3D Ultrasound Shear Wave Elastography for Musculoskeletal Tissue Assessment Under Compressive Load: A Feasibility Study.

Given its real-time capability to quantify mechanical tissue properties, ultrasound shear wave elastography holds significant promise in clinical musculoskeletal imaging. However, existing shear wave elastography methods fall short in enabling full-limb analysis of 3D anatomical structures under diverse loading conditions, and may introduce measurement bias due to sonographer-applied force on the transducer. These limitations pose numerous challenges, particularly for 3D computational biomechanical tissue modeling in areas like prosthetic socket design. In this feasibility study, a clinical linear ultrasound transducer system with integrated shear wave elastography capabilities was utilized to scan both a calibrated phantom and human limbs in a water tank imaging setup. By conducting 2D and 3D scans under varying compressive loads, this study demonstrates the feasibility of volumetric ultrasound shear wave elastography of human limbs. Our preliminary results showcase a potential method for evaluating 3D spatially varying tissue properties, offering future extensions to computational biomechanical modeling of tissue for various clinical scenarios.

Non-pyrogenicity and biocompatibility of parylene-coated magnetic bead implants.

Clinical grade magnetic bead implants have important applications in interfacing with the human body, providing contactless mechanical attachment or wireless communication through human tissue. We recently developed a new strategy, magnetomicrometry, that uses magnetic bead implants as passive communication devices to wirelessly sense muscle tissue lengths. We manufactured clinical-grade magnetic bead implants and verified their biocompatibility via intramuscular implantation, cytotoxicity, sensitization, and intracutaneous irritation testing. In this work, we test the pyrogenicity of the magnetic bead implants via a lagomorph model, and we test the biocompatibility of the magnetic bead implants via a full chemical characterization and toxicological risk assessment. Further, we test the cleaning, sterilization, and dry time of the devices that are used to deploy these magnetic bead implants. We find that the magnetic bead implants are non-pyrogenic and biocompatible, with the insertion device determined to be safe to clean, sterilize, and dry in a healthcare setting. These results provide confidence for the safe use of these magnetic bead implants in humans.

Constitutive parameter identification of transtibial residual limb soft tissue using ultrasound indentation and shear wave elastography.

Finite element analysis (FEA) can be used to evaluate applied interface pressures and internal tissue strains for computational prosthetic socket design. This type of framework requires realistic patient-specific limb geometry and constitutive properties. In recent studies, indentations and inverse FEA with MRI-derived 3D patient geometries were used for constitutive parameter identification. However, long computational times and use of specialized equipment presents challenges for clinical, deployment. In this study, we present a novel approach for constitutive parameter identification using a combination of FEA, ultrasound indentation, and shear wave elastography. Local shear modulus measurement using elastography during an ultrasound indentation experiment has particular significance for biomechanical modeling of the residual limb since there are known regional dependencies of soft tissue properties such as varying levels of scarring and atrophy. Beyond prosthesis design, this work has broader implications to the fields of muscle health and monitoring of disease progression.

Untethered muscle tracking using magnetomicrometry.

Muscle tissue drives nearly all movement in the animal kingdom, providing power, mobility, and dexterity. Technologies for measuring muscle tissue motion, such as sonomicrometry, fluoromicrometry, and ultrasound, have significantly advanced our understanding of biomechanics. Yet, the field lacks the ability to monitor muscle tissue motion for animal behavior outside the lab. Towards addressing this issue, we previously introduced magnetomicrometry, a method that uses magnetic beads to wirelessly monitor muscle tissue length changes, and we validated magnetomicrometry via tightly-controlled in situ testing. In this study we validate the accuracy of magnetomicrometry against fluoromicrometry during untethered running in an in vivo turkey model. We demonstrate real-time muscle tissue length tracking of the freely-moving turkeys executing various motor activities, including ramp ascent and descent, vertical ascent and descent, and free roaming movement. Given the demonstrated capacity of magnetomicrometry to track muscle movement in untethered animals, we feel that this technique will enable new scientific explorations and an improved understanding of muscle function.

Clinical viability of magnetic bead implants in muscle.

Human movement is accomplished through muscle contraction, yet there does not exist a portable system capable of monitoring muscle length changes in real time. To address this limitation, we previously introduced magnetomicrometry, a minimally-invasive tracking technique comprising two implanted magnetic beads in muscle and a magnetic field sensor array positioned on the body's surface adjacent the implanted beads. The implant system comprises a pair of spherical magnetic beads, each with a first coating of nickel-copper-nickel and an outer coating of Parylene C. In parallel work, we demonstrate submillimeter accuracy of magnetic bead tracking for muscle contractions in an untethered freely-roaming avian model. Here, we address the clinical viability of magnetomicrometry. Using a specialized device to insert magnetic beads into muscle in avian and lagomorph models, we collect data to assess gait metrics, bead migration, and bead biocompatibility. For these animal models, we find no gait differences post-versus pre-implantation, and bead migration towards one another within muscle does not occur for initial bead separation distances greater than 3 cm. Further, using extensive biocompatibility testing, the implants are shown to be non-irritant, non-cytotoxic, non-allergenic, and non-irritating. Our cumulative results lend support for the viability of these magnetic bead implants for implantation in human muscle. We thus anticipate their imminent use in human-machine interfaces, such as in control of prostheses and exoskeletons and in closed-loop neuroprosthetics to aid recovery from neurological disorders.

Erratum: Publisher Correction: Agonist-antagonist muscle strain in the residual limb preserves motor control and perception after amputation.

[This corrects the article DOI: 10.1038/s43856-022-00162-z.].

Agonist-antagonist muscle strain in the residual limb preserves motor control and perception after amputation.

Background: Elucidating underlying mechanisms in subject-specific motor control and perception after amputation could guide development of advanced surgical and neuroprosthetic technologies. In this study, relationships between preserved agonist-antagonist muscle strain within the residual limb and preserved motor control and perception capacity are investigated. Methods: Fourteen persons with unilateral transtibial amputations spanning a range of ages, etiologies, and surgical procedures underwent evaluations involving free-space mirrored motions of their lower limbs. Research has shown that varied motor control in biologically intact limbs is executed by the activation of muscle synergies. Here, we assess the naturalness of phantom joint motor control postamputation based on extracted muscle synergies and their activation profiles. Muscle synergy extraction, degree of agonist-antagonist muscle strain, and perception capacity are estimated from electromyography, ultrasonography, and goniometry, respectively. Results: Here, we show significant positive correlations (P < 0.005-0.05) between sensorimotor responses and residual limb agonist-antagonist muscle strain. Identified trends indicate that preserving even 20-26% of agonist-antagonist muscle strain within the residuum compared to a biologically intact limb is effective in preserving natural motor control postamputation, though preserving limb perception capacity requires more (61%) agonist-antagonist muscle strain preservation. Conclusions: The results suggest that agonist-antagonist muscle strain is a characteristic, readily ascertainable residual limb structural feature that can help explain variability in amputation outcome, and agonist-antagonist muscle strain preserving surgical amputation strategies are one way to enable more effective and biomimetic sensorimotor control postamputation.

ARACAM: A RGB-D Multi-View Photogrammetry System for Lower Limb 3D Reconstruction Applications.

In the world, there is a growing need for lower limb prostheses due to a rising number of amputations caused primarily, by diabetic foot. Researchers enable functional and comfortable prostheses through prosthetic design by integrating new technologies applied to the traditional handcrafted method for prosthesis fabrication that is still current. That is why computer vision shows to be a promising tool for the integration of 3D reconstruction that may be useful for prosthetic design. This work has the objective to design, prototype, and test a functional system to scan plaster cast molds, which may serve as a platform for future technologies for lower limb reconstruction applications. The image capture system comprises 5 stereoscopic color and depth cameras, each with 4 DOF mountings on an enveloping frame, as well as algorithms for calibration, segmentation, registration, and surface reconstruction. The segmentation metrics of dice coefficient and Hausdorff distance (HD) show strong visual similarity with an average similarity of 87% and average error of 6.40 mm, respectively. Moving forward, the system was tested on a known 3D printed model obtained from a computer tomography scan to which comparison results via HD show an average error of ≤1.93 mm thereby making the system competitive against the systems reviewed from the state-of-the-art.

Rejecting Impulse Artifacts from Surface EMG Signals using Real-time Cumulative Histogram Filtering.

This paper presents a cumulative histogram filtering (CHF) algorithm to filter impulsive artifacts within surface electromyograhy (sEMG) signal for time-domain signal feature extraction. The proposed CHF algorithm filters sEMG signals by extracting a continuous subset of amplitude-sorted values within a real-time window of measured samples using information about the probabilistic distribution of sEMG amplitude. For real-time deployment of the proposed CHF algorithm on an embedded computing platform, we also present an efficient, iterative implementation of the proposed algorithm. The proposed CHF algorithm was evaluated on synthetic impulse artifacts superimposed upon undisturbed sEMG recorded from a subject with transtibial amputation. Results suggest that the CHF algorithm effectively suppresses the simulated impulse artifacts while preserving a minimum signal-to-noise ratio of 95% and an average Pearson correlation of 0.99 compared to the undisturbed sEMG recordings.

Spatiotemporally Synchronized Surface EMG and Ultrasonography Measurement Using a Flexible and Low-Profile EMG Electrode.

The temporally synchronized recording of muscle activity and fascicle dynamics is essential in understanding the neurophysiology of human motor control which could promote developments of effective rehabilitation strategies and assistive technologies. Surface electromyography (sEMG) and ultrasonography provide easy-to-use, low-cost, and noninvasive modalities to assess muscle activity and fascicle dynamics, and have been widely used in both clinical and lab settings. However, due to size of these sensors and limited skin surface area, it is extremely challenging to collect data from a muscle of interest in a spatially as well as temporally synchronized manner. Here, we introduce a low-cost, noninvasive flexible electrode that provides high quality sEMG recording, while also enabling spatiotemporally synchronized ultrasonography recordings. The proposed method was verified by comparing ultrasonography of a phantom and a tibialis anterior (TA) muscle during dorsiflexion and plantarflexion with and without the electrode acutely placed under an ultrasound probe. Our results show no significant artifact in ultrasonography from both the phantom and TA fascicle strains due to the presence of the electrode, demonstrating the capability of spatiotemporally synchronized sEMG and ultrasonography recording.

Acquisition of Surface EMG Using Flexible and Low-Profile Electrodes for Lower Extremity Neuroprosthetic Control.

For persons with lower extremity (LE) amputation, acquisition of surface electromyography (sEMG) from within the prosthetic socket remains a significant challenge due to the dynamic loads experienced during the gait cycle. However, these signals are critical for both understanding the clinical effects of LE amputation and determining the desired control trajectories of active LE prostheses. Current solutions for collecting within-socket sEMG are generally (i) incompatible with a subject's prescribed prosthetic socket and liners, (ii) uncomfortable, and (iii) expensive. This study presents an alternative within-socket sEMG acquisition paradigm using a novel flexible and low-profile electrode. First, the practical performance of this Sub-Liner Interface for Prosthetics (SLIP) electrode is compared to that of commercial Ag/AgCl electrodes within a cohort of subjects without amputation. Then, the corresponding SLIP electrode sEMG acquisition paradigm is implemented in a single subject with unilateral transtibial amputation performing unconstrained movements and walking on level ground. Finally, a quantitative questionnaire characterizes subjective comfort for SLIP electrode and commercial Ag/AgCl electrode instrumentation setups. Quantitative analyses suggest comparable signal qualities between SLIP and Ag/AgCl electrodes while qualitative analyses suggest the feasibility of using the SLIP electrode for real-time sEMG data collection from load-bearing, ambulatory subjects with LE amputation.

The Agonist-Antagonist Myoneural Interface.

The agonist-antagonist myoneural interface is a novel surgical construct and neural interfacing approach designed to augment volitional control of adapted prostheses, preserve proprioception, and prevent limb atrophy in the setting of limb amputation.

Neural interfacing architecture enables enhanced motor control and residual limb functionality postamputation.

Despite advancements in prosthetic technologies, patients with amputation today suffer great diminution in mobility and quality of life. We have developed a modified below-knee amputation (BKA) procedure that incorporates agonist-antagonist myoneural interfaces (AMIs), which surgically preserve and couple agonist-antagonist muscle pairs for the subtalar and ankle joints. AMIs are designed to restore physiological neuromuscular dynamics, enable bidirectional neural signaling, and offer greater neuroprosthetic controllability compared to traditional amputation techniques. In this prospective, nonrandomized, unmasked study design, 15 subjects with AMI below-knee amputation (AB) were matched with 7 subjects who underwent a traditional below-knee amputation (TB). AB subjects demonstrated significantly greater control of their residual limb musculature, production of more differentiable efferent control signals, and greater precision of movement compared to TB subjects (P < 0.008). This may be due to the presence of greater proprioceptive inputs facilitated by the significantly higher fascicle strains resulting from coordinated muscle excursion in AB subjects (P < 0.05). AB subjects reported significantly greater phantom range of motion postamputation (AB: 12.47 ± 2.41, TB: 10.14 ± 1.45 degrees) when compared to TB subjects (P < 0.05). Furthermore, AB subjects also reported less pain (12.25 ± 5.37) than TB subjects (17.29 ± 10.22) and a significant reduction when compared to their preoperative baseline (P < 0.05). Compared with traditional amputation, the construction of AMIs during amputation confers the benefits of enhanced physiological neuromuscular dynamics, proprioception, and phantom limb perception. Subjects' activation of the AMIs produces more differentiable electromyography (EMG) for myoelectric prosthesis control and demonstrates more positive clinical outcomes.

Restoration of bilateral motor coordination from preserved agonist-antagonist coupling in amputation musculature.

BACKGROUND: Neuroprosthetic devices controlled by persons with standard limb amputation often lack the dexterity of the physiological limb due to limitations of both the user's ability to output accurate control signals and the control system's ability to formulate dynamic trajectories from those signals. To restore full limb functionality to persons with amputation, it is necessary to first deduce and quantify the motor performance of the missing limbs, then meet these performance requirements through direct, volitional control of neuroprosthetic devices. METHODS: We develop a neuromuscular modeling and optimization paradigm for the agonist-antagonist myoneural interface, a novel tissue architecture and neural interface for the control of myoelectric prostheses, that enables it to generate virtual joint trajectories coordinated with an intact biological joint at full physiologically-relevant movement bandwidth. In this investigation, a baseline of performance is first established in a population of non-amputee control subjects ([Formula: see text]). Then, a neuromuscular modeling and optimization technique is advanced that allows unilateral AMI amputation subjects ([Formula: see text]) and standard amputation subjects ([Formula: see text]) to generate virtual subtalar prosthetic joint kinematics using measured surface electromyography (sEMG) signals generated by musculature within the affected leg residuum. RESULTS: Using their optimized neuromuscular subtalar models under blindfolded conditions with only proprioceptive feedback, AMI amputation subjects demonstrate bilateral subtalar coordination accuracy not significantly different from that of the non-amputee control group (Kolmogorov-Smirnov test, [Formula: see text]) while standard amputation subjects demonstrate significantly poorer performance (Kolmogorov-Smirnov test, [Formula: see text]). CONCLUSIONS: These results suggest that the absence of an intact biological joint does not necessarily remove the ability to produce neurophysical signals with sufficient information to reconstruct physiological movements. Further, the seamless manner in which virtual and intact biological joints are shown to coordinate reinforces the theory that desired movement trajectories are mentally formulated in an abstract task space which does not depend on physical limb configurations.

An Ankle-Foot Prosthesis for Rock Climbing Augmentation.

This research presents the design and preliminary evaluation of an electromyographically (EMG) controlled 2-degree-of-freedom (DOF) ankle-foot prosthesis designed to enhance rock climbing ability in persons with transtibial amputation. The prosthesis comprises motorized ankle and subtalar joints, and is capable of emulating some key biomechanical behaviors exhibited by the ankle-foot complex during rock climbing maneuvers. The free space motion of the device is volitionally controlled via input from EMG surface electrodes embedded in a custom silicone liner worn on the residual limb. The device range of motion is 0.29 radians of each dorsiflexion and plantar flexion, and 0.39 radians each of inversion and eversion. Preliminary evaluation of the device was conducted, validating the system mass of 1292 grams, build height of 250 mm, joint velocity of 2.18 radians/second, settling time of 120 milliseconds, and steady state error of 0.008 radians. Clinical evaluation of the device was performed during a preliminary study with one subject with transtibial amputation. Joint angles of the ankle-foot, knee, and hip were measured during rock climbing with the robotic prosthesis and with a traditional passive prosthesis. We found that the robotic prosthesis increases the range of achieved ankle and subtalar positions compared to a standard passive prosthesis. In addition, maximum knee flexion and hip flexion angles are decreased while climbing with the robotic prosthesis. These results suggest that a lightweight, actuated, 2-DOF EMG-controlled robotic ankle-foot prosthesis can improve ankle and subtalar range of motion and climbing biomechanical function.

Reinventing Extremity Amputation in the Era of Functional Limb Restoration.

BACKGROUND: Recent progress in biomechatronics and vascularized composite allotransplantation have occurred in the absence of congruent advancements in the surgical approaches generally utilized for limb amputation. Consideration of these advances, as well as of both novel and time-honored reconstructive surgical techniques, argues for a fundamental reframing of the way in which amputation procedures should be performed. METHODS: We review sentinel developments in external prosthetic limb technology and limb transplantation, in addition to standard and emerging reconstructive surgical techniques relevant to limb modification, and then propose a new paradigm for limb amputation. RESULTS: An approach to limb amputation based on the availability of native tissues is proposed, with the intent of maximizing limb function, limiting neuropathic pain, restoring limb perception/proprioception and mitigating limb atrophy. CONCLUSIONS: We propose a reinvention of the manner in which limb amputations are performed, framed in the context of time-tested reconstructive techniques, as well as novel, state-of-the-art surgical procedures. Implementation of the proposed techniques in the acute setting has the potential to elevate advanced limb replacement strategies to a clinical solution that perhaps exceeds what is possible through traditional surgical approaches to limb salvage. We therefore argue that amputation, performed with the intent of optimizing the residuum for interaction with either a bionic or a transplanted limb, should be viewed not as a surgical failure, but as an alternative form of limb reconstruction.

Agonist-antagonist myoneural interface amputation preserves proprioceptive sensorimotor neurophysiology in lower limbs.

The brain undergoes marked changes in function and functional connectivity after limb amputation. The agonist-antagonist myoneural interface (AMI) amputation is a procedure that restores physiological agonist-antagonist muscle relationships responsible for proprioceptive sensory feedback to enable greater motor control. We compared results from the functional neuroimaging of individuals (n = 29) with AMI amputation, traditional amputation, and no amputation. Individuals with traditional amputation demonstrated a significant decrease in proprioceptive activity, measured by activation of Brodmann area 3a, whereas functional activation in individuals with AMIs was not significantly different from controls with no amputation (P < 0.05). The degree of proprioceptive activity in the brain strongly correlated with fascicle activity in the peripheral muscles and performance on motor tasks (P < 0.05), supporting the mechanistic basis of the AMI procedure. These results suggest that surgical techniques designed to restore proprioceptive peripheral neuromuscular constructs result in desirable central sensorimotor plasticity.

Flexible Dry Electrodes for EMG Acquisition within Lower Extremity Prosthetic Sockets.

Acquisition of surface electromyography (sEMG) from a person with an amputated lower extremity (LE) during prosthesis-assisted walking remains a significant challenge due to the dynamic nature of the gait cycle. Current solutions to sEMG-based neural control of active LE prostheses involve a combination of customized electrodes, prosthetic sockets, and liners. These technologies are generally: (i) incompatible with a subject's existing prosthetic socket and liners; (ii) uncomfortable to use; and (iii) expensive. This paper presents a flexible dry electrode design for sEMG acquisition within LE prosthetic sockets which seeks to address these issues. Design criteria and corresponding design decisions are explained and a proposed flexible electrode prototype is presented. Performances of the proposed electrode and commercial Ag/AgCl electrodes are compared in seated subjects without amputations. Quantitative analyses suggest comparable signal qualities for the proposed novel electrode and commercial electrodes. The proposed electrode is demonstrated in a subject with a unilateral transtibial amputation wearing her own liner, socket, and the portable sEMG processing platform in a preliminary standing and level ground walking study. Qualitative analyses suggest the feasibility of real-time sEMG data collection from load-bearing, ambulatory subjects.