Reliable in vitro method for the evaluation of the primary stability and load transfer of transfemoral prostheses for osseointegrated implantation.

Osseointegrated transfemoral prostheses experience aseptic complications with an incidence between 3% and 30%. The main aseptic risks are implant loosening, adverse bone remodeling, and post-operative periprosthetic fractures. Implant loosening can either be due to a lack of initial (primary) stability of the implant, which hinders bone ingrowth and therefore prevents secondary stability, or, in the long-term, to the progressive resorption of the periprosthetic bone. Post-operative periprosthetic fractures are most often caused by stress concentrations. A method to simultaneously evaluate the primary stability and the load transfer is currently missing. Furthermore, the measurement errors are seldom reported in the literature. In this study a method to reliably quantify the bone implant interaction of osseointegrated transfemoral prostheses in terms of primary stability and load transfer was developed, and its precision was quantified. Micromotions between the prosthesis and the host bone and the strains on the cortical bone were measured on five human cadaveric femurs with a typical commercial osseointegrated implant. To detect the primary stability of the implant and the load transfer, cyclic loads were applied, simulating the peak load during gait. Digital Image Correlation was used to measure displacements and bone strains simultaneously throughout the test. Permanent migrations and inducible micromotions were measured (three translations and three rotations), while, on the same specimen, the full-field strain distribution on the bone surface was measured. The repeatability tests showed that the devised method had an intra-specimen variability smaller than 6 µm for the translation, 0.02 degrees for the rotations, and smaller than 60 microstrain for the strain distribution. The inter-specimen variability was larger than the intra-specimen variability due to the natural differences between femurs. Altogether, the measurement uncertainties (intrinsic measurement errors, intra-specimen repeatability and inter-specimen variability) were smaller than critical levels of biomarkers for adverse remodelling and aseptic loosening, thus allowing to discriminate between stable and unstable implants, and to detect critical strain magnitudes in the host bone. In conclusion, this work showed that it is possible to measure the primary stability and the load transfer of an osseointegrated transfemoral prosthesis in a reliable way using a combination of mechanical testing and DIC.

Organ Neuroprosthetics: Connecting Transplanted and Artificial Organs with the Nervous System.

Implantable neural interfaces with the central and peripheral nervous systems are currently used to restore sensory, motor, and cognitive functions in disabled people with very promising results. They have also been used to modulate autonomic activities to treat diseases such as diabetes or hypertension. Here, this study proposes to extend the use of these technologies to (re-)establish the connection between new (transplanted or artificial) organs and the nervous system in order to increase the long-term efficacy and the effective biointegration of these solutions. In this perspective paper, some clinically relevant applications of this approach are briefly described. Then, the choices that neural engineers must implement about the type, implantation location, and closed-loop control algorithms to successfully realize this approach are highlighted. It is believed that these new "organ neuroprostheses" are going to become more and more valuable and very effective solutions in the years to come.

A Sensory Feedback Neural Stimulator Prototype for Both Implantable and Wearable Applications.

The restoration of sensory feedback is one of the current challenges in the field of prosthetics. This work, following the analysis of the various types of sensory feedback, aims to present a prototype device that could be used both for implantable applications to perform PNS and for wearable applications, performing TENS, to restore sensory feedback. The two systems are composed of three electronic boards that are presented in detail, as well as the bench tests carried out. To the authors' best knowledge, this work presents the first device that can be used in a dual scenario for restoring sensory feedback. Both the implantable and wearable versions respected the expected values regarding the stimulation parameters. In its implantable version, the proposed system allows simultaneous and independent stimulation of 30 channels. Furthermore, the capacity of the wearable version to elicit somatic sensations was evaluated on healthy participants demonstrating performance comparable with commercial solutions.

Improving Walking Energy Efficiency in Transtibial Amputees Through the Integration of a Low-Power Actuator in an ESAR Foot.

Reducing energy consumption during walking is a critical goal for transtibial amputees. The study presents the evaluation of a semi-active prosthesis with five transtibial amputees. The prosthesis has a low-power actuator integrated in parallel into an energy-storing-and-releasing foot. The actuator is controlled to compress the foot during the stance phase, supplementing the natural compression due to the user's dynamic interaction with the ground, particularly during the ankle dorsiflexion phase, and to release the energy stored in the foot during the push-off phase, to enhance propulsion. The control strategy is adaptive to the user's gait patterns and speed. The clinical protocol to evaluate the system included treadmill and overground walking tasks. The results showed that walking with the semi-active prosthesis reduced the Physiological Cost Index of transtibial amputees by up to 16% compared to walking using the subjects' proprietary prosthesis. No significant alterations were observed in the spatiotemporal gait parameters of the participants, indicating the module's compatibility with users' natural walking patterns. These findings highlight the potential of the mechatronic actuator in effectively reducing energy expenditure during walking for transtibial amputees. The proposed prosthesis may bring a positive impact on the quality of life, mobility, and functional performance of individuals with transtibial amputation.

A sensory-motor hand prosthesis with integrated thermal feedback.

BACKGROUND: Recently, we reported the presence of phantom thermal sensations in amputees: thermal stimulation of specific spots on the residual arm elicited thermal sensations in their missing hands. Here, we exploit phantom thermal sensations via a standalone system integrated into a robotic prosthetic hand to provide real-time and natural temperature feedback. METHODS: The subject (a male adult with unilateral transradial amputation) used the sensorized prosthesis to manipulate objects and distinguish their thermal properties. We tested his ability to discriminate between (1) hot, cold, and ambient temperature objects, (2) different materials (copper, glass, and plastic), and (3) artificial versus human hands. We also introduced the thermal box and block test (thermal BBT), a test to evaluate real-time temperature discrimination during standardized pick-and-place tasks. FINDINGS: The subject performed all three discrimination tasks above chance level with similar accuracies as with his intact hand. Additionally, in all 15 sessions of the thermal BBT, he correctly placed more than half of the samples. Finally, the phantom thermal sensation was stable during the 13 recording sessions spread over 400 days. CONCLUSION: Our study paves the way for more natural hand prostheses that restore the full palette of sensations. FUNDING: This work was funded by the Bertarelli Foundation (including the Catalyst program); the Swiss National Science Foundation through the National Centre of Competence in Research (NCCR) Robotics; the European Union's Horizon 2020 research and innovation program; the Horizon Europe Research & Innovation Program; the Ministry of University and Research (MUR), National Recovery and Resilience Plan (NRRP); and the Tuscany Health Ecosystem.

Quantitative analysis of interface pressures in transfemoral prosthetic sockets.

BACKGROUND: Among the different factors affecting socket comfort, the pressure applied on residual limb tissues is a crucial parameter for the success or failure of any prosthetic device. However, only a few incomplete data are available on people with transfemoral amputation, in this regard. This work aims at filling this gap in the literature. METHODS: Ten people with transfemoral amputation wearing 3 different socket designs were recruited in this study: 2 ischial containment sockets featured by proximal trim lines that contain the ischial tuberosity and ramus and greater trochanter, 2 subischial sockets with proximal trim lines under the ischium level, and 6 quadrilateral sockets with proximal trim lines that contain the greater trochanter and create a horizontal seat for the ischial tuberosity. The pressure values at the anterior, lateral, posterior, and medial areas of the socket interface were recorded during 5 locomotion tasks (ie, horizontal, ascent, and descent walking, upstairs and downstairs) by using an F-Socket System (Tekscan Inc., Boston, MA). Gait segmentation was performed by exploiting plantar pressure, which was acquired by an additional sensor under the foot. Mean and standard deviation of minimum and maximum values were calculated for each interface area, locomotion task, and socket design. The mean pressure patterns during different locomotion tasks were reported, as well. RESULTS: Considering all subjects irrespective of socket design, the mean pressure range resulted 45.3 (posterior)-106.7 (posterior) kPa in horizontal walking; 48.3 (posterior)-113.8 (posterior) kPa in ascent walking; 50.8 (posterior)-105.7 (posterior) kPa in descent walking; 47.9 (posterior)-102.9 (lateral) kPa during upstairs; and 41.8 (posterior)-84.5 (anterior) kPa during downstairs. Qualitative differences in socket designs have been found. CONCLUSIONS: These data allow for a comprehensive analysis of pressures acting at the tissue-socket interface in people with transfemoral amputation, thus offering essential information for the design of novel solutions or to improve existing ones, in this field.

Patient-matched osseointegrated prostheses for thumb amputees: a cadaver and feasibility study.

Thumb amputations affect 50% of hand functionality. Common solutions consist of microsurgical treatments or silicone vacuum prosthesis. Not all patients are eligible for microsurgical treatment and the use of vacuum prosthesis is often discouraged because of their instability. On the contrary, osseointegrated prosthesis provide stable retention and osseoperception. This cadaveric study evaluated the process of a patient-matched osseointegrated prosthesis for the treatment of thumb amputees. Computed tomography (CT) medical images reconstruction provided information on metacarpal stump, used as input for the parametric screw design. Preoperative planning guided the surgeons in the surgery: postoperative placement confirmed the accuracy of the preoperative planning. Surgeons were directly involved in the implant design to meet their requirements and patient needs. Implants were inserted into cadaveric specimens in one-stage surgery. A similar process can be adopted and exploited for the treatment of different levels of thumb amputations and long finger amputations.

Exploring the EMG transient: the muscular activation sequences used as novel time-domain features for hand gestures classification.

Introduction: Muscular activation sequences have been shown to be suitable time-domain features for classification of motion gestures. However, their clinical application in myoelectric prosthesis control was never investigated so far. The aim of the paper is to evaluate the robustness of these features extracted from the EMG signal in transient state, on the forearm, for classifying common hand tasks. Methods: The signal associated to four hand gestures and the rest condition were acquired from ten healthy people and two persons with trans-radial amputation. A feature extraction algorithm allowed for encoding the EMG signals into muscular activation sequences, which were used to train four commonly used classifiers, namely Linear Discriminant Analysis (LDA), Support Vector Machine (SVM), Non-linear Logistic Regression (NLR) and Artificial Neural Network (ANN). The offline performances were assessed with the entire sample of recruited people. The online performances were assessed with the amputee subjects. Moreover, a comparison of the proposed method with approaches based on the signal envelope in the transient state and in the steady state was conducted. Results: The highest performance were obtained with the NLR classifier. Using the sequences, the offline classification accuracy was higher than 93% for healthy and amputee subjects and always higher than the approach with the signal envelope in transient state. As regards the comparison with the steady state, the performances obtained with the proposed method are slightly lower (<4%), but the classification occurred at least 200 ms earlier. In the online application, the motion completion rate reached up to 85% of the total classification attempts, with a motion selection time that never exceeded 218 ms. Discussion: Muscular activation sequences are suitable alternatives to the time-domain features commonly used in classification problems belonging to the sole EMG transient state and could be potentially exploited in control strategies of myoelectric prosthesis hands.

Continuous Phase Estimation in a Variety of Locomotion Modes Using Adaptive Dynamic Movement Primitives.

Accurate gait phase estimation algorithms can be used to synchronize the action of wearable robots to the volitional user movements in real time. Current-day gait phase estimation methods are designed mostly for rhythmic tasks and evaluated in highly controlled walking environments (namely, steady-state walking). Here, we implemented adaptive Dynamic Movement Primitives (aDMP) for continuous real-time phase estimation in the most common locomotion activities of daily living, which are level-ground walking, stair negotiation, and ramp negotiation. The proposed method uses the thigh roll angle and foot-contact information and was tested in real time with five subjects. The estimated phase resulted in an average root-mean-square error of 3.98% ± 1.33% and a final estimation error of 0.60% ± 0.55% with respect to the linear phase. The results of this study constitute a viable groundwork for future phase-based control strategies for lower-limb wearable robots, such as robotic prostheses or exoskeletons.

Decoding Upper-Limb Movement Intention Through Adaptive Dynamic Movement Primitives: A Proof-of-Concept Study with a Shoulder-Elbow Exoskeleton.

This work presents an intention decoding algorithm that can be used to control a 4 degrees-of-freedom shoulder-elbow exoskeleton in reaching tasks. The algorithm was designed to assist the movement of users with upper-limb impairments who can initiate the movement by themselves. It relies on the observation of the initial part of the user's movement through joint angle measures and aims to estimate in real-time the phase of the movement and predict the goal position of the hand in the reaching task. The algorithm is based on adaptive Dynamic Movement Primitives and Gaussian Mixture Models. The performance of the algorithm was verified in robot-assisted planar reaching movements performed by one healthy subject wearing the exoskeleton. Tests included movements of different amplitudes and orientations. Results showed that the algorithm could predict the hand's final position with an error lower than 5 cm after 0.25 s from the movement onset, and that the final position reached during the tests was on average less than 4 cm far from the target position. Finally, the effects of the assistance were observed in a reduction of the activation of the Biceps Brachii and of the time to execute the reaching tasks.

Optimization of Piezoresistive Response of Elastomeric Porous Structures Based on Carbon-Based Hybrid Fillers Created by Selective Laser Sintering.

Recently, piezoresistive sensors made by 3D printing have gained considerable interest in the field of wearable electronics due to their ultralight nature, high compressibility, robustness, and excellent electromechanical properties. In this work, building on previous results on the Selective Laser Sintering (SLS) of porous systems based on thermoplastic polyurethane (TPU) and graphene (GE)/carbon nanotubes (MWCNT) as carbon conductive fillers, the effect of variables such as thickness, diameter, and porosity of 3D printed disks is thoroughly studied with the aim of optimizing their piezoresistive performance. The resulting system is a disk with a diameter of 13 mm and a thickness of 0.3 mm endowed with optimal reproducibility, sensitivity, and linearity of the electrical signal. Dynamic compressive strength tests conducted on the proposed 3D printed sensors reveal a linear piezoresistive response in the range of 0.1-2 N compressive load. In addition, the optimized system is characterized at a high load frequency (2 Hz), and the stability and sensitivity of the electrical signal are evaluated. Finally, an application test demonstrates the ability of this system to be used as a real-time wearable pressure sensor for applications in prosthetics, consumer products, and personalized health-monitoring systems.

Bactericidal Activity of Silver-Doped Chitosan Coatings via Electrophoretic Deposition on Ti6Al4V Additively Manufactured Substrates.

Prosthetic reconstruction can serve as a feasible alternative, delivering both functional and aesthetic benefits to individuals with hand and finger injuries, frequent causes of emergency room visits. Implant-related infections pose significant challenges in arthroplasty and osteosynthesis procedures, contributing to surgical failures. As a potential solution to this challenge, this study developed a new class of silver (Ag)-doped chitosan (CS) coatings via electrophoretic deposition (EPD) on osseointegrated prostheses for infection therapy. These coatings were successfully applied to additively manufactured Ti6Al4V ELI samples. In the initial phase, the feasibility of the composite coating was assessed using the Thermogravimetric Analysis (TGA) and Attenuated Total Reflection (ATR) techniques. The optimized structures exhibited impressive water uptake in the range of 300-360%. Codeposition with an antibacterial agent proved effective, and scanning electron microscopy (SEM) was used to examine the coating morphology. Biologically, CS coatings demonstrated cytocompatibility when in direct contact with a fibroblast cell line (L929) after 72 h. When exposed to the Staphylococcus epidermidis strain (ATCC 12228), these coatings inhibited bacterial growth and biofilm formation within 24 h. These findings underscore the significant potential of this approach for various applications, including endoprostheses like hip implants, internal medical devices, and transcutaneous prostheses such as osseointegrated limb prosthetics for upper and lower extremities.

A Locomotion Mode Recognition Algorithm Using Adaptive Dynamic Movement Primitives.

Control systems of robotic prostheses should be designed to decode the users' intent to start, stop, or change locomotion; and to select the suitable control strategy, accordingly. This paper describes a locomotion mode recognition algorithm based on adaptive Dynamic Movement Primitive models used as locomotion templates. The models take foot-ground contact information and thigh roll angle, measured by an inertial measurement unit, for generating continuous model variables to extract features for a set of Support Vector Machines. The proposed algorithm was tested offline on data acquired from 10 intact subjects and 1 subject with transtibial amputation, in ground-level walking and stair ascending/descending activities. Following subject-specific training, results on intact subjects showed that the algorithm can classify initiatory and steady-state steps with up to 100.00% median accuracy medially at 28.45% and 27.40% of the swing phase, respectively. While the transitory steps were classified with up to 87.30% median accuracy medially at 90.54% of the swing phase. Results with data of the transtibial amputee showed that the algorithm classified initiatory, steady-state, and transitory steps with up to 92.59%, 100%, and 93.10% median accuracies medially at 19.48%, 51.47%, and 93.33% of the swing phase, respectively. The results support the feasibility of this approach in robotic prosthesis control.

A biomechanical study of osseointegrated patient-matched additively manufactured implant for treatment of thumb amputees.

Thumb amputations leads to 50 % loss in hand functionality. To date, silicone vacuum prosthesis and autologous transplantation are the most adopted treatment solutions: nevertheless, vacuum prostheses lack in stability and cause skin issue and surgical treatment is not always accepted by patients. Osseointegrated implants were demonstrated to enhance stability, restore osseoperception and increase the time of prosthesis use. Thumb amputations present varying stump sizes: a standard size implant cannot address specificity of each patient, while a patient matched solution can meet surgeon requirements, by geometrical features of implant. The fixture presented in the current paper is the first additively manufactured patient matched osseointegrated implant for the treatment of thumb amputees. The current work aims to verify and validate a predictive finite element model (FEM) for mechanical strength of the presented fixture. FEM was demonstrated to correctly evaluate the mechanical strength of patient matched device. Minimum strength requirements were calculated in different core diameters: FEM were experimentally validated. Safety factor of 1.5 was guaranteed. Finally, considerations on performance of the prototype were carried out by means of insertion tests in Sawbones and axial pull-out force assessment. Cadaver tests to evaluate the entire procedure and production process are ongoing.

A Workflow for Studying the Stump-Socket Interface in Persons with Transtibial Amputation through 3D Thermographic Mapping.

The design and fitting of prosthetic sockets can significantly affect the acceptance of an artificial limb by persons with lower limb amputations. Clinical fitting is typically an iterative process, which requires patients' feedback and professional assessment. When feedback is unreliable due to the patient's physical or psychological conditions, quantitative measures can support decision-making. Specifically, monitoring the skin temperature of the residual limb can provide valuable information regarding unwanted mechanical stresses and reduced vascularization, which can lead to inflammation, skin sores and ulcerations. Multiple 2D images to examine a real-life 3D limb can be cumbersome and might only offer a partial assessment of critical areas. To overcome these issues, we developed a workflow for integrating thermographic information on the 3D scan of a residual limb, with intrinsic reconstruction quality measures. Specifically, workflow allows us to calculate a 3D thermal map of the skin of the stump at rest and after walking, and summarize this information with a single 3D differential map. The workflow was tested on a person with transtibial amputation, with a reconstruction accuracy lower than 3 mm, which is adequate for socket adaptation. We expect the workflow to improve socket acceptance and patients' quality of life.

A magnetic endourethral sphincter against stress urinary incontinence: preliminary pilot study in humans.

BACKGROUND: Urinary incontinence (UI) is a common and frustrating condition that affects patients' quality of life as well as the Healthcare systems. Currently, the most severe cases of UI are treated using implanted, invasive artificial sphincters. We propose an innovative, minimally invasive magnetic endourethral sphincter for the treatment of stress UI (SUI) in patients for whom previous medical and surgical treatments have failed. METHODS: Six patients with severe SUI were enrolled at a single center and underwent cystoscopic sphincter implantation. After 10 days, correct device position was confirmed by ultrasonography. The sphincter was explanted after 28 days. RESULTS: In all patients, the sphincter was successfully implanted using an endoscopic approach. One patient reached the end of the pilot test (28 days) with the sphincter correctly placed. Patients' responses on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire improved from a score of 18 out of 21 at the screening visit (UI without reasons) to a score of 3 out of 21 (almost perfect continence). No major pain and discomfort were reported. CONCLUSIONS: This study showed the feasibility of sphincter implantation, explantation, and overall tolerability, although a redesign of the sphincter distal part is needed.

Restoration of natural thermal sensation in upper-limb amputees.

The use of hands for gathering rich sensory information is essential for proper interaction with the environment; therefore, the restoration of sensation is critical for reestablishing the sense of embodiment in hand amputees. Here, we show that a noninvasive wearable device can be used to provide thermal sensations on amputees' phantom hands. The device delivers thermal stimuli to specific regions of skin on their residual limb. These sensations were phenomenologically similar to those on the intact limbs and were stable over time. Using the device, the subjects could successfully exploit the thermal phantom hand maps to detect and discriminate different thermal stimuli. The use of a wearable device that provides thermal sensation can increase the sense of embodiment and improve life quality in hand amputees.

Uneven Terrain Recognition Using Neuromorphic Haptic Feedback.

Recent years have witnessed relevant advancements in the quality of life of persons with lower limb amputations thanks to the technological developments in prosthetics. However, prostheses that provide information about the foot-ground interaction, and in particular about terrain irregularities, are still missing on the market. The lack of tactile feedback from the foot sole might lead subjects to step on uneven terrains, causing an increase in the risk of falling. To address this issue, a biomimetic vibrotactile feedback system that conveys information about gait and terrain features sensed by a dedicated insole has been assessed with intact subjects. After having shortly experienced both even and uneven terrains, the recruited subjects discriminated them with an accuracy of 87.5%, solely relying on the replay of the vibrotactile feedback. With the objective of exploring the human decoding mechanism of the feedback startegy, a KNN classifier was trained to recognize the uneven terrains. The outcome suggested that the subjects achieved such performance with a temporal dynamics of 45 ms. This work is a leap forward to assist lower-limb amputees to appreciate the floor conditions while walking, adapt their gait and promote a more confident use of their artificial limb.

Longitudinal Gait Analysis of a Transfemoral Amputee Patient: Single-Case Report from Socket-Type to Osseointegrated Prosthesis.

The aim of the present case report was to provide a longitudinal functional assessment of a patient with transfemoral amputation from the preoperative status with socket-type prosthesis to one year after the osseointegration surgery. A 44 years-old male patient was scheduled for osseointegration surgery 17 years after transfemoral amputation. Gait analysis was performed through 15 wearable inertial sensors (MTw Awinda, Xsens) before surgery (patient wearing his standard socket-type prosthesis) and at 3-, 6-, and 12-month follow-ups after osseointegration. ANOVA in Statistical Parametric Mapping was used to assess the changes in amputee and sound limb hip and pelvis kinematics. The gait symmetry index progressively improved from the pre-op with socket-type (1.14) to the last follow-up (1.04). Step width after osseointegration surgery was half of the pre-op. Hip flexion-extension range significantly improved at follow-ups while frontal and transverse plane rotations decreased (p < 0.001). Pelvis anteversion, obliquity, and rotation also decreased over time (p < 0.001). Spatiotemporal and gait kinematics improved after osseointegration surgery. One year after surgery, symmetry indices were close to non-pathological gait and gait compensation was sensibly decreased. From a functional point of view, osseointegration surgery could be a valid solution in patients with transfemoral amputation facing issues with traditional socket-type prosthesis.

Hierarchical strategy for sEMG classification of the hand/wrist gestures and forces of transradial amputees.

Introduction: The myoelectric control strategy, based on surface electromyographic signals, has long been used for controlling a prosthetic system with multiple degrees of freedom. Several methods classify gestures and force levels but the simultaneous real-time control of hand/wrist gestures and force levels did not yet reach a satisfactory level of effectiveness. Methods: In this work, the hierarchical classification approach, already validated on 31 healthy subjects, was adapted for the real-time control of a multi-DoFs prosthetic system on 15 trans-radial amputees. The effectiveness of the hierarchical classification approach was assessed by evaluating both offline and real-time performance using three algorithms: Logistic Regression (LR), Non-linear Logistic Regression (NLR), and Linear Discriminant Analysis (LDA). Results: The results of this study showed the offline performance of amputees was promising and comparable to healthy subjects, with mean F1 scores of over 90% for the "Hand/wrist gestures classifier" and 95% for the force classifiers, implemented with the three algorithms with features extraction (FE). Another significant finding of this study was the feasibility of using the hierarchical classification strategy for real-time applications, due to its ability to provide a response time of 100 ms while maintaining an average online accuracy of above 90%. Discussion: A possible solution for real-time control of both hand/wrist gestures and force levels is the combined use of the LR algorithm with FE for the "Hand/wrist gestures classifier", and the NLR with FE for the Spherical and Tip force classifiers.