Devices with integrated remote patient monitoring technology and methods of use

Abstract

A brace configured to be attached to a joint of a subject is provided. The brace includes a first arm having a first end and a second end. The brace includes a second arm having a first end and a second end. The brace includes a hinge assembly connecting the first end of the first arm and the first end of the second arm, such that the first arm and the second arm are movable to different relative angular orientations. The brace includes a potentiometer coupled to the hinge assembly. A method of monitoring the relative angular orientation of the first arm of the brace with respect to the second arm of the brace is also provided. The method includes monitoring the output of a potentiometer coupled to one of the first arm and the second arm.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 582,863, filed November 7, 2017, and U.S. Provisional Application No. 62 / 583,168, filed November 8, 2017, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Field of Disclosure FIELD OF THE DISCLOSURE The present disclosure relates generally to braces with integrated remote patient monitoring technology and methods of use thereof. Conventional Technology

[0003] Injuries to joint ligaments, cartilage, and tendons are not uncommon, especially with today's emphasis on physical activity and conditioning. Few injuries impair movement more than knee injuries. Knee injuries account for approximately 60% of all sports-related injuries, and nearly half of these injuries involve the ACL. ACL injuries are most common in patients aged 15 to 45 (1 in 1,750), which is often due to more active lifestyles and higher participation in sports. People who have torn their ACL have a 15-fold higher risk of a second ACL injury in the first 2 months after ACL reconstruction, and the risk of ACL injury to the contralateral knee is twice that of the reconstructed knee.

[0004] There are four major ligaments that hold the knee together: the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL). More than 200,000 ACL injuries occur each year in the United States. Approximately 50% of ACL injuries occur with damage to other knee structures. While less common than ACL injuries, injuries to the PCL account for 3% to 20% of all knee ligament injuries. The collateral ligaments, MCL, and LCL, are responsible for 25% of knee injuries in competitive athletes.

[0005] Treatment for ACL and other ligament injuries includes surgical and non-surgical options. Brace support and stabilization are used to promote healing while the ligament heals. Following ACL surgery, the strength of the new ACL graft is significantly weaker than the natural ACL for the first 12 months; therefore, during this initial period, a brace helps protect against harmful external forces encountered during daily activities or sports. Summary of the Invention

[0006] This disclosure includes the following [1] to

[20] . [1] A brace configured to be attached to a joint of a subject, comprising: a first arm having a first end and a second end; a second arm having a first end and a second end; a hinge assembly connecting the first end of the first arm and the first end of the second arm, the hinge assembly allowing the first arm and the second arm to be movable to different relative angular orientations; a potentiometer coupled to the hinge assembly; An appliance comprising: [2] The orthosis according to [1] above, wherein the potentiometer is an analog mechanical potentiometer. [3] The orthosis according to [1] above, wherein the potentiometer is a digital potentiometer. [4] The orthosis according to any one of [1] to [3] above, wherein the potentiometer includes a rotatable shaft coupled to the first end of the first arm. [5] The orthosis of [4], wherein the rotatable shaft is coupled to the first end of the first arm so as to have a fixed angular orientation. [6] The orthosis of [5], wherein the potentiometer includes a resistive element, the resistive element configured to rotate relative to the first end of the first arm. [7] The orthosis of any one of [1] to [6], wherein the hinge assembly allows the first arm to rotate about a first axis and allows the first arm and the second arm to rotate about a second axis when moved in different angular directions relative to the hinge assembly, the first axis being parallel to and spatially separated from the second axis. [8] The orthosis according to [7] above, wherein the spatial separation is fixed. [9] The orthosis of [8], wherein the rotatable shaft of the potentiometer is arranged to rotate about the first axis.

[10] The device described in [9], wherein a portion of the rotatable shaft of the potentiometer is keyed and fits into a fitting opening in the first end of the first arm.

[11] The device according to

[10] , further comprising a second shaft mechanically fixed to the shaft of the potentiometer and parallel to the shaft of the potentiometer.

[12] The brace described in

[11] above, wherein the second axis is arranged to rotate around the second axis.

[13] The device according to any one of [1] to

[12] , wherein the potentiometer is mounted on a printed circuit board.

[14] The orthosis of any one of [1] to

[13] , wherein the output of the potentiometer indicates the relative angular orientation of the first arm with respect to the second arm.

[15] The device according to any one of [1] to

[14] , wherein the output of the potentiometer is connected to a buffer.

[16] The appliance of any one of [1] to

[15] , wherein the input of the potentiometer is coupled to a battery.

[17] A method for monitoring a relative angular orientation of a first arm of an orthosis with respect to a second arm of the orthosis, the method comprising monitoring an output of a potentiometer coupled to one of the first arm and the second arm.

[18] The method of

[17] , further comprising attaching a shaft of the potentiometer to one of the first arm and the second arm of the orthosis.

[19] The method of

[17] , further comprising wirelessly transmitting an indication of the output of the potentiometer.

[20] The method of

[19] , wherein the indication of the output of the potentiometer comprises an indication of the relative angular orientation between the first arm and the second arm as a function of time. A brace configured to be attached to a joint of a subject is provided. The brace includes a first arm having a first end and a second end. The brace includes a second arm having a first end and a second end. The brace includes a hinge connecting the first end of the first arm and the first end of the second arm, such that the first arm and the second arm are movable to different relative angular orientations. The brace includes a potentiometer coupled to the hinge.

[0007] A method for monitoring a relative angular orientation of a first arm of a brace relative to a second arm of the brace is provided, the method including monitoring an output of a potentiometer coupled to one of the first arm and the second arm. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 illustrates a system comprising a prosthesis with integrated remote patient monitoring, according to some embodiments.

[0009] [Figure 2] FIG. 2A shows a perspective view of the medial side of the brace, according to some embodiments.

[0010] FIG. 2B shows a perspective view of the lateral side of the brace of FIG. 2A.

[0011] [Figure 3A] FIG. 3A shows an exploded perspective view of a hinge assembly of the brace of FIGS. 2A and 2B, according to some embodiments.

[0012] [Figure 3B] FIG. 3B illustrates an exemplary analog potentiometer according to some embodiments.

[0013] [Figure 3C] FIG. 3C illustrates an exemplary digital potentiometer according to some embodiments.

[0014] [Figure 4] FIG. 4 illustrates a perspective view of the first and second axes of rotation of the first and second arms, respectively, of the brace of FIGS. 2A and 2B according to some embodiments.

[0015] [Figure 5] FIG. 5A shows a cross-sectional view of a portion of the brace of FIGS. 2A and 2B according to some embodiments.

[0016] FIG. 5B shows a cross-sectional view of a portion of the brace, according to some embodiments.

[0017] [Figure 6] FIG. 6 shows a schematic diagram of an electrical circuit of a brace configured to monitor at least one aspect of patient joint motion, according to some embodiments.

[0018] [Figure 7] FIG. 7A shows the wrap of the brace of FIGS. 2A and 2B in an unlocked orientation, according to some embodiments.

[0019] FIG. 7B illustrates the wrap of FIG. 7A in a fixed orientation, according to some embodiments.

[0020] [Figure 8] FIG. 8A shows a perspective view of the medial side of the brace, according to some embodiments.

[0021] FIG. 8B shows a side perspective view of the brace of FIG. 8A.

[0022] [Figure 9] FIG. 9A shows a side perspective view of a brace, according to some embodiments.

[0023] FIG. 9B shows a side perspective view of the brace of FIG. 9A further comprising thigh and shin pads, according to some embodiments.

[0024] [Figure 10] FIG. 10 illustrates a flowchart of a method for monitoring the relative angular orientation of a first arm of a brace relative to a second arm of the brace, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0025] Detailed Description of the Invention Embodiments of the present disclosure relate to orthopedic braces for use in treating various injuries to the knee or other joint and surrounding ligaments. More particularly, embodiments of the braces disclosed herein may be intended for use in activities of daily living for patients with ACL deficiencies, collateral ligament deficiencies, hyperextension injuries, or for prophylactic use.

[0026] Orthotic braces and supports can promote healing and wellness through the benefits of natural movement through a safe range of motion (ROM). However, the efficacy of such braces and supports in promoting healing and wellness may depend, at least in part, on whether the patient is using the brace as intended, whether recovery is progressing as expected, and / or whether the patient is reaching predetermined goals as directed by the treating physician. Furthermore, the physician's ability to guide a patient's postoperative recovery may depend, at least in part, on the physician being informed that the patient is using the brace as expected, whether recovery is progressing as expected, and / or how the patient is engaging in the recovery process. Therefore, there is a need for a solution that provides such feedback to the patient and / or the treating physician.

[0027] The braces described and / or claimed herein address the shortcomings of prior art devices by providing physicians with a way to more effectively manage and track a patient's post-surgical care and rehabilitation, at least in part, via an embedded patient activity monitor attached to or integrated into the post-surgical brace that intermittently or continuously captures, tracks, and reports on the patient's mobility, activity, and protocol compliance, enabling such physicians to provide virtual care and provide advance warning to high-risk patients who require additional post-surgical support.

[0028] The prosthetic devices described and / or claimed herein further provide methods for tracking a patient's progress against their post-operative protocols and tools to better manage the patient's physical therapy. As described in more detail below, in some embodiments, mobile smart devices combined with a platform for virtual therapy, frequently asked questions (FAQs), and mobility support may enable such patients to better self-manage their care and track their rehabilitation progress before visiting their physician, which may effectively alert physicians about their post-surgical care and provide more flexibility for communicating with them.

[0029] A better understanding of the various features of the present disclosure can be gleaned from the following description read in conjunction with the accompanying drawings, in which like reference numerals refer to like elements, where reasonably applicable. While the present disclosure is susceptible to various modifications and alternative constructions, certain illustrative features have been shown in the drawings and are described in detail below. It will be understood, however, that there is no intention to limit the disclosure to the particular embodiments disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, combinations, and equivalents within the spirit and scope of the present disclosure.

[0030] Furthermore, unless a term is expressly defined in this disclosure to have a stated meaning, it will be understood that there is no intention, either explicitly or implicitly, to limit the meaning of such term beyond its plain or ordinary meaning.

[0031] To facilitate understanding of the disclosed features of the orthopedic devices as used herein, the term "proximal" has its ordinary meaning and refers to a location located next to or near a point of attachment or origin or center point, or toward the center of the body. Similarly, the term "distal" has its ordinary meaning and refers to a location located away from a point of attachment or origin or center point, or away from the center of the body. The term "medial" refers to a location closer to the midline of the body, while the term "lateral" refers to a location away from the midline of the body. The terms "superior" and "inferior" describe the location of a particular element as being either above or below the hinged portion of the prosthetic assembly. "Upper" elements are above the hinge and knee or other joint, while "lower" elements are below the hinge and knee or other joint. The term "posterior" also has its ordinary meaning and refers to a location that is posterior or rearward of another element or feature. Finally, the term "anterior" has its ordinary meaning and refers to a location that is forward or anterior to another element or feature.

[0032] The terms "rigid," "flexible," "malleable," and "elastic" may be used herein to distinguish between certain characteristics of an orthopedic device. The term "rigid" is intended to mean that the elements of the device are generally or substantially inflexible. Within the context of a frame or support member or shell that is "rigid," the term "rigid" is intended to indicate that it does not lose its overall shape when a force is applied. In contrast, the terms "flexible" or "malleable" are intended to encompass the characteristic of being able to bend or flex under load.

[0033] 1 illustrates a system including an orthosis 100 with an integrated remote patient monitoring device 102, according to some embodiments. FIG. 1 also illustrates a user smartphone 110 or other suitable communication device, a cloud-based database, portal and / or communication network 120, and a user and / or physician communication device 130, each of which may be configured as described below.

[0034] The remote patient monitor 102 may include a goniometer (not shown in FIG. 1 ) configured to measure the angle, rotation, range of motion, angular velocity and / or acceleration of the user's joints, or any average, peak, minimum, or maximum value of any of these aspects. The device 102 may further utilize such measurements alone or in conjunction with measurements from other types of sensors as described below to determine, among other things, the number of steps taken, distance traveled, ground contact force, or the time period it takes for the patient to stand and begin walking.

[0035] In some embodiments, device 102 may further comprise one or more accelerometers configured to measure the acceleration of a portion of the user's limb, a gyroscope configured to measure the orientation of a portion of the user's limb and / or a gyroscope configured to measure the chance in that orientation, a contact and / or non-contact thermometer configured to measure skin temperature and / or ambient temperature, a capacitive and / or magnetic proximity sensor, a humidity and / or humidity sensor configured to measure the ambient humidity level or humidity levels of a portion of the Orthosis 100, and / or a light sensor configured to measure ambient light levels. In some embodiments, device 102 may be waterproof to meet at least an IPX7 standard.

[0036] Thus, the device 102 may be configured to measure, determine, or estimate parameters such as peak inversion and / or eversion forces during gait, rotational and / or pivotal shift forces, average and / or peak range of motion and / or joint angle during flexion and / or extension alone or as a function of post-operative time, ACL shear, brace motion and / or sliding, ground reaction forces, quadriceps to hamstring strength ratio, acceleration and / or velocity of the patient, a portion of the patient's limb, or the brace 100, and / or any other characteristic desirable for post-operative physical therapy and / or rehabilitation of the patient's joint.

[0037] Device 102 may be powered by one or more replaceable, non-replaceable, rechargeable, or non-rechargeable batteries (not shown in FIG. 1 ), or any other suitable power source. Thus, once enabled, device 102 may be configured to monitor and record continuous operation without substantial patient interaction, for example, for more than 30 days without battery recharging or replacement. In some embodiments, such battery recharging may be achieved by a standard AC or DC charging system or by an on-board energy harvesting device (also not shown in FIG. 1 ), such as a solar, vibration, thermal, kinetic, and / or magnetic induction charging device. Device 102 is configured to capture, store, and transmit, intermittently, periodically, or continuously, data related to such indicators of patient activity and physical therapy compliance in real time to smartphone 110 or other suitable communication device.

[0038] Smartphone 110 or other suitable communication device may have one or more applications running thereon configured to receive and display the above-described data transmitted from device 102. In some embodiments, smartphone 110, via such one or more applications, may be configured to continuously, periodically, or intermittently transmit the above-described data to a cloud-based database, portal, and / or communication network 120.

[0039] Through such one or more applications, the smartphone 110 or other suitable communications device may connect and download the above-described patient activity and physical therapy compliance data from the device 102 via a patient account setup function, a patient login function, a wired or wireless connection. The smartphone 110 or other suitable communications device may further be configured to allow, through such one or more applications, the patient to view activity and compliance data, view and compare prescribed activity and compliance goals with actual activity and compliance indicators, and / or compare the individual's recovery rate with that of the general population under similar circumstances.

[0040] The smartphone 110 or other suitable communications device may be further configured, via such one or more applications, to download activity monitor firmware from a cloud-based database, portal and / or communications network 120 or other source and transfer the firmware via either wired or wireless communications to the device 102. The smartphone 110 or other suitable communications device may be further configured, via such one or more applications, to download activity monitoring operating parameters from a cloud-based database, portal and / or communications network 120 and transfer such parameters to the device 102.

[0041] The cloud-based database, portal and / or communication network 120 may be configured to store any data received from at least the device 102, the smartphone 110 or other suitable communication device, and / or the device 130.

[0042] Device 130 may include a computer, mobile device, or any other suitable communications device and may be configured to run one or more applications that enable device 130 to access the cloud-based database, portal, and / or communications network 120 using, for example, a standard web browser such as Internet Explorer. Utilizing such one or more applications, device 130 may provide account setup functionality, patient account login functionality, and / or prescribing physician or other practitioner login functionality. Device 130 may provide the patient and / or prescribing physician with alerts regarding such patient activity and compliance data, range of motion, step counting, and / or patient progress regarding activity level, securely store such patient activity and compliance data, provide a format for remote monitoring, send and receive messages to and from the patient, and even receive wound photographs or videos from the patient. Remotely viewing such patient activity and compliance data may enable the prescribing physician to advantageously provide feedback to the patient regarding established physician-prescribed goals, encourage and track the patient's compliance with such goals, and / or update or modify such goals and protocols.

[0043] 1 can enable a patient to receive feedback regarding whether the patient is using the brace as intended, whether recovery is progressing as expected, and / or whether the patient is reaching their goals as directed by a physician. Additionally, a physician can receive feedback regarding whether the patient is using the brace 100 as expected, whether the patient is progressing as expected, and / or how engaged the patient is in the recovery process. Such benefits can reduce the number of touch points between patients and their healthcare providers, shorten hospital stays, reduce readmissions and extra visits to healthcare providers, reduce physical therapy costs, and improve patient satisfaction.

[0044] Several embodiments of braces corresponding to brace 100 of FIG. 1 will now be described with reference to at least FIGS. 2A-10.

[0045] Figure 2A shows a medial side perspective view of the brace 200, according to some embodiments, and Figure 2B shows an lateral side perspective view of the brace 200, according to some embodiments. Figures 2A and 2B are described together below.

[0046] The brace 200 includes a first medial arm 222 connected to a second medial arm 224 via a medial hinge assembly 226. As used herein, the term "hinge" or "hinge assembly" refers to a mechanical connector that connects the two arms of the brace together while allowing rotational movement through various angular orientations of the longitudinal axes of the two arms. In use, the hinge of the brace is generally proximate to the anatomical joint to be reinforced. The first medial arm 222 may be configured to be positioned along the medial side of the patient's upper leg. Thus, in some embodiments, the first medial arm 222 may be bent at an angle that allows the first medial arm 222 to be so positioned when the medial hinge assembly 226 is positioned on or adjacent to the medial side of the patient's knee. The second medial arm 224 may be configured to be positioned along the medial side of the patient's lower leg. Thus, in some embodiments, the second inner arm 224 may be bent at an angle that allows the second inner arm 224 to be positioned when the inner hinge assembly 226 is positioned on or adjacent the medial side of the patient's knee. In some embodiments, the first and second inner arms 222, 224 may comprise a metal, such as aluminum, or any other substantially rigid material. In some embodiments, the first and second inner arms 222, 224 may each be approximately 0.625 inches wide, approximately 0.100 inches thick, and approximately 5.25 inches long from the hinge center to the bar end. However, the present disclosure is not so limited, and the first and second inner arms 222, 224 may have any suitable dimensions, which may be the same or different from one another.

[0047] The brace 200 may further include a medial condyle pad 228 configured to be positioned between the medial hinge assembly 226 and the medial side of the patient's knee. In some embodiments, the medial condyle pad 228 may comprise foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material (thermoformed or otherwise) to provide cushioning between the medial hinge assembly 226 and the medial side of the patient's knee. In some embodiments, the medial condyle pad 228 may be secured to the hinge assembly 226 via any suitable method, such as hook-and-loop fasteners, snaps, clips, rivets, adhesives, etc.

[0048] The brace 200 may further include a wrap 210 configured to be wrapped around and secured to at least a portion of the patient's upper leg, knee, and lower leg. The wrap 210 includes a first pocket 212 configured to receive and secure at least a portion of the first inner arm 222 and a second pocket 214 configured to receive and secure at least a portion of the second inner arm 224. The wrap 210 may include breathable foam, Lycra, nylon, or any other suitable material.

[0049] The brace 200 further includes a first outer arm 252 coupled to a second outer arm 254 via a lateral hinge assembly 256. The first outer arm 252 may be configured to be positioned along the lateral side of a patient's upper leg. Accordingly, in some embodiments, the first outer arm 252 may be bent at an angle that allows the first outer arm 252 to be so positioned when the lateral hinge assembly 256 is positioned on the lateral side of the patient's knee. The second outer arm 254 may be configured to be positioned along the lateral side of a patient's lower leg. Accordingly, in some embodiments, the second outer arm 254 may be bent at an angle that allows the second outer arm 254 to be so positioned when the lateral hinge assembly 256 is positioned on or adjacent to the lateral side of the patient's knee. In some embodiments, the first and second outer arms 252, 254 may comprise a metal, such as aluminum, or any other substantially rigid material. In some embodiments, each of the first and second outer arms 252, 254 may have a width of approximately 0.625 inches, a thickness of approximately 0.100 inches, and a length from the hinge center to the bar end of approximately 5.25 inches. However, the disclosure is not so limited, and the first and second outer arms 252, 254 may have any suitable dimensions, which may be the same or different from one another. As described in connection with FIGS. 3A and 5A-6 below, and FIG. 1 above, the outer hinge assembly 256 may include an integrated remote patient monitoring device 102 configured to measure one or more of the angle, rotation, range of motion, angular velocity, and / or acceleration of the user's joint.

[0050] The brace 200 may further include a lateral condyle pad 258 configured to be positioned between the lateral hinge assembly 256 and the lateral side of the patient's knee. In some embodiments, the lateral condyle pad 258 may comprise foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material to provide cushioning between the lateral hinge assembly 256 and the lateral side of the patient's knee. In some embodiments, the lateral condyle pad 258 may be secured to the hinge assembly 256 via any suitable method, such as hook-and-loop fasteners, snaps, clips, rivets, adhesives, etc.

[0051] The brace 200 may further include an upper pad 262 configured to be positioned between the first outer arm 252 and the lateral side of the patient's upper limb. The upper pad 262 may comprise foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material for providing cushioning between the first outer arm 252 and the lateral side of the patient's upper limb. In some embodiments, the upper pad 262 may be secured to the first outer arm 252 via any suitable method, such as hook and loop fasteners, snaps, clips, rivets, adhesives, etc.

[0052] The brace 200 may further include a lower pad 264 configured to be positioned between the second outer arm 254 and the lateral side of the patient's lower leg. The lower pad 264 may comprise foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material that can be thermoformed or used to provide cushioning between the second outer arm 254 and the lateral side of the patient's lower leg. In some embodiments, the lower pad 264 may be secured to the second outer arm 254 in any suitable manner, such as via hook-and-loop fasteners, snaps, clips, rivets, adhesives, etc.

[0053] The brace 200 may further include an upper strap 230 configured to secure one or more of the upper pad 262, first outer arm 252, and upper inner arm 222 to the patient's upper limb. In some embodiments, the upper strap 230 may comprise a "Y"-shaped strap including a first end 232 that bifurcates at a junction to form a second end 234 and a third end 236, respectively. Each of the first, second, and third ends 232, 234, 236 may be secured to at least one of the upper pad 262 and the first outer arm 252 via respective fastening elements 272, 274, 276. In some embodiments, the fastening elements 272, 274, 276 may comprise D-rings. However, the disclosure is not so limited, and the upper strap 230 may comprise any suitable type of restraining element secured to one or more of the upper pad 262 and the first outer arm 252 by any suitable method, as shown in the figures. In Figures 2A and 2B, upper strap 230 can be wrapped around a patient's upper limb such that first end 232 is positioned around a posterior portion of the patient's upper limb and second and third ends 234, 236 are positioned around an anterior portion of the patient's upper limb. However, the disclosure is not so limited, and upper strap 230 can be configured in the opposite orientation from that shown in Figures 2A and 2B. In some embodiments, upper strap 230 can be trimmed to a length suitable for the patient.

[0054] In some embodiments, the brace 200 can further include thigh pads 238 configured to be positioned between and secured by the upper straps 230 and the patient's thighs. The thigh pads 238 can include foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material (thermoformed or otherwise) to provide cushioning between the upper straps 230 and the patient's thighs.

[0055] The brace 200 may further include a lower strap 240 configured to secure one or more of the lower pad 264, the second outer arm 254, and the lower inner arm 224 to the patient's lower limb. In some embodiments, the lower strap 240 may comprise a "Y" shaped strap including a first end 242 that bifurcates at a junction to form a second end 244 and a third end 246, respectively. Each of the first, second, and third ends 242, 244, 246 may be secured to at least one of the lower pad 262 and the first outer arm 252 via a respective fastening element 282, 284, 286. In some embodiments, the fastening elements 282, 284, 286 may comprise D-rings. However, the disclosure is not so limited, and the lower strap 240 may include any suitable type of restraining element secured to one or more of the lower pad 262 and the first outer arm 252 by any suitable method. 2A and 2B, lower strap 240 can be wrapped around a patient's lower leg such that first end 242 is positioned around an anterior portion of the patient's lower leg and second and third ends 244, 246 are positioned around a posterior portion of the patient's lower leg. However, the disclosure is not so limited, and lower strap 240 can be configured in an orientation opposite to that shown in FIGS. 2A and 2B. In some embodiments, lower strap 240 can be trimmed to a length suitable for the patient.

[0056] In some embodiments, the brace 200 may further include a calf pad 248 configured to be placed between the lower strap 240 and the patient's calf and thereby secured in place. The calf pad 248 may comprise foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material to provide cushioning between the lower strap 240 and the patient's calf.

[0057] One exemplary embodiment of outer hinge assembly 256 will now be described in more detail in connection with FIG. 3A below. While first outer arm 252, second outer arm 254, and outer hinge assembly 256 are described in connection with FIG. 3, first inner arm 232, second inner arm 234, and inner hinge assembly 236 may additionally or alternatively comprise substantially similar or identical features. Furthermore, while certain features are described with respect to first outer arm 252, such features may alternatively apply to second outer arm 254 or second inner arm 224.

[0058] FIG. 3A shows an exploded perspective view of the outer hinge assembly 256 of the orthosis 200 of FIG. 2B , according to some embodiments. The outer hinge assembly 256 includes an upper shell 306 configured to cover an outer-facing surface of the outer hinge assembly 256. The outer hinge assembly 256 further includes at least one printed circuit board (PCB) 308 including a rotational / angle encoder mounted on the PCB 308 configured to measure and / or track one or more aspects of joint function, as described anywhere in this disclosure. As described in more detail in connection with FIGS. 3B-3C and 5A-6 , in some embodiments, the rotational / angle encoder 310 can be an analog mechanical potentiometer, a digital potentiometer, or any other type of electrical potentiometer or rotary encoder configured to present a resistance that varies based on the position of a rotatable shaft of the rotational / angle encoder 310. In some embodiments, the PCB 308 including the rotational / angle encoder 310 can form at least a portion of the remote patient monitoring device 102, as described above in connection with FIG. 1. Thus, in some embodiments, PCB 308 may further include one or more of the sensors and / or elements described above in connection with FIG. 1, as well as any additional circuitry necessary for any functionality described herein.

[0059] 3A , the first outer arm 252 includes a first end 252 a and a second end 252 b, and the second outer arm 254 includes a first end 254 a and a second end 254 b. The outer hinge assembly 256 may further include a hinge plate 312 configured to couple the first end 252 a of the first outer arm 252 to the first end 254 a of the second outer arm 254 via a first shaft 314 and a second shaft 316, respectively, such that the first outer arm 252 and the second outer arm 254 are movable in different relative angular orientations with respect to the hinge assembly 256 in some embodiments. In some embodiments, the first shaft 314 may correspond to or alternatively be coupled to a rotatable shaft of the rotation / angle encoder 310. A portion 314a of the rotatable shaft 314 of the rotation / angle encoder 310 is keyed or otherwise shaped for rotational engagement with a mating aperture 318 in the first end 252a of the first outer arm 252, thereby coupling the rotatable shaft 314 to the first end 252a of the first outer arm 252. Thus, the rotatable shaft 314 can have a fixed angular orientation relative to the first end 252a of the first outer arm 252. Additionally, the second shaft 316 can be configured to fit within a second opening 320 in the first end 254a of the second outer arm 254.

[0060] In some embodiments, the first end 252a of the first outer arm 252 may include at least one stop 302 configured to limit extension and / or flexion of the patient's joint about the outer hinge assembly 256. Similarly, in some embodiments, the first end 254a of the second outer arm 254 may include at least one stop 304 configured to limit extension and / or flexion of the patient's joint about the outer hinge assembly 256. In some embodiments, one or both of the first ends 252a, 254a may include an additional stop (not shown) positioned substantially opposite the respective stop 302, 304 configured to limit extension and / or flexion of the patient's joint in the opposite direction.

[0061] The outer hinge assembly 256 may further comprise a back cover 322. In some embodiments, the outer hinge assembly 256 may further include a light, for example, a blue light emitting diode (LED) (not shown) configured to indicate whether the electronics on the PCB 308 are currently turned on or off.

[0062] In one advantageous embodiment, the rotary / angle encoder comprises a potentiometer. Examples of potentiometers will now be described with reference to FIGS. 3B and 3C. For purposes of this disclosure, a potentiometer is an electrical component or set of interconnected components that acts as a variable three-terminal resistor and / or provides a voltage divider function between the three terminals.

[0063] FIG. 3B illustrates a rotary / angle encoder 310 as an analog potentiometer, according to some embodiments. Examples of analog potentiometers include, but are not limited to, slider pots, thumbwheel pots, and trimmer pots. As illustrated in FIG. 3B, the potentiometer 310 includes a first terminal 354 coupled to a first end of a resistive element 350, a second terminal 358 coupled to a second end of the resistive element 350, and a third terminal 356 coupled to a sliding contact 352. The sliding contact 352 is coupled to a rotatable shaft 314 and configured to contact the resistive element 350 at a position that depends on the angular orientation of the rotatable shaft 314. In some embodiments, the resistive element 350 may have a substantially semicircular shape such that the sliding contact 352 can make contact at any point along the resistive element 350 while rotating about an axis defined by the central axis of the rotatable shaft 314. In some other embodiments, the resistive element 350 may be substantially linear in shape, and the sliding contact 352 may contact any point along the resistive element 350 while rotating about an axis defined by the axial center of the rotatable shaft 314. In some embodiments, the resistive element 350 may comprise any one or more of graphite, resistive wire, carbon particles suspended in plastic, a ceramic / metal mixture, a resistive polymer or resin paste, or any other suitable relatively high-resistivity conductive material. In some embodiments, the resistance provided by the resistive element 350 between the first terminal 354 and the third terminal 356 may increase linearly with the angular orientation of the rotatable shaft 314. In other embodiments, the resistance provided by the resistive element 350 between the first terminal 354 and the third terminal 356 may increase nonlinearly with the angular orientation of the rotatable shaft 314, for example, exponentially, logarithmically, or any other nonlinear manner.

[0064] As will be described in more detail in connection with FIG. 6 , during operation, a first voltage is provided across the first and second terminals 354, 358. Based on the angular orientation of the rotatable shaft 314, the sliding contact 352 contacts a single variable location on the resistive element 350. Thus, the portion of the resistive element 350 in the electrical path between the first terminal 354 and the third terminal 356 provides a first variable resistance, and the portion of the resistive element 350 in the electrical path between the third terminal 356 and the second terminal 358 provides a second variable resistance, with the sum of the first and second variable resistances generally equaling the total resistance of the resistive element 350. A second voltage appearing between the third terminal 356 and the second terminal 358 is related to and / or proportional to the ratio between the second variable resistance and the total resistance of the resistive element 350. Alternatively, the third voltage appearing between the first terminal 354 and the third terminal 356 is related to and / or proportional to the ratio between the first variable resistor and the total resistance of the resistive element 350. Thus, the potentiometer 310 functions as a voltage divider, where either the second voltage or the third voltage varies with, and can be utilized as, an indication of the angular orientation of the rotatable shaft 314. Because the first outer arm 252 of FIGS. 2A-3A is attached to the rotatable shaft 314, the second voltage or the third voltage varies with, and can be utilized as, an indication of the angular orientation of the first outer arm 252 and the patient's joint when secured to the orthosis 200.

[0065] FIG. 3C illustrates a potentiometer 310 as a digital potentiometer, according to some embodiments. As illustrated in FIG. 3C, the potentiometer 310 includes a first terminal 354 coupled to a first end of a resistive element including a plurality of series-connected resistors 350a, 350b, 350c,... 350y, 350z (also referred to herein as a resistor ladder), a second terminal 358 coupled to a second end of the resistive element, and a third terminal 356. The connection points between the terminals of adjacent resistors 350a-350z and between the resistor ladder and the first and second terminals 254, 258 comprise unique nodes of the resistor ladder. Each of a plurality of switches 360a, 360b, 360c,... 360y is connected between a respective node of the resistor ladder and the third terminal 356. Switches 360a-360z may be relays, transistors, or any other type of electrically controllable switch. Sliding contact 352 is coupled to rotatable shaft 314 and configured to make electrical contact with a control terminal of one of switches 360a-360z depending on the angular orientation of rotatable shaft 314. In some embodiments, the resistance of each of resistors 350a-350z may be substantially the same, such that the resistance provided between first terminal 354 and third terminal 356 may increase linearly, in steps, with the angular orientation of rotatable shaft 314. In other embodiments, the resistance of each of resistors 350a-350z may not be substantially the same, such that the resistance provided between first terminal 354 and third terminal 356 may increase in a nonlinear, stepwise manner with the angular orientation of rotatable shaft 314, for example, exponentially, logarithmically, or any other nonlinear manner. A number of steps in the resistor ladder is associated with a number of resistors in the ladder. The present disclosure contemplates any number of steps in the resistor ladder.

[0066] As described in more detail in connection with FIG. 6 , during operation, a first voltage is provided across first and second terminals 354, 358. Based on the angular orientation of rotatable shaft 314, sliding contact 352, which may be coupled to a voltage or signal suitable as an enable signal, makes electrical contact with the control terminal of one of switches 360a-360z, closing that switch and providing an electrical path with a first variable resistor between first terminal 354 and third terminal 356 and a second variable resistor between third terminal 356 and second terminal 354. The sum of the first and second variable resistors generally equals the total resistance of the entire resistor ladder. A second voltage appearing between third terminal 356 and second terminal 358 is related to and / or proportional to the ratio between the second variable resistor and the total resistance of the resistor ladder. Alternatively, the third voltage appearing between the first terminal 354 and the third terminal 356 is related to and / or proportional to the ratio between the first variable resistor and the total resistance of the resistor ladder. Thus, the potentiometer 310 functions as a voltage divider in which either the second voltage or the third voltage varies with, and can be used as, an indication of the angular orientation of the rotatable shaft 314. Because the first outer arm 252 of FIGS. 2A-3A is attached to the rotatable shaft 314, the second voltage or the third voltage varies with, and can be used as, an indication of the angular orientation of the first outer arm 252 and the patient's joint within the brace 200.

[0067] As shown in FIG. 4 , the first axis of rotation 402 of the first outer arm 252 passes substantially through the center of the mating aperture 318, and the second axis of rotation 404 of the second outer arm 254 passes substantially through the center of the aperture 320. The first axis 402 is shown as being parallel to and spatially separated, e.g., outwardly, from the second axis 404 by a fixed distance “d.” As further shown in FIG. 4 , the outer arm 252 defines a longitudinal axis 420, and the outer arm 254 defines a longitudinal axis 440. As described above, as the relative angular orientation of the two longitudinal axes 420, 440 changes with respect to the printed circuit board 308 inside the hinge, the orientation of the printed circuit board 308 will change by the same amount relative to the openings 318 and 320. If the shaft 314 of the potentiometer 310 is rotatably fixed within the opening 318, such as by having flats of other mating features on one or more sides while the body of the potentiometer is fixed to the printed circuit board 308, adjusting the orientation of the arms 252 and 254 adjusts the rotational position of the potentiometer shaft and changes its sensed resistance.

[0068] FIG. 5A shows a cross-sectional view of a portion of the brace of FIGS. 2A and 2B according to some embodiments. Portions of the outer hinge assembly 256 are shown, including the PCB 308, the potentiometer 310, the first outer arm 252, and the second outer arm 254. The rotatable shaft 314 of the potentiometer 310 is shown as constraining the first outer arm 252 to rotate about the first axis 402, and the second axis 316 is shown as constraining the second outer arm 254 to rotate about the second axis 404. The potentiometer 310 is illustrated as described above in connection with FIG. 3B and includes at least a resistive element 350 and a sliding contact 352, among other features. However, digital embodiments, such as those described above in connection with FIG. 3C, are also contemplated. The sliding contact 352 is coupled to the rotatable shaft 314 and configured to make electrical contact with the resistive element 350 at a position that depends on the angular rotation of the rotatable shaft 314 and the sliding contact 352, although the resistive element 350 may have a fixed orientation with respect to the potentiometer 310 and the outer hinge assembly 256. As previously mentioned, the rotatable shaft 314 may be coupled to the first outer arm 252 such that as the first outer arm 252 rotates (into or out of FIG. 5A ) about axis 402, the rotatable shaft 314 and the sliding contact 352 also rotate about axis 402, as indicated by the double-sided arrow. Thus, the sliding contact 352 contacts the resistive element 350 at varying positions, causing the potentiometer to provide a correspondingly varying resistance. The output of the potentiometer, therefore, indicates the relative angular orientation of the first outer arm 252 with respect to the second outer arm 254. Furthermore, because the resistive element 350 has a fixed orientation relative to the potentiometer 310 and the outer hinge assembly 256, when the first outer arm 252 rotates the rotatable shaft 314 and the sliding contact 352, the resistive element 350 is configured to rotate (or at least change orientation) relative to the first end 252a of the first outer arm 252.

[0069] In some other embodiments, rather than the first outer arm 252 rotating about the first axis 402 and the second outer arm 254 rotating about the second axis 404, FIG. 5B shows an alternative embodiment in which the first outer arm 252 and the second outer arm 254 are both configured to rotate about the same first axis 402. Thus, the first outer arm 252 may be fixed to the rotatable shaft 314 as described above, but the second outer arm 254 is not fixed to the rotatable shaft 314, but instead is simply constrained by the rotatable shaft 314 to rotate freely about the first axis 402 while the orientation of the printed circuit board is fixed to the outer arm 254 by, for example, standoffs 520. In such an embodiment, all other functionality may be as described above.

[0070] 6 shows a schematic diagram of an exemplary electrical circuit 600 of a brace configured to monitor at least one aspect of patient joint motion, according to some embodiments. While one embodiment is disclosed in FIG. 6, the disclosure is not so limited and contemplates any circuit or configuration that provides the functionality as described in this disclosure.

[0071] The PCB 308 may include circuitry 600, as described above. Circuitry 600 may include a battery 602, a smoothing capacitor 606, first and second resistors 604, 608, a potentiometer 310 having first, second, and third terminals 354, 358, 356, a resistive element 350 and a sliding contact 352, a buffer 616, a controller 618 having transmit and receive capabilities, and an antenna 620. While the potentiometer 310 is illustrated as described above in connection with FIG. 3B (e.g., an analog potentiometer), the potentiometer 310 may also be as described above in connection with FIG. 3C (e.g., a digital potentiometer).

[0072] The battery 606 has a negative terminal electrically connected to ground potential and a positive terminal electrically connected to the first terminal of the first resistor 604. The smoothing capacitor 606 has a first terminal electrically connected to ground potential and a second terminal electrically connected to the second terminal of the first resistor 604 and the first terminal of the second resistor 608. The second resistor 608 has a second terminal electrically connected to the first terminal 354 of the potentiometer 310 (e.g., the first terminal of the resistive element 350), which may be considered an input of the potentiometer 310. The second terminal 358 of the potentiometer 310 (e.g., the second terminal of the resistive element 350) is electrically connected to a potentiometer enable output of the controller 618. The sliding contact 352 of the potentiometer 310 is in electrical contact with a physical position on the resistive element 350, which depends on the orientation of the rotatable shaft coupled to the sliding contact 352, and with a third terminal 356 of the potentiometer 310. The third terminal 356 is in electrical contact with a first input terminal of a buffer 616. An output terminal of the buffer 616 is electrically connected to both a second input terminal of the buffer 616 and a potentiometer input of a controller 618. An antenna terminal of the controller 618 is in electrical contact with an antenna 620. Thus, an input (e.g., the first terminal 354) of the potentiometer 310 is electrically coupled to a battery 602 via first and second resistors 604, 608. Although not shown, the buffer 616 and the controller 618 may each be coupled to and receive power from the battery 602 and may further be appropriately coupled to ground potential to complete an electrical circuit.

[0073] In the operating battery 602, the smoothing capacitor 606 and the first and second resistors 604, 608 provide a predetermined voltage across the first and second terminals 354, 358 of the potentiometer 310 (e.g., across the resistive element 350) when a potentiometer enable input of the controller 618 is activated (e.g., electrically coupled to ground or any other potential within the circuit 600). Because the sliding contact 352 makes electrical contact with different physical locations on the resistive element 350 depending on the angular orientation of the rotatable shaft of the potentiometer 310 based on the degree of flexion or extension of the patient's joint, the potentiometer 310 operates as a voltage divider that outputs a variable fraction of the predetermined voltage to the sliding contact 352, the third terminal 356, and the buffer 616. Therefore, the variable resistance provided between the input and output terminals of the potentiometer 310, as well as the variable voltage provided at the sliding contact 352, are proportional to and indicative of the relative angular orientation between the first outer arm 252 and the second outer arm 254, as previously described.

[0074] The buffer 616 presents a high impedance at its input, and the output is equal to the voltage at the sliding contact 352 to the potentiometer input of the controller 618. The combination of the high resistance of the resistive element 350 and the relatively high input impedance of the buffer 616 also allows the circuit 600 to draw a very small amount of current, and therefore power, from the battery 602, allowing uninterrupted operation of the circuit 600 for a relatively long period (e.g., six months or more) without replacing or recharging the battery 602. This is a particularly advantageous feature in the post-surgical recovery environment, where such braces are typically worn for several months after surgery. The low-power potentiometer-based rotation sensing circuitry allows for continuous or near-continuous rotation monitoring without the need to recharge or replace the batteries in the hinge. As far as the user is concerned, the hinge on the brace is treated exactly like a conventional hinge during the recovery period, with no measurement capabilities and no maintenance.

[0075] The controller 618 can configure the driven antenna 620 to convert the voltage received from the output of the buffer 616 into a signal indicative of the received voltage and transmit the signal to, for example, the user smartphone 110 or other suitable communication device, as described above in connection with FIG. 1. Thus, the controller 618, alone or in conjunction with the antenna 620, can include a wireless transmitter configured to transmit, as a function of time and based on the received voltage, an indication of the relative angular orientation between the first outer arm 252 and the second outer arm 254 of the orthosis 200 to the user smartphone 110 or other suitable communication device, as described above. In some embodiments, the controller 618 can be further configured to receive and appropriately process signals from the antenna 620 transmitted from, for example, the user smartphone 110 or other suitable communication device, as described above in connection with at least FIG. 1.

[0076] FIG. 7A shows the wrap 210 of the brace 200 of FIGS. 2A and 2B in an unlocked orientation, according to some embodiments. The wrap 210 may include one or more upper fastening elements 712 configured to secure an upper portion of the wrap 210 around a patient's upper limb. The wrap 210 may further include one or more lower fastening elements 714 configured to secure a lower portion of the wrap 210 around a patient's lower limb. The fastening elements 712, 714 may include hook-and-loop fasteners, snaps, clips, or any other elements that removably fasten the wrap 210 around a patient's limb. The wrap 210 may further include an opening 710 configured to align with the patient's patella, thereby providing increased comfort as well as more stable alignment of the wrap 210 with the patient's leg. FIG. 7B shows the wrap 210 of FIG. 7A with the upper fastening element 712 and the lower fastening element 714 secured around the patient's leg.

[0077] FIG. 8A shows a perspective view of the medial side of a brace 800 that is substantially identical to brace 200 without the wrap 210 or first inner arm 222, second inner arm 224, and medial hinge assembly, according to some embodiments. FIG. 8B shows a perspective view of the lateral side of brace 800 of FIG. 8A. As shown, brace 800 includes all of the features of brace 200 described above, except that the wrap 210, first inner arm 222, second inner arm 224, and medial hinge assembly are omitted. All other features are as described above for brace 200.

[0078] 9A shows a side perspective view of a brace 900, according to some embodiments. As shown, the brace 900 includes all of the features of the brace 800 described above in connection with FIGS. 8A and 8B, except for the thigh pads 238 and calf pads 248, as further described below.

[0079] The brace 900 may include a lower pad 964 configured to be positioned between the second outer arm 254 and the lateral side of the patient's lower leg in a configuration mirroring the lower pad 264, as described above in connection with FIGS. 2A and 2B. Accordingly, the fastening elements 282, 284, 286 may be secured to the lower pad 964 and at least one of the second outer arm 254 in a configuration mirroring that described above in connection with FIGS. 2A and 2B. The lower pad 964 may comprise foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material for providing cushioning between the second outer arm 254 and the lateral side of the patient's lower leg. In some embodiments, the lower pad 964 may be secured to the second outer arm 254 in any suitable manner, such as via hook and loop fasteners, snaps, clips, rivets, adhesives, etc.

[0080] 2A and 2B, the lower strap 240 is configured to secure the lower pad 264 and one or more of the second outer arms 254 to the patient's lower leg. The lower strap 240 can be wrapped around the patient's lower leg such that the first end 242 is positioned around a posterior portion of the patient's lower leg and the second end 244 and the third end 246 are positioned around an anterior portion of the patient's lower leg.

[0081] 9B shows a side perspective view of the brace 900 of FIG. 9A further including a thigh pad 938 and a shin pad 948, according to some embodiments. The thick pad 938 is configured to be positioned and secured between the upper strap 230 and the patient's shell. The thigh pad 938 may be substantially similar to the thigh pad 238 described above in connection with FIGS. 2A and 2B.

[0082] In some embodiments, the brace 200 can further include a shin pad 948 configured to be positioned between the lower strap 240 and the patient's shin and secured in place. The shin pad 948 can comprise foam, rubber, elastomer, plastic, 2# EVA, Lycra laminate, brushed nylon, or any other suitable material (thermoformed or otherwise) to provide cushioning between the lower strap 240 and the patient's shin.

[0083] 10 shows a flowchart 1000 of a method for monitoring the relative angular orientation of a first arm of a brace relative to a second arm of the brace, according to some embodiments. Flowchart 1000 may be applied to the use of any brace described in this disclosure.

[0084] Block 1002 includes affixing the shaft of a potentiometer to one of the first and second arms of the orthosis. For example, the rotatable shaft 314 of the potentiometer 310 may be affixed to one of the first outer arm 252 or the first inner arm 222, as previously described in connection with any previous figure. In some embodiments, the rotatable shaft 314 of the potentiometer 310 may alternatively be affixed to one of the second outer arm 254 or the second inner arm 224, similar and with similar functionality as described above for at least the first outer arm 252.

[0085] Block 1004 includes monitoring the output of the potentiometer. For example, the controller 618 (FIG. 6) or any other suitable circuit or circuits of the PCB 308 (FIG. 3) may be configured to monitor the voltage, current, or resistance output from the third terminal 356 (e.g., between the second and third terminals 358, 356) of the potentiometer 310, as described above in connection with any previous figure.

[0086] Block 1006 includes wirelessly transmitting an indication of the output of the potentiometer. For example, as described above in connection with FIG. 6, the controller 618 may be configured to convert the voltage, current, or resistance received from the output of the buffer 616 as a function of time and based on the received voltage into a signal indicative of the relative angular orientation between the first outer arm 252 and the second outer arm 254 of the orthosis 200.

[0087] Although the present disclosure has been described with respect to certain preferred features, other features of the present disclosure, including variations in dimensions, configurations, and materials, will be apparent to those skilled in the art in light of the disclosure herein. Moreover, all features detailed in connection with any one aspect of this specification can be readily adapted for use in other aspects of this specification. The use of different terms or reference numbers for similar features in different embodiments does not imply differences other than those that may be explicitly stated. Accordingly, the present disclosure is intended to be described solely by reference to the appended claims and is not limited to the preferred embodiments disclosed herein.

Claims

1. 1. An orthosis configured to be attached to a joint of a subject, comprising: a first arm having a first end and a second end; a second arm having a first end and a second end; a hinge assembly connecting the first end of the first arm and the first end of the second arm, the hinge assembly allowing the first arm and the second arm to be movable at different relative angular orientations; a potentiometer coupled to the hinge assembly; Equipped with a first terminal (354) of the potentiometer is connected to a battery through a resistor; The second terminal (358) of the potentiometer is connected to a controller (618); a third terminal connected to the sliding contact (352) of the potentiometer is connected to a buffer (616); The buffer (616) is connected to a potentiometer input of the controller (618); the potentiometer comprises a rotatable shaft (314) coupled to the first end of the first arm; the sliding contact (352) is coupled to the rotatable shaft and configured to make electrical contact with a variable position on a resistive element (350) between the first terminal (354) and the second terminal (358) of the potentiometer depending on an angular orientation of the rotatable shaft; The controller (618) transmits a signal indicative of a relative angular orientation of the first arm with respect to the second arm.

2. 10. The orthosis of claim 1, wherein the potentiometer is an analog mechanical potentiometer.

3. The brace of claim 1 , wherein the rotatable shaft is coupled to the first end of the first arm so as to have a fixed angular orientation.

4. The brace of claim 3 , wherein the resistance element is configured to rotate relative to the first end of the first arm.

5. 5. The orthosis of claim 3, wherein the hinge assembly allows the first arm to rotate about a first axis and allows the first arm and the second arm to rotate about a second axis when moved at different angular orientations relative to the hinge assembly, the first axis being parallel to and spatially separated from the second axis.

6. The brace of claim 5 , wherein the spatial separation is fixed.

7. The orthosis of claim 6 , wherein the rotatable shaft of the potentiometer is arranged to rotate about the first axis.

8. The orthosis of claim 7 , wherein a portion of the rotatable shaft of the potentiometer is keyed and fits into a mating opening in the first end of the first arm.

9. 10. The orthosis of claim 8, comprising a second shaft mechanically fixed to and parallel to the shaft of the potentiometer.

10. The brace of claim 9 , wherein the second shaft is arranged to rotate about the second axis.

11. The appliance of claim 1 , wherein the potentiometer is mounted on a printed circuit board.

12. 1. A method for monitoring a relative angular orientation of a first arm of a brace relative to a second arm of the brace, comprising: monitoring an output of a potentiometer coupled to one of the first arm and the second arm; a first terminal (354) of the potentiometer is connected to a battery through a resistor; The second terminal (358) of the potentiometer is connected to a controller (618); a third terminal connected to the sliding contact (352) of the potentiometer is connected to a buffer (616); The buffer (616) is connected to a potentiometer input of the controller (618); the potentiometer comprises a rotatable shaft (314) coupled to the first end of the first arm; the sliding contact (352) is coupled to the rotatable shaft and configured to make electrical contact with a variable position on a resistive element (350) between the first terminal (354) and the second terminal (358) of the potentiometer depending on an angular orientation of the rotatable shaft; The method of claim 1, wherein the controller (618) transmits a signal indicative of a relative angular orientation of the first arm with respect to the second arm.

13. The method of claim 12, wherein the controller (618) is configured to transmit the signal wirelessly.

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