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.

Hydraulic Detrusor for Artificial Bladder Active Voiding.

The gold standard treatment for bladder cancer is radical cystectomy that implies bladder removal coupled to urinary diversions. Despite the serious complications and the impossibility of controlled active voiding, bladder substitution with artificial systems is a challenge and cannot represent a real option, yet. In this article, we present hydraulic artificial detrusor prototypes to control and drive the voiding of an artificial bladder (AB). These prototypes rely on two actuator designs (origami and bellows) based either on negative or positive operating pressure, to be combined with an AB structure. Based on the bladder geometry and size, we optimized the actuators in terms of contraction/expansion performances, minimizing the liquid volume required for actuation and exploring different actuator arrangements to maximize the voiding efficiency. To operate the actuators, an ad hoc electrohydraulic circuit was developed for transferring liquid between the actuators and a reservoir, both of them intended to be implanted. The AB, actuators, and reservoir were fabricated with biocompatible flexible thermoplastic materials by a heat-sealing process. We assessed the voiding efficiency with benchtop experiments by varying the actuator type and arrangement at different simulated patient positions (horizontal, 45° tilted, and vertical) to identify the optimal configuration and actuation strategy. The most efficient solution relies on two bellows actuators anchored to the AB. This artificial detrusor design resulted in a voiding efficiency of about 99%, 99%, and 89%, in the vertical, 45° tilted, and horizontal positions, respectively. The relative voiding time was reduced by about 17, 24, and 55 s compared with the unactuated bladder.

A Layer Jamming Actuator for Tunable Stiffness and Shape-Changing Devices.

Changing the shape and the stiffness of a device in a dynamic and controlled way enables important advancements in the field of robotics and wearable robotics. Variable stiffness materials and technologies can be used to address this challenge. In particular, layer jamming actuation is a very promising technology, featured by high efficiency and low cost. In this article, a stiffness- and shape-changing device based on a novel mechanism including a multiple-chamber structure is proposed. It allows to effectively modulate the shape and stiffness of a device, by activating two jamming chambers while pressurizing/depressurizing one or more interposed inflatable chambers. Prototypes with a size of 45 × 270 mm2 and an average thickness ranging from 4.4 to 13 mm were developed and their ability to undergo a stiffness change over two orders of magnitude was demonstrated. The prototypes were also able to change their shape according to the position and inflation level of the interposed inflatable chambers, thus resulting in an overall deflection >10 mm. The possibility to wear the system as an orthotic brace was also demonstrated: this technology increased the patient comfort in static positions, yet keeping a supportive function when needed (e.g., in dynamic conditions). The device working principle highlighted in this article could also be exploited in other domains, for example, to build walking soft robots, prostheses, or grippers, as demonstrated through additional tests.

Residual limb volume fluctuations in transfemoral amputees.

This study constitutes the first attempt to systematically quantify residual limb volume fluctuations in transfemoral amputees. The study was carried out on 24 amputees to investigate variations due to prosthesis doffing, physical activity, and testing time. A proper experimental set-up was designed, including a 3D optical scanner to improve precision and acceptability by amputees. The first test session aimed at measuring residual limb volume at 7 time-points, with 10 min intervals, after prosthesis doffing. This allowed for evaluating the time required for volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16 residual limb scans in a day for each amputee were captured to evaluate volume fluctuations due to prosthesis removal and physical activity, in two times per day (morning and afternoon). These measurements were repeated in three different days, a week apart from each other, for a total of 48 scans for each amputee. Volume fluctuations over time after prosthesis doffing showed a two-term decay exponential trend (R2 = 0.97), with the highest variation in the initial 10 min and an average stabilization time of 30 min. A statistically significant increase in residual limb volume following both prosthesis removal and physical activity was verified. No differences were observed between measures collected in the morning and in the afternoon.Clinical Trials.gov ID: NCT04709367.

Sockets for Limb Prostheses: A Review of Existing Technologies and Open Challenges.

In the prosthetics field, one of the most important bottlenecks is still the human-machine interface, namely the socket. Indeed, a large number of amputees still rejects prostheses or points out a low satisfaction level, due to a sub-optimal interaction between the socket and the residual limb tissues. The aim of this paper is to describe the main parameters (displacements, stress, volume fluctuations and temperature) affecting the stump-socket interface and reducing the comfort/stability of limb prostheses. In this review, a classification of the different socket types proposed in the literature is reported, together with an analysis of advantages and disadvantages of the different solutions, from multiple viewpoints. The paper then describes the technological solutions available to face an altered distribution of stresses on the residual limb tissues, volume fluctuations affecting the stump overtime and temperature variations affecting the residual tissues within the socket. The open challenges in this research field are highlighted and the possible future routes are discussed, towards the ambitious objective of achieving an advanced socket able to self-adapt in real-time to the complex interplay of factors affecting the stump, during both static and dynamic tasks.