PRODUCTS AND SYSTEMS

BACKGROUND

1. CROSS-REFERENCE TO RELATED APPLICATIONS

[001] The present application claims priority benefit to a provisional patent application entitled "Ankle Foot Orthosis Products and Systems," which was filed on February 20, 2015, and assigned Serial No. 62/118,646. The entire content of the foregoing provisional patent application is incorporated herein by reference. The present application is also related to a commonly assigned U.S. patent entitled "Foot Orthotic," which was issued as U.S. Patent No. 9,131,746 on September 15, 2015. The entire content of the foregoing U.S. patent is incorporated herein by reference.

2. TECHNICAL FIELD

[002] The present disclosure generally relates to ankle foot orthoses and, in particular, to an ankle foot orthosis including an orthotic that functions, inter alia, to increase propulsion.

3. BACKGROUND ART

[003] Foot orthotics are often used to compensate for impaired foot function by controlling abnormal motion across the joints of the foot. Specific impairments that a foot orthotic may assist include mild "foot drop" due to neurological conditions, orthopedic gait abnormality, clubfoot, mid-tarsal fracture, partial foot amputation, arthritis, hallux valgus, hallux rigidus, turf toe, and plantar fasciitis. Foot orthotics may also be prescribed and/or employed to reduce pain, to provide support, to prevent foot deformity and/or to prevent the worsening thereof, to relieve pressure on a certain area of the foot, and/or to improve the overall biomechanical function of the foot and lower extremity limbs.

[004] Foot orthotics normally include a specially fitted insert or footbed for use in conjunction with a shoe. Foot orthotics may provide support for the foot by distributing pressure or realigning foot joints while standing, walking or running. As such, foot orthotics are often used by athletes to relieve symptoms associated with a variety of soft tissue inflammatory conditions, e.g., plantar fasciitis. Also, foot orthotics have been designed and/or used to address arch support or cushioning requirements. [005] According to the 2005 Americans with Disabilities report, approximately 27 million people over the age of 15 had a walking-related disability. Ankle joint musculature plays an important role during walking and is thought to be the primary muscle group that supports upright stance and produces forward propulsion. Individuals with muscular weakness about the ankle, an impairment often caused by upper motor neuron disorders and lower extremity injuries, are frequently prescribed ankle-foot orthoses which brace the ankle during gait and aim to improve gait function.

[006] Generally, foot orthotics are designed to remove pressure and/or stress from painful areas of the foot and ankle. The main focus of orthotic technology has been to increase the comfort and cushioning of the product. Shock attenuation (absorption) has been addressed by myriad footwear innovations in the past, but efforts at increasing the efficiency of motion have been largely absent. Foot orthotics may also function to address positioning and movement of the foot, ideally addressing balance issues. Many foot orthotics deliver an equal or constant stiffness along their length which can contribute to gait and/or balance issues that the foot orthotic is intended to improve and/or resolve.

[007] Beyond the realm of foot orthotics, ankle-foot orthosis have been developed that are intended to substitute and/or compensate for various anatomical issues, e.g., weak dorsiflexors during the swing phase and weak plantarflexors during the stance phase of a user's gait. In general, ankle-foot orthosis systems may function to support and align the ankle and the foot and generally improve the functions of the foot with particular focus on ankle/knee biomechanics.

[008] The products that are currently on the market in this category are generally designed to assist the impaired individual in gaiting more normally. The focus of prior designs in the orthotic/prosthetic marketplace has been to substitute, with a mechanical device, the normal operation of the human foot/ankle/leg complex. Consistent with this focus, improvements in the orthotic/prosthetic marketplace have been aimed at replacing the normal function of the impaired lower extremity complex. However, in addition to assisting such individuals to gait more normally, it is desirable to also improve the ability of the impaired individual to propel themselves forward.

[009] Thus, despite efforts to date, there remains a need for ankle-foot orthosis systems that improve biomechanical function, including biomechanical function of the foot, ankle and/or knee. Furthermore, it is desirable to provide an ankle-foot orthosis that imparts propulsive force in connection with a user's gait. Still further, a need exists for products/systems that function to assist or improve the ability of the human foot/leg complex of an impaired individual to spring or propel the individual either forward or upward (or any combination of the two). These and other objectives are satisfied by the disclosed apparatus, systems and methods.

SUMMARY OF THE DISCLOSURE

[0010] The present disclosure advantageously meets the needs of end users interested in improving the efficiency of motion in relation to normal activity. Instead of just attempting to replace lost function, the systems and methods of the present disclosure increase the amount and rate of plantarflexion to assist in gait. Thus, the systems and methods of the present disclosure, in addition to assisting able-bodied individuals, also assists individuals who suffer from an array of neurological impairments.

[0011] The present disclosure provides an advantageous ankle foot orthosis (AFO) that improves biomechanical function, including biomechanical function of the foot, ankle and/or knee. The disclosed AFO system advantageously imparts propulsive force in connection with a user's gait by storing and releasing an individual's own energy to assist in walking and/or standing. In particular, the AFO functions, inter alia, to increase and/or maximize propulsion of the ankle at push off. Thus, rather than merely replacing anatomical function, the present disclosure advantageously improves function to increase propulsivity.

[0012] According to exemplary embodiments of the present disclosure, the carbon fiber layers are placed in such a way on the spring plate so that there are more layers under the metatarsal heads (ball of the foot), where there is the most downforce exerted by the foot, gradually getting thinner (less layers) progressively as you approach the toes, where there is less downforce. This ability to gradually lower the stiffness of the plate as we head distally gives maximum spring to the user, something that cannot be done with standard materials. The carbon layers can also be arranged on various biases in order to increase or decrease stiffness as desired for any particular activity. To maximize the spring effect, the plate is shaped in a slight arc from heel to toe so that just by the user stepping on it a slight pre-load is achieved. The plate is also slightly torqued so that the medial distal aspect (under the great toe) is lower than the lateral aspect (little toe). This maximizes the spring effect by using the natural flow of the gait cycle (laterally from the heel to medially at the great toe). This arched shaped allows the plate to deflect plantarly thereby causing the rear of the brace at the calf to push the leg forward allowing easier propulsion.

[0013] There are four (4) phases of gait. The disclosed footplate advantageously enhances propulsion across the four phases of gait, as described hereinbelow:

• Heel strike: When the foot initially contacts the ground while walking or running. At heel strike, the posterior (rear) of the AFO footplate deflects slightly, attenuating shock, storing energy and allowing a smooth flow to the next phase.

• Foot Flat: When both the heel and the forefoot are on the ground at the same time. At foot flat, the footplate's slight arch from heel to toe provides a pre-load to increase the spring force going into the next gait phase (see, e.g., the downward force represented by Arrow "X" in Fig. 18 that establishes the noted pre-load). A secondary benefit to the arched shape of the footplate from heel-to-toe is that when the footplate deflects, the posterior strut moves forward, providing added "push" during gait (see, e.g., the forward force represented by Arrow "Y" in Fig. 18).

• Heel off: When the foot is flexed with the heel off of the ground (see, e.g., Figs. 5B/5C and Figs. 6B/6C). At heel off, when the foot is maximally flexed is when the potential energy of the footplate is stored ready to be released.

• Toe off: When the foot leaves the ground on its way to the next step. At toe off is when the potential energy stored in the "foot flat" and "heel off phases of gait is released, increasing the force and rate of plantarflexion, propelling the user forward (and/or upward), thereby assisting the impaired individual in walking.

[0014] In exemplary implementations of the present disclosure, the footplate is fabricated, in whole or in part, from pre-impregnated carbon fiber composite. Of note, pre-impregnated carbon fiber composites may be used to deliver desired levels of stiffness and flex in a precise manner through placement so that maximum (and/or desired) spring force can be achieved to assist propulsion of the impaired individual. The footplate is attached/connected to an ankle/leg brace structure to provide lower leg bracing. The attachment/connection may be permanent or designed to facilitate detachment therebetween. The AFO may be advantageously inserted into appropriate footwear, and may function to assist an individual who is suffering from various maladies and/or pathologies, e.g., to compensate for muscle weakness (foot drop) caused by stroke, spinal cord injury, muscular dystrophy, cerebral palsy, peripheral neuropathy and less commonly, polio amongst other conditions.

[0015] The carbon fiber composites may be advantageously arrayed in layers to deliver desired force response characteristics. Moreover, the fiber alignment may be selected so as to deliver a desired force response. Thus, in exemplary implementations of the present disclosure, a plurality of carbon fiber layers are arranged so that the footplate is the stiffest where the pressure is greatest and gradually exhibits greater flexibility (i.e., less rigidity) as it extends distally toward the toe region. As noted in the gait-related discussion above, a purpose of the footplate is to pre-load a spring force at the heel off phase of the human gait cycle, and then to unload the pre-loaded spring force upon toe-off. Since the pre-loaded spring force cannot move the ground beneath the user, it necessarily and advantageously moves the user. More particularly, the loaded spring force releases its potential energy as the user picks his/her foot up off of the ground on the way to the next step. As such, the footplate increases the plantarflexion moment (rate of downforce) as the bottom of the metatarsal heads distally to the toe region, propelling the user forward and/or upward, depending upon the applicable user activity.

[0016] According to another exemplary embodiment of the present disclosure, the foot ankle orthotic includes a footplate and a brace structure. The footplate may include a toe platform, the toe platform comprising a toe, sulcus, and ball; a longitudinal arch pad in communication with the toe platform; a heel cup in communication with the longitudinal arch pad, the heel cup comprising a heel; where the orthotic is made from a flexible material, and where in order to form an angle β that is greater than 0° between the toe platform and the remainder of the orthotic, a pre-load pressure P is required. The brace structure is joined with respect to the footplate and is configured and dimensioned for securement with respect to the lower leg region of a user. The brace structure may be secured with respect to the user' s leg from the front, back, side and/or a combination thereof. Thus, the securement mechanism may be accessed from an anterior, posterior, medial and/or lateral direction relative to the patient' s leg.

[0017] These, and other aspects and objects of the present disclosure will be better appreciated and understood when considered in conjunction with the following detailed description and accompanying drawings. It should be understood, however, that the following description, while indicating exemplary embodiments of the present disclosure, is given by way of illustration and not of limitation. Changes and modifications may be made within the scope of the present disclosure without departing from the spirit thereof, and the disclosure includes all such variations.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The features, aspects, and advantages of the present disclosure, as detailed in the following description, will be better understood by reference to the accompanying drawings, in which:

[0019] FIG. 1 is a side perspective view of a footplate for a right foot according to an exemplary embodiment of the present disclosure;

[0020] FIG. 2 is a top perspective view of the right orthotic footplate shown in FIG. 1;

[0021] FIG. 3 is a front perspective view of an orthotic footplate for a left foot (the "left orthotic footplate") according to another exemplary embodiment of the present disclosure;

[0022] FIG. 4 is a side perspective view of the left orthotic footplate shown in FIG. 3;

[0023] FIGS. 5A-D are schematic views of the right orthotic footplate at various phases of human gait according to an exemplary embodiment of the present disclosure;

[0024] FIGS. 6A-D are schematic views of the left orthotic footplate at various phases of human gait according to an exemplary embodiment of the present disclosure;

[0025] FIG. 7 is a side perspective view of the lateral side of a right orthotic footplate according to another exemplary embodiment of the present disclosure;

[0026] FIG. 8 is a perspective view of an ankle foot orthosis (AFO) for use on the lower right limb of a patient according to an exemplary embodiment of the present disclosure;

[0027] FIG. 9 is a perspective view of the medial side of the AFO of FIG. 8 according to an exemplary embodiment of the present disclosure;

[0028] FIG. 10 is a front perspective view of the AFO of FIG. 8 according to an exemplary embodiment of the present disclosure; [0029] FIG. 11 is a back perspective view of the AFO of FIG. 8 according to an exemplary embodiment of the present disclosure;

[0030] FIG. 12 is a side view of the AFO of FIG. 8 according to an exemplary embodiment of the present disclosure;

[0031] FIG. 13 is a perspective view of the side of the AFO of FIG. 8 according to an exemplary embodiment of the present disclosure;

[0032] FIG. 14 is a perspective view of the AFO of FIG. 8 according to an exemplary embodiment of the present disclosure;

[0033] FIG. 15 is a perspective view of the medial side of the AFO of FIG. 8 according to an exemplary embodiment of the present disclosure;

[0034] FIG. 16 is a front view of an alternative AFO according to an exemplary embodiment of the present disclosure;

[0035] FIG. 17 is a rear view of the alternative AFO of FIG. 16 according to an exemplary embodiment of the present disclosure.

[0036] FIG. 18 is a side view of the alternative AFO of FIG. 16 according to an exemplary embodiment of the present disclosure;

[0037] FIG. 19 is a perspective view of the side of the AFO of FIG. 16 according to an exemplary embodiment of the present disclosure;

[0038] FIGS. 20 and 21 are front and rear views of an alternative AFO according to the present disclosure; and

[0039] FIGS. 22-24 are side views of alternative AFO's according to the present disclosure.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0040] The following description details ankle foot orthosis ("AFO") products in accordance with exemplary embodiments of the present disclosure. However, as will be readily apparent to persons skilled in the art, the present disclosure is not limited by or to the exemplary embodiments disclosed herein, but extends to and encompasses variations and/or modifications that draw upon the innovative systems and modalities described herein. [0041] The disclosed AFO generally includes (i) an orthotic footplate, and (ii) an upwardly extending brace structure that is adapted to engage and be detachably secured with respect to an individual's lower leg region, e.g., ankle region. The disclosed footplate and brace structure are generally integrally joined, although it is contemplated that the disclosed AFO may be implemented with distinct footplate and brace structures that are adapted to be joined, e.g., based on a mating junction. The mating design may offer advantages in situations where flexibility in footplate and/or brace structure properties is desired, e.g., based on the particular anatomy and/or orthotic needs of an individual. Indeed, it is contemplated that an inventory of differently "biased" footplates and differently sized brace structures may be maintained to provide flexibility in implementation of the disclosed AFO systems.

[0042] The disclosed AFO advantageously functions to assist individuals who may be suffering and/or experiencing a variety of pathologies. Thus, the disclosed AFO may be used for control of ankle position, to compensate for muscle weakness (foot drop) caused by stroke, spinal cord injury, muscular dystrophy, cerebral palsy, peripheral neuropathy and, less commonly, polio amongst other conditions. Due to these various conditions, an individual may lose the ability to gait properly and efficiently. The present disclosure advantageously facilitates control and provides assistance during walking, but also beneficially increases the ability of the individual to push against the ground. Thus, broadly stated, the present disclosure advantageously improves balance and propulsion capabilities of an impaired person, replacing (or augmenting) the function of the human foot/ankle/leg complex.

[0043] The disclosed footplate/brace structure combination enables use of a person's own energy and returns it to the individual, thereby advantageously increasing the downforce exerted during walking or running upon the ground. The overall force profile of the disclosed AFO thus functions to propel the user forward or upward, whichever is desired. The disclosed AFO design also increases the dorsiflexion moment, thereby assisting the individual in clearing the ground during swing phase in order to advance to heel strike efficiently and effectively. This increase in propulsive capability is invaluable for individuals suffering from neurological impairment resulting in impaired dorsiflexion control or "foot drop." Indeed, the additional energy return provided by the disclosed AFO during plantarflexion functions to replace (or augment) the propulsion that a normal foot-ankle complex would generate, thereby improving balance, forward movement and proprioception in the impaired individual. [0044] The disclosed footplate and associated brace structure are designed to increase propulsivity in walking, running and jumping activities. The footplate is generally designed with about a 15° plantar flexion from the ball of the foot to the toe, and about a 5° plantar flexion from the 5th metatarsal to the hallux. Based on the noted design, as the user progresses through the phases of gait, the footplate progressively loads potential energy at "foot flat" and "heel-off, and releases that energy at "toe off.

[0045] The footplate may be advantageously fabricated using "pre-impregnated" or "pre- preg" composite fibers where a material, such as epoxy, is already present. These pre-preg composite fibers, e.g., carbon fibers, may take the form of a weave or may be uni-directional. The pre-preg composite fibers typically contain an amount of matrix material used to bond them together and to other components during manufacture. The pre-preg composite fibers are generally stored in cooled areas, since activation is most commonly done by heat. Hence, composite structures built of pre-pregs will mostly require an oven or autoclave to cure.

[0046] In exemplary implementations of the present disclosure, pre-preg carbon fibers are employed in fabricating the footplate. Owing to the use of "pre-preg" carbon fiber in the disclosed footplate, the footplate can be designed with varying amounts of resistance or spring at specific parts and/or regions of the footplate. Depending on how the pre-preg carbon fiber layers are arranged, the footplate can be stiff where the user needs it to be stiff, and flexible where desired and/or required. Pre-preg layering offers superior flexibility and results as compared to standard carbon fiber in that it can be tailored to accomplish an increase in propulsion by increasing the natural spring effect of the human arch and foot structure in a footplate. The carbon fiber layers may be thickest under the ball of the foot and to the heel where the weight is the greatest and gradually get thinner distally under the user's toe region.

[0047] This unique layering process tailors the spring effect of the footplate so that it is stiff where it is needed and flexible where it is necessary to maximize its effect on the human foot. Of note, orthotics are customarily shaped to mirror the shape and motion of the foot. The disclosed footplate is generally shaped in the opposite direction, thereby using the body's own weight to load spring force into the footplate, and further using the user's own motion to increase spring potential. Owing to the stiffness and lightweight characteristics of carbon fiber, the pre-loaded spring force is advantageously unloaded at a rapid rate, propelling the user forward. [0048] The disclosed footplate design loads a spring force while the user is simply standing still and this spring effect is amplified when the toes are dorsiflexed (turned up). As the foot leaves the ground, preparing for its next heel strike, the footplate unloads into plantarflexion at a rapid rate using ground reactive force to propel the user forward by amplifying push-off.

[0049] The disclosed footplate may be made from pre-preg carbon fiber fabrics, although alternative fiber materials may be employed (in whole or in part), e.g., glass fibers, aramid fibers and the like. The carbon fiber fabric may be shipped as a dry loosely woven cloth. A variety of methods may be used to apply wet epoxy resin to the cloth. After application of the epoxy resin, the cloth/resin combination generally cure at room temperature. In forming the disclosed footplate, a molding operation is generally employed. The pre-preg carbon fibers/woven cloth may be applied in layers to an appropriately sized/configured mold. Once positioned within the mold, a clear plastic sheet may be mounted over the pre-preg fibers/cloth and affixed to the edges of the mold, e.g., with foam tape, thereby creating an air tight seal between the inside of the mold and the outside. A vacuum pump is then used to apply a vacuum within the mold as air is removed. As the air is removed, the plastic presses against the pre-preg fibers/cloth and against the inside of the mold. The pre-preg is allowed to cure within the mold as heat is applied to the fiber/mold. The thermoset resin cures at an elevated temperature, undergoing a chemical reaction that transforms the pre-preg into a solid material that is highly durable, temperature resistant, exceptionally resilient and extremely lightweight. Thereafter, the cured fiber system is separated from the mold.

[0050] The carbon fiber layers are generally placed in such a way that there are more layers under the metatarsal heads (ball of the foot), where there is the most downforce exerted by the foot, gradually getting thinner (less layers) progressively approaching the toe region, where there is less downforce. This ability to gradually lower the stiffness of the footplate moving distally from heel-to-toe delivers maximum spring force to the user. The carbon layers can also be arranged on various biases in order to increase or decrease stiffness, as desired, for any particular activity.

[0051] To maximize the spring effect, the footplate is generally shaped in a slight arc from heel-to-toe so that just by the user stepping on the footplate, a slight pre-load is achieved. The footplate may also be slightly torqued so that the medial distal aspect (under the great toe) is lower than the lateral aspect (little toe). This torqued/arched geometric arrangement maximizes the spring effect by using the natural flow of the gait cycle, which generally runs laterally from the heel to medially at the great toe. Moreover, the arched shape allows the footplate to deflect plantarly, thereby causing the rear of the brace structure of the AFO in the calf region to push the leg forward and allowing easier/more effective propulsion.

[0052] Once the footplate is formed from the layered fibers as described above, the footplate is advantageously joined to a brace structure that is configured and dimensioned to secure the combined structure with respect to the lower leg region of a user. Thus, the brace structure may be welded, physically joined (e.g., based on a mechanical junction) or otherwise adhered to the footplate to form a desired monolithic AFO. Alternatively, the brace structure may be integrally formed with the footplate, e.g., during the molding process. Thus, an insert molding process may be employed to form an integral AFO system, whereby a brace structure fabricated from suitable material(s), e.g., a metal, may be joined to layers of pre- preg carbon fibers during a molding process.

[0053] With reference to the appended figures, initial reference is made to FIGS. 1-7 which relate specifically to footplate design according to exemplary embodiments of the present disclosure. In particular, FIG. 1 is a side view of one embodiment of an exemplary footplate 10 according to the present disclosure. This figure shows a right foot footplate. One of ordinary skill will recognize that the present disclosure also encompasses left foot footplates. The footplate 10 may have a toe platform 14, a longitudinal arch pad 18 and a heel cup 22. One embodiment of how the footplate 10 can preload the spring function of the footplate is shown in dashed line 26. The dashed line 26 shows how the toe platform 14 can flex with respect to the rest of the footplate, providing a preload in the footplate 10. When this preload is released, the footplate 10 may provide thrust or propulsion to the user.

[0054] FIG. 2 is a top view of the footplate 10 from FIG. 1. FIG. 2 shows where thickness measurements were made below. Thicknesses were measured generally at the toe 42, sulcus 46, ball 50, and heel 54.

[0055] FIG. 3 is a generally front perspective view of another embodiment of the disclosed footplate 30. The shown footplate 30 is for a left foot. This embodiment of the footplate 30 may have a toe platform 14, a longitudinal arch pad 18, a heel cup 22, and a peroneal arch pad 34.

[0056] FIG. 4 is a side view of the footplate 30 from FIG. 3. The thickness of the material that makes up the footplate 30 may vary. For instance, for a female small sized footplate, the thickness may be about 1 mm at the toe 42, about 1.25 mm at the sulcus 46, and about 1.5 mm at the ball 50 to the heel 54. The small sized female footplate may correspond to a ladies' shoe sizes 5-6. For a female medium sized footplate, the thickness may be about 1.25 mm at the toe 42, about 1.5 mm at the sulcus 46, and about 1.75 mm at the ball 50 to the heel 54. The medium sized female footplate may correspond to a ladies' shoe sizes 7-8. For a female large sized footplate, the thickness may be about 1.5 mm at the toe 42, about 1.75 mm at the sulcus 46, and about 2 mm at the ball 50 to the heel 54. The large sized female footplate may correspond to a ladies' shoe sizes 9-10. For a female extra- large sized footplate, the thickness may be about 1.75 mm at the toe 42, about 1.75 mm at the sulcus 46, and about 2.25 mm at the ball 50 to the heel 54. The extra-large sized female footplate may correspond to a ladies' shoe sizes 11-12.

[0057] For a male small sized footplate, the thickness may be about 1 mm at the toe 42, about 1.25 mm at the sulcus 46, and about 1.5 mm at the ball 50 to the heel 54. The small sized male footplate may correspond to men's shoe sizes 6-7. For a male medium sized footplate, the thickness may be about 1.25 mm at the toe 42, about 1.5 mm at the sulcus 46, and about 1.75 mm at the ball 50 to the heel 54. The medium sized male footplate may correspond to men's shoe sizes 8-9. For a male large sized footplate, the thickness may be about 1.5 mm at the toe 42, about 1.75 mm at the sulcus 46, and about 2 mm at the ball 50 to the heel 54. The large sized male footplate may correspond to men's shoe sizes 10-11. For a male extra-large sized footplate, the thickness may be about 1.75 mm at the toe 42, about 1.75 mm at the sulcus 46, and about 2.25 mm at the ball 50 to the heel 54. The extra-large sized male footplate may correspond to men's shoe sizes 12-13. Of course, one of ordinary skill in the art will recognize that smaller and larger thicknesses may be used depending on the amount of "spring effect" one desires from the disclosed footplate.

[0058] FIG. 5 shows the footplate 30 of a right foot during the different phases of a step or stride. FIG. 5- A shows the footplate 30 as the foot is about to strike the ground 38 heel first. At FIG. 5-A, the flex angle β is generally 0°, that is the angle made between the toe platform and rest of the footplate due to a force applied by a user to the footplate, generally during walking, running, and/or jumping. FIG. 5-B shows the footplate as the foot begins to leave the ground and a pre-load has already started to occur in the toe platform 14, such that angle β is about 20°. FIG. 5-C shows an even greater pre-load in the toe platform 14, such that there is an angle β of about 45°. FIG. 5-D shows the foot off of the ground 38, and the footplate 30 has expended its pre-load by providing thrust or propulsion to the user's foot and/or leg. The angle β is now back to 0°.

[0059] FIG. 6 shows the footplate 30 of a left foot during the different phases of a step or stride. FIG. 6- A shows the footplate 30 as the foot is about to strike the ground 38 heel first. At FIG. 6- A, the flex angle β between the toe platform 14 and the rest of the footplate 30 is generally 0° (or no angle). FIG. 6-B shows the orthotic as the foot begins to leave the ground and a pre-load has already started to occur in the toe platform 14, such that β is about 20°. FIG. 6-C shows an even greater pre-load in the toe platform 14, such that there is an angle β of about 45°. FIG. 6-D shows the foot off of the ground 38, and the footplate 30 has expended its pre-load by providing thrust or propulsion to the user's foot and/or leg. The angle β is now back to 0°.

[0060] In order to form a non-zero angle β, a pre-load force of F is required to create the preload (and the flex angle β). The force of course is spread over an area of the footplate, and in the table below will be described generally as a pressure (psi). The pressure required to create the flex angle β may range from about 1 psi to about 100 psi. According to an exemplary embodiment of the disclosed footplate, the pressures P for various flex angles β are shown below:

Flex Angle β Pressure P

10° 6.7 psi

20° 9.4 psi

30° 12.8 psi

40° 16.8 psi

50° 23.8 psi

60° 28.3 psi

70° 32.8 psi

80° 37.2 psi

90° 39.5 psi

[0061] One of ordinary skill in the art will recognize that the pressure associated with the flex angle β may be changed from the table above depending on the amount of "spring effect" one desires from the footplate. [0062] The footplate 10, 30 works in that it decreases the rate of dorsiflexion of the toes (loading a spring) and increases the rate of plantarflexion of the toes (releasing the spring) in the 4 ^th phase of gait (e.g., FIGS. 5-D and 6-D). This phenomenon maximizes the first ray leverage against ground reactive forces, thereby imparting maximum force to improve propulsion linearly (forward) and vertically (up) and laterally (side to side).

[0063] FIG. 7 shows another embodiment of a footplate 58 according to the present disclosure. In this embodiment, there is an additional preload in the footplate 58. More particularly, the additional preload derives from a dip in the toe 42 with respect to the toe platform 14, such that the toe 42 makes an angle γ with the toe platform. The dip in the big toe area yields a greater spring force for purposes of footplate 58.

[0064] The normal human gait starts at heel strike which is at the back/outside portion of the heel. As gait progresses, the foot rolls through the arch area and the center of gait starts to move medially. In the human gait, the last thing that leaves the ground is the big toe. Therefore, if the big toe is the last thing that leaves the ground, then the big toe area of the footplate must also be the last thing that leaves the ground. To accomplish this objective, the big toe area of the disclosed footplate advantageously dips and provides the last thing on the ground with more associated spring. Having an angle γ gives the footplate 58 an increased spring loading rate. The angle γ may range from about 1° to about 25° in exemplary embodiments of the present disclosure, and is preferably about 15°.

[0065] When the footplate 58 is placed on a flat surface, the heel and the toe are the only parts that touch the surface. Therefore, when one applies weight to the footplate 58, then the entire footplate 58 generally flattens, thus preloading the spring effect of the footplate 58. This additional preloading may make a big difference in the functional attributes of the disclosed AFO system. When one flexes his or her foot to walk or run, the spring load is increased, giving the user an extra push.

[0066] In use, the footplate of the present disclosure advantageously generally functions such that:

(i) in the absence of an applied force to the top surface of the footplate and with the bottom surface of the footplate resting on a horizontal surface (a) the bottom surface of the toe platform region and the heel region contact the horizontal surface; and (b) the footplate bows upward in the longitudinal arch pad region relative to the toe platform region and the heel region, such that the bottom surface of the longitudinal arch pad region is spaced from the horizontal surface, and

(ii) in response to a force being applied to the top surface of the footplate with the bottom surface of the toe platform region and the heel region in contact with a horizontal surface the bowed longitudinal arch pad region flexes downward relative to the toe pad region and the heel region to load a first pre-load force in the footplate (see, e.g., the downward force represented by Arrow "X" that establishes the first pre-load in Fig. 18); and

(iii) in response to the heel region thereafter moving upward from the horizontal surface while maintaining the toe platform region in contact with the horizontal surface (c) the bowed longitudinal arch pad reaches flexes upward and the first pre-load force is released to deliver a propulsive force to the top surface of the footplate; and (d) the footplate flexes to define a flex angle between the toe platform region and the longitudinal arch pad region to load a second pre-load force into the footplate; and

(iv) in response to the toe platform region thereafter moving upward from and out of contact with the horizontal surface the footplate returns from its flexed position to eliminate the flex angle and the second pre-load force is released to deliver a propulsive force to the top surface of the footplate.

[0067] Of note, a secondary benefit to the arched shape of the footplate from heel-to-toe is that when the footplate deflects, the posterior strut moves forward, providing added "push" during gait (see, e.g., the forward force represented by Arrow "Y" in Fig. 18). As will be readily apparent to persons skilled in the art, the relationship of the downward force (Arrow "X") and forward force (Arrow "Y") as shown in Fig. 18 will exist across all disclosed implementations of the AFO products disclosed herein.

[0068] It is noted that in certain implementations, the disclosed footplate may include a heel cup having first and second sides to support a user's heel, or may omit a heel cup altogether. Further, the disclosed footplate may include or define a notch out at the fifth metatarsal to facilitate comfort thereof. Additional modifications and/or refinements to the design of the disclosed footplate may be made without departing from the spirit or scope of the present disclosure. [0069] Turning to FIGS. 8-15, a series of views of an exemplary AFO 100 are provided. The AFO 100 includes a footplate 102 and a brace structure 104 extending upwardly with respect to the footplate 102. Although exemplary brace structures are disclosed in the present application, the present disclosure is not limited by or to the exemplary brace structures disclosed herein. Rather, any brace structure that is effective to secure the footplate relative to the leg of a user may be employed. Of note, the brace structure may be secured with respect to the user's leg from the front, back, side and/or a combination thereof. Thus, the securement mechanism may be accessed from an anterior, posterior, medial and/or lateral direction relative to the patient's leg.

[0070] The footplate 102 generally includes the features and functions of the various footplates described above, and is generally fabricated in like manner. The brace structure 104 generally includes a securing region 106 and an intermediate extension arm 108 that joins the footplate 102 with the securing region 106. In the exemplary embodiment of FIGS. 8-15, the intermediate extension arm 108 advantageously defines an arcuate geometry that extends from a side of the footplate 102 to a central position above the heel region of the footplate 102. In this way, the intermediate extension arm 108 advantageously connects the securing region 106 of the brace structure 104 relative to the footplate 102 without unduly interfering with or abrading the lower leg region of the user.

[0071] The securing region 106 generally defines a semi-cylindrical geometry that is configured and dimensioned to cooperate with the user's rear ankle/calf region. Slots or openings 110 are generally defined in the securing region 106 to reduce weight and materials cost, as well as to reduce the potential for discomfort when attached with respect to the user's lower leg. In the exemplary embodiment of FIGS. 8-15, a central spine 112 is defined between opposed slots/openings 110 of securing region 106 to impart structural stability thereto. A strap or other securement member (not pictured) generally cooperates with the securing region 106 and is adapted to extend around the front of the user's ankle/calf region to secure the AFO 100 relative to the user.

[0072] Although the exemplary AFO 100 shown in FIGS. 8-15 is of integral design/construction, it is contemplated that the securing region 106 may be detachably mounted with respect to the footplate 102, e.g., by providing a detachment mechanism at the junction of intermediate extension arm 108 and central spine 112. Alternative mechanisms for joining/detaching the footplate and the securing region 106 of brace structure 104 may be employed without departing from the spirit or scope of the present disclosure, as will be readily apparent to persons skilled in the art.

[0073] With reference to FIGS. 16-19, an alternative AFO 150 is schematically depicted. The AFO 150 is generally of the same design and operation of AFO 100, including a footplate 152 and a brace structure 154 that includes a securing region 156 and an intermediate extension arm 158 that joins the footplate 152 with the securing region 156. However, unlike AFO 100, the securing region 156 of brace structure 154 does not include a vertically aligned central spine, but instead includes a horizontal member 162 that separates top and bottom slots/openings 160, 161. The overall design of AFO 150 generally facilitates securement with respect to higher points on the lower leg of a user as compared to AFO 100. However, the general features and functions of AFO 150, including the potential for integral and detachable implementations, are the same as compared to AFO 100.

[0074] An alternative AFO 200 is schematically depicted in Fig. 20 (front view) and Fig. 21 (rear view). The brace structure of AFO 200 is similar in design to the embodiment shown in Figs. 10-15. The footplate of AFO 200 is noteworthy in that it is associated with a heel structure 202 that may enhance the comfort and/or function thereof. The height of heel structure 202 may be selected based on comfort and/or functional considerations, as will be apparent to persons skilled in the art. Figs. 22-24 provide schematic side views of exemplary AFO 300 that further highlight an embodiment of the present disclosure that include a heel structure 302. Of note, by ensuring appropriate geometric and structural characteristics of the footplates associated with AFO's 200, 300, the advantageous propulsive properties of the disclosed AFO's are not impacted by the inclusion of a heel structure according to the present disclosure.

[0075] Of note, in exemplary embodiments of the disclosed AFO, the footplate and the brace structure continuously define inner and outer surfaces of the orthosis, and combine to form a monolithic structure. Moreover, the disclosed AFO may be fabricated with variable thicknesses, e.g., in the region of the brace support, and an uninterrupted variable thicknesses may be defined by the footplate and the brace structure. In fabricating the disclosed AFO, it may be desirable to fabricate the brace structure at least in part from fibers, e.g., pre-preg carbon fibers, and to interleave the brace structure fibers with layers of the footplate fibers so as to join the respective structures, e.g., during the molding process. Of further note, it is contemplated that the junction between the footplate and the brace structure may accommodate relative movement therebetween, e.g., a relative sliding movement, so as to facilitate comfort and/or therapeutic results. Thus, for example, a pin-in-track design may be employed to employ relative movement between the noted components.

[0076] The disclosed AFO has many advantages. The AFO may be specifically designed for different ailments/maladies and may be designed to deliver different levels of propulsive force, thereby enhancing the recuperative process. The disclosed AFO may provide more "spring" or "push" to an individual closer to full recovery, while providing less spring/push to users who are less ambulatory. The footplate portion of the disclosed AFO may replace the insole that comes with off the shelf footwear, although alternative modes of combining the disclosed AFO with a user's footwear needs and options may be employed, as will be readily apparent to persons skilled in the art. The footplate associated with the disclosed AFO advantageously pre-loads a propulsive force while the user is simply standing and this spring effect is amplified when the toes are dorsiflexed (turned up). As the foot leaves the ground, preparing for its next heel strike, the footplate unloads into plantarflexion at a rapid rate using ground reactive force to propel the user forward by amplifying push-off.

[0077] While the disclosure has been described with reference to several embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from the essential scope thereof. Therefore, it is intended that the disclosure not be limited to the particular embodiments disclosed as the best mode contemplated for carrying out this disclosure, but that the disclosure will include all embodiments falling within the scope of the appended claims.