Field of Technology

[000.1] The present disclosure generally relates to an in-shoe orthotic device, and more particularly relates to an orthotic device configured to channel kinetic energy and maintain potential energy through a person’s foot during e.g., the stance phase of gait and a method of manufacturing such orthotic device.

Background

[0002] When a person’s heel hits the ground, the heel is in an inverted or supinated position. This is due to the angle and base of gait and also the Q angle in the pelvis. The Q angle, which is also known as quadriceps angle, is defined as the angle formed between the quadriceps muscles and the patella tendon. It was described for the first time by Brattstrom in 1964. The extrinsic muscles (muscles originating in the lower leg but attaching to the foot), specifically the tibialis posterior and the tibialis anterior muscles, should relax in a controlled manner to allow the foot to absorb ground reaction force (force equal to approximately three times body weight) and control the speed of movement between the rearfoot and the forefoot. This is called eccentric muscle control and when carried out properly the foot loads onto the ground in a smooth constant rate, not loading at excessive speed and therefore the muscles are not placed under major stress and the foot moves in a controlled manner from the back of the foot to the front of the foot.

[0003] When the heel hits the ground at an uncontrolled speed, it moves from an inverted to an everted or pronated position placing stress on the muscles that are trying to control this action. It also means that the pressure exerted on the foot by ground (ground reaction force which is equal to the person’s body mass times movement acceleration) moves to the front of the foot too early. This results in an early loading response under the first metatarsophalangeal (1 ^st MTP) joint which can lead to a block in normal sagittal plane movement due to elevation of the 1 ^st MTP joint, preventing the joint from dorsiflexing. Sagittal plane movements generally include any forward and backward movements parallel to an anatomical plane which divides a human body into right and left parts. Some example sagittal plane movements may include flexion (a bending moving that decreases the angle at a joint ), extension (an extending moving that increases the angle at a joint), hyperextension (extending the angle at a joint beyond neutral), dorsiflexion (bending al the ankle so the top of the foot moves toward the shin) and plantarflexion (moving the sole of the foot downward (pointing the toes)). [0004] During the course of any step, the great toe is one structure that is virtually immobile. Once it touches the ground, it will not move until the entire body has passed over it and toe off has occurred. To permit this action, the 1 ^st MTP joint which is located at the base of the big toe of a foot, as shown in Figs. 1 A and 1 B, is designed to permit at least 65 degrees of dorsiflexion (extension of the toe at the I* MTP joint) in the weight bearing phase or stance phase of the step. This hinge action permits the toe’s immobility while permitting the body’s mobility. The stance phase, which comprises approximately 62% of a gait cycle, begins with heel strike of one foot and ends with toe off of the same foot. During this phase, the foot is weight bearing. Some argued that free dorsiflexion is required at the metatarsophalangeal joints to permit efficient bipedal ambulation.

[0005] Human being’s big toe joint ( 1 ^st MTP joint) has become specifically modified to allow bilateral ambulation in the sagittal plane. The joint is a ginglymoarthrodial joint, meaning a ball and socket hinged joint with a sliding component. This join t may bend to 70 90 degrees, thereby allowing a person to pivot at this point and move body weight forward over the top of the joint. Without this ability, human beings would have to waddle or walk with an ataxic (stomping pattern placing entire foot onto the ground) gait, using rotation at the pelvis to twist to gain forward momentum rather than bending the big toe. This joint works properly when the head of the joint stays in a plantarflexed position and the base in a dorsiflexed position.

[0006] The position of the first metatarsal is shown in Fig. 1C with the head of the first metatarsal bone and the 1 ^st MTP joint in a downward position (plantarflexed) 102 and the base of the bone pushed upwards (dorsiflexed) 104. This allows the joint to function properly and to allow the foot to move over the top of the joint and allow the body to move in the sagittal plane, therefore keeping the lower limb aligned. When the 1 ^st MTP joint 106 bends, it creates what is known as the Windlass mechanism, as shown in Fig. 1D. The plantar fascia 108 is a thick band of tissue that runs along the sole of a foot (the fascia). It starts in the heel, runs along the arch and fans out to connect with the base of each toe. It stabilizes a person’s foot when one is walking and acts as a shock absorber. If it’s damaged, it causes pain in one’s heel, and sometimes in the arch of one’s foot The Windlass mechanism is a mechanical model that describes how the bow-string structure of the plantar aponeurosis pulls the calcaneus 110 and the 1 ^st MTP joint 106 closer together and is done so when the plantar-flexed first ray moves into extension. The outcome of these bones moving closer together in distance is tension in the plantar fascia and supination (rolling outwards) of the foot which farther offloads the 1 ^st MTP joint 106 and further facilitates normal sagittal plane motion. Poor eccentric control at the rearfoot means that the 1 ^st MTP joint head loads too early, before it is ready to accept the pressure and it is still unstable and not in a fixed position. This is said to be functionally unstable because it only happens during weight bearing gait and has the ability to function normally when non-weight beating.

[0007] This instability at the rearfoot may be due to the increased speed of loading which is very common in humans and may result in the head of the joint being pushed up by the ground and the base of the first metatarsal falling down. This prevents the Windlass mechanism, prevents normal supination to offload the big toe and to roll off the outside of the foot, and stops normal forward momentum. To regain the forward momentum, the body may learn to compensate, by externally twisting from a flat and compensated position (a compensated position is one in which the joints move from a position of maximum congruency to a position in which their ability to function efficiently is reduced) and rolling off the outside of the foot, and placing the extrinsic muscles on the outside of the leg under stress.

[0008] All joints have a range of motion in which they can work without placing excessive stress (stress that creates pathology) on the structures supporting them, or on a joint itself. When the foot loads at speed or in an uncontrolled manner, a joint loads maximally into its end range and this places stress on the structures. It also means that the foot or the joint has further to travel to move back into normal range of motion to allow it work efficiently.

[0009] Accordingly, it is desirable to design an orthotic device to utilize the ground reaction forces (the forces exerted by the ground on the foot relative to the body mass times the movement acceleration) to achieve maximum control and efficiency in a person’s foot.

Summary

[0010] The present disclosure provides an energy flow orthotic (EFO) device that may be configured to focus on how the ground reaction forces are directed in order to achieve maximum control and efficiency in the foot. In one embodiment, the disclosed EFO device may include multiple channels and at least one textured region implemented thereon. The density of each channel may be determined based at least on a number of parameters such as the body weight of a patient, speed of loading and activity being carried out by the patient. Among other features, the EFO device of the present disclosure may provide visualization of how the orthotics work and indication of the direction of flow of energy.

[0011] In one embodiment, the present disclosure relates to an orthotic device having an energy flow system, comprising: a shell; an energy flow channel implemented in the shell and configured to resist a calcaneal eversion of a foot of a patient when the patient is walking on the orthotic device and direct a ground reaction force of the patient to move at a controlled rate toward the first metatarsophalangeal joint; an energy return channel implemented in the shell and configured to return energy when the foot of the patient moves into a propulsive stage; and a textured region implemented on the shell and configured to generate a feedback into the energy flow system through a neural feedback system of the patient.

[0012] In some aspects, the shell of the orthotic device may have a first density, the energy flow channel may have a second density, and the energy return channel may have a third density. The second density of the energy flow channel may be determined based at least on a body weight of the patient and a speed of loading of the patient. The third density of the energy return channel may be greater than that of the second density of the energy flow channel. The energy return channel may be configured to decelerate a movement off a heel as it loads, and hold the heel within a zone of optimal stress. The energy return channel may be configured to be positioned on the shell in an angle in order to generate a forward momentum. Further, the energy return channel may be configured to push the foot from a low gear push off to a high gear push off, thereby returning an energy into a kinetic chain of toe off. The textured region may be positioned on a medial heel and a distal medial edge of the shell. The neural feedback system of the patient may generate a change in a musculoskeletal system of the patient. In one embodiment, the textured region may be configured to have a selected roughness and stiffness. In some implementations, the energy return channel may be made of polyamide- 11 (PA11) or polyamide-12 (PA 12) nylon powder with a specific thickness. In another embodiment, the energy return channel may be made of asymmetrical carbon fiber and the energy flow channel may be made of dynamic carbon fiber.

[0013] Moreover, a method of manufacturing an orthotic device is disclosed. An example method of the present disclosure may comprise obtaining three-dimensional data of a foot of a patient; establishing a computer-aided design (CAD)'computer-aided manufacturing (CAM) model of the orthotic device based on the three-dimensional data of the foot of the patient; determining positions and densities of energy flow channels and at least one textured region of the orthotic device; and printing a three-dimensional model of the orthotic device.

[0014] In one aspect, the printing the three-dimensional model may use either selective laser sintering (SLS) or fused filament fabrication (FFF) technology. The plurality of channels may comprise an energy flow channel and an energy return channel. Moreover, the method may further comprise implementing the energy flow channel on the shell to resist a calcaneal eversion of a foot of a patient when the patient is walking on the orthotic device and direct a ground reaction force of the patient to move at a controlled rate toward the first metatarsophalangeal joint The method may additionally comprise implementing the energy return channel on the shell to return when the foot of the patient moves into a propulsive stage. In some example, the method may comprise implementing the textured region on the shell to generate a feedback into the energy flow system through a neural feedback system of the patient. The method may also comprise determining a first density of the shell of the orthotic device, a second density of the energy flow channel, and a third density of the energy return channel. The energy return channel may be configured to decelerate a movement off a heel as it loads, and hold the heel within a zone of optimal stress. The method may further comprise positioning the energy return channel on the shell in an angle in order to generate a forward momentum. In one embodiment, the energy return channel may be configured to push the foot from a low gear push off to a high gear push off, thereby returning an energy into a kinetic chain of toe off. The method may further comprise positioning the textured region on a medial heel and a distal medial edge of the shell, and determining a roughness and stiffness of the textured region. In one aspect, the method may determine the second density of the energy flow channel based at least on a body weight of the patient and a speed of loading of the patient. The third density of the energy return channel may be greater than that of the second density of the energy flow channel. In one embodiment, the energy return channel may be made of polyamide-11 (PA11) or polyamide-12 (PA 12) nylon powder with a specific thickness. In another embodiment, the energy return channel may be made of asymmetrical carbon fiber, and the energy flow channel may be made of dynamic carbon fiber. Furthermore, the obtaining the three-dimensional data of the foot of the patient may comprise using at least one of: a laser triangulation device, a structured light scanner, and a contact digitization device. The printing the three-dimensional model of the orthotic device may use a selected 3D printer.

[0015] The above simplified summary of example aspects serves to provide a basic understanding of the present disclosure. This summary is not an extensive overview of all contemplated aspects, and is intended to neither identify key or critical elements of all aspects nor delineate the scope of any or all aspects of the present disclosure. Its sole purpose is to present one or more aspects in a simplified form as a prelude to the more detailed description of the disclosure that follows. To the accomplishment of the foregoing, the one or more aspects of the present disclosure include the features described and exemplary pointed out in the claims. Brief Description of the Drawings

[0016] The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate one or more example aspects of the present disclosure and, together with the detailed description, serve to explain their principles and implementations.

[0017] Figs. 1 A- 1 D illustrate foot anatomy and specific parts of a foot;

[0018] Fig. 2 illustrates how to use a medial or lateral wedge to control a rearibot;

[0019] Fig. 3 illustrates the resistance offered by the high density channels of an example orthotic of the present disclosure and how this results in deflection of forward movement;

[0020] Figs. 4A and 4B illustrate a high gear push off and low gear push off, respectively;

[0021] Figs. 5 and 6 illustrate an example insole or orthotics with an example energy flow system having multiple energy flow channels implemented onto the orthotics, according to an exemplary aspect:

[0022] Figs. 7-9 illustrate different perspective views of energy flow channels of an example orthotic device, according to an exemplary aspect; and

[0023] Fig. 10 illustrates a flow chart of an example method of manufacturing an orthotic device, according to an exemplary aspect.

Detailed Description

[0024] Various aspects of the present disclosure will be described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to promote a thorough understanding of one or more aspects of the present disclosure. It may be evident in some or all instances, however, that any aspects described below can be practiced without adopting the specific design details described below.

[0025] Functional foot orthotics may comprise devices used to control, support, or promote correct function of the foot during ambulation. Traditional theories describe their mechanism of action as altering the angles at which the foot strikes a walking surface using wedges placed under the rearfoot and the forefoot, or a specific position the foot is placed in when in a static position.

[0026] Foot orthotics may generally fulfil three main functions. First, foot orthotics may be configured to control the speed at which the heel hits the ground and moves from an inverted position to an everted position. This reduces the stress on the extrinsic muscles acting eccentrically to control this motion. As shown in Fig. 2, the normal mechanism to control the rearfoot may be a wedge, placed under the medial or lateral aspect of the foot This is used to restrict movement and arrest the speed of movement of the rearfoot as it hits the ground in an inverted position. An everted position may refer to the position when the rearfoot bisection is at an angle less than 90 degrees with the ground in weight bearing and an inverted position may occur when the rearfoot bisection is more than 90 degrees.

[0027] Second, foot orthotics may function to support the base of the 1 ^st MTP and keep it in a dorsiflexed position so that the head of the joint can fall into a plantarflexed position. This position is difficult to quantify due to the poor interrater reliability of measurement. The important feature is that the base of the 1 ^st MTP is higher than the head of the 1 ^st MTP when the foot is maintained in subtalar joint neutral with the forefoot locked on the rearfoot.

[0028] Third, foot orthotics may function to promote normal sagittal plane motion through the forefoot and limit the amount of resultant compensation generated. For example, a medial arch support may be used to hold the base of the 1 ^st MTP in an elevated position with a piece of an orthotic shell cut away in order to allow the 1 ^st MTP joint head to drop into the space. This encourages the head of the 1 ^st MTP joint to drop and bend, thereby stimulating the joint to function in the sagittal plane.

[0029] Traditionally, the way the orthotics achieve one or more of the aforementioned functions is by restricting foot movement using wedges at the heel as shown in Fig. 2 and the front of the foot, and by supporting the arch. A wedge 202 may be placed under a specific part of the foot to prevent that part of the foot from rolling inwards or outwards. This type of wedge may function to hold the foot in a specific position, known as a subtalar neutral position, which is proposed to be the best position for the foot to work around. In a subtalar neutral position, the foot is proposed to be neither pronated nor supinated, and the joints will be in their most congruent position, therefore the structures above each joint will work most efficiently. This subtalar neutral theory has been subject to much criticism over the years and the current body of knowledge points more towards promoting normal sagittal plane movement and reducing the stress on tissues trying to control the movement.

[0030] The subtalar neutral theory has been based on anecdotal evidence and while widely adopted by the podiatry profession, it was not scientifically proven. The concept of a wedge (e.g., wedge 202 of Fig. 2) under the heel in order to restrict movement creates a block to natural momentum. This in turn converts movement energy within the lower system of a person into rotational and heat energy, with the result that this energy is subsequently lost from the kinetic chain.

[0031] In addition, a traditional wedge at the back of an orthotic may be made from ethylenevinyl acetate (EVA) material with universal density. That is, the wedge density is not altered or determined in accordance with the weight of a patient, or the force and/or speed with which the patient hits the ground. These factors may not be taken into consideration when manufacturing a functional foot orthotic. This high density EVA loses its stability after a period of time resulting in instability of the primary piece of the orthotic responsible for stability.

[0032] Among other things, the present disclosure presents a solution that may decelerate the speed of loading using resistance and change in direction rather than by using a wedge. By controlling the rate of eccentric loading and reducing the speed, the present disclosure may reduce the stress on the soft tissues (tendons, ligaments and muscles), specifically the tibialis posterior, tibialis anterior and peroneus longus muscles trying to control the speed during the loading phase, which is approximately 3-12% of a gait cycle. In this portion, the knee flexes slightly in order to absorb shock as the foot falls flat on the ground, stabilizing in advance of single limb support. Movement of the foot in the correct direction and control of toe speed may allow the energy stored within the foot to become channeled in the sagittal plane, or the forward direction of travel, and this will result in less compensation occurring at the hip. This may provide a much more fluid approach to controlling the foot without blocking movement.

[0033] In accordance with aspects of the present disclosure, an EFO device may be configured to focus on how the ground reaction force (GRF) are directed in order to achieve maximum control and efficiency in the foot. When a person’s foot hits the ground, the ground hits it back with an equal and opposite force. The exact amount may be based on the body mass of the person times acceleration of loading and may not be a constant between individuals or even within each individual. This accompanied by friction will work to reduce the efficiency of transfer of energy through the fool. An example EFO device of the present disclosure may be designed to create at least one directional force. This may be defined as pathways, created or implied using physical structures to control a physical force and visual effects to lead the eyes of a user through the process. Energy may be directed through the EFO device of the present disclosure, rather than using an external device to maintain the foot in a specific position. In one embodiment, the EFO device may be configured to create a resistive force equal to the loading force, and apply the force at an oblique angle. As a result, a vector may be created based on the magnitude of the force and the direction of application. This resultant vector of force may be aligned with the direction of flow of the foot and may reduce friction, both of which may allow the foot to function more efficiently. Energy flow may include a fluid and positive flow of energy from, when the heel strikes the ground until when the toes leave the ground. It relates to how the GRF may be directed through the foot with minimum stress to the anatomical structures controlling normal movement.

[0034] In accordance with aspects of the present disclosure, an example EFO device may be configured to create resistance in at least one plastic shell using variable density plastic channels. In one embodiment, the density of the plastic shell may be altered during a printing process to make it thicker and therefore more rigid, and it may became proportional to the amount of flex that may be available in that section of the orthotic. This may increase in scale with the weight of a user or patient or the speed of loading of a user or patient at the rearfoot.

[0035] Unlike the rearfoot post applied currently to orthotics, the density of the plastic shell of the present disclosure may be specific to the weight of the user or patient with movement controlled through the material at that section and the thickness in the material. For example, when a foot starts to roll inwards at the heel and hits the denser area of the plastic shell, it may resist the inward movement and this may push the direction of movement laterally, towards the outside of the foot. The EFO device of the present disclosure may be manufactured according to a number of patient-specific characteristics such as the height, weight and dynamic capacity of the patient. Dynamic capacity refers to the amount of stress the patient places on an orthotic device. For example, a rugby player may place a large amount of dynamic capacity on an orthotic device and this factor will need to be considered when calculating the density of the energy flow channels. In one embodiment, a thickness of the EFO device of the present disclosure may be 2 mm for a patient with a body weight up to 70 Kilogram (Kg), 3 mm between 70 and 115 Kg, and 3.5 mm beyond 115 Kg. In another embodiment, the energy flow channels of the present disclosure may be manufactured with an increased thickness of 0.5 mm to increase the relative rigidity of the plastic shell. This is how the density of the plastic shell may be configured to control the direction of a person’s movement. As a type of directional flow, the EFO device of the present disclosure also relates directly to the energy stored in a foot of a patient during a gait cycle which begins at the heel strike of one toot and continues until the heel strike of the same foot in preparation for the next step. [0036] In an embodiment of the present disclosure, an exoskeleton made from carbon fiber may be utilized to create the energy flow components) of the EFO device, which may be adhered to an inferior surface of the plastic shell of the EFO device. For example, the plastic shell may be configured to act as a carrier for the exoskeleton inferiorly and as a support for the foot superiorly. The plastic shell may be configured to have limited structural integrity on its own merit, because it may be manufactured from a thin plastic designed primarily to contour to the arch of a person’s foot. In one embodiment, the plastic shell may be manufactured using conventional thermoplastic or using polyamide- 11 (PA11) or polyamide-12 (PA12) or any suitable polymer materials using additive manufacture techniques.

[0037] In another embodiment, an example exoskeleton of the present disclosure may be made using a combination of different materials (e.g., combining at least two materials). A first material may include dynamic carbon fiber DFX. For example, dynamically flexible Carbitex DFX may increase stiffness as it bends, providing progressive power as a person achieves higher movement speeds, while remaining more flexible at slower movement speeds. The properties of this material may allow it to change its flexibility based on the velocity of loading force acting on it. Among other features, the use of this material may allow the EFO device of the present disclosure to at least offer dynamic control, changing during the gait cycle based on the load acting on it or the activity being carried out. The benefit of this is that the EFO device of the present disclosure may be configured to provide more control if a person is running on it and more flexibility if the person is walking. That is, the EFO device of the present disclosure may be configured to deliver control at least through the properties of the material of the device rather than through the prescription of the device, and the properties of the material may be altered based at least upon the stress applied to the material of the device. In one aspect, one of the differences between the EFO device of the present disclosure and other conventional orthotic devices is that the disclosed EFO device may be configured to alter control through, e.g., at least a thickness of the plastic shell of the device and the properties of the material may not change with time.

[0038] A second material that may be used in combination with the first material may include asymmetrical carbon fiber AFX, Asymmetrically flexible Carbitex AFX may be stiff in one direction providing underfoot protection that enhances stability. That is, the second material may allow itself to be completely flexible in one direction but completely stiff in another. The properties of such material may be used to create energy return into the EFO device of the present disclosure as a person’s foot moves into the propulsive phase of loading. The resistance to flexion absorbs kinetic energy and releases it again as the foot leaves the ground entering the swing phase of the gait cycle.

[0039] In one embodiment, as a person’s heel rolls towards the medial aspect of the EFO device of the present disclosure, the properties of the dynamic carbon fiber may resist this movement and the result is that the medial movement may be directed in the direction of the vector of the force, which is in the forward direction of the foot. Rather than this control happening from the variable density of PA 11 or PA 12, it comes from the addition of an exoskeleton made of dynamic carbon fiber. This is also the case in the energy return system due to the use of the asymmetrical carbon fiber rather titan variable thickness PA11 or PA 12. The thickness of carbon fiber may not be relevant because it would all be the same thickness of 0.2 mm. The exerted control is from the physical nature of the AFX or the DFX - the latter which works dynamically to control force.

[0040] In accordance with aspects of the present disclosure, two methods of manufacturing the disclosed EFO device may achieve similar functions in channeling the energy through the kinetic chain: one uses the varying thickness of materials of the EFO device, and one uses dynamic carbon fiber.

[004.1] Moreover, one of the key components of the EFO device of the present disclosure is the visual journey a patient has taken. Research has shown that much of a person’s sensory cortex is devoted to vision and that there is a powerfill association between visual imagery and understanding. For example, using colors to indicate energy flow may be used to help a patient associate the change in function in her foot and further understand how an orthotic device is helping her. Pathways presented visually, as disclosed in the present disclosure, may be understood by a layperson with limited knowledge of structural and functional characteristics of the neuromuscular and skeletal system. These unique features of the EFO device of the present disclosure may also help the patient understand the functionality of the EFO device.

[0042] In one embodiment, the channel energy flow of the disclosed EFO device may be configured based at least on the following three factors.

[0043] 1. Sensory cortex stimulation indicating how the movement within a foot is controlled and that the energy is directed in the appropriate direction.

[0044] 2. Achieving optimal movement from heel strike through toe off using resistance channels within the EFO device. As the heel rolls towards the medial aspect of the EFO device, the resistance channel of the EFO device may be actively configured to resist this movement and the result is that the medial movement may be directed in the direction of the vector of the force, which is in the forward direction.

[0045] As such, the disclosed EFO device may increase efficiency of motion and utilize extrinsic muscles acting on the foot to aid with control. Normally, the extrinsic muscles required to help plantarflex and invert the foot are blocked by the role of the extrinsic post. This can cause jarring and although the excessive stress is offloaded through the muscle, it does not assist with the action of the muscle. The resistance channel in the EFO device does not arrest the energy flow but deflects it, and in doing so, some of the energy from loading of the heel is maintained in the foot when it hits the ground.

[0046] 3. Density specific channels of the disclosed EFO device may be based on the speed at which the foot loads the device, one or more patient-specific characteristics (e.g., the weight of the patient) and an activity being carried out by the patient. In one embodiment, these channels may be configured to be denser and therefore stiffer. For example, this may be achieved by geometry of the material being used. The increased stiffness may create a resistance, which may be customized to the weight of the patient and activity levels of the patient. In an example process of manufacturing the EFO device of the present disclosure, the thickness of the plastic shell may be determined based at least upon one or more patient-specific characteristics (e.g., the weight of the patient). For example, the plastic shell may start around 2 mm thick and then be increased to 3 mm thick when a patients is 70 --- 75 Kg in weight and then to 3.5 mm when the patient’s weight exceeds 1 15 Kg, with the energy flow channel being manufactured 0.5 mm thicker. In an alternative embodiment, the manufacture of the EFO device may require the use of two types of dynamic carbon fiber, as discussed above.

[0047] In accordance with aspects of the present disclosure, an energy flow system may be implemented to provide control to the disclosed EFO device. Instead of trying to block excessive movement, the energy flow system of the present disclosure may be configured to drive the excessive movement towards a position where it becomes beneficial, creating a vector of the force. Blocking movement by orthotics (e.g., generating resistance from an orthotic device) creates friction and heat in larger quantities which takes energy out of an energy system associated with the orthotic device when the foot hits the ground. When the direction of movement is not blocked, but rather deflected, then less energy is converted to heat and friction and more is retained within the energy system associated with the orthotic device. When the foot is allowed to load excessively (at an increased speed and for a period of time that moves the foot into a compensated position), it moves to a point outside its zone of optimal stress. The fool then has to compensate to move back to the position it should be at and this extra movement causes stress and wastes energy. As noted above, one of the classic methods of controlling excessive movement in the foot may include placing a wedge (e.g., wedge 202 of Fig. 2) under the foot and blocking the movement - the larger the wedge, the more one may block foot movement. However, this method blocks movement rather than pushing it towards better movement. In one embodiment of the present disclosure, the density channels at the rearfoot may be configured to decelerate the movement of the heel as it loads, and hold it within its zone of optimal stress and also because of the angle the channels is positioned at, it may be configured to generate forward momentum.

[0048] Referring to Fig. 3, in accordance with aspects of the EFO device of the present disclosure, energy may be configured to return through high flex material of the EFO device when the foot moves into its propulsive stage 302 (e.g. , the point immediately prior to the foot lifting from the ground). As the 1 ^st MTP joint bends, it causes the foot to supinate onto the 3-5 metatarsal heads and the flexion of the energy return channels 304 will act to return energy back into the kinetic chain ready for the next gait cycle.

[0049] Referring to Figs. 4(A) and 4(B), in accordance with aspects of the present disclosure, a person's weight travels through the medial forefoot and the disclosed EFO device may be configured to push off the 1 ^st ray complex, that is called “high gear push off" (Fig.4(A)). When this is unable to occur and the 1 ^st ray is elevated then it blocks movement in the sagittal plane and forces the foot into “low gear push off’ (Fig. 4(B)).

[0050] High gear may be desirable over low gear push off, but sometimes circumstances or biomechanics do not permit. High gear push off' ensures the forefoot is dorsi-flexed and everted with respect to the rearfoot and the calcaneocuboid and talonavicular joint axes are perpendicular to one smother, providing a rigid lever to push off of as the center of gravity moves medially across the foot. In low gear push off, the foot is inverted and plantarflexed and the stress falls on the lesser metatarsals and lateral stabilizing complex of the ankle, moving the center of gravity laterally, in addition to the calcaneocuboid and subtalar joint axes being more parallel, creating a less rigid lever for push off and decreased mechanical efficiency.

[005.1] The above processes may occur when the calcaneocuboid locking mechanism is functioning properly and there is adequate control, endurance and strength of the extensor hallucis brevis and tibialis anterior muscle. [0052] In accordance with aspects of the present disclosure, one or more energy return channels or strips of the disclosed EFO device may be configured to push a person’s foot from the low to high gear. As such, as the foot rolls over the top of the disclosed EFO device, the associated energy channels may bend and then subsequently return generated energy into the kinetic chain at toe off.

[0053] In one embodiment, adding texture to the shell of the disclosed EFO device on the medial heel and the distal medial edge of the shell may provide control the foot using proprioceptive neural feedback. That is, adding a stimulus to the foot may produce a stimulus that sends a signal through the neural pathway to the brain to effect a change in the musculoskeletal system. The disclosed EFO device may be configured to provide a sensory stimulus that is powerful enough to effect a motor response strong enough to control the foot, without producing a painful stimuli. For example, the amount of texture applied may include a series of 0.2 mm grooves cut into the plastic shell of the EFO device, 2 mm apart for a 16 mm section, creating a ripple in the material that feels similar to a ripple in a sock, in order to make the foot move away from full load bearing.

[0054] In another embodiment where friction may be used, flexible ridging or even ranted shapes under the surface of the top cover of the disclosed EFO device may create the pea in the mattress effect. When the foot senses certain texture of the EFO device, it may create a proprioceptive feedback or signal that is sent to the brain that indicates there is something below the foot. As such, in order to protect the foot, a patient may not put very much pressure on this sensed area. In order to get a significant change in the direction of movement, the stimulus may need to produce pain because this is the strongest stimulus. In one embodiment, texture may be added to the disclosed EFO device to produce a stretch sensation in the skin, which may be sufficient to promote movement from the sensed area without generating pain. The use of texture generated during printing (eg. , 3D printing) may provide sufficient feedback to generate directional movement and assist in the energy flow through the foot during loading.

[0055] Figs. 5 and 6 illustrate an example insole or orthotics with an example energy flow system having multiple energy flow channels (e.g. , channels 502 and 504 of Fig. 5 and channels 602 and 604 of Fig. 6) implemented onto or in the EFO device, in accordance with aspects of the present disclosure. In one embodiment, channel 504 of Fig. 5 and channel 604 of Fig. 6 may indicate the energy flow channels that may be printed in a different density than that of the plastic of the main body of the shell. The densities of these channels 504 and 604 may be determined based at least on a body weight of a patient and speed of loading. For example, the weight and speed of movement may be mul tiplied to yield a force that may be applied to a chart to determine the thickness of the material required to control this movement. Such a chart may identify specific orthotics materials and characteristics determined based at least on personal preferences of patients, podiatrists’ training and experience, and pertinent biomechanical and scientific principles. In one aspect, channels 504 and 604 may be made of dynamic carbon fiber which has more flexibility when walking but becomes more resistance when one bends it fast or puts more velocity of loading through it.

[0056] Area 506 of Fig, 5 and area 606 of Fig. 6 may include a rough textured surface that is designed to generate feedback into the system through the neural feedback system. The roughness or texture of areas 506, 606 may be configured to create a stimulus that sends a signal through sensory nerves to the brain to indicate that something is not correct at that point under the fool The brain then sends a signal through the motor neurons to the nerve to effect a muscular response and move the weight from that area and towards the outside of the foot.

[0057] The channels 502 of Fig. 5 and 602 of Fig. 6 may be an energy return system built into the plastic shell which facilitates returning energy to assist with the natural elastic recoil built into the muscles in the lower limb. In one embodiment, channels 502, 602 may be made from a material like carbon, because it is stiff with high energy retention and low deformation characteristics. For another example, materials with a specific thickness of PA11 or polyamide-PA12 nylon powder may be used. In another embodiment, channels 502 and 602 may be made of asymmetrical carbon fiber, different from the materials of channels 504 and 604, such that channels 502 and 602 only bend in one direction.

[0058] In a preferred embodiment, as shown in Figs. 5 and 7-9, channel 502 may be a straight component and channel 504 may be configured to be L-shaped, and both channels 502 and 504 may join each other at a selected point (e.g., the outer edge of one of the legs of channel 504), thereby forming an angle between channel 502 and one of the legs of channel 504. Channel 504 may be configured to start at the medial aspect or inside of a person’s heel on one distal end and move obliquely across to the lateral aspect of the heel. The distance or length of this 1 ^st leg of channel 504 may be configured to vary between foot sizes. Channel 504 may then move obliquely from lateral heel to the 1 ^st MTP joint and contour along the medial longitudinal arch of the foot. Human foot height from the ground on average may be 26 mm and the distance or lengtli of the 2 ^nd leg of channel 504 may be determined based on the length of each individual’s foot. Channel 502 may be configured to run from 10 mm distal to the metatarsal head 4 and 5 and run proximally ending where channel 504 meets the lateral aspect of the plastic shell. The length of channel 502 may be determined based on the length of each individual’s foot. In one embodiment, the inside angle of channel 504 may form a 90 degree angle, such that channel 504 runs at an oblique angle between the medial and lateral border of the foot and the lateral aspect of the heel and the 1 ^st MTP joint.

[0059] It should be appreciated that channel 504 may be configured to have a different shape or have a different inside angle and the actual shape, dimensions, and displacements of channels 502 and 504 on or inside a plastic shell of the EFO device may be determined based on anatomy of each individual’s foot.

[0060] Fig. 10 illustrates a flow chart of an example method 1000 of manufacturing an orthotic device (e.g., the disclosed EFO device), in accordance with aspects of the present disclosure. The first step 1002 in manufacturing the orthotic device may include obtaining three- dimensional data of a patient’s foot with which the orthotic device is to be used. In one embodiment, such data may be obtained using a scan of the foot using appropriate hardware and software. For example, laser triangulation may use a laser light to measure the distance between the laser source and the patient’s foot to create an accurate model of that foot. Alternatively, a structured light scanner may use the same trigonometric triangulation used in laser scanning, however instead of using a laser light, it projects a light pattern onto an object and calculate the distance to the light source. Further, one may use contact digitization technology which uses a three-dimensional pin matrix to capture contours of the plantar aspect of the foot. These scanning technologies may not use computer algorithms, extrapolations, or interpretations to calculate shapes and contours from two-dimensional pressure readings, ink impressions, single aspect photographs, or any other two-dimensional methods. In another embodiment, three-dimensional data of a patient’s foot may be obtained indirectly using an imprint of the foot. Alternatively, an existing orthotic device of the patient may be scanned in order to reproduce existing foot shape and corrective features.

[0061] In yet another embodiment, one may use an image capture device (e.g., a smart phone) to capture multiple still images of a patient’s foot and/or video of the foot when walking, and transmit captured information to a computing device with an image processor to determine landmarks of the foot. For example, artificial intelligence (Al) in the form of an expert system, neural network or fuzzy logic may be used to determine landmarks of the foot in the captured images and video using an Al library stored in an associated database. The image processor may be configured to process the received images and identify a number of anatomical landmarks of the foot. Al may be used to determine how the channels of the disclosed EFO device may be positioned in relation to these landmarks.

[0062] Next, step 1004 may include establishing a CAD/CAM model based at least on the processing results of the images and three-dimensional data of the patient’s foot. For example, the design may be thickened and edges may be capped off to form a solid surface model. The model may also be manipulated to include any features such as any extension portions to the orthotic device, or any recesses or raised portions required. Additional computer-aided design technology (e.g., haptic feedback modeling and simulation) may be used to add features and smooth and blend features of the orthotic device in order to improve comfort for a user. As a result, a 3D image file of the resulting orthotic device may be generated.

[0063 ] In the next step 1006 of the method 1000 and further in connection with the discussions above with respect to Figs. 5-9, the positions and densities of energy flow channels 502, 504, 602, 604 and textured regions 506, 606 on the orthotic device may be determined via appropriate software. The model of the orthotic device may be divided into sections according to the level of support or compressibility required. The level of support or compressibility may be determined using materials of a different hardness and/or geometric grading.

[0064] The orthotics model may be exported to any appropriate software from which a 3D printer may operate. In one embodiment, one may further revise the orthotics model based on a specific user’s needs or patient’s prescription.

[0065] In the final step 1008, a selected suitable 3D printer may be used to print the orthotic device. For example, selective laser sintering (SLS) and fused filament fabrication (FFF) technologies may be used, both of which work by raising the temperature of a thermoplastic material to the point that the molecules flow together and bond. Example materials may include nylon which may allow one to modify with additives (e.g., glass fibers), polystyrene, rubber, polypropylene, polyethylene, copolymer, PAU, PA 12, carbon fiber, thermoplastic polyurethane, and EVA.

[0066] The EFO device of the present disclosure may be configured to channel energy through the foot and create a perpetual flow of energy with the best efficiency of motion as possible. In one example, this may be measured using a triaxial vibration monitor to measure if the amount of hard stop momentum has been decreased and deflection has allowed the movement to reduce harmful vibration through the leg. The amount of internal tibia-fibula rotation and velocity of loading at the rearfoot may provide a measure of how much the EFO device is allowing the foot to absorb GRF and move through the sagittal plane in high gear without the need for compensation.

[0067] The effect of the disclosed EFO device may be measured in connection with the ability to reduce pain. When a patient attends for a physio or chiropractic appointment, the objective is pain relief and ability to function normally. The disclosed EFO device may be part of a spectrum of treatments, stretching, strengthening, footwear and orthotics to allow a fully holistic treatment approach. When patients receive relief of symptoms, the treatment is deemed successful.

[0068] In one aspect, the specificity of the control provided by the disclosed EFO device may be achieved by making the channels specific to a number of parameters such as the body weight of a patient, speed of loading, and activity being carried out by the patient. The customization of the EFO device may be programmed into a 3D primer which may print the directional lines and alter the densities of various portions of the device based on the prescription. For example, this may be achieved by geometry when inputting the prescription data into the computer prior to manufacture.

[0069] Among other features, the EFO device of the present disclosure provides visualization of how the device works and an indication of the direction of flow of energy. That is, the disclosed EFO device may offer a visual journey of how the orthotic will control the foot, or how it moves energy through the foot As such, the disclosed EFO device connects a specific patient to a recommended treatment. The understanding of how the EFO device works will help patients understand the changes they feel in their feet when they wear the device and this will help compliance. The visual imagery process simulates perceptual representations on the basis of past experience and provides a mental template that can influence subsequent perception. Moreover, the disclosed EFO device may use texture to change the direction of motion and create self-regulation through proprioceptive feedback.

[0070] The above description of the disclosure is provided to enable a person skilled in the art to make or use the disclosure. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the common principles defined herein may be applied to other variations without departing from the spirit or scope of the disclosure. Further, the above description in connection with the drawings describes examples and does not represent the only examples that may be implemented or that are within the scope of the claims.

[0071] Furthermore, although elements of the described aspects and/or embodiments may be described or claimed in the singular, the plural is contemplated unless limitation to the singular is explicitly stated. Additionally, all or a portion of any aspect and/or embodiment may be utilized with all or a portion of any other aspect and/or embodiment, unless stated otherwise. Thus, the disclosure is not to be limited to the examples and designs described herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.