in the brace.

[0271] Discussion now turns to several alternative embodiments of braces having different functional ways of closing the braces. For example, in embodiments according to FIGs. 1A-4, a shin cover 160 is completely separate from a forefoot cover 170, which is completely separate from a lower leg shell 110. However, FIG. 84 illustrates a brace 1700 having a lower leg shell 1710, a foot shell 1730 and outer sole assembly 1740 substantially similar to any corresponding lower leg shell, foot shell and / or outer shole assembly asDONJOY.123WO PATENT described anywhere in this disclosure. However, in the embodiment of FIG.84, shin cover 160 and forefoot cover 170 may be integrated and manufactured as a physically unitary front cover 1760 hingedly coupled, at a most anterior edge, to foot shell 1730 at or adjacent to a most anterior edge thereof.

[0272] FIGs. 85A-85B illustrates a brace 1800 having a lower leg shell 1810, a foot shell 1830 and outer sole blade 1842 substantially similar to that previously described in connection with FIGs.78A-78B, however, instead of having separate shin and / or foot covers, a front of lower leg shell 1810 integrates, into a single structure, the lower leg shell and shin and foot covers (e.g., covering the shin and forefoot of the wearer itself) and, instead, having an open back that allows the wearer to enter the brace from the rear.

[0273] In embodiments according to FIGs.1A-4, brace 100 is secured to the wearer using a multi-strap 102, 104, 106 system. However, FIGs.86-87 illustrate braces 1800, 1900 utilizing one or more reel and lace systems for securing the braces to the wearer. For example, in FIG.86, brace 1800 utilizes a first lace 1802a strung between a plurality of lace brackets 1802c disposed on opposing edges of lower leg shell 1810. A first reel 1802b is coupled to shin cover 1860 and configured to rotate and, thereby, tighten or loosen lace 1802a and secure lower leg shell 1810 around the wearers lower leg. Brace 1800 also utilizes a second lace 1804a strung between a plurality of lace brackets 1804c disposed on opposing edges of foot shell 1830. A second reel 1804b is coupled to forefoot cover 1870 and configured to rotate and, thereby, tighten or loosen lace 1804a and secure foot shell 1830 around the wearers foot.

[0274] Alternatively, in FIG.87, brace 1900 utilizes a first lace 1902a strung between a plurality of lace brackets 1902c disposed on opposing edges of lower leg shell 1910 and of foot shell 1930. A first reel 1902b is coupled to shin cover 1960 and configured to rotate and, thereby, tighten or loosen lace 1902a and secure lower leg shell 1910 around the wearers lower leg and secure foot shell 1930 around the wearers foot.

[0275] Language for several embodiments of a lower leg brace, at least as described above, are disclosed below. Embodiment 1 of a lower leg brace configured to support a wearer’s foot in a desired range of angles of plantarflexion comprises: a lower leg shell 110 configured to wrap around at least a posterior and sides of a lower leg of the wearer; a foot shell 130,130a pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell to, thereby, set the wearer’s foot in the desired range of angles of plantarflexion; a range of motion (ROM) limiting assembly 120a coupled to the lower leg shell and configured to set an upper limit and a lower limit for the desired range of angles of plantarflexion; and an outer sole assembly 140 hingedly coupled to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace: the brace isDONJOY.123WO PATENT configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell.

[0276] Embodiment 2, a sub-embodiment of embodiment 1, further comprising a wedge spacer assembly 150 configured to be disposed between the foot shell and the outer sole assembly, the wedge spacer assembly comprising: a plurality of wedge spacers 151; and a plurality of locking plates 155, each configured to lock a wedge spacer to an adjacent wedge spacer or to an underside of the foot shell.

[0277] Embodiment 3, a sub-embodiment of embodiment 2, wherein each of the plurality of wedge spacers is defined by: a first planar surface; and a second surface offset from first surface by a predetermined angle θ1, wherein the second surface comprises: a first planar portion 153a, and a second planar portion 153b recessed or offset compared to the first planar portion by a thickness of the locking plate, the second planar portion corresponding to a footprint of the locking plates such that, when a locking plate is disposed on the second planar portion, an outward facing surface of the locking plate is coplanar with the first planar portion.

[0278] Embodiment 4, a sub-embodiment of embodiment 3, wherein the first planar surface of each wedge spacer comprises: a first protrusion 154e configured to mate with a first recess 154d disposed in the first portion of the second surface of a mating wedge spacer; and a post 154f configured to mate with a second recess 154c disposed in the second portion of the second surface of the mating wedge spacer.

[0279] Embodiment 5, a sub-embodiment of embodiment 4, wherein the second planar surface of each wedge spacer comprises: a first recess 154d disposed in the first planar portion and configured to receive a protrusion 154e disposed on the first planar surface of a mating wedge spacer; a first post 154a disposed on the second planar portion and configured to mate with a first aperture 156a in a mating locking plate; a second post 154b disposed on the second planar portion and configured to mate with a first arcuate slot 156b in the mating locking plate; and a second recess 154c disposed in the second planar portion and configured to receive a post 154f disposed on the first planar surface of the mating wedge spacer.

[0280] Embodiment 6, a sub-embodiment of embodiment 5, wherein each locking plate comprises: a first aperture 156a configured to receive a first post 154a disposed on the second planar portion of a first mating wedge spacer; a first arcuate slot 156b configured to receive a second post 154b disposed on the second planar portion of the first mating wedge spacer; and a second arcuate slot 156c configured to receive a post 154f disposed on the first planar surface of the first mating wedge spacer therethrough, the post 154f disposed on the first planar surface of the first mating wedge spacer being configured to further extend into aDONJOY.123WO PATENT mating second recess 154c disposed in the second planar portion of a second mating wedge spacer disposed on an opposite side of the locking plate from the first mating wedge spacer.

[0281] Embodiment 7, a sub-embodiment of embodiment 2, wherein an outer perimeter of each locking plate has a same outer perimeter as the second portion of the wedge spacers such that, when the locking plate is properly secured to a wedge spacer 151, the outer perimeter of the locking plate and a mating outer perimeter of the wedge spacer are coextensive.

[0282] Embodiment 8, a sub-embodiment of embodiment 1, wherein at least one side of the lower leg shell comprises: an aperture through which a respective side of the foot shell is pivotally coupled to the lower leg shell; and an arcuate slot adjacent the aperture configured to receive therethrough a post extending from the side of the foot shell such that, when the foot shell is rotated with respect to the lower leg shell, the respective post slides along the arcuate slot of the lower leg shell.

[0283] Embodiment 9, a sub-embodiment of embodiment 8, wherein the ROM-limiting assembly comprises: a rotatable ROM dial comprising: a central aperture configured to receive a rivet that also pivotally couples the foot shell to the lower leg shell, the ROM dial configured to rotate about the central aperture; and at least one arcuate slot configured to receive the post extending from the respective side of the foot shell, wherein an overlap between the arcuate slot of the lower leg shell and the arcuate slot of the ROM dial defines a range of travel through which the post can freely slide and the range of angles of plantarflexion.

[0284] Embodiment 10, a sub-embodiment of embodiment 1, wherein the outer sole assembly comprises an outer sole 142 coupled to a soft sole 144.

[0285] Embodiment 11, a sub-embodiment of embodiment 10, wherein the outer sole assembly is configured to maintain a bottom surface of the soft sole 144 substantially parallel to the ground when the wearer is standing regardless of the degree of plantarflexion of the wearer’s foot.

[0286] Embodiment 12, a sub-embodiment of embodiment 10, wherein the soft sole comprises: an anterior portion 144a configured to support the toes and the ball of the foot of the wearer, the anterior portion being sufficiently flexible to flex during a toe-off phase of a gait of the wearer, thereby providing a natural gait for the wearer during ambulation in the brace; and a posterior portion 144b configured to receive the outer sole.

[0287] Embodiment 13, a sub-embodiment of embodiment 10, wherein the foot shell comprises at least one hinge aperture 134a and a front edge of the outer sole comprises at least one hinge aperture 142a, each configured to receive a metallic hinge axle therethrough, such that the outer sole assembly is hingedly coupled to the foot shell at the metallic hinge axle.DONJOY.123WO PATENT

[0288] Embodiment 14, a sub-embodiment of embodiment 1, further comprising a shin cover 160 configured to be disposed against an anterior portion of the wearer’s lower leg in any one of a plurality of vertically translated positions that depend on the angle of plantarflexion of the wearer’s foot.

[0289] Embodiment 15, a sub-embodiment of embodiment 14, wherein the shin cover comprises: a first slot 162 centrally disposed on an upper portion of the shin cover and configured to receive a first strap 102; and a second slot 163 centrally disposed on a lower portion of the shin cover and configured to receive a second strap 104.

[0290] Embodiment 16, a sub-embodiment of embodiment 14, wherein the shin cover comprises one or more fasteners 164 disposed on a wearer-facing surface of the shin cover and configured to secure one side of a flexible junction 165.

[0291] Embodiment 17, a sub-embodiment of embodiment 16, further comprising a forefoot cover 170, separate from the shin cover, configured to be disposed against the wearer’s forefoot.

[0292] Embodiment 18, a sub-embodiment of embodiment 17, wherein the forefoot cover comprises: a slot 172 configured to receive a foot strap 106; and a living hinge 175 extending between lateral edges at approximately the midpoint between a front edge and a rear edge of the forefoot cover.

[0293] Embodiment 19, a sub-embodiment of embodiment 18, wherein the forefoot cover comprises one or more fasteners 174 disposed on a wearer-facing surface of the forefoot cover and configured to secure another side of the flexible junction such that the flexible junction elastically couples the shin cover to the forefoot cover.

[0294] Embodiment 20, a sub-embodiment of embodiment 1, further comprising an adjustable, inflatable liner configured to provide multiple adjustable zones of pressure and support to different portions of the lower foot of the wearer.

[0295] Embodiment 21, a sub-embodiment of embodiment 20, wherein: the lower leg shell comprises a fluid pump 181 and a rotatable dial 182 configured to select one or more of the multiple adjustable zones portions for selective inflating and / or deflating; and the adjustable, inflatable liner comprises: a first adjustable, inflatable liner portion 180 configured to be disposed against the inner facing surfaces of lower leg shell; and a second adjustable, inflatable liner portion 190 configured to be disposed against the inner facing surface(s) of the shin cover of the forefoot cover.

[0296] Embodiment 22, a sub-embodiment of embodiment 21, wherein the first adjustable, inflatable liner portion comprises one or more of: a first lower distal air cell 184a configured to be disposed against a distal portion of one side of the lower leg of the wearer; a second lower distal air cell 184b configured to be disposed against a distal portion of the other side of the lower leg of the wearer; a first upper distal air cell 185a configured to be disposedDONJOY.123WO PATENT against a side portion of the one side of the lower leg of the wearer proximal of the ankle; a second upper distal air cell 185b configured to be disposed against a side portion of the other side of the lower leg of the wearer just proximal of the ankle; a lower posterior air cell 186 configured to be disposed against a posterior portion of the lower leg at the ankle of the wearer; and an upper posterior air cell 187 configured to be disposed against the posterior portion of the lower leg at the calf and Achilles tendon.

[0297] Embodiment 23, a sub-embodiment of embodiment 22, wherein the posterior air cell 186 has a “U” shape.

[0298] Embodiment 24, a sub-embodiment of embodiment 22, wherein the posterior air cell 186 comprises two parallel vertical cells configured to be disposed adjacent each side of the Achilles tendon of the wearer.

[0299] Embodiment 25, a sub-embodiment of embodiment 1, further comprising a toe liner 187e configured to cover the toes and forefoot of the wearer’s foot, the toe liner comprising: a base portion 187d on which a cushioned insole 188 is disposed; a right flap 187a, a left flap 187b, and a front flap 187c, each configured to be wrapped and / or disposed over the toes and forefoot of the wearer’s foot.

[0300] Additional Embodiments of An Orthopedic Brace

[0301] FIGs.90-108 illustrate yet another orthopedic walking brace 2000 for a lower leg of a wearer, according to example embodiments of the present disclosure. For example, FIG. 90 illustrates a rear right perspective view of brace 2000, which further illustrates a magnified portion of brace 2000. FIG.91 illustrates a rear view of brace 2000. FIGs. 92-96 illustrate various left perspective views of at least a portion of brace 2000. FIG.97 illustrates a bottom and related side view of a wedge spacer 2051 for use in brace 2000, while FIG.98 illustrates a top and related perspective view of the wedge spacer 2051 of FIG.97. FIG.99 illustrates a left perspective view of a foot shell 2030 of brace 2000. FIG.100 illustrates brace 2000 accepting a wedge spacer 2051, while FIG.101 illustrates brace 2000 with the wedge spacer 2051 properly installed. FIGs.102 and 103 illustrate various rear perspective views of brace 2000 accepting a plurality of wedge spacers 2051, while FIGs.104-106 illustrate brace 2000 with the plurality of wedge spacers 2051 properly installed. And FIGs. 107 and 108 illustrate various embodiments of a front panel assembly 2075 for brace 2000.

[0302] Turning to FIGs.90-96, for example, brace 2000 comprises a lower leg shell 2010. Lower leg shell 2010 is configured to wrap around and provide support for at least a posterior portion of the lower leg of a wearer (e.g., a calf and Achilles tendon region of the wearer). Lower leg shell 2010 may be configured to generally follow the contours of the lower leg of the wearer, for example, being wider at the top, adjacent to where the wearer’s calf would be disposed, tapering to a narrower dimension toward the middle-bottom, adjacent toDONJOY.123WO PATENT where the narrowest part of the wearer’s lower leg would be disposed, and flaring out to a relatively wider dimension again at the bottom, adjacent to where the malleolus of the wearer’s ankle would be disposed. Lower leg shell 2010 may comprise a plastic material, such as polypropylene. However, the present disclosure is not so limited and also / alternatively contemplates lower leg shell 2010 and / or any other element of brace 2000 being manufactured of another material, for example polyamide and / or polyamide + glass fiber. In some embodiments, brace 2000 may be offered in a variety of sizes, to accommodate a wider range of sizes of wearers. In some such embodiments, lower leg shell 2010 may be manufactured to have different sizes corresponding to different sized braces 2000. For example, brace 2000 may be manufactured in one or more of an extra-small (XS), small (S), medium (M), large (L) and extra-large (XL) sizes, where an XS brace 2000 utilizes a lower leg shell 2010 having around 88% of the size of the medium brace 2000, an S brace 2000 utilizes a lower leg shell 2010 having about 93% of the size of the medium brace 2000, an L brace 2000 utilizes a lower leg shell 2010 having approximately 108% of the size of the medium brace 2000 and an XL brace 2000 utilizes a lower leg shell 2010 having about 119% of the size of the medium brace 2000.

[0303] In some embodiments, lower leg shell 2010 comprises a plurality of windows (not shown, but see, e.g., windows 111 of brace 100) configured to provide breathability to the lower leg of the user disposed therein. In some embodiments, lower leg shell 2010 may further function as a platform for securing other components of brace 2000, comprising one or more slots configured to receive one or more straps, and one or more apertures and / or recesses for receiving such other components. For example, while not shown in FIGs. 90-108, in some embodiments, lower leg shell 2010 may comprise an aperture or recess (see, e.g., recess 113 disposed near a top of lower leg shell 110) configured to receive a pump for selectively inflating and / or deflating portions the above-mentioned adjustable, inflatable liner. Similarly, lower leg shell 2010 may comprise an aperture or recess (see, e.g., recess 114 disposed near a middle of lower leg shell 110) configured to receive a dial and / or a fluid manifold for selectively inflating and / or deflating portions of the above-mentioned adjustable, inflatable liner. In some embodiments, such an aperture or recess corresponding to recess 113 of brace 100 may be on a same side of lower leg shell 2010 as the aperture or recess corresponding to aperture or recess 114 so as to ensure easy adjustment of the inflating and / or deflating of the portions of the above-mentioned adjustable, inflatable liner using the same hand of the wearer.

[0304] Brace 2000 comprises a foot shell 2030 pivotally coupled to lower leg shell 2010. Foot shell 2030 is configured to rotate in relation to lower leg shell 2010, for example about a post or an axle 2031 extending along an axis 2031a. Such a post or axle 2031 may extend from respective coaxial locations on the left and right sides of foot shell 2030 and such posts or axles 2031 may nest or rest within and / or extend through apertures of lower leg shellDONJOY.123WO PATENT 2010, thereby, allowing the adjustment of a desired angle of the wearer’s ankle joint, at the malleolus and about an axis of rotation coextensive with post or axles 2031, when the wearer’s lower leg is properly disposed within brace 2000. Post(s) 2031 may be formed of any suitably rigid material, for example, plastic or metal.

[0305] However, the present disclosure is not so limited and the arrangement may also be the reverse of that disclosed above, for example, such posts or axles 2031 may extend from the left and right sides of lower leg shell 2010 and nest or rest within and / or extend through apertures of foot shell 2030, thereby, allowing the same adjustment of the desired angle of the wearer’s ankle joint, at the malleolus and about the axis of rotation coextensive with post or axles 2031, when the wearer’s lower leg is properly disposed within brace 2000.

[0306] A distal or anterior edge or end of foot shell 2030 is hingedly coupled to an outer sole assembly 2040, for example about a post or an axle 2041 coextensive with an axis 2041a. Such a post or axle 2041 may extend from respective coaxial locations on the left and right sides of outer sole assembly 2040 and such posts or axles 2031 may nest or rest within and / or extend through apertures of foot shell 2030, thereby, allowing a desired orientation of ground contact surfaces of outer sole assembly 2040 when the wearer’s lower leg is properly disposed within brace 2000 and the desired angle of the wearer’s ankle joint is established.

[0307] However, the present disclosure is not so limited and the arrangement may also have any other form that provides substantively the same operation, for example, the reverse of that disclosed above, where such posts or axles 2041 extend from the left and right sides of foot shell 2030 and nest or rest within and / or extend through apertures of outer sole assembly 2040, thereby, allowing the same desired orientation of ground contact surfaces of outer sole assembly 2040 when the wearer’s lower leg is properly disposed within brace 2000 and the desired angle of flexion or extension of the wearer’s ankle joint is established.

[0308] Alternatively, post or axle 2041 may comprise a metallic rod extending transversely across the width of outer sole assembly 2040 and / or of foot shell 2030 about which outer sole assembly 2040 and foot shell 2030 pivot with respect to one another.

[0309] Accordingly, when a wearer’s foot is properly disposed in brace 2000, the toes and ball of the foot are disposed on a distal or anterior portion of outer sole assembly 2040 and portions of the foot proximal or posterior of the ball of the foot are disposed on foot shell 2030. Accordingly, brace 2000 is configured to hinge at the ball of the foot of the wearer instead of at a most-distal end of the toes of the wearer.

[0310] Outer sole assembly 2040 may comprise an outer sole coupled to a soft sole, for example EVA or a similarly pliable material, as previously described in connection with at least FIGs.23A-26 and / or 89A-89B. Such an outer sole assembly is configured to maintain a neutral orientation of the bottom surface of the soft sole (e.g., substantially parallel to theDONJOY.123WO PATENT ground) when the wearer is standing, regardless of the angle of plantar flexion of the wearer’s foot at the ankle joint (e.g., at any degree of plantarflexion or dorsiflexion).

[0311] As will be described in more detail below, in connection with at least FIGs.97- 106, brace 2000 is also configured to receive one or more interlocking wedge spacers 2051 in a space formed between an underside of foot shell 2030 and a top surface of outer sole assembly 2040 when the angle of rotation between outer sole assembly 2040 and foot shell 2030, about an axis extending through posts or axles 2041, is increased above substantially zero degrees.

[0312] To establish or set a desired angle of plantar flexion of the wearer’s foot at the ankle joint, brace 2000 comprises a range of motion (ROM) limiting assembly 2020. ROM limiting assembly 2020 is configured to allow the setting of separate upper and lower limits on the angle of plantarflexion and / or dorsiflexion of the wearer’s foot at the ankle joint that is allowed when the user’s lower leg is properly secured within brace 2000. Accordingly, when the upper and lower limits are set to substantively the same angle, the ROM limiting assembly 2020 acts to lock brace 2000 at the set angle of plantar- or dorsi-flexion of the wearer’s foot at the ankle joint.

[0313] ROM limiting assembly 2020 comprises an upper adjustable stirrup 2021 for setting the upper limit on the angular range of plantar- or dorsi-flexion of the wearer’s foot at the ankle joint that is allowed when the user’s lower leg is properly secured within brace 2000. ROM limiting assembly 2020 also comprises a lower stirrup 2022 for setting the lower limit for the angular range of plantar- or dorsiflexion flexion of the wearer’s foot at the ankle joint that is allowed when the user’s lower leg is properly secured within brace 2000.

[0314] As best illustrated in at least FIGs.90 and 92-96, upper adjustable stirrup 2021 and lower adjustable stirrup 2022 both rotate about axis 2031a, which may be the same axis about which foot shell 2030 is configured to rotate with respect to lower leg shell 2010. Accordingly, upper and lower adjustable stirrups 2021, 2022 pivot or rotate about a heel area of brace 2000 and not outer sole assembly 2040. For example, upper adjustable stirrup 2021 may extend substantially posteriorly from axis 2031a along one side of lower leg shell 2010, then may extend transversely across a posterior portion of lower leg shell 2010 (e.g., a distal posterior portion), and then extend anteriorly toward axis 2031a on the other side of lower leg shell 2010 so as to create the stirrup shape that is rotatable about axis 2031a. As upper adjustable stirrup 2021 rotates about axis 2031a, the transversely-extending portion of upper adjustable stirrup 2021 may rotate up and down along a curved posterior portion of low leg shell 2010. Similarly, lower adjustable stirrup 2022 may extend substantially posteriorly from axis 2031a along one side of lower leg shell 2010, then may extend transversely across a posterior portion of lower leg shell 2010 (e.g., a distal posterior portion), below upper adjustable stirrup 2021, and then extend anteriorly toward axis 2031a on the other side ofDONJOY.123WO PATENT lower leg shell 2010 so as to create the stirrup shape that is rotatable about axis 2031a. As lower adjustable stirrup 2022 rotates about axis 2031a, the transversely-extending portion of lower adjustable stirrup 2022 may rotate up and down along the curved posterior portion of low leg shell 2010, below upper adjustable stirrup 2021.

[0315] To set the upper and lower adjustable limits for rotation of foot shell 2030 with respect to lower leg shell 2010, the posterior portion of lower leg shell 2010 comprises at least one toothed track 2014, 2016, over which the transversely-extending portions of upper and lower adjustable stirrups 2021,2022 are configured to move as the stirrups are rotated about axis 2031a. The embodiment shown in FIGs.94-96 illustrates two such toothed tracks, a first toothed track 2014 extending substantially vertically and disposed to a left side of the posterior portion of lower leg shell 2010, and a second toothed track 2016 extending substantially vertically and disposed to a right side of the posterior portion of lower leg shell 2010. Having first and second toothed tracks 2014, 2016 disperses the load placed on locking assembly 2020 when brace 2000 is in use, thereby allowing for a stronger, more robust, and more durable locking assembly 2020. While FIGs. 90-93 do not illustrate tracks 2014, 2016 for simplified viewing, it is noted that brace 2000 includes one or both of tracks 2014, 2016.

[0316] Upper adjustable stirrup 2021 comprises an upper stop 2023 configured to adjustably secure upper adjustable stirrup 2021 to lower leg shell 2010. For example, upper stop 2023 may comprise at least one tooth configured to be disposed in any one of a plurality of positions along first toothed track 2014 of lower leg shell 201 and at least one tooth configured go be disposed in any corresponding one of a plurality of positions along second toothed track 2016. To toggle upper stop 2023 between an unlocked orientation and a locked orientation, upper stop 2023 may be translated toward and away from upper adjustable stirrup 2021 (e.g., radially toward and / or away). For example, when upper stop 2023 is translated away from upper adjustable stirrup 2021, the teeth of upper stop 2023 are pulled sufficiently away from toothed track 2014 to clear toothed track 2014 and allow upper adjustable stirrup 2021 to be rotated about axis 2031a to align with another of the plurality of positions along first and second toothed tracks 2014,2016. When upper stop 2023 is translated sufficiently toward upper adjustable stirrup 2021, the teeth are pushed into the currently aligned positions along first and second toothed tracks 2014,2016, thereby locking upper adjustable stirrup 2021 at a position corresponding to an upper limit for the allowed degree of plantarflexion and / or dorsiflexion of the wearer’s ankle. In some embodiments, upper stop 2023 may be spring- biased such that a default position of upper stop 2023 is the above-described locked position. However, the present disclosure is not so limited and also contemplates embodiments in which upper stop 2023 is formed with one or more mechanical restrictions configured to generateDONJOY.123WO PATENT friction and prevent undesired unlocking of upper stop 2023 at an inopportune, or otherwise undesired time.

[0317] Similarly, lower adjustable stirrup 2022 comprises a lower stop 2024 configured to adjustably secure lower adjustable stirrup 2022 to lower leg shell 2010. For example, lower stop 2024 may comprise at least one tooth configured to be disposed in any one of the plurality of positions along first toothed track 2014 of lower leg shell 201 and at least one tooth configured go be disposed in any corresponding one of the plurality of positions along second toothed track 2016. To toggle lower stop 2024 between an unlocked orientation and a locked orientation, lower stop 2024 may be translated toward and away from lower adjustable stirrup 2022. For example, when lower stop 2024 is translated away from lower adjustable stirrup 2022, the teeth of lower stop 2024 are pulled sufficiently away from toothed track 2014 to clear toothed track 2014 and allow lower adjustable stirrup 2022 to be rotated about axis 2031a to align with another of the plurality of positions along first and second toothed tracks 2014,2016. When lower stop 2024 is translated sufficiently toward lower adjustable stirrup 2022, the teeth are pushed into the currently aligned positions along first and second toothed tracks 2014,2016, thereby locking lower adjustable stirrup 2022 at a position corresponding to a lower limit for the allowed degree of plantarflexion and / or dorsiflexion of the wearer’s ankle. In some embodiments, lower stop 2024 may be spring-biased such that a default position of lower stop 2024 is the above-described locked position. However, the present disclosure is not so limited and also contemplates embodiments in which lower stop 2024 is formed with one or more mechanical restrictions configured to generate friction and prevent undesired unlocking of lower stop 2024 at an inopportune, or otherwise undesired time.

[0318] Each side of lower leg shell 2010 (e.g., each of the left and right side) also comprises an arcuate slot 2012 within which a post 2025 is configured to slide or translate. A center of curvature of arcuate slots 2012 may be axis 2031a, and post(s) 2025 may extend laterally away from the left and right sides of foot shell 2030 and through respective arcuate slots 2012 such that, when foot shell 2030 is rotated with respect to lower leg shell 2010 about axis 2031a, each post 2025 translates along its respective arcuate slot 2012. In some embodiments, to ensure the transversely-extending portions of upper and lower adjustable stirrups 2021, 2022 maintain a substantially constant spacing from the curved posterior portion of lower leg shell 2010, a radius of curvature of at least the portion of the curved posterior portion of lower leg shell 2010 over which stirrups 2021,2022 are configured to rotate may be substantially constant and may also have a center of curvature at axle 2031.

[0319] As best illustrated in FIG. 94, each posteriorly-extending portion of upper adjustable stirrup 2021 may also comprise an upper notch 2021a configured to contact the respective post 2025 on that side of brace 2000 when the foot shell 2030 is rotated sufficiently in a direction associated with plantarflexion of the ankle joint to reach the upper limit set byDONJOY.123WO PATENT upper adjustable stirrup 2021. Similarly, each posteriorly-extending portion of lower adjustable stirrup 2022 may comprise a lower notch 2022a configured to contact the respective post 2025 on that side of brace 2000 when the foot shell 2030 is rotated sufficiently in a direction associated with dorsiflexion (or in a direction opposite of that associated with plantarflexion) of the ankle joint to reach the lower limit set by lower adjustable stirrup 2022. In FIGs.94-96, posts 2025 have a rectangular cross-section having rounded corners (e.g., a substantially pill shaped cross-section). And notches 2021a,2022a may each have complementary, substantially semi-circular form factors such that when the transversely-extending portions of upper and lower adjustable stirrups 2021,2022 are set directly (or immediately) against one another, notches 2021a,2022a are disposed immediately adjacent to one another with post 2025 immobilized therebetween. In this way, brace 2000 is not just configured to limit the range of motion of the wearer’s ankle between separately adjustable upper and lower limits, brace 2000 is also configured to substantially completely immobilize the wearer’s ankle at any one of those adjustable limits. Such features are both useful and desirable for rehabbing both Achilles tendon injuries and lower leg fractures.

[0320] However, the present disclosure is not so limited and brace 2000 is also, or alternatively, contemplated to include an alternative ROM adjustment assembly comprising a slightly different construction, for example, as previously described in connection with any of FIGs.1-89.

[0321] Brace 2000 further comprises a wedge spacer system 2050 that is configured to receive one or more interlocking wedge spacers 2051 in a space formed between an underside of foot shell 2030 and a top surface of outer sole assembly 2040 when the angle between outer sole assembly 2040 and foot shell 2030, about an axis extending through posts or axles 2041, is increased above substantially zero degrees. Accordingly, wedge spacer system 2050, as with all wedge spacers and wedge spacer systems described herein, operates to support a particular degree or range of degrees of plantarflexion of the wearer’s ankle externally of lower leg shell 2010 and / or foot shell 2030. In other words, wedge spacer system 2050 is not disposed within a same cavity as the foot of the wearer and is, instead, disposed entirely outside of any cavity in which the foot of the wearer is disposed when brace 2000 is properly donned. Moreover, wedge spacers 2051, as described herein, are discrete, rigid, and stackable (e.g., slidably coupleable) components. Wedge spacers 2051 are not “soft” in the cushioning sense and, so, are not tearable nor designed to be trimmed so as to modify their shape, size and / or profile as can be distinguished from prior art braces which may include a wedge to adjust the height of an insole within the cavity of the foot portion of a brace.

[0322] Wedge spacer system 2050 comprises one or more wedge spacers 2051 that are couplable between the underside of foot shell 2030 and the top surface of outer sole assembly 2040 utilizing proprietary slots and complementary rails respectively disposed onDONJOY.123WO PATENT the top and bottom of each wedge 2051 as well as on the underside of foot shell 2030 and on the top surface of outer sole assembly 2040. In combination with ROM limiting system 2020, cooperation of wedge spacer system 2050 with both outer sole assembly 2040 and foot shell 2030 allows the wearer’s foot to be set, maintained and comfortably supported with the ankle in any one of a plurality of desired angles of plantar flexion. Such an ability is particularly desirable for treating Achilles tendon injuries as well as lower leg bone breaks.

[0323] Discussion now turns to an example wedge spacer 2051, as illustrated in FIGs. 97 and 98. Discussion then turns to example manners in which such wedge spacer(s) 2051 may be utilized in wedge spacer system 2050.

[0324] FIG.97 illustrates a bottom and related side view of an example wedge spacer 2051, while FIG.98 illustrates a top and related perspective view of wedge spacer 2051 of FIG.97, to more completely illustrate its features. Wedge spacer 2051 comprises a bottom surface 2051a and a top surface 2051b. Bottom surface 2051a is planar. Top surface 2051b is also planar but offset by an angle θ1with respect to bottom surface 2051a. The offset angle θ1 is illustrated as being 15° in FIGs. 97 and 98. However, the present disclosure is not so limited and contemplates the use of any one or more wedge spacers having the same and / or different offset angles θ1 (e.g., 5°, 10°, 15°, 20°, 25° etc.). Simultaneously utilizing multiple combined wedge spacers 2051, for example having different offset angles, θ1, allows for a greater variety of aggregate offset angles from a reduced number of components.

[0325] Bottom surface 2051a comprises a rail 2052 extending longitudinally on bottom surface 2051a of wedge spacer 2051. Rail 2052 comprises an aperture 2053 extending transversely therethrough, e.g., through a posterior portion of rail 2052. Aperture 2053 is configured to receive a locking bar 2043 therethrough for securing one or more wedge spacers 2051 to outer sole 2040 of brace 2000, as will be described in more detail below. Rail 2052 also comprises flanges 2054 extending laterally from each side of an anterior portion of rail 2052. Flanges 2054 are configured to interlock with and / or friction-fit within complementary recesses 2057, 2058 in a slot 2055 in top surface 2051b of a mating wedge spacer 2051 having the same design, as will be described in more detail below. In some embodiments, rail 2052 may have width W5 along at least the posterior portion of rail 2052 through which aperture 2053 transversely extends. A width of at least a portion of rail 2052 may increase from W5 to a width W4 that is greater than width W5 along the anterior portion so as to form flanges 2054 extending from either side of rail 2052. As illustrated in FIG.97, flanges 2054 may have a thickness than is less than a height of rail 2052 so as to create a negative space between flanges 2054 and bottom surface 2051a of wedge spacer 2051. The thickness of flanges 2054 may taper toward their posterior edges so as to provide a guiding feature for interacting with the slot 2055 in a top surface 2051b of a mating wedge spacer 2051 whenDONJOY.123WO PATENT being coupled to one another. The width W4may also taper toward the posterior edges of flanges 2054 so as to provide a similar guiding wedge feature when coupling with another wedge spacer 2051.

[0326] Turning to FIG. 98, top surface 2051b comprises a slot 2055 extending longitudinally therein. An anterior portion of slot 2055 has a width W1. W1may be nominally larger than the width W4of flanges 2054 so as to allow rail 2052 to slide into slot 2055. A width of at least a portion of slot 2055 may taper, posterior of the anterior portion, and decrease from W1 to a width W2 that is less than W1 so as to form flanges 2056 extending from either side of slot 2055, for example, at top surface 2051a. Width W2 may be nominally wider than the width W5 of rail 2052 so as to allow rail 2052 to slide fully into slot 2055. As illustrated in FIG.98, flanges 2056 may have a thickness than is less than a height of slot 2055 so as to create negative spaces, or recesses, 2057 between each flange 2056 and the bottom of slot 2055 at either side. As shown in FIG.98, recess 2057 may have a height that is greater than a largest thickness of flanges 2054 so as to allow rail 2052 to slide fully into slot 2055. In some embodiments, a posterior portion 2058 of recesses 2057 may taper to have a reduced height so as to retain, therein, (e.g., friction fit) at least posterior portions of flanges 2054 when wedge spacer 2051 is fully mated. As shown in FIG.98, flanges 2056, and therefore also recesses 2057, 2058, may not extend all the way to the posterior portion of slot 2055. Rather, posterior of flanges 2056 and recesses 2057, 2058, sidewalls of slot 2055 may extend the entire depth of slot 2055 and to the posterior end of slot 2055 (e.g., the sidewalls of slot 2055 may be planar and uninterrupted along an entire depth of slot).

[0327] To more fully appreciate the operation and interconnectivity of wedge spacer(s) 2051 with foot shell 2030 and outer sole 2040, discussion turns to FIG. 99. As shown, the underside of foot shell 2030 comprises a rail 2052 substantially as previously described for wedge spacer(s) 2051. Outer sole 2040 comprises an aperture 2042 extending through a heel of the outer sole 2040. Specifically, outer sole 2040 has a length or direction of extension extending from heel to toe, e.g., a longitudinal extension, and aperture 2042 extends transversely to (e.g., substantially perpendicular to, at right angles, or sometimes referred to as normal to) this longitudinal direction of extension of outer sole 2040. For example, aperture 2042 may comprise, or be formed at least in part by, a first tunnel 2044 disposed to a left side of the top surface of outer sole assembly 2040 and a second tunnel 2045 disposed to a right side of the top surface of outer sole assembly 2040, such that the negative space between the first and second tunnels 2044, 2045 forms at least a portion of the slot in which a rail 2052 of either foot shell 2030 or of a bottom-most wedge spacer 2051 that is ultimately (e.g., directly or indirectly through another wedge spacer) slidingly coupled to foot shell 2030 may be seated and / or disposed. Since the foot shell 2030 and / or wedge spacer(s) 2051 are coupled to outer sole assembly 2040 utilizing a transverse bar 2043, this slot need not have any of the featuresDONJOY.123WO PATENT of slot 2055 of wedge spacers 2051 and need only be wide enough and deep enough to fully accommodate rail 2052 therein. In this way, the underside of the foot shell 2030 and the wedge spacer(s) 2051 may be interchangeably secured to outer sole assembly 2040 using the same principle of operation.

[0328] For example, a bar 2043 is configured to slidably translate through aperture 2042. When no wedge spacers 2051 are utilized and bar 2043 is translated sufficiently into aperture 2043, bar 2043 extends transversely through first tunnel 2044, through an aligned aperture 2053 extending transversely through a longitudinally-extending rail 2052 in the underside of foot shell 2030, and through second tunnel 2044 to lock foot shell 2030 to outer sole 2040. Such an arrangement is shown in at least FIGs.90-96.

[0329] When at least one wedge spacer 2051 is utilized and bar 2042 is translated sufficiently into aperture 2043, bar 2043 extends transversely through first tunnel 2044, through the aligned aperture 2052 extending transversely through the longitudinally-extending rail 2052 in the underside of wedge spacer 2051, and extends through second tunnel 2044 to lock the wedge spacer 2051 to the outer sole 2040. Examples of such wedge spacers 2051 are shown in at least FIGs.97 and 98, arrangements of brace 2000 utilizing a single wedge spacer 2051 are shown in at least FIGs.100 and 101, while arrangements using more than one wedge spacer 2051 are shown in at least FIGs.102-106.

[0330] Installing a single wedge spacer 2051, for example as shown in FIGs.100 and 101, a wedge spacer 2051 is slidingly coupled to the underside of foot shell 2030 by orienting top surface 2051b up and sliding wedge spacer 2051 along the underside of foot shell 2030 such that flanges 2056 of slot 2055 slide into the negative space between flanges 2054 of rail 2052 and the underside of foot shell 2030 until wedge spacer 2051 is fully seated under foot shell 2030 and rail 2052 on the underside of foot shell 2030 is fully inserted into, or accepted by, slot 2055 in top surface 2051b of wedge spacer 2051. FIG.100 illustrates wedge spacer 2051 in an orientation just before being slidingly coupled to foot shell 2030, while FIG. 101 illustrates wedge spacer 2051 in an orientation upon being slidingly coupled to foot shell 2030, and with bar 2043 fully inserted into aperture 2042.

[0331] Multiple wedge spacers 2051, for example as shown in FIGs.102-106, may be slidingly coupled to one another, and then that coupled set of wedge spacers may be slidingly coupled to the underside of foot shell 2030. Alternatively, a first wedge spacer 2051 may be coupled to the underside of foot shell 2030 and then one or more additional wedge spacers may be slidingly coupled to the bottommost wedge spacer already so-coupled to the underside of foot shell 2030. Accordingly, such a single wedge spacer 2051 or already-coupled set of wedge spacers 2051 may be attached to the underside of foot shell 2030 as just described.

[0332] To couple wedge spacers 2051 to one another, a lower wedge spacer 2051 is slidingly coupled to the underside of an upper wedge spacer 2051 by orienting top surfaceDONJOY.123WO PATENT 2051b of lower wedge spacer 2051 up and sliding lower wedge spacer 2051 along the bottom surface 2051a of the upper wedge spacer 2051 such that flanges 2056 of lower wedge spacer 2051 slide into the negative space between flanges 2054 of rail 2052 and the bottom surface 2051a of the upper wedge spacer 2051 until the lower wedge spacer 2051 is fully seated under the upper wedge spacer 2051 and rail 2052 on the underside of upper wedge spacer 2051 is fully inserted into, or accepted by, slot 2055 in top surface 2051b of lower wedge spacer 2051. This may be repeated for the desired number of wedge spacers 2051 to be slidingly coupled to one another.

[0333] FIGs. 102 and 103 illustrate the upper and lower wedge spacers 2051 in an orientation just before being slidingly coupled to one another and to foot shell 2030, FIG.104 illustrates the wedge spacers 2051 slidingly coupled to one another and to foot shell 2030, but with bar 2043 retracted from aperture 2042, and FIGs. 105 and 106 illustrate the wedge spacers 2051 slidingly coupled to foot shell 2030, and bar 2043 fully inserted into aperture 2042 of outer sole assembly 2040, thereby locking the foot shell 2030, wedge spacer(s) 2051, and outer sole assembly 2040 to one another. For illustrative purposes, FIG.105 shows brace 2000 with upper and lower adjustable stirrups 2021, 2022 of ROM-limiting assembly 2020 disposed at disparate settings so as to allow a non-zero range of motion of plantarflexion and / or dorsiflexion about a wearer’s ankle joint. Such settings may be utilized for treating and / or rehabilitating Achilles tendon injuries. By contrast, FIG. 106 shows brace 2000 with upper and lower adjustable stirrups 2021, 2022 of ROM-limiting assembly 2020 disposed in immediately-adjacent settings so as to substantially immobilize the wearer’s ankle joint at a single angle of flexion. Such settings may be utilized for treating and / or rehabilitating Achilles tendon injuries as well as for treating lower leg bone breaks.

[0334] Turning to FIGs.107-108, brace 2000 further comprises a front cover assembly 2075 comprising a shin cover 2060 configured to be disposed against an anterior portion of the wearer’s lower leg (e.g., the shin), a forefoot cover 2070 configured to be disposed over a top surface of the wearer’s toes and distal or anterior part of the foot, and a bridge panel 2080 configured to couple with, or be disposed against, at least a portion of each of shin cover 2060 and forefoot cover 2070. Several different embodiments will be discussed in connection with at least one of FIGs.107-108.

[0335] Shin cover 2060 is a separate component from lower leg shell 2010. While any suitable construction material is also contemplated, shin cover 2060 may comprise polyethylene high density (PEHD), polyethylene low density (PELD) or any other material allowing similar mild deformation, e.g., polypropylene compounds. In some embodiments, shin cover 2060 is configured to curve from a central line of extension (e.g., the substantially vertical line running along the center of shin cover 2060) laterally toward lateral sides 2065 of shin cover 2060. In some embodiments, similar to that shown in FIG.27A, these lateral sidesDONJOY.123WO PATENT 2065 are configured to be disposed between lower leg shell 2010 and the wearer’s leg when brace 2000 is properly secured to the wearer. Accordingly, in such embodiments, lateral sides 2065 curve sufficiently to extend posteriorly, substantially perpendicular to that the central line of extension. In some other embodiments, lateral sides 2065 may be, or comprise, winglets configured to at least partially overlap the outer sides of lower leg shell 2010, rather than being configured to entirely tuck within the inner surfaces of leg shell 2010. In some embodiments, shin cover 2060 also flares outward toward a bottom edge so as to more closely track a contour of the front of the lower leg of the wearer at or just above the ankle. In some embodiments, shin cover 2060 comprises a plurality of windows 2061 configured to provide breathability to the lower leg of the user disposed therein. In some embodiments, shin cover 2060 does not comprise a formal slot or strap retaining feature but is, instead, configured to be held against the front of the wearer’s lower leg by a bridge panel 2080 and / or retaining straps.

[0336] Forefoot cover 2070 is also a separate component from lower leg shell 2010 and a separate component from shin cover 2060. While any suitable construction material is also contemplated, forefoot cover 2070 may comprise polyethylene low density (PELD) or, alternatively, polyethylene high density (PEHD) , polyethylene low density (PELD) or any other material allowing similar mild deformation, e.g., polypropylene compounds. In some embodiments, forefoot cover 2070 is configured to curve at the lateral sides of forefoot cover 2070 such that these lateral sides are configured to be disposed between sidewalls of an anterior portion of outer sole assembly 2040 and / or sidewalls of foot shell 2030 and the wearer’s foot when brace 2000 is properly secured to the wearer. In some embodiments, as with shin cover 2060, forefoot cover 2070 comprises a plurality of windows 2071 configured to provide breathability to the foot of the user disposed therein. In some embodiments, shin cover 2060 does not comprise a formal slot or strap retaining feature but is, instead, configured to be held against the front of the wearer’s lower leg by retaining straps and / or a bridge panel 2080.

[0337] Bridge panel 2080 is also a separate component from lower leg shell 2010, shin cover 2060 and forefoot cover 2070. Bridge panel 2080 is semi-rigid and specifically designed to possess sufficient flexibility to follow a shape of front panel assembly 2075 when a strap is sufficiently tightened over bridge panel 2080 and yet rigid enough to exert a desired, and appropriate, level of pressure against the instep of the wearer’s ankle joint for immobilization and / or limitation on the ankle joint range of motion as described anywhere herein. Accordingly, while any suitable construction material is also contemplated, bridge panel 2080 may comprise polyethylene low density (PELD) or, alternatively, polyethylene high density (PEHD). In some embodiments, bridge panel 2080 may be formed of multiple materials. For example, one more rigid material (e.g., polyamide or polypropylene) and oneDONJOY.123WO PATENT relatively softer material (e.g., elastomer or PEHD), combined through bi-injection or over- injection (e.g., overmolding) processes. In some embodiments, bridge panel 2080 is configured to curve at the lateral sides of bridge panel 2080.

[0338] Bridge panel 2080 also comprises a plurality of upper winglets 2082 configured to hook into and / or couple with a distal portion of shin cover 2060. For example, winglets 2082 may slide into slots on the outward facing surface and / or the inward surface of shin cover 2060. However, the present disclosure is not so limited and also contemplates embodiments in which shin cover 2060 does not include such slots for winglets 2082 and, instead, bridge panel 2080 is configured to be disposed over an outward facing surface of at least a distal portion of shin cover 2060 and configured to secure underlying shin cover 2060 to the lower leg of the wearer by maintaining physical contact with, and pressure against, shin cover 2060 when a strap is secured through slot 2084 and around brace 2000, and then appropriately tightened.

[0339] Bridge panel 2080 also comprises a plurality of lower winglets 2083 configured to hook into and / or couple with a proximal portion of forefoot cover 2070. For example, winglets 2083 may slide into slots on the outward facing surface and / or the inward surface of forefoot cover 2070. However, the present disclosure is not so limited and also contemplates embodiments in which forefoot cover 2070 does not include such slots for winglets 2083 and, instead, bridge panel 2080 is configured to be disposed over an outward facing surface of at least a proximal portion of forefoot cover 2070 and configured to secure underlying forefoot cover 2070 to the lower leg of the wearer by maintaining physical contact with, and pressure against, forefoot cover 2070 when a strap is secured through slot 2084 and around brace 2000, and then appropriately tightened.

[0340] While not shown in FIG.107, a foam pad may be disposed on an inward-facing surface of bridge panel 2080 to provide added cushion and comfort to the wearer’s lower leg when bridge panel 2080 is tightened against shin panel 2060, forefoot panel 2070 and / or the wearer’s lower leg.

[0341] In other embodiments, rather than utilizing a single semi-rigid bridge panel 2080 between shin cover 2060 and forefoot cover 2070, a combination of rigid bridge panel 2090 and elastomeric sheet 2095 may be utilized to secure shin cover 2060 to forefoot cover 2070. For example, as shown in FIG.108, elastomeric sheet 2095 may be coupled between a distal portion of shin cover 2060 (e.g., to an inward-facing surface of shin cover 2060) and a proximal portion of forefoot cover 2070. In addition to flexibly coupling shin cover 2060 with forefoot cover 2070, elastomeric sheet 2095 also maintains a shape of the wearer’s ankle joint when brace 2000 is worn. Elastomeric sheet 2095 also maintains a shape of assembly 2075 when opening and closing the front opening of brace 2000. Rigid bridge panel 2090 may be substantially as described for bridge panel 2080 except as otherwise discussed below. RigidDONJOY.123WO PATENT bridge panel 2090 may comprise polyethylene low density (PELD) or, alternatively, polyethylene high density (PEHD). In some embodiments, rigid bridge panel 2090 may be formed of multiple materials. For example, one more rigid material (e.g., polyamide or polypropylene) and one relatively softer material (e.g., elastomer or PEHD), combined through bi-injection or over-injection (e.g., overmolding) processes. At least a portion of rigid bridge panel 2090 that is configured to extend between shin cover 2060 and forefoot cover 2070 may have a substantially convex shape (as viewed from the outside of the panel) so as to ensure rigid bridge panel 2090 does not contact the elastomeric sheet 2095 or the wearer’s ankle and, thereby cause unwanted pain or pressure to the wearer. Rigid bridge panel 2090 may comprise a slot 2094, substantially as previously described for slot 2084, configured to receive a strap for tightening the brace 2000 and thereby securing rigid bridge panel 2090, shin cover 2060 and forefoot cover 2070 to brace 2000. Rigid bridge panel 2090 may also comprise a proximal wing or plurality of winglets 2092 (e.g., see winglets 2083) that extend from rigid bridge panel 2090 at an angle and act as a contact point or contact points with a distal portion of shin cover 2060. Rigid bridge panel 2090 may, similarly, comprise a distal wing or plurality of winglets 2093 (e.g., see winglets 2083) that extend from rigid bridge panel 2090 at an angle and act as a contact point or contact points with a proximal portion of forefoot cover 2070. When a strap extends through slot 2094 and is tightened, rigid bridge panel 2090 is held fast against the contacting points with shin cover 2060 and with forefoot cover 2070, without making direct contact with either elastomeric sheet 2095 or the wearer’s ankle.

[0342] As previously described in connection with one or more other brace embodiments, brace 2000 may also comprise an adjustable, inflatable liner having a plurality of individually inflatable (and deflatable) air cells configured to provide multiple adjustable zones of pressure and / or support to various different portions of the lower foot of the wearer while the wearer’s foot is held and secured in any desired degree of plantar flexion.

[0343] Methods of Use

[0344] FIG. 109 illustrates a flowchart 3000 for a method of utilizing a brace as disclosed anywhere in this disclosure. Although blocks, steps or actions are shown in a particular order, the present application is not so limited and more or fewer actions in the same or different order than those described are also contemplated.

[0345] Flowchart 3000 includes block 3002, which includes disposing a lower leg of the wearer in a lower leg shell of the brace such that: the lower leg shell wraps around at least a posterior and sides of the lower leg, portions of the wearer’s foot proximal of a ball of the foot are disposed on a foot shell that is pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell, and toes and the ball of the wearer’s foot are disposed on an anterior portion of an outer sole assembly that is hingedly coupled to an anterior edgeDONJOY.123WO PATENT of the foot shell. For example, a lower leg of the wearer may be disposed in lower leg shell 2010 of brace 2000 such that: lower leg shell 2010 wraps around at least a posterior and sides of the lower leg, portions of the wearer’s foot proximal of a ball of the foot are disposed on foot shell 2030 that is pivotally coupled to lower leg shell 2010 and configured to rotate in relation to lower leg shell 2010, and toes and the ball of the wearer’s foot are disposed on an anterior portion of outer sole assembly 2040 that is hingedly coupled to an anterior edge of foot shell 2030.

[0346] Flowchart 3000 includes block 3004, which includes adjusting a range of motion (ROM) limiting assembly to set an upper limit for rotation of the foot shell in relation to the lower leg shell and to set a lower limit for rotation of the foot shell in relation to the lower leg shell. For example, upper and lower stirrups 2023, 2024 of range of motion (ROM) limiting assembly 2020 may be adjusted to set respective upper and lower limits for rotation of foot shell 2030 in relation to lower leg shell 2010.

[0347] In some embodiments, flowchart 3000 includes block 3006, which includes slidably coupling at least one wedge spacer of a wedge spacer assembly between the foot shell and the outer sole assembly to, thereby, support the wearer’s foot within the desired range of angles of plantarflexion. For example, at least one wedge spacer 2051 of wedge spacer assembly 2050 may be slidingly coupled between foot shell 2030 and outer sole assembly 2040 as described anywhere in this disclosure, or as would be understood by one of ordinary skill in the art upon reading this disclosure. However, the present disclosure is not so limited and at least one wedge spacer of any wedge spacer system may be coupled between a foot shell and an outer sole assembly of any brace as described anywhere in this disclosure. In some embodiments, a method of utilizing such a wedge spacer of a wedge spacer assembly, configured to be disposed between the foot shell and the outer sole assembly as described anywhere in this disclosure or as would be understood by one of ordinary skill in the art upon reading this disclosure, is also contemplated.

[0348] Methods of Manufacture

[0349] FIG.110 illustrates a flowchart 4000 for a method of manufacturing a brace as disclosed anywhere in this disclosure. Although blocks, steps or actions are shown in a particular order, the present application is not so limited and more or fewer actions in the same or different order than those described are also contemplated.

[0350] Flowchart 4000 includes block 4002, which includes providing, or otherwise forming, a lower leg shell configured to wrap around at least a posterior and sides of a lower leg of the wearer. For example, lower leg shell 2010, configured to wrap around at least a posterior and sides of a lower leg of the wearer, may be provided, or otherwise formed as described anywhere in this disclosure or as would be understood by one of ordinary skill inDONJOY.123WO PATENT the art upon reading this disclosure. However, the present disclosure is not so limited and any lower leg shell described in this disclosure is also contemplated.

[0351] Flowchart 4000 includes block 4004, which includes pivotally coupling a foot shell to the lower leg shell such that the foot shell is configured to rotate in relation to the lower leg shell for setting the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion. For example, foot shell 2030 may be pivotally coupled to lower leg shell 2010 such that foot shell 2030 is configured to rotate in relation to lower leg shell 2010 for setting the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion. However, the present disclosure is not so limited and manufacture of any brace having any foot shell described in this disclosure is also contemplated.

[0352] Flowchart 4000 includes block 4006, which includes coupling at least one component of a range of motion (ROM) limiting assembly to the brace, the ROM limiting assembly configured to set an upper limit and a lower limit for rotation of the foot shell in relation to the lower leg shell. For example, at least one component of range of motion (ROM) limiting assembly 2020 may be coupled to brace 2000. ROM limiting assembly 2020 is configured to set an upper limit and a lower limit for rotation of foot shell 2030 in relation to lower leg shell 2010. However, the present disclosure is not so limited and manufacture of any brace having any ROM limiting assembly described in this disclosure is also contemplated.

[0353] Flowchart 4000 includes block 4008, which includes hingedly coupling an outer sole assembly to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion. For example, outer sole assembly 2040 may be hingedly coupled to an anterior edge of foot shell 2030 such that, when the wearer’s foot is properly disposed in brace 2000: brace 2000 is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of outer sole assembly 2040, and portions of the wearer’s foot proximal of the ball are disposed on foot shell 2030 and within the desired range of angles of plantarflexion and / or dorsiflexion. However, the present disclosure is not so limited and manufacture of bracing having any outer sole assembly described in this disclosure is also contemplated.

[0354] In some embodiments, flowchart 4000 further includes block 4010, which includes providing, otherwise forming, and / or assembling at least one component of a wedge spacer assembly configured to be disposed between the foot shell and the outer sole assembly. For example, at least one component of wedge spacer assembly 2050, configured to be disposed between foot shell 2030 and outer sole assembly 2040, may be provided, otherwise formed, and / or assembled as described anywhere in this disclosure or as would beDONJOY.123WO PATENT understood by one of ordinary skill in the art upon reading this disclosure. In some embodiments, a method of manufacturing such a wedge spacer of a wedge spacer assembly, configured to be disposed between the foot shell and the outer sole assembly as described anywhere in this disclosure or as would be understood by one of ordinary skill in the art upon reading this disclosure, is also contemplated.

[0355] Testing of Braces and / or Components Thereof

[0356] Discussion now turns to a summary of results of a testing of a brace, as described herein. These assessments were conducted on an individual who was pain and pathology free. Only walking tasks were included. The data from the Achilles Walkers is reflective of the Orthotic Walker with no wedge, with a 10- and 20-degree wedge, which was compared with the biomechanics when wearing a shoe. The following data is presented: Knee joint angles in the sagittal plane (flexion / extension), Knee joint moments in the sagittal plane (flexion / extension / hyperextension) and Muscle activity of the medial gastrocnemius.

[0357] Knee Joint Angle. FIG.111 shows the knee joint angles in the sagittal plane when wearing the Achilles Orthotic Walker with no wedge (Boot0), 10 (Boot 10) and 20 (Boot 20) degree wedges compared with a shoe condition. No differences were seen between the shoe, the Orthotic Walker with no wedge, and the Orthotic Walker with a 10-degree wedge. However, at 20 degrees, an increase in knee flexion was seen. In mid stance phase, similar amounts of re-extension of the knee was seen between the shoe, the Orthotic Walker with no wedge, and the Orthotic Walker with a 10-degree wedge. However, with the 20-degree wedge there was less movement towards knee extension. When considering these findings in relation to published work (see, e.g., Richards, J., Payne, K., Myatt, D., & Chohan, A. (2016). Do orthotic walkers affect knee and hip function during gait? Prosthetics & Orthotics International, 40(1), 137–141. https: / / doi.org / 10.1177 / 0309364614546525 Richards et al., 2016) there have been significant improvements made in knee kinematics, with the Achilles Orthotic Walker now providing a normal pattern comparable with the shoe condition, even with a 10-degree wedge. These improvements are likely to be due to the incorporation of a 6-degree forward inclination of the tibia, and modified rocker profiles within the new design of the Achilles Orthotic Walker.

[0358] Knee Joint Movements. FIG.112 shows the knee joint moments in the sagittal plane when wearing the Achilles Orthotic Walker with no wedge (Boot 0), 10 (Boot 10) and 20 (Boot 20) degree wedges compared with a shoe condition. With the Orthotic Walker without a wedge, there is a slightly lower knee flexion moment. When the wedges are introduced, the initial knee flexion moment increases with similar peak flexion moments observed in the 10- and 20-degree wedges. When considering the knee extension moments the Orthotic Walker without a wedge had almost identical patterns of knee extension moments compared to theDONJOY.123WO PATENT shoe condition. This is particularly noteworthy, as previous published work (Richards et al., 2016) showed a considerable unfavorable hyperextension moment when wearing several different designs of Orthotic Walker, which have previously been associated with increased load at the knee. As suggested in the knee joint angle findings, these findings are also likely to be due to the incorporation of a 6-degree forward inclination of the tibia, and modified rocker profiles within the new design of the Achilles Orthotic Walker. Interestingly, with the addition of both the 10- and 20-degree wedge, the knee extension moment is further reduced, but not to the extent of exceeding normal values.

[0359] Muscle Activity. FIG. 113 shows the activity of the medial gastrocnemius during the stance phase of the gait cycle when wearing the Achilles Orthotic Walker with no wedge (Boot 0), 10 (Boot 10) and 20 (Boot 20) degree wedges compared with a shoe condition. The data shows that there is an incremental reduction in the peak muscle activity between the shoe, Boot 0, Boot 10 and Boot 20, which can be associated with a reduction of Achilles tendon load. When considering the area under the EMG curves which indicates the amount of work done by the gastrocnemius, Boot 0 showed a 14% reduction, Boot 10 a 35% reduction and Boot 20 a 45% reduction when compared to the shoe condition.

[0360] Language for several embodiments of a lower leg brace, at least as described above, for example, in connection with one or more of FIGs. 90-113, are disclosed below. Reference to embodiments is considered to correspond to at least the embodiments described below. Embodiment 1 of a lower leg brace configured to support a wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion, where the brace includes a lower leg shell 2010 configured to wrap around at least a posterior and sides of a lower leg of the wearer; a foot shell 2030 pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell to, thereby, set the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion, a range of motion (ROM) limiting assembly 2020 configured to set an upper limit and a lower limit for rotation of the foot shell in relation to the lower leg shell; and an outer sole assembly 2040 hingedly coupled to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace: the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion.

[0361] Embodiment 2, a sub-embodiment of Embodiment 1, wherein the ROM-limiting assembly comprises: a post 2025 extending from the foot shell and through an arcuate slot 2012 in the lower leg shell; an upper adjustable stirrup 2021 for setting the upper limit for rotation of foot shell in relation to the lower leg shell; and a lower adjustable stirrup 2022 for setting the lower limit for rotation of foot shell in relation to the lower leg shell, wherein: rotatingDONJOY.123WO PATENT the foot shell to the upper limit causes the post to physically contact the upper adjustable stirrup, thereby, preventing further rotation of the foot shell beyond the upper limit, and rotating the foot shell to the lower limit causes the post to physically contact the lower adjustable stirrup, thereby, preventing further rotation of the foot shell beyond the lower limit.

[0362] Embodiment 3, a sub-embodiment of Embodiment 2, wherein the upper adjustable stirrup, the lower adjustable stirrup, and the foot shell each rotate about a same axis.

[0363] Embodiment 4, a sub-embodiment of Embodiment 2, wherein setting the upper limit and the lower limit to a same value cause the ROM limiting assembly to disable rotation of the foot shell in relation to the lower leg shell and lock the foot shell at an amount of plantarflexion corresponding to the value.

[0364] Embodiment 5, a sub-embodiment of Embodiment 3, wherein the upper adjustable stirrup is configured to rotate up and down along a curved posterior portion of the lower leg shell and the lower adjustable stirrup is configured to rotate up and down along the curved posterior portion of the lower leg shell below the upper adjustable stirrup.

[0365] Embodiment 6, a sub-embodiment of Embodiment 5, wherein the ROM limiting assembly further comprises: an upper stop 2023 configured to secure the upper adjustable stirrup in any one of a plurality of different positions, each corresponding to a different upper limit for the rotation of the foot shell in relation to the lower leg shell; and a lower stop 2024 configured to secure the lower adjustable stirrup in any one of a plurality of different positions, each corresponding to a different lower limit for the rotation of the foot shell in relation to the lower leg shell.

[0366] Embodiment 7, a sub-embodiment of Embodiment 6, wherein: the curved posterior portion of the lower leg shell comprises a toothed track (2014); the upper stop comprises at least one tooth configured to be disposed in any one of a plurality of positions along the toothed track; and the lower stop comprises at least one tooth configured to be disposed in any other one of the plurality of positions along the toothed track.

[0367] Embodiment 8, a sub-embodiment of Embodiment 7, wherein translating the upper stop away from the upper adjustable stirrup causes the at least one tooth of the upper stop to translate sufficiently to clear the toothed track and allow the upper adjustable stirrup to be aligned with another of the plurality of positions along the toothed track.

[0368] Embodiment 9, a sub-embodiment of Embodiment 2, wherein the upper adjustable stirrup comprises an upper notch 2021a and the lower adjustable stirrup comprises a lower notch 2022a such that, when the upper adjustable stirrup is disposed directly against the lower adjustable stirrup, the upper notch is disposed immediately adjacent to the lower notch and the post is immobilized at least partly within the upper notch and at least partly within the lower notch.DONJOY.123WO PATENT

[0369] Embodiment 10, a sub-embodiment of Embodiment 1, further comprising a wedge spacer assembly (2050) configured to be disposed between the foot shell and the outer sole assembly, the wedge spacer assembly comprising: a rail (2052) on an underside of the foot shell, the rail having an aperture (2053) extending transversely therethrough; a plurality of wedge spacers (2051), each wedge spacer comprising: a first planar surface (2051a) comprising a rail (2052) having an aperture (2053) extending transversely therethrough, and a second planar surface (2051b) offset by a respective one of a plurality of different angles (θ1) compared to the first planar surface, the second planar surface comprising a slot (2055) configured to slidingly receive: the rail on the underside of the foot shell when the wedge spacer is directly slidingly coupled to the foot shell, and the rail on the first surface of an other wedge spacer of the plurality of wedge spacers when the wedge spacer is directly coupled to the other wedge spacer; and a slot in a top surface of the outer sole assembly configured to slidingly receive: the rail on the underside of the foot shell when none of the plurality of wedge spacers are slidingly coupled to the foot shell, and the rail on a bottom-most wedge spacer that is ultimately slidingly coupled to the foot shell when at least one of the plurality of wedge spacers is ultimately slidingly coupled to the foot shell.

[0370] Embodiment 11, a sub-embodiment of Embodiment 10, wherein the wedge spacer system further comprises a locking bar 2043 disposed within an aperture 2042 extending transversely through the outer sole assembly, the locking bar configured to: slidingly extend through the aperture extending transversely through the rail on the underside of the foot shell when none of the plurality of wedge spacers are slidingly coupled to the foot shell, thereby locking the foot shell directly to the outer sole assembly; and slidingly extend through the aperture extending transversely through the rail in the second surface of the bottom-most wedge spacer that is ultimately slidingly coupled to the foot shell when at least one of the plurality of wedge spacers is ultimately slidingly coupled to the foot shell, thereby directly locking the bottom-most wedge spacer to the outer sole assembly.

[0371] Embodiment 12, a sub-embodiment of Embodiment 11, wherein the aperture extending transversely through the outer sole assembly is formed at least in part by: a first tunnel 2044 disposed to a left side of a top surface of the outer sole assembly; and a second tunnel 2045 disposed to a right side of the top surface of outer sole assembly, wherein a negative space between the first tunnel and the second tunnel forms at least a portion of the slot in the top surface of the outer sole assembly.

[0372] Embodiment 13, a sub-embodiment of Embodiment 1, further comprising a front cover assembly 2075 comprising: a shin cover 2060 configured to be disposed against an anterior portion of the wearer’s lower leg; a forefoot cover 2070 configured to be disposed against the wearer’s forefoot; and a semi-rigid bridge panel 2080 configured to couple with, orDONJOY.123WO PATENT be disposed against, at least a portion of each of shin cover and the forefoot cover, thereby securing the shin cover and the forefoot cover to the brace.

[0373] Embodiment 14, a sub-embodiment of Embodiment 13, wherein the bridge panel comprises at least one of: at least one upper winglet 2082 configured to couple with mating features in a distal portion of the shin cover; and at least one lower winglet 2083 configured to couple with mating features in a proximal portion of the forefoot cover.

[0374] Embodiment 15, a sub-embodiment of Embodiment 11, wherein the bridge panel comprises a slot 2084 for receiving a tightening strap and the bridge panel is configured to be disposed at least partially over a distal portion of the shin cover and at least partially over a proximal portion of the forefoot cover such that, when the strap is secured through the slot and appropriately tightened, the shin cover and the forefoot cover are each held against the lower leg of the wearer by direct physical pressure exerted by the bridge panel against the shin cover and against the forefoot cover.

[0375] Embodiment 16, a sub-embodiment of Embodiment 1, further comprising a front cover assembly 2075 comprising: a shin cover 2060 configured to be disposed against an anterior portion of the wearer’s lower leg; a forefoot cover 2070 configured to be disposed against the wearer’s forefoot; an elastomeric sheet 2095 coupled between a distal portion of the shin cover and a proximal portion of the forefoot cover; and a rigid bridge panel 2090, comprising: a proximal portion configured to directly contact an outer surface of the shin cover, a distal portion configured to directly contact an outer surface of the forefoot cover, and a convex portion configured to extend between the proximal portion and the distal portion, the convex portion comprising a slot 2094 for receiving a tightening strap such that, when the strap is secured through the slot and appropriately tightened, the rigid bridge panel directly contacts the outer surface of the shin cover and the outer surface of the forefoot cover but does not contact the elastomeric sheet or the wearer’s ankle.

[0376] Embodiment 17, a sub-embodiment of Embodiment 1, wherein the outer sole assembly is configured to maintain a bottom surface of the outer sole assembly sole substantially parallel to the ground when the wearer is standing and the wearer’s foot is disposed at any degree of ankle plantarflexion within the desired range of angles of plantarflexion.

[0377] Embodiment 18 is a stackable wedge spacer for use in a lower leg brace that is configured to support a wearer’s foot in any of a desired range of angles of plantarflexion. The stackable wedge spacer comprises: a first planar surface 2051a comprising a rail 2052 extending longitudinally along the first planar surface, the rail configured to be received into a slot in a top surface of an outer sole assembly 2040 of the lower leg brace 2000 or slidingly received into a slot 2055 in another one of the stackable wedge spacers, the rail comprising: an aperture 2053 extending transversely through the rail, and flanges 2054 extending laterallyDONJOY.123WO PATENT from each side of an anterior portion of rail, and a second planar surface 2051b offset by an angle θ1 compared to the first planar surface, the second planar surface comprising a slot 2055 configured to slidingly receive a rail 2052 of an underside of a foot shell 2030 of the lower leg brace 2000 or a rail 2052 of another one of the stackable wedge spacers 2051, wherein the slot comprises: flanges 2056 extending from either side of the slot, and recesses 2057 formed between flanges 2056 and a bottom of the slot.

[0378] Embodiment 19, a sub-embodiment of Embodiment 18, wherein: the rail has a first width W5 along at least a posterior portion of the rail through which the aperture transversely extends; a width of an anterior portion of the rail increases from the first width W5 to a second width W4 along the anterior portion of the rail so as to form the flanges extending from either side of the rail; and the flanges have a thickness than is less than a height of the rail so as to create a negative space between the flanges and the first planar surface of the wedge spacer.

[0379] Embodiment 20, a sub-embodiment of Embodiment 18, wherein the flanges of the rail are configured to interlock with the recesses 2057,2058 in the slot 2055 in the second planar surface 2051b of another of the stackable wedge spacers 2051.

[0380] Embodiment 21, a sub-embodiment of Embodiment 19, wherein: a width W1 of an anterior portion of the slot is nominally larger than the width W4of the flanges of rail soas to allow the rail 2052 of the underside of the foot shell or the rail 2052 of another of the stackable wedge spacers 2051 to slide into the slot; a width of the slot posterior of the anterior portion tapers from the width W1 to a width W2 so as to form the flanges 2056 extending from either side of the slot; the width W2 is nominally wider than the width W5 of the rail 2052 so as to allow the rail to slide fully into the slot; the flanges of the slot may have a thickness than is less than a height of the slot 2055 so as to create the recesses 2057 between each flange and the bottom of the slot; and the recesses 2057 have a height that is greater than a largest thickness of the flanges of the rail so as to allow the rail on another one of the stackable wedge spacers or on the underside of the foot shell of the lower leg brace to slide fully into the slot.

[0381] Embodiment 22, a sub-embodiment of Embodiment 18, wherein the aperture 2053 extending transversely through the rail of the stackable wedge spacer is configured to receive a locking bar 2043 of the lower leg brace 2000 therethrough to, thereby, directly lock the stackable wedge spacer to the outer sole assembly 2040 of the lower leg brace 2000.

[0382] Embodiment 23, a sub-embodiment of Embodiment 18, wherein the offset angle θ1 is any one of 5°, 10°, 15°, 20°, 25° and 30°.

[0383] Embodiment 24, a sub-embodiment of Embodiment 18, wherein the stackable wedge spacer is rigid.

[0384] Embodiment 25, a sub-embodiment of Embodiment 18, wherein the stackable wedge spacer is not tearable or trimmable so as to modify any of its shape, size and profile.DONJOY.123WO PATENT

[0385] Embodiment 26 is a method of manufacturing a lower leg brace configured to support a wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion, the method comprising: providing, or otherwise forming, a lower leg shell 2010 configured to wrap around at least a posterior and sides of a lower leg of the wearer; pivotally coupling a foot shell 2030 to the lower leg shell such that the foot shell is configured to rotate in relation to the lower leg shell for setting the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion; coupling at least one component of a range of motion (ROM) limiting assembly 2020 to the brace, the ROM limiting assembly configured to set an upper limit and a lower limit for rotation of the foot shell in relation to the lower leg shell; and hingedly coupling an outer sole assembly 2040 to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace: the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion and / or dorsiflexion.

[0386] Embodiment 27, a sub-embodiment of Embodiment 26, wherein the lower leg brace is the brace of any one of Embodiments 1-17 and / or the wedge spacer(s) are the wedge spacer(s) of any one of Embodiments 18-25, and the method further comprises providing, otherwise forming and / or assembling any one or more components of the brace of the one of Embodiments 1-17 and / or of the wedge spacer(s) of the one of Embodiments 18-25.

[0387] Embodiment 28, a sub-embodiment of Embodiment 26, further comprising providing, otherwise forming, and / or assembling at least one component of a wedge spacer assembly 2050 configured to be disposed between the foot shell and the outer sole assembly.

[0388] Embodiment 29, a sub-embodiment of Embodiment 28, wherein the wedge spacer assembly is the wedge spacer assembly of any one of Embodiments 18-25.

[0389] Embodiment 30, a method of utilizing a lower leg brace configured to hinge at a ball of the wearer’s foot and support the wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion, the method comprising: disposing a lower leg of the wearer in a lower leg shell 2010 of the brace such that: the lower leg shell wraps around at least a posterior and sides of the lower leg, portions of the wearer’s foot proximal of a ball of the foot are disposed on a foot shell 2030 that is pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell, and toes and the ball of the wearer’s foot are disposed on an anterior portion of an outer sole assembly 2040 that is hingedly coupled to an anterior edge of the foot shell; and adjusting a range of motion (ROM) limiting assembly 2020 to set an upper limit for rotation of the foot shell in relation to the lower leg shell and to set a lower limit for rotation of the foot shell in relation to the lower leg shell.

[0390] Embodiment 31, a sub-embodiment of Embodiment 30, wherein the lower leg brace is the brace of any one of Claims 1-17.DONJOY.123WO PATENT

[0391] Embodiment 32, a sub-embodiment of Embodiment 30, further comprising slidably coupling at least one wedge spacer 2051 of a wedge spacer assembly 2050 between the foot shell and the outer sole assembly to, thereby, support the wearer’s foot within the desired range of angles of plantarflexion.

[0392] Embodiment 33, a sub-embodiment of Embodiment 32, wherein the wedge spacer assembly is the wedge spacer assembly of any one of Claims 18-25.

[0393] While various embodiments of the present disclosure have been described above, it should be understood that they have been presented by way of example only, and not of limitation. Likewise, the various diagrams may depict an example architectural or other configuration for the disclosure, which is done to aid in understanding the features and functionality that can be included in the disclosure. The disclosure is not restricted to the illustrated example architectures or configurations, but the desired features can be implemented using a variety of alternative architectures and configurations. Indeed, it will be apparent to one of skilled in the art how alternative functional, logical, or physical partitioning and configurations can be implemented to implement the desired features of the present disclosure. Also, a multitude of different constituent module names other than those depicted herein can be applied to the various partitions. Additionally, with regard to diagrams, operational descriptions, and method claims, the order in which the steps are presented herein shall not mandate that various embodiments be implemented to perform the recited functionality in the same order unless the context dictates otherwise.

[0394] Although the disclosure is described above in terms of various embodiments and implementations, it should be understood that the various features, aspects, and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead can be applied, alone or in various combinations, to one or more of the other embodiments of the disclosure, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described embodiments.

[0395] Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; and adjectives such as “conventional,” “traditional,” “typical,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as ofDONJOY.123WO PATENT a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future.

[0396] The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent. The use of the term “element” does not imply that the components or functionality described or claimed as part of the element are all configured in a common package. Indeed, any or all of the various components of an element can be combined in a single package or separately maintained and can further be distributed in multiple groupings or packages or across multiple locations.

[0397] Additionally, the various embodiments set forth herein are described in terms of exemplary diagrams, flow charts, and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives can be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular architecture or configuration.

Claims

DONJOY.123WO PATENT CLAIMS We Claim:

1. A lower leg brace configured to support a wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion, the brace comprising: a lower leg shell (2010) configured to wrap around at least a posterior and sides of a lower leg of the wearer; a foot shell (2030) pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell to, thereby, set the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion; a range of motion (ROM) limiting assembly (2020) configured to set an upper limit and a lower limit for rotation of the foot shell in relation to the lower leg shell; and an outer sole assembly (2040) hingedly coupled to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace: the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion.

2. The brace of Claim 1, wherein the ROM-limiting assembly comprises: a post (2025) extending from the foot shell and through an arcuate slot (2012) in the lower leg shell; an upper adjustable stirrup (2021) for setting the upper limit for rotation of foot shell in relation to the lower leg shell; and a lower adjustable stirrup (2022) for setting the lower limit for rotation of foot shell in relation to the lower leg shell, wherein: rotating the foot shell to the upper limit causes the post to physically contact the upper adjustable stirrup, thereby, preventing further rotation of the foot shell beyond the upper limit, and rotating the foot shell to the lower limit causes the post to physically contact the lower adjustable stirrup, thereby, preventing further rotation of the foot shell beyond the lower limit.

3. The brace of Claim 2, wherein the upper adjustable stirrup, the lower adjustable stirrup, and the foot shell each rotate about a same axis.DONJOY.123WO PATENT 4. The brace of Claim 2, wherein setting the upper limit and the lower limit to a same value cause the ROM limiting assembly to disable rotation of the foot shell in relation to the lower leg shell and lock the foot shell at an amount of plantarflexion corresponding to the value.

5. The brace of Claim 3, wherein the upper adjustable stirrup is configured to rotate up and down along a curved posterior portion of the lower leg shell and the lower adjustable stirrup is configured to rotate up and down along the curved posterior portion of the lower leg shell below the upper adjustable stirrup.

6. The brace of Claim 5, wherein the ROM limiting assembly further comprises: an upper stop (2023) configured to secure the upper adjustable stirrup in any one of a plurality of different positions, each corresponding to a different upper limit for the rotation of the foot shell in relation to the lower leg shell; and a lower stop (2024) configured to secure the lower adjustable stirrup in any one of a plurality of different positions, each corresponding to a different lower limit for the rotation of the foot shell in relation to the lower leg shell.

7. The brace of Claim 6, wherein: the curved posterior portion of the lower leg shell comprises a toothed track (2014); the upper stop comprises at least one tooth configured to be disposed in any one of a plurality of positions along the toothed track; and the lower stop comprises at least one tooth configured to be disposed in any other one of the plurality of positions along the toothed track.

8. The brace of Claim 7, wherein translating the upper stop away from the upper adjustable stirrup causes the at least one tooth of the upper stop to translate sufficiently to clear the toothed track and allow the upper adjustable stirrup to be aligned with another of the plurality of positions along the toothed track.

9. The brace of Claim 2, wherein the upper adjustable stirrup comprises an upper notch (2021a) and the lower adjustable stirrup comprises a lower notch (2022a) such that, when the upper adjustable stirrup is disposed directly against the lower adjustable stirrup, the upper notch is disposed immediately adjacent to the lower notch and the post is immobilized at least partly within the upper notch and at least partly within the lower notch.DONJOY.123WO PATENT 10. The brace of Claim 1, further comprising a wedge spacer assembly (2050) configured to be disposed between the foot shell and the outer sole assembly, the wedge spacer assembly comprising: a rail (2052) on an underside of the foot shell, the rail having an aperture (2053) extending transversely therethrough; a plurality of wedge spacers (2051), each wedge spacer comprising: a first planar surface (2051a) comprising a rail (2052) having an aperture (2053) extending transversely therethrough, and a second planar surface (2051b) offset by a respective one of a plurality of different angles (θ1) compared to the first planar surface, the second planar surface comprising a slot (2055) configured to slidingly receive: the rail on the underside of the foot shell when the wedge spacer is directly slidingly coupled to the foot shell, and the rail on the first surface of an other wedge spacer of the plurality of wedge spacers when the wedge spacer is directly coupled to the other wedge spacer; and a slot in a top surface of the outer sole assembly configured to slidingly receive: the rail on the underside of the foot shell when none of the plurality of wedge spacers are slidingly coupled to the foot shell, and the rail on a bottom-most wedge spacer that is ultimately slidingly coupled to the foot shell when at least one of the plurality of wedge spacers is ultimately slidingly coupled to the foot shell.

11. The brace of Claim 10, wherein the wedge spacer system further comprises a locking bar (2043) disposed within an aperture (2042) extending transversely through the outer sole assembly, the locking bar configured to: slidingly extend through the aperture extending transversely through the rail on the underside of the foot shell when none of the plurality of wedge spacers are slidingly coupled to the foot shell, thereby locking the foot shell directly to the outer sole assembly; and slidingly extend through the aperture extending transversely through the rail in the second surface of the bottom-most wedge spacer that is ultimately slidingly coupled to the foot shell when at least one of the plurality of wedge spacers is ultimately slidingly coupled to the foot shell, thereby directly locking the bottom-most wedge spacer to the outer sole assembly.DONJOY.123WO PATENT 12. The brace of Claim 11, wherein the aperture extending transversely through the outer sole assembly is formed at least in part by: a first tunnel (2044) disposed to a left side of a top surface of the outer sole assembly; and a second tunnel (2045) disposed to a right side of the top surface of outer sole assembly, wherein a negative space between the first tunnel and the second tunnel forms at least a portion of the slot in the top surface of the outer sole assembly.

13. The brace of Claim 1, further comprising a front cover assembly (2075) comprising: a shin cover (2060) configured to be disposed against an anterior portion of the wearer’s lower leg; a forefoot cover (2070) configured to be disposed against the wearer’s forefoot; and a semi-rigid bridge panel (2080) configured to couple with, or be disposed against, at least a portion of each of shin cover and the forefoot cover, thereby securing the shin cover and the forefoot cover to the brace.

14. The brace of Claim 13, wherein the bridge panel comprises at least one of: at least one upper winglet (2082) configured to couple with mating features in a distal portion of the shin cover; and at least one lower winglet (2083) configured to couple with mating features in a proximal portion of the forefoot cover.

15. The brace of Claim 11, wherein the bridge panel comprises a slot (2084) for receiving a tightening strap and the bridge panel is configured to be disposed at least partially over a distal portion of the shin cover and at least partially over a proximal portion of the forefoot cover such that, when the strap is secured through the slot and appropriately tightened, the shin cover and the forefoot cover are each held against the lower leg of the wearer by direct physical pressure exerted by the bridge panel against the shin cover and against the forefoot cover.

16. The brace of Claim 1, further comprising a front cover assembly (2075) comprising: a shin cover (2060) configured to be disposed against an anterior portion of the wearer’s lower leg;DONJOY.123WO PATENT a forefoot cover (2070) configured to be disposed against the wearer’s forefoot; an elastomeric sheet (2095) coupled between a distal portion of the shin cover and a proximal portion of the forefoot cover; and a rigid bridge panel (2090), comprising: a proximal portion configured to directly contact an outer surface of the shin cover, a distal portion configured to directly contact an outer surface of the forefoot cover, and a convex portion configured to extend between the proximal portion and the distal portion, the convex portion comprising a slot (2094) for receiving a tightening strap such that, when the strap is secured through the slot and appropriately tightened, the rigid bridge panel directly contacts the outer surface of the shin cover and the outer surface of the forefoot cover but does not contact the elastomeric sheet or the wearer’s ankle.

17. The brace of Claim 1, wherein the outer sole assembly is configured to maintain a bottom surface of the outer sole assembly sole substantially parallel to the ground when the wearer is standing and the wearer’s foot is disposed at any degree of ankle plantarflexion within the desired range of angles of plantarflexion.

18. A stackable wedge spacer for use in a lower leg brace that is configured to support a wearer’s foot in any of a desired range of angles of plantarflexion, the stackable wedge spacer comprising: a first planar surface (2051a) comprising a rail (2052) extending longitudinally along the first planar surface, the rail configured to be received into a slot in a top surface of an outer sole assembly (2040) of the lower leg brace (2000) or slidingly received into a slot (2055) in another one of the stackable wedge spacers, the rail comprising: an aperture (2053) extending transversely through the rail, and flanges (2054) extending laterally from each side of an anterior portion of rail, and a second planar surface (2051b) offset by an angle (θ1) compared to the first planar surface, the second planar surface comprising a slot (2055) configured to slidingly receive a rail (2052) of an underside of a foot shell (2030) of the lower leg brace (2000) or a rail (2052) of another one of the stackable wedge spacers (2051), wherein the slot comprises:DONJOY.123WO PATENT flanges (2056) extending from either side of the slot, and recesses (2057) formed between flanges 2056 and a bottom of the slot.

19. The stackable wedge spacer of Claim 18, wherein: the rail has a first width (W5) along at least a posterior portion of the rail through which the aperture transversely extends; a width of an anterior portion of the rail increases from the first width (W5) to a second width (W4) along the anterior portion of the rail so as to form the flanges extending from either side of the rail; and the flanges have a thickness than is less than a height of the rail so as to create a negative space between the flanges and the first planar surface of the wedge spacer.

20. The stackable wedge spacer of Claim 18, wherein the flanges of the rail are configured to interlock with the recesses (2057, 2058) in the slot (2055) in the second planar surface (2051b) of another of the stackable wedge spacers (2051).

21. The stackable wedge spacer of Claim 19, wherein: a width (W1) of an anterior portion of the slot is nominally larger than the width (W4) of the flanges of the rail so as to allow the rail (2052) of the underside of the foot shell or the rail (2052) of another of the stackable wedge spacers (2051) to slide into the slot; a width of the slot posterior of the anterior portion tapers from the width (W1) to a width W2so as to form the flanges (2056) extending from either side of the slot; the width (W2) is nominally wider than the width (W5) of the rail 2052 so as to allow the rail to slide fully into the slot; the flanges of the slot may have a thickness than is less than a height of the slot 2055 so as to create the recesses (2057) between each flange and the bottom of the slot; and the recesses (2057) have a height that is greater than a largest thickness of the flanges of the rail so as to allow the rail on another one of the stackable wedge spacers or on the underside of the foot shell of the lower leg brace to slide fully into the slot.

22. The stackable wedge spacer of Claim 18, wherein the aperture (2053) extending transversely through the rail of the stackable wedge spacer is configured toDONJOY.123WO PATENT receive a locking bar (2043) of the lower leg brace (2000) therethrough to, thereby, directly lock the stackable wedge spacer to the outer sole assembly (2040) of the lower leg brace (2000).

23. The stackable wedge spacer of Claim 18, wherein the offset angle (θ1) is any one of 5°, 10°, 15°, 20°, 25° and 30°.

24. The stackable wedge spacer of Claim 18, wherein the stackable wedge spacer is rigid.

25. The stackable wedge spacer of Claim 18, wherein the stackable wedge spacer is not tearable or trimmable so as to modify any of its shape, size and profile.

26. A method of manufacturing a lower leg brace configured to support a wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion, the method comprising: providing, or otherwise forming, a lower leg shell (2010) configured to wrap around at least a posterior and sides of a lower leg of the wearer; pivotally coupling a foot shell (2030) to the lower leg shell such that the foot shell is configured to rotate in relation to the lower leg shell for setting the wearer’s foot in the desired range of angles of plantarflexion and / or dorsiflexion; coupling at least one component of a range of motion (ROM) limiting assembly (2020) to the brace, the ROM limiting assembly configured to set an upper limit and a lower limit for rotation of the foot shell in relation to the lower leg shell; and hingedly coupling an outer sole assembly (2040) to an anterior edge of the foot shell such that, when the wearer’s foot is properly disposed in the brace: the brace is configured to hinge at a ball of the wearer’s foot, the toes and ball of the wearer’s foot are disposed on an anterior portion of the outer sole assembly, and portions of the wearer’s foot proximal of the ball are disposed on the foot shell and within the desired range of angles of plantarflexion and / or dorsiflexion.

27. The method of Claim 26, wherein the lower leg brace is the brace of any one of Claims 1-17 and the method further comprises providing, otherwise forming and / or assembling any one or more components of the brace of the one of Claims 1-17.DONJOY.123WO PATENT 28. The method of Claim 26, further comprising providing, otherwise forming, and / or assembling at least one component of a wedge spacer assembly (2050) configured to be disposed between the foot shell and the outer sole assembly.

29. The method of Claim 28, wherein the wedge spacer assembly is the wedge spacer assembly of any one of Claims 18-25.

30. A method of utilizing a lower leg brace configured to hinge at a ball of the wearer’s foot and support the wearer’s foot in a desired range of angles of plantarflexion and / or dorsiflexion, the method comprising: disposing a lower leg of the wearer in a lower leg shell (2010) of the brace such that: the lower leg shell wraps around at least a posterior and sides of the lower leg, portions of the wearer’s foot proximal of a ball of the foot are disposed on a foot shell (2030) that is pivotally coupled to the lower leg shell and configured to rotate in relation to the lower leg shell, and toes and the ball of the wearer’s foot are disposed on an anterior portion of an outer sole assembly (2040) that is hingedly coupled to an anterior edge of the foot shell; and adjusting a range of motion (ROM) limiting assembly (2020) to set an upper limit for rotation of the foot shell in relation to the lower leg shell and to set a lower limit for rotation of the foot shell in relation to the lower leg shell.

31. The method of Claim 30, wherein the lower leg brace is the brace of any one of Claims 1-17.

32. The method of Claim 30, further comprising slidably coupling at least one wedge spacer (2051) of a wedge spacer assembly (2050) between the foot shell and the outer sole assembly to, thereby, support the wearer’s foot within the desired range of angles of plantarflexion.

33. The method of Claim 32, wherein the wedge spacer assembly is the wedge spacer assembly of any one of Claims 18-25.

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