[1] FIELD OF THE DISCLOSURE

[2] The disclosure relates to a modular rehabilitation system for rehabilitating or assisting an individual recovering from physical impairment.

[3] BACKGROUND

[4] Strokes can be disabling. Despite methods and tools for rehabilitation, time for recovery from strokes can vary widely depending on the individual and the severity of the stroke. The impact on an individual from a stroke may likewise depend on the individual, as each stroke affects an individual differently. A stroke may cause hemiparesis or hemiplegia, wherein one side of the body is weakened or paralyzed, which further complicates recovery.

[5] While the population of stroke survivors is not homogeneous, several common gait issues impact an individual’s ability to walk with a normal gait. A stroke may cause the individual to have muscle weakness, spasticity, impaired sensorimotor control, and/or loss of cognitive function. Secondary impairments may include muscle atrophy, contracture, and reduced aerobic capacity. Depending on the severity of the stroke, degrees of recovery of ambulatory capability may range from severe limitation to normal.

[6] In early recovery of a stroke, the hip, knee, ankle and foot may be flaccid; this makes it difficult for an individual to advance the leg during a swing phase, stabilize the knee during a stance phase, and even clear the toes during swing phase while walking. The hip and knee are typically the first to improve in function with the foot and ankle often seeing minimal recovery. The inability to articulate the foot and ankle into dorsiflexion may lead to persistent plantarflexion contracture, possibly accompanied by supination. Although the swing phase is important for advancement of the limb and for setting up each step for successful weight bearing, many of the most significant gait problems facing stroke survivors occur during stance phase because of instability and abnormal biomechanical function.

[7] Some therapists and physicians have used orthoses in the management of stroke recovery rehabilitation. Despite a long history of using orthoses, particularly for the upper and lower limbs of recovering individuals, many solutions exist, yet there are many conflicting results and it has been difficult to reach conclusions on their effectiveness. In view of the disparate solutions and results, there are few if any unified systems that can be used individually or in combination to treat stroke victims to assist or regain full functional mobility in a normal gait pattern. For example, existing solutions do not always provide an effective, customizable, dynamic approach to recovery that is suited to the needs and pathologies of an individual user. The individual’s path to recovery may change the individual’s needs vis-a-vis orthopedic solutions, requiring a dynamic treatment plan and accompanying devices without sacrificing effectiveness of the individual components.

[8] Powered orthoses, whether for hip, knee, or foot/ankle, are problematic because of the inconvenience to the individual in terms of the added bulk of battery systems, the inconvenience of charging the battery systems, maintenance and safety issues, and added costs.

[9] Many solutions comprise a knee-ankle-foot orthosis (KAFO), or an ankle-foot orthosis (AFO), or a hip orthosis such as a reciprocating-gait orthosis (RGO), or a hip-knee-ankle-foot orthosis (HKAFO), but these solutions are often limited in their focus for treating impairment. These solutions lack flexibility and dynamic customization in treatment options during rehabilitation.

[ 10] There is a need for a system of orthopedic devices that overcomes the existing problems of devices not being adjustable for different stages of treatment and for different levels of recovery. There is further a need for a system of orthopedic devices that provides aid to an individual without the inconveniences and costs of powered orthotic systems.

[11] SUMMARY

[12] A modular rehabilitation system is provided to treat a spectrum of rehabilitation, and to address hip, knee and ankle-foot issues. As a stroke victim or other individual’s strength, coordination, and balance improve, the modular rehabilitation system can be modified by removing or adding components at each joint to accommodate the functional progress made by the individual. For instance, if the individual has progressed and regained hip function, the hip component may be removed, allowing the KAFO component to continue to offer functional assistance of stabilization of the knee and ankle. If the hip and ankle persist in weakness or coordination but the individual can stabilize the knee, the knee component may be removed.

[13] The modular rehabilitation system is provided to match the functional requirements of the individual throughout the rehabilitation process. Rather than replacing the initial orthosis for a secondary appropriate functional design to match the individual’s current needs, this system allows a clinician to add, remove, or adjust each component, providing clinicians with the ability to adapt the rehabilitation system according to the individual’s increasing (or even decreasing for some medical indications) capability during their rehabilitation.

[14] An objective of the disclosure is to provide a rehabilitation system which overcomes the above problems in the prior art. It is desired that the modular rehabilitation system be suited for long-term use during rehabilitation, and is adaptable to the progress made and treatment needs unique to the individual. The rehabilitation system is modular so it is easily modified from time-to-time to accommodate for the individual’s progress or treat specific impairments if not all components of the rehabilitation system are required. The components of the system work in harmony with one another, eliminating multiple or disparate orthoses and simplifying the prescription and adaption of the system to a unique individual.

[15] The modular rehabilitation system recognizes bilateral movement, between right and left sides of the individual, and offers not only support but also gait movement assistance. For instance, in an embodiment of the modular rehabilitation system, a bilateral modular HKAFO reciprocating gait rehabilitation system enables support and gait assistance by relying on movement of a healthy side of the individual.

[16] Of basic concern is the use of hip, knee, ankle and foot components, firmly securable from the hip to the foot, each working together to protect and maintain necessary joint stability, mobility, and integrity, encourage normal orthopedic recovery and development, and assist with upright mobility. Said components may be added or removed as determined necessary during treatment.

[ 17] BRIEF DESCRIPTION OF THE DRAWINGS

[18] These and other features, aspects, and advantages of the present disclosure will become better understood regarding the following description, appended claims, and accompanying drawings.

[19] Figs. 1A and 1B are schematic views showing a normal gait cycle.

[20] Fig. 2A is a frontal view exemplifying a modular rehabilitation system fitted on legs.

[21] Fig. 2B is a side view exemplifying the modular rehabilitation system of Fig. 2A.

[22] Fig. 2C is a rear view exemplifying the modular rehabilitation system of Fig. 2A.

[23] Fig. 3 A is a front elevational view showing a hip orthosis for the modular rehabilitation system of Fig. 2A.

[24] Fig. 3B is a side elevational view of the hip orthosis of Fig. 3A.

[25] Fig. 3C is a rear elevational view of the hip orthosis of Fig. 3A.

[26] Fig. 4A is a schematic view showing flexion/extension adjustment of the hip orthosis of Fig. 3A in a first position.

[27] Fig. 4B is a schematic view showing flexion/extension adjustment of the hip orthosis of Fig. 3A in a second position.

[28] Fig. 5A is a schematic view showing a cuff of the hip orthosis of Fig. 3 A in a first position.

[29] Fig. 5B is a schematic view showing the cuff of Fig. 5 A in a second position. [30] Fig. 6 is a side elevational view of a knee orthosis for the modular rehabilitation system of Fig. 2A.

[31] Fig. 7A is a schematic view of a hinge in the knee orthosis of Fig. 6.

[32] Fig. 7B is a schematic view of the hinge of Fig. 7A in a first position.

[33] Fig. 7C is a schematic view of the hinge of Fig. 7A in a second position.

[34] Fig. 8A is a front elevational view showing an ankle orthosis for the modular rehabilitation system of Fig. 2A.

[35] Fig. 8B is a side elevational view showing the ankle orthosis of Fig. 8A.

[36] Fig. 9A is a schematic view of a first embodiment of an ankle lock configured for the ankle orthosis of Fig. 8 A in a first position.

[37] Fig. 9B is a schematic view of the ankle lock of Fig. 9A in a second position.

[38] Fig. 10A is a schematic view of a second embodiment of an ankle lock configured for the ankle orthosis of Fig. 8A in a first position.

[39] Fig. 10B is a schematic view of the ankle lock of Fig. 10A in a second position.

[40] Fig. 11 is a side elevational view of a variation of the ankle orthosis of Fig. 8A.

[41] The drawing figures are not drawn to scale, but instead are drawn to provide a better understanding of the components, and are not intended to be limiting in scope, but to provide exemplary illustrations.

[42] DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

[43] A. Overview

[44] A better understanding of different embodiments of the disclosure may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements.

[45] While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are in the drawings and are described below. It should be understood, however, there is no intention to limit the disclosure to the embodiments disclosed, but on the contrary, the intention covers all modifications, alternative constructions, combinations, and equivalents falling within the spirit and scope of the disclosure.

[46] It will be understood that, unless a term is defined in this disclosure to possess a described meaning, there is no intent to limit the meaning of such term, either expressly or indirectly, beyond its plain or ordinary meaning.

[47] B. Modular Rehabilitation System and Gait Pattern

[48] According to the modular rehabilitation system of embodiments of the disclosure, different components are arranged to be connected and disconnected to one another depending on an individual’ s rehabilitation requirements. A hip component may assist in initiating a swing phase, an ankle component such as an AFO may control drop foot and provide stability to the individual while walking, and a knee component may prevent hyperextension, provide support and stabilization, and provide stance control such as by locking a knee joint in stance phase and unlocking in a swing phase.

[49] The modular rehabilitation system may be employed for treating chronic and acute stroke victims. The modular rehabilitation system can treat other neurological or physical conditions which assist lower limb mobility. The components of the modular rehabilitation system may be adjusted, added, or removed during rehabilitation. The components can work together to support the functionality of each other.

[50] The impact of the stroke may affect all, some, or one functional phase of gait. The modular rehabilitation system is adapted to treat each of these phases of gait, as considered necessary for a particular individual’s recovery and rehabilitation.

[51] Figs. 1 A and 1B exemplify the functional phases of gait. Normal gait involves a cyclic movement, and a stereotypic movement pattern with rhythmic alternating motion of the trunk and lower limbs. In healthy individuals without impairment from a stroke or other pathology, the cycle-to-cycle variation is relatively low. For individuals requiring compensatory movement for ambulation, they produce abnormal and exaggerated vertical and horizontal displacement of the center of gravity. Impaired balance, sensory and visual deficits and foot drop all contribute to poor ambulation. During a gait cycle, the leg or limb L moves through functionally distinct postural sequences including stance and swing phases. In each of these phases, there are events critical to assuring a normal gait, and which are achieved by synergistic patterns of the muscles controlling the limb.

[52] Transitional actions occur among the stance and swing phases. During weight acceptance three major functions include shock absorption to the ground reaction force, limb stability accepting body weight, and preservation of the progression of gait. Double support is a period during which both feet are in contact with the ground, whereas single support is the period during which only one foot is in contact with the ground.

[53] Next in the stance phase is the stance limb progression or single limb support. In part, there is midstance where the ankle serves as a rocker allowing the limb to advance over the stationary foot. The forefoot then provides a rocker allowing the foot and limb to roll forward. As the foot and limb progress, initial contact of the contralateral foot initiates limb loading and weight acceptance, during which double support by both legs begins again. [54] In swing phase or limb advancement, there is a pre-swing where actions of the ankle and hip of the unloaded limb initiate knee flexion and preparation for swing. During initial swing, the muscle action at the hip, knee, and ankle lifts the foot and advances the limb. Next comes mid-swing during which the limb is advanced by continued hip flexion and early knee extension, and the tibia is held vertical, and active foot support is required. At terminal swing, the limb advancement is completed by knee extension, while further hip flexion is inhibited by the preparation for stance. During each of these phases, there are individual joint motion patterns, requiring individual and synergistic muscle action.

[55] C. Modular Rehabilitation System

[56] Figs. 2A - 2C exemplify an embodiment of a modular rehabilitation system 10, which includes a hip component 100, an ankle and/or foot component 300, and a knee component 200 connected to the hip component 100 and the ankle and/or foot component 300. Each of these components 100, 200, 300 may be used individually or combined synergistically to improve an individual’s gait. At the onset of rehabilitation of an hemiparetic individual or an individual otherwise in need of rehabilitation, all components 100, 200, 300 may be employed together on the affected or impaired side, and as the individual recovers or improves components 100, 200, 300 can be selectively removed as they are no longer needed.

[57] The components 100, 200, 300 may not be directly secured to one another, but may be employed together simultaneously. The components 100, 200, 300 may be co-dependent upon one another. For example, the knee component 200 may have a lockable hinge 204 operable or activated by the ankle and/or foot component 300.

[58] D. Hip Orthosis

[59] The major hip motions during gait occur in the plane of progression, and include an arc of extension through stance, reaching 10 degrees hyperextension in terminal stance. A similar arc of flexion occurs from pre-swing through mid-swing. There are small postural accommodations from pelvic motions which yield to body weight and follow the advancing limb in swing. The hip extensor muscles begin with the hamstrings in terminal swing and proceed to the gluteus maximus and adductor magnus during the loading response. The gluteus medius - gluteus minimus complex and the tensor fascia lata provide lateral stability in stance. Hip flexion results from serial activation of the adductor longus, iliacus, sartorius, and gracilis.

[60] The prior art does not show devices tested extensively for clinical purposes to cope with weakness in the hip flexors in individuals with stroke-related issues and/or other pathologies. Hip flexion weakness can reduce the ability of the individual to advance the leg into swing phase and can indirectly reduce the ability to provide toe clearance through elevation of the knee. The hip orthosis proposed here in one configuration allows for the harvest of hip flexion power from the sound side (the unimpaired leg); this is then transmitted to the affected side to drive the affected hip (the impaired leg) into flexion. The hip component 100 of the modular rehabilitation system 10 is provided to solve these problems. Utilizing the individual’s normal motion to provide actuation of an impaired limb advantageously reduces cost, bulk, and manufacturing and operational complexities of powered orthoses.

[61] In one configuration, the hip component 100 aims to improve gait by assisting with initiating swing phase, and reducing circumduction or scissoring of the affected side. The hip component 100 may be used in combination with the ankle component 300 to improve gait through enhancing advancement of the limb and improving toe clearance. When there is moderate weakness at the knee, the ankle component 300 may be optionally configured to provide some improved knee stability during mid- to late-stance phase through the transmission of ground reaction forces. Where the hip is weak and the knee is too weak to provide stability, the hip component 100 may be used in combination with the knee component 300 to lock the knee during weight bearing while also preventing hyperextension.

[62] The hip component 100 operates to provide support during level walking and maintaining a standing position. The hip component 100 can use energy from the sound, healthy leg HL to provide hip flexion of the impaired leg IL during swing phase. The hip component 100 can correct excessive hip/abduction and adduction of the impaired limb IL to enable an optimal hip abduction/adduction for gait.

[63] The hip component 100 provides reciprocal gait, particularly due to action of the healthy leg HL, by shifting body weight forward and laterally, with the healthy leg HL driving the impaired leg IL. The hip component 100 drives the impaired leg IL into flexion during the swing phase of gait, thereby maintaining a more normal gait pattern and assisting the impaired leg IL through the stages of gait.

[64] As shown in Figs. 2A through Fig. 5B, the hip component 100 preferably comprises a posterior component 102 arranged to store energy and to initiate a swing phase. The posterior component 102 is an elongate torsional bar extended between right and left lateral sides of an individual and about the individual’s back. The posterior component 102 is preferably a rigid or semi-rigid torsional bar.

[65] Orthotic hinges 108, 109 may be arranged proximate the individual’s trochanter and positioned in various positions of flexion or extension and may be fixed in that position or be maintained with partial range-of-motion control while being allowed to swing freely as deemed necessary by the clinician. [66] The posterior component arranged in the depicted embodiment as a torsional bar 102 is arranged so that as each leg moves into flexion and extension, the torsional bar 102 torsionally twists in the sagittal plane. The pelvis can articulate independently from the hip. In accordance with pelvic motion, the torsion from the torsional bar 102 twists generally downwardly on one end, and generally upwardly on another end depending on movement of the healthy and impaired legs HL, IL, to return to a rest position.

[67] Torsion in the posterior component 102 may be modified according to the location of the struts 110, 111 relative to one another. A force is generated during the swing phase by the healthy leg HL which can aid in propelling the impaired leg IL into swing phase. According to the location of the struts 110, 111, force incurred by the posterior component 102 can be modified. As an example, when the sound-side orthotic hip joint (thigh) position is set relatively extended relative to the affected-side orthotic hip joint (thigh) while the orthosis is at rest, and the sound side hinge motion is blocked from further flexion while the affected side hinge motion is blocked from further extension. Then when the system is donned and the individual is asked to stand with legs vertically parallel, this would create a reactive torsion of the posterior component 102.

[68] The modular rehabilitation system 10 and the hip component 100 first create pressure generated on the anterior thigh of the sound side with a concomitant torsion of the posterior component 102 which transmits that torsion to the affected side via“preloaded” pressure on the posterior thigh of the affected side. The greater the differential relative angle between the sound and affected side positions (as defined by a position of the struts 110, 111), the greater the torsion and flexion force enhancement created for the affected side. With correct alignment adjustment of the relative side positions, the affected thigh may be provided with controlled flexion enhancement.

[69] The posterior component 102, particularly when adapted as a torsion spring, may be provided from a selection of different torsion springs or even stacked springs that could be used according to the degree of torsional stiffness required. The posterior component 102 may be advantageously selectively added to or removed from the hip component 100 depending on the torsion required for an individual. Other means may increase or decrease torsion, including overlaying different torsion springs, or other known means. An individual’s need for actuation of an affected leg may thus be accommodated simply and effectively.

[70] With the ability to alter the stiffness or torsion of the posterior component 102, another method of controlling the relative torsion and flexion between the sound side and the affected side of the hip may be illustrated between the two anatomical segments. If an individual or clinician were to stiffen the posterior component 102 and adjust both hip joints to be fixed parallel in a neutral position, another control strategy would be generated. In this orientation, while standing, no torsion would be created. Once the sound side is advanced, however, it would theoretically create enhancement of the affected hip flexion force. As the individual then swings through on the affected side past a neutral position, the hip orthosis 100 would then provide resistance to flexion (or slight extension force against the flexion movement), decelerating the thigh segment and allowing the calf segment to continue on to full knee extension.

[71] With this approach, the hip orthosis 100 provides both active thigh flexion and passive knee flexion assistance during initial swing phase and early swing phase on the affected side IL, followed by active thigh and passive knee extension assistance as the affected side IL swings past mid swing phase. In this way, the link to the sound side HL via posterior component 102 enhances stability of the affected knee in early stance phase. As one can see, through the modification of the posterior component’s 102 stiffness or the relative positions of the first and second struts 110, 111, several gait enhancements may be made.

[72] Relying on the features in the described embodiments, the hip component 100 may be secured onto the individual according to a variety of ways. In the illustrated example, the hip component 100 has first and second cuffs 104, 105 extending from the posterior component 102 by the first and second struts 110, 111 and attaching to the individual’s thighs. The first cuff 104 is a dorsal cuff, such that the dorsal cuff comprises a rigid or semi-rigid element 132 and a strap 134 connecting to opposed sides of the dorsal cuff 104. The second cuff 105 is a ventral cuff arranged similarly as the first cuff 104 although the rigid or semi-rigid element and strap are reversed. The dorsal cuff 104 is adapted to secure about an impaired hip or leg, and the ventral cuff 105 is adapted to secure about a healthy hip or leg.

[73] The arrangement of the dorsal and ventral cuffs is exemplary and not limiting. It can be seen in the depicted embodiment that the arrangement of the dorsal and ventral cuffs is arranged to harness energy from a forward motion of a healthy leg as the front of the healthy leg presses forward, and by the operation of the torsional bar 102 to transfer the harnessed energy to the impaired leg by pressing on a back of the leg. The first and second cuffs 104, 105 are pivotally mounted to the first and second struts 110, 111 by first and second lower pivots 128, 129. The first and second cuffs 104, 105 are arranged to rotate in the sagittal plane.

[74] The hip component 100 may be provided in combination with a lumbar support 106 connected to the posterior component 102, and arranged to extend circumferentially about an individual. An exemplary lumbar support is taught in U.S. patent application publication no. 2017/0007435, published on January 12, 2017, and incorporated herein by reference.

[75] The hip component 100 may have first and second ROM hinges 108, 109 arranged proximate to an individual’s hip-joint center of rotation. The first and second ROM hinges 108, 109 are preferably connected to the posterior component 102 and to the first and second struts 110, 111. The first ROM hinge 108 includes at least first and second range of motion stops 120, 122, such that the first and second range of motion stops 120, 122 limit rotation R of the first strut 110 relative to the posterior component 102. The first ROM hinge 108 is connected to the posterior component 102.

[76] An anterior belt 112 can secure to the posterior component 102, and may be configured with the posterior component 102 to extend circumferentially about an individual. The anterior belt 112 is connected to the posterior component 102 by a belt connection 130.

[77] A strut hinge 114 may be defined on the first strut 110. The first strut 110 may have first and second strut segments 116, 118 connected to one another by the strut hinge 114. The strut hinge 114 aids in abduction/adduction adjustment. The first and second struts 110, 111 and the ROM hinges 108, 109 may be similar to those described in U.S. patent application publication no. 2016/0228277, published on August 11, 2016, and incorporated herein by reference. A corresponding hinge may likewise be defined on the second strut 111.

[78] The ROM hinge 108 slidably secures to the posterior component 102 along a slider mount 124, between at least first and second positions (I, II). The first and second ROM hinges 108, 109 are pivotally secured to the posterior component 102 by first and second pivot elements 126, 127. The adjustment of the ROM hinges 108, 109 enables better location of the ROM hinges 108, 109 according to the individual’s trochanter, and the ROM hinges 108, 109 are adjustable relative to anterior and posterior positions. The ROM hinges 108, 109 also enable flexion/extension adjustment to decrease/increase pre-tension and to provide more or less moment during swing phase.

[79] The positions of the ROM hinges 108, 109 may serve as stops to the posterior component 102, such that the ROM hinges 108, 109 serve as terminal points by/at which the posterior component 102 twists. Once the posterior component 102 twists to a certain degree, it returns to twist at the other side.

[80] The features described herein provide an improved hip orthosis that not only aids an individual impaired by a stroke or other pathologies by using a healthy leg to provide a driving force for an impaired leg, but also allows for an orthosis with reduced bulk, cost, and maintenance compared to powered hip orthoses. The hip orthosis of the disclosure is combinable in a modular fashion with a knee component and/or an ankle-foot component to form a modular rehabilitation system according to embodiments of the disclosure as needed according to an individual’s recovery.

[81] E. Knee Component

[82] Exemplary embodiments of the knee component 200 are shown in Figs. 6 - 7C. Fig. 6 shows a knee component 200 arranged in cooperation with an ankle-foot component 300 according to an embodiment of the disclosure. The knee component 200 is preferably arranged to lock at the knee so it remains locked until there is rollover onto the toe of the foot which unweights the heel. This enables the late stance phase to remain relatively stable since the ground reaction force should reside anterior to the knee joint.

[83] According to certain embodiments disclosed below, a locking mechanism 232 may generally employ a pneumatic bladder provided in combination with the ankle foot component 300 that extends a lever into the knee joint, which pushes a locking plate into a position to lock the knee. The locking plate is spring loaded to move into a free-motion position, but if the knee is loaded, the locking plate is bound in place locking the knee. Once the knee is fully extended, the plate frees up and the springs pull the locking plate out of the way so the knee joint can freely flex.

[84] Two conditions are desirable for the knee joint to lock: 1) knee extension position and 2) load on the heel. Three conditions are desirable for the knee joint to unlock: 1) knee extension, 2) no load on the heel, and 3) no flexion moment on the knee joint. The knee component 200 may bind the locking mechanism 232 into a locked position even if load is removed from the heel until the knee flexion moment is removed.

[85] With each gait cycle, the knee alternately flexes and extends both in the stance and swing phases. The quadriceps muscle group restrains knee flexion in stance and assists extension during swing, and all vasti respond simultaneously. Terminal swing knee extension is dampened to prevent terminal impact of the knee joint by the hamstring muscle group.

[86] For sagittal stability of the knee, the knee component 200 may comprise a knee support 202 having first and second frame components 208, 210 connected to one another by a lockable hinge 204 which is lockable in extension. A hinge lock 232 is arranged to lock the first and second frame components 208, 210 relative to each other when the knee component 200 is in extension. The hinge lock 232 is arranged to unlock when the knee component 200 is first placed in full extension while the heel is unweighted. The knee joint then remains free to flex until reaching a position wherein knee extension and heel weight bearing occur concurrently. If a flexion moment persists on the locked knee hinge 204 while weight is borne on the heel, or even if the heel is unweighted but the toe is loaded as in a stumble, the hinge 204 will remain locked.

[87] To additionally stabilize the knee component 200 on the individual, an intermediate support 214 is connected to the first frame component 208. An intermediate strap 216 may be connected to the second frame component 210. The first frame component 208 includes a first strut 218, and the second frame component 210 includes a second strut 220.

[88] A line system 206 connects the ankle component 300 to the hinge lock 232, and the line system components 222, 224, 226 are adapted to actuate the hinge lock 232 when the knee hinge 204 is in extension. The line system 206 relies on hydraulic or pneumatic actuation. This may be a closed system once the bladder 238 is connected to the knee joint via the line system 206, which may comprise a quick disconnect connector.

[89] The line system 206 has an ankle line 222 extending to an intermediate line 224, which connects to a knee line 226 coupled to the hinge lock 232. A first branch line 228 extends from the ankle line 222 and connects to an ankle lock 308 of the ankle foot component 300. A second branch line 230 extends from the ankle lock 308 to the knee line 226. The intermediate line 224 extends between the connection of the first branch line 228 to the ankle line 222 and the connection of the second branch line 230 to the knee line 226.

[90] The line system 206 may comprise tubes arranged for passing and withdrawing air from at least one bladder 238, 306 arranged for inflation and deflation. The line system 206 in the aforementioned arrangement is not limited to the embodiment as shown, but may be adapted to activate and deactivate the hinge lock 232 according to movement and the gait cycle, and is not limited to specific movement of the foot and/or ankle.

[91] Referring to Figs. 7A - 7C, an example of the hinge lock 232 is arranged for locking first and second frame segments 218, 220 relative to one another at a hinge 204. The hinge lock 232 includes a plate 234, a lever 236 connected to and movable relative to the plate 234, and a bladder 238 connected to the lever 236. Deflation of the bladder 306 of the foot ankle component 300 under compression pressurizes the line system 206 and inflates the bladder 238 which drives the lever 236 into the hinge 204. The movement of the lever 236 as the bladder 238 inflates drives or pivots the lever 236 relative to the plate 234 into an interference position, in which the lever 236 may be aligned with the plate 234, locking the hinge 204 and the first and second frame segments 218, 220 in extension. Loading the heel extends the lever 236, and unloading the heel retracts the lever 236. [92] If a load is maintained on the heel and a knee flexion moment is generated, it binds the interference plate 234 into a locking position. If the knee flexion moment is maintained and the heel is unloaded, the lever 236 retracts but the plate 234 is still bound in the interference position. As soon as the knee is extended and load is removed from the heel, the lever 236 will be retracted, the plate 234 would no longer be bound in the interference position, and the spring 246 will automatically pull the plate 234 out of the interference position, thereby unlocking the knee hinge 204.

[93] The spring 246 connects the plate 234 to the lever 236 so the hinge 204 remains locked until the knee is flexed such that when the leg is lifted, the hinge lock 232 is released. A bar 242 couples the spring 246 to the lever 236. A link 244 couples to the lever 236 and the bladder 238. The link 244 is connected to the spring 246 and is pivotable according to inflation of the bladder 238. A cover 240 may couple the link 244 to the bladder 238. The spring 246 may attach on opposed sides of the hinge lock 232 or the cover 240, or may alternatively attach in any suitable arrangement.

[94] The spring 246 biases or predisposes the hinge to an unlocked position. The knee joint must be placed in full extension at heel strike, then the lever 236 (because of a load on the heel/bladder compresses the air in the bladder 238) drives the knee joint plate 234 into the locked (interference) position. The moment the knee is put in full extension with no flexion moment on the hinge 204, the spring 246 pulls the plate 234 back into the non-interference position. In the illustrated embodiment, the heel bladder 306 is necessary for proper knee lock/unlock function. Other arrangements for locking and unlocking the knee joint are likewise envisioned by the disclosure and the depicted embodiment is by no means limiting.

[95] The knee component 200 is not limited to the aforementioned embodiment on the hinge lock 232, but other methods and means may lock the hinge 204 according to the gait cycle. The knee component 200 need not be directed only to embodiments in which the knee component 200 is connected to the hip component 100, but the components 100, 200 can be used simultaneously together. The components 100, 200 may be directly connected to one another such that the hip cuffs are attached to the frame components of the knee component 200, thereby removing redundant features in the rehabilitation system.

[96] The knee component 200 advantageously allows for enhanced control of flexion/extension of an individual’s impaired leg based on appropriate indications, but without complicated and maintenance-heavy electronic components. The knee component 200 is further advantageous because it is configured to be modular with an ankle foot component 300 and/or a hip component 100, with the precise arrangement of the components 100, 200, 300 dynamic throughout an individual’s recovery based on the individual’s need.

[97] F. Ankle-Foot Component

[98] During each stride, the ankle passes through four arcs of motion, whereby at the onset of stance, the ankle is in a neutral dorsiflexion, and contacts the floor by the heel. Rapid loading of the heel causes the ankle to plantar flex before forefoot contact. For upright mobility, an ankle-foot orthosis (AFO) is provided in the form of ankle foot component 300 to aid individuals with decreased dorsiflexion strength and to help prevent a foot from dragging the toes on the ground. The ankle-foot component 300 reduces hip flexion required during swing phase of gait.

[99] The ankle-foot component 300 may be a ground- or floor-reaction orthosis so that when the individual moves from a foot-flat position to the midstance of gait, the ground reaction force on the ankle-foot component 300 creates an extension moment at the knee. This ankle- foot component 300 stabilizes the knee in stance phase.

[100] According to an embodiment, the ankle-foot component 300 includes a foot plate 304, a component body 310, and an ankle hinge 302 connecting the foot plate 304 to the component body 310.

[101] The footplate 304 includes a first plate 312 and a second plate 314, such that the first and second plates 312, 314 are connected to one another at their first ends 313, and the first and second plates 312, 314 define a clearance 317 from one another at their second ends 315. The first and second plates 312, 314 are displaceable relative to one another at their second ends 315 such that the first plate 312 is cantilevered from its first end 313 relative to the second plate 314 at its second end 315, the clearance 317 being variable along a length of the footplate 304 according to displacement of the first plate 312 relative to the second plate 314.

[102] A bladder 306 connects to the second ends 315 of the first and second footplates 312, 314 and is within at least a portion of the clearance 317. The bladder 306 is connected to the line system 206 of the knee component 200.

[103] The ankle hinge 302 may couple a first strut 316 to the component body 310 and a second strut 318 connecting to the footplate 304. The ankle hinge 302 may define a hinge opening 320 for receiving a locking mechanism 320, 330.

[104] According to an embodiment, the locking mechanism 320, 330 comprises at least one locking element 321, 331 arranged to lock the first and second struts 316, 318 relative to one another. The locking mechanism 320 defines first and second rotatable members, or rings 322, 324 arranged concentrically and rotatable relative to one another, and a magnet lock 321 maintaining the first and second rings 322, 324 in a first position for resisting movement of the first and second rings 322, 324 relative to one another.

[105] The magnet lock 321 defines first and second magnets 326, 328 each supported by the first and second rings 322, 324, respectively. The first and second magnets 326, 328 are attractable relative to one another. The first and second rings 322, 324 are aligned with one another in a first position, and the first and second rings 322, 324 are rotatable relative to one another when in a second position resulting from the first and second magnets 326, 328 being out of alignment. The out-of-alignment position and rotation correspond to an unlocked state in which the footplate 304 may rotate relative to the component 310, with the ankle and foot correspondingly rotating relative to each other.

[106] In another embodiment, the locking mechanism 330 defines first and second rotatable members, or rings 332, 334 arranged concentrically and rotatable relative to one another. A detent mechanism 331 maintains the first and second rings 332, 334 in a first position for resisting movement of the first and second rings 332, 334 relative to one another. The detent mechanism 331 includes a housing 338 supporting a biased detent element 336 by a biasing element 340 arranged toward a detent 342 provided by the second ring 334, the detent 342 arranged to receive the biasing element 340. The detent mechanism 331 is preferably carried by the first ring 332.

[107] The biased detent element 336 may be a ball biased by a spring forming the biasing element 340 within the housing 338 and biased toward the second rotatable member or ring 334. The first and second rotatable members or rings may be formed from or connected to the first and second struts 316, 318. The locking mechanisms 320, 330 may be arranged such that when the mechanisms are unlocked the ankle hinge 302 allows movement of a foot relative to an ankle only at preferred times and positions, while ensuring that the foot is locked relative to the ankle at preferred times, e.g. during a stance phase or during portions of a swing phase.

[108] The modular rehabilitation system disclosed herein aids an individual suffering from impairment from a stroke or related pathologies by providing a modular and adjustable system of orthoses suitable for the hip, knee, and/or ankle foot regions, the orthoses being independently functional and combinable with each other as needed and tunable to an individual’s particular needs. An individual may utilize only the hip orthosis if needed, or the hip, knee, and ankle foot orthoses, just the ankle foot orthosis, or the knee and ankle foot orthoses, as required during treatment. The rehabilitation system overcomes the problems associated with powered orthoses and provides a solution having reduced bulk, cost, and operational and manufacturing complexity. [109] While the foregoing embodiments have been described and shown, alternatives and modifications of these embodiments, such as those suggested by others may be made to fall within the scope of the invention. While the components of the rehabilitation system have been described in combination or separately, it will be understood that the principles described may be extended to other types of orthopedic and prosthetic devices.