Assessment of 3D printed mechanical metamaterials for prosthetic liners.

This study focuses on novel design and evaluation of Elastic 50A (EL50) mechanical metamaterials with open-cell patterns for its potential application to lower limb residuum/socket interfaces, specifically that of a transtibial (TT) amputee. Mechanical characteristics, that is, effective Young's modulus (E), was tuned by altering metamaterial porosity, which was experimentally verified. Specifically, pore radius of the unit cell was varied to achieve a range of E-values (0.05-1.71 MPa) for these 3D printed metamaterials. Finite Element Analysis (FEA) was conducted to evaluate pressure distribution across key load-bearing anatomical sites of a TT residuum. Using designed metamaterials for homogeneous liners, pressure profiles were studied and compared with a silicone liner case. Additionally, a custom metamaterial liner was designed by assigning appropriate metamaterials to four load-sensitive and tolerant anatomical sites of the TT residuum. The results suggest that lowest pressure variation (PV), as a measure of pressure distribution levels and potential comfort for amputees, was achieved by the custom metamaterial liner compared to any of the homogeneous liners included in this study. It is envisaged that this work may aid future design and development of custom liners using now commonly available 3D printing technologies and available elastomer materials to maximise comfort, tissue safety and overall rehabilitation outcomes for lower limb amputees.

Antibacterial evaluation of different prosthetic liner textiles coated by CuO nanoparticles.

Prosthetic liners are mainly used as an interface between residual limbs and prosthetic sockets to minimize physical and biological damage to soft tissue. However, the closed and moist conditions within liners and the amputee's skin provide a suitable environment for bacterial growth to cause infections. This study aimed to coat a comprehensive variant material with copper oxide nanoparticles (CuO NPs) and compare their surface analysis and antibacterial properties. These materials were covered with CuO NPs solution at a concentration of 70 µg mL-1 to achieve this purpose. After drying, their surface characteristics were analyzed by measuring zeta potential, contact angle, surface roughness, and fiber arrangement. Cu-released concentration from the coatings into the acetate buffer solution by inductively coupled plasma mass spectrometry indicated that lycra and nylon quickly released Cu ions to concentrations up to ∼0.2 µg mL-1 after 24 h, causing low metabolic activity of human bone-marrow mesenchymal stem cells (bMSC) in the indirect assay. Antibacterial activity of the coated specimens was evaluated by infecting their surfaces with the Gram-positive bacteria Staphylococcus epidermidis, reporting a significant ∼40 % reduction of metabolic activity for x-dry after 24 h; in addition, the number of viable bacterial colonies adhered to the surface of this material was reduced by ∼23 times in comparison with non-treated x-dry that were visually confirmed by scanning electron microscope. In conclusion, CuO NPs x-dry shows optimistic results to pursue further experiments due to its slow speed of Cu release and prolonged antibacterial activity, as well as its compatibility with human cells.

Assessing Phase-Change Materials as Effective Long-Term Biosensors in Limb Prosthetics.

Monitoring and controlling the microclimate at the skin-socket interface of limb prostheses is an important, yet unresolved, clinical problem. Phase-change materials (PCMs) represent a promising biosensor technology that holds the potential to both detect and alter (i.e., stabilize) changes in the temperature of a hybrid biological/mechanical system, such as a prosthesis. The biologically inspired sensor capabilities of PCMs can enhance the internal socket conditions and offer improved comfort and suspension while minimizing skin injuries for prosthesis users. This study investigated how prosthetic liners equipped with PCM biosensors affected the long-term outcomes for prosthesis users. In this double-blinded longitudinal crossover study, a cohort of transtibial prosthesis users wore regular conventional liners for six months and PCM liners for another six months. Prosthesis utilization, physical performance, and gait symmetry were studied using Modus StepWatch, the 2-minute walk test, and the TekScan F-Scan gait test, respectively. Measured parameters from these various tests, acquired at multiple timepoints during the study, were compared pairwise between the two liners per individual. While the obtained quantitative data trends, such as the gait symmetry, favored the PCM liners, no statistically significant differences were found between the PCM and conventional gel liners in any of the study parameters.

Evaluating Feasibility and Durability of the Aero Prosthetic Liner in Transtibial Prosthetic Users.

BACKGROUND: The choice of prosthetic socket interface material significantly affects user comfort and satisfaction. The Affordable Ethylene-Vinyl Acetate Roll-On (AERO) liner was created with the aim of improving functionality and streamlining the wearing process for users. OBJECTIVE: The purpose of this study was to comprehensively assess user satisfaction, comfort, and durability of the AERO liner and compare it with the common soft Pe-Lite liner. METHODOLOGY: Fourteen individuals with transtibial amputation participated in this three-month randomized crossover trial study. The Prosthesis Evaluation Questionnaire (PEQ), Expanded Socket Comfort Score (ESCS), and liner thickness measurements were used to comprehensively compare the AERO and Pe-Lite liner. FINDINGS: The AERO liner demonstrated notable improvements in prosthetic comfort and functionality over Pe-Lite liner. After three months use, there was a significant reduction in reported frustration with the AERO liner (p=0.023, r=0.604) in the PEQ subscale. Specific aspects, such as walking with the prosthesis (p=0.030, r=0.601) and odor perception (p=0.024, d=0.579), favored the use of the AERO liner. The expanded socket comfort score (ESCS) revealed significant superiority for the AERO liner "at best" (p=0.04) and "on average" (p=0.02) after one and three months, respectively. Liner thickness analysis showed significant reductions at the mid-patellar tendon location for the AERO liner at one (0.57±0.48) and three months (0.90±0.69, p=0.01) and in the posterior region after three months (0.63±0.64, p=0.05). CONCLUSION: Our study highlights the potential advantages of the AERO liner in enhancing comfort and satisfaction. Yet, durability and thinning of the liner when compared to Pe-Lite may be a concern which may eventually affect socket fit. These findings contribute to ongoing efforts to optimize prosthetic interventions and improve the quality of life of individuals with lower limb prosthesis in resource-limited environments.

Compression and tension behavior of the prosthetic foam materials polyurethane, EVA, Pelite™ and a combination of polyurethane and EVA: a preliminary study.

Materials with low-strength and low-impedance properties, such as elastomers and polymeric foams are major contributors to prosthetic liner design. Polyethylene-Light (Pelite™) is a foam liner that is the most frequently used in prosthetics but it does not cater to all amputees' limb and skin conditions. The study aims to investigate the newly modified Foam Liner, a combination of two different types of foams (EVA + PU + EVA) as the newly modified Foam Liner in terms of compressive and tensile properties in comparison to Pelite™, polyurethane (PU) foam, and ethylene-vinyl acetate (EVA) foam. Universal testing machine (AGS-X, Shimadzu, Kyoto, Japan) has been used to measure the tensile and compressive stress. Pelite™ had the highest compressive stress at 566.63 kPa and tensile stress at 1145 kPa. Foam Liner fell between EVA and Pelite™ with 551.83 kPa at compression and 715.40 kPa at tension. PU foam had the lowest compressive stress at 2.80 kPa and tensile stress at 33.93 kPa. Foam Liner has intermediate compressive elasticity but has high tensile elasticity compared to EVA and Pelite™. Pelite™ remains the highest in compressive and tensile stiffness. Although it is good for amputees with bony prominence, constant pressure might result in skin breakdown or ulcer. Foam Liner would be the best for amputees with soft tissues on the residual limbs to accommodate movement.

Additive manufacturing techniques for smart prosthetic liners.

Elastomeric liners are commonly worn between the prosthetic socket and the limb. A number of improvements to the state of the art of liner technology are required to address outstanding problems. A liner that conforms to the residuum more accurately, may improve the skin health at the stump-socket interface. Previous work has shown that for effective thermal management of the socket environment, an active heat removal system is required, yet this is not available. Volume tracking of the stump could be used as a diagnostic tool for looking at the changes that occur across the day for all users, which depend on activity level, position, and the interaction forces of the prosthetic socket with the limb. We believe that it would be advantageous to embed these devices into a smart liner, which could be replaced and repaired more easily than the highly costly and labour-intensive custom-made socket. This paper presents the work to develop these capabilities in soft material technology, with: the development of a printable nanocomposite stretch sensor system; a low-cost digital method for casting bespoke prosthetic liners; a liner with an embedded stretch sensor for growth / volume tracking; a model liner with an embedded active cooling system.

A personalised prosthetic liner with embedded sensor technology: a case study.

BACKGROUND: Numerous sensing techniques have been investigated in an effort to monitor the main parameters influencing the residual limb/prosthesis interface, fundamental to the optimum design of prosthetic socket solutions. Sensing integration within sockets is notoriously complex and can cause user discomfort. A personalised prosthetic liner with embedded sensors could offer a solution. However, to allow for a functional and comfortable instrumented liner, highly customised designs are needed. The aim of this paper is to presents a novel approach to manufacture fully personalised liners using scanned three-dimensional image data of the patient's residual limb, combined with designs that allow for sensor integration. To demonstrate the feasibility of the proposed approach, a personalised liner with embedded temperature and humidity sensors was realised and tested on a transtibial amputee, presented here as a case study. METHODS: The residual limb of a below knee amputee was first scanned and a three-dimensional digital image created. The output was used to produce a personalised prosthesis. The liner was manufactured using a cryogenic Computer Numeric Control (CNC) machining approach. This method enables fast, direct and precise manufacture of soft elastomer products. Twelve Hygrochron Data Loggers, able to measure both temperature and humidity, were embedded in specific liner locations, ensuring direct sensor-skin contact. The sensor locations were machined directly into the liner, during the manufacturing process. The sensors outputs were assessed on the below amputee who took part in the study, during resting (50 min) and walking activities (30 min). To better describe the relative thermal properties of new liner, the same tests were repeated with the amputee wearing his existing liner. Quantitative comparisons of the thermal properties of the new liner solution with that currently used in clinical practice are, therefore, reported. RESULTS: The liner machining process took approximately 4 h. Fifteen minutes after donning the prosthesis, the skin temperature reached a plateau. Physical activity rapidly increased residuum skin temperatures, while cessation of activity caused a moderate decrease. Humidity increased throughout the observation period. In addition, the new liner showed better thermal properties with respect to the current liner solution (4% reduction in skin temperature). CONCLUSIONS: This work describes a personalised liner solution, with embedded temperature and humidity sensors, developed through an innovative approach. This new method allows for a range of sensors to be smoothly embedded into a liner, which is capable of measuring changes in intra-socket microclimate conditions, resulting in the design of advanced socket solutions personalised specifically for individual requirements. In future, this method will not only provide a personalised liner but will also enable dynamic assessment of how a residual limb behaves within the socket during daily activities.

Using Perforated Liners to Combat the Detrimental Effects of Excessive Sweating in Lower Limb Prosthesis Users.

BACKGROUND: Excessive sweating of the residual limb has a substantial effect on the daily activities of people with lower limb amputation. Prosthetic liners offer protection and comfort to sensitive areas but often exacerbate perspiration. They act as insulators, trapping sweat on the skin's surface to the detriment of skin health. Recently, liners with perforations have been developed, allowing the moisture to escape. The goal of this study was to assess the impact of such liners. METHODS: A sample group of 13 patients with unilateral transtibial amputation, who wore a perforated liner (PL) as part of their current prescription, was compared to 20 control patients who wore non-perforated liners (NPL). During their routine appointments, they completed a survey of scientifically validated outcome measures relating to their limb health, pain and the impact on daily life over a 12-month period. RESULTS: Patients using the PL had healthier residual limbs, reporting higher scores on questions relating to limb health, experiencing fewer skin issues (p<0.001) and estimating a 61.8% lower rating in perceived sweat (p=0.004). Perhaps consequentially, there was a lower incidence of residual (p=0.012) and phantom (p=0.001) limb pain when compared to the control group. The prevalence of individual issues affecting the residual limbs of PL users was also lower. Of the issues that remained, only 23% were attributed to sweating in PL users, compared to 49% for the NPL group (p=0.066). PL users missed fewer days of work in the year (2.4 vs 11.6, p=0.267) and were also limited on fewer days (1.4 vs 75.4, p=0.009). CONCLUSION: The use of perforated liners shows much promise within prosthetic care, significantly improving the health of the residual limb. The observed effects on perceived sweat reduction, residual skin health, pain levels and patient limitation suggest that perforated liners are highly beneficial to patients.

Prosthetic liner wear in total hip replacement: a longitudinal 13-year study with computed tomography.

This case report follows a woman who had a total hip replacement in 1992 when she was 45 years old. Six serial computed tomography (CT) examinations over a period of 13 years provided information that allowed her revision surgery to be limited to liner replacement as opposed to replacement of the entire prosthesis. Additionally, they provided data that ruled out the presence of osteolysis and indeed none was found at surgery. In 2004, when the first CT was performed, the 3D distance the femoral head had penetrated into the cup was determined to be 2.6 mm. By 2017, femoral head penetration had progressed to 5.0 mm. The extracted liner showed wear at the thinnest part to be 5.5 mm, as measured with a micrometer. The use of modern CT techniques can identify problems, while still correctable without major surgery. Furthermore, the ability of CT to assess the direction of wear revealed that the liner wear changed from the cranial to dorsal direction.

The evidence-base for elevated vacuum in lower limb prosthetics: Literature review and professional feedback.

BACKGROUND: An optimal suspension system can improve comfort and quality of life in people with limb loss. To guide practice on prosthetic vacuum suspension systems, assessment of the current evidence and professional opinion are required. METHODS: PubMed, Web of Science, and Google Scholar databases were explored to find related articles. Search terms were amputees, artificial limb, prosthetic suspension, prosthetic liner, vacuum, and prosthesis. The results were refined by vacuum socket or vacuum assisted suspension or sub-atmospheric suspension. Study design, research instrument, sample size, and outcome measures were reviewed. An online questionnaire was also designed and distributed worldwide among professionals and prosthetists (www.ispoint.org, OANDP-L, LinkedIn, personal email). FINDINGS: 26 articles were published from 2001 to March 2016. The number of participants averaged 7 (SD=4) for transtibial and 6 (SD=6) for transfemoral amputees. Most studies evaluated the short-term effects of vacuum systems by measuring stump volume changes, gait parameters, pistoning, interface pressures, satisfaction, balance, and wound healing. 155 professionals replied to the questionnaire and supported results from the literature. Elevated vacuum systems may have some advantages over the other suspension systems, but may not be appropriate for all people with limb loss. INTERPRETATION: Elevated vacuum suspension could improve comfort and quality of life for people with limb loss. However, future investigations with larger sample sizes are needed to provide strong statistical conclusions and to evaluate long-term effects of these systems.

Transtibial prosthesis suspension systems: systematic review of literature.

BACKGROUND: Today a number of prosthetic suspension systems are available for transtibial amputees. Consideration of an appropriate suspension system can ensure that amputee's functional needs are satisfied. The higher the insight to suspension systems, the easier would be the selection for prosthetists. This review attempted to find scientific evidence pertaining to various transtibial suspension systems to provide selection criteria for clinicians. METHODS: Databases of PubMed, Web of Science, and ScienceDirect were explored to find related articles. Search terms were as follows: "Transtibial prosthesis (32), prosthetic suspension (48), lower limb prosthesis (54), below-knee prosthesis (58), prosthetic liner (20), transtibial (193), and prosthetic socket (111)". Two reviewers separately examined the papers. Study design (case series of five or more subjects, retrospective or prospective), research instrument, sampling method, outcome measures and protocols were reviewed. FINDINGS: Based on the selection criteria, 22 articles (15 prospective studies, and 7 surveys) remained. Sweat control was found to be a major concern with the available suspension liners. Donning and doffing procedures for soft liners are also problematic for some users, particularly those with upper limb weakness. Moreover, the total surface bearing (TSB) socket with pin/lock system is favored by the majority of amputees. INTERPRETATION: In summary, no clinical evidence is available to suggest what kind of suspension system could have an influential effect as a "standard" system for all transtibial amputees. However, among various suspension systems for transtibial amputees, the Iceross system was favored by the majority of users in terms of function and comfort.