OFFLOADING DEVICE

An offloading device includes: a base structure configured to be disposed at least partially around a foot of a user; a securing component configured to secure around a leg of the user; and one or more offloading components coupled between the base structure and the securing component to offload weight from the foot of the user.

TECHNICAL FIELD

Embodiments of the present disclosure relate to a device, and in particular to an offloading device.

BACKGROUND

People use their ankles and feet in many activities including moving between locations, performing tasks of employment, participating in sports activities, and so forth. The ankle and foot can have problems, such as injuries and other conditions, which cause pain, limit movement capability, and so forth.

DETAILED DESCRIPTION OF EMBODIMENTS

An orthosis is an externally applied device used to modify the structural and/or functional characteristics of the neuromuscular and/or skeletal system. An orthosis may: control, guide, limit, and/or immobilize an extremity, joint, or body segment; restrict movement in a given direction; assist movement generally; reduce weight bearing forces; aid rehabilitation from fractures after the removal of a cast; and/or correct the shape and/or function of the body to provide easier movement capability or reduce pain.

A lower-limb orthosis is an external device applied to a lower-body segment to improve function by controlling motion, providing support through stabilizing gait, reducing pain through transferring load to another area, promoting better healing (e.g., for diabetic foot ulcers), correcting flexible deformities, and/or preventing progression of fixed deformities. Examples of lower limb orthoses include a walking boot (e.g., controlled ankle motion walking boot, below knee walking boot, moon boot) and a walking brace (e.g., foot ankle brace) which are orthopedic devices that can be used for treatment and stabilization of severe sprains, fractures, and tendon or ligament tears in the ankle or foot. In cases where ankle motion is to be limited, a walking boot can be used in place of a cast.

Walking boots can be used to protect and/or immobilize the foot and ankle to promote healing. Walking braces can reduce the amount of force the foot ankle complex experiences. Walking boots and walking braces can be used as a post-operative rehabilitation device, a post injury rehabilitation device, and/or treatment device for foot and/or ankle problems. Walking boots and/or walking braces may be custom fabricated.

Conventional devices have disadvantages. For example, conventional devices may take advanced fabrication skills and methods to manufacture which dramatically limits the reach of the devices. Conventional devices are designed primarily for immobilizing and protecting the foot-ankle complex while allowing most of the weight of the user to rest on the foot-ankle complex (e.g., do not take a quantifiable amount of weight off of the foot-ankle complex). Conventional devices do not quantify and/or control the amount of weight of the user that is loaded onto the foot-ankle complex. Conventional devices restrict ankle and foot movement and cause leg length imbalance. These two factors alter gait and may cause other musculoskeletal problems.

The devices, systems, and methods disclosed herein provide an offloading device (e.g., offloading walker boot, offloading foot brace, etc.).

An offloading device may include a base structure, one or more offloading components, and a securing component. The base structure is configured to contact an external surface (e.g., ground, floor, etc.). For an offloading walking boot, the base structure is disposed under the foot of the user. For an offloading brace, the base structure is disposed at least on the sides of the foot of the user.

The securing component is configured to be secured around the lower leg via one or more fasteners (e.g., hook and loop fasteners, laces, tightening buckle, ratcheting system, and/or the like).

The offloading component may include one or more springs, a motorized piston, a pneumatic device, and/or the like. The offloading component separates the securing component from the base structure. The offloading component is configured to offload at least a portion of the weight of the user from the foot-ankle complex.

The systems, devices, and methods of the present disclosure have advantages over conventional solutions. The offloading device of the present disclosure may be made without advanced fabrication skills and methods of manufacture which allows the offloading device to be available to more users. The offloading device of the present disclosure removes at least a portion of the load from the foot-ankle complex which may decrease pain, quicken recovery, and allow users to perform more activities. The offloading device of the present disclosure may be used to quantify and/or control the amount of weight (e.g., 60 pounds (lbs), 120 lbs) of the user that is to be offloaded from the foot-ankle complex. The offloading device of the present disclosure may cause less gait changes and may cause less musculoskeletal problems compared to conventional solutions.

The offloading device of the present disclosure can be manufactured using lower complexity manufacturing processes compared to conventional solutions. This allows the offloading device to be distributed widely to those whom the offloading device is of benefit.

The offloading device of the present disclosure may have adjustability of offloading which is absent in conventional solutions. The adjustability of the offloading of the offloading device allows practitioners to recommend and modify the offloading device to deliver a specified amount of offloading to speed recovery and/or mitigate the foot ankle disorder.

In some embodiments, the offloading device of the present disclosure does not use custom fitting and/or fabrication. This allows the offloading device to be distributed widely to those whom the offloading device may benefit.

In some embodiments, the offloading device of the present disclosure can be used during rehabilitation after operative procedures. This allows the user to walk with less load on the affected area. This partial offload allows for ambulation without damaging the areas in which the procedure(s) were performed. Ambulation with partial weight bearing provided by the present disclosure can improve rehabilitation time and lessen patient temporary disability.

In some embodiments, the offloading device of the present disclosure can be used to address chronic foot ankle pain. The user can selectively or exclusively use the offloading device to reduce the forces that the foot-ankle complex experiences. Reduced forces provided by the present disclosure may result in a reduction of pain experienced.

In some embodiments, the offloading device of the present disclosure can be used in the treatment of wounds, such as diabetic foot ulcers. Research shows that offloading is integral to healing foot wounds. Patient compliance to non-weight bearing orders is very low. The offloading device of the present disclosure reduces loading while allowing the user to ambulate. The offloading device improves both healing and mobility during rehabilitation.

In some embodiments, the offloading device provides offloading of the foot-ankle complex without any connection to the foot-ankle complex or with less connection to the foot-ankle complex than conventional solutions.

The offloading device may allow the foot-ankle complex to move naturally (e.g., free to move naturally). This is advantageous in rehabilitation situations and improves experience of the user which improves user compliance in use of the offloading device.

Although some embodiments of the present disclosure refer to offloading boots and offloading braces, other embodiments that include a base structure, offloading component, and securing component that are not a boot or brace may be used. Although some embodiments of the present disclosure refer to the offloading component of the offloading device including one or more springs, other embodiments may provide offloading without use of a spring.

FIGS. 1A-Billustrate views of an offloading device100, according to certain embodiments.FIG. 1Ais a side view of an offloading device100andFIG. 1Bis a front or rear view of the offloading device100. The offloading device100can include a base structure110, one or more offloading components120, and a securing component130.

The base structure110may be configured to rest on a surface, such as the ground, the floor, a surface on which the user is to be disposed (e.g., walking surface, standing surface, running surface, etc.), and/or the like. The base structure110provides an offset between a bottom surface of the foot and the surface under the foot (e.g., foot bed of the base structure110, the ground, the floor, etc.) when the offloading component120is in an unloaded state. The bottom of the foot or component around the foot (e.g., shoe, sock, liner, etc.) may come in contact with the surface under the foot when the offloading component120is in a loaded state.

The base structure110is configured to be disposed under (e.g., the foot bed of the base structure110is disposed under) and/or on one or more sides of (e.g., at least partially around) the foot of the user. In some embodiments, the base structure110is disposed under the foot of the user (e.g., an offloading walker boot). In some embodiments, a compressible material (e.g., foam pad, neoprene) is disposed on the foot bed of the base structure110. Responsive to the offloading component120being in an unloaded state (e.g., weight is not being supported by the leg), the compressible material prevents the toes of the user from contacting the foot bed of the base structure110(e.g., the compressible material maintains the entire foot offset from the foot bed. Responsive to the offloading component120being in a loaded state (e.g., weight is supported by the leg), the compressible material compresses to allow the foot to be more proximate the foot bed of the base structure110(e.g., the compressible material maintains the entire foot offset from the foot bed.

In some embodiments, the base structure110is disposed proximate the sides of the foot of the user without being disposed under the foot of the user (e.g., an offloading foot brace). In some embodiments, the base structure110is a U-shape that is disposed on lateral sides and behind the foot. In some embodiments, the base structure110has two side pieces that are configured to be disposed on either side of the foot (e.g., without being a U-shape). In some embodiments, the two side pieces of the base structure110are connected by a component that is configured to go over the foot.

In some embodiments, the base structure110is not directly connected to the securing component130(e.g., the securing component can be varying distances away from the base structure110based on compression of the offloading component120). In some embodiments, the base structure110has a fixed connection (e.g., non-rotating connection, attachment plate, etc.) to the offloading component120.

The securing component130may be configured to be disposed around the lower leg (e.g., shin and calf) of the user (e.g., around a portion of the lower limb between the knee to the ankle, the crus, the calf, etc.). In some embodiments, the securing component130includes one or more indicators (e.g., markings) indicating how much to tighten the securing component130for different amounts of offloading. For example, for greater offloading, the securing component130may secure tighter to the leg and for less offloading, the securing component130may secure less to the leg.

In some embodiments, to provide the offset between the bottom of the foot and the surface (e.g., floor, ground, foot bed of base structure110) under the foot, a platform structure (e.g., rigid foam pad, wood block, etc.) is placed on the surface under the foot and the foot is placed on the platform (e.g., when weight is not being supported by the leg or the offloading device100). The securing component130is then secured to the lower leg (e.g., around the shin and calf, etc.) and the platform is removed from under the foot of the user to provide the offset (e.g., gap) between the bottom of the foot and the surface under the foot. In some embodiments, the height of the offset is determined based on the amount of offloading (e.g., compression of the offloading component120) and the amount of skin movement (e.g., amount skin stretches when secured by the securing component). In some examples, the amount of offset equals the compression of the offloading component120plus the distance of skin stretching. For example, for a half inch of compression of offloading component and a half inch of skin stretching, the offset (e.g., between the bottom of the foot and the surface under the foot, between the bottom of the shoe and the surface under the shoe, between the bottom of the liner and surface under the liner, the height of the platform) will be one inch.

In some embodiments, the distance of the offset between the bottom of the foot and the surface under the foot and the tightness of the securing component130are based on trial and error until a predetermined amount of offloading (e.g., compression of the offloading component120from an unloaded state to a loaded state) occurs (e.g., and there is no slipping between an inner surface of the securing component130and an outer surface of the leg between the unloaded state and the loaded state).

In some embodiments, the securing component130includes a compressible material (e.g., foam, neoprene, rubber, pneumatic bladder, silicone, etc.) and a fastener, where the compressible material is disposed between the fastener and the leg. As the fastener tightens, the compressible material compresses to avoid high pressure points and to more evenly distribute the pressure from the fastener onto the leg. The fastener can include hook and loop straps (e.g., Velcro® fastener), cams with rigid components (e.g., seeFIG. 8A, different sizes and/or shapes for different legs, compressible material on inner surface of rigid components to conform to size and/or shape of leg, etc.), cams with fabric components (e.g., seeFIG. 8B), laces, BOA system, tightening buckle, ratcheting system, laces that pull and are inserted into a component to secure the amount of tightening provided by the lace, and/or the like. The compressible material can include a foam or gel structure. In some embodiments, the securing component includes one or more fasteners, a compressible material, and a liner (e.g., boot liner) disposed between the fasteners and the compressible material. In some embodiments, the liner and/or compressible material is secured to the leg via multiple fasteners. In some embodiments, each of liner and/or compressible material has a single fastener.

In some embodiments, the liner is disposed around one or more of the lower leg, ankle, and/or foot. The liner may protect the lower leg, ankle, and/or foot from abrasion and/or impact.

In some embodiments, the securing component130includes a pneumatic bladder to secure to the leg (e.g., seeFIGS. 10A-C). The amount of pressure provided by the securing component130against the leg may be adjustable (e.g., via an input bulb and release valve) to adjust tightness of the securing component130around the leg. The pneumatic bladder may be filled with one or more of a fluid, gas, liquid, air, water, gel, etc.

The securing component130may include a supporting structure (e.g., rigid or semi-rigid structure) disposed between the offloading component120and the fasteners of the securing component130to prevent bending of the securing component130(e.g., of the supporting structure) during compression of the offloading component120. The supporting structure pushes down on the offloading component120when in a loaded state. The supporting structure may wrap around the sides and rear of the leg. The supporting structure may include a first structure on the first side of the leg (e.g., above the first offloading component120) and a second structure on the second side of the leg (e.g., above the second offloading component120). The support structure may have holes to provide airflow to the leg. The supporting structure could be disposed on the front of the leg (e.g., formed to conform to the shin of the leg). The liner or compressible material may be secured to an inner surface of the supporting structure (e.g., via hooks and loops, via sewing, etc.) and the fasteners (e.g., hook and loop straps) may be secured to the outer surface of the supporting structure (e.g., via hooks and loops, via sewing, etc.).

The offloading component120may include one or more springs, a motorized piston, a pneumatic device, and/or the like. The securing component130separates the securing component130from the base structure110. The securing component130is secured around the leg of the user with the foot elevated from the walking surface (e.g., ground, floor, inner surface of the base structure, etc.) when weight is not applied on the leg (e.g., down towards the foot-ankle complex). The offloading component120is configured to offload at least a portion of the weight of the user from the foot-ankle complex. In some examples, the offloading component120offloads about 60 to 120 lbs of weight off of the foot-ankle complex. In some examples, the offloading component120offloads about 30 to 180 lbs of weight off of the foot-ankle complex. In some examples, the offloading component120offloads about 0 to 240 lbs of weight off of the foot-ankle complex.

Responsive to the body of a user being supported by the legs of the user (e.g., standing, walking, running, etc.), the weight of the user is distributed between the two legs. Conventionally, the foot-ankle complexes of the user support the weight of the user. For example, for a user that weighs 200 lbs, 100 lbs is supported by a first foot-ankle complex and 100 lbs is supported by a second foot-ankle complex. The offloading component120can offset a set amount of weight from the foot-ankle complex. In the example of 100 lbs being supported by the foot-ankle complex, the offloading component120can be set to offload 60 lbs. When the offloading component is not supporting weight, there is a gap between a surface under the foot (e.g., ground, floor, floor bed of the base structure110) and the bottom of the foot (e.g., shoe, liner, etc.). As the 100 lbs weight is applied to the leg, the securing component130pushes down on the offloading component120with 100 lbs (e.g., to compress the offloading component120) and the offloading component120pushes back on the securing component130with 60 lbs. As the offloading component120compresses, the bottom surface of the foot comes in contact with the surface under the foot (e.g., floor, ground, foot bed of base structure). In the compressed state, 40 lbs of the 100 lbs is applied to the foot-ankle complex and 60 lbs is translated from the base structure110that is disposed on the ground (e.g., bypassing the foot-ankle complex), through the compressed offloading component120, and to the securing component130.

In some embodiments, the offloading component120is adjustable to provide different amounts of offloading. In some embodiments, for a first state of the foot-ankle complex, more weight (e.g., a substantial portion of the weight) is to be offloaded from the foot-ankle complex and for a second state of the foot-ankle complex, less weight is to be offloaded from the foot-ankle complex. In some embodiments, in addition to offloading weight from the foot-ankle complex, the offloading component120reduces the impact felt by the foot-ankle complex (e.g., softens the blow) responsive to the offloading device100coming in contact with the ground (e.g., the offloading component compresses and then puts a portion of the weight on the foot-ankle complex).

In some embodiments, the amount of offloading of the offloading device100is adjustable by adjusting offloading of the offloading component120. In some embodiments, the offloading component120is adjustable by switching out the springs to different springs that have a different spring rate (e.g., different spring constant), so that with the same offset or gap, different amounts of offloading can be achieved. In some embodiments, the offloading component120is adjustable by adjusting the compression of the springs of the offloading component120in the unloaded state (e.g., adjusting separation of brackets between which the spring is disposed via tightening or loosening a screw, turning a knob, etc.) and securing the securing component130with the same size of gap between the foot and surface under the foot (e.g., foot bed of the base structure110, ground, etc.). In some embodiments, the amount of offloading is adjustable by adjusting the distance between the foot and the surface under the foot (e.g., foot bed of the base structure110, ground, etc.) to adjust the amount of compression of the offloading component120when weight is supported by the leg.

In some embodiments, there is an offloading component120on opposing sides of the leg of the user. This may provide more stability, more even offloading, more protection of the foot-ankle complex, and so forth. In some embodiments, there is an offloading component120at the rear of the leg. This may provide offloading for the heel of the user.

In some embodiments, offloading device100has a controller122. The controller122may include one or more components of computer system900ofFIG. 9. The controller122may receive user input (e.g., via one or more buttons, a liquid crystal display (LCD)), via a wireless component, etc.) and may cause the offloading component120to adjust amount of offloading based on the user input. In some embodiments, the controller122receives sensor data (e.g., pressure data from a pressure sensor in the base structure110, distance data from a sensor in the base structure110, etc.) from a sensor124and controls the amount of offloading based on the sensor data. In some embodiments, the controller122controls the amount of offloading based on user input and sensor data.

In some embodiments, the offloading component120includes one or more electrical components that are controlled by the controller122. In some examples, the offloading component120includes a motor that adjusts spring load, a piston that adjusts spring load, an electrical actuator (e.g., instead of or in addition to a knob or a screw) that adjusts compression of the offloading component120when in an unloaded state, a pneumatic piston, etc.

In some embodiments, the securing component130includes one or more electrical components coupled to the controller122, such as an electronic valve on a pneumatic bladder, a sensor124(e.g., a pressure sensor, a heart rate sensor), etc. In some embodiments, the base structure110includes one or more electrical components coupled to the controller122, such as a sensor124(e.g., pressure sensor, a distance sensor, a heart rate sensor), etc.

FIGS. 2A-Dillustrate components of offloading devices100(e.g., offloading walking boot), according to certain embodiments.FIG. 2Aillustrates the offloading device100without weight applied (e.g., without weight applied on the leg in a downward direction, offloading component120in an uncompressed state, in an unloaded state).FIG. 2Billustrates the offloading device100with weight applied (e.g., with weight applied on the leg in a downward direction, offloading component120in a compressed state, a loaded state). InFIG. 2B, the foot (e.g., and bottom surface of the liner) is proximate (e.g., rests on) the foot bed of the base structure110and the offloading component120is compressed (e.g., springs are compressed).FIG. 2Cillustrates an offloading component120in an uncompressed state (e.g., unloaded state) andFIG. 2Dillustrates an offloading component120in a compressed state (e.g., loaded state).

The offloading device100(e.g., offloading orthopedic walker boot) may include a base structure110that is a rockered base constructed of plastic with a rubber outsole and foam foot bed. The offloading device100may include two offloading components120(e.g., two spars) that protrude out of the base structure110on either side of the leg of the user. Each offloading component120(e.g., spar) has an offloading mechanism integrated into the offloading component120. The offloading components120may connect to a soft fabric and foam boot liner that protects and cushions the lower leg and foot-ankle complex.

Conventional devices do not include offloading components120(e.g., offloading mechanisms). Conventional devices also do not include the fabric and foam liner (e.g., of the securing component130).

In some embodiments, the offloading component120(e.g., offloading mechanism) includes an upper bracket210, a lower bracket220, guide pins230, springs240, an adjustment screw250, and bushings260. The lower brackets220are attached to the lower spars and the upper brackets210are attached to the upper spars. The lower bracket220has two holes (e.g., recesses, etc.) into which the guide pins230are attached. The lower bracket220also has a threaded hole that accommodates the adjustment screw250. The upper bracket210has three unthreaded holes in it, where two of the holes accommodate bushings260and the other hole accommodates the adjustment screw250. The springs240are installed by sliding the springs240on top of the guide pins230which keeps the springs240constrained and prevents spring buckling. Additionally, the guide pins230align with and slide through the bushings260of the upper bracket210. The upper bracket210“floats” on the springs constrained in the negative z-dimension by the maximum travel of the springs240and in the positive z-direction by the adjustment screw250.

In some embodiments, the offloading component120has a different number of guide pins230, bushings260, springs240, etc. In some examples, the offloading component120has one guide pin230and spring240per side of the offloading device100(e.g., instead of two guide pins230and springs240for each bracket210,220).

In some embodiments, the offloading component120uses an elastic material (e.g. carbon fiber spar, fiberglass rod, etc.) that either deflects or extends as the offloading device100is loaded to achieve an offloading effect. The elastic material may include a portion of the boot spar(s) including a material such as carbon fiber that is configured to flex outwards upon loading acting as a spring and providing offloading.

In some embodiments, the offloading component120includes a motor that exerts a force that translates a portion of the weight user away from the foot-ankle complex.

In some embodiments, the amount of offloading of the offloading component120is adjusted via a screw that compresses the springs which causes an increased load to further compress the springs, this increases the offloading amount. In some embodiments, adjustment of the amount of offloading (e.g., of the offloading component120) that the offloading device100provides includes one or more of: changing the springs which allows springs with different spring rates to be used (e.g., those adjusting the amount of offload provided); engaging or disengaging springs in the system; a knob that is configured to compress the springs; donning the boot with varying heights between the foot bed and the foot of the user, such as different thicknesses of platforms that could be place on the foot bed of the base structure110when the offloading device100is used; a ratcheting system that increases spring tension or compresses springs; and/or the like.

The offloading device100may include a boot liner that includes fabric and compressible material (e.g., foam, gripping fabric, coating, gel) that is attached together in a pattern that wraps around the foot and ankle and lower leg to just below the knee. The boot liner is configured to protect the foot, ankle, and leg and to distribute the forces that are placed on the lower leg comfortably and without slipping. The compressible material used is an impact resistant compressible material that distributes loads very well. The compressible material may be the contact surface between a leg of the user and the boot liner. The compressible material mitigates slipping and comfortably distributes the offloading load by conforming to the leg. The fabric is attached to the compressible material to allow the compressible material to conform to the leg of the user. The fabric has loop material on the outside which is how the boot liner attaches to the boot spars which have hook fabric affixed to them. The boot liner lower portion is lightly secured together by a strip of hook and loop. The upper portion of the boot liner that is around the lower leg is secured by hook and loop cinch straps that are attached to be configured to pull the liner together (e.g., like the lacing of a shoe, rather than just going around the liner). This helps to create and maintain the proper amount of pressure on the leg to prevent significant slipping of the liner up the leg when loaded.

In some embodiments, the boot liner (e.g., securing component130) that enables an offloading effect includes one or more of: a custom upper constructed out of fiberglass or carbon fiber (e.g., similar to sockets created to support prosthetic limbs); an upper portion including materials that may be formed to the leg of the user (e.g., heat softening plastics); an upper portion including leather and compressible material (e.g., foam, gripping fabric, coating, gel) that conforms to the leg of the user; fabric and compressible material (e.g., foam, gripping fabric, coating, gel, silicone) upper portion integrated with one or more inflatable air bladders; and/or the like.

In some embodiments, the securing component130includes one or more of: hook and loop (e.g., Velcro®) cinching straps; spin laces (e.g., BOA fit system); laces; buckles; and/or the like. To maintain and adjust the tightness of the liner, the offloading device100may include one or more of: hook and loop fasteners; laces pulled through a ratcheting device; laces pulled tight and then prevented from loosening by a cam-ing mechanism or locking cleat; and/or the like.

In some embodiments, to use the offloading device100, the liner (e.g., boot liner) is securely attached to the leg of the user and then the liner is attached to the boot spars (e.g., offloading component120so that the foot is suspended above the foot bed of the offloading device100. This distance between the foot bed and the foot is based on the amount of offloading that is desired, the spring travel distance, and/or a platform of specific height. When the user walks or stands and thereby loads the offloading device100, the springs compress and transfer load to the lower leg. As more load is added, the foot of the user eventually contacts the foot bed of the offloading device100. The amount of offloading then stops increasing and stays at a semi-constant amount (e.g., the amount of offloading may change in different phases of gait).

Referring toFIG. 2A, the offloading device100(e.g., offloading boot) includes a liner (e.g., boot liner) that holds the foot and ankle above the foot bed. In some embodiments, a structure (e.g., foam, such as a soft foam that compresses easily) is placed on the foot bed to provide offsetting of the foot from the foot bed when securing the offloading device100to the user. When weight is put onto the limb the offloading component120(e.g., springs on the boot spars) compress which provides an increasing amount of offloading until the foot of the user contacts the foot bed of the offloading device100.

In some embodiments, the base structure110includes one or more materials that are stiff and strong enough to enables transfer of load from the ground to the offloading component120and then from the offloading component120to the upper portion (e.g., securing component130, brace upper) of the offloading device100.

In some embodiments, the base structure110has a rocker geometry at the bottom of the base structure that may mimic the roll of natural gait.

In some embodiments, the base structure110is constructed of one or more of plastic, foam, aluminum, carbon fiber composite, plastic, fiberglass composite, wood, and/or metal. The bottom of base structure110may have material or coating to increase grip, such as a rubber coating.

The liner (e.g., boot liner) may connect to one or more portions of the offloading device100(e.g., the securing component130) via hook and loop fasteners.

The offloading component120may take the load of ambulation and transfer part of the load around the foot and ankle to the lower leg.

Responsive to the offloading device100(e.g., offloading boot) being loaded, the offloading component (e.g., springs240) may compress and the foot of the user rests on the foot bed. The offloading device100translates a portion of the weight to the lower leg.

In some embodiments, the offloading component120is made from one or more of steel, aluminum, and composite bushings, plastic, fiberglass composite, carbon fiber composite, and other metals.

FIG. 4illustrates a securing component130of an offloading device100, according to certain embodiments. In some embodiments, the offloading device100includes a liner (e.g., boot liner) that has a foam and fabric construction.

The liner attaches to the lower leg and to the securing component130. The liner securely and comfortably holds the lower leg of the user so that part of the load of ambulation can be transferred around the foot and ankle to the lower leg.

The liner may include a foam layer (e.g., seamless foam layer) that prevents the liner from slipping when loaded by gripping the skin of the user and conforming to the leg responsive to the liner being tightened. The foam layer may also transfer the load from the securing component130(e.g., tightening medium, straps) which makes the liner more comfortable and prevents harm to the user.

In some embodiments, the securing component130(e.g., straps) is positioned and secured to the outside surface of the liner so that the securing component130pulls the liner together (e.g., pulls the liner together evenly to distribute pressure similar to laces of a shoe pulling the shoe together evenly distributing pressure).

The outer surface of the liner may include a loop fabric that removably attaches to hook fabric attached to the securing component130(e.g., boot base spars).

The securing component130(e.g., straps) may provide compression that assists in securing the offloading device100to the leg of a user. The securing component130(e.g., straps) may be sewn to an upper portion of the offloading device100or may be independent of the upper portion of the offloading device100. The securing component130may include a variable number of straps depending on the amount and location of compression to be applied. In some embodiments, this compression is provided by one or more of straps, lacing, and/or a pneumatic bladder.

FIG. 5illustrates a base structure110of an offloading device100(e.g., offloading boot, offloading brace), according to certain embodiments. The base structure110may be a rigid base that has a U-shape, where the base structure110is positioned around the foot (e.g., proximate the sides and rear of the foot) without being connected to the foot (e.g., without contacting the foot, without being under the foot, etc.). The offloading device100may include rods that transfer load from the base structure110to an offloading component120that includes springs that are in a housing. The offloading component120(e.g., housing that houses the springs) is connected to the lower leg of a user by a securing component130(e.g., tightening calf sleeve). The amount of offloading that the offloading component120is to provide may be adjusted (e.g., the spring housing includes a feature for adjusting amount of offloading that the spring is to provide).

When using the offloading device100(e.g., brace), the user positions the offloading device100so that the foot is suspended above the surface (e.g., ground, floor) on which the base structure110is disposed (e.g., the bottom of the base structure110is below the bottom of the shoe of the user). This distance corresponds to the amount of offloading to be provided and the spring travel distance. Responsive to walking or standing with the offloading device100, the base structure110contacts the ground first and force is translated to the lower leg. As more load is added, the foot of the user contacts the ground and the amount of offload stops increasing and stays at a semi-constant amount (e.g., the amount of offloading may change in different phases of gait).

Referring toFIG. 5, the base structure110may be disposed around (e.g., on lateral sides of) the foot (e.g., shoe) of the user. A portion (e.g., a bottom surface) of the base structure110may sit below the bottom of the shoe or foot of the user when the offloading device100is unweighted.

The base structure110may include material that allows transfer of load from the ground to the upper portion (e.g., securing component130) of the offloading device100.

The base structure110does not connect with the foot or ankle in a load bearing manner. The base structure110is rigid enough to pass the load to the offloading component120(e.g., spring mechanism) without significant deflection.

A bottom surface of the base structure110may have a rocker geometry to mimic the roll of natural gait.

In some embodiments, the base structure110has a U-shape (e.g., seeFIG. 5). In some embodiments, the base structure110includes a first runner on a first side of the foot and a second runner on a second side of the foot that are connected by a component (e.g., rigid component) that is configured to be disposed over the foot (e.g., connected by a piece that goes over the foot).

In some embodiments, the base structure110is constructed of one or more of acrylonitrile butadiene styrene (ABS) plastic (e.g., thermoformed ABS plastic), shaped aluminum, carbon fiber composite, plastic, fiberglass composite, wood, and/or metal. The bottom surface (e.g., bottom edge) of the base structure110can include a material or coating to increase grip, such as a rubber coating or rubber strip.

In some embodiments, the base structure110is connected to the offloading component120(e.g., spring mechanism) via a hole in the base structure110into which the spring compression rod is inserted. In some embodiments, the base structure110is connected to the offloading component120(e.g., spring compression road) via a hinge, a clamp, welding, adhesive, and/or the like.

In some embodiments, the base structure110includes multiple holes that allow adjustability of the attachment point of the offloading component120(e.g., via the spring compression rod).

FIG. 6illustrates offloading components120of an offloading device100, according to certain embodiments. The offloading component120(e.g., spring offloading mechanism) may include a spring compression rod610, spring housing620, and spring630(e.g., spring240).

The offloading component120takes load from the base structure110and transfers the load to a spring630or spring-like device.

Responsive to the offloading device100being loaded, the offloading component120(e.g., spring630) compresses and the foot of the user rests on the ground while the offloading device100translates a portion of the weight to the lower leg of the user.

The spring compression rod610may be made from steel and the spring housing620may be made from aluminum. The spring compression rod610and spring housing620may be made of one or more of steel, aluminum, plastic, fiberglass composite, carbon fiber composite, and/or other metals.

The offloading component120may include a knob configured to compress the spring630when turned to provide offloading adjustment. The offloading component120may include a screw on/off cap that allows for changing the type of spring630for offloading adjustment (e.g., replace spring with a spring that has a different spring constant).

The offloading component120may include bushings640in the spring housing620or attached to the spring compression rod610. The offloading component120may include a feature that holds the spring compression rod610inside the spring housing620when the offloading device100is unweighted, such as a cap with a rod-sized hole on the bottom of the spring housing and a bushing640secured to the spring compression rod610that sits on top of the cap.

FIGS. 7A-Billustrate securing components130(e.g., upper portions) of offloading devices100, according to certain embodiments. The securing component130may include one or more pockets710into which a portion (e.g., the spring housing620) of the offloading component120is configured to enter (e.g., slide).

The securing component130attaches to the lower leg and to the offloading component120(e.g., offloading spring mechanism).

As shown inFIG. 7A, an inner sleeve720(e.g., foam material) of the securing component130may attach to an outer sleeve730(e.g., fabric) of the securing component130via attachment component740(e.g., via hoop and loop fasteners, via sewing, etc.). The inner sleeve720may be coated with a mineral gel that limits slipping on the skin. The offloading device100may or may not have the inner sleeve720.

The outer sleeve730in which the pockets710are attached can include one or more of fabric, foam, plastic, and/or other materials. The pockets710may be attached to the outer sleeve730via sewing, stitches, rivets, and/or adhesive.

As shown inFIG. 7B, the securing component130may include straps750that provide compression that assist in securing the offloading device100(e.g., spring housing620and/or spring compression rod610) to the leg of the user. The straps750may be sewn to the outer sleeve730and/or inner sleeve720or may be independent. The number of straps750is variable depending on the amount and location of compression to be provided. The compression could be obtained via straps750, lacing, and/or a pneumatic bladder.

In some embodiments, the offloading component120is connected to the securing component130via a sleeve, a pivot point, a clamping mechanism, and/or the like.

FIGS. 8A-Billustrate securing components130of offloading devices100, according to certain embodiments. The securing components130may include cams810. The cams810may be a first component configured to contact a first side of the leg and a second component configured to contact a second side of the leg, where a connector820(e.g., pivoting component) is rotatably connected to the first component, the second component, and the offloading component120. Responsive to a weight load (e.g., loaded cams810), the securing component130tightens (e.g., cams810when loaded) onto the lower leg.

The securing component130includes two components (e.g., cams810) connected by a cam component (e.g., connector820) that causes compression forces when the offloading device100is loaded.

In bothFIG. 8AandFIG. 8B, there are two components (e.g., cams810) that make primary contact with the lower leg. One component (e.g., cam810) may primarily load on the shin while the other component (e.g., cam810) may primarily load on the calf. The components (e.g., cams810) are connected by two cam arms (e.g., connectors820). The two cam arms (e.g., connectors820) may pivot about their attachment points on plastic pieces. The offloading component120(e.g., offloading spring mechanism) attaches to the cam arms (e.g., connectors820) with another pivoting joint. The cam arms (e.g., connectors820) could be one single piece with a bend to allow the single piece to be attached to both sides of the lower leg.

In some embodiments, the securing component130includes rigid plastic pieces (e.g., cams810) to contact the lower leg (e.g., seeFIG. 8A). The plastic pieces (e.g., cams810) may be secured to the lower leg via a compression sleeve that attaches (e.g., via hook and loop fastener) to the plastic pieces (e.g., cams810). The securing component130may or may not have a compression sleeve.

The components of the securing component130that contact the lower leg can be manufactured from a variety of materials. For example,FIG. 8Aillustrates the use of rigid plastic andFIG. 8Billustrates the use of fabric with a foam insert. Other examples of materials of the securing component include one or more of plastic (e.g., rigid or compliant), foam, fabric, and/or the like.

AlthoughFIGS. 8A-Billustrate a securing component130(e.g., brace upper) with multiple components, the securing component130could be a soft product in which the cam features are integrated with one or more final components.

The securing component130may be of custom manufacture or may have adjustability integrated into the securing component130via one or more of straps, multiple sizes, and/or the like. The securing component130may be coupled (e.g., rotatably coupled) to an offloading device, such as a spring housing620that is coupled to a spring compression rod610(e.g., that is coupled to a base structure110).

FIG. 9is a block diagram illustrating a computer system900, according to certain embodiments. In some embodiments, computer system900may be connected (e.g., via a network, such as a Local Area Network (LAN), an intranet, an extranet, or the Internet) to other computer systems. In some embodiments, computer system900may operate in the capacity of a server or a client computer in a client-server environment, or as a peer computer in a peer-to-peer or distributed network environment. Computer system900may be provided by controller122, a PC, a tablet PC, a Personal Digital Assistant (PDA), a cellular telephone, a web appliance, a server, a network router, switch or bridge, or any device capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that device. Further, the term “computer” shall include any collection of computers that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methods described herein.

In a further aspect, the computer system900may include a processing device902, a volatile memory904(e.g., random access memory (RAM)), a non-volatile memory906(e.g., read-only memory (ROM) or electrically-erasable programmable ROM (EEPROM)), and a data storage device916, which may communicate with each other via a bus908.

Computer system900may further include a network interface device922. Computer system900also may include a video display unit910(e.g., a liquid crystal display (LCD)), an alphanumeric input device912(e.g., a keyboard), a cursor control device914(e.g., a mouse), and a signal generation device920.

In some implementations, data storage device916may include a non-transitory computer-readable storage medium924on which may store instructions926encoding any one or more of the methods or functions described herein, including instructions encoding components ofFIG. 1(e.g., controller122, etc.) and for implementing methods described herein.

Instructions926may also reside, completely or partially, within volatile memory904and/or within processing device902during execution thereof by computer system900, hence, volatile memory904and processing device902may also constitute machine-readable storage media.

FIGS. 10A-Cillustrate offloading devices100, according to certain embodiments. In some embodiments, an offloading device100includes a pneumatic air bladder1010(e.g., part of the securing component130). The pneumatic air bladder1010may include a bladder configured to wrap around the leg of a user, a tube connected to the bladder, and a pneumatic user interface connected to the tube outside of the boot liner. A user may pump one portion of the pneumatic user interface to increase pressure and may press another portion of the pneumatic user interface to release pressure. In some embodiments, the bladder of the pneumatic air bladder1010is configured to be inflated with a bulb that is detachable, where a knob of the pneumatic air bladder1010may allow air to go into or out of the bladder.

The methods and illustrative examples described herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used in accordance with the teachings described herein, or it may prove convenient to construct more specialized apparatus to perform methods described herein and/or each of their individual functions, routines, subroutines, or operations. Examples of the structure for a variety of these systems are set forth in the description above.

Various operations are described as multiple discrete operations, in turn, in a manner that is helpful in understanding the present disclosure, however, the order of description should not be construed to imply that these operations are necessarily order dependent. In particular, these operations need not be performed in the order of presentation.

The terms “over,” “under,” “between,” “disposed on,” and “on” as used herein refer to a relative position of one material layer or component with respect to other layers or components. For example, one layer disposed on, over, or under another layer may be directly in contact with the other layer or may have one or more intervening layers. Moreover, one layer disposed between two layers may be directly in contact with the two layers or may have one or more intervening layers. Similarly, unless explicitly stated otherwise, one feature disposed between two features may be in direct contact with the adjacent features or may have one or more intervening layers.

Various embodiments can have different combinations of the structural features described above. For instance, all optional features a device or system described herein can also be implemented in a device or system and specifics in the examples can be used anywhere in one or more embodiments.

In the description herein, numerous specific details are set forth, such as examples of specific types of material, specific sizes, specific surfaces, specific structures, specific details, specific configurations, specific types, specific system components, specific operations, etc. in order to provide a thorough understanding of the present disclosure. It will be apparent, however, to one skilled in the art that these specific details need not be employed to practice the present disclosure. In other instances, well known components or methods, such as specific and alternative material, sizes, surfaces, structures, details, configurations, types, system components, operations, etc. have not been described in detail in order to avoid unnecessarily obscuring the present disclosure.

Although some of the embodiments herein are described with reference to specific devices or systems, other embodiments are applicable to other types of structures and surfaces. Similar techniques and teachings of embodiments of the present disclosure can be applied to other types of structures and surfaces that can benefit from advantages described herein. In addition, the description herein provides examples, and the accompanying drawings show various examples for the purposes of illustration. However, these examples should not be construed in a limiting sense as they are merely intended to provide examples of embodiments of the present disclosure rather than to provide an exhaustive list of all possible implementations of embodiments of the present disclosure.

As used herein, the terms “substantially,” “about,” and/or the like, in some embodiments refer to a range of 2% greater and 2% less, in some embodiments refer to a range of 5% greater and 5% less, in some embodiments refer to a range of 10% greater and 10% less, in some embodiments refer to a range of 15% greater and 15% less, and in some embodiments refer to a range of 20% greater and 20% less,

Use of the phrase ‘configured to,’ in one embodiment, refers to arranging, putting together, manufacturing, offering to sell, importing and/or designing an apparatus, hardware, logic, or element to perform a designated or determined task. In this example, an apparatus or element thereof that is not operating is still ‘configured to’ perform a designated task if it is designed, coupled, and/or interconnected to perform said designated task.

Furthermore, use of the phrases ‘to,’ ‘capable of/to,’ and or ‘operable to,’ in one embodiment, refers to some apparatus, hardware, and/or element designed in such a way to enable use of the apparatus, hardware, and/or element in a specified manner. Note that use of to, capable to, or operable to, in one embodiment, refers to the latent state of an apparatus, hardware, and/or element, where the apparatus, hardware, and/or element is not operating but is designed in such a manner to enable use of an apparatus in a specified manner.

Reference throughout this specification to “one embodiment,” “an embodiment,” or “some embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases “in one embodiment,” “in an embodiment,” and “in some embodiments” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics can be combined in any suitable manner in one or more embodiments.