Unloading joint orthosis device

Abstract

An adjustable tension knee brace for unloading weight from a knee joint affected by osteoarthritis, thereby reducing pain and improving mobility, comprising upper and lower frames connected by an unloading hinge assembly, a tension-adjustable hinge assembly, and optionally sensors and processors that allow for remote or automatic control of brace tension. In embodiments, the brace includes a user mechanism that allows adjustment of the tension elements while the brace is being worn. In other embodiments, electronic motors, sensors, and indicators may be included within the brace to improve brace performance and user interaction.

Description

[Technical Field]

[0001] The invention disclosed herein generally relates to an orthopedic knee brace for relieving pain and discomfort by unloading the joint by redistributing weight on the knee joint to other parts of the body and / or by providing assistance in extension of the joint. [Background technology]

[0002] Osteoarthritis (OA) is a degenerative joint disease characterized by chronic inflammation, destruction, and eventual loss of articular cartilage, leading to deterioration of the underlying bone. In particular, the patellofemoral compartment is one of the most frequent points of knee pain experienced by OA patients. While off-loading braces have been used as an inexpensive treatment solution for knee OA, they have been largely ineffective in preventing and reducing joint pain. Various embodiments of the present invention aim to design a knee brace that offloads the knee joint and reduces pain in knee joints damaged by OA.

[0003] Arthritis is currently the most common cause of disability among adults in the United States. Over 100 different rheumatic conditions are classified as arthritis, the most common of which is osteoarthritis (OA), a degenerative joint disease characterized by chronic deterioration of articular cartilage and underlying bone. OA is one of the most common joint disorders in the United States, and the number of affected individuals is estimated to increase primarily among the elderly population and with increasing levels of obesity. 27 million adults in the United States alone suffer from the disease. As the most common type of arthritis, this disorder commonly affects the knee, and the patellofemoral (PF) compartment within the knee joint, in particular, is one of the most frequent knee pain points in outpatient settings. The PF compartment plays a critical role in daily movement and activity, allowing mobility throughout a wide range of motion through flexion, extension, and rotation of its associated components. One of the most non-invasive and widely accepted methods for preventing further deterioration of articular cartilage within the knee joint is through the use of knee braces. The joint itself, including the underlying cartilage, can only support a certain amount of force before the cartilage begins to wear down, and an off-loading knee brace reduces the amount of force on the joint.

[0004] According to the American Academy of Orthopaedic Surgeons and the Centers for Disease Control and Prevention, nearly half of Americans develop symptoms attributable to knee osteoarthritis by the age of 85, with the incidence of PF pain syndrome reportedly reaching approximately 22 per 1,000 adults per year. Additionally, up to 10 percent of the U.S. population suffers from pain and loss of function due to patellar arthritis and cartilage wear. The high prevalence of these injuries suggests that this condition affects a significant portion of the adult population and will have a significant impact on the healthcare system in the future. On average, total knee arthroplasty or knee replacement surgery costs between $10,000 and $30,000, with over 600,000 procedures performed annually. Other surgical procedures, such as articular cartilage repair, osteotomy, and unicompartmental knee replacement, as well as corticosteroid and hyaluronic acid injections to reduce inflammation and shock absorption, respectively, are also very costly. Therefore, preventative treatments that reduce stress, pressure, and the amount of invasive procedures on the knee are needed to improve patients' quality of life and potentially reduce healthcare costs.

[0005] Additionally, robust braces allow individuals with severe joint damage to remain active when joint replacement surgery is not appropriate. It is estimated that 27 million adults in the United States suffer from osteoarthritis, and 454,652 patients with severe joint damage and arthritis underwent knee replacement surgery in 2004. Currently, non-pharmacological approaches such as physical therapy and pharmacological methods are primarily used to treat knee OA. When these prove ineffective, treatment methods lead to surgery, with drawbacks including internal joint bleeding, bone healing failure, nerve or tissue damage, and infection. Therefore, to address the challenges associated with establishing a purely non-pharmacological corrective approach to treating knee OA, there is a need for a knee brace that significantly unloads forces from the affected joint, preventing pain and disability while eliminating the need for numerous other treatments. The primary objective of various embodiments of the present disclosure is to develop a knee brace that significantly unloads forces from the patellofemoral compartment of knee joints affected by osteoarthritis to reduce pain and disability.

[0006] OA knee brace Osteoarthritis knee braces primarily comprise a rigid or semi-rigid frame with an upper frame member called the "upper cuff" that sits across the front of the thigh and a "lower cuff" that sits across the front or back of the tibia, with straps on opposite sides of the cuffs that secure the frame to the user's leg. The upper and lower cuffs are connected by a rotating hinge assembly that pivots through the user's normal range of motion or to a lesser extent in response to injury.

[0007] In OA, the disease process involves degradative enzymes that erode the joint cartridge, resulting in bone-on-bone contact, which is the primary cause of knee pain in users. OA knee braces, classified as "off-loading" braces, separate the femur and tibia so that there is no bone-on-bone contact when the user is bearing weight, such as during walking, standing, exercise, etc. This is accomplished by the brace elevating the femur and / or lowering the tibia, or otherwise preventing direct contact between the femoral and tibial condyles through the action of upper and lower cuffs that lock the femur and tibia in place relative to one another.

[0008] The offloading knee brace may also include a hinge assembly that applies a force in a medial-to-lateral direction to push the knee joint medially, separating the femoral and tibial condyles. There may be one hinge assembly in the brace, such as in the case of a brace for treating OA in the left medial compartment, with the hinge assembly on the medial side of the knee joint, or there may be hinge assemblies on both sides. The hinge assembly may include a component (e.g., an inflatable pad) that pushes the knee joint laterally, e.g., inward and / or apart, to offload the force on the medial side of the knee and thus reduce pain for the user.

[0009] The hinge in the unloading knee brace may also include a component similar to a built-in collapse system, where the user experiences increased tension as the knee is bent to prevent the user's knee from collapsing during bending. The hinge assembly and cuff are responsible for much of the work that the leg muscles would otherwise do to stabilize the knee joint throughout its range of motion.

[0010] More recently, many OA knee braces have been marketed to consumers who wish to maintain an active lifestyle regardless of their medical condition. Currently, OA knee braces are available that include hinge assemblies capable of applying a force to assist the user's movement, also known as a "swing assist" or "knee extension assist." The applied restoring force of the hinge can be opposite the direction of the user's original movement, such as propelling the user's knee from a flexed position to an extended position after the user bends. The hinge assembly primarily includes springs and / or elastic members (tension elements), which store potential energy when the user bends their leg, such as by squatting, while the elastic members are elongated or the spring members are compressed or extended. The restoring force generated from the compression or extension is used to assist the user when moving to extend their leg.

[0011] However, what is needed in the OA knee brace industry is a knee brace that effectively unloads the user's weight from the knee joint while simultaneously generating a restoring resistance that attenuates downward forces and provides stability and support to weakened muscles. It would also be beneficial if the knee brace provided knee extension assistance to the user during activities. What is also needed is an improved unloading mechanism that does not require the knee to be forced inward, but instead relies on a well-fitting rigid or semi-rigid frame and strap and / or hinge assembly with adjustable tension that can be activated as needed by the user, and at significantly higher tension levels than in the prior art, to participate in the mechanical work normally performed by the knee muscles in pulling the femoral and tibial condyles apart. Summary of the Invention

[0012] Various embodiments of the present disclosure include a novel type of unloading knee brace designed to reduce the amount of pain patients experience as a result of knee OA. The knee brace and hinge assembly disclosed herein generate a force that opposes bending or contraction / flexion of the knee joint. While the brace may be suitable for either the knee or elbow joint, only the knee joint will be described in detail herein so that those skilled in the art can easily apply this disclosure to elbow braces. The brace effectively unloads a significant amount of force within the knee by using the low-to-high tension resistance mechanism described herein and by distributing the force to other areas of the body. This reduces contact pressure in the area of ​​the knee affected by OA, thus reducing pain. The embodiments described herein enable the user to: In some embodiments, the device rapidly engages and disengages tension (e.g., in approximately 1-5 seconds) at each joint mechanism as needed, including while the brace is being worn, allowing the amount of tension to be adjusted without the assistance of a medical professional, increasing with increasing degrees of flexion, and limiting the range of extension and flexion at the joint. The device is particularly suitable for people with patellofemoral osteoarthritis (OA), cartilage injuries, meniscus injuries, knee stability issues, and other types of knee disorders that cause increased pain during knee flexion or contraction, as well as for patients who lack the strength to extend their knee during exercise or simple life functions such as rising from a seated position (e.g., quadriceps weakness). Various embodiments of the brace and hinge assembly disclosed herein provide enhanced support for stabilizing the knee joint, and they can enhance the user's physical capabilities by providing extension assistance. Another version of the brace may have tension elements oriented so that the brace resists extension and assists flexion. The tensioning mechanism may be used with or without the device. This type of device can treat knee flexion contractures and can be used to help patients recovering from joint replacement surgery improve their range of motion.

[0013] Various embodiments of the braces and hinge assemblies disclosed herein may also be applied to other orthotics designed to treat other human joints, such as the elbow, shoulder, ankle, wrist, and hip, where a support in one part of the joint is operatively connected to another part of the joint via various tensioning mechanisms, described below, that can change the amount of force between the parts of the joint. For example, a shoulder brace may apply a force directed posteriorly through the shoulder and unload in an anterior or other direction to relieve pain. In this example, one part of the shoulder brace is attached to an injured part of the body and anchored to another part of the body, such as the shoulder opposite the injured shoulder. Rigid and semi-rigid parts may be used in conjunction with tensioning mechanisms to create a desired force environment for the joint.

[0014] Unloading Orthosis Vertical Support Various embodiments of the present disclosure include a knee brace that effectively unloads a user's body weight from the knee joint via a rigid or semi-rigid vertical support that partially or completely covers the user's femur and tibia, and with a pivoting hinge assembly connecting the upper and lower portions of the vertical support. In some embodiments, the rear of the vertical support includes one to three straps or other mechanisms for connecting the device to the upper and lower portions, for example, the knee, or elbow, or ankle, which can be oriented in various ways relative to the vertical support.

[0015] It should be noted that the vertical supports of the present disclosure may also be used with a wide variety of types of hinge assemblies previously known in the art for use by knee patients to effectively unload weight from the knee joint. One such assembly may be a combination of rigid and semi-rigid materials that allow the brace to be connected to or housed within an elastic sleeve or support that partially or completely surrounds the joint.

[0016] Various embodiments of the knee brace include a vertical support having upper and lower frames connected on one side via a hinge assembly (in the case of a medial or lateral brace) or via two hinge assemblies (in the case of a full brace). Furthermore, in embodiments, the vertical support comprises arcuate, curved, semicircular, rigid, or semi-rigid units located above and below the knee, connected, for example, via a geared or non-geared pivoting hinge assembly. The upper and lower frames may further include at least one strap or other connection mechanism for securing the brace to the user's leg, and the upper portion may have straps and / or material for supporting the rear of the thigh to effectively distribute forces away from the knee. The upper and lower portions may also be secured with hook-and-loop material, clip-type fasteners, or similar methods.

[0017] The brace may be unilateral or bilateral (as in right and left, or medial and lateral supports), the decision being based on whether the knee is injured on the medial or lateral side, or whether the femoral compartment is injured in the approximate middle. The tensioned brace hinge assembly should be proximal to the injured portion of the knee. Users who benefit from a high-tension brace would ideally use a brace with both lateral and medial supports to generate torque on both sides.

[0018] The amount of torque can be modified by the strength and number of elastic materials, and the amount of torque may vary on each side to address a user's specific OA condition. The prosthetic frame disclosed herein can target injuries to the patellofemoral compartment. However, other types of knee injuries and conditions may benefit from only one supporting vertical member and / or only one hinge assembly.

[0019] The brace can also be adapted for patients who experience more OA symptoms in one compartment of the knee than the other by applying force to the opposite side of the unicondylar OA present in the patient's knee. This can be achieved by various methods known in the art. For example, the condylar pad on one side of the joint may be harder or thicker than the condylar pad on the other side of the joint. The use of shims connected to the side plates or hinge capsules and adjustable based on the degree of varus / valgus present in the user's knee may also be applied.

[0020] Another application of the brace may involve using the same tensioning mechanism taught herein to assist flexion rather than oppose it. This can be achieved by repositioning the tensioning element so that it is positioned on the posterior side of the hinge assembly and promoting flexion of the joint by maintaining tension in the tensioning element. This application of the device would be useful for those recovering from injury or undergoing physical therapy, as an indicator of knee health after recovery is the range of motion (flexion) that the knee can achieve as swelling decreases in the joint.

[0021] Brace Materials: In embodiments, the vertical supports are made from rigid and / or semi-rigid plastics, metals, other lightweight materials such as carbon fiber, or another suitable material that is largely inelastic but flexible, thus distributing weight-bearing knee forces. 3D printing with common thermoplastics is an ideal material for fabricating the braces described herein.

[0022] Because knee braces are subject to high tension or torque from the hinge assembly, intimate conformal contact with the body is preferred. The brace may further comprise lightweight padding lining the upper and lower sections and / or straps or other connection mechanisms. In aspects, the fit and material composition are designed to provide a coefficient of friction between the brace and the user's leg to increase adhesion to the user's leg and thus facilitate the transfer of weight-bearing forces from the knee joint while maintaining a comfortable fit. The upper and lower sections and / or straps or other connection mechanisms can be housed or constructed within elastic sleeves to reduce the coefficient of friction at the body / brace interface. Fabrication methods combined with the use of sturdy, lightweight materials facilitate this design feature. Furthermore, the brace can be made from common materials, such as braided tension elements, and therefore may be less expensive and more accessible to users who may not normally be able to afford a high-performance brace. 3D-printed versions of the brace frame can have 3D-printed padding attached continuously or separately. The 3D printed pad features a compressible matrix that conforms to the body and provides cushioning.

[0023] In aspects, the brace frame or vertical support comprises an upper rigid or semi-rigid frame sized to fit over the user's femur adjacent to and above the user's knee joint, and a lower rigid or semi-rigid frame sized to fit over the user's tibia adjacent to and below the user's knee joint.

[0024] Sizing: Knee braces can be custom-made for a user based on one or more of the user's size, weight, level of physical activity, brace weight and flexibility, etc. Alternatively, knee braces can be sold over the counter based on size (e.g., small, medium, or large) and / or by tension level (low / medium / high). Alternatively, the brace may be custom-made to fit a specific user using digital imaging. In a preferred embodiment, the brace conforms to the knee joint, lower femur, and upper tibia to redistribute load from the knee joint when the device is used to unload forces. The brace may be matched to a digital image or a 3D scan, and this fitting process may be automated or partially automated. Software can properly orient the leg and scale the leg and brace appropriately.

[0025] Hinge Assembly In embodiments, the invention includes at least one tension element (e.g., a tension element, elastic band, or spring) of low, medium, or high tension, two intermeshed toothed gears that rotate in unison as a user flexes and extends the knee joint, and a method for controlling the degree of extension and flexion that the joint can achieve while the user is wearing the brace.

[0026] The hinge assembly can be used with the unloading brace vertical support disclosed herein and / or with other knee or joint braces known in the art.

[0027] In the hinge assemblies disclosed herein, the amount of tension for unloading can be adjusted, for example, by adding more tension elements of the same or different levels of tension, adding more tension elements of the same or different levels of diameter, and / or replacing tension elements with different elastic properties (e.g., stiffer bands or springs to create more tension), and / or moving hinge components to fixate one end and / or center of the tension element to prevent it from extending further, thus increasing the tension in the element (see, e.g., hinge assembly embodiments 2-4, below). The hinge assemblies may include smoothed sections to prevent damage to the tension elements and allow the tension elements to be pulled-stretched-extended across the hinge, regardless of whether the tension elements contact the rotating gear.

[0028] When two or more tension elements are used, the tension elements can, in certain embodiments, be positioned longitudinally adjacent, e.g., parallel, or one above the other, e.g., in series, on the front and / or rear sides of the hinge assembly. Another design feature is that, in embodiments, multiple tension elements improve the safety of the brace by providing backup support in the event that a band breaks or separates.

[0029] When tension elements are used, embodiments contemplate hinges with bands as large as 3 / 4 inch and as small as 1 / 8 inch in diameter, and larger and smaller bands can be used within the same brace.

[0030] Examples of tension elements with different levels of tension include materials such as real rubber, braided synthetic rubber cord, exotic elastic, or other elastic materials. Braided bands provide protection for the elastic material, while other bands may use thin protective sheaths or wet or dry lubricants to allow smooth retraction across the hinges. 3D printed bands with many individual elastic strands oriented in the direction of tension make preferred tension elements.

[0031] Additional hinge assemblies may be envisioned that mimic the sliding and rolling movement of the knee joint. This version may involve slots that allow for the sliding and rolling movement of the knee, which are pins in the upper and / or lower frames. A tension element may be anchored between the upper and lower frames to slow or prevent forward movement of the knee joint to best match the natural movement of the knee.

[0032] Extension-Flexion Stops: In addition to the controllable tensioning mechanisms described in embodiments 1-5, for example, extension-flexion stops may be used to not only limit the degree of flexion or extension, but also to prevent the user from hyperextending or hyperflexing a joint that may already be susceptible to injury. In the hinge assemblies disclosed herein, the brace hinge may include various methods of controlling the degree of joint extension and flexion. In one embodiment of the present invention, a slot oriented radially relative to the hinge pivot point can be cut out of the hinge or formed during fabrication of the joint. In other words, the hinge may include a slot, for example, a slot oriented radially relative to the hinge pivot point. The degree of flexion and extension that the angle between the two frames of the brace can achieve during articulated joint movement can be controlled by placing prefabricated inserts at selected locations within the radially oriented slots. Pre-fabricated inserts can be manufactured with the material strength and geometry to withstand the rigors of articulating joint motion without breaking, bending, or slipping out of the slot. Either a side plate or hinge capsule helps secure the insert within the hinge without restricting the smooth movement of the hinge / interlocking toothed gears. The slots and inserts at various points within the brace allow for user customization of the degree of flexion and extension allowed by the device at the hinge point.

[0033] Another variation of the extension-flexion stop is through the manufacturing process; inserts that can be placed between the anterior and / or posterior of the upper and lower frame hinges can be used to control the degree of flexion and extension of the joint at the hinge point. For example, an insert may be placed in front of the frame hinge between the gears to limit the degree of extension of the joint. Alternatively, an insert may be placed behind the hinge to limit the degree of flexion of the joint.

[0034] The geometry of the toothed gears and hinges may also be altered during the fabrication of the hinge groups to limit the degree of extension and flexion the joint can undergo during use of the brace, or to limit the limitations on the degree of flexion and extension permitted by the hinge points on the device. For example, the geometry of one gear can be designed so that it does not fit within the opposing meshing gear at certain degrees of flexion or extension. The toothed gears / hinge preferably comprise a durable material that can resist the tendency for movement during joint extension or flexion.

[0035] Tubes: In another embodiment, the hinge assembly comprises tubes that run through the geared components in the brace and / or brace frame, and tubes in the support structure. The tubes may be partially or fully integrated into the frame, or may be external to the frame. The tubes in the brace components may be balanced to provide sufficient strength while minimizing the bulk and weight of the components. Materials can be selected to allow for smaller or larger sized brace components. The tubes may be positioned anywhere within the brace frame, and the bands may be oriented in multiple ways depending on the user's needs, treatment, preferences, comfort, injury, performance requirements, etc.

[0036] Another feature involves using tension elements with distinct endpoints that limit the degree of bending based on the length of the tension element and the length of the components by limiting the amount of band pulled across the section of the hinge, which acts as a cam, creating a mechanical advantage when pulling the tension element away from its anchored end. For example, in embodiment 1, the band is fixed at both ends. In embodiments 2 and 4 below, for example, the band is fixed only at the distal end and the tension is adjustable at the proximal end, and in embodiment 3 below, the band is fixed at both ends but adjustable for tension. The shape of the cam can be modified to increase or decrease the stretch on the tension element, thus affecting the torque generated.

[0037] The tension or reaction force in the hinge assembly may be adjusted by increasing the number of tension elements to increase the tension and / or by using stiffer tension elements for higher tension. In one embodiment, the knee brace is manufactured for specific tensions (low, medium, and high). In another embodiment (e.g., the second through fifth hinge embodiments below), the tension can be adjusted by deactivating the hinge mechanism to allow the tension elements to extend, or by activating the mechanism to prevent the tension elements from extending at one or both ends, thus increasing the tension in the band.

[0038] In other embodiments with multiple bands, the elements can be mixed or matched with different strengths and sizes based on the user's preferences or needs, and different elements can be engaged at different degrees of flexion. For example, one band can be engaged at, by way of example only, 5-20 degrees of flexion, at which point another band engages to provide increased resistance.

[0039] The bands can be secured by several methods, including the use of clamps or pins or anchors that pass through or through which the tensioning elements can be engaged, and holes in the brace can include components to prevent the band ends from slipping out of the holes while the brace is under tension. Other band shapes can be used, such as circular bands that hook onto the upper and lower components of the brace.

[0040] The distal and proximal hinges are preferably fabricated as a continuous piece of material with the vertical support, or alternatively, are secured to the brace frame by bolts, rivets, pins, screws, or another similar attachment mechanism. The brace support may be plastic or carbon fiber and may be molded to include the tension element support and gear mechanism. The unloading brace can be fabricated by any combination of 3D printing, injection molding, water jetting, casting, extrusion, pultrusion, or other similar methods. The brace may use multiple injection-molded components that house tubes, tension elements, and / or wires connected together, partially or completely, on or within the components. These components may be connected to metal frame parts that are generally molded around the leg or other limb. This version of the brace may be an alternative to a 3D-printed version as a lower-cost or more mass-produced alternative.

[0041] The hinge components on the lateral and / or medial sides of the knee can be closely spaced to maintain a narrow profile. When multiple elastic materials are stretched across the hinge, they can be oriented vertically or horizontally relative to the desired size and / or tension of the brace. The components can be symmetrical or molded to the contours of the leg.

[0042] The hinges connecting the upper and lower components of the brace can, in embodiments, be U-joints or separate components that provide lateral stability to the brace. They can be threaded or designed to minimize size and profile, such as using E-clips (circlips) or pressing the components into place.

[0043] Additional uses The hinges and tensioning assemblies described herein may be applied to other human joints, including, but not limited to, the ankle, shoulder, hip, elbow, and wrist joints. These embodiments of the invention may include a support for one portion of a joint operatively connected to a support for another portion of the same joint. This connection may include a tensioning element, which may or may not be adjustable, so that the prosthesis can apply forces in a direction favorable for joint rehabilitation or support.

[0044] For example, in one embodiment, the ankle brace may include an ankle cuff and a lower portion that connects to a region of the foot. The ankle cuff may be connected to the lower portion of the ankle brace by one or more materials and / or adjustable tension elements that apply force to desired locations on the ankle and foot to provide more support to the ankle.

[0045] In another embodiment, the brace may include a portion that can be secured at one end to the user's hip joint and at the other end to the user's leg. By connecting these two ends of the brace with a tension element, the ball and socket joint of the hip joint can be adjusted to better align the femur and pelvis in a way that is physically favorable for the patient.

[0046] Any additional embodiments of this brace, when applied to other joints, may employ a variety of optionally adjustable tensioning elements, such as combinations of series or parallel tensioning elements, and the strength of the tensioning elements may be adjusted depending on the type of joint and the treatment required for each user. These additional embodiments may also employ the following adjustable tensioning mechanisms to allow for dynamic use of the brace.

[0047] Tension adjustment and engagement / disengagement features Another feature of the brace design taught herein, in embodiments 2-5 below, is that the user can fully or partially disengage the tensioning mechanism. The tensioning engage-disengage feature allows the user to increase the tension in the hinge assembly, such as when climbing stairs, to provide more stability and take their weight off their knee, and then turn the mechanism off or reduce the tension when it is no longer needed, such as at the top of the stairs, allowing the user to walk or jog more easily with a fuller range of motion. The present invention allows this adjustment in real time or near real time, and while the user is wearing the brace.

[0048] Example 1 - Fixed tension Hinge Assembly 1: In a first embodiment, the pivoting hinge assembly comprises two opposing, facing subunits having proximal (upper) and distal (lower) short ends and anterior (front) and posterior (rear) sides. Each subunit houses one gear (e.g., a proximal gear and a distal gear) that meshes with the opposing gear during articulating joint movement, at least one tension element extending between the subunits on the front side of the gear and fixedly connected to the rear side of the subunit on the end of a band, and inner and outer connectors that pin the subunits together while allowing the gears to rotate. Tension can vary within the hinge depending on the strength of the tension element provided within the hinge assembly. This can be determined during fabrication of the brace. Alternatively, the hinge may pivot freely without toothed gears.

[0049] Hinge Assembly - Embodiment 2 - Adjustable Tension - Via Handle and Slider Hinge Assembly 2: Various embodiments of the present disclosure further include a second embodiment of a hinge assembly for use in a brace as disclosed herein or other knee brace for treating a condition requiring joint unloading. The hinge assembly of embodiment 2 is similar to embodiment 1, but with the addition of a handle or knob attached to a mechanism that allows the user to adjust the tension on one end of the tension element in real time or near real time, and in some cases while the user is wearing the brace, by pulling the handle or knob in one direction to increase tension and then moving it in another direction to decrease or release tension.

[0050] In one embodiment, the proximal end of the tension element is attached to a slide member that moves vertically (e.g., proximal-to-distal or distal-to-proximal) to, in some aspects, pull the band taut and increase its tension. For example, when a user moves a handle or other mechanism positioned on the outer portion of the hinge above the knee (or, in some aspects, below or beside the knee), the handle or other mechanism moves back-to-back. This handle movement moves the connecting slide member proximally up, thus stretching the proximal end of the tension element. Thus, in one embodiment, a user can increase the stability and / or stiffness and / or tension of the brace / hinge / tension element by moving the hinge handle back, and then move it anterior-to-anterior to release or decrease the tension and make the brace more flexible, which may include a fuller range of motion. In other aspects, the handle may slide front-to-back, back-to-front, or diagonally. In aspects, a user can increase the stability and / or stiffness and / or tension of the brace / hinge / tension element by moving the hinge handle forward, upward, downward, sideways, or diagonally, and then release or decrease the tension by moving the handle in the opposite or different direction.

[0051] Hinge Assembly - Embodiment 3 - Adjustable Tension via Ratchet-Pawl Hinge Assembly 3: In another embodiment, each subunit houses one gear, e.g., a proximal gear and a distal gear, that meshes with an opposing gear during articulating joint movement, and at least one tension element that extends between the subunits on the side of the gear (or above or below the gear) and is fixedly connected to the rear side of the subunit on its end. In aspects, a core bracket member fully or partially covers the tension element between the open spaces of the subunits to protect the element and pin the gears together while still allowing the gears to move relative to each other.

[0052] This embodiment may further include rotatable or linear ratchet-pawl members on the upper and / or lower frames of the brace to vary the tension in the bands. A user can rotate a knob or slide a lever to different positions to pull the tension elements tighter while reducing their effective length. This can be achieved by winding a portion of the tension element, such as a wire, around a coil as the member is rotated. For example, rotating the ratchet-pawl member clockwise increases the tension in the hinge assembly, reducing its flexibility and removing more of the user's weight from the knee joint, providing greater stability. The user can then release the ratchet-pawl member by pulling up or down on a knob or deactivation lever positioned with the member (or turning the knob in the opposite or different direction or rotation), and / or the user can then rotate the knob in a second, opposite direction to relieve tension in the tension element stretched between the gears.

[0053] Hinge Assembly - Embodiment 4 - Adjustable Tension - Wire with Spool Hinge Assembly 4: Various embodiments of the present disclosure may further include another embodiment of a hinge assembly for use in a knee brace as disclosed herein or other brace for treating a condition requiring joint unloading. The embodiment includes one or more strands of tension elements, each end of the element being fixed at the distal subunit. The end point of the element on the proximal end is tensioned by a wire surrounding it.

[0054] In this embodiment, a rotatable knob is connected to a spool of wire that pulls on the proximal end of the tension element when a user rotates the knob (if the knob is on the proximal portion; if the knob is on the distal portion, the distal end is pulled). In aspects, the knob is rotatable to a fixed position, allowing a user to adjust the tension in the tension element to a desired level and release the tension by rotating the knob in a different or opposite direction. In aspects, the more or longer the knob is turned, the higher the tension in the tension element and the greater the force load on the user's knee joint.

[0055] Hinge Assembly - Embodiment 5 - Wire Tie Band with Adjustable Tension Hinge Assembly 5: Various embodiments of the present disclosure further include another embodiment of a hinge assembly for use in a knee brace as disclosed herein or other brace for treating a condition requiring joint unloading. This embodiment includes one or more tension elements housed completely or partially within the frame of the brace, both in the proximal and distal frame portions. The one or more tension elements are further connected to each other by wires extending across the gear assembly, and one or both bands are connected to an adjustable tensioning mechanism using another wire.

[0056] In this embodiment, equal tension should be applied to one or more bands within the hinge assembly, and tension is generated within the frame of the brace to create resistance to bending. The adjustable tension mechanism of embodiments 2, 3, and 4, such as those described above, is connected, either directly or indirectly, to at least one of the bands.

[0057] Usage method - Embodiments 1 to 5 In various embodiments of the present disclosure, the amount of weight unloading (or resistance or tension generated within the brace) can be easily tailored to the user based on the user's size, weight, injury, treatment needs, and / or desired athletic performance. Braces as described herein are lightweight, robust, and have narrow side profiles, allowing for a good fit to the user. Unlike prior art braces, the braces disclosed herein can be narrow and lightweight to be worn under clothing, something not typically possible with athletic performance braces. For these reasons, the braces may be ideal for a range of injury types and severities, as well as methods for improving athletic performance.

[0058] Various embodiments of the knee brace of the present disclosure can be used, by way of non-limiting example, prophylactically to prevent injury, to reduce joint pain (e.g., during normal activity, physical exercise, or athletics), to rehabilitate existing injuries, post-operatively (high tension braces to immobilize the joint at a comfortable level), as an extension assist device for conditions such as osteoarthritis with some stability support for proper knee alignment through range of motion, to improve athletic performance (e.g., by adding force, e.g., explosiveness, as an athlete jumps or starts running, as the knee extends), and / or to prolong the life of a natural knee affected by osteoarthritis or other knee injuries or to prolong the life of an artificial joint, in some cases to delay, prevent, or avoid knee surgery.

[0059] Similarly, the knee brace and / or hinge assembly disclosed herein can reduce weight, force, and / or pressure on the knee joint when a user is bearing weight with their leg, such as when standing, and / or the knee brace and hinge assembly can provide knee extension assistance when walking, bending, moving from a seated position to a standing position, exercising, etc. Thus, a user must exert less physical effort to move their knee between flexion and extension.

[0060] In one embodiment, a method of use for reducing load bearing on a knee joint includes attaching a knee brace, for example, one of the embodiments listed above, to a user's knee, including pressing an inner surface of the brace vertical support, including an upper portion and a lower portion, against the user's leg, and closing the brace straps or other means of connecting the brace to the user, such as multiple straps around the user's femur and multiple straps around the user's tibia, and bearing a load on the user's knee joint, wherein the load and / or pressure on the knee joint is reduced to a degree that the user experiences reduced pain or improved movement compared to the load they would bear without the knee brace.

[0061] The method of use may also or alternatively include extension assistance, which includes extending the hinge tension element and generating a reaction or restoring force in the hinge tension element when the user flexes the knee joint, urging the hinge back from a bent, flexed position to a straight, extended position, wherein the brace reduces the amount of force that needs to be applied by the user's leg and knee and associated muscles to return the brace hinge (and knee joint) from a bent position to an extended position, and the load and / or pressure on the user's knee joint is reduced to such an extent that the user experiences reduced pain or improved movement compared to flexing and extending the user's knee without the knee brace.

[0062] In yet another embodiment, the method of use involves the user actuating the hinge mechanism to pull one end (or both ends) of the tension element tauter, increasing tension and stability in the hinge assembly and knee brace, and then deactivating the mechanism (or decreasing tension) when the mechanism is no longer needed. Various embodiments of the hinge mechanism include a handle or engagement piece attached to the slide lever, where moving the handle back (or forward, upward, downward, or diagonally) moves the slide lever to pull one end (or both ends) of the tension element taut (see, e.g., the second embodiment above); a rotatable or linear ratchet-pawl mechanism on one or both ends of the hinge (or above, below, or beside the hinge) that a user can move clockwise or counterclockwise (or up or down) to impact the tension element, increasing and then releasing tension in the tension element (see, e.g., the third embodiment); and a rotatable knob connected to an internally housed spool of rigid line or wire attached to the folded tension element, where turning the knob pulls the tension element to increase tension in the band, and turning the knob in the opposite direction releases or decreases tension (see, e.g., the fourth embodiment).

[0063] Production method Various embodiments of the present disclosure use traditional manufacturing processes for knee braces and / or 3D printing to produce prototypes or final versions of components (such as gears and / or subunits of a hinge assembly), which may then be injection molded, extruded, pultruded from parts into the entire brace, or may be fully 3D modeled and / or printed. In one embodiment, the brace can be sized to fit the user and form-fit to the user. Unique fabrication methods and materials enable this form-fitting brace. For example, two-dimensional or three-dimensional photographs, videos, or scans can be used to create a model or final product (or part) that contours or fits the user's leg or other joint, with material properties that, in aspects, have an amount of flexibility, for example, in the lateral direction and less flexibility in the direction of extension or stretch, depending on the purpose of the brace.

[0064] The fabrication techniques for the braces herein allow the braces to include unexpected advantages not found in the prior art, including manufacturing and performance advantages. Thus, improved fitting braces that are higher functioning, safer, more effective, and more comfortable are possible with the inventions taught herein. The fabrication methods and materials can also help keep production costs lower than the prior art.

[0065] In addition to injection molding and 3D printing of the brace frame, the brace may also be entirely constructed of a material that allows it to be thermoformed around a specific patient's leg after fabrication, or similarly, sections of the brace may be made of a material that can be thermoformed to generate specific forces on the patient's leg at a given location, for example, to provide varus / valgus support. Additionally, it may be desirable for the padding on the brace to be thermoformable to the patient's leg, whether 3D printed as an extension of the brace frame or separately attached using another method. The advantage of this is that the padding can potentially be replaced or modified (if not continuous with the brace) as desired by the patient without requiring re-fabrication of the brace. Pultrusion and extrusion techniques are also contemplated.

[0066] Unloading and torque The disclosed knee brace vertical support differs from the prior art by unloading a significant amount of force normally applied within the knee. The reason for patellofemoral pain is that large forces are distributed over a small area. Damage to this surface can result in severe pain and loss / injury, and the cartilage surface can deteriorate, thus exposing bone and nerves in an accelerated timeframe. The tension-generating unloading mechanism in the disclosed knee brace addresses this by distributing the forces experienced at the knee to other body parts and attenuating the impact that would otherwise be painful to a joint affected by osteoarthritis. The effect of the brace's action is equivalent to a significant reduction in the user's weight. Weight loss is the most basic treatment for people with osteoarthritis.

[0067] The amount of force unloaded in a knee brace of the present disclosure is characterized by its relative torque measured around the hinge (e.g., in inch-pounds [in-lbs]) and the amount of body weight unloaded or counterbalanced (in pounds [lbs]). For example, the approximate strength or tension of a knee brace of the present disclosure generally falls into three categories:

[0068] [Table 1]

[0069] The reduced force at the OA-affected knee joint through the use of the present brace and / or hinge assembly allows the user's knee to flex more deeply, which would normally be prevented by pain. This deeper flexion engages the user's quadriceps to an extent that would normally be avoided by the user due to debilitating pain, thus facilitating the user's gaining strength through exercise. Additionally, the resistance generated by the brace can strengthen supporting soft tissues during exercise; for example, the hamstrings can be strengthened through the brace vertical support and / or hinge assembly as disclosed herein, which resist tension on the quadriceps.

[0070] Use of condylar spacers The knee braces described herein may include condylar pads that may or may not increase or decrease in width depending on the severity of the knee's varus or valgus alignment. The condylar spacers are used to shift the knee's Q angle, i.e., the angle of the femur relative to the tibia. Methods have been developed to correlate the Q angle to the degree of varus and valgus alignment, which may automatically generate inputs into the digital model of the brace to be fabricated to fully compensate for the pathology.

[0071] In embodiments of the present invention, the condylar portion of the brace can be telescopically adjusted to increase or decrease pressure on one side of the joint. For example, a certified prosthetist may be required to assess the Q angle of the user's knee and then assign a specific number of condylar spacers to be inserted into the adjustable condylar hinge region of the brace. The condylar spacers can be inserted by removing the screws and caps of the condylar hinge, inserting the desired number of condylar spacers into the condylar region of the brace, and replacing the caps and screws after adjustment. This embodiment provides the advantage of being able to readjust or add width to the condylar region if a gradual treatment path is desired for the patient. Another variation involves different sized sliding spacers in a tongue-and-groove that can lock or snap into place and allow for quick adjustment of the condylar spacing.

[0072] In an additional embodiment of the present invention, a predetermined width of the intercondylar region may be desirable. In this embodiment, the width of the condylar region is not expected to change over the course of a patient's treatment, and the width of the hinge is determined during fabrication of the brace so that the condylar hinge cap of the brace can have a thickness determined based on the desired correction of the Q angle of the knee.

[0073] Use of sensors and motors The knee braces described herein may have sensors in place to measure and monitor the position of the brace relative to either or both of the leg and other parts of the brace. This position data can provide velocity and acceleration data that is used as input to the brace's processor or monitoring system. Velocity and acceleration may be measured by positioning sensors or other sensors. This data can provide the basis for adjustments by the motor system to assist or support the joint by increasing or decreasing tension.

[0074] The sensors may also be used to measure and monitor the amount of tension present in the brace or joint assist device and the amount of unloading force applied to the joint, including the variable amount that changes as the joint is extended or flexed. The analog value of the tension present in the joint can be converted to a digital signal in various ways so that the user of the brace has knowledge of how much tension is present in the brace at any time, or when a change in tension is recognized by the sensor.

[0075] The sensor may be fabricated on or within the brace. The sensor may output a digital or electronic signal and may be connected to one or more LED lights that can indicate information about the brace, such as the amount of force or tension in the brace at any given moment. Additionally, the sensor may be connected to one or more lights that illuminate different colors depending on the amount of force or tension in the brace. For example, the light may illuminate one color for maximum force and another color for lighter amounts of force.

[0076] The orthosis motor, sensor, and control processor system may also include a potentiometer, a gear box for a gear system, and one or more servo arms or levers. The motor is operatively connected to the tension element via a gear system or another method, such as a screw, that can acquire or release tension based on input from the sensor managed by the controller or processor.

[0077] The sensors may also be connected to a screen on the orthosis that communicates information such as the forces generated within the orthosis or the weight unloaded by the orthosis, with associated unit values, etc., to the user. The sensors may also be synchronized to an application on a smart device, such as a smartphone, tablet, or computer, that provides feedback to the user regarding the amount of force being applied by the orthosis and / or the direction in which a joint is being overloaded or flexed or extended. Data from these sensors may be recorded and analyzed and used to identify patterns and may be used as input to a controller that determines how the motors should function, either assistively or supportively.

[0078] The sensor may also be connected to the tensioning mechanism. For example, using feedback from the sensor, the tensioning mechanism may loosen or tighten the tension in the tensioning element based on the feedback it receives and a preset level of desired tension as determined by the user. This eliminates the need for the user to adjust the amount of tension present in the brace while using the brace. In one embodiment, the user sets certain parameters, and based on feedback from the sensor as processed by the processor, the brace can automatically adjust the tension using, for example, a motor, hydraulics, or microdrive, or alert the user to change the resistance. In aspects, the sensor and associated processor may be connected to a server or the internet, which may notify the processor whether to adjust the tension or provide advice to the user about tension recommendations or other information related to treatment or use of the brace. Similarly, sensors associated with the processor may notify a physician of tension in the knee brace or other information from the brace and its use, allowing the treating physician to, for example, diagnose the patient, monitor the patient, monitor treatment, provide treatment options, alert the user to problems, adjust tension, determine when there is improper use of the brace, determine if damage has occurred, monitor performance, etc. Thus, sensors used with a processor may be capable of providing more automatic use and adjustment of the brace, including using predetermined parameters implemented by software to adjust tension or otherwise monitor and control use of the knee brace. Tension may also be adjusted electronically in the absence of sensors, where one button or input may increase tension and another button or input may decrease tension. This may be accomplished using a toggle switch, a rotatable knob, or a touch button.

[0079] Electromyography (EMG) sensors can be used to actuate joint assistance mechanisms to unload weight at the joint to which the device is applied. This can be done with or without other sensors and with or without motors. The degree of assistance can be modified and calibrated to suit the needs of the user.

[0080] In other aspects, the adjustable tension mechanism, including, for example, a ratchet-pawl system, can be electronically controlled, such as by a motor, and the wearer of the brace can adjust the tension by, for example, activating a button, switch, knob, lever, or other physical mechanism, but no sensors may be included in the system or brace. [Brief explanation of the drawings]

[0081] These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings. [Figure 1] FIG. 1 is a left front view of the knee brace frame in an extended position. [Figure 2] FIG. 1B is a right rear view of the knee brace frame in an extended position with the toothed gear exposed. [Figure 3] FIG. 10 is a left anterior perspective view of the knee brace of the present disclosure in a flexed position with the toothed gear exposed, and an exploded view of the extension-flexion stop. [Figure 4] FIG. 1 is a left side view of a knee brace in an extended position with an adjustable tensioning mechanism. [Figure 5] FIG. 10 is an exploded view of the meshing toothed gear assembly with exploded views of the extension and flexion stops. [Figure 6] 10A-10C are views of several possible applications of an adjustable tension mechanism using a ratchet-pawl assembly, a spool, and a rotatable knob. [Figure 7] FIG. 16 is a left anterior view of the fully assembled brace, including the adjustable tensioning mechanism and straps. [Figure 8] FIG. 1 is an internal view of the knee with the three compartments labeled. DETAILED DESCRIPTION OF THE INVENTION

[0082] As used herein, the term "proximal" is synonymous with top or upper side, such as above the knee or the side closest to the user's torso. Similarly, the term "distal" is synonymous with bottom or lower side, such as below the knee or the side furthest from the user's torso.

[0083] As used herein, the term "anterior" refers to the front of the knee and / or brace, and "posterior" refers to the back. When the hinge is oriented up and down, as seen in the figures, anterior is up and posterior is down.

[0084] Throughout the following detailed description, like reference numerals refer to like elements in all figures.

[0085] Knee brace vertical support Table 1 below lists the components shown in FIGS. 1-4 for the knee brace frame. The knee brace includes a knee brace frame 12, or vertical support, a geared pivot hinge assembly 22, and an adjustable tensioning mechanism 6. As shown in FIGS. 1-4, the vertical support includes an upper (proximal) frame 1 and a lower frame 2. In this particular embodiment, both portions 1 and 2 fit over the front or anterior aspect of the user's leg, just above and just below the knee. In one embodiment, the knee brace frame 12 is sized small, medium, or large, depending on the circumference of the user's thigh. Alternatively, the knee brace can be custom designed and manufactured to fit a specific patient's knee, which can be done via an electronic digital scan. Typically, the diameter and circumference of the upper frame 1 are larger than the diameter and circumference of the lower frame 2.

[0086] Straps: In some embodiments, the brace includes straps. In this embodiment, the vertical support further includes at least one horizontal strap above and below the knee on the back, rear, side of the knee brace 12 to secure the brace to the user's leg. In the embodiment shown in Figures 1-4, two external loops 4 are present on the rear side of the upper frame, and two external loops 5 are present on the rear side of the lower frame, with each frame having loops on both the inside and outside. The embodiment shown in Figure 7 shows the brace fully assembled with straps (27, 28, 29, 30), tension element 18, and adjustable tensioning mechanism 6 with knob 19. At least one strap 27 extends horizontally on the rear of the brace 12 within the upper frame external loop 4 between the inside and outside of the brace upper portion 1, and at least one strap 30 extends horizontally within the lower frame external loop 5 between the inside and outside of the brace lower cuff 2.

[0087] As seen in FIG. 7, straps (28, 29) extend between upper frame internal loop 7 and lower frame internal loop 9 for additional support. These straps can encircle both the front and back of the legs. The ends of straps (27, 28, 29, 30) include fastening members for securing the strap ends in an overlapping manner so that they lie flat on the user's legs and do not hang freely or droop. Fastening members include commonly known materials such as Velcro-like materials, buckles whose female ends can be integrated into the frame, etc.

[0088] [Table 2]

[0089] Hinge Assembly Table 2 lists the components shown in FIG. 5 for the hinge assembly. In aspects, the present disclosure includes at least five different pivoting hinge assemblies, each comprising at least one tension element 18 and two gear teeth comprising a proximal gear 13 and a distal gear 14. Each type of hinge assembly can be used to generate tension in a unilateral brace (inner or outer hinge) or a full knee brace (inner and outer hinge). In embodiments, the proximal end of the hinge assembly is connected to the brace upper frame 1, and the distal end of the hinge assembly is connected to the lower section 2, or in a manner similar to various knee braces known in the prior art for removing weight from the knee joint.

[0090] The two opposing gears 13, 14 of the hinge assembly 22 are connected via a central core bracket 8. The frame has a proximal opening 10 and a distal opening 11 that houses a tension element 18, allowing the tension element to extend across the mating gears and resist bending. The toothed gear has a central hole 16, and the central core bracket has a hole 20 operatively attached to the central core bracket 8 that aligns with the gear central hole 16, allowing rotation around the gear while generating tension (or breaking or restoring force), thus allowing the brace wearer to flex and extend more easily. The gears and brackets can be operatively attached using screws, bolts, or another method known in the art. The central core brackets are positioned on the inside and outside of the subunits and can function as follows: pin the subunits together while allowing the gears to rotate as one; protect the gears and tension element; and limit the maximum degree of bending of the hinge assembly. In another embodiment, the element can be extended under the gear to assist in flexion, which can be used in braces designed to aid in knee rehabilitation after injury.

[0091] The subunit may further include a cam unit positioned within the subunit, for example, engraved or molded into the subunit's internal housing, slightly above and forward of the gear so that the tension element is pulled across the cam and gear. The cam unit increases tension in the tension element as the user's knee flexes. The cam shape is variable and designed to generate a force corresponding to the unloading requirements.

[0092] The toothed gear further provides a mechanism for limiting the maximum extension of the tension element and hinge assembly to prevent hyperextension of the knee using extension and flexion stops 17 and, in embodiments, radially oriented slots 15. The slots 15 allow for the insertion of extension and flexion stops 17, which are prefabricated inserts that limit the range of motion of the joint. The extension and flexion stops 17 do not allow the gear or hinge to rotate further once they contact the stop. The allowable surface angle between the gear contact points is a design variable that can be modified to meet user requirements. Additionally, the extension and flexion stops 17 may be designed in ways not present in the drawings. For example, the extension and flexion stops could be designed to fit between gears on either the rear or front of the hinge assembly to limit the range of motion of the joint.

[0093] [Table 3]

[0094] The hinge assembly incorporates at least one tension element 18 attached to each side of the upper and lower hinge assemblies. The tension elements store energy when pulled across the hinges during knee flexion by the wearer of the knee brace. The tension elements are ported through holes (10, 11) in the hinges or support members and secured in place within the brace at either the proximal or distal ends, or both, using tethers and slots 21. For example, the tension elements are tethered in and to the proximal and distal subunits and pull apart across the gears with increased flexion and gear articulation. The tension elements generate an amount of resistance that opposes flexion, thereby reducing the amount of force in the knee joint and the amount of friction in the OA-affected area.

[0095] Table 3 lists the components shown in FIG. 6 for the adjustable tension assembly. The tension element 18 may also be attached to an adjustable tension mechanism 6, which is inserted into a female receptacle 3 in the brace frame, as in FIG. 6, or printed directly into the brace frame. The tension mechanism may include a ratchet and pawl assembly 24, 25 having a knob 19 and a spool 23 around which the tension element 18 is wound. A pawl connecting plate 26 is attached to the bottom of the spool to connect the pawls 24 so that the pawls interact with a ring of teeth / ratchets 25. The spool 23 winds up the tension element 18 when the knob 19 is rotated in a first direction, and the ratchet and pawl mechanism is engaged when the knob is rotated in a second, opposite direction. This opposes the movement of the dial and prevents the tension element from unwinding unless the ratchet and pawl mechanism is disengaged.

[0096] Alternative designs, based on the user's needs, include one or more tensioning elements within the hinge assembly on either the medial or lateral side of the knee brace, or above or below the hinge. These alternative designs also include bands of various sizes that generate different amounts of resistance. The use of two or more bands can be tailored to engage and increase tension as the degree of flexion increases.

[0097] [Table 4]

[0098] Embodiments of the present invention that include one or more sensors on a device, and in aspects, a processor on or off the device, also include a computer-readable medium that includes one or more computer files that include a set of computer-executable instructions for performing one or more of the calculations, steps, processes, and operations described and / or illustrated herein. In exemplary embodiments, the files may be stored contiguously or non-contiguously on the computer-readable medium. Embodiments may include a computer program product that includes the computer files, in the form of a computer-readable medium that includes the computer files, and that is optionally made available to consumers through packaging or, alternatively, through electronic distribution. As used in the context of this specification, a "computer-readable medium" is a non-transitory computer-readable medium and includes any type of computer memory, such as a floppy disk, a conventional hard disk, a CD-ROM, a flash ROM, a non-volatile ROM, an electrically erasable programmable read-only memory (EEPROM), and a RAM. In exemplary embodiments, the computer-readable medium stores a set of instructions that, when executed by a processor, causes the processor to perform tasks based on data stored in an electronic database or memory described herein. The processor may perform this process through any of the procedures described in this disclosure, or through any equivalent procedure.

[0099] In other embodiments of the invention, a file containing a set of computer-executable instructions may be stored in computer-readable memory on a single computer or may be distributed across multiple computers. Those skilled in the art will further appreciate, in light of this disclosure, how the invention may be implemented using hardware or firmware, in addition to software. Thus, as used herein, operations of the invention may be implemented in a system comprising a combination of software, hardware, or firmware.

[0100] Embodiments of the present disclosure include one or more computers or devices loaded with a set of computer-executable instructions described herein. The computer or device may be a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus for producing a specific machine, such that one or more computers or devices are instructed and configured to perform the calculations, processes, steps, operations, algorithms, statistical methods, formulas, or computational routines of the present disclosure. A computer or device that performs a specified calculation, process, step, operation, algorithm, statistical method, formula, or computational routine of the present disclosure may comprise at least one processing element, such as a central processing unit (i.e., processor), and a form of computer-readable memory, which may include random access memory (RAM) or read-only memory (ROM). The computer-executable instructions can be embedded in computer hardware or stored in computer-readable memory, such that the computer or device can be instructed to perform one or more of the calculations, steps, processes, and operations shown and / or described herein.

[0101] Additional embodiments of the present disclosure include computer systems for executing the computer-implemented methods of the present disclosure. The computer system may include a processor for executing computer-executable instructions, one or more electronic databases containing the data or information described herein, an input / output interface or user interface, and a set of instructions (e.g., software) for performing the methods. The computer system may include a standalone computer such as a desktop computer, a portable computer such as a tablet, laptop, PDA, or smartphone, or a set of computers connected via a network including a client-server configuration and one or more database servers. The network may use any suitable network protocol, including IP, UDP, or ICMP, and may be any suitable wired or wireless network, including any local area network, wide area network, Internet network, telecommunications network, Wi-Fi-enabled network, or Bluetooth-enabled network. In one embodiment, the computer system includes a central computer connected to the Internet having computer-executable instructions stored in memory operatively connected to an internal electronic database. The central computer can execute the computer-implemented methods based on input and commands received from remote computers via the Internet. The central computer can effectively function as a server, and the remote computers can function as client computers such that a server-client relationship is established, with the client computers issuing queries or receiving output from the server over the network.

[0102] The input / output interface may include a graphical user interface (GUI) that may be used in conjunction with computer-executable code and an electronic database. The graphical user interface may allow a user to perform these tasks through the use of text fields, check boxes, pull-downs, command buttons, etc. Those skilled in the art will understand how such graphical features may be implemented to perform the tasks of the present disclosure. The user interface may optionally be accessible via a computer connected to the Internet. In one embodiment, the user interface is accessible by typing an Internet address via an industry-standard web browser and logging into the web page. The user interface may then be operated via a remote computer (client computer) that accesses the web page and sends queries over a network connection or receives output from a server. Additionally, in aspects, the Orthosis may allow a user to interact with the Orthosis using other interfaces, such as, but not limited to, foot pedals, physical buttons, haptic feedback, or projected interface elements, and may include multiple interface options in combination with each other to allow maximum flexibility in how the user can interact with the Orthosis.

[0103] While the above examples should not be construed as limiting the scope of various embodiments of the present disclosure, these examples illustrate that a knee brace and hinge assembly can be configured for use with an elbow brace. It is apparent that one skilled in the art can modify the dimensions of the brace and hinge assembly to treat pain and inflammation associated with various elbow disorders, as well as for the ankle and other joints.

[0104] Also, within the scope of the present invention, the range of adjustability of the brace is readily apparent, inter alia, by selecting different elastic materials for the construction of the arm members, by selecting different longitudinal or cross-sectional dimensions for the arm members, or by selecting pads of different constant thicknesses or different ranges of adjustable thicknesses.

[0105] Furthermore, while the knee brace and hinge assembly of the present invention have been described above with reference to only certain embodiments adapted to treat osteoarthritis, it will be apparent to those skilled in the art that these embodiments are readily adaptable to treat pain associated with a variety of knee disorders. For example, additional embodiments contemplated within the scope of the present disclosure include a hinge assembly having a user tension adjustment handle, knob, or the like on the user's tibia, relative to the exemplary embodiment on the user's femur.

[0106] It will also be apparent that one skilled in the art can easily modify the dimensions, materials, number, type, etc. of the tension elements to achieve a level of pain relief comparable to the embodiments disclosed herein.

[0107] While various features of the invention may be described in the context of a single embodiment, these features may also be provided separately or in any suitable combination. Conversely, although the invention may be described herein for clarity in the context of separate embodiments, the invention may also be implemented in a single embodiment.

[0108] As used herein, the term "about" refers to plus or minus 5 units (eg, a percentage) of the stated value.

[0109] References herein to "some embodiments," "embodiments," "one embodiment," or "other embodiments" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least some embodiments of the invention, but not necessarily in all embodiments.

[0110] As used herein, the terms "substantial" and "substantially" refer to something that would be readily recognizable to one of ordinary skill in the art.

[0111] It is to be understood that the phraseology and terminology employed herein should not be construed as limiting, but is for the purpose of description only.

[0112] It is to be understood that the details set forth herein are not to be construed as limitations on the application of the invention.

[0113] Furthermore, it is to be understood that the present invention can be practiced or carried out in various ways and that the present invention can be embodied in embodiments other than those outlined in the description above.

[0114] Furthermore, all references cited in this disclosure are each individually incorporated herein by reference in their entirety and are therefore intended to provide an efficient method of supplementing the enabling disclosure of the present invention as well as to provide a background detailing the level of ordinary skill in the art.

[0115] It is to be understood that the terms "comprise," "comprise," and "consist of," and grammatical variations thereof, do not exclude the addition of one or more elements, features, steps, or integers, or groups thereof, and that these terms should be interpreted as specifying elements, features, steps, or integers.

Claims

1. A joint orthosis, The following components: upper and lower portions, the upper portion including an upper rigid, semi-rigid, or soft portion that conforms to a first body portion of the wearer adjacent to or above a joint of the wearer, and the lower portion including a lower rigid, semi-rigid, or soft portion that conforms to a second body portion of the wearer adjacent to or below a joint of the wearer; b. at least one pivoting hinge assembly, a hinge assembly proximal end connected to said upper portion and a hinge assembly distal end connected to said lower portion, said at least one pivoting hinge assembly further comprising a proximal subunit and a distal subunit, each subunit housing a gear that meshes with an opposing gear during articulating joint movement; c) at least one tension or compression element extending between the proximal subunit and the distal subunit, wherein a first end of the at least one tension or compression element is attached directly or indirectly to the upper portion and a second end of the at least one tension or compression element is attached directly or indirectly to the lower portion; d. A tension or compression adjustment mechanism, wherein the amount of tension or compression stored in the at least one tension or compression element is adjustable by the wearer of the joint orthosis while the joint orthosis is being worn, and the amount of tension or compression is adjustable to three or more different amounts of tension or compression stored in the at least one tension or compression element; Equipped with when the at least one pivoting hinge assembly is moved to a bent position, a force in the at least one tension or compression element increases or decreases; The adjustment mechanism comprises at least one dial, lever, knob, push button, or pulley system.

2. 10. The joint orthosis of claim 1, further comprising an adjustment mechanism that allows a wearer of the joint orthosis to (a) engage and release the at least one tension or compression element, (b) increase and decrease the tension or compression of the at least one tension or compression element, or both (a) and (b).

3. The joint brace of claim 1 , wherein the at least one tension or compression element comprises one or more elastic bands, one or more springs, one or more hydraulic mechanisms, or a combination thereof.

4. The joint prosthesis of claim 1 , wherein the joint prosthesis or one or more of the components is three-dimensional printed.

5. The joint prosthesis of claim 1 , wherein the joint prosthesis or one or more of the components is customized in size using digital imaging of the wearer's joint or adjacent body part.

6. 10. The joint orthosis of claim 1, further comprising one or more motors, one or more controllers, or a combination thereof, wherein the one or more motors adjust the amount of tension or compression stored in the at least one tension or compression element.

7. 10. The joint orthosis of claim 1, wherein a force in the at least one tension or compression element generates a force around, across, or between a joint or body part, and the force generated around, across, or between a joint or body part can be increased or decreased by pulling, tightening, or folding the at least one tension or compression element.

8. 10. The joint orthosis of claim 1, wherein the force in the at least one tension or compression element generates a force around, across, or between a joint or body part, and the force generated around, across, or between a joint or body part can be increased or decreased by adding or removing one or more tension or compression elements of the same or different diameter and / or same or different level of tension as the at least one tension or compression element, by replacing the at least one tension or compression element with one or more stiffer or less stiff tension or compression elements, and / or by using multiple tension or compression elements configured to engage at different degrees of flexion.

9. 10. The joint orthosis of claim 1, further comprising a cam unit positioned with a gear housed within the proximal subunit, the distal subunit, or both, wherein the at least one tension or compression element is pulled across the cam unit and the housed gear increases tension during knee flexion.

10. 2. The joint orthosis of claim 1, wherein the at least one tension or compression element connects at one end to the proximal or distal subunit, and the at least one tension or compression element connects at a second end to a substantially inelastic line or wire.

11. 3. The joint orthosis of claim 2, wherein the adjustment mechanism is a rotatable knob that can vary the force in the at least one tension or compression element by winding a cable or substantially inelastic line or wire around a spool.

Images