Patient treatment system and method

Abstract

Embodiments of the invention provide a system and method for delivering a stimulating treatment or relief to a patient. The system includes a pair of stimulating electrodes coupled to an article that can be coupled to a patient to deliver stimulation controlled through a wired or wireless link. The system includes a controller that can generate and apply stimulating pulses to the pair of stimulating electrodes based on a stimulation program and signals or data. The system includes a sensor coupled to the controller and the article and a user interface that enables a user to remotely view or exchange information through the link and monitor and set or reconfigure the stimulating pulses. In some embodiments, the article includes a brace assembly that can be a brace, a strut, a sleeve, a sling, a garment, a wrap, or a band.

Description

[0001] This application is a divisional application. The original application is a PCT application with application number PCT / US2016 / 014973, filed on January 26, 2016, which entered the Chinese national phase on August 16, 2017, with national application number 201680010489.8, entitled "Patient Treatment System and Method".

[0002] Related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 107,954, filed January 26, 2015, and U.S. Provisional Application No. 62 / 170,001, filed June 2, 2015, the entire contents of which are incorporated herein by reference. Background Technology

[0004] Orthotic braces and wraps can be used as preventative aids to prevent joint injury caused by movement or orientation outside the biomechanical limits of the joint. Orthotic braces and wraps can also be used to promote proper healing of joints after injury or surgery and to stabilize joints in patients with arthritis, thereby reducing pain.

[0005] A key part of the successful healing process after injury and potential surgery is the rehabilitation process. As a major part of the rehabilitation process, after injury, surgery, or when suffering from arthritis—a condition that can cause muscle atrophy—patients typically see a physical therapist to restore their range of motion (ROM) and strengthen their muscles. Knee braces are particularly widely used to treat a variety of knee joint conditions. These braces can be configured to provide limb force or leverage around the knee joint to relieve compressive forces within a portion of the knee joint or to reduce the load on that portion of the knee. Furthermore, if the knee ligaments are weak or have been surgically repaired, knee braces can stabilize, protect, support, or facilitate knee rehabilitation. Typical knee braces and their various types have several significant limitations and drawbacks. First, after an injury occurs and a medical professional, such as a physician, recommends that the patient wear a knee brace, the professional may not see the patient for weeks or months after the initial visit. The professional may not receive any feedback regarding the range of motion of the joint or the strength of the muscles around the joint.

[0006] If the patient is already fitted with a brace, the physical therapist can manually adjust the brace under the guidance of a physician to reduce or increase the permissible movement of the injured joint, or to adjust a brace that has become loose due to muscle atrophy, or both. These manual adjustments often lead to errors because they are based on the physical therapist's (or medical professional's) personal judgment; for example, the muscles and surrounding tissues may not have sufficient strength to support the joint.

[0007] In some cases, patients may receive electromuscular stimulation (EMS) at the start of a physical therapy session to regain the ability to contract their muscles spontaneously before exercise and stretching begin. EMS, also known as neuromuscular electrical stimulation (“NMES”), has been used in therapeutic practice and has remained largely unchanged over the past 30 years. The current modality of use involves targeting a muscle group and providing electrical stimulation to mimic the action potentials typically generated by nerve signals, thereby activating and evoking action potentials in muscle fibers and the resulting contraction, thus inducing muscle contraction. Electrical stimulation therapy can be determined by specifying the appropriate level of power and / or duration of the electrical pulses, pulse width, phase characteristics (monophagic, biphasic, triphasic, multiphasic, symmetrical), frequency, waveform shape (sine, square, triangular, trapezoidal, sawtooth, custom), duty cycle, duty cycle on / off time, and duty cycle ramp type. Therapists (as prescribed by healthcare professionals) also use EMS to strengthen atrophied muscles. However, the delivery of EMS for muscle strengthening is suboptimal because it is typically performed with the therapist present. Furthermore, the physician treating the patient (e.g., surgeon) often sees the patient several times after treating the injury (e.g., surgery). The physician typically determines the next course of treatment based on the patient's appearance and feeling during follow-up visits. However, physicians often lack objective data associated with the patient's injury to aid in their assessment and next steps. Specifically, physicians may not have precise data on joint range of motion or muscle strength. Therefore, physicians often determine the next course of treatment based on their subjective analysis of the patient during follow-up visits; this analysis may be suboptimal. Besides the suboptimal data, the timing of observing this data is also inefficient and suboptimal. Patients may heal faster or slower than typical patients, and a patient's treatment could potentially be better tailored to their actual progress.

[0008] Therefore, there is still a need for a support system that can provide monitoring of the support system during use and provide feedback and adjustment of the support system during treatment (preferably in real time). Summary of the Invention

[0009] Some embodiments of the present invention include a system for delivering stimulation therapy or relief to a patient, the system comprising: at least one processor; and a non-transitory computer-readable storage medium including at least one stimulation program and communicating data with said at least one processor. The system includes at least one pair of stimulation electrodes coupled to an article, wherein said at least one pair of stimulation electrodes is configured and arranged for coupling to the patient and controlled via a link. Furthermore, the system includes at least one controller including or coupled to said at least one stimulation program and at least one signal or data source, wherein said at least one controller is configured and arranged to generate at least one stimulation pulse and apply it to said at least one electrode pair, at least in part based on said at least one stimulation program and said at least one signal or data processed by said at least one processor. The system includes: at least one sensor coupled to said at least one controller and said article; and at least one user interface configured and arranged to enable a user to remotely view or exchange information via a link, and to monitor and set or reconfigure said at least one stimulation pulse. Furthermore, the at least one controller is configured and arranged to (a) apply a sensing pulse to the patient's tissue using at least one sensor, (b) measure at least one electrical parameter from the patient's tissue relating to the power dissipation of the sensing pulse in the tissue, (c) adjustably apply at least one stimulation pulse to the patient's tissue based at least in part on the measured power dissipation, the at least one stimulation pulse being adjustably controlled by the at least one controller to maintain a constant power output to the patient's tissue based at least in part on the at least one electrical parameter, and (d) repeat steps (a)-(c). In some embodiments, the article includes a support assembly. In some embodiments, the support assembly includes a support, a strut, a sleeve, a strap, a sling, clothing, a wrap, and / or a strap.

[0010] Some embodiments of the present invention include a link, the link comprising wired coupling. In some embodiments, the link includes wireless coupling, the wireless coupling comprising: generation 0 wireless signals, generation 1 wireless signals, generation 2 wireless signals, generation 3 wireless signals, generation 4 wireless signals, generation 5 wireless signals, global positioning satellite signals, and the 2400-2493.5MHz frequency band. Wireless signals, RFID electromagnetic radiation, WiFi wireless signals, two-way radio RF signals, UHF or VHF signals, millimeter wave signals and / or near-field wireless signals.

[0011] In some embodiments, at least one sensor includes an accelerometer. In some other embodiments, the at least one sensor includes: a motion sensor, a gyroscope, a proximity sensor, a position sensor, a global positioning sensor (GPS), an optical sensor, a magnetic sensor, a magnetometer, an inductive sensor, a capacitive sensor, an eddy current sensor, a resistive sensor, a magnetoresistive sensor, an inductive sensor, an infrared sensor, an inclinometer sensor, a piezoelectric material or piezoelectric-based sensor, a blood oxygen sensor, and / or a heart rate sensor.

[0012] In some other embodiments of the invention, the at least one sensor includes at least one laser- or ultrasound-based sensor configured and arranged for measuring tissue or fluid movement. In some other embodiments, the at least one sensor includes at least one hydration sensor configured and arranged to measure interstitial fluid levels to determine hydration levels. In some embodiments, the at least one sensor includes at least one force or pressure sensor configured and arranged for measuring muscle activity or response. Other embodiments of the invention include at least one sensor comprising an electromyographic sensor configured and arranged to measure muscle recruitment or muscle fatigue.

[0013] In some embodiments of the invention, accelerometers, gyroscopes, magnetometers, or other motion sensors may be used to assess spontaneously induced or involuntary movements at the skin site via electromuscular stimulation. This motion or acceleration profile can provide feedback on the intensity of muscle contraction and can be used in closed-loop feedback control methods to optimize / customize electrical stimulation parameters to provide the most effective or strongest muscle contraction for the patient. Alternatively, these motion / acceleration profiles may be evaluated for changes over time to determine improvement or progress in the user treated with the system.

[0014] In some other embodiments, the at least one sensor includes at least one pair of stimulating electrodes. In some embodiments, the at least one sensor is configured and arranged to monitor or measure the location of a portion of a patient. In other embodiments, the at least one sensor is configured and arranged to monitor or measure the location of a portion of an article. In some embodiments, the at least one sensor is configured and arranged to respond to at least one physiological response or parameter from a patient. In some embodiments, the at least one signal or data is at least partially based on the response of the at least one sensor.

[0015] In some embodiments of the invention, the at least one user interface includes a display presented on the user's device. In some other embodiments, the user's device includes: a desktop computer, a laptop computer, a digital tablet computer, a digital assistant, a cellular phone, a smartphone, a smartwatch, a wearable activity monitor, glasses, a camera, a pager, and / or an internet device.

[0016] In some embodiments of the invention, the at least one controller is configured to update the at least one user interface with at least one of the following: the state of a portion of the item, the position of a portion of the item, and data from at least one sensor. In some other embodiments, the at least one user interface includes a display that includes options for scanning the item and synchronizing the item with the at least one controller. In other embodiments, the at least one user interface includes a display that includes options for scanning more than one item and synchronizing the items. In some embodiments, the at least one user interface includes a display that includes options for activating the link to connect the item to the at least one controller. In some embodiments, link activation includes a wireless link between the item and the at least one controller. In some other embodiments of the invention, the at least one user interface includes a display configured and arranged such that a user can set or reconfigure at least one stimulus pulse.

[0017] In some embodiments of the invention, the controller includes a rechargeable power storage device. In some other embodiments of the invention, at least one sensor is located in a sensor housing, which includes an onboard or adjacently coupled power source.

[0018] Some embodiments of the present invention include a computer-implemented method of providing stimulation therapy or relief to a patient, the method comprising providing a computer system including at least one processor, and providing an article including at least one sensor that generates at least one signal or data based on or in response to at least one physiological response or parameter from the patient. Furthermore, the method includes providing at least one pair of stimulation electrodes coupled to the article, and providing at least one control system, and using the at least one processor to generate a user interface. The method further includes providing a server coupled to the control system and the user interface, and using the at least one processor via a link enabling the user to configure the at least one control system to generate at least one stimulation pulse and apply it to the at least one electrode pair, at least in part based on at least one stimulation program and at least one signal or data processed by the at least one processor. The at least one controller (a) applies the sensing pulse to the patient's tissue using at least one sensor, (b) measures at least one electrical parameter from the patient's tissue related to the power dissipation of the sensing pulse in the tissue, (c) adjustably applies the at least one stimulation pulse to the patient's tissue, at least in part based on the measured power dissipation, the at least one stimulation pulse being adjustably controlled by the at least one controller to maintain a constant power output to the patient's tissue, at least in part based on the at least one electrical parameter, and (d) repeats steps (a)-(c). Attached Figure Description

[0019] Figure 1A This is a representation of a knee brace according to one embodiment of the invention, the knee brace comprising two sets of geometries, each set coupled to a rigid segment for the joint.

[0020] Figure 1B A knee brace comprising a support and a wrapping component is shown according to some embodiments of the present invention.

[0021] Figure 1C The diagram illustrates the range of motion data capture from a strut and the strut sensor used for motion capture according to some embodiments of the invention.

[0022] Figure 1D A portion of a knee wrap according to some embodiments of the present invention is shown.

[0023] Figure 1E A knee wrap according to some embodiments of the present invention is shown.

[0024] Figure 1F A strut system according to some embodiments of the present invention is shown, the strut system comprising a combined modular orthopedic strut and a conductive wrapping.

[0025] Figure 1GA side view of a modular orthopedic brace and conductive wrapping, combining some embodiments of the invention, is shown.

[0026] Figure 2A Shoulder straps according to some embodiments of the present invention are shown.

[0027] Figure 2B A wrist brace including multiple sensors is shown according to some embodiments of the present invention.

[0028] Figure 2C A rear view of a full-shoulder vest according to some embodiments of the present invention is shown.

[0029] Figure 2D A rear view of a full-shoulder vest according to some embodiments of the present invention is shown.

[0030] Figure 2E A front view of a full-shoulder vest according to some embodiments of the present invention is shown.

[0031] Figure 2F A full-shoulder vest according to some embodiments of the invention is shown, which shows integrated straps.

[0032] Figure 2G A full-shoulder vest according to some embodiments of the present invention is shown, which shows an electrode compression band.

[0033] Figure 2H A full-shoulder vest according to some embodiments of the present invention is shown, which shows the center-line vest closure.

[0034] Figure 2I A full-shoulder vest according to some embodiments of the invention is shown, which shows electrode inlets and trapezius compression bands.

[0035] Figure 2J A rear view of a half-vest according to some embodiments of the present invention is shown.

[0036] Figure 2K A close-up rear view of a half-vest according to some embodiments of the invention is shown.

[0037] Figure 2L A front view of a half-vest according to some embodiments of the present invention is shown.

[0038] Figure 2M A side front perspective view of a half-vest according to some embodiments of the present invention is shown.

[0039] Figure 2N and 2O An airbag according to some embodiments of the present invention is shown.

[0040] Figure 2P An arm support including multiple accelerometer sensors is shown according to some embodiments of the present invention.

[0041] Figure 2Q A leg support 470 comprising a plurality of accelerometer sensors is shown according to some embodiments of the invention.

[0042] Figure 2R An ankle support including multiple accelerometer sensors is shown according to some embodiments of the present invention.

[0043] Figure 2S An internal region of a support frame according to some embodiments of the invention is shown, illustrating two contact points for determining whether the support frame is worn by a human body.

[0044] Figure 2T A front view of a hip brace assembly with integrated sensors according to some embodiments of the present invention is shown.

[0045] Figure 2U A side view of a hip brace assembly with integrated sensors according to some embodiments of the present invention is shown.

[0046] Figure 2V A rear view of a hip brace assembly with integrated sensors according to some embodiments of the present invention is shown.

[0047] Figure 2W A front view of an abdominal / back device with integrated sensors according to some embodiments of the present invention is shown.

[0048] Figure 2X A rear view of an abdominal / back device with integrated sensors according to some embodiments of the present invention is shown.

[0049] Figure 3A A representation of wireless data collection including cellular data from a knee brace is shown according to some embodiments of the present invention.

[0050] Figure 3B Wireless data transmission between a knee brace and a controller according to some embodiments of the present invention is described.

[0051] Figure 4 Computer system control according to some embodiments of the present invention is illustrated.

[0052] Figure 5 A computer system including a backend server is shown according to some embodiments of the present invention.

[0053] Figure 6Screen images are shown according to some embodiments of the invention, illustrating the current state of the support, including a representation of deflection and orientation relative to the ground.

[0054] Figure 7 A representation of a strut system with motion data collection sensors according to some embodiments of the present invention is shown.

[0055] Figure 8-9 Each provides some embodiments according to the present invention. Figure 7 The representation in the figure shows the potential motion of each part of the scaffold system that can be monitored.

[0056] Figure 10 A sensor assembly for detecting surface edema by optical sensing according to some embodiments of the present invention is shown.

[0057] Figure 11 A system for non-anesthetic pain relief using electrical stimulation therapy with controlled pain pulses, according to some embodiments of the present invention, is shown.

[0058] Figure 12 Biofeedback data collection according to some embodiments of the present invention is illustrated.

[0059] Figure 13 A smart electrode according to some embodiments of the present invention is shown.

[0060] Figures 14A-14C Adaptive electrodes according to some embodiments of the present invention are shown.

[0061] Figure 15 An operational oscilloscope scan of a pulse train after NMES is shown according to some embodiments of the present invention.

[0062] Figure 16 The following is an NMES post-operational oscilloscope scan of individual pulses of a channel according to some embodiments of the present invention.

[0063] Figure 17 The following is an NMES post-operational oscilloscope scan of individual pulses of a channel according to some embodiments of the present invention.

[0064] Figure 18 An operational oscilloscope scan of a pulse train after NMES is shown according to some embodiments of the present invention.

[0065] Figure 19 An NMES intensity oscilloscope scan of individual pulses of a channel according to some embodiments of the present invention is shown.

[0066] Figure 20An NMES intensity oscilloscope scan of individual pulses of a channel according to some embodiments of the present invention is shown.

[0067] Figure 21 A TENS oscilloscope scan of a pulse train according to some embodiments of the present invention is shown.

[0068] Figure 22 A TENS oscilloscope scan of individual pulses according to some embodiments of the present invention is shown.

[0069] Figure 23 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0070] Figure 24 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0071] Figure 25 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0072] Figure 26 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0073] Figure 27 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0074] Figure 28 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0075] Figure 29 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0076] Figure 30 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0077] Figure 31 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0078] Figure 32 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0079] Figure 33 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0080] Figure 34 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0081] Figure 35 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0082] Figure 36 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0083] Figure 37 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0084] Figure 38 The display portion of a treatment system control GUI according to some embodiments of the present invention is shown.

[0085] Figure 39 The display portion of a treatment system control GUI according to some embodiments of the present invention is shown.

[0086] Figure 40 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0087] Figure 41 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0088] Figure 42 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0089] Figure 43 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0090] Figure 44 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0091] Figure 45 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0092] Figure 46 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0093] Figure 47 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0094] Figure 48 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0095] Figure 49A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0096] Figure 50 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0097] Figure 51 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0098] Figure 52 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0099] Figure 53 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0100] Figure 54 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0101] Figure 55 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0102] Figure 56 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0103] Figure 57 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0104] Figure 58 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0105] Figure 59 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0106] Figure 60 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0107] Figure 61 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0108] Figure 62 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0109] Figure 63 A display of a treatment system control GUI according to some embodiments of the present invention is shown.

[0110] Figure 64 A portion of the stimulation circuitry of a treatment control system according to some embodiments of the present invention is shown.

[0111] Figure 65A , 65B Figures 66-74 show various displays of a treatment system control GUI according to some embodiments of the present invention.

[0112] Figure 75 A treatment system according to some embodiments of the present invention is shown.

[0113] Figure 76 Some embodiments of the present invention are shown. Figure 75 Data types of treatment systems.

[0114] Figure 77 Some embodiments of the invention are shown in Figure 75 The data categories exchanged and stored between the components of the treatment system. Detailed Implementation

[0115] Before detailing any embodiment of the invention, it should be understood that the invention is not limited in its application to the details of the construction and arrangement of the components stated in the following description or shown in the following figures. The invention can be implemented in other embodiments and can be practiced or carried out in various ways. Moreover, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “comprising,” “including,” “having,” and variations thereof herein is intended to include the items listed thereafter and their equivalents, as well as additional items. Unless otherwise specified or limited, the terms “mounted,” “connected,” “supported,” and “coupled,” and variations thereof are used extensively and include direct and indirect mounting, connection, support, and coupling. Furthermore, “connected” and “coupled” are not limited to physical or mechanical connections or couplings.

[0116] The following discussion is presented to enable those skilled in the art to make and use embodiments of the invention. Those skilled in the art will readily understand various modifications to the illustrated embodiments, and the general principles herein can be applied to other embodiments and applications without departing from the spirit or scope of the invention. Therefore, embodiments of the invention are not intended to be limited to the illustrated embodiments, but are given the widest scope consistent with the principles and features disclosed herein. The following detailed description is read with reference to the accompanying drawings, in which similar elements in the different drawings have similar reference numerals. The drawings, not necessarily drawn to scale, depict selected embodiments and are not intended to limit the scope of embodiments of the invention. Those skilled in the art will recognize that the examples provided herein have many useful alternatives and fall within the scope of embodiments of the invention.

[0117] Figure 1A This is a representation of a knee brace 100 having one or more struts coupled to a user (where the user's leg is shown in the representation). In some embodiments, the knee brace 100 may include a strut 105 movably coupled to a strut 110 via a pivot region 115. When positioned in this way, the knee brace 100 includes two sets of geometries in which the strut 105 is freely movable relative to the strut 110, which pivots and / or moves about the pivot region 115. In some embodiments of the invention, the knee brace 100 and any brace system or component disclosed herein may include systems and methods for determining positional data of any component or portion of the brace system. For example, in some embodiments, one or more sensors may be integrated or coupled to at least a portion of the brace system and used to measure or monitor user parameters, track functional characteristics of the brace system, and / or monitor the user's environment. In some embodiments, one or more sensors may be integrated or coupled to at least a portion of the brace system and used, when attached to a user, to measure the absolute or relative position and / or movement of any portion of the brace system. In some embodiments, the wrap can be used without a support frame and can fully support the sensors and other components disclosed herein as coupled to the support frame. In some embodiments, one or more sensors can be added to any rigid portion of the support system. For example, in some embodiments, the knee brace 100 may include at least one sensor coupled to at least one of the struts 105, 110. For example, in some embodiments, the knee brace 100 may include a sensor 120 coupled to the strut 105. In some other embodiments, the knee brace 100 may include a sensor 125 coupled to the strut 110. Through their coupling with the struts 105, 110, the sensors 120, 125 may include three-axis movement. Furthermore, depending on the user's movement, the sensors 120, 125 may each move independently of each other in three dimensions. In some embodiments, the strut 105 may be coupled to the upper portion 132 of the wrap 130 for positioning against, near, adjacent to the user's thigh, and the strut 110 may be coupled to the lower portion 134 of the wrap 130 for positioning against, near, adjacent to the user's lower leg. For example, Figure 1B A knee brace 100 according to some embodiments of the present invention is shown, comprising struts 105, 110 and a wrap 130. In some embodiments, the wrap 130 may comprise a breathable, highly compressible, and non-slip material. In some embodiments, sensors 120, 125 may measure the position and / or movement and acceleration of any set of geometries of the brace 100 in any x, y, and / or z axis. In some embodiments, sensors 120, 125 may be coupled to the outer surface of any portion of the brace 100, including, for example, coupling to... Figure 1BThe location of the package 130 or the support pillars 105, 110 system is shown. In some embodiments, the sensor may be integrated with the support 100 by means of integration into an internal portion of the support 100 or by coupling to the outer surface of the support 100.

[0118] In some embodiments of the invention, the sensor may include an accelerometer. For example, in some embodiments, the sensor may include one or more small solid-state or microelectromechanical system (MEMS) accelerometers, gyroscopes, and / or magnetometers that may be coupled to one or more portions of the strut system and used to measure / sensor position and orientation, acceleration, velocity, vibration, or shock along one or more axes. In some embodiments of the invention, the sensor may include at least one Hall effect sensor. In some other embodiments, the strut system may include one or more magnets coupled to portions of the strut system that may be used in conjunction with magnetic sensors. For example, some embodiments of the invention may include at least one Hall effect sensor that may be used with one or more magnets to determine motion of at least a portion of the strut system. For example, in some embodiments, the sensor may determine rotation relative to a fixed point on a hinge of the strut system.

[0119] Some embodiments of the invention include a strut system or component capable of capturing range of motion (ROM). In some embodiments, the range of motion data can be used preoperatively to determine when a patient has adequately recovered from the initial injury to undergo surgery, potentially indicating that swelling and soft tissue mobility are at an acceptable level for the surgery. In some other embodiments, the range of motion data can be used postoperatively to determine when a patient has recovered (and thus can be used to determine the rate of surgical recovery). For example, Figure 1CAn example of the range of motion data captured from a strut system 140 is shown. In some embodiments, position data may be added to any strut system 140 having one or more rigid structures, to which one or more motion sensors may be coupled. For example, in some embodiments, the strut system 140 may include a strut 145 including coupled sensors 155, and a strut 150 may include coupled sensors 160. In some embodiments, strut sensors 155, 160 may include one or more accelerometers, gyroscopes, and / or position encoders coupled to at least one rigid portion of the strut system. In some embodiments, sensors 155, 160 may be used to provide active feedback to the patient about the current range of motion as one or both struts 145, 150 move, rotate, or pivot about a coupling element 170. In some embodiments, the range of motion data may be used to continuously provide feedback to the user to encourage them to stretch muscles or move joints during the recovery phase. For example, in some embodiments, tactile feedback may be provided whenever the user has exceeded a prescribed maximum range of motion. Furthermore, in some embodiments, the strut system 140 can be used to warn a user when the user hits a range of motion that is not considered safe, based on the user's recovery phase. In some other embodiments, the strut system 140 may include dynamic drag, spring rate of motion, and / or force or damping to protect the joints if high acceleration or range of motion is detected. In some embodiments, this can be achieved using magnetorheological fluids, inertial valve designs, piezoelectric springs / materials, etc. Some embodiments of the invention include motion data collection sensors for measuring the position and movement of the strut system 140. Furthermore, in some embodiments, the strut system 140 may include range of motion sensors for any strut system including one or more hinge features. In some embodiments, the sensors may include index points such that absolute position can be determined. Some embodiments of the invention may include proximity or contact-based sensors to determine if a set point on the hinge is near the sensor. In some embodiments, the sensors may be optical (shading, self-imaging, or interferometric) sensors, magnetic sensors, inductive sensors, capacitive sensors, eddy current sensors, resistive sensors, magnetoresistive sensors, inductive sensors, infrared sensors, accelerometer sensors, inclinometer sensors, piezoelectric sensors, etc.

[0120] In some embodiments of the invention, any strut system or component disclosed herein may include one or more controllers. In some embodiments, the controllers may be integrated and / or coupled to the struts, joints, pivots, or enclosures of the strut system. For example, in some embodiments of the invention, the control electronics may include a pivot joint configured to allow the strut of the strut system to bend (e.g., during flexion and extension by a patient). The pivot joint may include a solenoid and an accelerometer for locking the strut (e.g., after sensing stress). In one embodiment, the pivot joint includes a digital position encoder for determining the absolute position of a joint. The position encoder enables adjustment of the physical resistance applied to the joint as the patient moves the joint. The strut control electronics may include a communication module (e.g., a transmitter or transceiver or wire) for communicating with a computing device.

[0121] Some implementations include a dynamic support system with integrated electrical stimulation, which can be configured to assist in joint flexion and / or extension. In some implementations, one or more linear springs, torsion springs, and / or cam-based systems may be used to provide dynamic support options. In some implementations, the support system may include a hip brace with integrated electrical stimulation for delivering NMES treatment to targeted tissues in the pelvic region.

[0122] In some implementations, one or more sensors may be integrated into wearable wraps or clothing. For example, Figure 1D A portion of the knee wrap 180 is shown, and Figure 1EA knee wrap 180 according to some embodiments of the present invention is illustrated. As shown, in some embodiments, the knee 180 may include a main wrap 185 comprising an anti-slip compression material 187. In some embodiments, this material helps prevent movement of the knee wrap 180 when positioned on the wearer by friction and compression forces. In some embodiments, the main wrap 185 may include various extensions 189 to allow the wrap 180 to wrap around and attach to the user's knee, and may include various openings to accommodate different parts of the wearer's body. For example, in some embodiments, the knee wrap 180 may include a posterior fossa incision 191 to accommodate structures and movement near the back of the wearer's knee. Furthermore, in some embodiments, various electronic devices may be coupled to or integrated with the main wrap 185. For example, in some embodiments, the main wrap 185 may include one or more stimulation electrodes or electrode pairs 195, such as a quadriceps electrode 195a and / or a calf electrode 195b. Furthermore, in some embodiments, the electrode or electrode pair 195 may be positioned on the inner surface 181 of the cover 180 to allow contact with the wearer's skin. As used herein, each stimulation electrode pair may include a first electrode structure having a first polarity and a second electrode structure having a second polarity. The first and second polarities may be different, such that the first and second electrode structures function to form an electrode pair capable of providing electrical stimulation. In some embodiments, the structure of the first electrode may be substantially the same as or similar to that of the second electrode. In other embodiments, the structures of the first and second electrodes may be different. In some embodiments, the electrodes are not limited to conventional electrode structures. For example, in some embodiments, one or more electrodes may include a conductive material capable of effectively transmitting signals, or in some embodiments, may have significant loss or degradation while still providing sufficient signal strength for a particular application. As used herein, the terms "stimulation electrode" and "stimulation electrode pair" are used interchangeably.

[0123] In some implementations, one or more brace components may be integrated and / or coupled to the knee wrap to form a combined modular orthopedic brace and conductive wrap. For example, Figure 1F A strut system 200 according to some embodiments of the present invention is shown, the strut system comprising a combined modular orthopedic strut 210 and a conductive wrapping assembly 220, and Figure 1GA side view of a modular orthotic brace 210 and conductive wrapping assembly 220 combined according to some embodiments of the invention is shown. In some embodiments of the invention, the wrapping assembly 220 may include a brace strap 230, an ankle pad 235, and a sliding lock 240 for positioning, compression, and comfort. Furthermore, in some embodiments, a stimulation module 250 may be coupled to the assembly 220 to enable the application of stimulation therapy. Additionally, in some embodiments, the assembly may include a dial hinge 245 with a ROM stop for customized fitting and treatment.

[0124] Some implementations include a support system or component configured for targeted areas of the wearer's body. For example, Figure 2A A shoulder sling 300 according to some embodiments of the present invention is illustrated. In some embodiments, the shoulder sling 300 may include a wrap or portion of clothing 301 that wraps or surrounds at least a portion of the wearer's body, including at least the shoulder region. In some embodiments, the shoulder sling 300 may include electrodes on its inner side that can be used to stimulate rotator cuff muscles (e.g., supraspinatus, infraspinatus, etc., scapularis, other muscle groups, and / or the shoulder joint). For example, in some embodiments, the shoulder sling 300 may include electrodes 305 coupled to or integrated with the sling 300. Furthermore, in some embodiments, the sling 300 may include at least one accelerometer capable of measuring, monitoring, or tracking the wearer's movement, including movement of the wearer's shoulder relative to their torso. For example, in some embodiments, the sling 300 may include an accelerometer 310 positioned at one end of the sling 300 near the wearer's head or neck. In some other embodiments, the sling 300 may include an accelerometer 310 positioned at one end of the sling 300 near, adjacent to, or close to the wearer’s shoulder or arm.

[0125] Figure 2B A wrist brace 320 is shown, comprising a wrap 325 configured to at least partially wrap around or surround the wearer's wrist and / or hand. In some embodiments, the wrist brace 320 may include multiple sensors 330. In some embodiments, the sensors may include one or more accelerometers. In some other embodiments, other types of sensors may be included, such as motion sensors, proximity sensors, optical sensors, magnetic sensors, inductive sensors, capacitive sensors, eddy current sensors, resistive sensors, magnetoresistive sensors, inductive sensors, infrared sensors, inclinometer sensors, piezoelectric materials, and piezoelectric-based sensors. In some embodiments, the wrist brace 320 may also include electrodes 335 positioned on the inside of the wrap 325, the electrodes being configured to stimulate distal arm muscles and / or the wrist joint.

[0126] Some implementations include wraps, frames, or vests that include integrated support and / or tension members. In some implementations, tension or support members may be used to provide support and / or impart tension to the wraps, frames, or vests. For example, Figure 2C A rear view of a full-shoulder vest 350 according to some embodiments of the present invention is shown. In some embodiments, the vest 350 may include one or more internal tension members 355. In some embodiments, one or more tension members 355 may be used to provide mechanical force to the wearer's body (e.g., such as the wearer's shoulders) to correct posture. In some embodiments, the vest 350 may include functional electrodes for posture correction. For example, Figure 2D A rear view of a full-shoulder vest 350 according to some embodiments of the present invention is shown, and Figure 2E A front view of a full-shoulder vest 350 according to some embodiments of the present invention is shown. In some embodiments, the vest 350 may include a main vest body 351, which may be closed using one or more closure extensions 372. In some embodiments, the vest 350 may include paraspinal / scapular / stabilizer electrodes 362 for posture support. Furthermore, some embodiments may include an airbag 364 comprising at least one airbag configured for sleep support and electrode compression.

[0127] Figure 2N and 2O An airbag 425 is illustrated as applicable to various embodiments of the invention described herein. In some embodiments, the airbag 425 may include at least one reversibly inflatable airbag 430 coupled to an inflation assembly 433. In some embodiments, the inflation assembly 433 may include a detachable inflation tube 440 and a deflation valve 438 coupled to a pump 435 (e.g., a manual pump). In some other embodiments, the vest 350 may also include integrated heat or cold therapy by inserting or attaching a heat or ice pack against the patient's skin into a bag or below the shoulder area of ​​the vest. Furthermore, some embodiments provide the wearer with an integrated sling support 358.

[0128] Figure 2F-2I Various views of a full-shoulder vest 350 worn by a wearer can be seen. For example, Figure 2F A full-shoulder vest 350 according to some embodiments of the present invention is shown, which shows integrated straps 358. Figure 2G The full-shoulder vest 350 is shown, illustrating the proximity of the electrode compression strap 368 and the compression electrode 360. Figure 2H A full-shoulder vest 350 according to some embodiments of the present invention is shown, which shows a center vest closure including a closure extension 372. Figure 2IA full-shoulder vest 350 according to some embodiments of the invention is shown, which illustrates electrode inlets and a trapezius compression band 368a. In some embodiments, band 368 includes band 368a.

[0129] Some implementations include vests that cover other areas of the wearer's upper body. For example, some implementations include vests that cover specific areas of the wearer's torso (e.g., the left, right, or central area). Figure 2J A rear view of a half-vest 380 according to some embodiments of the present invention is shown. Furthermore, Figure 2K A close-up rear view of the half-vest 380 is shown, and Figure 2L A front view of a half-vest 380 according to some embodiments of the invention is shown. Similar to the full vest 350 described above, some embodiments may include one or more electrical stimulation electrodes 386. In some embodiments, the half-vest 380 may include one or more airbags 390. Some embodiments include at least one compression strap. For example, as... Figure 2L As shown, in some embodiments, the half-vest 380 may include a trapezius compression strap 384 coupled to the torso wrap 382. The half-vest 380 may also include an integrated sling 388 coupled to the torso wrap 382. Some embodiments include at least one electrode inlet 400. Furthermore, some embodiments may include at least one strap or pouch configured to hold or support a portion of the wearer's body. For example, some embodiments include an adjustable quarterback pouch 395 coupled to or integrated with the half-vest 380. Additionally, Figure 2M A side front perspective view of a half-back 380 according to some embodiments of the present invention is shown. In some embodiments, the vest 380 may include at least one strap or fastener 405, which may be used by the wearer to secure, tighten, loosen, or remove the vest.

[0130] Furthermore, in some embodiments, the vest may include at least one stimulation module 410. In some embodiments, one or more stimulation modules 410 may be integrated into the vest 380. In some other embodiments, one or more stimulation modules 410 may be reversibly secured to the vest using various attachment mechanisms, including but not limited to fasteners, clips, Velcro, buttons, snap-fits, or snap-fit ​​assemblies.

[0131] Figure 2PAn elbow support 450 comprising a plurality of accelerometer sensors is illustrated according to some embodiments of the invention. In some embodiments, the elbow support may include electrodes 455 on the inner side of the support 450, said electrodes being usable for stimulating proximal arm muscles, distal arm muscles, and / or the elbow joint. In some embodiments, electrodes 455 may be positioned in the upper arm portion 452 and / or the lower arm portion 454 of the support 450. In some embodiments, the support 450 may include an accelerometer 460 integrated or coupled to the upper arm portion 452, and an accelerometer 462 integrated or coupled to the lower arm portion 454.

[0132] Figure 2Q A calf support 470 comprising multiple accelerometer sensors is illustrated according to some embodiments of the invention. In some embodiments, the calf support 470 may include a cover 475, which may also include sensors and / or electrodes 480 on the inner side of the support 470, which can be used to stimulate distal leg muscles and / or the knee joint, and / or the ankle joint. In some embodiments, electrical stimulation can be used to power the electrodes 480 to stimulate the calf muscle group to induce an electro- or mechanical pumping effect that pumps bodily fluids such as blood, thereby reducing edema and preventing deep vein thrombosis (DVT).

[0133] Figure 2R An ankle support 500 comprising a wrap 501 according to some embodiments of the invention is shown, the wrap including a plurality of accelerometer sensors. In some embodiments, the ankle support 500 may include electrodes 505 on the inner side of the wrap 501, the electrodes being usable for stimulating distal leg muscles and / or the ankle joint, and / or the foot joint. The support 500 may include an accelerometer 510 in the leg portion 503 of the wrap 501. In other embodiments, the support 500 may include an accelerometer 515 in the foot portion 504 of the wrap 501.

[0134] In some other implementations, one or more sensors can be coupled to various internal regions of the strut system. For example, Figure 2SAn internal region of the support frame is shown, illustrating two sensors located within this region. In some embodiments, portions of the sensors may include contact points positioned and configured on the outer surface of the internal region of the support frame system. In some embodiments, the sensors may include human contact sensors that can be used to determine whether the support is being worn by a person. In some embodiments, measurements from the sensors may be used to provide patient compliance data, where the use of the support frame system is monitored and recorded. In some other embodiments, the sensors may be used to monitor whether the support frame system is correctly positioned on the user. For example, in some embodiments, the support frame 550 may include a body portion 555 and upper and lower strap portions 557, 559. In some embodiments, the hip support frame 550 may include electrodes on the inner side of one of the strap portions 557, 559, which may be used to stimulate muscle groups. For example, in some embodiments, the strap portion 557 may include a plurality of electrodes 560 located on various regions of the strap portion 557. Furthermore, in some embodiments, one or both of the strap portions 557, 559 may include at least one contact sensor. For example, in some embodiments, the strap portion 557 may include at least one integrated or coupled contact sensor 565.

[0135] Some embodiments of the present invention may include a wrap, support, and / or vest suitable for the wearer's hip area. Similar to the wrap, support, and vest described above, some embodiments of the hip device may include various integrated or coupled sensors, electrodes, supports, and / or tension members. For example, Figure 2T A front view of a hip brace assembly 570 with integrated sensors according to some embodiments of the present invention is shown. Figure 2U A side view of the hip support assembly 570 is shown. Furthermore, Figure 2V A rear view of a hip brace assembly 570 with integrated sensors according to some embodiments of the present invention is shown. In some embodiments, the hip brace assembly 570 may include an abdominal / back belt 575, a compression short conductive garment 578, and a support rod assembly 580. In some embodiments, the support rod assembly 580 may include an upper rod 582 and a lower rod 584 coupled via a support hinge 586. In some embodiments, the hip brace assembly 570 may also include electrodes on its inner side for stimulating proximal leg muscles, abductors, adductors, gluteal muscles, and / or the hip joint. For example, in some embodiments, the hip brace assembly 570 may include an abdominal electrode 577 integrated or coupled to the abdominal / back belt 575 for stimulating abdominal muscles, lower back muscles, and / or back joints and / or pelvic joints and / or hip joints. In other embodiments, the compression short conductive garment 578 may include a gluteal muscle stimulation electrode 590.

[0136] In some other embodiments of the invention, measurements of the position, movement, and / or acceleration of a portion of the support assembly can be used to determine the position and movement of the tracking user. For example, in some embodiments, the assembly can be used to monitor the user to determine how much time the user spends in an upright and / or supine position. In some embodiments, acceleration data from the support system can be calculated on a per-limb basis, which can be calculated as a running average. Furthermore, in some embodiments, this average acceleration value can be used to directly correlate with the amount of limb movement the patient is making and can be used as a key indicator of a reduction in range of motion. For example, the smaller the number, the lower the user's overall level of movement. In some embodiments, if the number of maximum flexions received from the sensors is high and the average acceleration value is very low, the user is sitting in the correct position with limbs flexed. However, if the average acceleration value is very high and the number of maximum flexions is low, the user is moving, but they are holding the supported limb in a locked position without movement at the joints. In some other embodiments, using any integrated or coupled sensors or accelerometers disclosed herein, freefall events may be determined by one or more sensors of the strut assembly and reported to a computer system (e.g., a coupled computer or server or backend system or mobile device as disclosed herein). In some embodiments, the strut system may record the freefall to indicate any time the strut (and user) has descended. Furthermore, in some embodiments, the strut system may determine the height of the descent based on duration and acceleration. In some embodiments, the strut system may determine whether the user has begun the descent and subsequently captured themselves. Additionally, in some embodiments, the backend system may create follow-up requests from medical professionals and / or schedule them to determine if the fall caused any damage. References Figure 2U In some embodiments, component 570 may include a sensor / accelerometer 588 integrated and / or coupled to one or more portions of strut assembly 580, said portions including, for example, upper strut 582 and / or lower strut 584 and / or strut hinge 586.

[0137] In some other embodiments of the invention, patient compliance data obtained from cumulative measurements from sensors may be stored in a database (e.g., in a back-end computer system) and made available to, for example, physicians or medical professionals to retrieve, review, and / or analyze data from the strut system. In some embodiments, physicians may utilize data from the strut in their analysis or recommendations to patients. Furthermore, physicians may use data from the strut system in recommendations from one patient for other patients with similar conditions or injuries. For example, if a physician tells a patient to recover from ACL reconstruction surgery to perform Program 1 for the first week and Program 2 for the second week, and if the physician sees a significant improvement in the patient's knee strength compared to these programs, then the physician may tell another patient to recover from a similar surgery to perform the same programs over the same time period. In some embodiments, physicians may have access to a second patient's program that is remotely updated via a wired or wireless connection to the Internet or a dedicated network. The physician can then obtain data from both patients to understand how they respond to the strut system and the programs performed by the strut system.

[0138] Some embodiments of the present invention may include a wrap, support, and / or vest suitable for the wearer's abdominal / back area. Like the wrap, support, and vest described above, some embodiments of the abdominal / back device may include various integrated or coupled sensors, electrodes, supports, and / or tension members. For example, Figure 2W A front view of an abdominal / back device 600 with integrated sensors according to some embodiments of the present invention is shown, and Figure 2X A rear view of an abdominal / back device 600 with integrated sensors according to some embodiments of the present invention is shown. Some embodiments may include a body 605 having a coupled or integrated support panel 610. In some embodiments, abdominal electrodes 615 may be coupled or integrated with the abdominal / back device 600. Furthermore, some embodiments include an abdominal / back support 620 coupled to the body 605. In some embodiments, the abdominal / back support 620 may include one or more coupled or integrated back electrodes 625. Additionally, similar to other embodiments described above, some embodiments of the abdominal / back device 620 may include one or more optional airbags for electrode compression and / or back support.

[0139] In some embodiments of the invention, various electronic components may be integrated into one or more modules of the strut system, and the modules may be combined and reconfigured into various configurations. For example, in some embodiments, some strut systems or components may include a set of modules, each with a different function, and their combination creates a universal NMES platform with different user interfaces and / or different sensors for data collection. In some embodiments, this platform may include at least one stimulation system, one or more sensor systems, and at least one display system. Furthermore, in some embodiments, the strut system may be controlled and / or transmit data via a controller, either wired or wirelessly. For example, in some embodiments of the invention, any strut system or component described herein may be configured to wirelessly transmit and / or receive information. Figure 3A A representation of a wireless brace system 630 configurable for wirelessly collecting data from a knee brace assembly 670 is shown. This data includes data transmitted via a cellular 650 and / or WiFi network 655 to a coupled or integrated controller 675 including a wireless antenna 675a. In some embodiments, one or more portions of the knee brace assembly 670 may include one or more sensors (e.g., accelerometers or other sensors as discussed earlier), such as sensor 681 coupled to strut 682 and / or sensor 683 coupled to strut 684, which may be coupled to the controller 675 to enable wireless transmission of data from and / or to the controller 676 and / or sensors 681, 683. In some embodiments, a graphical user interface (GUI) 640 may be used to control and / or monitor various functional aspects of the wireless brace system 630, including any components of the system 630. In some embodiments, the controller 675 may include a rechargeable power supply and control unit configured to stimulate and collect sensor data.

[0140] In some embodiments, controller 675 can manage sensing and / or stimulation of a patient wearing a brace system or garment (e.g., a wireless brace system 630). In some embodiments of the invention, controller 675 may be configured to: (a) apply at least one stimulation sensing pulse to the patient's tissue using at least one sensor and / or electrode; (b) measure at least one electrical parameter from the patient's tissue relating to the power dissipation of the sensing pulse in the tissue; and (c) adjustably apply at least one stimulation pulse to the patient's tissue based at least in part on the measured power dissipation. In some embodiments, the at least one stimulation pulse may be adjustably controlled by the at least one controller to maintain a constant power output to the patient's tissue based at least in part on the at least one electrical parameter. In some embodiments, steps (a) through (c) may be repeated at least once.

[0141] Figure 3BWireless data transmission between a knee brace assembly 670 and a controller 675 according to some embodiments of the present invention is depicted. In some embodiments, the wireless RF transmission from the brace system 670 may have sufficient power to reliably operate and transmit data from the brace system with sufficient bandwidth, while minimizing tissue propagation characteristics and specific absorption rates (to avoid tissue heating) and reducing user exposure to near-field and far-field RF transmissions. In some embodiments, the brace system 670 may be configured to transmit and / or receive RF transmissions, including but not limited to 0th generation wireless signals, 1st generation wireless signals, 2nd generation wireless signals, 3rd generation wireless signals, 4th generation wireless signals, 5th generation wireless signals, any global positioning satellite signals (such as "GPS" or "GLONASS"), industrial, scientific, and medical (ISM) bands (e.g., 2400-2493.5 MHz). Wireless signals (such as IEEE 802.15.4) (Class), RFID electromagnetic radiation, WiFi wireless signals, two-way radio RF signals, UHF or VHF signals (such as citizen band radio signals or other radio signals transmitted from "walkie-talkie" type devices), high-speed and millimeter wave signals, and near-field wireless signals. It is a computing and telecommunications industry standard that details how mobile devices can easily interconnect with each other and with non-mobile devices using short-range wireless connections. It is a registered trademark of Bluetooth SIG, Inc.

[0142] In some embodiments, controller 675 may include a computer system or device. In some embodiments, the strut system may be configured to communicate (e.g., wirelessly or via a wired connection) with a computing device capable of performing the functions of controller 675. Examples of computing devices include, but are not limited to, personal computers, digital assistants, personal digital assistants, mobile phones, wearable technology devices (e.g., smartwatches, activity monitors, heart rate monitors, glasses, monitoring devices, etc.), smartphones, tablet computers, or laptop computers. In some embodiments, the computing device may be a patient's device or a device associated with a healthcare professional. Both types of devices enable healthcare professionals to retrieve and analyze data transmitted from the strut system. In one embodiment, this data is transmitted in real time, allowing healthcare professionals to analyze the data and / or adjust the strut at any time. For example, in some embodiments, a patient may access the data using a mobile application on their device. In some other embodiments, physicians and / or therapists may access the data via a website portal. In some embodiments, one or more conventional encryption methods may be used to secure any data accessed from any strut system described herein, including any data collected or directed by a controller such as controller 675. In some embodiments, the protocols and methods used for data transmission as described are HIPAA compliant.

[0143] refer to Figure 4 In some embodiments, any of the strut system or components described herein may be electronically coupled to a computer system 700, which may be configured to transmit data from and / or to the strut system. Furthermore, in some embodiments, the strut system may also include strut control electronics configured to provide NMES via a program selected from a plurality of programs. In at least one embodiment of the invention, the strut control electronics may be configured to receive program selection (e.g., from a patient, from a medical professional, etc.) via a receiver. In one embodiment, the medical professional may prevent the patient from controlling the strut (e.g., for a period of time). Furthermore, as... Figures 3A-3BAs shown, in some embodiments, a support system (such as support system 670) may communicate with computer system 700 using a controller such as controller 675. In some embodiments, controller 675 may function as an internet transceiver coordinating and routing data between the support system and computer system 700. In some embodiments, system 700 includes controller 675. In some embodiments of the invention, computer system 700 may be a local computer system (e.g., a computer system within a user's home) configured to receive and / or send information to support system 670. In some embodiments, computer system 700 may include a bus 701 for communicating information between components within computer system 700. Furthermore, in some embodiments, at least one processor 702 may be coupled to bus 701 for executing software code or instructions and processing information. In some embodiments of the invention, computer system 700 further compromises with main memory 704, which may be implemented using random access memory (RAM) and / or other random access memory storage devices. In some embodiments, main memory 704 may be coupled to bus 701 for storing information and instructions to be executed by processor 702. In addition, in some embodiments, main memory 704 may also be used to store temporary variables, NMES program parameters, or other intermediate information during instruction execution by processor 702. In some embodiments, computer system 700 may also include read-only memory (ROM) and / or other static storage devices coupled to bus 701 for storing static information and instructions of processor 702. In some embodiments of the invention, computer system 700 may include one or more peripheral components that enable a user to interact with system 700. For example, in some embodiments, system 700 may include cursor control device 723, such as a conventional mouse, touch mouse, trackball, trackpad, or other types of cursor direction keys for conveying directional information and command selection to processor 702 and for controlling cursor movement on display 721. Furthermore, system 700 may also include at least one keyboard 722 for data input and for commands and control facilitating various aspects of system 700; and at least one communication device 725 operatively coupled to processor 702 via bus 701.

[0144] In some implementations, any scaffolding system or component described herein (including scaffolding system 670) may be coupled to and / or transmit data to a computer system configured to receive and / or send information to the scaffolding system and any coupled computer system. Reference Figure 5In some embodiments, computer system 800 may include a backend system that can be used as a host computer for storing information measured and transmitted by the scaffolding system. In some embodiments of the invention, information can be received and / or transmitted between the scaffolding system and computer system 800 using computer system 700 (i.e., a local computer system and / or controller configured to receive and / or transmit information to the scaffolding system locally). In some other embodiments, information can be received and / or transmitted directly between the scaffolding system and computer system 800 (e.g., using cellular wireless transmission). Furthermore, in some embodiments, the scaffolding may communicate with computer system 800 and computer system 700 using a controller such as controller 100. In some embodiments, the controller can be used as an internet transceiver to coordinate and route data between the scaffolding and computer systems 700 and 800.

[0145] In some embodiments of the invention, system 800 may include at least one computing device, including at least one or more processors 820. In some embodiments, some processors 820 may include processors 820 residing in one or more conventional server platforms. In some embodiments, system 800 may include a network interface 850a and an application interface 850b coupled to at least one processor 820 capable of running at least one operating system 840. Furthermore, system 800 may include a network interface 850a and an application interface 850b coupled to at least one processor 820 capable of processing one or more software modules 880 (e.g., one or more enterprise applications). In some embodiments, software module 880 may include a server-based software platform. In some embodiments, system 800 may also include at least one computer-readable medium 860. In some embodiments, at least one computer-readable medium 860 may be coupled to at least one data storage device 870b and / or at least one data source 870a and / or at least one input / output device 870c.

[0146] In some embodiments, the invention may also be embodied as computer-readable code on a computer-readable medium 860. In some embodiments, the computer-readable medium 860 may be any data storage device capable of storing data that can subsequently be read by a computer system. Examples of the computer-readable medium 860 may include hard disk drives, network-connected storage devices, read-only memory, random access memory, flash memory, CD-ROMs, CD-Rs, CD-RWs, DVDs, magnetic tapes, other optical and non-optical data storage devices, or any other physical or material medium that can be used to tangibly store desired information or data or instructions and is accessible by a computer or processor.

[0147] In some embodiments, the computer-readable medium 860 may also be distributed on a conventional computer network. For example, in some embodiments, the computer-readable medium 860 may also be distributed on and / or accessed via network interface 850a. In this case, computer-readable code can be stored and executed in a distributed manner using computer system 800. For example, in some embodiments, one or more components of system 800 may be connected to send and / or receive data via a local area network (“LAN”) 890a. In some other embodiments, one or more components of system 800 may be connected to send or receive data via the Internet 890b (e.g., wireless Internet). In some embodiments, at least one software module 880 running on at least one processor 820 may be configured to be coupled for communication via networks 890a, 890b.

[0148] In some embodiments, one or more components of networks 890a, 890b may include one or more resources for data storage and retrieval. This may include any computer-readable medium other than computer-readable medium 860 and may be used to facilitate information communication from one electronic device to another. Furthermore, in some embodiments, networks 890a, 890b may include a wide area network (“WAN”), a direct connection (e.g., via a Universal Serial Bus port), other forms of computer-readable medium 860, or any combination thereof. In some embodiments, software module 880 may be configured to transmit data and receive data from a database (e.g., from computer-readable medium 860, which includes a data source 870a and a data storage device 870b that may include the database). Furthermore, in some embodiments, data may be accessed and received by software module 880 from at least one other source.

[0149] In some embodiments, one or more components of networks 890a, 890b may include multiple user coupling devices 900, such as desktop computers, laptop computers, digital assistants, personal digital assistants, cellular phones, mobile phones, smartphones, wearable technology devices (e.g., smartwatches, activity monitors, heart rate monitors), glasses, cameras, pagers, digital tablets, internet devices, and other processor-based devices. Typically, client devices can be any type of external or internal device, such as a mouse, CD-ROM, DVD, keyboard, monitor, or other input or output device 870c. In some embodiments, at least one of software modules 880 may be configured within system 800 to output data to a user via at least one digital display. Furthermore, in some embodiments, various other forms of computer-readable media 860 may send or carry instructions to the user interface, such as coupling devices 900, including routers, private or public networks, or other transmission devices or channels (both wired and wireless).

[0150] In some embodiments, the system 800, as described, enables one or more users 950 to receive, analyze, input, modify, create, and send data to and from the system 800, including to and from one or more software modules 880 running on the system 800. Some embodiments include at least one user 950 who accesses one or more modules, including at least one software module 880, via a fixed I / O device 870c through a LAN 890a. In some other embodiments, the system 800 enables at least one user 950 to access the software module 880 via a fixed or mobile I / O device 870c through an Internet 890a.

[0151] In some implementations, the support system or controller may include an upgradeable software module. In some implementations, the software module can be downloaded via the Internet (e.g., via...). Figure 5 The Internet 890a shown is used for upgrades. In some embodiments of the invention, Internet downloads may include accessing at least one or more software modules stored in a cloud-based storage location. In some embodiments, the scaffolding system may access the cloud-based storage location to perform periodic software updates and / or store scaffolding system data, and / or data from the scaffolding system controller, and / or user data (i.e., data from the scaffolding system connected to the user).

[0152] In view of the above embodiments, it should be understood that some embodiments of the present invention may involve storage in a computer system (such as...) Figure 5Various computer-implemented operations are performed on the data in the system 800 shown. Furthermore, in some embodiments, the aforementioned applications of the monitoring system may be stored on a computer-readable storage medium (such as computer-readable medium 860). These operations are operations requiring the physical manipulation of physical quantities. Typically, although not essential, these quantities take the form of electrical, electromagnetic, or magnetic signals, optical or magneto-optical signals that can be stored, transmitted, combined, compared, and otherwise manipulated.

[0153] Any operation described herein that forms part of this invention is a useful machine operation. The invention also relates to an apparatus or device for performing these operations. Embodiments of the invention can be defined as machines that transform data from one state to another. The data may represent articles, which may be represented as electronic signals and electronic manipulation data. In some cases, the transformed data may be visually presented on a display, representing a physical object resulting from the data transformation. The transformed data may generally be stored in a storage device, or may be stored in a specific format capable of constructing or depicting physical and tangible objects. In some embodiments, manipulation may be performed by one or more processors 820. In such an example, processor 820 may transform data from one thing to another. Furthermore, the method may be processed by one or more machines or processors that can be networked. Each machine may transform data from one state or thing to another and may also process the data, store the data in a storage device, transmit the data over a network, display the results, or communicate the results to another machine. Furthermore, the brace system described herein would require a large amount of data to be manipulated, transformed, modified, restored, or changed from one state to another in order to be efficiently parsed into meaningful data segments that can be used by the user or clinician and upon which medically based judgments are based. In one embodiment, the brace system or controller includes software that performs data collection and pre-filtering algorithms, which only stores data onto a storage medium after certain desired conditions are met (e.g., the user is wearing the brace and movement is occurring above / below a desired threshold, or only when the user is upright, or at periodic times throughout the day, such as once per minute, or during the user's wake-up time, etc.). In another embodiment, computer system 800 performs data restoration and pre-filtering functions. As used herein, a computer-readable storage medium (such as computer-readable medium 860) refers to a physical or tangible storage device (as opposed to a signal) and includes, but is not limited to, volatile and non-volatile, removable and non-removable storage media implemented with any method or technique for tangibly storing information such as computer-readable instructions, data structures, program modules, or other data.

[0154] In some embodiments of the invention, initiating wireless data transmissions to and / or to the strut system (e.g., via cellular data transmission) can be autonomous and / or semi-autonomous and can be configured to require no user configuration. For example, in some embodiments, the device can automatically check in upon power-up. In some embodiments of the invention, the strut system may include a backend system comprising one or more servers that are searching for devices to check in for setup use at any time. The backend system is a system for recording patient compliance data. In some embodiments, if the device does not check in, the backend system or controller may send a message to the patient (or anyone in a contact list) indicating that the device should be checked in.

[0155] Some embodiments of the present invention may include uploading data to a backend via coupling to a smart device or computer. For example, in some embodiments, The product can be used to provide a link between any of the support systems or components described herein and mobile computers, mobile phones, portable handheld devices, wearable technology devices (e.g., smartwatches, activity monitors, heart rate monitors, glasses, cameras, etc.), personal digital assistants (PDAs), tablet computers, and other mobile devices and their connection to the Internet. In some embodiments, this can be achieved via... Wireless signals are transmitted wirelessly from the support system to a smart device or computer. In some implementations, a user interface screen can be used to access the device. The protocol enables device pairing. In some other implementations, uploading data to the backend occurs via coupling to a WiFi network to connect to a user's home or office network. In some implementations, this will require creating a user interface screen that allows the user to select the wireless network to connect to and provide credentials for connecting to that network.

[0156] In some embodiments of the invention, the strut system may utilize wireless protection schemes to control data access to and from the strut system. This protects patient confidentiality and data security. Some embodiments include preventing unauthorized wireless access to device data and controls. In some embodiments, this may include software and / or hardware-enabled protocols that maintain communication security while avoiding known drawbacks of existing older protocols, including, for example, Wired Equivalent Privacy (WEP). In some embodiments, access to this medical information may be encrypted for usage data transmitted from the device (via Bluetooth, WiFi, or other devices). Encryption may be performed via software executing on the processor or via external hardware that processes the data before transmission. In one embodiment, each set of logs is uniquely bound to the device that created them. This can be accomplished by the device tagging data being transmitted from the device using a unique identifier associated with the device. The unique identifier is set by the processor or by an external component of the system (e.g., a UUID chip).

[0157] In some embodiments, wireless collection may include the wireless collection of compliance data. For example, in some embodiments, support system data including user compliance with certain daily mobility and / or one or more physical therapy or exercise routines may be wirelessly monitored and recorded. In some embodiments, the support system may include the wireless collection of compliance data and may include the creation of records of all situations in which support system sensors determine that a patient is wearing the support system. In some embodiments, this may include stored data (e.g., data previously measured by the support system and stored in volatile or non-volatile memory). For example, this may include the wireless collection of kinematic data, including data such as orientation data and acceleration data. In some embodiments, the support system may continue to store and transmit data when the user is not wearing the support system. In some embodiments, data may be ignored, and in other embodiments, data may be stored and / or wirelessly transmitted. In some embodiments, the support system may wirelessly transmit data from the support system to at least one telemedicine system. In some embodiments, the support system may wirelessly transmit data from the support system to at least one physical therapist and / or physical therapy system.

[0158] Figure 6An image is shown on screen 950, illustrating the current state of the support assembly 960. In some embodiments of the invention, the support system 951 may include a display screen 950 configured to project the state of the support system 951, including the support assembly 960, and a representation 965 showing the curvature and orientation of the support assembly 960 relative to the ground. In some embodiments, the support system 951 may present a display of the support system 951 substantially in real time and may display graphical representations or data relating to sensor data obtained from the support assembly 960 (e.g., usage trends, muscle strength trends, ROM trends, etc.) (see display portion 970 with trend data graph 975). In some embodiments of the invention, using one or more sensors, the support system may communicate the position and movement of one or more portions or sections of the support system 951 substantially in real time. This information may be processed by system 951 for representation on display screen 950 and / or for communication via wired or wireless connections (e.g., such as...). Figure 3B Wireless data transmission is shown between the knee brace assembly 670 and the controller 675. In some embodiments, data collected by the brace system 951 allows medical professionals to adjust the brace system 951 based on this data. For example, the brace system 951 may measure the muscle strength around the knee and / or the range of motion of the knee (e.g., obtained via an accelerometer or position encoder). Medical professionals can then use this feedback and data to adjust patient treatment and / or adjust the brace system 951 based on these readings.

[0159] In some implementations, one or more brace control programs may be selected by a medical professional or patient who is dynamic (e.g., changeable or variable, not a fixed frequency, not a fixed timing, not a fixed waveform, etc.) and may result in the execution of different types of EMS at different sites on the patient's body. For example, if feedback data obtained and presented by the brace system 951 from the control electronics of the brace system indicates that the patient's vastus medialis oblique is strengthening, while the patient's distal central tendon (or, in another implementation, the patient's calf muscles) is not strengthening, then a medical professional (e.g., a physician or physical therapist) may instruct the brace system 951 to execute a predetermined brace control program via one or more of these programs. In some implementations, the brace system 951 may include a specific program for the first week post-surgery, a specific program for the first month post-surgery, a specific program for arthritis, etc.

[0160] In some other embodiments, movement of any part of any support assembly or system described herein can be sensed. In some embodiments, at least one optical or other type of sensor may be coupled or integrated with the component or system used to sense motion and / or position. For example, Figure 7A representation of a strut system 980 with motion data collection sensors 982, 984 according to some embodiments of the invention is shown. In some embodiments, one or more components of the strut assembly 986 may be monitored by sensors 982, 984. Figure 8-9 Provided Figure 7 The diagram illustrates a representation of potential movements of various portions of the support system 950 being monitored (where support system 980 represents support system 950). In some embodiments, optical sensors (e.g., sensors 982, 984) may be used in conjunction with a portion of support system 980 including an optically discernible region comprising an observation region. For example, in some embodiments, one or more optical sensors 982, 984 may be positioned to detect movement of adjacent regions of support system 980, including the observation region (i.e., the region of the support system sensed by the optical sensors). In some other embodiments, one or more optical sensors 982, 984 may be positioned to detect movement relative to adjacent regions of the support system including the observation region (e.g., the portion of the support system including the observation region remains stationary, while the portion of the support system including the optical sensors may move relative to the observation region). In some embodiments of the invention, the observed region may include an optically reflective material. In some other embodiments, the observation region may include one or more markers detectable by one or more optical sensors. In some embodiments, the observation region may include an optical emitter. For example, in some embodiments, one or more observation areas may include optical or infrared LEDs. For example, in some embodiments, the position and / or movement of the support 987 may be monitored by sensor 982. In some embodiments, sensor 982 may include an optical sensor, and support 987 may include an optical encoder 987a (e.g., a tab or marker that can be read or sensed by sensor 982). Furthermore, in some embodiments, the position and / or movement of support 988 may be monitored by sensor 984. In some embodiments, sensor 984 may include an optical sensor, and support 988 may include an optical encoder 988a (e.g., a tab or marker that can be read or sensed by sensor 984).

[0161] In some other embodiments of the invention, the movement of the support system 950 may be electrically sensed. For example, in some embodiments, components of the support system 950 (e.g., a hinge) may include resistors and / or resistive portions whose resistance changes as a portion of the support system 950 moves. For example, in some embodiments, the resistance may start at a known value and increase as the hinge opening increases.

[0162] In some embodiments, one or more of sensors 982, 984 may include linear, angular, rotation-based position sensors / encoders. Some embodiments of the invention may include linear displacement sensors on the hinge rod for determining which length setting the patient has selected. In some embodiments, position sensors may be used to determine which ROM stops have been engaged and compared to which ROM limits should or should not be applied, or whether an extended lock has been applied as specified. In some other embodiments, any strut system or component described herein (e.g., strut system 950) may include force sensors, torque sensors, and / or dynamometers, which may be integrated to determine joint and patient rehabilitation-related strength or force / torque outputs.

[0163] Conventional NMES uses various DC, AC, and biphase waveforms to elicit muscle responses in human tissues. These can be voltage- or current-driven open-loop or closed-loop, and the amplitude of the waveform can be directly controlled via device settings. Electrical stimulation can also be used to reduce edema or swelling in target tissues. Figure 10A sensor assembly 1000 for detecting surface edema by optical sensing according to some embodiments of the present invention is shown. In some embodiments, assembly 1000 can be used for closed-loop feedback in regulating electrical stimulation therapy for edema. In some embodiments, the transmitter / sensor assembly 1005 can be configured to emit red light from one or more LEDs 1010 into the patient's epidermis (1060) and dermis (1070), and to detect the light signal and wavelength (1085) reflected back from the skin using one or more photodetectors (e.g., such as phototransistors 1020). In some embodiments, assembly 1000 can optically determine the level of surface edema near the detector. Water has a characteristic optical absorption band that can be used to make this determination. In some embodiments, using the output from this assembly 1000 in a closed-loop feedback manner allows the electrical stimulation system to optimize stimulation parameters to achieve a desired level of edema reduction. Some embodiments include waveform modulation by setting the amplitude by setting a maximum current. Furthermore, in some embodiments, two separate feedback loops can be used to modulate the wave (dynamically changing both current and voltage) to maintain constant power dissipation. The amplitude of the current and voltage waveforms can be changed, but the general shape of the waveforms cannot be altered. In some implementations, the waveforms can be accumulated on a carrier pulse of about 30 Hz to about 100 Hz, providing pulse blocks of about 100 μs to about 10,000 μs width. Some implementations include closed-loop feedback mechanisms. In some implementations, the power supply can provide a high-current, low-voltage supply with multiple nested feedback loops that, when added together, create a time-approximate constant power system. In some implementations, the power supply can maintain a constant power output by attempting to first maintain the current load of the system and then, secondly, maintain the voltage load of the system. The power supply output can be relatively constant as it adds over time and is based on the amplitude selected by the user in the user interface.

[0164] In some embodiments, feedback can be collected on the back side of the feedback loop after the feedback loop has passed the user. Some embodiments include a control system configured to maintain a constant output from the system. In some embodiments, the system can be configured to maintain a constant output as it passes the user. In some embodiments, the conductivity of the user's tissue changes during NMES. In some embodiments of the invention, the support system may include a feedback loop that compensates for tissue changes by attempting to maintain a constant output. As resistance increases, the system may induce more current to maintain a constant power dissipation level. In some embodiments, if the resistance exceeds a certain point, the system voltage will suddenly rise to attempt to overcome the high-resistance element and allow current to flow.

[0165] Some embodiments of the present invention may include a system for pain relief. In some embodiments, pain relief may be provided using electrical stimulation without the use of anesthetics. In some embodiments, electrical stimulation may be provided by using a strut system coupled to one or more electrical stimulators of the user. In some embodiments, the strut system may include at least one electrical stimulator configured to provide electrical stimulation to provide pain relief to the user. Nerves responsible for transmitting sharp pain send encoded signal bursts back to the autonomic nervous system. Introducing a constant signal may disrupt the encoding of the pain signal and provide some pain relief. Some embodiments of the present invention are configured to allow the user to self-tune the signal for maximum effectiveness. In some embodiments, this may be achieved by varying the pulse amplitude, pulse width, and / or pulse duration. For example, Figure 11 A system 1100 for non-anesthetic pain relief using electrical stimulation to induce hyperstimulated pain impulses, according to some embodiments of the invention, is illustrated. In some embodiments of the invention, electrical stimulation can be used to induce hyperstimulated pain impulses to provide non-anesthetic pain relief. In some embodiments, the non-anesthetic pain relief system may include a control unit 1105 coupled to an epidermis 1103 via electrodes 1110, 1115, the electrodes being configured to provide current 1120 through nociceptors 1125 of a user 1101.

[0166] Some embodiments of the present invention may include a system configured to obtain biofeedback. In some embodiments, biofeedback may be provided by using a strut system coupled to one or more biofeedback sensors of a user. In some embodiments, the one or more strut systems or components described herein may include at least one biofeedback sensor configured to provide biofeedback data from a user. For example, in some embodiments, Figure 2S The human contact sensors shown may include one or more biofeedback sensors located within the internal region of the support frame. In some embodiments, these sensors may be proximity or contact sensors capable of determining whether a user is wearing a device (e.g., such as a support frame). Additionally, for example, electrical sensors may be included to determine the impedance between the sensors to determine whether the device is attached to human skin. In some other embodiments, other sensors may be used, such as blood pressure sensors, blood oxygen level sensors, heart rate sensors, laser- or ultrasound-based sensors for measuring tissue or fluid movement, hydration sensors for measuring interstitial fluid levels to determine hydration levels, force or pressure sensors for measuring muscle activity / response, or electromyographic sensors for measuring muscle recruitment during electrical stimulation therapy or for measuring the degree of muscle fatigue. In some other embodiments, by measuring the user's hydration level, the system may tune the electrical stimulation signal to be more optimized or less painful for the user, or provide feedback to the user to drink more fluid.

[0167] In some other embodiments, the biofeedback sensor may include one or more temperature sensors. In some embodiments, one or more temperature sensors may be coupled to or integrated with the support system and are used to monitor temperature near the user. In some embodiments, one or more temperature sensors may be used in combination with NMES therapy and for sensing temperature near the stimulating electrodes. In some embodiments of the invention, one or more temperature sensors may be used in combination with NMES therapy and for feedback control. For example, in some embodiments, the support system may include a closed-loop feedback system that provides electromuscular stimulation (EMS) to the joints of a human patient in response to feedback from sensed temperature. In some embodiments, the support system may include one or more sensors that are in physical contact with the patient's skin and are configured to obtain sensation and / or information from the skin area and / or NMES electrodes in contact with the patient's skin. For example, in some embodiments, one or more temperature sensors may be used to sense temperature near one or more NMES electrodes. In some embodiments, the support system may also include support control electronics that communicate with the sensors to form a closed-loop system via the combination of joint support and electromuscular stimulation (EMS). Furthermore, in some embodiments, the strut control electronics may be configured to receive temperature measurements of the patient's skin and / or one or more electrodes, and are also configured to instruct sensors to apply current / voltage / power to the skin based on temperature. For example, NMES may be reduced or increased based at least in part on temperature measurements from one or more temperature electrodes. In some embodiments, one or more temperature sensors are used to sense the temperature near one or more NMES electrodes, wherein the sensed temperature is used to control NMES, which may significantly reduce or eliminate NMES burns. In some other embodiments, one or more temperature sensors that sense changes in the user's body and / or core body temperature may be used to estimate the user's activity level or the presence of infection.

[0168] Some embodiments of the present invention include systems for monitoring the presence or concentration of at least one chemical, biochemical marker, or other analyte. In some embodiments, the analyte may include naturally occurring or synthetic compounds or molecules, and / or metabolites. For example, in some embodiments, the strut system may include a blood oxygen sensor device configured for measuring blood oxygen content. In some embodiments, the strut system configured with a blood oxygen monitor can enable the assessment of blood stasis and can be used to prevent deep vein thrombosis (DVT) and other potentially fatal events such as pulmonary embolism, limb edema, etc. For example, Figure 12 An example of biofeedback collection is shown. Some embodiments include a blood oxygen sensor 1200 coupled to a stimulation system comprising at least two electrodes 1205, 1210.

[0169] In some other embodiments, one or more of the support systems or components described herein may include sensor devices configured to measure nicotine, nicotine metabolites, and / or other drugs or drug metabolites (including stimulants, depressants, hallucinogens, engineered drugs, and anabolic steroids). In some embodiments, at least one of the support systems or components described herein may include one or more sensors configured to detect one or more of these substances in vivo and notify healthcare professionals as they may affect the healing and recovery process. In some other embodiments, the support system may be configured with sensors to detect the user's immediate environment. For example, in some embodiments, nicotine from firsthand or secondhand smoke may be sensed using one or more support system chemical sensors and used to determine whether the user may have smoked and / or been exposed to high levels of tobacco smoke.

[0170] In some embodiments, any of the support system or components described herein may include at least one sensor configured to measure a user's heart rate. For example, in some embodiments, at least one heart rate sensor may be used to determine whether a patient is performing prescribed exercise and / or physical therapy. Furthermore, in some embodiments, at least one heart rate sensor may be used to determine the user's overall activity level (for healing and data correlation). In some other embodiments, lung and / or respiratory sensors may be used to provide data for VO2 maxima calculation and to provide additional data regarding activity level. In some embodiments, the support system may include at least one heart rate sensor integrated with a portion of the support. In other embodiments, the support system may include at least one heart rate sensor coupled to and adjacent to or at a distance from the support.

[0171] Some embodiments of the present invention may include a non-invasive blood pressure sensor configured to continuously or intermittently measure arterial blood pressure. In some other embodiments, in addition to sensing the user's blood pressure, the user's heart rate may also be measured. In some embodiments, one or more of the support system or components described herein may include at least one blood pressure sensor integrated with a portion of the support. In other embodiments, the support system may include at least one blood pressure sensor coupled to and adjacent to or at a distance from the support.

[0172] In some other embodiments of the invention, one or more of the support systems or components described herein may include electromyography (EMG) sensors, strain gauge sensors, or other sensors configured to continuously or intermittently measure strain. In some embodiments, these measurements can be used to assess movement, deflection, or to provide quantifiable data on muscle growth, muscle contraction, or the force, torque, or pressure generated by muscle contraction. Muscle contraction may be voluntary or involuntary via electromuscular stimulation. In some embodiments, data collected from EMG or strain gauge sensors can be used in closed-loop feedback control methods to optimize / customize electrical stimulation parameters to provide the most effective or strongest muscle contraction for the patient. The data can also be used by healthcare providers to fine-tune treatment procedures based on patient data captured from EMG or strain gauge sensors.

[0173] Some embodiments of the present invention may include the support system or components described herein, which may include at least one smart electrode. For example, Figure 13A smart electrode 1300 according to some embodiments of the present invention is illustrated. In some embodiments, at least one of the support systems, components, or methods described herein may include one or more smart electrodes 1300, which may include temperature-responsive color-changing pigments that can be used to determine whether the electrode has experienced a heated state. In some embodiments, temperature-responsive color change may be used to determine whether the electrode has been heated above a point that would cause dielectric breakdown of the electrode material. Deterioration of the stimulation electrode due to dielectric breakdown, caused by changes in electrical properties, can result in an unsafe electrode, and such a deteriorated electrode should not be used on a person. In some embodiments, any color change within the smart electrode 1300 may be used to indicate whether the electrode is safe to use or whether the electrode should be replaced. In some embodiments, color change may also be used to indicate to a physical therapist whether the electrode may potentially cause skin burns or to allow the physical therapist to select an electrical stimulation setting that produces an energy output below a temperature threshold where skin burns can occur. Some embodiments of the smart electrode 1300 may include a conductive silicon layer 1310, which includes one or more sensors 1320 comprising a temperature-sensitive color-changing material mounted on a fabric substrate 1340. In addition, some embodiments include a transparent hydrogel layer 1330 covering at least a portion of the conductive silicon layer. The transparent hydrogel layer 1330 provides physical protection for a sensor layer that is optically transparent to allow detection of one or more sensors. In some other embodiments, the conductive silicon layer may be replaced by an alternative conductive or semiconductive layer, including PCBs, HDMI, conductive glass layers, conductive polymer layers, ceramic layers, etc. In some other embodiments, an optical sensor or photodetector element may be included to detect color changes in the smart electrode. In some embodiments, this automation may be achieved by including a color detection sensor placed directly on and / or near the electrode surface, wherein the sensor may be configured to monitor the color of at least a portion of the electrode. In some embodiments, the color sensor may be coupled to a controller to monitor color changes of the electrode indicating unsafe electrode operating conditions for human use. In some embodiments, the color sensor may be available for the system to identify changes and disable the system's output upon detecting a change. Furthermore, in some embodiments, color changes may be automatically detected and may be used in a closed-loop feedback manner to optimize electrical stimulation parameters to prevent excessive temperatures and patient burns during electrical stimulation.

[0174] In some embodiments of the invention, at least one support system or component described herein may include one or more adaptive electrodes. For example, Figures 14A-14CAdaptive electrodes 1400, 1425, and 1450 according to some embodiments of the invention are shown. In some embodiments, the adaptive electrodes can be positioned relative to one or more muscles to provide stimulation. In some embodiments, the electrodes may comprise a flexible PCB layer (shown as layer 1450), a layer comprising an array of silicone pads (layer 1425), and a hydrogel layer (layer 1400). Some embodiments include electrode clusters comprising multiple individual electrodes (e.g., electrodes comprising layers 1400, 1425, and 1450). In some embodiments of the invention, the support system can be self-tuned by allowing current to pass through a selective number or all of the electrodes. In some embodiments, electrode selectivity may include devices with minimal power dissipation and greater conductor performance, which may be indicators aligned with muscle fibers or muscle movement points. Furthermore, by dividing individual electrodes into electrode clusters, improved current distribution, such as that applied to the user's skin surface, can be provided. Furthermore, the current electrode has the highest current density around the edge of its pad, and the use of the adaptive electrode as described can effectively lay the electrode flat to distribute the current outside the hot area, as well as over a larger area to improve user comfort and prevent skin burns.

[0175] In some other embodiments of the invention, the support system may include one or more electrodes, each comprising a circuit board located at the electrode. Some embodiments of the invention include systems and methods for communicating with a setting gate at the electrode site using SPI communication from a controller. Furthermore, the setting gate can determine which segment of the electrode generates an effective electrical stimulation signal. In some embodiments of the invention, one or more electrodes and / or an array of electrodes may include the placement of electrodes configured for a specific stimulation pattern, such that muscles of a given limb contract to a pattern that introduces blood into the tissue or reduces edema in that area.

[0176] Some embodiments of the present invention include a scaffold system that integrates stimulation with cryotherapy or thermotherapy. In some embodiments, the scaffold system can apply selective thermotherapy and cryotherapy, delivered to the limb within the scaffold using an embedded system capable of altering the internal temperature of at least a portion of the scaffold. In some embodiments, this can be achieved in conjunction with applying stimulation to the selected limb. In some embodiments, heating and / or cooling can be applied to the entire interior of the scaffold or to selected locations within the scaffold. In some embodiments, the scaffold system may include a solid-state heat exchanger that directly heats or cools a specific location or area within the scaffold using the Peltier effect. Some embodiments of this system may use a heat exchanger located external to the scaffold. For example, in some embodiments, a pipe system in a thermally conductive material circulates fluid cooled by an external heat exchanger. In some other embodiments, the system may use a phase change cooling material to provide cooling to the entire interior of the scaffold or to selected locations within the scaffold. In some embodiments, the system may use a phase change cooling material that freezes at 58°F and does not lower the temperature of the treated limb below a safe level.

[0177] Some embodiments of the invention may include a strut system that provides mechanical manipulation of muscles to improve blood flow and / or prevent blood clot formation. Some embodiments of the invention may use multiple air bladders forming concentric rings around a given limb. In some embodiments, if the pressure in these rings increases in a series of matching rings, a peristaltic pumping action can be introduced into the underlying tissue, thereby resulting in increased blood flow in the tissue of the given limb.

[0178] Some implementations include shoulder strap vests or slings with integrated electrical stimulation electrodes and inflatable cushions, which can be used to apply pressure to the electrodes to enhance skin contact, conductivity, and comfort. In some implementations, the inflation of the airbag can be selectively applied and electronically controlled as a method to improve electrode contact pressure and provide user comfort without mechanically repositioning the electrodes. Furthermore, in some implementations, pumps and / or inflatable gas and / or fluid systems (e.g., including airbags) can be used for electrode compression. Additionally, in some implementations, inflatable cushions can be used to increase or decrease pressure on specific tissues to provide comfort to the patient during exercise, sleep, or other activities. For example, an inflatable cushion can be applied behind the shoulder joint complex during sleep and manually inflated by the user to provide pain relief and comfort while lying down.

[0179] Some implementations include a strut system with an integrated pressure therapy system. For example, in some implementations, the integrated pressure therapy system can be used to treat deep vein thrombosis as well as for general compression therapy. For example, in some implementations, the strut system can be used as a pressure therapy system in conjunction with selectively applied and electronically controlled actuation using an inflatable pillow or airbag. In some implementations, this pressure therapy system can be combined with electrical stimulation electrodes and systems to provide a comprehensive tissue therapy system. Furthermore, in some implementations, the pressure therapy system can be combined with an electrical stimulation system and integrated with the application of heat / ice temperature therapy to provide a comprehensive tissue therapy system.

[0180] Figure 15-22 Oscilloscope scan data of NMES under various stimulation conditions generated using at least one of the strut systems or components described herein are shown. For example, the original reference Figure 15 The image shows a post-NMES oscilloscope scan 1500 of the pulse train, which shows a pulse train view where the pulse train duration is 3 seconds, the duty cycle is 13 seconds on / 10 seconds off, the vertical split is 20V and the horizontal split is 5 seconds. The electrical stimulation pulses shown are monophasic pulses at a rate of approximately 50 pulses per second, with a pulse width of 5 ms, a duty cycle of 25%, and a power level set to 100 on the device at a 500-ohm load. As shown, the pulse train oscillates over time between channels (e.g., muscle groups) and does not overlap. In some embodiments, the pulse train is extended to 3 seconds to better allow the patient to use the contractions of the electrical stimulation to coordinate voluntary contractions to regain willpower.

[0181] Figure 16 An oscilloscope scan 1600 is shown after NMES operation of individual pulses of a channel according to some embodiments of the present invention, showing a waveform view where the vertical division is 20V and the horizontal division is 5 milliseconds (hereinafter "ms"). Monophase pulses are applied at a rate of approximately 50 pulses per second, with a pulse width of 5ms, a duty cycle of 25%, and a device power level set to 100 at a 500-ohm load. The waveform shown is not typical of what is seen during electrical stimulation because it is not a standard square wave, sine wave, triangle wave, sawtooth wave, or other waveform. The waveform shown is a complex waveform with a high voltage spike at the leading end, which rapidly transitions to a lower voltage saddle, and then increases in voltage towards the end of the pulse. The waveform illustrates the closed-loop feedback power control employed by the system, as it responds rapidly to the desired power delivery and current for each device setting. The voltage is much lower than conventional NMES electrical stimulation parameters, while the pulse width is much longer than conventional NMES electrical stimulation parameters. Figure 16 This describes the electrical stimulation pulses targeting the vastus medial oblique (VMO) muscle group. Figure 17 Similar to Figure 16The image shows a 1700-degree scan with a waveform targeting the rectus femoris (RF) muscle group. In some embodiments, this waveform is the same as the VMO, but in other embodiments, this waveform is modified and the optimal stimulation for the two muscle groups is different.

[0182] Figure 18 An NMES intensity oscilloscope scan 1800 of a pulse train according to some embodiments of the present invention is shown. It shows a pulse train view with a duration of 1 second and a duty cycle of 12 seconds on / 10 seconds off. The vertical division is 20V, and the horizontal division is 5 seconds. The view shows a single-phase pulse at a rate of 50 pulses per second, with a pulse width of 5 ms, a duty cycle of 25%, and a device power level set to 100 at a 500-ohm load. As can be seen in the oscilloscope scan, the pulse train oscillates over time between channels (e.g., muscle groups) and does not overlap. The 1-second pulse train allows for a sustained contraction time, similar to the contraction length a patient would experience during exercise.

[0183] Figure 19 A scan of 1900° with an electrical stimulation pulse waveform is shown, with a vertical division of 20V and a horizontal division of 5ms. It shows a monophasic pulse at a rate of 50 pulses per second, with a pulse width of 5ms, a duty cycle of 25%, and a device power level set to 100 at a 500-ohm load. The waveform shown is not typical of what is seen during electrical stimulation because it is not a standard square wave, sine wave, triangle wave, sawtooth wave, or other waveform. The waveform shown is complex, with a high voltage spike at the beginning, which rapidly transitions to a lower voltage saddle, and then increases in voltage towards the end of the pulse. The waveform illustrates the closed-loop feedback power control employed by the system, as it responds rapidly to the desired power delivery and current for each device setting. The voltage is much lower than conventional NMES electrical stimulation parameters, while the pulse width is much longer than conventional NMES electrical stimulation parameters. Figure 19 This describes the electrical stimulation pulses targeting the vastus medial oblique (VMO) muscle group. Figure 20 Similar to Figure 19 The image shows a 1900-degree scan with a waveform targeting the rectus femoris (RF) muscle group. In some embodiments, this waveform is the same as the VMO, but in other embodiments, this waveform is modified and the optimal stimulation for the two muscle groups is different.

[0184] Figure 21 A TENS oscilloscope scan 2100 of a pulse train according to some embodiments of the present invention is shown. Figure 21A pulse train view is shown, with the vertical segment divided into 20V segments and the horizontal segment divided into 10ms segments. The electrical stimulation pulses are bi-symmetrical pulses with a rate of 100 pulses per second, a pulse width of 1ms, a duty cycle of 20%, and a device power level set to 50 for a 500-ohm load.

[0185] Figure 22 A TENS oscilloscope scan 2200 of an individual pulse according to some embodiments of the present invention is shown. This figure shows a view of the electrical stimulation pulse waveform, with a vertical division of 20V and a horizontal division of 2.5ms. The electrical stimulation pulse is a double-symmetrical pulse with a rate of 100 pulses per second, a pulse width of 1ms, a duty cycle of 20%, and a device power level set to 50 at a 500-ohm load. The waveform shown is not a typical waveform seen during electrical stimulation because it is not a standard square wave, sine wave, triangle wave, sawtooth wave, or other waveform. The waveform shown is a complex waveform with a high voltage spike at the beginning, which rapidly transitions down to a lower voltage ramp at the end of the pulse. The waveform illustrates the closed-loop feedback power control employed by the system, as it responds quickly to the desired power delivery and current for each device setting. The voltage is much lower than conventional TENS electrical stimulation parameters, while the pulse width is much longer than conventional TENS electrical stimulation parameters.

[0186] As previously described, some embodiments of the present invention may include a support system or component that includes a controller 675 coupled to a computer system or device such as a personal computer and / or a smartphone. When coupled as a therapeutic control system, the computer system or device may be used to control or monitor one or more functional and / or operational aspects of the support system or component for the wearer via a graphical user interface (“GUI”). For example, Figure 23A display 2300 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, display 2300 may include an introductory and initiation menu or process to encourage and enable the user to couple, pair, or synchronize and / or register support components for use, and / or view help information, including text, audio, video, and / or other media files. Furthermore, display 2300 may include one or more selectable actions or steps from which the user can select actions or steps to combine, pair, and / or register support components, or access help information as described above. For example, in some embodiments, step 2310 may include a “locate barcode” selector, which the user may choose to initiate the delivery of help information for display on the GUI and / or the delivery of audio information (e.g., voice instructions) to a sound generator coupled to the user’s computer system or device. In some other embodiments, step 2320 may be used to select a scanner in an application to scan and synchronize a support or support component, including clothing. In some other embodiments, step 2330 may be used to add additional documentation to the system and associated applications. In other embodiments, alternative steps or processes may be used instead of steps 2310, 2320, and 2330, and / or further optional steps may be included.

[0187] In some implementations, if the user selects step 2310, the media window may display instructions on the barcode location. For example, Figure 24 A display 2400 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 2400 may include a media window 2410, in which information relating to the location of a clothing barcode may be displayed. The information may include text, graphics, video, still images, or combinations thereof. In some embodiments, instead of text, graphics, video, still images, or combinations thereof, or in addition to these, audio information may be played.

[0188] In some embodiments of the invention, a user can download the treatment control application to a wireless device (e.g., a mobile phone or smartphone). In some embodiments, the user can set up a profile and then pair the application with the user's brace to initiate the range of stimulation and / or movement therapy using the user's GUI. For example, in some embodiments of the invention, the user's GUI can be used to initiate, guide, or monitor one or more components of the treatment control system. Enabled pairing or coupling. Figure 25An embodiment of a display 2500 for a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 2500 may include at least one indicator 2510 that displays or indicates the synchronization status with the user's clothing. In some embodiments, the display 2500 may include a step 2520 that enables the user to activate Bluetooth. Furthermore, in some embodiments, step 2530 may be used for synchronization with a mobile device.

[0189] Figure 26 A display 2600 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 2600 may include a media window 2610, wherein a media window may be displayed. Synchronize related information. This information may include text, graphics, video, still images, or combinations thereof. In some embodiments, audio information may be displayed instead of text, graphics, video, still images, or combinations thereof, or in addition to these.

[0190] Figure 27 A display 2700 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 2700 may include visual icons 2710 that encourage the user to pair the user's clothing with the user's device using a selection bar 2720. In some embodiments, an information bar 2730 may display information between the user's clothing and the device. The state of coupling. Furthermore... Figure 28 A display 2800 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 2800 may include an information bar 2810 indicating faulty connections.

[0191] In some embodiments of the invention, the GUI can provide guidance on using the clothing. For example, Figure 29 A display 2900 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, an information display 2910 may ask the user for help with trying on clothes. Furthermore, associated visual icons 2920 may provide a display of clothing that the user may need to assist or guide in trying on clothes, and a selection bar 2930 may provide the user with optional access to the help display. For example, Figure 30A display 3000 for a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 3000 may include an information bar 3010 having one or more instructions, and an information segment 3030 may include a fitting instruction. Furthermore, a visual indicator 3020 may include a visual display of text, graphics, video, still images, or combinations thereof, showing or illustrating one or more steps of the clothing fitting process. In some embodiments, instead of text, graphics, video, still images, or combinations thereof, or in addition to these, audio information may be played.

[0192] In some implementations, selection bar 3040 can be used to exit help or proceed to another help step or body. For example, Figure 31 A display 3100 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 3100 may include an information bar 3110 indicating assistance with electrode alignment. Furthermore, a visual indicator 3120 may include a visual display of text, graphics, video, still images, or combinations thereof, showing or illustrating one or more steps of a fitting procedure for electrode alignment. In some embodiments, instead of text, graphics, video, still images, or combinations thereof, or in addition to these, audio information may be played.

[0193] Figure 32 A display 3200 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 3200 may include an information bar 3210 indicating assistance for securing the brace straps. Furthermore, a visual indicator 3220 may include a visual display of text, graphics, video, still images, or combinations thereof, showing or illustrating one or more steps of the fitting process for securing the brace straps. In some embodiments, instead of text, graphics, video, still images, or combinations thereof, or in addition to these, audio information may be played.

[0194] Figure 33 A display 3300 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 3300 may include an information bar 3310 indicating instructions for inserting clothing into a clothing controller. Furthermore, a visual indicator 3320 may include a visual display of text, graphics, video, still images, or combinations thereof, showing or illustrating one or more steps of inserting clothing into the controller. In some embodiments, instead of text, graphics, video, still images, or combinations thereof, or in addition to these, audio information may be played.

[0195] In some implementations, a GUI can be used to activate clothing. For example, Figure 34A display 3400 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 3400 may include information or an action bar 3410 indicating clothing activation. In some embodiments, the information segment 3420 may include instructions or information related to the clothing activation state or procedure. In some embodiments, the visual indicator 3425 may include an icon of the clothing requiring activation, and the action selector 3430 may include a test clothing action icon 3430.

[0196] In some embodiments of the invention, the GUI allows users to test clothing. For example, Figure 35 A display 3500 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, display 3500 displays information related to the status of various aspects of the user's clothing. For example, in some embodiments, function 3515 may include... A connection status indicator 3515a. Additionally, function 3520 may include a connection-related indicator 3520a for the controller. Figure 36 The display sections 3600 and 3650 shown illustrate different Status and connection status. For example, the display section 3600 includes indicators of ongoing status. The connection status is 3610, and the display section 3650 includes a status 3625 indicating that the controller connection is in progress.

[0197] Figure 37 A display 3700 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, display 3700 may include a help icon 3710 to enable the user to access one or more help information sections (e.g., those sections previously described). Display 3700 may also include an access bar 3725 comprising various functions or access icons. For example, a main icon 3750 may be used to point to the GUI's home page. Furthermore, the user may use a stimulator icon 3760 or a range of motion icon 3770 to select a treatment. For example, the stimulator icon 3760 may be used to access one or more functions or states of a stimulator coupled to or integrated with the user's clothing, and the range of motion icon 3770 may be used to initiate a treatment designed to enhance the wearer's range of motion. Additionally, a menu icon 3780 may enable the user to access additional goals and application preferences.

[0198] In some implementations, the GUI may be able to set treatment goals. For example, Figure 38A display portion 3800 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, display 3800 may include a target section 3810 and a setting stimulation target section 3825 including a movement target range section 3827. In some embodiments, target section 3910 may include one or more icons referring to treatment areas. For example, icon 3815 may include a reference to knee treatment, and icon 3820 may include a reference to shoulder treatment. In some embodiments, the setting stimulation target 3825 section may include suggestions related to the target and the benefits of the target, including suggested treatment methods. In some embodiments, movement range target 3827 may include a date selector 3830 configured to allow a user to select a treatment date. In some embodiments, movement setting display 3832 may include a movable indicator 3832a for setting a user-guided target associated with a body part displayed as icon 3834. For example, referring to a target related to the user's selection of icon 3815 for knee treatment, the exercise settings display 3832 may include a movable indicator 3832a for setting the user's desired target extension angle. Furthermore, the exercise settings display 3836 may include a movable indicator 3836a for setting a user's guidance target related to the body part displayed as icon 3838. In this case, the exercise settings display 3836 may include a movable indicator 3836a for setting the user's desired target flexion angle. Additionally, Figure 39 A display portion 3900 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 3900 may include an infographic 3850 with goals selected by the user, said goals including goals that change according to a date selected, such as by a date selector 3830. For example, in some embodiments, user-defined ranges of flexion, extension, and movement goals may be displayed according to date.

[0199] Some implementations allow users to increase the number of goals. For example, in some implementations, a pain relief goal segment 3860 can be used to set a target pain relief goal. In some implementations, this can be set based on a date as defined using a date selector 3860a. In some implementations, a pain meter 3870 can be used to set a target pain level using a movable indicator 3872. Furthermore, the pain meter 3870 may include multiple icons 3875 representing pain levels from no pain to moderate pain to worst pain. Additionally, in some implementations, an action indicator 3878 can be used to add goals, and an action selector 3890 can be used to set goals. In some implementations, a display 3879 may include a display of goals based on a date 3880 and a pain level 3885. At any time, an access bar 3892 may be provided to allow the user to access other functions of the system.

[0200] Figure 40 A display portion 4000 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 4000 may include a drop-down menu 4010 configured for selecting a date range, and Figure 41 A corresponding display portion 4100 of a treatment system control GUI according to some embodiments of the present invention is shown.

[0201] Figure 42 A display portion 4200 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display portion 4200 may include a selector 4220 configured to allow a user to switch between goals and achievements. In some embodiments, icons 4230 may display one or more main sections related to goals or achievements, and the goal and achievement display 4240 may include a display of actual achievements 4250 based on changing treatment type 4260 and date 4270 (e.g., daily, weekly, and / or monthly goals). In some embodiments, the goal and achievement display 4240 may be configured as a goal and achievement display 4340 that compares goals and achievements daily (see, for example, see...). Figure 43 (and display unit 4300). Figure 44 A display 4400 of a treatment system control GUI according to some embodiments of the present invention is shown, and a monthly version of a target and achievement display 4240 (displayed as a target and achievement display 4440) is also shown.

[0202] Figure 45A display portion 4500 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display portion 4500 may include an achievement display 4510 (selector toggle 4505 set to achievement), wherein a reward section 4515 may include one or more achievement rewards based on the user achieving or exceeding a specific or non-specific goal. The reward section 4515 may include rewards for stimulating the goal. Figure 46 A display portion 4600 of a treatment system control GUI according to some embodiments of the present invention is shown, and rewards related to flexion (reward display 4610), extension (reward display 4620), and range of motion (reward display 4630) are displayed. Figure 47 The diagram shows a display portion 4700 of a treatment system control GUI according to some embodiments of the present invention, and includes a reward display 4715 having an awarding reward 4720. Figure 48 A display portion 4800 of a treatment system control GUI according to some embodiments of the present invention is shown, and includes reward displays 4810, 4820 and 4830. Figure 49 A display portion 4900 of a treatment system control GUI according to some embodiments of the present invention is shown, and includes a reward display 4915 having a reward 4918, and Figure 50 A display portion 5000 of a treatment system control GUI according to some embodiments of the present invention is shown, and reward displays 5015, 5020 and 5025 are also shown.

[0203] Figure 51 A display portion 5100 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5100 may include a notification or information display 5110 configured to display treatment status (e.g., such as the number of stimulations completed). In some embodiments, a reward indicator 5120 may be displayed based on the displayed treatment status.

[0204] Figure 52 A display 5200 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5200 may be displayed based on the user's selection of access bar 3725. In some embodiments, the display 5200 may include a help icon 5210 to allow the user to access one or more help menus. The display 5200 may also include a clothing selector 5220, which can be selected by the user as needed to add additional clothing to the stimulation session. Furthermore, in some embodiments, a battery indicator 5230 may be used to indicate battery charging of the user device. Stimulation pulse activity may also be monitored. For example, Figure 53A display 5300 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5300 may include a pulse current indicator 5310 and / or a pulse level indicator 5320.

[0205] Figure 54 A display 5400 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5400 may include a timer 5410 that can display the remaining time in a treatment session. Furthermore, some embodiments include a pause selector 5420 configured to allow a user to pause a treatment session.

[0206] In some implementations, the GUI may be configured with various help menus that allow users to select from a range of help topics. For example, Figure 55 A display 5500 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5500 may include a dashboard help section 5510, which includes a menu 5525 enabling a user to select one or more help topics. Furthermore, Figure 56 A display 5600 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5600 may include a pin management help section 5610, which may include a menu 5620 configured with optional topics related to pin management.

[0207] Figure 57 A display 5700 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5700 may include a menu 5710 configured with selectable preferences. Furthermore, Figure 58 A display 5800 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 5800 may include a menu 5810 configured with user-selectable brief help topics. Figure 59 A display 5900 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, display 5900 may include a topic title 5910, and menu 5920 may include one or more questions related to the topic. Visual window 5930 may include a visual overview of the treatment, and information segment 5940 may include treatment-related guidance, suggestions, or other information. Furthermore, Figure 60 A display 6000 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 6000 may include a range of motion test help 6010, which includes a menu 6020 configured for selecting at least one help topic.

[0208] Figure 61 A display 6100 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 6100 may include a range of motion assistance 6110, which includes a menu 6120 containing one or more selectable assistance topics. Furthermore, Figure 62 A display 6200 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, the display 6200 may include a pause stimulation help 6210, which includes a menu 6220 containing one or more help topics related to the stimulation. Furthermore, Figure 63 A display 6300 of a treatment system control GUI according to some embodiments of the present invention is shown. In some embodiments, display 6300 may include a pause stimulation help 6325, which includes a menu 6330 containing one or more help topics related to the stimulation.

[0209] Figure 64 A portion of the stimulation circuitry 6400 of a therapeutic control system according to some embodiments of the present invention is shown. In some embodiments, circuitry 6400 may include at least one resistor 6450 coupled in parallel with at least one capacitor 6460 coupled to ground. In some embodiments, this configuration makes the stimulation pulses comfortable when delivered to the wearer.

[0210] Figure 65A A display 6500 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, the display 6500 allows a user to input and / or view personal information, including but not limited to height, weight, date of birth, and gender, within an information window 6510. Furthermore, Figure 65B A display 6550 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, display 6550 may include an information window 6560 that includes at least some of the user's health information. For example, in some embodiments, certain specific information may include information about previous surgeries related to current or pending treatments provided by the treatment control system.

[0211] In some implementations, users can select the type of clothing and initiate a connection with the clothing. For example, Figure 66 A display 6600 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, the display 6600 may include clothing type 6610, from which a user can select and add one or more garments for one or more treatment sessions. With the 6620 connection, users can connect to one or more garments to begin a treatment session. Additionally, Figure 67 A display 6700 of a treatment control system is shown, which includes a scrolling portion of display 6600 that displays a background information window 6710. In some embodiments, a user can scroll the information window 6710 to access different portions of the window 6710.

[0212] In some implementations, users can use a dashboard to monitor and track treatment sessions. For example, Figure 68 A display 6800 of a treatment control system including a dashboard 6810 is shown. In this example, focusing on knee joint treatment, a progress bar 6820 may include treatment status, including the number and type of completed or ongoing treatment sessions, and / or the number and type of pending or planned treatment sessions. Furthermore, in some embodiments, one or more access tabs may allow the user to access various treatment sessions or procedures, session or procedure settings, or data recorded during any session or procedure. For example, some embodiments include a stimulation tab 6830 and / or a ROM / flexion / extension tab 6840, a pain indication tab 6850, and a step count indication tab 6860.

[0213] Some implementations include a display of treatment settings that can be configured or reconfigured by the user. For example, Figure 69 A display 6900 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, the display 6900 may include a treatment session window 6910, which includes one or more treatment settings or controls. For example, some embodiments include a thigh area dial 6920 and / or a knee area dial 6930 and / or a three-area dial 6940 and / or a four-area dial 6950. In some embodiments, any dial 6920, 6930, 6940, 6950 may include controls that allow the user to increase or decrease one or more treatment parameters represented by the dial 6920, 6930, 6940, 6950.

[0214] Some implementations may include visual or graphical displays during a treatment session. For example, Figure 70 A display 7000 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, the display 7000 may include a visual guide 7010 that provides an anatomical representation of a part of the user's body undergoing treatment. In some embodiments, the visual guide 7010 may include treatment parameters 7020 from the user, including flexion and / or extension and / or range of motion data. In some other embodiments, the treatment parameters 7020 may be tracked and plotted over time. For example, Figure 71A display 7100 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, the display 7100 may include a treatment progress graph 7110 showing flexion and / or extension and / or range of motion data plotted over time. Furthermore, in some embodiments, a detail section 7120 may include a list of flexion and / or extension and / or range of motion data along with pain data. Reference Figure 72 Some other embodiments include a display 7200 with a treatment progress graph 7210, which shows progress expressed as average power. The display 7200 may also include a treatment date section 7220 to allow a user to display graph 7210 within a selected data range. Furthermore, a session details section 7230 may include a list of session data, which includes the start and end times of treatment sessions and the average power from the sessions.

[0215] In some implementations, users can monitor pain based on timing, session activity, or other desired parameters. For example, Figure 73 A display 7300 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, the display 7300 may include a treatment pain graph 7305, which includes pre-session pain and / or post-session pain and / or daily average pain levels. Furthermore, a session details section 7310 may include a list of pain data arranged according to the session date.

[0216] In some other embodiments of the invention, the user's step count can be monitored and displayed. For example, Figure 74 A display 7400 of a treatment control system according to some embodiments of the present invention is shown. In some embodiments, the display 7400 may include a treatment step diagram 7405, which is based on steps that change over time, wherein a session details section 7410 provides a list of steps that changes according to date.

[0217] As previously mentioned Figure 3A and 3B As shown, some embodiments include various electronic components that can be integrated into one or more modules of the support system, and these modules can be combined and reconfigured into various configurations. For example, Figure 75 A treatment system 7500 is shown, comprising a garment 7510, the garment including a controller 7520 integrated into or coupled to the garment 7510. Furthermore, some embodiments include one or more sensor boxes 7525 integrated into or coupled to the garment 7510. In some embodiments, the controller 7520 includes a rechargeable power memory. Additionally, in some embodiments, the sensor boxes include an onboard power supply.

[0218] In some implementations, one or more sensor boxes 7525 may be linked to the controller 7520 using a wired or wireless link. For example, in some implementations, one or more sensor boxes 7525 may be linked to the controller 7520 using a wired or wireless link. A wireless link is connected to controller 7520. In some embodiments, one or more sensor boxes 7525 can exchange data with controller 7520, which can exchange data or related data with a user's device, such as mobile device 7530. Furthermore, in some embodiments, mobile device 7530 can exchange data or related data with an external server system 7540 (e.g., a cloud server and / or storage system). In some embodiments, controller 7520 can be configured to exchange information with one or more sensor boxes 7525 and mobile device 7530 substantially simultaneously. Reference Figure 76 Some embodiments of the present invention are shown. Figure 75 The data type 7600 of the treatment system, in some embodiments, may include exchanged data such as stimulation data 7610 and / or range of motion data 7630 and / or pain data 7660 and / or activity level data 7690. In some embodiments, stimulation data 7610 may include information or data from one or more treatment sessions, and / or treatment power level and / or power level variation, and / or treatment type and / or stimulation comfort. In some embodiments, range of motion data 7630 may include range of motion once per day (or multiple times over other periods), and / or flexion and / or extension information or data. In some embodiments, this data may enable passive monitoring and gait analysis. In some other embodiments, pain data 7660 may include pre- and post-stimulation pain levels measured and / or distributed at least three times per day or other time periods. In some other embodiments, activity level data 7690 may include steps, acceleration, and velocity data.

[0219] Some embodiments of the present invention use one or more of a ROM, accelerometer, gyroscope, and EMG to analyze activity level data 7690, including gait phase. This gait phase analysis can compare post-injury or post-training data with pre-injury, pre-treatment, or pre-training baseline data to better assess rehabilitation and / or training progress. In some embodiments, gait phase analysis may also be used alone or in conjunction with other biometric analyses to identify patients.

[0220] In some implementations, EMG signal and force relationship analysis can also help assess rehabilitation and training progress. Some implementations provide customized treatment and / or training based on feedback from gait phasing or EMG signal and force analysis. In some implementations, EMG signals are assessed alternately with stimulation therapy. In some other implementations, EMG signals are assessed simultaneously with stimulation therapy using conventional signal filtering and analysis techniques. Finally, in some implementations, surface EMG analysis can be used to diagnose muscular and / or neurological disease characteristics.

[0221] Figure 77 Some embodiments of the invention are shown in Figure 75 Data category 7700 is used to exchange and store data between components of the treatment system. For example, some embodiments include server data category 7710, which includes data or information exchanged and / or stored on servers, such as in cases where mobile device 7530 may exchange data or related data to an external server system 7540 (e.g., a cloud server and / or storage system). Some embodiments also include mobile device application data category 7740, which includes data exchanged and / or stored on user devices (such as mobile device 7530). Other embodiments include clothing controller data category 7770, which includes data exchanged and / or stored on clothing controllers such as controller 7520. In some embodiments, any data category may include read / write access settings that restrict access or provide access levels. In some embodiments, read / write access protocols and data transfer methods may be configured to comply with HIPAA.

[0222] Those skilled in the art will understand that while the invention has been described above with reference to specific embodiments and examples, it is not necessarily so limited, and many other embodiments, examples, uses, modifications, and deviations from those embodiments, examples, and uses are intended to be encompassed by the appended claims. Each patent and publication cited herein, in its entirety, is incorporated herein by reference as if each such patent or publication were individually incorporated herein by reference. Various features and advantages of the invention are set forth in the appended claims.

Claims

1. A system for delivering stimulation to a patient, comprising: Computer systems (700, 800) include at least one processor (702, 820); A non-transitory computer-readable storage medium (860) that communicates data with the at least one processor (702, 820), the non-transitory computer-readable storage medium (860) comprising at least one stimulus program; At least one pair of stimulating electrodes (195) coupled to the article, the at least one pair of stimulating electrodes (195) being configured and arranged for coupling to the patient and controlled via a link; At least one controller (675) includes or is coupled to the at least one stimulation program and at least one signal or data source, wherein the at least one controller (675) is configured and arranged to generate at least one stimulation pulse and apply it to the at least one electrode pair (195) based at least in part on the at least one stimulation program and the at least one signal or data processed by the at least one processor (702, 820). At least one sensor (681, 683) coupled to the at least one controller (675) and the article; The at least one controller (675) is configured and arranged to (a) apply a sensing pulse to the patient's tissue using the at least one sensor (681, 683), (b) measure from the patient's tissue at least one electrical parameter related to the power dissipation of the sensing pulse in the tissue, (c) apply the at least one stimulation pulse to the patient's tissue in an adjustable manner based at least in part on the measured power dissipation, the stimulation pulses not overlapping and the at least one stimulation pulse being adjustablely controlled by the at least one controller (675) to maintain a constant power output to the patient's tissue at least in part on the at least one electrical parameter, and (d) repeat steps (a)-(c), wherein the waveform of the stimulation pulse is a complex waveform having a high voltage spike at the leading end, the spike rapidly transitioning to a lower voltage saddle, and then increasing the voltage toward the end of the pulse; At least one user interface (640) is configured and arranged to enable a user to remotely view or exchange information via the link and to monitor and set or reconfigure the at least one stimulation pulse based on one or more therapeutic targets, the at least one user interface (640) being configured to display at least one stimulation target and / or at least one range of motion targets.

2. The system of claim 1, wherein the link includes wired coupling.

3. The system of claim 1, wherein the link includes a wireless coupling, the wireless coupling comprising at least one of the following: a zero-generation wireless signal, a first-generation wireless signal, a second-generation wireless signal, a third-generation wireless signal, a fourth-generation wireless signal, a fifth-generation wireless signal, a global positioning satellite signal, a 2400-2493.5 MHz frequency band, a Bluetooth® wireless signal, RFID electromagnetic radiation, a WiFi wireless signal, a two-way radio RF signal, a UHF or VHF signal, a millimeter-wave signal, and a near-field wireless signal.

4. The system of claim 1, wherein the article includes a support assembly (570, 670, 960).

5. The system of claim 1, wherein the at least one sensor (681, 683) comprises at least one of the following: an accelerometer (460, 462), a proximity sensor, an optical sensor (982, 984), a motion sensor, a gyroscope, a magnetometer, a position sensor, a global positioning sensor (GPS), an optical sensor, a magnetic sensor, a magnetometer, an inductive sensor, a capacitive sensor, an eddy current sensor, a resistive sensor, a magnetoresistive sensor, an inductive sensor, an infrared sensor, an inclinometer sensor, a piezoelectric material or a piezoelectric-based sensor, a blood oxygen sensor, and / or a heart rate sensor.

6. The system of claim 1, wherein the at least one sensor (681, 683) comprises at least one of the following: at least one laser- or ultrasound-based sensor configured and arranged to measure tissue or fluid movement; at least one hydration sensor configured and arranged to measure interstitial fluid levels to determine hydration levels; at least one force or pressure sensor configured and arranged to measure muscle activity or response; at least one sensor comprising an electromyographic sensor configured and arranged to measure muscle recruitment or muscle fatigue, and the at least one pair of stimulation electrodes.

7. The system of claim 1, wherein the at least one sensor is configured and arranged to monitor or measure the location of a portion of the patient.

8. The system of claim 1, wherein the at least one sensor is configured and arranged to monitor or measure the position of a portion of the article.

9. The system of claim 1, wherein the at least one sensor is configured and arranged to respond to at least one physiological response or parameter from the patient; and wherein the at least one signal or data is based at least in part on the response of the at least one sensor.

10. The system of claim 4, wherein the support assembly (570, 670, 960) comprises at least one of a support (100, 210, 320, 450), a support column (682, 684, 987, 988), a sleeve, a belt, a sling (300, 388), clothing (301, 578), a wrap (130), and a strap (230, 368, 384).

11. The system of claim 1, wherein the at least one user interface (640) comprises a display presented on the user's device.

12. The system of claim 11, wherein the user's device includes at least one of the following: a desktop computer, a laptop computer, a digital tablet computer, a digital assistant, a cellular phone, a smartphone, a smartwatch, a wearable activity monitor, glasses, a camera, a pager, and an internet device.

13. The system of claim 11, wherein the at least one controller is configured to update the at least one user interface (640) with at least one of the state of a portion of the article, the position of a portion of the article, and data from the at least one sensor (681, 683).

14. The system of claim 11, wherein the at least one user interface (640) includes a display that includes options for scanning the item and synchronizing the item with the at least one controller (675).

15. The system of claim 11, wherein the at least one user interface (640) includes a display that includes options for scanning more than one item and synchronizing the items.

16. The system of claim 11, wherein the at least one user interface (640) includes a display that includes an option to activate the link to connect the item to the at least one controller.

17. The system of claim 16, wherein the link activation includes a wireless link between the item and the at least one controller (675).

18. The system of claim 11, wherein the display is configured and arranged such that the user can set or reconfigure the at least one stimulation pulse.

19. The system of claim 1, wherein the controller (675) includes a rechargeable power storage device.

20. The system of claim 1, wherein the at least one sensor is located in a sensor housing, the sensor housing including an onboard power supply.

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